chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LOWER BACK STIFFNESS; SEVERE KNEE PAIN ON BOTH KNEES; JOINT PAIN; This spontaneous report received from a consumer concerned a 56 year old male. The patient's weight was 170 pounds, and height was 69 inches. The patient's concurrent conditions included seasonal allergy, non-smoker, and no alcohol consumption, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 24-JUL-2021) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced lower back stiffness. On APR-2021, the subject experienced severe knee pain on both knees. On APR-2021, the subject experienced joint pain. On 15-JUN-2021, treatment medications included: meloxicam. On 26-JUN-2021, Laboratory data included: Magnetic resonance imaging (NR: not provided) unspecified. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe knee pain on both knees, joint pain, and lower back stiffness. This report was non-serious.
Low grade fever (100.2F); Body aches; Headache; Chills; This is a spontaneous report from a contactable consumer (patient herself).  This 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EN5318), via an unknown route in the left arm, on 16Feb2021 13:15 (at the age of 38-year-old) at single dose for COVID-19 immunisation, administered at Workplace facility. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number Lot number EN5318), via an unknown route in the left arm, on 26Jan2021 10:00 AM (at the age of 38-year-old) at single dose for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included hyperthyroidism. Past drug history included penicillin allergy. Relevant concomitant medications included methimazole. On 16Feb2021 at 20:00, the patient had low grade fever (100.2F), body aches, headache and chills. The events were assessed as non-serious. Pre and Post-vaccination COVID-19 test were not done. No treatments were given for the events. The patient had recovered from the events on unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Uncontrollable muscle spasms, whole body shakes. Woke from sleep - unable to walk from shaking. Heart Rate @ 120 bpm. Took normal adult dose of Tylenol, symptoms ceased after 1 hour.
clot on the left pulmonary vein; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program COVAX US Support. A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 13Jan2021 09:30 (lot number: FL3022; expiration date: May2021) at the age of 75 years old, as single dose for COVID-19 immunisation. Medical history included high blood pressure (taking losartan), anxiety with COVID; both from an unknown date and unknown if ongoing. Concomitant medications included losartan taken for high blood pressure from Jun2020 to an unspecified stop date; escitalopram oxalate (LEXAPRO) taken for anxiety with COVID from Jun2020 to an unspecified stop date. The patient previously received first dose of bnt162b2 on 23Dec2020 at the age of 75 years old for COVID-19 immunisation (lot number: ELD140; Pfizer product; expiry date: unknown). It was the first time they found a clot on the left pulmonary vein of the patient on 17Apr2021. The patient stated that she felt this was medically significant and that she had no symptoms. She stated that her inner voice said it was related to the vaccine. She started apixaban (ELIQUIS) 5mg twice a day on 09Apr2021 for the clot. She had nothing medical and she was in denial and shock as she had never had an issue until now and she never took pills. She is waiting to get a heart monitor and after that to have a TEE as they want to be sure the clot doesn't go to her heart. She was in complete denial, that she has no symptoms and she is feeling fine. She was told no exertion for 2 weeks, that she can go for walks, she thought it may be until the apixaban kicks in. The patient underwent lab tests and procedures which included chest scan: everything came back normal on unspecified date (6 months ago she had another chest scan), chest scan: unknown result on 07Apr2021. The patient has not recovered from the event.; Sender's Comments: Based on the current available information, the event Pulmonary venous thrombosis is most likely related to an intercurrent or underlying condition which is not related to the suspected drug (weak temporal association). The case will be reassessed if additional information becomes available.  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 Committees and Investigators, as appropriate.
Stiif arm; Little Edema around injection site; Little Swelling around injection site; This spontaneous case was reported by a nurse and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiif arm), VACCINATION SITE OEDEMA (Little Edema around injection site) and VACCINATION SITE SWELLING (Little Swelling around injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Stroke. Concomitant products included INSULIN, ATORVASTATIN CALCIUM (LIPITOR), ASPIRIN [ACETYLSALICYLIC ACID] and CLOPIDOGREL for an unknown indication.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiif arm), VACCINATION SITE OEDEMA (Little Edema around injection site) and VACCINATION SITE SWELLING (Little Swelling around injection site). On 02-Feb-2021, MUSCULOSKELETAL STIFFNESS (Stiif arm) had resolved. At the time of the report, VACCINATION SITE OEDEMA (Little Edema around injection site) and VACCINATION SITE SWELLING (Little Swelling around injection site) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   o No treatment medications provided by the reporter.
Was feeling great after the vaccine, felt some tightening in the arm, soreness.  Later in the afternoon felt tightness and felt like food poisoning.  Significant swelling and harness to the area, chills, nausea and vomiting x2, with fever of 102.   Later that evening did take an Aleve.  Things settled down and was Saturday before he felt like doing anything and comfortable.   He is fine today, just feeling weak, hard swelling at the injection site, but otherwise well.  He does occasional gets chills as well.
Dark red erythema - (L) deltoid - Tdap - painful. Dark red erythema - (R) - Hep A - painful. Dark red erythema (R) - deltoid- MCV - painful. Cold compresses - MOTRIN.
I felt fatigue and a horrible headache. I had a lot of coughing sneezing, nasal congestion. I did not have a fever I felt hot inside. My stomach was hurting, and I was very nauseous. The headache was like I've never experienced. I don't know if that was the medication. I stayed home a week to the 12th and went back to work. On the end of the week, I finally had a fever. I remained to have a cough and music with it now. I was prescribed PAXLOVID during all of this and it had helped.
Fever  flu like symptoms  Narrative:  Approximately 5 hours after vaccine administration she began to have flu like symptoms
This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. on 02-JUN-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017 dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Delayed localized reaction - onset of swelling, erythema, itching at vaccine site 7 days after injection
Patient with local reaction erythema, swelling and itching. Mild headache. Patient take two tablets of Tylenol and apply ice in area.
My period started over a week early, which has never happened in my life. It began five days after receiving the Moderna booster.
I started getting symptoms of muscle aches and pains, headache, night sweats, and chills. About a week later, I had a horrible dizzy event. I went to the urgent care clinic and I was told it was vertigo. I could not drive for 2 weeks. The vertigo was constant that lasted 2 weeks.
Information has been received from a 72 year old male patient with allergy to several unspecified medications, Parkinson's disease, hypertension and gastrooesophageal reflux disease and a history of cataract and anaemia, who in "Fall 2008" approximately September 2008, was vaccinated with "one dose" of ZOSTAVAX (MERCK) (lot # not available). "6 weeks post vaccination" approximately October 2008 the patient developed a case of shingles. The patient also experienced copious emesis that was black and tarry and was hospitalized 5 days for anemia. The patient's shingles and copious emesis that was black and tarry and anemia persisted. Additional information has been requested.
One vaccine was administered on 26-Feb-2022 after the 2 excursion events on 25-Feb-2022 and 26-Feb-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (One vaccine was administered on 26-Feb-2022 after the 2 excursion events on 25-Feb-2022 and 26-Feb-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Feb-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (One vaccine was administered on 26-Feb-2022 after the 2 excursion events on 25-Feb-2022 and 26-Feb-2022). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (One vaccine was administered on 26-Feb-2022 after the 2 excursion events on 25-Feb-2022 and 26-Feb-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter reported that there were three excursion events,1st excursion was on 25-Feb-2022 at 35.6 degrees F for 3 and 30 minutes, 2nd excursion was on 26-Feb-2022 at 46.6 degrees F for 10 minutes and 3rd excursion was on 28-Feb-2022 at 35.6 degrees F for 35 minutes.  Vials were moved from freezer to refrigerator on 24-Feb-2022. It was reported that the vaccines were at refrigerated condition at the time of excursion.   No treatment medications were reported.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received HAV (Havrix) (batch number T57F3, expiry date 16th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 28th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient received Havrix vaccine on 28th February 2023 which was expired on 16th February 2023. The reporter did consent to follow up. Additional supportive information: The patient received a Havrix which was already expired, which led to expired vaccine used.
swollen lymph node on left jaw; itchy skin; This is a spontaneous report from a contactable other healthcare professional, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8737) via an unspecified route of administration in the arm left on 02Apr2021 at 16:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included finasteride (MANUFACTURER UNKNOWN) and minoxidil (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6199) via an unspecified route of administration in the arm left on 12Mar2021 at 16:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. 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 four weeks prior to the vaccination. On 23Apr2021 at 16:00 the patient experienced swollen lymph node on left jaw and itchy skin. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events swollen lymph node on left jaw and itchy skin was not recovered.  No follow-up attempts are needed. No further information is expected.
Inadvertent  higher  than recommended dose given 1.0 ml VS 0.5 ml IM
Fever, chills, cold sensitivity, muscle aches in legs and hands and lower back, and injection site pain.
The patient did not have his COVID vaccination card. When searching the electronic record to determine what dose was appropriate, there were duplicate records because of a name spelling error. It was overlooked that he had had a dose one month prior. He was given a bivalent booster one month early
Pt recvd DTP/OPV/HIB on 24FEB92 & on the noc of 25FEB92 had several episodes over the course of an hr, consisting of 7 or 8 beats of rhythmic simultaneous neck extension & leg flexion followed by postictal drowsiness; 24FFEB also had otitis
This non serious case was extracted from the VAERS database via QSCAN on 11 March 2009 (reference number 266605). A 37-year-old female patient had received an injection of FLUZONE SV 2006-2007 (route site of administration not reported), lot number U2189AA on 01 November 2006 and six hours later she developed red watery eyes, a dry cough and chills(without fever body aches). All symptoms resolved approximately nine hours later and the patient recovered. No additional information was provided.
Information has been received from a health care professional concerning an 18 year old female with HPV high risk, allergy to AMOX, BEANDRYL and penicillins who at 15:00 on 16-MAY-2011 was vaccinated with the third dose of GARDASIL (lot # 0299AA) in her right arm. On 17-MAY-2011, the patient noticed pink rash and tiny bumps where injection was given, and were sore. Patient did not get in reaction from the first shot. At the time of the report, the outcomes were unknown. The patient did not seek medical attention. Additional information has been requested.
The area around injection site had become swollen in a circular shape of (2 1/2 x 3 1/2 inches) in size; hot and pain upon touch; itching. The pharmacy was informed on 12/20/17 at which time the patient was Instructed to take Aleve every 8 hours for 3 days and Benadryl 25mg every 6 hours for 3 days. If the irritation did not resolved or became worst to seek medical attention from her physician.  The patient informed the pharmacy that by 12/23/17 the side effects had resolved.
Pt found in crib unresponsive at 09:00 6-27-90; DTP & OPV given on 06-25-90 at 15:00.  Pt to ER via ambo, no spontaneous heartbeat, pulse or resp. CPR and defib attempted, could not convert v-fib to NSR.  Pupils fixed & unresp.  See WORM.
4/6/11 - 22 y.o. healthy male, student backpacking with friends from May 17 - July 11 2011. Discussed immunization recommendations. Discussed food, water, and mosquito precautions. He is not quite sure of itinerary will consider malaria meds. Options discussed. Client states he has passed out before after receiving shots (states last time was when he was at the dentist to have a cavity filled). HAVRIX and Hepatitis B given. About 2 minutes after injection the client went unconscious without any warning, while sitting in chair. I lowered client to the floor with the help of his friend that was also in the room. He was very pale and had no sign of respirations. He had a piece of gum in his mouth near front teeth that I immediately removed. Mouth to mouth resuscitation was begun. I could not feel a pulse so I gave him 4 compressions when his color improved and he began to breathe. Within another 30 seconds he regained consciousness. As I was lowering him to the floor the owner called 911. By the time the paramedics arrived (approximately 5 min) he was alert and oriented, had good color. He remained on the floor. Paramedics took vital signs. After about 5 more minutes on the floor they sat him in a chair. He started to again become pale and skin became clammy. They placed an oxygen mask on the client and returned him to the floor. He then vomited. The oxygen mask was removed and he was turned on his side. He then had another episode of syncope. He had several tonic/clonic movements. He regained consciousness in less than a minute. Client was able to sit up again to be transferred to stretcher for transport. Transferred by EMT to ER. The entire event from time he received immunizations to transport to ER was 9:45 to 10:10 am. 3:30 pm spoke with client on the phone. He was just discharged from the emergency room. His heart rate was low so they did a stress test that showed no arrhythmia. I told client to call if he has any other issues/questions. Asked if he wanted me to call and speak with his parents he said no. They (his parents) spoke to the staff at the ER. Client should go to medical facility for close monitoring if he receives another immunization.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 03Apr2021 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in left arm and on 24Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17May2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (17May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Report was about covid treatment. No Other medications in two weeks. Anti-viral details reported as, Product = Covid-19 treatment, Brand=Paxlovid. Treatment started on 06May2022 and Treatment stop date was 10May2022, Indication was reported as Treatment of Covid-19. Covid vaccine details reported as, Vaccine brand was other= Moderna, Vaccine lot was unknown, Vaccine lot unknown reason reported as, Misplaced/discarded, Vaccine dose Number was 3, Vaccine location was Left arm. Vaccine lot was unknown for Pfizer vaccine, Vaccine lot unknown reason was mentioned as, Misplaced/ discarded, Vaccine dose Number was 2. Vaccine lot was unknown for dose 1, Vaccine lot unknown reason was reported as, Misplaced/ discarded. Adverse event was reported as One week after stopping Paxlovid, I got running nose & watery eyes & lost sense of taste & smell. I started testing positive again after testing negative on day 7. Adverse event start date was 17May2022. adverse event start time was 05:00 PM. Patient was Recovering. No treatment ae. No Known allergies. No Other medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Shingles like rash along v cranial nerve on the left side only, extreme pain in left ear, left eye, left upper jaw.
Child got Varivax on 9/16/02 and receive developed chicken pox (full case) on 10/01/2002. May have been incubating at the time of vaccination.
Erythematous rash on face trunk and arms and legs.  Both thighs (site of the injections) were swollen, indurated and warm to the touch.
inadvertently administered an expired Boostrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 59-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 775YF, expiry date 22-APR-2023) for prophylaxis.   On 10-JUN-2023, the patient received Boostrix. On 10-JUN-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: inadvertently administered an expired Boostrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-JUN-2023 The reporter called to inquire if the patient should be revaccinated with Boostrix. The reporter did not consent to follow-up. A patient was inadvertently administered an expired vaccine of Boostrix, which led to expired vaccine used.
Resident had chest pains and rapid heart rate and felt like he was going to have a seizure. Laid back down for a few hours, then EMT called at 6:19 am and transported to hospital. Hospital update that he does have a fever and have him on IV fluids. Tests came back that his cumin levels were high. Patient is back home.