chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received Pfizer booster dose 10Dec2021; received Pfizer booster dose 10DEC21, reports ongoing headache ever since; anti-inflammatory response to vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 30 year-old male patient received bnt162b2 (BNT162B2), administration date 10Dec2021 (Batch/Lot number: unknown) at the age of 30 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021, outcome "unknown", described as "received Pfizer booster dose 10Dec2021"; HEADACHE (non-serious) with onset 10Dec2021, outcome "not recovered", described as "received Pfizer booster dose 10DEC21, reports ongoing headache ever since"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Dec2021, outcome "unknown", described as "anti-inflammatory response to vaccine".  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a nurse concerning to an 8 weeks old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse practitioner refers to an elderly male patient of unknown age. The patient was vaccinated with PNEUMOVAX23 (lot # reported H009826, expiration date 11-FEB-2014) intramuscularly in the arm on 24-SEP-2012. Concomitant vaccine included FLUZONE in the opposite arm on 24-SEP-2012. Sometime between 24-SEP-2012 and 26-SEP-2012 the patient developed redness and swelling at the site of PNEUMOVAX23 injection. He went to see an unspecified physician who diagnosed him with cellulitis at the site of PNEUMOVAX23 injection. The physician prescribed KEFLEX to the patient. He was recovering. A lot check was requested. The patient sought medical attention for the event by going to a physician. This is one of several reports from the same reporter. Additional information has been requested.
muscle pain all over the body; cant sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "muscle pain". The following information was reported: MYALGIA (non-serious), outcome "not recovered", described as "muscle pain all over the body"; INSOMNIA (non-serious), outcome "unknown", described as "cant sleep".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Inadvertently gave Dtap past age 6. She had No Reaction locally or systemically  she en closed
Immediately following vaccination: Myalgia, fatigue, night sweats Persistent following vaccination: Night sweats on a nightly basis, dependent on the amount of sleep / quality of sleep
pt stated she had a sore arm and stiff neck after vaccine and then approximately 11 days later, 3/20/21, developed red, purple, black toes. C/o of numbness and tingling in same toes and developed blisters on her toes. She tested negative for COVID infection 3/22/2021. Stated she feels like she has "Covid Feet" per information on media. Evaluated by PCP at this time.
Vaccines went into 2-8 C thaw state on or about 20-Dec-2021; Received vaccine past  its 30-days Exp date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past  its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 20-Dec-2021) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2022 at 3:07 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past  its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 20-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past  its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 20-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.   No treatment medication was provided.
Patient stated she did not feel bad for the first three days after she got her vaccination(4/23) but that on the third day(Monday 4/26) she started to feel nauseated, had diarrhea, and felt weak.  She said this proceeded to get worse on Tuesday and was worst on Wednesday April 28th, when she felt almost too weak to stand per her reporting.  When we spoke on 4/29/2021- she said she was feeling much better and felt she would continue to improve.
pt recvd vax 4MAR93 & exp numbness on entire rt side, from lips to foot which persisted for 15 to 20 mins; 9MAR93 BP was 152/96;
Extreme vomiting for 5 days, migraine headaches 5 days, arm soreness and body aches.
Soreness, swelling, and itching at the injection site                     Headache Virtigo Lightheadedness Confusion Muscle aches
This is a spontaneous report received from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN] via an unspecified route of administration in the left arm on 16Mar2021 at 16:15 (at the age of 32-years-old) as a single dose for COVID-19 immunization. The patient's' medical history includes Birth control. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medication included TRI FEMYNOR for an unknown indication from an unknown date. On 17Mar2021 at 20:00 the patient began period early, which was not due for another week since the patient has been on birth control for over a decade it was  extremely consistent and patient experienced chills and nausea. The patient did not receive any treatment for event. The clinical outcome of events menstrual cycle abnormal, feeling chills and nausea was recovering. No follow-up attempts are possible; information about lot number cannot be obtained.
That day they diagnosed four other patients with Bell's Palsy who received Pfizer.; This is a spontaneous report from a contactable other hcp (nurse). A non-pregnant female patient of unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration, on an unspecified date, as a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 06May2021, the patient experienced that day they diagnosed four other patients with bell's palsy who received Pfizer. The evet was medically significant. The patient was visited to emergency room. The outcome of the event was unknown.  Follow-up attempts needed; information about lot/batch no. requested. Further information expected.; Sender's Comments: Based on the information provided, A possible contributory role of the suspect product to the development of Bell's Palsy cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021662119 same reporter/product/event, different patient
Rash and Redness and swelling. Started itching 10/02/2016. She left it alone.
Severe shoulder pain; Dose 2 administered on 28-Aug-2021 and dose 3 administered on 21-Jan-2022; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Severe shoulder pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 administered on 28-Aug-2021 and dose 3 administered on 21-Jan-2022) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 01-Jul-2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 administered on 28-Aug-2021 and dose 3 administered on 21-Jan-2022). On an unknown date, the patient experienced ARTHRALGIA (Severe shoulder pain). At the time of the report, ARTHRALGIA (Severe shoulder pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 administered on 28-Aug-2021 and dose 3 administered on 21-Jan-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: 160 lost weight went from 160 pounds to 143 pounds and 143 lost weight went from 160 pounds to 143 pounds.   Concomitant medication was not provided. Treatment information was not provided. Reporters causality for Rinvoq with respect to weight loss and shoulder pain was reported as not related.   This case was linked to MOD-2022-600445 (Patient Link).
Patient received more than one type of COVID-19 vaccine. They received one dose of Moderna 4/14/2021, then one dose of Janssen 9/30/2021.
injection site hurts; coming down with the flu / feel like you are coming down with flu; slight fever; you do not want to move that muscle; restless night of sleep; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced injection site pain, influenza-like symptoms, fever, injected limb mobility decreased and sleep restless. The patient was treated with ibuprofen, benadryl (nos) (Benadryl) and paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, influenza-like symptoms, fever, injected limb mobility decreased and sleep restless were recovered/resolved.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, fever, injected limb mobility decreased and sleep restless to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient got the vaccine in night at 6:30 p.m.  It was very restless night of sleep. The bourbon or rum did not help. The patient probably should have taken Benadryl. The patient requested to take shortly before or after the injection Tylenol or ibuprofen and continue every 4 to 6 hours for 24 hours. The patient would felt coming down with the flu and might have slight fever. The injection site hurts, then move that muscle a lot, even though you were not going to move it. The follow up was not required. This is 1 of the 3 linked cases reported by the same reporter.
No adverse event; Nurse Aid called in to report a temperature excursion for VARIVAX where one dose was administered on 01/05/2023; This spontaneous report has been received from a Nurse aid, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 05-JAN-2023, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, 0.5 milliliters once as prophylaxis (lot number: U026207, which was determined to be valid, with an expiration date on 24-AUG-2023) (product storage error). The administered dose underwent a temperature excursion of 5.7 degrees Fahrenheit (F) for 9 minutes. It was reported that there was no any  previous temperature excursion. No additional adverse event was reported.
He had a vasovagal response. He was diaphoretic, had dilated pupils, and was seen drooping his head. He was attended to by RNs who checked his blood pressure and pulse. His BP was 60/30 and his pulse was in the 40s. He was laid flat with his feet up. His blood pressure was then rechecked a few minutes later and it had come up to 102/60. His pupils constricted back to a normal size and he said he was feeling better. He was given water to drink, observed for 30 minutes and walked out to his car by an RN after 30 minutes of observation. He did report that he does this with all vaccines. He was driven home by another driver.
They had too many days with dizzy; pain only the first day I had pain when I put the vaccine; Headache; Nausea; Feeling sick; I have very frustration; I walk to the front I feeling like somebody pull like itself hard for me to walk; Not feeling good; I  have my pressure high; Tired; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, (Batch/Lot number was not reported), via an unspecified route of administration on 24May2021 as a single dose for COVID-19 immunization. Medical history included hypertension. The patient concomitant medications were not reported. The patient got the vaccine on the 24May2021 and after that patient had problems with disease High pressure for that. The patient had pain only the first day when he/she put the vaccine. The next day it was little bit very dizzy like drunk. The patient thought to report it because they had too many days with dizzy. The patient reported feeling sick. The patient did not know what to do, his/her pressure was so high. The patient reported that he/she had High pressure before but this time it was so much, and he/she was so dizzy that it had caused problem to walk and was like somebody pulling back to his/her place. The patient reported that he/she walk to the front and feeling like somebody pull like itself hard for him/her to walk. Second day after putting the vaccine patient got the dizzy and a little, he/she tried to lower his/her pressure because his/her pressure was high all the time. The patient did not know it was for these and all then he/she had headache, but it was ok. The patient was tired. The patient had nausea. The patient reported that it was already two weeks since his/her pressure was so high every day. The patient was worried because his/her pressure was far to normal. The patient stated that he/she had no medical records. The patient tried to call and click all day to talk to anyone and gone to the internet and there was no answer. The patient had very frustration. The patient did not want to go hospital and did not want to see doctor. The patient wants somebody to talk for his/her many things. The patient got to do something to down his/her high pressure. The patient reported that it already happened to him/her with flu shot. The patient underwent lab tests and procedures which included blood pressure measurement: high in 2021. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 40 years old male patient who received expired 0.5 ml single vaccine ADACEL (lot U5459AB and expiry date 05-Oct-2018) via unknown route in the left deltoid on an unknown date (reported as today). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was not reported if patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
36 hrs p/vax woke up w/rash; no fever; MD dx cause of rash reaction to vax-observe & give APAP for discomfort per mom;
I had pain from my left shoulder that was going down my left arm. It was treated like muscle spasm or tension that was irritating the nerve. I went to see the doctor within a day or two. The doctor did an x-ray and prescribed muscle relaxants. I also alternated between heat and cold to relax the shoulder. Within the last 2 weeks I went to a chiropractor to get my neck adjusted also as my neck was bothering me. That has also helped with the symptoms.
This spontaneous report was received from a 67 years old female patient reporting on herself with high cholesterol and age-related macular degeneration (AMD), allergy to morphine, codeine and "many others" (unspecified) who on 01-OCT-2012 was vaccinated with a dose of AFLURIA under the skin in the upper left arm (dose and lot # not provided). Secondary suspect therapy included PNEUMOVAX23 (dose/frequency, route and lot # not provided). The patient stated that she might have also gotten the pneumonia vaccine at the same time but it was not sure. Concomitant medications included ALEVE, ibuprofen, ZETIA, xanthophyll and vitamins (unspecified, OTC). The patient stated that on 02-OCT-2012 "the day after she got her vaccine", her face was very red and blotchy and it felt hot and almost felt sun burnt although it was not sunburn. On 09-OCT-2012, the patient received a cortisone injection (unspecified) into the ankle. The patient also indicated that on 10-OCT-2012, she noticed a big black blotch on her left wrist extending about 6 inches up her arm. It began to appear as if it were clearing up until 22-OCT-2012 she stated the area was a raised red patch with smaller red areas within it. The patient claimed it might also have something to do with the cortisone injection she received in her ankle but did not know the brand of cortisone injectable she received either. Treatment given for the events included rubbed ice cubes on the area. No laboratory tests were performed. The patient did not seek medical attention. At the time of the report, the outcome of the event was unknown. The relatedness for the events was unknown for AFLURIA and PNEUMOVAX23. Additional information has been requested.
Tingling, Numbness, Vision, Ear issues, Headache, Insomnia, Depression, Anxiety, Muscle injury, Weight loss, Dizziness, GI issues.
Red, sore injection site, large lump forv5 days Nausea for 14 days- helped by ginger tea  and chicken soup 101.2 Oral temp for 2 days followed by temp 99.4-99.7 for  7 days Back and leg pains in both legs caused great difficulty in walking  for v3 days, back pain Weight loss- 4-5 lbs
Patient had small heated patches around the injection site that were warm to touch. NO itching or pain.
5-10 minutes after shot had a metallic taste in mouth, no adverse reactions. Next 2 days the injection site became red, swollen (knot under skin) and grew in size to a silver dollar. My left arm was sore.  Redness and swelling dissipated on 4th day and looked like a bruise.  About 6pm on 4th day, I was itchy on my stomach. I didn't think twice as had a neoprene/spandex brace around stomach/back from exercise. When I finally took a shower at 8pm, I noticed my torso was completely red.  I immediately took 2 Benadryl. Throughout the evening the rash/hives spread to my shoulders. Took 2 more Benadryl at 1am. By morning rash around torso  was almost gone, but some spread slightly to wrists, shoulders, breasts and knees. Took 2 more Benadryl at 8 am. Applied Benadryl cream to few spots on body throughout today. Itching mostly gone but splotches on legs, neck and few on back. Will take more Benadryl about 6pm.
Patient received a third dose of the Pfizer-BioNTech COVID-19 vaccine. Her second dose had been given on 6/11/21.
Dizziness; feeling weak; runny nose; really bad headache; felt it was hard to breath; felt like hisfelt like his chest was pounding/rapidly going; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), HEADACHE (really bad headache), DYSPNOEA (felt it was hard to breath), HEART RATE INCREASED (felt like hisfelt like his chest was pounding/rapidly going) and DIZZINESS (Dizziness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced RHINORRHOEA (runny nose), HEADACHE (really bad headache), DYSPNOEA (felt it was hard to breath) and HEART RATE INCREASED (felt like hisfelt like his chest was pounding/rapidly going). On 21-Apr-2021, the patient experienced DIZZINESS (Dizziness) and ASTHENIA (feeling weak). At the time of the report, RHINORRHOEA (runny nose), HEADACHE (really bad headache), DYSPNOEA (felt it was hard to breath), HEART RATE INCREASED (felt like hisfelt like his chest was pounding/rapidly going), DIZZINESS (Dizziness) and ASTHENIA (feeling weak) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Urticaria 1 hour after immunizations. Returned to office. No wheezing or respiratory changes. Oxygen saturation 99%.
2/10/21- RECEIVED MODERNA; 2/11/2021- FEVER AND FATIGUE; 2/19/2021- CHEST PAIN AND SHORTNESS OF BREATH; 2/20/2021- CONTINUED CHEST PAIN AND SHORTNESS OF BREATH- ER VISIT (ADMITTED FOR PULMONARY EMBOLISM); 2/23/2021- DISCHARGED FROM HOSPITAL TO HOME
Breakthrough case - covid positive with moderate symptoms. Symptoms started 6/17/22. Positive home antigen 6/20/22