chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very sore arm near injection site; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590) via an unspecified route of administration in the right arm on 11Oct2021 at 20:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 30Aug2021 at 10:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. On 12Oct2021 at 08:00, the patient experienced very sore arm near injection site. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the event. The clinical outcome of the event very sore arm near injection site was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
The child had a seizure right after the needle was removed from her arm. The seizure lasted about 3-4 seconds. The child had no recollection of what had happened and was very tired but alert. EMS arrived in about 7 minutes. While they were talking to her and her parents, the child fainted again. EMS took her to the hospital in an ambulance.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid like symptoms), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in September 2020.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced COVID-19 (Covid like symptoms), HEADACHE (headache), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and VOMITING (vomiting). On 05-Mar-2021, COVID-19 (Covid like symptoms), HEADACHE (headache), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.
felt a little stuffy; sick; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. This Nurse reported information regarding a coworker. The patient felt a little stuffy and mentioned that no one was sick like her; no one else missed work; they all went around the same dates to get the vaccine because they work in home health kind of roles; so they did not all get them at the same time like if they were in a facility. The outcome of the events was unknown.  Information about Lot/Batch number is requested.
The patient presents with weakness and Presents with multiple medical issues including dermatomyositis cirrhosis of the liver atrial fibrillation ascites pleural effusion hypoxia patient's increasingly confused and weak
**Please note, the report does not mention which COVID vaccine, only that it was the second vaccine so we are not certain if it was Pfizer or Moderna)   The patient presents 6/5/21  with fever, Began feeling poorly the night prior. Received second COVID vaccine 6/4/21. Mild abdominal pain worsening throughout night. Fever noticed this morning. Mild nausea without vomiting or diarrhea. Denies ill contacts. S/P red cell exchange 6/2/2011 and no chest pain. The fever began last night, the maximum temperature is subjective and course is constant. The associated symptom is none. Differential Diagnosis: Fever, viral syndrome, Vaccine reaction. Heme recommends Reviewed case and labs. Recommends single dose Rocephin IV and agrees PT is stable for discharge home pending F/U in clinic. Pt sleeping. Sao2 88% on room air. PT feels the same. Plan to admit for obs.
This spontaneous report as received from a medical assistant refers to an unknown number of patients. On unknown dates the patient were inadvertently vaccinated with improperly stored PROQUAD (Merck) (lot #, expiration date, dose and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Pt was in chair in observation area when he started becoming lightheaded. His companion asked for water which was provided along with candy.  Pt fainted in chair at which time, pharmacist and Clinic NP attended to him. He was slid from chair to floor. He became somewhat conscious but not fully cognizant. NP called for emergency assistance, paramedics arrived, examined him and left approximately 10 minutes later when pt was feeling better
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (pfizer) concerned a 65 year old male. Initial information was processed along with additional information on 25-OCT-2022.  The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (unspecified). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient received three doses of spikevax (elasomeran) (Dose number in series 2) (form of admin and route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered on an unspecified date for covid-10 prophylaxis.  It was unknown whether the patient had any adverse events following vaccination with three doses of spikevax (elasomeran) (Dose number in series 2).  The patient also received spikevax (elasomeran) (Dose number in series 3) (form of admin and route of admin was not reported, batch number: AS71448, expiry: Unknown) dose was not reported, administered at left arm on 07-SEP-2022 15:30 for covid-19 prophylaxis and was associated with revaccination with different covid-19 vaccine. On 03-OCT-2022, the patient had covid-19 symptoms and had confirmed covid-19 infection (Dose number in series 3) which leads to confirmed clinical vaccination failure (Dose number in series 1).  The patient received non company suspect drug paxlovid (form of admin, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered from 05-OCT-2022 to 10-OCT-2022 for covid-19 treatment.  On 08-OCT-2022, the symptoms were resolved (Dose number in series 3).  On 11-OCT-2022, Laboratory data included: continued to had COVID-19 virus test Positive. On 13-OCT-2022, Laboratory data included: COVID-19 virus test Negative. On 15-OCT-2022, with no symptoms the patient again COVID-19 virus tested Positive. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and with paxlovid was drug discontinued. The patient was not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000256598; Sender's Comments: V0:20221046930-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure.The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Rash at injection site and swelling in the upper arm and shoulder, beginning Sunday and worsening by Monday, then lessening over the next couple days. Sunday night-Tuesday: Headache, fatigue, chills, generally feeling like garbage.   Took Benadryl pills for the rash and Excedrin for the headache. Topical treatment of Instaflex pain relief.   Took 2 days off from work and slept, mostly.  Reported to Dr. with photos, over first two days, who recommended antihistamine and continuing to receive shot #2 on May 1.   Feeling better by Wed. Back working remotely, with just a minor rash at injection site. Most of the swelling is gone.
Swollen lymph node on injection side of body, pain in the armpit. Pain radiating down the arm.
PATIENT REPORTS HEART PALPITATIONS WHICH BEGAN 3-4 HRS POST INOCULATION. THERE WAS AN APPARENT EXPERIENCE OF BREATHING DIFFICULTY ALSO.
This spontaneous report as received from a medical assistant refers to 3 patients. The age range of all 3 patients involved was from 55 to 65 years old. This involved one male patient and 2 female patients. All patients were vaccinated subcutaneously in the deltoid area of the upper arm with a 0.65 ml dose of ZOSTAVAX (lot number reported as H109779, expiration date unspecified). No other co-suspects were reported. No concomitant medications were reported. On approximately 03-AUG-2012, approximately a week ago, all 3 patients experienced similar localized reactions that included redness and swelling. One of the patients (unspecified which one) also had a headache and another patient (unspecified which one) had a lump at the injection site. It was reported that all 3 doses of ZOSTAVAX came from the same lot number. All 3 patients did not seek medical attention. No treatment was given for the events. No lab diagnostics studies were performed. The causality between the events and a ZOSTAVAX was unknown. At the time of the reports patients' outcomes were unknown. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Slept as usual the night of injection. The next morning, I felt like when I had COVID back in October ... a little fatigue, headache, difficult breathing. I went to work, but came home to rest for an hour before going back. I took Tylenol and felt better. Over the weekend, I took Tylenol 2 or 3 times more. Today, Monday, I feel fine.
Patient fainted and felt dizzy roughly after 10 minutes upon receiving the vaccine. She immediately gain consciousness  but could not recall that she fainted and just said she "blacked out". The pharmacy staff took her blood pressure, and said it was low but after monitoring for 10 minutes, it went back to normal. She felt no more dizziness, was able to stand up, walk normally and went home shortly after.
Fluish-like symptoms; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: This age at the vaccination was not reported. The physician reported that patient had flu-like symptoms after 12 hours of Shingrix vaccine and lasted for about 36 hours. The reporter consented to follow-up.
Patient was admitted because of generalized fatigue, confusion and loss of appetite due to loss of taste sensation for last 2 weeks.   Patient was sleeping a lot recently and not taking his medication.  He denies any chest pain or shortness of breath. Patient was placed on oxygen.  Started on a dexamethasone and Decadron.  Also started on vitamin C vitamin D and zinc.  He did have a period of confusion it was felt to be due to delirium tremens.    CT scan of the brain was negative.  He does not have any respiratory distress.  He was able to wean off the oxygen completely.  He was clear for discharge.
Joint & muscle pain. Severe muscle cramps in feet & hands. Foot cramps still continue 1 year later.
This spontaneous report as received from a registered nurse refers to a 3 patients of unknown age and gender. On 28-AUG-2014 the patients were vaccinated with a dose of improperly stored VARIVAX (Merck) (route and dose not reported, lot # K002925, expiration date 26-FEB-2016). It was reported that the excursion for the VARIVAX (Merck) in question was found to be supported with in-house stability data. No adverse symptoms reported. This is one of several reports from the same source. Additional information has been requested.
swelling lump on the injection side; received a dose of Shingrix subcutaneously; swelling lump on the injection side; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2020, the patient received Shingrix (subcutaneous). On 15th August 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling and intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site lump. On an unknown date, the outcome of the injection site swelling was not recovered/not resolved and the outcome of the injection site lump and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site swelling and injection site lump to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix subcutaneously on her left arm, which led to intramuscular formulation administered by other route and then developed a swelling lump on the injection side, it was administered. The reporter consent to follow up.
After taking this vaccine at 9am Monday 12/21/2020 (which I normally do not get a flu vaccine every year) I went to bed at 11pm and 5am the next day 12/22/20.  I had burses on my thigh and bug bites going from my groin to my knee. I talked to a doctor already, and It is NOT scabies since she saw it.  I never got burses before and I LIVE ALONE. No one comes within 6 feet of me ever. I washed my sheets and all bedding Tuesday morning, I looked for bed bugs the day and night after the bites appeared. I still have the bug bites on my leg.
pain in my arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in my arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (pain in my arm). At the time of the report, MYALGIA (pain in my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Between 2 and three weeks after the initial dose, I started developing joint pain in the right elbow of the arm that was vaccinated. By the following night, I felt the same type of pain in the ulnar and radial side of my wrist as well as in my right metacarpophalangeal joints,  and proximal and distal interphalangeal joints. The joint pain has, since, spread to the left side of my body and can be felt in both knees. The pain is sore and slightly warm and is unlike any joint issues I have experienced before, much less all at once within a short span of time.  The second dose was administered on April 13 (yesterday) and I have experienced an increase in affected joints but not in the level of severity.
Suspected vaccination failure; flare ups of shingles; This case was reported by a other health professional and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. The reporter stated that, the patient experienced shingles after vaccination with Shingrix. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Patient reported that one week after vaccination they experienced hives that started on the arm that was vaccinated and spread to the chest, abdomen, and legs. They report that the hives lasted 3-4 days and were mild. They reported taking Benadryl and that it helped with the hives. The hives resolved after 3-4 days. Denies any itching or swelling in the mouth or throat. Patient reported that they did go camping a few days before the hives showed up. They are unsure if that is related to the hives.
Slight headache, tiredness, chills, and partial loss of appetite through most of the third day following the injection. ( I FORGOT TO MENTION THAT I HAVE BEEN DIAGNOSED WITH A LOW HEART RATE).
Patient took acetominophen(tylenol) as she cannot take advil or motrin per md instructions.
she still isn't feeling too well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 22Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset Sep2021, outcome "not recovered", described as "she still isn't feeling too well".  Additional information: This is the second case of the two cases. This case is for the reporter sister. Reporter stated that they had Covid vaccine first one on 22Sep. Her sister had the very same day she called up and she had a same reaction (further not clarified), other than that I think she has something little bit extra but she still was not felling too well (hence, split made) and both of us are very concern about it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Covid-19 for which Paxlovid was given; Dose 1 12-FEB-2021 and Dose 2 3-MAR-2022; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 12-FEB-2021 and Dose 2 3-MAR-2022) and COVID-19 (Covid-19 for which Paxlovid was given) in a 66-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) from 01-May-2022 to 02-May-2022 for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 12-FEB-2021 and Dose 2 3-MAR-2022). On an unknown date, the patient experienced COVID-19 (Covid-19 for which Paxlovid was given). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 03-May-2022 to 08-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 12-FEB-2021 and Dose 2 3-MAR-2022) and COVID-19 (Covid-19 for which Paxlovid was given) outcome was unknown.            Company comment: This spontaneous case concerns a 66-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19, approximately two months after receiving the second dose of mRNA-1273 vaccine. The patient was treated with a course of Paxlovid (Nirmatrelvir + Ritonavir) for 5 days; following this, she had rebound COVID-19. Outcome was reported as unknown. Details of medical history, clinical course, further investigation reports, and treatment were not provided. It is noted that the patient received first two doses of mRNA-1273 vaccine at a time interval of 1 year and 19 days (Inappropriate schedule of vaccine administered), which could be a confounder in conjunction with current pandemic situation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-577169 (Patient Link).; Sender's Comments: This spontaneous case concerns a 66-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious of COVID-19, approximately two months after receiving the second dose of mRNA-1273 vaccine. The patient was treated with a course of Paxlovid (Nirmatrelvir + Ritonavir) for 5 days; following this, she had rebound COVID-19. Outcome was reported as unknown. Details of medical history, clinical course, further investigation reports, and treatment were not provided. It is noted that the patient received first two doses of mRNA-1273 vaccine at a time interval of 1 year and 19 days (Inappropriate schedule of vaccine administered), which could be a confounder in conjunction with current pandemic situation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
pt states her arm was puffy and hurt for one day after taking the covid vax.  This was better the next day but a week later her left arm started itching.  It became red and had a pea size knot around the injection site.  The next morning it was more swollen, red and itchy.  Pt states the symptoms are not any better but not any worse at this time.
Immuns adm @ 9AM; mom called @ 430PM stating pt exhibited persistent unconsolable crying for "several hours"; took to PMD who advised no further pertussis;