chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine was administered; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.   On 25-JAN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) lot # S035354 has been verified to be a valid lot number, expiration date was reported as 04-NOV-2021, but upon internal validation, it was established as 05-NOV-2021, 1 injection for prophylaxis (exact doses, dose #, route of administration and anatomical location were not reported). The temperature excursion was above 9 Celsius degrees (13.4 Celsius degrees) for 2 hours and 9 minutes. There were no previous excursions reported. The digital data logger was involved.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: Shingles on the right side, near the breast; itching; This case was reported by a consumer and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 4BA4A, expiry date 31st January 2022) for prophylaxis.   The patient's past medical history included shingles (eight separate occasions).   On 8th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 9th December 2020, 1 days after receiving Shingrix, the patient experienced shingles and pruritus. The patient was treated with benadryl (nos) (Benadryl) and hydrocortisone. On an unknown date, the outcome of the shingles and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the shingles and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. After receiving Shingrix, the patient experienced shingles on the right side, near the breast and itching.   The patient was using Benadryl and 1 percent hydrocortisone cream to help alleviate symptoms.  The reporter consented to follow up.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Arthralgia
Clinical narrative: soreness in the thumb joint; patient received 1 ml instead of 0.5 ml of the vaccine; A spontaneous report was received from a pharmacist concerning a 24-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced accidental overdose  patient received 1 milliliter instead of 0.5 milliliter of the vaccine and arthralgia  soreness in the thumb joint.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 12 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) in the right arm intramuscularly for prophylaxis of COVID-19 infection.   On 12 Jan 2021, the patient received 1 milliliter of the Moderna COVID-19 vaccine instead of the recommended 0.5 milliliters.  On 15 Jan 2021, the patient reported he had soreness in the right thumb.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, accidental overdose  patient received 1 milliliter instead of 0.5 milliliter of the vaccine, was considered resolved on 12 Jan 2021.  The outcome of the event, arthralgia  soreness in the thumb joint, was considered unknown.; Reporter's Comments: This case concerns a 24 year old male patient who experienced a  unexpected events of Accidental overdose and Arthralgia. The latter event occurred 3 days after first dose of the study medication administration.   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.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe Vomiting; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced severe vomiting.   The patient's medical history was not provided.  No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced severe vomiting and was hospitalized for two weeks.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, severe vomiting, was not reported.; Reporter's Comments: This spontaneous report concerns a female patient who experienced a serious event of severe vomiting. The event of occurred on an unknown date after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: unknown, expiration date-Unknown).  Treatment and outcome are unknown. There is not enough information of assess the causal association between he reported event and the administration of mRNA-1273 vaccine as critical details such as the date of treatment, onset of the event, patient's medical history including exclusion of other triggers cannot be established. Main field defaults to possibly related'
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: some of the vaccine trickled down arm; A spontaneous report was received from a consumer concerning a 55-year-old patient who received Moderna's COVID-19 vaccine and experienced "some of the vaccine trickled down arm".  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, on the same date of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011M2OA) intramuscularly for prophylaxis of COVID-19 infection.   On 29 Jan 2021 patient received first dose of vaccine but wasn't sure if the full dosage was administered because some trickled down their arm. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event "some of the vaccine trickled down arm" was considered resolved on 29 Jan 2021.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # 011M2OA.  There were no reported AEs associated with this case of Incorrect dose administered.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: a patient receives 0.3mL on their first administration of the moderna vaccine for covid; A spontaneous report was received from a healthcare professional concerning a patient, of unknown gender and age, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and administered 0.3mL of the mRNA-1273 vaccine, an underdose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of Covid-19 infection. The patient was administered 0.3mL of the mRNA-1273 vaccine, an underdose.   No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, vaccine underdose, was considered resolved.; Reporter's Comments: This case concerns a patient of unknown age and gender who received received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of Covid-19 infection and administered 0.3mL of the mRNA-1273 vaccine, an underdose. There were no reported adverse events in this case of underdose.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine administered to a 16-year old patient; A spontaneous report was received from a nurse concerning a 16-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, vaccine given to a 16-year old patient.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 29 Jan 2021, the Moderna COVID vaccine was given to a 16- year- old patient at their facility. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccine given to a 16-year old patient, was considered resolved on 29 Jan 2021.; Reporter's Comments: This case concerns a 16 year old female who received her first of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of product administered to patient of inappropriate age.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: patient did not receive more than half of the dose, maybe got a fraction of it; faulty syringe; A spontaneous report ) was received from a nurse concerning a 38-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) had a faulty syringe and did not receive more than half of the dose, maybe got a fraction of it.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch number not provided).   On 04 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 007M20A) on her right arm, intramuscularly for prophylaxis of Covid-19 infection.  The patient was administered the mRNA-1273 vaccine with a faulty syringe and therefore, she did not receive more than half of the dose, maybe got a fraction of it. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events. Therefore, action taken with mRNA-1273 in response to the events were considered not applicable.  The events did not receive more than half of the dose, maybe got a fraction of it and faulty syringe use, were considered resolved on 04 Feb 2021.; Reporter's Comments: This case concerns a 38-year-old female patient who received their second of two planned doses of mRNA-1273 (Lot# 007M20A), reporting Underdose and Syringe issue.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17- year old received the vaccine; A spontaneous report was received from a pharmacist assistant concerning a 17-year-old patient (gender unknown), who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, 17- year old received the vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number not provided) for prophylaxis of COVID-19 infection.   On 04 Feb 2021, the pharmacist assistant reported a 17-year old had received one dose of the Moderna's COVID vaccine. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The event, 17- year old received the vaccine was considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273 (Lot number not provided). This event of inappropriate age at vaccine administration had no associated AEs.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via skin contact, Underdose
Clinical narrative: When she was given the shot, part of it escaped the syringe and ran down her arm; When she was given the shot, part of it escaped the syringe and ran down her arm; When she was given the shot, part of it escaped the syringe and ran down her arm; A spontaneous report was received from a consumer who was also a 76-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and when she was given the shot, part of it escaped the syringe and ran down her arm/ device connection issue and underdose.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 26 Jan 2021, the patient presented to the pharmacy for their first of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 26 Jan 2021, during vaccination, part of it escaped the syringe and ran down her arm. The patient was concerned by how much vaccine escaped the needle and reported that it was "like a gush". She did not experience any symptoms. No treatment information was provided.   Action taken with mRNA-1273 in response to the event(s) was not reported.   The event, when she was given the shot part of it escaped the syringe and ran down her arm, was considered resolved.; Reporter's Comments: This report refers to a case of Device connection issue and Underdose for mRNA-1273, (Lot number: 007M20A) with no associated adverse events.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injection site erythema, Injection site pain, Vaccination site discharge
Clinical narrative: Arm started to leak a clear liquid; Arm started to leak a clear liquid; Arm was sore; Arm was red; A spontaneous report was received from a consumer who was also a 68-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced sore arm (injection site pain), redness (injection site erythema) and her arm leaked a clear liquid right after getting the vaccine (vaccination site discharge/ incorrect dose administered).  The patient's medical history was not provided.  No concomitant medications were reported.  On 20 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) in the left arm for prophylaxis of COVID-19 infection. After the injection, the patient's arm started to leak a clear liquid.  Her arm was also sore and red. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the events was not reported.  The outcome of the event, arm leaked a clear liquid, was considered as resolved on 20 Jan 2021.  The outcome of the events, sore arm and redness, was unknown.; Reporter's Comments: This concerns a 68-year old female patient who experienced injection site pain, redness, and her arm leaked clear liquid after mRNA-1273 administration.Based on the current available information and temporal association between the use of the product and the start date of the events (redness, site pain), a causal relationship cannot be excluded.
Sex: M
Vaccine: FLUX
Symptoms: Facial pain, Urticaria
Clinical narrative: bad reaction to the first one painful hives all over one side of his face; bad reaction to the first one painful hives all over one side of his face; Initial information was received on 18-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient's mother or father) via social media.  This case involves adult male patient (age not specified) who had bad reaction to the first one painful hives all over one side of his face (urticaria and pain), while he received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history or risk factor 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 were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious bad reaction to the first one painful hives all over one side of his face (urticarial and pain) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  Laboratory data was not provided.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events were unknown for both events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: sore arm; Initial information received on 19-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional and consumer or non-healthcare professional in the .  This case involves patient (unknown demographics) who experienced sore arm (pain in extremity), while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.   It is unknown if the patient had any medical history, concomitant disease or risk factor.  Patient concomitant medication include vitamins as he took since decades.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  Patient was saying as your age, you'll find out you've been having a mild case of the flu. It's easy to transmit the flu to others. The 1918 flu was delay for people with good immune systems which killed them. Most employers prefer it, some require it. But he do it because some of his friends are vulnerable. Why kill a buddy over a day. It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine not provided.   There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for pain in extremity.  There will be no information available on the batch number for this case.
Age: 22.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Wrong product administered
Clinical narrative: 22 year old patient received FLUZONE HD/ NO AE; 22 year old patient received FLUZONE HD/ NO AE; a patient received FLUZONE QUAD and FLUZONE HD on same day/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a Pharmacist via Agency(Reference number- 00438020) via call-center and transmitted to Sanofi on 20-Jan-2021.  This case involves a 22-years-old female patient who received 0.5 mL INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (batch number and expiry date not reported) in right deltoid and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (batch number: UJ507AA and expiry date: 30-Jun-2021) in left deltoid on same day 20-Jan-2021 for prophylactic vaccination (extra dose administered, product administered to patient of inappropriate age and overdose).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to extra dose administered, overdose and inappropriate age at vaccine administration (latency: same day).  Patient received no other vaccines or medications.  At the time of reporting, 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 holder's 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.  There will be no information available on the batch number for FLUZONE HIGH-DOSE QUADRIVALENT for this case.
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient inadvertently receive a Pentacel vaccine at 7 months of age with no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare Professional. This case involves a 7 month old male patient who receive 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ384AAA and expiry date 09-Oct-2021) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) (not produced by Sanofi Pasteur) ( lot number and expiry date not reported), patient inadvertently receive a pentacel vaccine at 7 months of age (accidental exposure to product).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEP [HEPATITIS B VACCINE]) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE SHANTHA) for  prophylactic vaccination.  It was a potential medication error case due to accidental exposure to product.  The caller stated that a patient inadvertently receive a pentacel vaccine at 7 months of age. See the additional event details field for more info. Additional Description of event Adverse events :The patient was given a pentacel vaccination at 7 months of age. Staff person SH administered 0.5 ml of penticacel in the patient's right thigh. He also received prevnar, Hep B and the Roto virus vaccines on this visit. NP wrote the orders.  At the time of reporting, 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 holder's 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.  There will be no information available on the batch number for this case.
Age: 33.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Dyspnoea, Swollen tongue
Clinical narrative: shortness of breath; tongue swelling; Initial information was received on 02-Feb-2021 regarding an unsolicited valid non-serious case from a physician.  This case involves a 33-year-old male patient who experienced shortness of breath (dyspnoea) and tongue swelling (swollen tongue), after vaccination with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 13-Jan-2015, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot (C4712AA, expiry date- 27-Mar-2017) via intramuscular route in left deltoid for prophylactic vaccination.  On 13-Jan-2015, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via intramuscular route in an unknown administration site for prophylactic vaccination.  On 13-Jan-2015, the patient developed non-serious shortness of breath (dyspnoea) and tongue swelling (swollen tongue) about 2 hours following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported that, the patient was asking for ingredients for Fluzone Quadrivalent and Adacel.  The patient was scheduled to have the COVID-19 vaccine tomorrow and was hoping to get an answer to question before then.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome was unknown. for both the events.  There will be no information available on the lot number of Fluzone Quadrivalent for this case.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Nausea
Clinical narrative: fever, fatigue, headache, chills, body aches, shortness of breath, nausea
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever, fatigue, headache, chills, body aches, shortness of breath, nausea
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Death, Listless, Pyrexia
Clinical narrative: 24 hours after shot had high fever 101, chills, weakness, became listless, family called 911,  client became unresponsive and died  in the Emergency room.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: 24 hours after shot had high fever 101, chills, weakness, became listless, family called 911,  client became unresponsive and died  in the Emergency room.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Chills, Pyrexia
Clinical narrative: 24 hours after shot had high fever 101, chills, weakness, became listless, family called 911,  client became unresponsive and died  in the Emergency room.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash erythematous, Rash vesicular
Clinical narrative: silver dollar sized red blistered rash around injection site lasted for 3 days.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: 103 -104 fever and chills, took Tylenol, and covered up with a lot of blankets.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on back and chest
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: SLUGHT SWELLING LEFT LIP
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion induced, Abortion missed
Clinical narrative: PATIENT HAD A MISSED ABORTION, FOUND OUT 6DAYS AFTER VACCINATION. HAD HISTORY OF PREVIOUS MISCARRIAGES. WAS ON PROGESTERONE PESSARIES AND ASPIRIN. FETAL HEART BEAT MISSING ON ROUTINE REVIEW. GESTATION 10WEEKS+4DAYS. REQUIRED MEDICAL TERMINATION OF PREGNANCY.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Chills, Headache, Myalgia
Clinical narrative: I woke up after a restless night after vaccination with chills, headache, joint and bone ache, muscles pain. Takin Advil and moving around helped a bit.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: I woke up after a restless night after vaccination with chills, headache, joint and bone ache, muscles pain. Takin Advil and moving around helped a bit.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: My left arm at injection site of my moderna vaccine became 4 inch diameter red hard hot to the touch and very sore. My joints ached for 30 hours after injection.  30 minutes after injection my face felt cold and tingly like I had been given novicane in my face. That went away after two hours.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Paraesthesia, Skin warm
Clinical narrative: My left arm at injection site of my moderna vaccine became 4 inch diameter red hard hot to the touch and very sore. My joints ached for 30 hours after injection.  30 minutes after injection my face felt cold and tingly like I had been given novicane in my face. That went away after two hours.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Adrenocortical insufficiency acute, Diarrhoea, Headache, Heart rate irregular, Hot flush
Clinical narrative: Triggered adrenal crisis/event (identical to same I usually experience every 3-4 months) Hot flashes, tremors, headache, nausea/vomiting, diarrhea, erratic heart rate, passing out.  Lasted approx 3 days
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, Tremor, Vomiting
Clinical narrative: Triggered adrenal crisis/event (identical to same I usually experience every 3-4 months) Hot flashes, tremors, headache, nausea/vomiting, diarrhea, erratic heart rate, passing out.  Lasted approx 3 days
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injection site pain
Clinical narrative: Initially there was only pain at the site and fatigue.  Later in the evening it became chills, fever, body aches, headache, loss of appetite, nausea, vomiting, fatigue.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Initially there was only pain at the site and fatigue.  Later in the evening it became chills, fever, body aches, headache, loss of appetite, nausea, vomiting, fatigue.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nystagmus
Clinical narrative: On Sat 2/6 at around 8 PM I had a scary episode of nystagmus in my left eye with dizziness that lasted around 15 seconds. This was the first time I?ve ever had this happen.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 02/09/21 1900: Nausea, vomiting, hives. 02/09/21 2200 - fever, chills, muscle and joint pain.  02/10/21 0700 - local injection site reaction (redness, swelling, warm). Symptoms still present 02/11/21 at 0600
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Urticaria, Vomiting
Clinical narrative: 02/09/21 1900: Nausea, vomiting, hives. 02/09/21 2200 - fever, chills, muscle and joint pain.  02/10/21 0700 - local injection site reaction (redness, swelling, warm). Symptoms still present 02/11/21 at 0600
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Ear discomfort, Ear swelling, Erythema, Swelling face
Clinical narrative: Second Moderna COVID 19 taken 2/5/21 at Hospital with no adverse reaction. I took Dupixent injection myself on 2/8/21. That night my face and ear lobes started to burn and turn very red and swollen. I took Benadryl 25mg and called Dr. She said probably an interaction.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: PATIENT COMPLAINED OF GENERALISED PRURITUS WITH FIVE MINUTES OF RECEIVING VACCINE. NO RESPIRATORY DISTRESS,VITAL SIGNS WERE STABLE. NO VISIBLE RASH OR URTICARIA SEEN. BENADRYL ADMINSTERED AND SYMPTOMS SUBSEQUENTLY RESOLVED. PATIENT OBSERVED AT THE HEALTH UNIT FOR ABOUT 4 HOURS TILL SYMPTOMS RESOLVED. NO OTHER INTERVENTION OR MEDICATION REQUIRED TO BE GIVEN
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: COVID Arm
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: A week after the injection a skin rash appeared under both arm pits, behind both knees and in one elbow.  Later in the day much smaller rash spots accrued on my wrist, chest, and neck.  Benadryl stopped the itching - now 4 days later all spots are gone except the most intense spot under one arm pit but it is decreasing daily and as of this am no longer itches
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Injection related reaction
Clinical narrative: Approximately 30 hours after initial administration, patient began experiencing mild to moderate abdominal cramping and frequent runny stools. Patient believes it was most probable an autoimmune reaction to the injection, given her history of Crohn's disease. Patient continued to monitor reaction and follow a low-residue diet for 3 days until symptoms resolved.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exfoliative rash, Injection site reaction, Neuralgia, Pain in extremity, Rash erythematous
Clinical narrative: Prolonged  rash at injection site: erythematous, plaque like, itchy., easy to irritate, along with neuralgic pain to the entire arm.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Prolonged  rash at injection site: erythematous, plaque like, itchy., easy to irritate, along with neuralgic pain to the entire arm.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body aches, chill, fever
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Muscle fatigue, Nausea
Clinical narrative: Began feeling body aches and soreness at 9pm. This developed into chills, headache, nausea, body aches, muscle fatigue, shortness of breath overnight. Symptoms slightly subsided by 7am following day.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Began feeling body aches and soreness at 9pm. This developed into chills, headache, nausea, body aches, muscle fatigue, shortness of breath overnight. Symptoms slightly subsided by 7am following day.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: After seven days, I had an itchy arm. I scratched it and it swelled up a lot. The injection site is red, puffy, itchy, tender, very hard. It looks much like "COVID arm". The reaction is large 6-7 inches in length.  I applied a bug bite gel. I took ratinidine and then later benedryl. I iced it off and on. After waking up swelling is still present but not as severe. Itchy feel has subsided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: After seven days, I had an itchy arm. I scratched it and it swelled up a lot. The injection site is red, puffy, itchy, tender, very hard. It looks much like "COVID arm". The reaction is large 6-7 inches in length.  I applied a bug bite gel. I took ratinidine and then later benedryl. I iced it off and on. After waking up swelling is still present but not as severe. Itchy feel has subsided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Swollen, painful, hard red bump at injection site, very painful to touch, persisting today (day 2 after shot). Slight fever and queasiness, only the first day after the shot and gone now.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Swollen, painful, hard red bump at injection site, very painful to touch, persisting today (day 2 after shot). Slight fever and queasiness, only the first day after the shot and gone now.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site induration, Injection site pain
Clinical narrative: Itchy, firm, sore arm at injection site. I  had fever, fatigue, mild nausea, headache, joint and muscle pain on the two days following the second vaccine. Those are reported widely as potential side effects of the vaccine. The itchy arm was not anticipated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Myalgia, Nausea, Pyrexia
Clinical narrative: Itchy, firm, sore arm at injection site. I  had fever, fatigue, mild nausea, headache, joint and muscle pain on the two days following the second vaccine. Those are reported widely as potential side effects of the vaccine. The itchy arm was not anticipated.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Headache Fever all over body pain
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: 7 days post COVID19 vaccine I woke up with discomfort in the left axillary area. Upon palpating   I noted some swollen lymph nodes. That continue on 2/11/2021 No other symptoms at this time
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: Red raised spot at injection site "COVID Arm" Inflamed Lymph notes in my armpit of the injection site Fatigue Chills
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Lip discolouration, Lip pain, Lip swelling, Oral discomfort
Clinical narrative: Lips and tip of tongue burning. Lips are cracked a little swollen. Very painful. Feels like razor cuts. Sometimes scratchy throat. Very small white spots on bottom lip
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Tongue discomfort
Clinical narrative: Lips and tip of tongue burning. Lips are cracked a little swollen. Very painful. Feels like razor cuts. Sometimes scratchy throat. Very small white spots on bottom lip
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Pt complained of tingling around mouth after injection.Symptoms quickly resolved. VSS 130/61 67, 99% ; observed for 30 minutes.  Counseled to call 911 for any symptoms of anaphylaxis
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site joint pain, Injection site pain
Clinical narrative: Sore arm Sore joints on injection arm
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza, Injection site pain, Injection site rash
Clinical narrative: First few hours I felt fine. After 24 hours I had arm soreness in left arm and chills and body aches all over, moderate to severe with exhaustion. Then the next day I felt fine in terms of flu symptoms were gone, but I started to develop swelling in lips and a rash on my arm near the injection site. This morning (3 days later ) I have extreme hives all over my face and moderate hives all over my body. They itch.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pain, Pruritus, Urticaria
Clinical narrative: First few hours I felt fine. After 24 hours I had arm soreness in left arm and chills and body aches all over, moderate to severe with exhaustion. Then the next day I felt fine in terms of flu symptoms were gone, but I started to develop swelling in lips and a rash on my arm near the injection site. This morning (3 days later ) I have extreme hives all over my face and moderate hives all over my body. They itch.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Headache, Skin warm, Stress
Clinical narrative: pt reported mild dull headache and warm head.given water and saltines with improvement.   BP slightly elevated. Pt admitted to stress. Monitored for additional 30 min. Pt felt ok to go.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain, Pain in extremity
Clinical narrative: Extremely sore arm, headache that went from dull to bad the morning after the shot. The joint and body aches
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: 02/08/2021 8pm-body aches and head ache.  During that night I had a fever, chills, body  aches.   02/09/2021 7am-In the morning I had extreme tiredness, fever, chills, head ache and body aches.   Those symptoms continued through the entire day.  02/10/2021 530 am-body aches, head ache and mild fever. 02/11/2021 530 am-body aches, head ache and mild fever.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: Huge red circle where shot was given.  The after the shot I had chills, fever and the arm where the shot was given hurt.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Nausea
Clinical narrative: headache, chiils, stomach pain,nausea
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Limb discomfort, Myalgia, Peripheral swelling
Clinical narrative: General fever, headache, muscle aches and red swollen arm
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: General fever, headache, muscle aches and red swollen arm
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Tremor
Clinical narrative: Dizziness, fatigue, nausea, shaking from 7:30am to 4pm
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: 45 minutes after injection the left side of my face became numb to half of my tongue  BP was higher than normal 177/97! Numbness lasted about 45 minutes!  BP was back to normal the next morning! 2/9/2021
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: Kidney pain on going through six hours.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiovascular evaluation, Fatigue, Hyperthyroidism, Laboratory test, Palpitations
Clinical narrative: I have experienced an extreme inflammatory response.  My immune system is now attacking my thyroid & has put me into a hyperthyroid state (causing tachycardia, palpitations, & extreme fatigue) with no prior history of thyroid or autoimmune disease.  Symptoms began 12hrs following vaccination & have continued to present.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Systemic inflammatory response syndrome, Tachycardia
Clinical narrative: I have experienced an extreme inflammatory response.  My immune system is now attacking my thyroid & has put me into a hyperthyroid state (causing tachycardia, palpitations, & extreme fatigue) with no prior history of thyroid or autoimmune disease.  Symptoms began 12hrs following vaccination & have continued to present.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: My lymph node under my left arm is swollen to the size of a big lemon & it hurts. My bra bothers it.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity
Clinical narrative: Sore arm; Chills; This case was reported by a consumer and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm and chills. On an unknown date, the outcome of the pain in arm and chills were recovered/resolved.   It was unknown if the reporter considered the pain in arm and chills to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient herself. The age at vaccination was not reported. The patient had received 1st dose of Shingrix in September 2020 (date unknown) and she experienced a sore arm and chills.  The reporter did not consent to follow-up. For tolerance to the 2nd dose of Shingrix, refer case US2020250654.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020250654:Same reporter, same suspect, same patient, similar AEs
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction with the first shot; This case was reported by a consumer and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. Shingrix was interrupted. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient was told not to receive the second shot due to an allergic reaction with the first shot. It was reported that Covid-19 shots were becoming available, the patient wanted to know what the ingredients were in the Shingrix shot.  The patient didn't know if the patient should get Corona virus shot?
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: fever; fatigue; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 1st dose of Shingrix. In January 2021, less than a day after receiving Shingrix, the patient experienced fever and fatigue. On an unknown date, the outcome of the fever and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the fever and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as per vaccine indication. The patient received the Shingrix shot and 2 days later the patient still had fever and fatigue. The patient wanted to know how long did this last?
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: itching all over; This case was reported by a consumer and described the occurrence of generalized pruritus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th November 2020, the patient received the 1st dose of Shingrix .5 ml. In November 2020, less than 3 months after receiving Shingrix, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was not recovered/not resolved.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as per vaccine indication. The patient experienced skin itching, all over, from about November. Itching was continued. The second dose due on 19th January 2021. The patient wanted to know should I receive 2nd dosage?
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Lethargy, Tinnitus
Clinical narrative: ringing in his ears / tinnitus; Lethargy; tenderness at injection site; redness and tenderness at injection site; This case was reported by a consumer and described the occurrence of tinnitus in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th September 2020, the patient received the 1st dose of Shingrix. In September 2020, 5 days after receiving Shingrix, the patient experienced tinnitus. On 29th September 2020, the patient experienced lethargy, injection site tenderness and injection site erythema. On 21st December 2020, the outcome of the tinnitus was recovered/resolved. On an unknown date, the outcome of the lethargy, injection site tenderness and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the tinnitus to be related to Shingrix. The reporter considered the lethargy, injection site tenderness and injection site erythema to be related to Shingrix.  Additional details were provided as follows: It was reported that patient received the 1st dose of Shingrix and 5 days after the vaccination patient experienced ringing in the ears. One day after the vaccination patient experienced lethargy and redness and tenderness at injection site. The events lasted for few days and later resolved. The reporter did not consent to follow up. This case was linked with US2020AMR253566 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR253566:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Skin lesion
Clinical narrative: Developed the shingles rash / still has lesions today; Developed the shingles rash / still has lesions today; still has lesions today; This case was reported by a other health professional and described the occurrence of shingles in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2020, the patient received the 1st dose of Shingrix. On 7th December 2020, 32 days after receiving Shingrix, the patient experienced shingles, rash and skin lesion. On an unknown date, the outcome of the shingles, rash and skin lesion were not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash and skin lesion to be related to Shingrix.  Additional details were provided as follows: The age at vacciantion was not reported. The reporter stated that, 1 month ago from the date of reporting, the partient developed the shingles rash, and still had lesions on the day of reporting. The reporter consented to follow up.