chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dermatomyositis, Headache
Clinical narrative: Dermatomyositis rash flare up/ facial skin inflamed, bright red, and swollen; rash on her face; Dermatomyositis rash flare up/ facial skin inflamed, bright red, and swollen; rash on her face; headache; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL9265, expiration date: May2021) via unspecified route of administration in the left arm on 16Feb2021 14:00 at single dose for COVID-19 immunization. Medical history included dermatomyositis since 1993 and sinus problems (sinus disorder). Concomitant medications included immunoglobulin human normal (GAMUNEX) and methotrexate 2.5 mg tablets, both for dermatomyositis; and diphenhydramine hydrochloride (BENADRYL 50 mg) IV as premedication. It was reported that every 2 weeks, a nurse comes to her home and gives her a Gamunex 85gram infusion. She clarified she use 4-Gamunex 20gram vials, and 1 Gamunex 5gram vial to make up her Gamunex 85gram infusion. Product information: Gamunex 5gram Vial (uses 1 vial) (NDC Number: 13533-800-20, Lot Number: B36JE00393, Expiration Date: 20Jul2023) and Gamunex 20gram Vial (uses 4 vials) (NDC Number: 13533-800-24, Lot Number: B8GLE00933, Expiration Date: Aug2023). Reported she takes Methotrexate 2.5mg tablets three times a week. She stated she gets pre-medicated every 2 weeks with IV Benadryl prior to her Gamunex 85gram infusion. She provided the IV Benadryl 50mg product vial information as: (NDC Number: 0641-0376-21, Lot Number: 080010, Expiration Date: Aug2022). The patient previously took budesonide 3 mg capsule (taper dose) from 18Nov2020 to 13Feb2021 for microscopic colitis. On 16Feb2021, on the first day after vaccination, patient had a mild headache. The patient woke up on Saturday morning, 20Feb2021, with her facial skin inflamed, bright red, and swollen. She had a rash on her face as she could feel the unevenness of her facial skin when she placed her hand on her face. Patient reported that she called her neurologist to inform her of the adverse reaction, and her neurologist told her to report the reaction to manufacturer. She said what she experienced on Saturday (20Feb2021) was a Dermatomyositis rash flare up, which for her is very rare. She said she normally doesn't have any skin involvement when she has a Dermatomyositis flare. As a treatment, she said she took generic diphenhydramine 25 mg on 20Feb2021 (lot number: Lot Number: P112026, Expiration Date: Sep2020); and took 2 more since then (She said she takes 1 Diphenhydramine 25mg at a time); and her facial redness is down, but she still has a rash, and her face is a little bit swollen. Her facial skin was still elevated a little bit. Her facial swelling has improved quite a bit from Saturday (20Feb2021), stated she does not have any swelling around her eyes now. She said her facial skin is not as red as it was on Saturday. Outcome of the event headache was recovered on unspecified date in Feb2021; while dermatomyositis rash flare up was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: lost of her hearing in her right ear; had a "budding sound like a bee" in her ears.; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no. and expiry date were not reported), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date in Jan2021 (reported as a couple hours or the day after the injection), the patient couldn't hear from both ears and had a "budding sound like a bee" in her ears. She specified it only persisted in her right ear and they are concerned that she will permanently lose her earing. The patient consulted an audiologist who said she has a "lost of her hearing in her right ear" after vaccination. She added she also went to the urgent care twice and once to the ER. The patient decided not to take the second dose of the vaccine. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Dry eye, Facial paralysis, Fatigue, Headache
Clinical narrative: facial drooped right side of face; headache; dry eye, right side; cannot taste anything; tired; This is a spontaneous report from a contactable consumer reported for self. This 73-year-old male received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el9269), via an unspecified route of administration, left arm on 10Feb2021 12:45 at single dose for COVID-19 immunisation. Medical history was none. No covid prior vaccination. No known allergies. Concomitant medications included Pantoprazole and Lisinopril. No other vaccine in four weeks. He experienced facial drooped right side of face; dry eye, right side; cannot taste anything; tired; headache on 13Feb2021 10:00 AM. Ae resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No covid tested post vaccination. No treatments were received. Outcome of the events were not recovered.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Disease recurrence
Clinical narrative: my AFib kicked in and lasted for over a week; my AFib kicked in and lasted for over a week; This is a spontaneous report from a contactable consumer. A 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL9269), via an unspecified route of administration from 08Feb2021 08:15 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on 21Jan2021 06:45 AM (also at age of 83 years old) on left arm for covid-19 immunization with lot number EK9231. The facility type vaccine was hospital. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included atrial fibrillation from an unknown date. Concomitant medication included apixaban (ELIQUIS). After the second dose, on 08Feb2021 08:45 AM, patient's AFib kicked in and lasted for over a week. Patient didn't received treatment for the event. The outcome of event was recovering.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Heart rate, Meniere's disease
Clinical narrative: my AFib kicked in and lasted for over a week; my AFib kicked in and lasted for over a week; This is a spontaneous report from a contactable consumer. A 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL9269), via an unspecified route of administration from 08Feb2021 08:15 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on 21Jan2021 06:45 AM (also at age of 83 years old) on left arm for covid-19 immunization with lot number EK9231. The facility type vaccine was hospital. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included atrial fibrillation from an unknown date. Concomitant medication included apixaban (ELIQUIS). After the second dose, on 08Feb2021 08:45 AM, patient's AFib kicked in and lasted for over a week. Patient didn't received treatment for the event. The outcome of event was recovering.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Gallbladder disorder
Clinical narrative: gall bladder issues; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient experienced gall bladder issues on an unspecified date. Consumer is reporting about the Pfizer COVID-19 vaccine on behalf of her father in law, who got his first dose of the vaccine at the health department in (name), and was due to get his second dose on 08Feb2021, but he was in the hospital for like a week and a half. She says after he got out of the hospital they contacted the health department but they said they were only getting Moderna right now and he can't get Pfizer vaccine at that site. She says they have contacted different pharmacies and health care providers but they are not getting anywhere, and he needs to get back to get his second dose but they can't find Pfizer vaccine to get. Reporter clarified that her father in law got his first dose of the vaccine on 18Jan2021, and was due for his second on 08Feb2021, but he was hospitalized. Caller says that her father in law's hospitalization is not related to COVID-19, he had gall bladder issues and was recovering.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: almost died from the vaccine; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter made the comment that a Rheumatoid Arthritis doctor at Native (ANMC), who is also one of the caller's friends, almost died from the first vaccine. She was hospitalized. The reporter thought maybe she should call this person to see what she had to say, but the person didn't answer. She mentioned she spoke with the person's husband and was told she would not be receiving the second shot because the first one was so traumatic. She is sure this person has already completed a report, she is sure she has done all the right stuff. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity, Myelitis transverse
Clinical narrative: Guillain-Barre Syndrome; allergic type of reaction; He has been given shingles, pneumonia an flu vaccines and this [transverse myelitis] happened several years after the swine flu.; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported as age: 71; unit: unknown) received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (tradename unspecified, solution for injection in pre-filled syringe, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history included swine flu. Concomitant medications included swine flu shot, and shingles vaccine. Patient was calling to see if he is a candidate for the Covid vaccine. He stated that he has heard of a number of cases transverse myelitis that happened after a vaccine. He stated he heard that it can be considered that transverse myelitis may have been from a vaccine but he doesn't believe that to be true. He has been given shingles (vaccine), pneumonia flu vaccines and this [transverse myelitis] happened several years after the swine flu; maybe it laid dormant and then reacted but he has been iffy of this as a possible answer. His wife seemed to think he received a flu shot prior to getting this diagnosis. The shot [flu vaccine] he remembered having was close to a year prior to this. It was a good distance of time before this diagnosis and he had no symptoms at least a year post vaccination. His wife seemed to think it was correlated but he did not. He can never receive a flu shot again because originally he was diagnosed with Guillain-Barre Syndrome on an unknown date and then later it was changed to transverse myelitis (1997). He stated it seemed to be more anomalous, a very fine number that had contracted GBS from the swine flu shot but "they" had to post it and that was why he cannot get a flu shot. He stated he supposed this reaction would be considered an allergic type of reaction (date unknown) . He asked if there was any data on this and asked on the way this vaccine was developed different from the flu shot. He asked why he can get a shingles shot and not this (covid vaccine). He stated he only has mild flu like symptoms with the shingles vaccine. He asked if this covid vaccine structured the same way as the flu shot. He stated understanding this was beyond his understanding. It was explained that agent was unbale to compare the ingredients/chemical structure of the flu shot or shingles shot with this Covid vaccine and was provided with instructions on how to access the prescribing information so that he can have more information about the ingredients and chemical structure and other details he may be interested in writing and can compare it with other vaccines he is interested in looking into. Patient was referred to HCP to assist with this comparison. The outcome of the events Guillain-Barre Syndrome, transverse myelitis and allergic type of reaction was unknown.   Information on Lot/Batch number has been requested.
Sex: U
Vaccine: FLUX
Symptoms: Coronavirus infection, Feeling abnormal
Clinical narrative: feeling bad; Covid; Initial information received on 27-Feb-2021 regarding an unsolicited valid serious case received from a consumer via media.  This case involves patient (unknown demographics) who experienced feeling bad (feeling abnormal) and Coronavirus Disease (COVID-19), while he/she received vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  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 (afternoon), the patient developed a serious feeling bad (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  On an unknown date, the patient developed a serious about a week later was in the hospital with Coronavirus Disease (COVID-19), (unknown latency) following the administration of INFLUENZA VACCINE. Eight days in the hospital and another couple weeks on oxygen at home.   It was also reported that Product name: Product name was not provided. Since this is a post on the Sanofi flu shot we are assuming the consumer is referring to the Sanofi flu vaccine. It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  Information on the batch number was requested.; Sender's Comments: This case involves patient (unknown demographics) who had feeling abnormal and COVID-19, after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLU3
Symptoms: Allergy to vaccine, Skin test positive
Clinical narrative: Allergic to the vaccine; This spontaneous case was received on 07-Jan-2021 from pharmacist via Med Communications (reference number: SEQW21-00085) and concerned a female patient of an unreported age.  The patient's medical history and concomitant medications were not reported.  On 15-Sep-2010, the patient was vaccinated with Fluvirin (inactivated influenza virus surface antigen (subunit), egg-derived, influenza vaccine; dose, route of administration, anatomical location: not reported) for influenza prophylaxis. The batch number reported was 111798PI and expiry date was 31-Mar-2011.  On an unspecified date, unknown amount of time after receiving Fluvirin, the patient followed up with a skin test, on which she reacted. The patient was allergic to the vaccine.  On an unspecified date in 2011, the patient saw an allergist.  The outcome of the event was not reported.  The reporter assessed the event to be releted to Fluvirin. The reporter stated that the patient was allergic to the vaccine.  The case was assessed as non-serious.  This case is linked to 202100271 due the same patient.  Company Comment: The event is considered as related to Fluvirin.; Reporter's Comments: The reporter stated that the patient was allergic to the vaccine.; Sender's Comments: The event is considered as related to Fluvirin.
Sex: F
Vaccine: FLU3
Symptoms: Allergy to vaccine, Skin test positive
Clinical narrative: Allergic to it as well; This spontaneous case from was received on 07-Jan-2021 from pharmacist via Med Communications (reference number: SEQW21-00095) and concerned a female patient of an unreported age.  The patient's past vaccination included Fluvirin ((inactivated influenza virus surface antigen (subunit), egg-derived, influenza vaccine) on 15-Sep-2010 after which the patient follow up skin test, which reacted to it and the patient was allergic to the vaccine. The patient's concomitant medications and medical history were not reported.  On an unspecified date in 2011, the patient was vaccinated with Fluvirin (dose, route of administration, anatomical location: not reported) for influenza prophylaxis. The batch number reported was 11035PA and expiry date was Apr-2020.  On an unspecified date in 2011, unknown amount of time after receiving Fluvirin, the patient performed a second skin test, which resulted positive. She was allergic to it as well. The patient saw allergist.   The outcome of the event was not reported.  The reporter assessed the event to be releted to Fluvirin. The reporter stated that the patient was allergic to it as well.  The case was assessed as non-serious.  This case is linked to 202100270 due the same patient.  Company Comment: The event is considered as related to Fluvirin.; Reporter's Comments: The reporter stated that the patient was allergic to it as well.; Sender's Comments: The event is considered as related to Fluvirin.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Hypotension, Nausea, Vomiting
Clinical narrative: Pfizer-BioNTech COVID-19 vaccine treatment under Emergency Use Authorization(EUA): Male received his second vaccine on February 28, 2021 and had been following the vaccine. Symptoms included nausea, vomiting, hypotension, and bradycardia. He was admitted to the hospital on March 1st. Medical history included Coronary Artery Disease, A-Fib, and a previous CABG procedure.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Immediate post-injection reaction, Respiratory rate increased
Clinical narrative: Pfizer-BioNTech COVID-19 vaccine treatment under Emergency Use Authorization(EUA): Female died 27 hours after receiving second dose of vaccine. Immediately after vaccine she had rapid breathing, almost hyperventilating. Medical history included Dementia and Parkinson's Disease.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Dysstasia, Fatigue, Gait inability, Loss of bladder sensation
Clinical narrative: I lost control of muscles in my arms, legs, bladder, and mouth. I could not sit up, stand up or even grasp a bottle of water. I had trouble speaking and lost complete control of my bladder. My husband called 911 and the end stayed with me and took vitals. I was in this state for about 7 hours. After this I continued to be very tired for about 5 days.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of control of legs, Mobility decreased, Speech disorder
Clinical narrative: I lost control of muscles in my arms, legs, bladder, and mouth. I could not sit up, stand up or even grasp a bottle of water. I had trouble speaking and lost complete control of my bladder. My husband called 911 and the end stayed with me and took vitals. I was in this state for about 7 hours. After this I continued to be very tired for about 5 days.
Age: 80.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Petechiae
Clinical narrative: Received 2nd covid vaccine on 2/9/21 and 1st shingrix on 3/3/21. Reported the following "I had the same reaction to the 1st shingles shot as I had to the 2nd Covid  shot.  I believe I have correctly diagnosed this reaction.  It has a photograph of one cluster of bleeding  capillaries (petechiae) and discussions regarding immune thrombocytopenia (ITP)  with respect to vaccines. "
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: On 2/28/21 a used vial of Pfizer vaccine was reconstituted again with sodium chloride, they were reconstituted in error and patient received diluent only immunization. The immunization administered that day was not effective in providing protection against COVID.   Patient did not have any adverse reaction to the sodium chloride and returned on 3/6/21 to receive the correct dosage of Pfizer vaccine.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Body aches, lassitude, headache, chills
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, International normalised ratio increased, Thrombophlebitis superficial, Thrombosis, Ultrasound scan abnormal
Clinical narrative: DVT blood clot and surface blood clot in lower left leg diagnosed at the ER on 2/12/21.  Levonox injections and warfarin have been started.  Twice weekly INR checks.  No longer need the injections; warfarin is continued.  Next INR check is scheduled for Thursday March 11, 2021.  Warfarin may need to continue life-long.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Client verbalized feeling numbness to left arm after receiving the vaccine.  Client was evaluated by Fire Rescue paramedics.  Client was released to go home after symptom was resolved at 9:25 am.  Per paramedics no further evaluation needed.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Cardiac monitoring abnormal, Chest pain, Dizziness, Nausea
Clinical narrative: 05:35PM STATES 'FEELS LIKE SHE WILL PASS OUT, NAUSEA & HAS CHEST PAIN'. PLACED ON COT AND CARDIAC MONITOR. A/O, PINK, W/D, RESP WITH EASE, NO DIAPHORESIS, NO DECREASED LOC.  SINUS TACH ON MONITOR. 5:49PM ASA P.O./CHEWED.  IV STARTED PER SQUAD. SMALL AMT EMESIS (APROX 2 TSP). TRANSPORTED TO ER PER SQUAD.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus tachycardia, Vomiting
Clinical narrative: 05:35PM STATES 'FEELS LIKE SHE WILL PASS OUT, NAUSEA & HAS CHEST PAIN'. PLACED ON COT AND CARDIAC MONITOR. A/O, PINK, W/D, RESP WITH EASE, NO DIAPHORESIS, NO DECREASED LOC.  SINUS TACH ON MONITOR. 5:49PM ASA P.O./CHEWED.  IV STARTED PER SQUAD. SMALL AMT EMESIS (APROX 2 TSP). TRANSPORTED TO ER PER SQUAD.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Impaired work ability, Pain, Tachycardia
Clinical narrative: At 23 hours post vaccination, I began to experiencing significant chills and tachycardia while sitting at my desk at work (HR 120-150). I proceeded to leave work, where my HR continued to remain elevated for the next ~30 hours. That night I vomited several times. Otherwise, only other noticeable s/s were or body soreness and a lingering headache.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: At 23 hours post vaccination, I began to experiencing significant chills and tachycardia while sitting at my desk at work (HR 120-150). I proceeded to leave work, where my HR continued to remain elevated for the next ~30 hours. That night I vomited several times. Otherwise, only other noticeable s/s were or body soreness and a lingering headache.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Large red oblong spot approximately 2 inches by 3 inches approximately 2 1/2  inches below injection site.  A little puffy and very itchy.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: 8 days after the vaccine patient reports a red rash on arm that extended to his elbow. Called his PCP who started him on a short course of prednisone.  The arm has improved and resolved as of March 8th.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: Got the vaccine, and later  noticed pain in her neck, knees, head.  She had dizziness, chills, shakes, nausea and a slight fever.   She went to bed that evening and everything was hurting, and felt very nauseous.  She had a very bad nights rest, but when she woke up her temp was over 100, normal is 97.  She did take her morning meds and an extra-strength Tylenol and went back to bed.   She took Tylenol, was feeling better, but still the chills and fatigue and was better.  The problem with the headache continued and her temp was about 99.   On 2/12/21 had temp over 100 again, no energy, slept a lot.   Had difficulty sleeping that night and had sweats, had temp, nausea and was shaking.  On Monday felt shaky, chills and difficulty sleeping.  On Tuesday she was having headache, not sleeping well and no energy.   She also was not sleeping well, had  a headache.  By 2/17/21 was feeling better, not great as she was still not sleeping well.   She did have covid in April of last year, and was not allowed to see her husband who was in a nursing home until 6/3/20.   When she had the covid test she was inconclusive and that's why she could not see her doctor.   Her doctor did the antibody test that showed she had antibodies.  She is feeling back to normal as of today, 3/8/21.  She had the malaise from COVID after she got the 1st vaccine.  Feels that they should ask people before getting the vaccine if they had COVID.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Malaise, Nausea, Neck pain
Clinical narrative: Got the vaccine, and later  noticed pain in her neck, knees, head.  She had dizziness, chills, shakes, nausea and a slight fever.   She went to bed that evening and everything was hurting, and felt very nauseous.  She had a very bad nights rest, but when she woke up her temp was over 100, normal is 97.  She did take her morning meds and an extra-strength Tylenol and went back to bed.   She took Tylenol, was feeling better, but still the chills and fatigue and was better.  The problem with the headache continued and her temp was about 99.   On 2/12/21 had temp over 100 again, no energy, slept a lot.   Had difficulty sleeping that night and had sweats, had temp, nausea and was shaking.  On Monday felt shaky, chills and difficulty sleeping.  On Tuesday she was having headache, not sleeping well and no energy.   She also was not sleeping well, had  a headache.  By 2/17/21 was feeling better, not great as she was still not sleeping well.   She did have covid in April of last year, and was not allowed to see her husband who was in a nursing home until 6/3/20.   When she had the covid test she was inconclusive and that's why she could not see her doctor.   Her doctor did the antibody test that showed she had antibodies.  She is feeling back to normal as of today, 3/8/21.  She had the malaise from COVID after she got the 1st vaccine.  Feels that they should ask people before getting the vaccine if they had COVID.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 antibody test positive, Sleep disorder, Tremor
Clinical narrative: Got the vaccine, and later  noticed pain in her neck, knees, head.  She had dizziness, chills, shakes, nausea and a slight fever.   She went to bed that evening and everything was hurting, and felt very nauseous.  She had a very bad nights rest, but when she woke up her temp was over 100, normal is 97.  She did take her morning meds and an extra-strength Tylenol and went back to bed.   She took Tylenol, was feeling better, but still the chills and fatigue and was better.  The problem with the headache continued and her temp was about 99.   On 2/12/21 had temp over 100 again, no energy, slept a lot.   Had difficulty sleeping that night and had sweats, had temp, nausea and was shaking.  On Monday felt shaky, chills and difficulty sleeping.  On Tuesday she was having headache, not sleeping well and no energy.   She also was not sleeping well, had  a headache.  By 2/17/21 was feeling better, not great as she was still not sleeping well.   She did have covid in April of last year, and was not allowed to see her husband who was in a nursing home until 6/3/20.   When she had the covid test she was inconclusive and that's why she could not see her doctor.   Her doctor did the antibody test that showed she had antibodies.  She is feeling back to normal as of today, 3/8/21.  She had the malaise from COVID after she got the 1st vaccine.  Feels that they should ask people before getting the vaccine if they had COVID.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Pain, Pruritus, Skin warm
Clinical narrative: Redness, itching, swelling, heat, pain 7 days post vaccine, redness not same as location of injection, cellulitis below vaccine injection site
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Redness, itching, swelling, heat, pain 7 days post vaccine, redness not same as location of injection, cellulitis below vaccine injection site
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pallor, Retching, Syncope
Clinical narrative: I was called by COVID vaccine observation staff at approximately 11:57AM to respond to patient who was reported to be diaphoretic, pale, and retching 15-20 minutes after having received one dose of Moderna COVID vaccine. Vital signs before my arrival were: 11:55AM BP 97/52 HR 75 Patient states history of diabetes, hypertension, anxiety, panic attacks, and pulmonary embolism and is on Xanax prn, Xarelto, an ace-receptor antagonist and an insulin pump.   States consumed about 12oz of water and a pop tart in the morning.  Physical assessment: Alert oriented to person, place, time and situation. Gait normal Firm bilateral hand grips Radial pulse 2+ bilaterally EOMS intact and PERRLA Lung sounds clear in all lobes S1 and S2 ascultated.  Advised patient to consume 2L of water before leaving clinic. Advised to stay additional 30 minutes for observation with blood pressure to be repeated at 5 minute intervals until blood pressure turns to normal range.  12:05PM BP 162/94 HR 95 12:10PM BP 134/51 HR 100  Gave emergency warnings to go to ER if experiences additional adverse reactions after returning home (shortness of breath, chest pain, etc.)  Diagnosis: Vasovagal syncope in response to vaccine
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Joint stiffness
Clinical narrative: The second shot produced flu-like aches with additional joint stiffness and headache at the top of the head within 12 hours.   After the second dose, I took a Tylenol and went to bed at about 9:30PM, but continued symptoms lasted until 18 hours after onset.  I took a second Tylenol at approximately 4PM and recovered by 8PM.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Hyperhidrosis, Malaise, Pallor
Clinical narrative: Shortly after being given the vaccine the person had an episode of near-syncope where she felt light-headed and was not feeling well.  She has had a history of this occurring in the past after an injection before (unknown if vaccination or other IM injection) and blood draws.  She did not have any loss of conscious, but she became pale and diaphoretic and felt like she could pass out if she would stand consistent with a vasovagal event.  She initially had an elevated pulse at 113 which came down to 65 and her blood pressure was initially 110/60 and then 98/62 on recheck.  Patient was placed supine on a cot and then her legs were elevated to help her symptoms.  She did have some improvement in her symptoms prior to transport to the ER via EMS at her request.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: Shortly after being given the vaccine the person had an episode of near-syncope where she felt light-headed and was not feeling well.  She has had a history of this occurring in the past after an injection before (unknown if vaccination or other IM injection) and blood draws.  She did not have any loss of conscious, but she became pale and diaphoretic and felt like she could pass out if she would stand consistent with a vasovagal event.  She initially had an elevated pulse at 113 which came down to 65 and her blood pressure was initially 110/60 and then 98/62 on recheck.  Patient was placed supine on a cot and then her legs were elevated to help her symptoms.  She did have some improvement in her symptoms prior to transport to the ER via EMS at her request.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: pt was underage (17) at time of immunization
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Pain, Pyrexia
Clinical narrative: Fever Cold Body aches
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pain, Pyrexia
Clinical narrative: 103 fever, chills, aching, vomiting, headache, weak. For two days. Could not get out of bed except to bathroom
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 103 fever, chills, aching, vomiting, headache, weak. For two days. Could not get out of bed except to bathroom
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dizziness, Dysphonia, Electrocardiogram normal
Clinical narrative: 03/04/21 No symptoms until 9:15 a.m. (approximately 30 mins after vaccination), began feeling faint, weak, rapid pulse, heart skipping, numbness and tingling in fingers and toes, ringing and heat in ears, rash/redness on chest, neck and ears, intermittently "seeing stars", extremely dry mouth, hoarseness in voice and dry cough when speaking. Made my way to my sister's dental office nearby, where approximately 1 hour later, she gave me 50 mg of Benadryl and 99% Oxygen 2L/min via nasal cannula.  BP 131/82, pulse 81, blood sugar 126 ml/dl.  When not resolved after approximately 1.5 hours,  I proceeded to the hospital Emergency Room.  They did an EKG (normal), gave me famotidine and a steroid and observed me for a couple of hours.  Most symptoms had subsided and was released at approximately 2:30 or 3:00 p.m.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Extrasystoles, Feeling hot, Heart rate increased, Hypoaesthesia
Clinical narrative: 03/04/21 No symptoms until 9:15 a.m. (approximately 30 mins after vaccination), began feeling faint, weak, rapid pulse, heart skipping, numbness and tingling in fingers and toes, ringing and heat in ears, rash/redness on chest, neck and ears, intermittently "seeing stars", extremely dry mouth, hoarseness in voice and dry cough when speaking. Made my way to my sister's dental office nearby, where approximately 1 hour later, she gave me 50 mg of Benadryl and 99% Oxygen 2L/min via nasal cannula.  BP 131/82, pulse 81, blood sugar 126 ml/dl.  When not resolved after approximately 1.5 hours,  I proceeded to the hospital Emergency Room.  They did an EKG (normal), gave me famotidine and a steroid and observed me for a couple of hours.  Most symptoms had subsided and was released at approximately 2:30 or 3:00 p.m.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rash, Tinnitus, Visual impairment
Clinical narrative: 03/04/21 No symptoms until 9:15 a.m. (approximately 30 mins after vaccination), began feeling faint, weak, rapid pulse, heart skipping, numbness and tingling in fingers and toes, ringing and heat in ears, rash/redness on chest, neck and ears, intermittently "seeing stars", extremely dry mouth, hoarseness in voice and dry cough when speaking. Made my way to my sister's dental office nearby, where approximately 1 hour later, she gave me 50 mg of Benadryl and 99% Oxygen 2L/min via nasal cannula.  BP 131/82, pulse 81, blood sugar 126 ml/dl.  When not resolved after approximately 1.5 hours,  I proceeded to the hospital Emergency Room.  They did an EKG (normal), gave me famotidine and a steroid and observed me for a couple of hours.  Most symptoms had subsided and was released at approximately 2:30 or 3:00 p.m.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Herpes zoster, Pain
Clinical narrative: Shingles on torso after 2nd dose. Started at navel, then around right side to spine, then back. Painful. No headache/fever, SOB. Backache prior to shingles
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Fatigue, Headache
Clinical narrative: 1. Injection site pain, tenderness, on February 2-4  2. Fever (never exceeding 101.3), chills, muscle and joint pain, fatigue, headache, cough  3. Productive cough with greenish colored sputum first occurred on February 4 reported to personal pulmonary physician; oral antibiotic prescribed
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Pyrexia, SARS-CoV-2 test, Sputum discoloured
Clinical narrative: 1. Injection site pain, tenderness, on February 2-4  2. Fever (never exceeding 101.3), chills, muscle and joint pain, fatigue, headache, cough  3. Productive cough with greenish colored sputum first occurred on February 4 reported to personal pulmonary physician; oral antibiotic prescribed
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Pt reports received covid vaccine on 3/6/2021 to R deltoid. The next day (3/7) she woke up and R side of cheek was bright red. No warmth/swelling. No bumps or sores. No difficulty breathing or swallowing. Feels completely fine, just the redness noted. She call PCP on 3/8 to report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: I had heart palpitations while taking a hot shower around 7 pm the day following my shot. The palpitations lasted for about 20-25 minutes and while I was having the palpitations, my fever was 103.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody negative, C-reactive protein increased, Computerised tomogram, Condition aggravated, Dyspnoea
Clinical narrative: Fever started 2 days after vaccination, followed by shortness of breath, dyspnea, weakness and pain and edema in both legs. edema was traveling up and reached umbilicus. Weakness in both legs. Started to improve with steroids. When steroids were starting to taper, symptoms worsened again. Patient was seen in ED.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Full blood count, Laboratory test abnormal, Muscular weakness, Oedema
Clinical narrative: Fever started 2 days after vaccination, followed by shortness of breath, dyspnea, weakness and pain and edema in both legs. edema was traveling up and reached umbilicus. Weakness in both legs. Started to improve with steroids. When steroids were starting to taper, symptoms worsened again. Patient was seen in ED.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Oedema peripheral, Pain in extremity, Pyrexia, Red blood cell sedimentation rate increased, SARS-CoV-2 antibody test negative
Clinical narrative: Fever started 2 days after vaccination, followed by shortness of breath, dyspnea, weakness and pain and edema in both legs. edema was traveling up and reached umbilicus. Weakness in both legs. Started to improve with steroids. When steroids were starting to taper, symptoms worsened again. Patient was seen in ED.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Scan with contrast, Serum ferritin increased, Transaminases increased, Urine analysis normal
Clinical narrative: Fever started 2 days after vaccination, followed by shortness of breath, dyspnea, weakness and pain and edema in both legs. edema was traveling up and reached umbilicus. Weakness in both legs. Started to improve with steroids. When steroids were starting to taper, symptoms worsened again. Patient was seen in ED.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Palpitations, Pyrexia, Urticaria
Clinical narrative: Seven hours after Moderna Vaccine, I experienced rapid heart rate, High Blood Pressure and itching hives under my chin.  I called 911 and EMTs checked my vitals & recommended I go to ER.  My husband drove me to hospital. But we waited in the car and I did breathing and husband massaged my neck until my BP and pulse were a bit lower.  We went home as I did not want to go into ER.  The next day, BP and pulse still high, so I called Nurse Line who said to take antihistamine & pain med to lower slight fever.  Today, my BP is  down to 95/58 but pulse is a little elevated at 97
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 2nd dose was administered 1 week early: patient received initial dose on 2/13/2021- vaccination card had return date of 3/13/2021 for 2nd dose.    3/6/2021 @ 1212: pt was called, no answer, LMOR. 3/6/2021 @ 1551: pt states injection was exactly 4 weeks ago, pt is doing well without any reported side effects; it was discussed that there is no recommendation for a 3rd dose.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Dizziness, Headache, Nausea, Vomiting
Clinical narrative: 1st vaccination on January 30 I had a very intense headache whole 24 hours until I could take a pain killer. 2nd vaccination on February 27 had a slight headache 1st day. THIRD day I had 3 straight days of EXTREME dizziness and nausea, throwing up a few times over the 3 days. Then on 8th day dizziness and nausea returned for a day (yesterday). I hope this does not continue off and on.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Chills, Dizziness, Headache, Musculoskeletal stiffness
Clinical narrative: Janssen COVID-19 Vaccine EUA  Approximately six hours after administration of the vaccine, patient experienced sever chills and dizziness. Unable to stop shaking, patient took temperature which registered at 95.4F and then 95.1F at 15 minutes. Patient donned flannel pants, thermal shirt, and oversized hooded sweatshirt and got in bed under flannel sheets, two doubled-over blankets, a bedspread, and quilt. A down-filled king-size pillow was placed on top of patient's torso and a space heater was turned on to highest setting. Patient reports heart seemed to be racing, but did not take BP. Unable to quell the chills, the patient continued to shake, developing very stiff shoulders, neck and back as a result. This continued until approximately 2 am. The next morning, patient's temperature was registering at 99.4F and pulse was 96, but patient did not report chills. General muscle aches and mild headache were noted. At time of this report, patient's temperature and pulse are normal (97.6F and 76 pulse).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Palpitations, Tremor
Clinical narrative: Janssen COVID-19 Vaccine EUA  Approximately six hours after administration of the vaccine, patient experienced sever chills and dizziness. Unable to stop shaking, patient took temperature which registered at 95.4F and then 95.1F at 15 minutes. Patient donned flannel pants, thermal shirt, and oversized hooded sweatshirt and got in bed under flannel sheets, two doubled-over blankets, a bedspread, and quilt. A down-filled king-size pillow was placed on top of patient's torso and a space heater was turned on to highest setting. Patient reports heart seemed to be racing, but did not take BP. Unable to quell the chills, the patient continued to shake, developing very stiff shoulders, neck and back as a result. This continued until approximately 2 am. The next morning, patient's temperature was registering at 99.4F and pulse was 96, but patient did not report chills. General muscle aches and mild headache were noted. At time of this report, patient's temperature and pulse are normal (97.6F and 76 pulse).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling, Paraesthesia oral
Clinical narrative: Approximately 12 minutes after the injection my lips began to tingle and feel like they were swelling. My mouth, jaw, and teeth began to tingle and became numb. I was in the 30-minute wait period. After 30 minutes I reported the side effect to personnel at the checkout station who said that was not a side effect he had on the list.  I took a Claritin 10 mg tab approximately 1 hour later with no resolve of numbness. I took a 10 ml dose of Benadryl at approximately 9 pm and again at 1 am.  I continue to have a slight tingling sensation on my face as of now.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Hypoaesthesia, Muscle tightness, Paraesthesia
Clinical narrative: C/o tingling left arm/shoulder 15 minutes after injection. Then increased tightening left side neck and numbness of neck and jaw with extension from her ear to nose. Felt some tightening of chest on 3/4/21 at noon. took benadryl. Majority of numbness subsided on Friday 3/5 however still having numbness at hairline on opposite side of face.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Discomfort, Fatigue, Haemoptysis, Headache
Clinical narrative: Coughing Blood, Chills, Fever, Headache, Nausea, Vomiting, Fatigue, Pain -Discomfort
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Coughing Blood, Chills, Fever, Headache, Nausea, Vomiting, Fatigue, Pain -Discomfort
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site reaction, Pain in extremity, Peripheral swelling, Rash erythematous
Clinical narrative: Pain upon injection unlike first shot.    Soreness and swelling grew worse into shoulder and down arm during next 36 hours. Red raised rash noticed next evening (36 hours) surrounding injection site approx 7 cm across. Fading this morning 48 hours after injection.    Tylenol taken 5 times for pain spaced out over the 36 hours.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: Pain upon injection unlike first shot.    Soreness and swelling grew worse into shoulder and down arm during next 36 hours. Red raised rash noticed next evening (36 hours) surrounding injection site approx 7 cm across. Fading this morning 48 hours after injection.    Tylenol taken 5 times for pain spaced out over the 36 hours.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Very foggy headed x3 days
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Primarily, extremely weak on the next day--in particular for several hours during the afternoon in which I lay down and did not wish to move.  Soreness and aching throughout my body, not unlike when one experiences influenza; however, I had no other flu symptoms, no nausea or indigestion.  There were occasional headaches, and a few times, light-headedness.  Weariness, and lack of physical drive continued, on and off, for another ten days.  On one day, one week later, during this period, I was able to function fairly normally, but I may have over-extended..  The next day, Friday, the weakness resumed.  Last night when I went to bed, I felt light-headed again, but slept soundly for seven hours.  Today, I feel much better, and I feel that I am returning to normal.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin fissures, Skin warm
Clinical narrative: large red patch on left arm, about 2.5 inches across.  slightly raised, reddened area looks chapped.  warm to touch.  a little sore.   I just noticed it today and don't really know when it started, but i know for sure it was not within the first 3 or 4 days after injection because at that time i was checking my arm daily.   As of now i have not seen a doctor as i read news reports that this is not a rare or harmful occurrence.