chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever. A mother reported that her son received injection of Prevnar on 1/24/01. Subsequently, the child developed a fever of 101F, irritability and limb restrictions. He recovered. Follow-up info received from the phsyician on 07/17/2001 indicated tha the child received an injection of Prevnar on 01/22/2001.
No adverse event; Received the Moderna vaccine monovalent on 30Oct2021 and second on 30Mar2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the Moderna vaccine monovalent on 30Oct2021 and second on 30Mar2022) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On 30-Oct-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the Moderna vaccine monovalent on 30Oct2021 and second on 30Mar2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the Moderna vaccine monovalent on 30Oct2021 and second on 30Mar2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the Moderna vaccine monovalent on 30Oct2021 and second on 30Mar2022).  The concomitant medication was not reported by reporter. Patient received bivalent on 19-Sep-2022. Patient was over 65 years old, so patient was at higher risk.  The treatment medication was not reported by reporter. This case contains information for the 1st patient out of 2 patients described by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2023-720119 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720119:Patient 2.
5/27/09 Immunizations administered at an exam. 5/31/09 Fever 100-101 degrees. No or rash. 6/1/09 Fever and malaise - no other localizing signs. 6/2/09 Headache, neck pain. Exam with minor symptoms. CBC, Chemistry, Urine ok. Refused LP Recheck 6/2/09 - Sx resolved.
Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 17-AUG-2015, the patient received an improperly stored dose of GARDASIL, lot # K005881, expiration date 14-JAN-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Patient called the pharmacy on 11/03/17 to ask if arm and leg numbness were side effects from the flu vaccination. Patient stated numbness started on 10/30/17 and worsened. Patient also stated that she had blurry vision and cold symptoms following the vaccination. Pharmacy referred patient to primary care for evaluation.
tounge numbness a month after vaccine.  no trouble breathing, no pain, just weird numb sensation on top and bottom of the tounge
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. Since 01-JUN-2017, on unspecified dates, these patients were vaccinated with improperly stored doses of VAQTA (lot # M036459, expiry date 28-OCT-2017 and lot#M036459, expiry date 18-JAN-2018) intramuscularly (strength, dosing details, anatomical location were unknown) for prophylaxis. The vaccine was exposed to the temperature of 47 F to 77 F, for a time frame of 10 hours and 42 minutes. Data logger was involved. The vaccines had previous temperature excursion. No adverse effects were reported. No PQC was involved. This is one of the several reports reported by the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA003783.
This spontaneous report as received from a pharmacist refers to a 55 year old female patient with high blood pressure and without any drug reactions and allergies. It was reported that the patient was also a nurse. On 15-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, lot number reported as K007769, expiration date 09-OCT-2015, dose and frequency were not reported). Concomitant therapies included metoprolol, lisinopril (manufacturer unknown) and lithium carbonate. On 15-NOV-2014, after receipt of ZOSTAVAX the patient experienced an injection site reaction described as swollen lump about the height of six quarters which was warm to the touch. On 17-NOV-2014 (also reported as Monday), the patient saw an unspecified physician assistant for this reaction and the physician assistant administered an injection of DEPO-MEDROL as treatment. No lab diagnostic studies were performed. On an unknown date (reported as now) approximately in November 2014, the injection site become red but the size of a mosquito bite. The outcome of adverse events was reported as not recovered. The relatedness between adverse events and ZOSTAVAX was not reported. Lot number K007769 is an invalid not number for zoster vaccine live. Additional information has been requested.
PATIENT REPORTED EXCESSIVE COUGHING, WITH SOME THROAT/FACE SWELLING AND SHORTNESS OF BREATH. INSTRUCTED TO GO TO URGENT CARE OR EMERGENCY ROOM TO SEEK TREATMENT. UPON EXAMINATION WAS GIVEN NAPROXEN, SENT HOME, AND SYMPTOMS RESOLVED AROUND MIDNIGHT THAT NIGHT. PATIENT RECEIVED FLUZONE HD AND ZOSTAVAX VACCINES.
felt dizzy, slumped, and fell over within 30 seconds of receiving shot. Was able to respond to questions and speak lightly, but not open eyes or sit up.
Recvd vax & 2 months following vax devel pain in lt shoulder & acute SOB; pt was hospitalized for 30 days, was intubated & required tracheostomy; while hospitalized, CAT Scans & MRI(s) done; dx idiopathic bilateral phrenic nerve neuropathy;
Contracted COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Contracted COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076c21A) for COVID-19 prophylaxis.     The patient's past medical history included Lumpectomy in February 2020. Previously administered products included for COVID-19 vaccination: PFIZER/BIONTECH COVID-19 VACCINE (Time 11:00 am, Anatomical site of injection: right shoulder, lot number: ER2613, Dose 1) on 24-Mar-2021, PFIZER/BIONTECH COVID-19 VACCINE (Time 10:20 am, Anatomical site of injection: right shoulder, lot number: EL8729 and Dose 2) on 14-Apr-2021. Past adverse reactions to the above products included No adverse event with PFIZER/BIONTECH COVID-19 VACCINE and PFIZER/BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Hyperlipidemia, High cholesterol and Breast cancer female (Lumpectomy Feb 2020) in February 2020. Concomitant products included ATORVASTATIN for High cholesterol, ANASTROZOLE for Prophylaxis.    On 23-Oct-2021 at 9:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Contracted COVID-19). At the time of the report, COVID-19 (Contracted COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2023, SARS-CoV-2 test: positive, First negative test was 16 days after symptoms onset.         Anatomical site of injection was reported as right shoulder.  On 06-Apr-2022 at 10:30 AM, the patient received fourth dose of PFIZER/BIONTECH COVID-19 VACCINE of route intramuscular, anatomical site of injection right shoulder, lot number FK9893.  On unknown date, the patient received fifth dose of PFIZER bivalent booster for Covid prevention of route intramuscular injection, lot number GJ3277. The action taken, dechallenge and rechallenge was reported as not applicable.  On 06-Feb-2023, the patient experienced non-serious Cough, Congestion, Aches, Fever for two weeks which required Physician office visit. The patient was recovered/resolved from this. No treatment medication information was reported.
This case was reported by a other health professional via call center representative and described the occurrence of erythropapular rash in a elderly patient who received SHINGRIX (batch number L7F7E, expiry date 22nd November 2020) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythropapular rash, itchy rash, pain and shingles. On an unknown date, the outcome of the erythropapular rash, itchy rash, pain and shingles were unknown. It was unknown if the reporter considered the erythropapular rash, itchy rash, pain and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported red bumpy itchy rash on back of neck towards left side was vaccinated on right arm.  No confirmation of shingles by physician.
reported increased hand stiffness after vaccination; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation. Medical history included psoriasis and psoriatic arthritis. The patient's concomitant medications were not reported. The patient previously took adalimumab (HUMIRA) and non compliant with Humira. The patient had psoriasis and psoriatic arthritis, reported increased hand stiffness after vaccination on an unspecified date with outcome of unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "psoriasis and psoriatic arthritis with increased hand stiffness after vaccination" and the administration of BNT162B2, based on the reasonable temporal association. The patient's pre-existing medical condition of psoriasis and psoriatic arthritis might have provided alternative explanations.   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 RA, IEC, as appropriate.
started to throw up, was vomiting; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information team. A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on the left arm (reported as left upper arm) on 23Jan2021 at 11:00 at a single dose for COVID-19 immunization. The vaccination facility type was reported as the clinic. The patient had no medical history. She had no family medical history relevant to the adverse event (AE). The patient's concomitant medications were not reported. The patient did not receive any other vaccines that day. She did get a flu shot maybe a month prior reporting or longer and again mentioned she had no problems with vaccines in the past. She did remember getting a pneumonia shot and another one that she did not remember the name of. She got flu shots every year. The patient had no history of previous immunization with a Pfizer vaccine. The patient explained she experienced vomiting 12 hours after the injection of the first dose of the COVID-19 vaccine. She asked if her symptom was a reported side effect for the vaccine. She also asked how to avoid this experience after the second dose of the vaccine. It was further reported that on 23Jan2021 at about 23:00, when she went to bed, she felt like going to the bathroom. She sat down and started to throw up, she was vomiting, and it came so fast without warning. She made a mess and had to take another shower. This was 12 hours after getting the vaccine and the first time she had ever had this happen. She got a flu vaccine every year, since her husband was a nurse and told her to get vaccinated, but she had never had this to happen with any other vaccine in past. This was her first reaction to anything. The patient was asking if this happens to other people. She had been fine since that had happened, but she didn't have any warning and didn't feel nauseous. She had the sheet and it said you could experience nausea, but she didn't. She even checked with her daughter, son-in-law, and grandson who she ate dinner with and no one else was sick and so they think it's the vaccine and didn't come from something they ate. She had to go back in 3 weeks and was given the sheets/paperwork. The patient also reported that she did wait there at least 15 minutes after getting it to make sure no bad reactions occurred immediately afterwards and she didn't and she figured she wouldn't. The patient thought this one was different. The AE did not require any visit to an emergency room or a physician office. The patient had no relevant tests or investigation assessment. The patient was recovering from the event.  Information on the batch/lot number has been requested.
Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients received improperly stored VARIVAX (Merck) (lot #K002922, expiration date: 26-FEB-2016, lot# reported as L006386, expiration date: 25-FEB-2017, lot# K004652, expiration date: 11-FEB-2017, route and dose were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
severe migraine sore throat swollen glands loss of appetite diarrhea nauseous light-headed fainted earaches cough tired and no energy I went to Hospital
THROMBOCYTOPENIA; ACHE ALL OVER; HOT FLASHES EXACERBATED; NERVOUSNESS; JUST FELT SICK LIKE GOING TO HAVE A VIRUS; FATIGUE; This spontaneous report received from a patient concerned a 65 year female. The patient's height, and weight were not reported. The patient's concurrent conditions included: ITP (Immune thrombocytopenia), penicillin allergy, hypoglycemia, and Hashimoto's disease. The patient was previously vaccinated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number, expiry: UNKNOWN) dose was not reported, dose number in series was 1, administered on 07-APR-2021 to left arm for prophylactic vaccination.  On an unspecified date after vaccinated with covid-19 vaccine ad26.cov2.s, the patient was little sick for 6 to 7 days (fatigue, low grade aching and low grade chills) (dose number in series was 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, 1 total, (dose number in series was 2), administered on 22-OCT-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. After vaccination, for about 15 days, the patient had experienced fatigue, ache all over and had exacerbated hot flashes. The patient stated that she felt sick like she was just going to have a virus. She On 23-NOV-2021, the blood platelet fell from 74 (when she got the booster that is on 22-OCT-2021) to 34. 8 days later, on 03-DEC-2021, they dropped 4 more points to 30. She had thrombocytopenia. All side effects after booster mostly recovered but the platelets are still dropping and the nervousness is still present. The patient stated that nervousness is possibly platelets related. She also said that she will follow up with her primary care doctor.  Laboratory data included: Platelet count (NR: not provided) 74. On 23-NOV-2021, Laboratory data included: Platelet count (NR: not provided) 34. On 03-DEC-2021, Laboratory data included: Platelet count (NR: not provided) 30. (dose number in series was 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache all over, hot flashes exacerbated, and just felt sick like going to have a virus, and had not recovered from thrombocytopenia, and nervousness. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20211215290.(dose number in series was 1 case).  .; Sender's Comments: V0-20211214362- covid-19 vaccine ad26.cov2.s-Thrombocytopenia. This event(s) is considered not related. The event(s) has a compatible/suggestive 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: MEDICAL HISTORY
Arm soreness, headache, fatigue starting morning after injection, not responsive to NSAID?s
I was having too much fever,  headache, feeling very weak up to know, pain whole body
On 2/27/15, patient reported rash/bumps on left back of scalp. Reported that she got poked by a cat's claw in the lip on 2/26/15 (center of lip) and stung by a wasp, also shortly after receiving the vaccine. On 3/25/15, saw her MD for rash/bumps on scalp and was diagnosed with possible cellulitis/folliculitis and prescribed BACTRIM DS ( one BID x 10 days). Patient called MD on 3/4/15 and reported to her MD that the rash/bumps were now painful and asked to be put on VALTREX 1 gm BID as she had not gotten better and thinks she may have shingles. She still currently has symptoms. Currently being treated by physician.
Patient stated that he was very anxious and nervous about receiving his vaccines today. Patient was given his vaccines and stated he felt ok, but we had his sit for about 10 minutes just to keep an eye on him. After about 10 minutes he was asked how he was feeling, he stated he was fine and so he was told he could leave. Upon leaving the room, he became a little lightheaded and fell on the floor. He did not loses consciousness and did not have any pain. He was examined by the provider who saw him and determined that he could leave. (Unsure if vaccine or anxiety related)
Patient received vaccine 7/16/21 and complained of numbness is the arm.  Patient's mother called today, 7/19/21, to inform us of the reaction.   She stated the patient was experiencing numbness from the shoulder down to the hand.  He can move his arm, but cannot feel.  Mother was advised to call patient's PCP.
whole body urticaria and tingling sensation in tongue and throat, facial swelling started 11/10/2021,  anaphylaxis reaction. Hypersensitivity to foods, clothes, dust, and other. I still have urticaria every day. I have used an epi pen three times since 11/10/2021 because several reactions. test perfomed, unable to determine cause of sensitivity and allergic reaction.
Pt received vaccine 9-16-14. We received a call (9/17/14) from pts mother stating the pt's right arm was swollen, red and painful. Mother stated pt had a fever and a headache on 9/17/14. Patient also felt dizzy.
Pt broke out with varicella. Started with few lesions inn bilateral axilla and spread. No fever.
Fever, muscle aches, testicular pain, lasted three days then resolved.  Tinnitus, ongoing.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-OCT-2015 at 20:34, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 6 and 1.8 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports from the same reporter. Additional information has been requested.
2/8/22 pt presents to ED with altered mental state; has had 7 episodes of blank staring, aphasia, upper body shaking/arms flailing; cough and chest heaviness today; pt had a positive COVID test on 1/5/22; EKG showed complete heart block; prepared for OR, and a pacemaker placement; 2/9/22 had a positive COVID test; while pt was in OR she coded and did not survive
THE LAST OF THE THREE SERIES OF VACCINATIONS WAS GIVEN ON 4/4/00.  I CONTINUED TO BE INFORMED THAT I HAVE LYME'S DISEASE AND GO ON EXTENDED COURSES OF ORAL ANTIBIOTICS FOR SEVERAL WEEKS.  I WAS SENT TO A RHEUMATOLOGIST WHO INFORMED ME THAT I HAD ARTHRITIS AND FIBROMYALGIA. I HAVE BEEN ON MEDICATION EVER SINCE AND STILL HAVE JOINT PAIN, NEUROPATHY, AND PROBLEMS WITH MEMORY AND CONCENTRATION. Per 60 day follow up report-Rheumatoid arthritis and fibromyalgia. Currently taking Humira and Methotrexate. Rheumatoid arthritis and fibromyalgia.
Patient received the covid vaccine  dose #2 on 1/13/2021 She reports that she was sick with chills, fever of 102.3, fatigue, headache, muscle pain.  Staff took Tylenol round the clock.   She also experienced bilateral knee and ankle pain .  All symptoms resolved by 1/18/2021. She is back to work on 1/19/2021.
Patient presented to Dr.'s office on 10/17/18 with mild right arm swelling from above elbow to shoulder area, was warm to touch, and erythema.
Fever 99.0 one day. Few scattered lesions.  Vaccination 01/2000.
Narrative:  65 y/o M w/ PMHx of COVID-19 vaccine, Janssen (1st dose: 9/9/21;2nd dose 2/1/22) and Moderna vaccine 0.25ml (08/25/22) reported chest and back pain, swollen face, and swollen left wrist through secure messaging on 8/29/22. This reaction was attributed to Moderna vaccine administered on 8/25/22. Patient was instructed to take diphenhydramine 25-50mg PO q4-6 prn if symptoms become too bothersome.
Information has been received from a consumer concerning her 6 year old son with a sulfonamide allergy who in 2003 was vaccinated with the first dose of MMR II. Secondary suspect vaccination included VARIVAX (Merck). It was reported that the patient experienced encephalitis and subsequently permanent brain damage. The reporter reported that she "thought that giving four live vaccines in one day may have contributed to it". The patient sought unspecified medical attention. Unspecified laboratory diagnostic tests were performed (results not provided). It was reported that the patient had not recovered at the time of the report. Upon internal review, encephalitis was determined to be other important medical event. This is an amended report. Upon internal review, "permanent brain damage" was considered to be an other important medical event. No further information is available.