chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positve for covid after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positve for covid after first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for an unknown indication.     No Medical History information was reported.   On 08-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (Tested positve for covid after first dose). At the time of the report, COVID-19 (Tested positve for covid after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact
Red rash surrounding injection site and up/ down the left arm from the PNEUMOVAX 23 vaccine.  Rash was warm to touch and painful. Patient reported to Urgent Care center for evaluation and was prescribed oral prednisone and doxycycline as a precaution for cellulitis.
Parents states "Saturday night child broke out. No fever. Rash-like whelps began from "head-to-toe." Mom gave child BENADRYL. Stopped and started again.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment with Paxlovid from 26Jul2023 to 31Jul2023. The patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient received 1st dose of Moderna COVID-19 vaccine on 3/4/21 at another facility. For the 2nd dose at this facility on 3/31/21, he received Pfizer COVID-19 vaccine in-error. No adverse event from this second dose, but this was the wrong vaccine given.
Vaccine administered and RN left room. Mom opened door and patient in arms passed out. Patient placed supine on exam table, vitals stable as patient begins to arouse, at 1120. Snack offered as patient rests. Vitals repeated and stable at 1130. Ambulates out of office with mom at 1135.
14 minutes post injection, patient laid head on table and started shaking. Complained of severe headache, h ands, arms and legs numb. No resp problems. 7:50am given 12.5mg of Benadryl IM. 0800 shaking slowing down, but headache, tinglig in arms, legs still numb. 8:04another 12.5 mg of Benadryl IM given. 8:15 shaking stopped but headache continues. Legs remain "heavy" but arms normal. Patient complains of copper taste in mouth. 8:20 legs mostly back to normal. 8:30 able to walk with no symptoms at this time except for headache. Husband arrives to take patient home.
dizziness; headache; pain; fatigue; nausea; vomiting; Menstruation delayed; Urinate every 5 to 10 min; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 20Apr2021 at 14:45, at single dose, for COVID-19 immunisation. Medical history was none. Patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously took hydrocodone (unknown manufacturer) and the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced dizziness (hospitalization for 1 day) in 2021 with outcome of recovering, headache (hospitalization for 1 day) in 2021 with outcome of recovering, pain (hospitalization for 1 day) in 2021 with outcome of recovering, fatigue (hospitalization for 1 day) in 2021 with outcome of recovering, nausea (hospitalization for 1 day) in 2021 with outcome of recovering, vomiting (hospitalization for 1 day) in 2021 with outcome of recovering, menstruation delayed (hospitalization for 1 day) in 2021 with outcome of recovering, urinate every 5 to 10 min (hospitalization for 1 day) in 2021 with outcome of recovering. The patient has not been tested for COVID-19 since vaccination.    The information on the lot/batch number has been requested.
Upset stomach; loose bowels; headache; arm sore around injection site; fatigue; This is a spontaneous report from a contactable consumer (patient).   A 70-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 07:45 (Batch/Lot number was not reported), age at vaccination of 70-years-old as single dose for covid-19 immunisation. Medical history included atrial fibrillation from an unknown date and unknown if ongoing, drugs hypersensitivity from an unknown date and unknown if ongoing known allergies (penicillin and erythromycin). Concomitant medications included metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported; rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported.  The patient experienced upset stomach, loose bowels, headache, arm sore around the injection site and fatigue, all on 11Feb2021 1900. The patient had not received other vaccine in four weeks. The patient was not tested for covid prior vaccination nor post vaccination.  No treatments were given for the events. The patient was considered to be recovering from the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial report was received from a healthcare professional on 17 September 2012, with follow-up information received on 20 September 2012. The reporter for this case is the same as serious case number 2012-08813 and non-serious case number 2012-08815. A 40-year-old female patient received one (single dose, prefilled syringe) of a left deltoid intramuscular injection of ADACEL, sanofi pasteur Ltd., (sanofi pasteur Inc lot number U2384AA (invalid lot number)) on 14 September 2012. On same day, 14 September 2012, the patient experienced severe itching at injections site, also redness and swelling at injection site. Three days later, on the morning of 17 September 2012, the patient was seen in employee health "Emp Hlt" with vesiculation (site not reported) and she was sent to the emergency room (ER). Laboratory or diagnostic testing and treatments were not reported. The patient had no relevant past medical history or pre-existing physician diagnosed allergies and no illness at time of vaccination. The patient's outcome was reported as unknown. Documents held by sender: None.
Received immunization vaccines, PPD, TD and varicella on 5/21/02. RTC on 05/23/02 for PPD to be read and revealed a red circular area, warm to the touch at the site of the Varicella.
Complained of aches in spine, hips, and knees that lasted a few weeks. Also, reported having a headache for a few days. Has been taking ibuprofen and is feeling better.
blood in her urine/bloody pee; she has difficulty in sleeping; difficulty to pee; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program COVAX US Support. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 05Feb2021 as Dose 2, Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 15Jan2021 as Dose 1, Single for COVID-19 immunization. The reporter stated that after the first dose she was fine, and no adverse events experienced. But after the second dose on an unknown date in Feb2021, she experienced on Saturday and Sunday night at 11:30 PM blood in her urine. Monday morning, she went to doctor and had a prescribed medication and took blood bladder control and antibiotic for the urinary infection 2x a day for 7 day. No bad feeling after taking the medication. She was afraid may be the medication would interfere with the vaccine. She had difficulty in sleeping, difficulty to pee and she experienced bloody pee that was when she needs to go to the clinic and to the hospital. They prescribed penicillin and other medication. She was asked if penicillin will affect the vaccine effectivity. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
STROKE; BLOOD CLOTS; This spontaneous report received from a consumer via social media through a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received with covid-19 vaccine ad26. cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, shortly after getting vaccinated with booster patient had stroke caused by a blood clots (dose number in series 2). As per reporter, "my brother had a stroke shortly after getting the booster caused by a blood clots." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke and blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220210330-COVID-19 VACCINE AD26.COV2.S- stroke, blood clots -This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
prolonged febrile seizure (more than 20 minutes) that required ER attention, (intubation, assisted ventilation w/inc oxygen hospitalization @ hosp;
Fine pinpoint rash started on face; now on arms, legs & stomach - fine red pin points turning yellowish with some crusting - doctor notified - viral infection no treatment given.
Pt. had fever 104F on 12/12/99. Seen in ER. Seen in DR's office on 12/13 & 12/14. Fever on 12/13 went to 104.7F. Skin lesions looked like varicella lesion papular.
11/9/2022 ~ 9:30 p.m. Minor headache, maybe low fever, treated with 500 mg Acetaminophen, stuffy nose - no treatment. 11/10/2022, 1:35 a.m. sneezing and runny nose, mild, not treated, and headache/mild fever treated with another 500 mg Acetaminophen at 2:50 a.m. At 3:10 a.m. ~2.5 mg zolpidem for difficulty sleeping. 11/10/2022 cont. 09:45 continued mild sneezing, runny nose a bit worse, no treatment done. 500 mg Acetaminophen at 1:35 p.m. Headache less, but mild malaise, feeling sick, from about 2:00 p.m. Am not up for much activity.
Pt was given a DTaP in left deltoid on 9/23/03. Mother reports she c/o pain during the evening after the injection and today she has significant swelling and some redness; area is sore to touch (left deltoid). Mother has been giving Tylenol pin. Instructed mother to give children's Motrin instead of Tylenol and apply cool compress.
Patient's mother reported the patient developed warmness and redness to the left upper arm on 10/19/2001, which became more red, hot and very hard by 10/20/2001. Reports redness and warmth continues today, 10/22/2001, but not as severe and hardness resolved.
Erythema, edema, warmth, pain with palpation (L) upper arm.
Started with chills about 12 hours after the shot, headaches, nausea, light-headedness (nearly passed out), dry-heaving, fatigue (slept on and off for 24 hours) Symptoms lasted about 36 hours and then I felt fine again.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 53 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Breast cancer treatment ended 30Dec2022. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid from 24Feb2023 to 01Mar2023.
The evening after getting the vaccine started having pain in armpit that radiated down arm to fingertips.  Woke up in night with pain on left side of chest from sternum to lateral side.
Small elevated erythematous lesions in group in site of injection and pain the palpation left forearm.
Warmth, redness, tenderness, induration at vaccine site, 10x10.5cm diameter, treated with observation.
swollen lymph node in the arm pit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph node in the arm pit) in a 24-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph node in the arm pit). At the time of the report, LYMPHADENOPATHY (swollen lymph node in the arm pit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified birth control. No treatment was provided.
22 year old female presented int eh COVID vaccine clinic for Pfizer #2.   After having sulfa drugs in the past, her platelets did drop.     Lot: EL3247  Administered at 9:54   EE reports that very soon after receiving the vaccine, she began to itch all over.  No shob, lip tingling, itching in her mouth or throat.  The only itching is on her skin.   Once her 30 minutes wait time was over, she told the observer that she was itchy.  I responded to the observation area.    10:34  o2 - 100  HR - 96   EE is pink, AA), does not appear to be in distress.    She has just gotten off of work and is headed home to go to bed.  She lives at home with her mom.  Her mom is a PA.   Discharged pt.  She will go home and take benadryl and tell her mom.
Patient had dose 1 on September 2020; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (1st dose received in September 2020).   On an unknown date, the patient did not receive the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 14-JUN-2022  Reporter's comment: Nurse practitioner (NP) reported a patient inquired about restarting the series or not Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Bexsero, which led to incomplete course of vaccination.
ringing in his ears; Headache; Watery stool, maybe diarrhea; felt like being on an airplane; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A child male patient received bnt162b2 (BNT162B2), administration date 15Nov2021 07:30 (Lot number: FK5618) 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: HEADACHE (non-serious) with onset 15Nov2021, outcome "not recovered", described as "Headache"; DIARRHOEA (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Watery stool, maybe diarrhea"; FEELING ABNORMAL (non-serious) with onset Nov2021, outcome "unknown", described as "felt like being on an airplane"; TINNITUS (non-serious) with onset 18Nov2021 10:00, outcome "recovered" (18Nov2021 13:00), described as "ringing in his ears". Therapeutic measures were taken as a result of headache.  Additional information: It was reported that, first dose at (withheld) on 15Nov2021 at 07:30 am. Stated that, headache immediately at first dose, lasting 48hrs so far. Stated that, gave 10mL children Motrin 24 hours after first dose. Stated that, headache slightly better, but still around. Watery stool, maybe diarrhea, one time between 24-36 hours at school. Stated that, gave another Motrin (same amount) at 36 hours as headache came back. Also expressed felt like being on an airplane. The child stated that, headaches comes and go but not as bad. Stated that, (withheld) continued to say he felt like his in an airplane. Stated that, not clear whether that's the headache or additional symptom. Stated that, (withheld) could not separate the two symptoms. Stated that, the mother reported (withheld) symptoms. Stated that, the mother reported, her son now said he was also experienced ringing in his ears from 10 to 13:00 pm today and so far it's gone. Stated that, events took place after use of product.  No follow-up attempts are possible. No further information is expected.
Severe hives from neck to upper thighs, severe burning and itching, occuring more than 24 hours after injection. Applied ice packs to relieve pain. Hives lasted over 13 hours. I had no over the counter remedy available. No other after effects. Resolved in time. This incident was extremely painful and I was not able to get to a medical facility for care.  No other vaccines in the past several years or medical conditions at this time. I am on no medications for health issues and am perfectly healthy aside from allergies from antibiotics, dust mites and molds.
Redness, tenderness, warm to the touch, a little itchy, swollen and firm to touch, slowly spreading.
3 weeks after she got her second dose, she developed a golf ball size lymph node on her left arm, it was huge; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2021 (Lot number: EN5318) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "foods" (unspecified if ongoing); "anaphylactic reactions" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot Number / Expiry Date: EL9261/ Unknown, Route, Anatomical Location:  Left arm, No. of Previous Doses: This was dose 1), administration date: 22Jan2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "3 weeks after she got her second dose, she developed a golf ball size lymph node on her left arm, it was huge".  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-Up (30Nov2021): Follow-up attempts are completed. No further information is expected.  No further information was provided or obtained.