chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 59-year-old female patient refers to herself. The patient's medical history and concurrent conditions were not provided, because she did not wish to participate in answering the questions within this report. On 17-OCT-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number, expiration date, dose, frequency and route of administration were not provided). No concomitant medications were provided. On 18-OCT-2016, she experienced severe pain at the injection site. On the next day, the patient experienced more pain and swelling at the injection site as well as headaches and fatigue. The adverse events did not improve. There was a treatment given for the events but the patient did not recovered from them at the time of this report. The patient sought medical attention via contacting with a physician. The relatedness between the events and PNEUMOVAX23 was not reported. Additional information has been requested.
Patient came in today (04/19/2021) so that she could let us know that she has been sick ever since she got her shot 2 months ago.
Guillian-Barre Syndrome and Bell's Palsy - inpatient hospitalization, treated with immunoglobulin infusion, transferred to another Hospital and awaiting further treatment
The patient experienced a near- syncope episode after vaccine administration. The event occurred in the parking lot as the patient was walking to her car. An injury was prevented as staff immediately ran to assist the patient. She was brought back into the clinic for observation and monitoring. She was diaphoretic and pale. The SBP was in the 70s, but vital signs were otherwise within normal limits. The patient was alert and oriented x3 throughout the observation.  The patient was monitored for 20 mins until blood pressure and condition stabilized. Vital signs before discharge were BP 95/62, HR 59, Spo2 99% on room air, and fingerstick blood sugar reading of 105.
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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
In the evening of 12/30 infant child developed inconsolable crying and not taking fluid (mother's breast milk) for about 8 hours. Temp was 100.8 degrees F. Mom took him to ER; all work up done finding was negative. Hospital stay for 1 day for observation. Discharged with no apparent findings. Treated with IV fluids, antibiotics and acetaminophen 80 mg/q.
12 hours after receiving PNEUMOVAX patient complaint of painful arm, then got hot, swollen, large urticarial patch, but not at site of injection. Patient took antihistamine and swelling went down substantially, called patient for follow-up and she said she was much better.
She says that "milk aggravates her stomach" but says she doesn't have an allergy to it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 97 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "She says that "milk aggravates her stomach" but says she doesn't have an allergy to it".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were inadvertently vaccinated with doses of oral, ROTATEQ (lot # reported as K007911 exp March 2016) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
About 7 minutes into my observation period my heart rate rose to 170 bpm and I felt warm and shaky. It took around 15 minutes to return to 70-80; About 7 minutes into my observation period my heart rate rose to 170 bpm and I felt warm and shaky. It took around 15 minutes to return to 70-80; About 7 minutes into my observation period my heart rate rose to 170 bpm and I felt warm and shaky. It took around 15 minutes to return to 70-80; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at first dose right arm on 21Dec2020 11:45 am at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took Zithromax and morphine both cause nausea and vomiting. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. About 7 minutes into patient's observation period, at 21Dec2020 11:45 am, her heart rate rose to 170 bpm and she felt warm and shaky. It took around 15 minutes to return to 70-80. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered. The events were non-serious.; Sender's Comments: A causal association between BNT162B2 and the event heart rate increased cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Patient received second dose of shingrix on 2/12/20, on 2/17/20 she developed a shingles rash on her face, she was treated within 8 hours, the rash was painful for 4 days, and mostly cleared up within 6 days though she is still experiencing headaches as a result.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand=Other/Vaccine brand other=Moderna/Vaccine administration date=29Oct2021/Vaccine dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EP7534), in left arm and on 03Apr2021 as dose 2, single (Lot number: EW0150) at the age of 49 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Oct2021 as dose 3 (booster), single (Lot number: 051F21A), in left arm and on 13Jul2022 as dose 4 (booster), single (Lot number: 049L21A), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Oct2021, outcome "unknown", described as "Vaccine brand=Other/Vaccine brand other=Moderna/Vaccine administration date=29Oct2021/Vaccine dose number=3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: after five days of being symptom free and testing negative; (30Mar2023) Positive, notes: Testing positive four days in a row (so far); (31Mar2023) Positive, notes: Testing positive four days in a row (so far); (01Apr2023) Positive, notes: Testing positive four days in a row (so far); (02Apr2023) Positive, notes: Testing positive four days in a row (so far). Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 21Mar2023 to 25Mar2023. The patient had no known allergies.
Arm itching for 9 days post vaccination; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset Nov2023, outcome "unknown", described as "Arm itching for 9 days post vaccination".
Developed tonic seizure activity (small ones) and duration not known with frothing in mouth, 9 hours, post vax. Also, he had a fever. Was taken to hospital.
Caller took his fist vaccine 18Jan, he got tested positive 25 th; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A male patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller took his fist vaccine on 18Jan2021, he got tested positive on 25Jan2021, her mom died because of covid. Wants to know if he can take his 2nd dose on 08Feb2021, he's going to be out of quarantine before the 2nd dose. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 25Jan2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
68 y.o. female who presents with FEVER, ALTERED MENTAL STATUS, URINARY INCONTINENCE.  DAUGHTER STATES INCONITNENCE STARTED Friday 4/9 AND FEVER AND CONFUSION STARTED TODAY WITH SHORTNESS OF BREATH.  PT WAS SEEN AND SWABBED FOR COVID AND FLU BUT REFERRED TO ER FOR FURTHER EVAL AND WORKUP.  PT IS DIABETIC BUT DAUGHTER REPORTS NOT KNOWING WHERE ACCUCHECKS ARE AS THEY HAVE NO MONITOR AT HOME.  Admitted Inpatient 4/13/21
My pancreas on flame; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PANCREATIC DISORDER (My pancreas on flame) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANCREATIC DISORDER (My pancreas on flame) (seriousness criterion hospitalization). The patient was hospitalized for 2 days due to PANCREATIC DISORDER. At the time of the report, PANCREATIC DISORDER (My pancreas on flame) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.
20AUG92 itching scalp & head w/rash on head w/joint pain, whelps on entire body, went to MD: gave Prednisone; 21AUG92 red rash, chills, no temp; 26AUG92 gave steroid inject; 27AUG92 improved today, edema subsiding, MD stated rxn to MMR;
4 inches in diameter redness. Slightly warm to touch. Denies itching. Only painful upon pressure.
pt recieve shot at 1pm. At 1.02 pm pt had a syncopy episode with brief moment of unconciousness and went to the ground, people around to aid fall. Pt was quickly back responsive and alert but repirations in the 30-40s range and pt was cool and clammy. Pt aided to bench. bp reading was 88/50 and pulse ox was 96%. pt was having a conversation with me (pharmacist). ambulance arrived about 10-15 minutes later and took over
chest pain, a very tight feeling in my chest; chest pain, a very tight feeling in my chest; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: GJ2526) at the age of 58 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (first Booster Dose; Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious), outcome "recovered", CHEST DISCOMFORT (non-serious), outcome "unknown" and all described as "chest pain, a very tight feeling in my chest". Therapeutic measures were taken as a result of chest pain, chest discomfort.  Follow-Up (22Sep2022): Follow-up attempts are completed. No further information is expected.
2 days after receiving the 2nd dose of covid-19 vaccine, I started urinating blood clots. It happened early in the morning and happened the next 4 times urinating. by the next morning I did not see any more blood in my urine.
Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case involves a 62 years old female patient who she received 0.5 ml of vaccine FLUZONE HIGH DOSE (batch number: UJ031AA) (expiry date and dose in series were not reported) via intramuscular route in the left deltoid on 29-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included SHINGRIX for Immunization. It was a case of actual medication error due to inappropriate age at vaccine administration and Overdose. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. Documents held by sender: none
Information has been received from a male physician who reported after he administered ROTATEQ physician will get 3 loose stools afterwards.  Unspecified medical attention was sought.  The outcome was unknown.  There was no product quality complaint.  No further information is available.
SADDLE PULMONARY EMBOLISM ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN ACUTE PULMONARY EMBOLISM HYPOXIA
My son experienced fever, hives all over his entire body, breathing complications, swelling of the face hands and feet.  Knots would appear on his body.  Nose bleeds.
tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 at 17:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Nov2022 at 03:00, outcome "recovering" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: Body temperature: (21Nov2022) 102; SARS-CoV-2 test: (unspecified date) Negative, notes: Tests for 2 days were negative; (unspecified date) Negative, notes: has been negative all this time, over 3 years; (21Nov2022) Positive, notes: she tested positive for Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient received Pfizer Covid-19 Booster, Friday around 5:15 PM. Tests for 2 days were negative then, became sick last night, had fever 102 and general malaise, 3am, going into today, 21Nov2022. This morning, tested positive for Covid-19. It was today, this morning, that she tested positive for Covid-19. General malaise went away, took the Tylenol and it went away. Patient had been negative all this time, over 3 years.  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.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug to the reported events Drug ineffective and COVID-19 cannot be ruled out.
Patient called on 10/29 complaining of pain in arm. Ibuprofen and BENADRYL was recommended. He presented to pharmacy 10/30 with redness, swelling and heat in his arm. He was seen by drop in clinic and prescribed doxycycline and prednisone for cellulitis. Arm much better 11/1/14.
This spontaneous report as received from a Medical Assistant refers to a 2 months old male patient. She reported that the patient was to receive his first dose of live, oral ROTATEQ (2ml) today(on 28-JAN-2013). No other co-suspects were reported. No concomitant medications were reported. She reported that 'two drops" of an expired dose of live, oral ROTATEQlot# unspecified, expiration date was in August 2012, no adverse experience reported. The patient was then given a full dose of live, oral, ROTATEQ (2 ml) lot# was reported a s1539aa, expiration date was on 15-JUN-2013. On 29-JAN-2013, follow up was received from consumer stated her niece's infant son, reported the event of the patient again. Consumer stated even though the child was a restful night last night, and no adverse effects, they are very worried if the child had a overdose of live, oral ROTATEQ. The outcome of event is unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Healthy 20 y/o male 1 day after 2nd Anthrax shot got local swelling, redness (3-4") and mild pruritis & tenderness. No other symptoms exam local reaction.
stuffed nose/stuffed up nose; fever (103F); headache; Cold like symptoms; This is a spontaneous report from a contactable consumer (consumer's daughter) via Medical information team. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 15:00 in arm, (want to say left arm but not sure) at single dose for COVID-19 immunization. Medical history included overweight 200 lbs upwards from an unknown date and unknown if ongoing. There were no concomitant medications. The patient had fever (103F), stuffed nose and a headache on 05Jan2021. The fever went down in the afternoon. The patient asked if it be caused by the vaccine, 1 week later? The patient works in the dietary department of a senior residency facility. The patient received her first dose of Pfizer COVID-19 Vaccine on 28Dec2020. In the morning of 05Jan2021, she woke up with a fever of 100.3 degrees fahrenheit and cold like symptoms. She knows that those symptoms are associated with the Pfizer COVID-19 vaccine from the product paperwork she has; but her question is is it could the symptoms still be from the vaccine when the symptoms did not start until 05Jan2021. The patient was supposed to receive second dose of vaccine around 18Jan2020. She was tested for COVID-19 05Jan2021 with unknown result as of this time. She was tested for COVID-19 31Dec2020 which was negative as far as caller knows. Patient has been tested for COVID-19 for weeks and so far as far as she knows the results have been negative. The results are supposed to be a 24 hour turn around to get results; and the patient explained to caller that if she does not hear anything back about the tests then she assumes they are negative. The patient underwent lab tests and procedures which included body temperature: 103 fahrenheit and 100.3 fahrenheit on 05Jan2021, COVID test: negative on 31Dec2020   , and unknown result on 05Jan2021. The outcome of the event cold like symptoms was recovering while unknown outcome for the remaining events.  Information about Lot/Batch number has been requested.
101 Fever, chills, body aches, severe swelling of arm around shot area, depression, fatigue.
After receiving the flu shot, my son started breaking out in hives after everything he ate, after two weeks it slowed down but did not go away. It's been three weeks and he is still breaking out in hives atleast once a day when he eats.
Headache, nausea, felt like I had a fever but then my forehead was not hot, felt dizzy.  Achy all over my body last night.  That part is better this morning.
Patient was instructed to be seated for monitoring after vaccine was administered. Patient came to my attention at the consultation window and stated she was feeling dizzy at approximately 11:10a.m.. Patient was responsive (breathing with pulse).  Patient requested to lie down on the floor with my assistance.  After a couple of minutes,  she stated she felt a little better and asked to sit up on the floor. We offered water and she drank  it. Her symptoms slowly improves as I was monitoring her. She had someone picked her up around 11:30a.m. Advised her to follow up with her primary provider and call medical personnel when necessary.