chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody, Therapy non-responder
Clinical narrative: received / Engerix in November 2019 / 2nd dose in December 2019 / dose of Engerix on 26May2020 / was not converting / titer testing / 20-JUL-2020; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 24-year-old female patient who received HBV (Engerix B) (batch number H2T35, expiry date 29th May 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Hepatitis B vaccine with an associated reaction of therapy non-responder (received 3 series (doses) in 1996, refer case US2021059726).   On 26th May 2020, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. In December 2019, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. In November 2019, the patient received the 1st dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 20th July 2020, 55 days after receiving Engerix B and Engerix B Pre-Filled Syringe Device, between 6 and 8 months after receiving Engerix B and Engerix B Pre-Filled Syringe Device and between 7 and 9 months after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: On 20th November 2019, the titer was tested, and the patient was found to be not converting. Since the patient was not converting, she then received 3 doses of Engerix B.  On 20th July 2020, the titer was again tested, and the patient was found to be not seroconverting The reporter consented to follow up. For tolerance of 3rd schedule refer case US2021AMR061704.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021059726:same reporter US-GLAXOSMITHKLINE-US2021AMR061704:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: horrible chills and shivering; This case was reported by a consumer and described the occurrence of chills in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21st March 2021, the patient received the 2nd dose of Shingles vaccine. On 21st March 2021, less than a day after receiving Shingles vaccine, the patient experienced chills. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the chills was unknown.   It was unknown if the reporter considered the chills to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination not reported. The age grp was selected as an adult.. The patient had horrible chills and shivering. Patient took advil so he/she could sleep last night and also took it again The advil helped so he/she was not in bed that day.  Patient  to make sure that there were no interaction with the shot and advil to lessen the side effects.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: developed a "chicken pox" rash all over her body /began on her back and progressed to trunk area and out, to hands and feet; This case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 20th November 2020, 31 days after receiving Shingrix, the patient experienced varicella-like rash. On an unknown date, the outcome of the varicella-like rash was recovered/resolved.   It was unknown if the reporter considered the varicella-like rash to be related to Shingrix.  Additional details were provided as follows: The patient got first dose of Shingrix vaccine and less than a month after that, the patient developed a chicken pox rash all over her body. The rash began on her back and progressed to trunk area and out, to hands and feet. The patient then stated, it gradually went away in a week. When asked if she had seen her provider and was diagnosed with chicken pox, the patient stated she had not seen her provider due to covid. The patient then clarified that she developed a rash that looked like chicken pox. The patient wanted to find out if anybody else had experienced a rash and if she should get the second dose. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site exfoliation, Injection site pain, Injection site pruritus
Clinical narrative: redness / at the injection site; area turned a brown color / There is still a slight brown discoloration at the site; skin sloughing off like that of a burn; excruciating pain when the vaccine was injected / felt like acid was being injected into her arm / soreness / at the injection site; itchiness at the injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 16th October 2020, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced injection site erythema, injection site discoloration, injection site itching and slough injection site. On 16th October 2020, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site itching and slough injection site were recovered/resolved and the outcome of the injection site discoloration was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site discoloration, injection site itching and slough injection site to be related to Shingrix.  Additional details were provided as follows: The case was reported by the nurse for herself.   The patient felt excruciating pain when Shingrix was being injected into the left arm. It felt like acid was being injected into her arm. The pain stopped after the needle was withdrawn.  There was soreness, redness and itchiness at the injection site. The soreness and redness lasted a few weeks but the itchiness last 4 months.  The area turned a brown color and the skin was sloughing off like that of a burn. There was still a slight brown discoloration at the site at the time of reporting. The reporter did not consent to follow up.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was patient's mother. The age at vaccination was not reported. The patient had arm soreness for two days after after receiving Bexsero. The reporter did not want to file report, hence information was very limited as she was reluctant to file report. The reporter did not consent to follow-up.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Ear pain, Feeding disorder, Injection site erythema, Injection site swelling
Clinical narrative: earache; slight lock jaw; pain; all over body weakness; redness and swelling that the injection site; swelling that the injection site; cannot eat; red line traveled from the injection site up his arm to a swollen lymph node on the left side; swollen lymph node; This case was reported by a consumer via call center representative and described the occurrence of weakness generalized in a 46-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3E52S, expiry date 21st June 2022) for prophylaxis.   On 18th March 2021, the patient received the 1st dose of Boostrix (intramuscular). In March 2021, less than a week after receiving Boostrix, the patient experienced unable to eat, erythema diffuse and enlargement of lymph nodes. On 18th March 2021, the patient experienced weakness generalized, injection site erythema, injection site swelling, lockjaw and pain. On 24th March 2021, the patient experienced ear pain. On an unknown date, the outcome of the weakness generalized, injection site erythema, injection site swelling and pain were recovering/resolving and the outcome of the ear pain and lockjaw were not recovered/not resolved and the outcome of the unable to eat, erythema diffuse and enlargement of lymph nodes were unknown.   It was unknown if the reporter considered the weakness generalized, injection site erythema, injection site swelling, ear pain, lockjaw, pain, unable to eat, erythema diffuse and enlargement of lymph nodes to be related to Boostrix.  Additional details were provided as follows: The reporter was the patient's wife.   The patient received Boostrix in the left arm and experienced all over body weakness and redness and swelling that the injection site.  The red line traveled from the injection site up and arm to a swollen lymph node on the left side.  The patient also had slight lock jaw.   The symptoms started to resolve but except for the lock jaw which had become more severe in the last 48 hours.  The patient cannot eat and presented earache. The batch number of Boostrix was reported as 3652S, it was corrected to 3E52S as per sales data sheet. The reporter consented to follow up.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy, Pain, Trismus
Clinical narrative: earache; slight lock jaw; pain; all over body weakness; redness and swelling that the injection site; swelling that the injection site; cannot eat; red line traveled from the injection site up his arm to a swollen lymph node on the left side; swollen lymph node; This case was reported by a consumer via call center representative and described the occurrence of weakness generalized in a 46-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3E52S, expiry date 21st June 2022) for prophylaxis.   On 18th March 2021, the patient received the 1st dose of Boostrix (intramuscular). In March 2021, less than a week after receiving Boostrix, the patient experienced unable to eat, erythema diffuse and enlargement of lymph nodes. On 18th March 2021, the patient experienced weakness generalized, injection site erythema, injection site swelling, lockjaw and pain. On 24th March 2021, the patient experienced ear pain. On an unknown date, the outcome of the weakness generalized, injection site erythema, injection site swelling and pain were recovering/resolving and the outcome of the ear pain and lockjaw were not recovered/not resolved and the outcome of the unable to eat, erythema diffuse and enlargement of lymph nodes were unknown.   It was unknown if the reporter considered the weakness generalized, injection site erythema, injection site swelling, ear pain, lockjaw, pain, unable to eat, erythema diffuse and enlargement of lymph nodes to be related to Boostrix.  Additional details were provided as follows: The reporter was the patient's wife.   The patient received Boostrix in the left arm and experienced all over body weakness and redness and swelling that the injection site.  The red line traveled from the injection site up and arm to a swollen lymph node on the left side.  The patient also had slight lock jaw.   The symptoms started to resolve but except for the lock jaw which had become more severe in the last 48 hours.  The patient cannot eat and presented earache. The batch number of Boostrix was reported as 3652S, it was corrected to 3E52S as per sales data sheet. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ulcerative keratitis
Clinical narrative: Corneal ulcer in her left eye; A spontaneous report was received from a  consumer concerning a 58-year-old, White female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced corneal ulcer in her left eye/ulcerative keratitis.  The patient's medical history, as provided by the reporter, included dry eye, kidney stones and osteoporosis. Concomitant medications reported included indapamide, alendronate sodium, ciclosporin.  On 9 Jan 2021, prior to the onset of the events, the patient received their dose of mRNA-1273 (Batch Number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Treatment details included erythromycin and desivance eye drops.  On 9 Jan 2021, at noon the patient experienced a corneal ulcer in her left eye a medically significant event.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event corneal ulcer in her left eye was not reported.; Reporter's Comments: This case concerns a 58-year-old, White female patient, who experienced ulcerative keratitis in her left eye, the day the first dose of mRNA-1273 was received. Very limited information regarding this event/s has been provided at this time.  Further information has been requested. The patient's medical history of dry eyes remains a confounder.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Injection site pain, Mental impairment
Clinical narrative: trouble thinking clearly; headache; funny feeling at top of head/foggy feeling; fatigue; nausea; soreness in injection arm; A spontaneous report was received from a (Consumer) concerning a 77 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced had trouble thinking clearly, headache, funny feeling around top of head,foggy feeling, fatigue, nausea, and soreness in her injection arm.   The patient's medical history was not provided however patient experienced nausea and fatigue on and off since their initial onsets.   Other relevant concomitant medications were reported as Zinc and echinacea supplements, Vitamin C, Vitamin B and C supplements and baby aspirin.   On 28 Jan 2021, patient received their first of two planned doses of mRNA-1273 (lot/batch: 025J202A) unknown route and site for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced foggy feeling, had trouble thinking clearly, headache, funny feeling around top of head, fatigue, nausea, and soreness in her injection arm. Laboratory details not provided. Treatment included as ginger ale.  Action taken with mRNA-1273 in response to the events was not reported.  On 30 Jan 2021, the outcome of the events, Headache, foggy feeling,  trouble thinking and soreness in injection arm were resolved.   At the time of this report, the outcome of the events, nausea and fatigue were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: trouble thinking clearly; headache; funny feeling at top of head/foggy feeling; fatigue; nausea; soreness in injection arm; A spontaneous report was received from a (Consumer) concerning a 77 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced had trouble thinking clearly, headache, funny feeling around top of head,foggy feeling, fatigue, nausea, and soreness in her injection arm.   The patient's medical history was not provided however patient experienced nausea and fatigue on and off since their initial onsets.   Other relevant concomitant medications were reported as Zinc and echinacea supplements, Vitamin C, Vitamin B and C supplements and baby aspirin.   On 28 Jan 2021, patient received their first of two planned doses of mRNA-1273 (lot/batch: 025J202A) unknown route and site for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced foggy feeling, had trouble thinking clearly, headache, funny feeling around top of head, fatigue, nausea, and soreness in her injection arm. Laboratory details not provided. Treatment included as ginger ale.  Action taken with mRNA-1273 in response to the events was not reported.  On 30 Jan 2021, the outcome of the events, Headache, foggy feeling,  trouble thinking and soreness in injection arm were resolved.   At the time of this report, the outcome of the events, nausea and fatigue were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Encephalitis allergic, Influenza like illness, Nightmare, Paranoia
Clinical narrative: Mildly paranoid; Mild tremor; Slight balance problems; Allergic to encephalitis; Flu like symptoms that were mild in feeling; Night mares; A spontaneous report (United States) was received from a 75-years-old male Healthcare Professional who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events allergic encephalitis, flu like symptoms, nightmares, mild tremors, paranoia, and slight balance problems.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, at 11:00 am, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On an unknown date in Jan 2021, the patient developed events, mild flu like symptoms and nightmares. On 29 Jan 2021, the patient experienced the events mild tremorsr and paranoia. On an unknown date, the patient felt that he had allergic encephalitis and had slight balance problems. On an unknown date, when the patient woke up in the morning, he became paranoid and trimmer increased. The event allergic to encephalitis was considered as medically significant.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, flu like symptoms, night mares, mild trimmer, paranoia, allergic to encephalitis and slight balance problems was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Mildly paranoid; Mild tremor; Slight balance problems; Allergic to encephalitis; Flu like symptoms that were mild in feeling; Night mares; A spontaneous report (United States) was received from a 75-years-old male Healthcare Professional who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events allergic encephalitis, flu like symptoms, nightmares, mild tremors, paranoia, and slight balance problems.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, at 11:00 am, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On an unknown date in Jan 2021, the patient developed events, mild flu like symptoms and nightmares. On 29 Jan 2021, the patient experienced the events mild tremorsr and paranoia. On an unknown date, the patient felt that he had allergic encephalitis and had slight balance problems. On an unknown date, when the patient woke up in the morning, he became paranoid and trimmer increased. The event allergic to encephalitis was considered as medically significant.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, flu like symptoms, night mares, mild trimmer, paranoia, allergic to encephalitis and slight balance problems was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: every time I got a flu shot I got sick; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional via social media (comment ID: 623369078341234).  This case involves an adult patient who experienced every time I got a flu shot I got sick (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious every time I got a flu shot I got sick (illness) Unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information on batch number for this case.
Age: 1.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, MMRV, VARCEL
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: Quadracel by mistake in the right thigh, Instead, the patient should have received hepatitis A, and separate vaccines for MMR and varicella/no AE; 12 months old patient received Quadracel/no AE; Initial information was received on 18-Mar-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 12-month-old male patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL]  (lot C5763AA, expiry date not reported) via an intramuscular route in the right thigh and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD), by mistake instead, the patient should have received HEPATITIS A VACCINE (HEPATITIS A) and separate vaccines for MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE [VARICELLA] (lot number, expiry date route and site were unknown) for prophylactic vaccination on 01-Mar-2021 (wrong product administered) and (Product administered to patient of inappropriate age).   Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  This was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Oropharyngeal discomfort, Skin burning sensation
Clinical narrative: About 45 minutes post vaccine my chest, neck, and face started to turn bright red and I had a horrible burning sensation as well as a scratchy throat.  I went to a walk in minor care clinic and they gave me a steroid shot.  The following day around 11:00 am the reaction spiked again and I went to the ER.  While at the ER they gave me more steroids, benadryl, and pepcid and observed the reaction for a couple hours.  The redness got better and the burning subsided but my skin was still a pinkish tone.  Today, the third day, I have a tingling feeling in my skin where the reactions occurred and they are bright pink.  I am on oral steroids and pepcid for a week.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Thrombosis
Clinical narrative: Blood clots in lungs
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: pt was vomiting , pt was on the floor, she called the ems twice. second time was taken to the hospital.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hyperhidrosis, Nausea, Wheezing
Clinical narrative: While in her 15 min. observation she became diaphoretic, nauseous, notable wheezes.  Stated she was having a difficult time breathing.  Pt. was given 1 dose of epi.  Has a hx of COPD and had her albuterol inhaler with her.  She took 2 puffs.  EMS was notified and transported pt. to ER.  2:20PM O2 sat 97% HR 110 BP 148/112.  2:25PM O2 sat 96% HR 110 BP 200/120.  2:32PM EMS arrived and transported pt. to ER. Pt. appeared less diaphoretic and breathing was less labored when EMS arrived.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Chills, fever, body flu like aches
Age: 0.75
Sex: M
Vaccine: FLU4
Symptoms: Full blood count normal, Metabolic function test, Pyrexia, Respiratory viral panel
Clinical narrative: The patient received the flu shot on 3/22/21, developed a high fever of 104F in the evening and continued to have high fever of 104F through 3/24/21. On 3/24/21, the patient developed complex febrile seizure. No other signs of infection. Unremarkable CBC and BMP.  Negative Respiratory Viral Panel.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hot flush, Insomnia, Pyrexia
Clinical narrative: Fever lasted for 24 hours, experienced chills and hot flashes, trouble sleeping, pain in joints (specifically ankles)
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Body temperature decreased, Dizziness, Heart rate abnormal, Intensive care
Clinical narrative: The first injection was uneventful. 30 hours after the second injection, respectively, patient suddenly became dizzy. VS assessed.  BP 90s/40s, which is abnormal for her, HR 30's which is abnormal, and temperature 95.1 orally. She became lethargic. EMS called and confirmed the same VS. Atropine give three times according to protocol without change in HR. Epinephrine dose given with some improvement in HR, but unable to sustain. Pt transported via EMS to Hospital where she was warmed mechanically, started on an IV epinephrine drip and transported to the cardiac ICU where she was monitored for 2 days. Clinically the patient improved after her body temperature normalized.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Lethargy
Clinical narrative: The first injection was uneventful. 30 hours after the second injection, respectively, patient suddenly became dizzy. VS assessed.  BP 90s/40s, which is abnormal for her, HR 30's which is abnormal, and temperature 95.1 orally. She became lethargic. EMS called and confirmed the same VS. Atropine give three times according to protocol without change in HR. Epinephrine dose given with some improvement in HR, but unable to sustain. Pt transported via EMS to Hospital where she was warmed mechanically, started on an IV epinephrine drip and transported to the cardiac ICU where she was monitored for 2 days. Clinically the patient improved after her body temperature normalized.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: 7 days after the vaccination a small red, itchy rash appeared at the injection site.  It?s gradually spreading down and under my left arm.  It?s very red,  itchy,  hard to the touch and blistering.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: 7 days after the vaccination a small red, itchy rash appeared at the injection site.  It?s gradually spreading down and under my left arm.  It?s very red,  itchy,  hard to the touch and blistering.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fear of injection, Immediate post-injection reaction
Clinical narrative: Immediately after getting the vaccination, he had a recurrence of his panic attack. He does have an aversion to needles.  Taken to a private area of the arena and monitored.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Hospitalization within 6 weeks after receiving vaccine
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Debilitating headache and nausea. In bed, eyes closed, in a dark room for 24 hours.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Eye pain, Eye pruritus, Eyelid oedema, Fatigue
Clinical narrative: Initially very mild muscle aches and fatigue. 3 to 4 days later there was weight gain of 3 pounds and edema most obvious to the upper eyelids. This worsened with itching and pain to eyes. Additionally I had difficulty focusing my mind and a general feeling of being ?unwell?.  Benadryl 60 mg reduced the eye discomfort.  Contacted providers? office, but have not heard back.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Ocular discomfort, Weight increased
Clinical narrative: Initially very mild muscle aches and fatigue. 3 to 4 days later there was weight gain of 3 pounds and edema most obvious to the upper eyelids. This worsened with itching and pain to eyes. Additionally I had difficulty focusing my mind and a general feeling of being ?unwell?.  Benadryl 60 mg reduced the eye discomfort.  Contacted providers? office, but have not heard back.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival bleeding, Pain
Clinical narrative: Body aches low fever boil on gums
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia, Syncope
Clinical narrative: Dizziness starting around 8:30 PM, fever from 10 PM to sometime after 3 AM, syncope x2 around 8:30 AM
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pruritus, Urticaria
Clinical narrative: Hives on the face cheek, body itch, dissiness.  I took benadryl 25mg Po, checked my Blood pressure 99/60 pulse 68, blood sugar lvls 87mg/dl
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Injection site erythema, Injection site swelling
Clinical narrative: Injection site redness and swelling that occurred days after the vaccine. Bell palsy that developed approximately 5 days after receiving the vaccine.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring normal, Chest discomfort, Dizziness, Dyspnoea, Nausea
Clinical narrative: 3-24-21 7:06PM PT STATES 'CHEST TIGHT/PRESSURE, SOB, NAUSEA & LIGHT HEADED'.  A/O, W/D, RESP REG WITH EASE. NO DIFFICULTY SWALLOWING. NO ACUTE/OBVIOUS DISTRESS. 7:15 AMBU TO BATHROOM.  7:26PM STATES SHE 'FEELS BETTER AND OK TO GO HOME'. AMBULATORY TO EXIT - GAIT BRISK AND STEADY. RESP REG WITH EASE. NO DISTRESS NOTED. 3-25-21 8:15 TC: PT STATES SHE IS 'ALL BETTER TODAY'.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Hypoaesthesia oral, Lymphadenopathy
Clinical narrative: Dizziness within the first 15 minutes. Tongue numb and sense of taste affected (this went away after an hour). Left arm very sore and swollen for 3 days. Swollen glands in armpit and neck on left side. Sever fatigue that has waxed and waned for three days. Chills and muscle aches the first two days. Severe vertigo that comes and goes and is ongoing. Have been taking Motrin for aches.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Peripheral swelling, Taste disorder, Vertigo
Clinical narrative: Dizziness within the first 15 minutes. Tongue numb and sense of taste affected (this went away after an hour). Left arm very sore and swollen for 3 days. Swollen glands in armpit and neck on left side. Sever fatigue that has waxed and waned for three days. Chills and muscle aches the first two days. Severe vertigo that comes and goes and is ongoing. Have been taking Motrin for aches.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia, Urticaria, Vision blurred
Clinical narrative: Light headed and some blurred vision 20 minutes after shot that lasted just a few minutes then some tingling in left leg and then started to notice hives on my hands and body, also had welts on my stomach after arriving at home. all of these events took place within the first hour. now several days later I still have the hives and non stop itching even in places that I dont have hives. my over all skin on my body just feels itchy
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Paraesthesia, Throat tightness
Clinical narrative: I started to feel tingling in my right arm and right hand at 3:45pm.  Shortly after, I began to feel like I was having trouble swallowing.   I immediately took 2 Benadryl tablets.  I called my best friend who is a nurse and is volunteering at Covid Vaccine sites.  She advised me to go park outside my local urgent care in case my symptoms worsened and I needed quick access to an epi-pen, etc.  I drove to the Urgent Care.  I continued to feel that my throat was constricted and could only swallow if I was drinking water through a straw.  I could not swallow on demmand.  I sat outside urgent care for an hour and my symtoms stayed the same for 35 min and then by 60 minutes I felt much better and could swallow without drinking water.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Induration, Mass, Pain in extremity
Clinical narrative: 20 hours after Pfizer immunization C/O left hand pain with dime size hard lump located on palm of hand.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Blood creatine phosphokinase normal, Blood test normal, Chest pain, Dizziness
Clinical narrative: Flash of light and heat from head to toe 10 minutes after 1st dose.  Numbness and tingling on face lips and tongue 60 minutes after 1st dose.  Premedicated with Pepcid 20 mg and Benadryl 50mg 1 hour prior to 2nd vaccination with no adverse reactions occurring. Presented with popping, in ears, eye  blurriness, numbness on face and head, swollen glands on bilateral neck, burning in chest happening in waves  2 -3weeks after 2 nd dose.   Normal CPK, CBC and CMP results.   2/4/2021 episodes of heat throughout body, questionable palpitations, headaches, blurry vision, numbness on head and face, feeling faint and unbalanced during episodes. - comes in waves. Electric shocked under skin all over body and once in Bihar eyes. Normal brain MRI and follow up bloodwork. Visits to neurologist, GYN and ophthalmologist.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Electric shock sensation, Feeling hot, Full blood count normal, Headache
Clinical narrative: Flash of light and heat from head to toe 10 minutes after 1st dose.  Numbness and tingling on face lips and tongue 60 minutes after 1st dose.  Premedicated with Pepcid 20 mg and Benadryl 50mg 1 hour prior to 2nd vaccination with no adverse reactions occurring. Presented with popping, in ears, eye  blurriness, numbness on face and head, swollen glands on bilateral neck, burning in chest happening in waves  2 -3weeks after 2 nd dose.   Normal CPK, CBC and CMP results.   2/4/2021 episodes of heat throughout body, questionable palpitations, headaches, blurry vision, numbness on head and face, feeling faint and unbalanced during episodes. - comes in waves. Electric shocked under skin all over body and once in Bihar eyes. Normal brain MRI and follow up bloodwork. Visits to neurologist, GYN and ophthalmologist.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hot flush, Hypoaesthesia, Hypoaesthesia oral, Lymphadenopathy, Magnetic resonance imaging head normal
Clinical narrative: Flash of light and heat from head to toe 10 minutes after 1st dose.  Numbness and tingling on face lips and tongue 60 minutes after 1st dose.  Premedicated with Pepcid 20 mg and Benadryl 50mg 1 hour prior to 2nd vaccination with no adverse reactions occurring. Presented with popping, in ears, eye  blurriness, numbness on face and head, swollen glands on bilateral neck, burning in chest happening in waves  2 -3weeks after 2 nd dose.   Normal CPK, CBC and CMP results.   2/4/2021 episodes of heat throughout body, questionable palpitations, headaches, blurry vision, numbness on head and face, feeling faint and unbalanced during episodes. - comes in waves. Electric shocked under skin all over body and once in Bihar eyes. Normal brain MRI and follow up bloodwork. Visits to neurologist, GYN and ophthalmologist.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Paraesthesia oral, Photopsia, Vision blurred
Clinical narrative: Flash of light and heat from head to toe 10 minutes after 1st dose.  Numbness and tingling on face lips and tongue 60 minutes after 1st dose.  Premedicated with Pepcid 20 mg and Benadryl 50mg 1 hour prior to 2nd vaccination with no adverse reactions occurring. Presented with popping, in ears, eye  blurriness, numbness on face and head, swollen glands on bilateral neck, burning in chest happening in waves  2 -3weeks after 2 nd dose.   Normal CPK, CBC and CMP results.   2/4/2021 episodes of heat throughout body, questionable palpitations, headaches, blurry vision, numbness on head and face, feeling faint and unbalanced during episodes. - comes in waves. Electric shocked under skin all over body and once in Bihar eyes. Normal brain MRI and follow up bloodwork. Visits to neurologist, GYN and ophthalmologist.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: patient was inadvertantly scheduled self on our online system for a second dose of vaccine on our pfizer clinic. Volunteer administered vaccine prior to looking at patients card to realize that patient had received Moderna from faciliity for his first dose. Pfizer was administered in left deltoid. Patient was advised of medication error and advised to monitor symptoms over the next several day. Pt was given Director of Nursing's cell phone number and asked to call with any concerns. Contacted department of health and advised of error. Patient was advised that he does not need to repeat this dose. Currently patient is not exhibiting any adverse symptoms.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Immediately after the shot and for up to four days after:  Swelling, fever in the injection area, a hard knot at the injection site, pain in and around the injection site area  Seven days after the injection:  Increased swelling, itching, fever in the injection area, a very large hard knot at and around the injection site, pronounced pain in and around the injection site area
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Heart rate increased, Hypoaesthesia, Paraesthesia oral, Skin warm
Clinical narrative: On same side as vaccination I experienced burning knuckles on middle finger and ring finger, warmth on side of neck, the cheek on the left side of my face was numb, my lips tingled, and my heart rate increased to 105 bpm. The facial numbness went away after a few hours and felt like I had received Novicane for dental work. The burning knuckles took 8 days to go away. I called my doctor's office and spoke to the on call nurse who said the reaction was likely due to the vaccine.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Ten hours after vaccination I went into convulsions lasting eight hours. Horrible experience!
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Ultrasound scan
Clinical narrative: Large swollen, tender lymph node in Right axilla 6 days after first shot  2/2/21 confirmed by ultrasound 2/9 second shot, in opposite arm, no adverse events, but right axilla lymph node still large and swollen
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Injection site rash, Nausea, Palpitations
Clinical narrative: Dizziness, nausea, headache - 5 hours post injection rash on injection arm - 24 hours post injection heart palpitations - 24 - 48 hours post injection
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever chills body aches headache
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Injection site pain
Clinical narrative: Diarrhea / abdominal pain, beginning ~36 hours post-vaccination Injection site pain, beginning within a few hours, lasting a few days
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Headache, Tinnitus
Clinical narrative: Constant pressure headache in front of head, tinnitus and anxiety that still has not resolved 4+ weeks after first shot. Anxiety is similar to GAD/Panic Disorder, which was previously controlled with Zoloft (since discontinued). Vaccine caused resurgence of anxiety/panic. Headache does not respond to any of the following: aspirin, Tylenol, Advil, Aleve or any combination thereof.  Neurologist prescribed gabapentin and fioricet. Acupuncture for temporary symptom relief.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Vaccine positive rechallenge
Clinical narrative: Patient c/o generalize weakness.  Pt verbalized that she had the same reaction with first dose.  Pt. seen and assessed by EMT and assessments are as follows: BP 113/79, HR 79, O2 100%, BS 109.  17 minutes into observation client voiced that she had felt better and was cleared to go home by EMT..  Client advised to seek medical attentions if symptoms worsen.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Raised red rash on torso, back, buttox, legs, and arms. Went to the doctor - told it looked like an allergic reaction to the vaccine.  Given 5 day round of prednisone and told to take antihistamine.  Rash has stopped spreading and is beginning to clear. No previous reaction to any vaccination.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Insomnia, Nausea
Clinical narrative: Nausea Feeling sick to the stomach Sleeplessness
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: 11 days following injection?itching arm
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Pain
Clinical narrative: Weakness, dizziness, headache, body aches
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling of eyelid, Swollen tongue
Clinical narrative: Patient stated her tongue, lips and eye lids were swelling.  Patient had children's liquid Benadryl with her and immediate started drinking the Benadryl.  Patient was assessed by the NP and also by her PCP while in the office.  Patient was advised that she needed to go to the ER via ambulance, she refused. She was observed for an additional 30 min. with no further symptoms. Vitals were taken again before she left the office.  Patient was contacted again via phone at 3:00 pm to check on her, she stated she was home and doing well. She contacted the after hours service at 6:37pm stating she was continuing to have swelling when the Benadryl wears off.  Patient was advised by the after hours provider to go directly to the ER and explained the risk of airway swelling during the night. Pt. verbalized understanding.  Pt. was seen in the ER on 3/26/21 in the ER for allergic reaction was discharged the same day with instructions to follow up with her PCP.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Lethargy, Pyrexia
Clinical narrative: Fever , sleeplessness, overall lethargic
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient did not suffer any adverse reaction.  Patient was below the age limit of Moderna vaccine.  Patient is 17 years and 8 months old, will be turning 18 in June of 2021
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Moderate muscle/Joint aches lasted approximately 24 hours. Treated with NSAIDs.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Goitre, Hyperthyroidism, Myalgia
Clinical narrative: Immediately developed soar arm, chills, swollen arm, fever, night sweats, body aches, tachycardia.  I have never missed a day of work in 22 years, I kept going to work and it eventually kept getting worse and made a appointment with my PCP. Over the two weeks my thyroid became swollen, every muscle in my body was hurting and had bad neck pain and my thyroid was swollen.  I went to get Blood work that my PCP ordered and it came back having Hyperthyroidism. She told me to see an Endocrinologist. I have seen the Endocrinologist twice and  have blood work again and said I was in with Hyperthyroidism and started 6 weeks of prednisone.  I still feel terrible.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Night sweats, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Immediately developed soar arm, chills, swollen arm, fever, night sweats, body aches, tachycardia.  I have never missed a day of work in 22 years, I kept going to work and it eventually kept getting worse and made a appointment with my PCP. Over the two weeks my thyroid became swollen, every muscle in my body was hurting and had bad neck pain and my thyroid was swollen.  I went to get Blood work that my PCP ordered and it came back having Hyperthyroidism. She told me to see an Endocrinologist. I have seen the Endocrinologist twice and  have blood work again and said I was in with Hyperthyroidism and started 6 weeks of prednisone.  I still feel terrible.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia
Clinical narrative: Immediately developed soar arm, chills, swollen arm, fever, night sweats, body aches, tachycardia.  I have never missed a day of work in 22 years, I kept going to work and it eventually kept getting worse and made a appointment with my PCP. Over the two weeks my thyroid became swollen, every muscle in my body was hurting and had bad neck pain and my thyroid was swollen.  I went to get Blood work that my PCP ordered and it came back having Hyperthyroidism. She told me to see an Endocrinologist. I have seen the Endocrinologist twice and  have blood work again and said I was in with Hyperthyroidism and started 6 weeks of prednisone.  I still feel terrible.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Hospitalization within 6 weeks after receiving vaccine
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Erythema, Rash
Clinical narrative: 3-25-21 @ 2:30PM PT STATES SHE HAD 'HIVES AND RASH TO CHEST, ARMS AND LEGS  THAT STARTED ON 3-14-21' NO SOB, NO DYSPNEA. STATED SHE' WENT TO HOME TOWN URGENT CARE AND MISSED WORK AND WAS UNABLE TO GIVE PLASM'. PT VERY ANGRY AND STATES IT IS 'COSTING HER MONEY!'. AS OF TODAY THE HIVES ARE GONE AND SHE STILL HAS SOME REDNESS AND RASH TO BOTH ARMS AND CHEST.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Hypoaesthesia, Nail discolouration, Pain in extremity, Paraesthesia
Clinical narrative: Within a few days of the first vaccine, patient experienced pain, numbness, and tingling in his toes L>R. After this, the pain diminished, but he noticed swelling and redness in his toes. Over the next few weeks, he noticed black patches on the toes. Now, he is noticing darkening/bruising on the toe nails