chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose  2, single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, 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), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever at 103-104 the night of the shot for about 3-4 hours and much crying. Fever next day 101-102.
Pt anxious prior to vaccinations. Stated felt ok afterward, sat in chair 5-10 min afterward. As pt. was walking out to car in hallway became dizzy, weak did not lose consciousness. Client pale in color, c/o tingling (L) arm & entire face. Given OJ. Cold compress BP 76/42 & 90/62. Verbalized 'none now' before leaving facility.
Plaintiffs allege that as a result of immunization in 1-DEC-81, healthy 20 month old suffered high fever & convulsions with resultant permanent paralysis of right extremities, mental retardation & behavioral problems.
PATIENT SAID GOT A RASH ON TRUNK ABOUT 24 HOURS AFTER VACCINE. STARTED TO HURT A DAY LATER, SO DECIDED TO GO TO URGENT CARE. PHYSICIAN AT URGENT CARE DIAGNOSISED HIM WITH SHINGLES AND TREATED HIM WITH ANTIVIRAL. PATIENT THOUGHT IT ODD SO CLOSE TO THE VACCINE, SO HE REPORTED IT WITH ME.
pt has a sz disorder;had a poss rxn to vax;pt recv vax 4JAN97 & had 1 small sz 5NOV97;33hr p/vax had another 8 sz;the final sz being 3 1/4hr status sz;taken by amb to hosp to ER;pt hosp started on sz med;
Received vaccine at 1615. Within 1 min of receiving vaccine pt c/o "feeling funny", looked flushed. Developed a mild HA and about a min later complained of chest tightness and shortness of breath (subjective only). VS at 1620: 192/89-hr 84, SaO2 99%.  Placed supine, placed on O2 @ 1L/Min via NC. EKG done, NSR w/o acute changes or ectopy.  HA worsened (sill only mild-mod) and developed pain to back of neck. BP returning toward normal in 5-10 min. VS @ 1630: 154/89-73 w SaO2 100%. Gradually felt better, discharged about an hour later with mild HA and slightly flushed color. It's worth noting that pt has hx of getting "red" easily on any exertion or emotional changes.
Patient came into the store the day after her Moderna covid booster reporting swelling. I took her into our clinical room so I could see the site and we could have privacy to talk about it. The site was swollen, about 3 or 4 inches in diameter, but it was not red. She reported no difficulty breathing or rash. She did say that she had a headache as well, but it was not severe.
warmth with no fever, fatigue, weakness (generalized), lasting 2 days, missed work 1 day
Case number PHEH2014US024975, is an initial spontaneous report from a nurse received on 09 DEC 2014. This report refers to a 61-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145701) intramuscularly at a dose of 0.5 ml on 06 NOV 2014. The  nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 OCT 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error (incorrect storage of drug).
Pressure in upper chest for 2 days,headaches,chronic fatigue,weakness, palpitations
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (dose, lot # and expiration date were not reported). The vaccine underwent two separate temperature excursions. In the first excursion the vaccine was exposed to temperature between 46 to 77 degrees Fahrenheit for 4 hours. The second temperature excursion details were unknown. There was no adverse effect reported. Data logger was not involved. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent to contact the reporter.; Sender's Comments: US-009507513-1701USA013510: US-009507513-1701USA013513:
had a positive Covid test after receiving the vaccine; had a positive Covid test after receiving the vaccine; This is a spontaneous report from a contactable nurse (patient) via a Pfizer Sponsored program, Pfizer First Connect. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EH9899, intramuscular in the left arm, on 18Dec2020 at 0.3 mL, single dose for COVID-19 immunization. Medical history included was none. There were no concomitant medications. The patient had a positive Covid test after receiving the vaccine with outcome of unknown. It was reported that the patient got the first dose of the vaccine on 18Dec2020, and tested positive on 28Dec2020 due to some exposure. She asked for any recommendations on the second dose whether or not she could get it. She is scheduled to get it this weekend. The reporter considered the event as non-serious and unrelated to the use of the vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded.  The case will be reassessed if additional information becomes available.
severe shaking chills; fever; muscle/bone aches; muscle/bone aches; headaches; nausea; significant weakness; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 40-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via unspecified route on left arm at single dose for COVID-19 immunization on 04Jan2021, 07:45 AM, at 40-year-old. No relevant medical history. No allergies to medications, food, or other products. No concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. On 04Jan2021, 08:00 PM, 12 hours after vaccine, the patient developed severe shaking chills, fever, muscle/bone aches, headaches, nausea, and significant weakness (this lasted about 8 hours). No treatment was received. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.
DTaP 2-28-07 Developed blistering rash on back the next day, then 2 days later developed rash on right leg (Leg DTaP was given) diagnosis contact dermatitis given Arapored. 3-12-07 rechecked and given Keflex and Cutivate for infected area on buttocks.
Tightness of chest, trouble breathing, headache, shivering and fever. Woke 0430 am. Wife called 911 and was taken to emergency room. BP 148/81. Temp. 100.5. Pulse 98.
Rec. vaccines (Hep B) at 4:30 pm. 6-6:30 pm - achy, feverish, sweating, chills, wheezing more than normal. Soup eaten. 715 pm nausea and vomiting x3, diarrhea 230 AM 1/10/08 x 4.5. Used inhaler x1 - helped with wheezing. T-97.
Seizures; Stopped breathing; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a male patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, less than a week after receiving DTPa vaccine, the patient experienced seizure (serious criteria GSK medically significant) and breathing arrested (serious criteria GSK medically significant). The patient was treated with non-drug therapy (Cardiopulmonary Resuscitation). On an unknown date, the outcome of the seizure and breathing arrested were unknown.   It was unknown if the reporter considered the seizure and breathing arrested to be related to DTPa vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine and had seizure, stopped breathing and had to be given cardiopulmonary resuscitation (CPR) in less than 48 hours. As per reporter it would not be easy to guilt people into profiting for you and why did not you let people knew that at the same time you were trying to portray them as predators. The VAERS details were already reported.
Nausea & vomiting, abdominal pain, joint pain, numbness & tingling in hands & feet, fatigue, weight loss. Unable to eat certain foods.  Developed allergy to wheat. These symptoms started 1 to 2 weeks after 1st vaccine. Pt stated felt like "she was 80 yrs old."  Started wheat free diet, visited doctor, lab tests for celiac disease negative, numerous lab tests (lyme titer, cbc, rheumatoid workup, ANA, Sed rate, lupus and all negative.  2 months after vaccine peripheral neuropathy, joint pain symptoms improved.  Continues with abdominal pain, weakness, weight loss & difficulty with foods.  Diarrhea begins and continues to present. Work up by GI specialist includes EGD, colonoscopy, CT's, MRI, GI series, video capsule endoscopy, numerous lab studies.  Allergy testing showing allergy to wheat. Positive for fructose malabsorption. Wheat free & fructose free diet.  Work up continues after 1 year to find source of abdominal pain and watery diarrhea.  7/30/09  PCP records received 7/11/08 to note written 7/28/09.  Initially presented 7/11/08 request to be tested for celiac disease. Reports 2 yr hx of abdominal pain, recently improved on wheat-free diet.  Returned 8/11/08 with c/o 2 months hx of "everything hurting"- joints and muscles, fatigue, decreased sleep, sensitive hearing.  Labs all WNL except (+) EBV Ab IgG showing recent infection.  10/8/09 Hospital records, DC summary received, service dates 3/16/09 to 3/18/09. Assessment: Chronic complex of abdominal pain with diarrhea. Patient developed myalgias, asthenia, fatigue, arthralgias, nausea and vomiting - now resolved. Lost weight. Constipated. Patient now presents with abdominal pain and postprandial diarrhea. Abdomen - diffuse tenderness to palpation.  ICD-9 Codes: 564.1 Irritable bowel syndrome, 787.91 Diarrhea.
Covid 19 I tested positive for covid 19 on July 8th experience stuffy nose, loss taste and smell, cough, body aches, congestion, sore throat, diarrhea; shortness of breath i also had a fever of 103. 0 I was prescribed paxlovid for my symptoms after taking that medication I still felt bad.
Swelling under are, size of 1/2 baseball. Sore and painful. Resolving
Dose 2 given March 16.  For evening of March 17 and into March 18,  nausea and tiredness plus sore arm.  For following 4 days felt OK, a little tired.  But on March 23  again experienced nausea, 1 day vomiting,  no fever though.  Chills.  Rash on lower back with red itchy bumps.  For 7 days had persistent itchy rash, nausea and tiredness.  Teleappointment with PCP on March 29 with prescriptions hydroxyzine pamoate 50 mg , corticosteroid cream and Ondansetron 4 mg with instructions to stay hydrated and go to ER for IV if not better.  This morning March 31 great relief and appetite returning.
Information has been received from a health professional concerning a 5 year old female patient, who on 18-OCT-2007 was vaccinated with a dose of VARIVAX (Oka/Merck) (Lot ####) in her right arm at 13:30. It was reported that the patient experienced fever, arm was very red and swollen, bruised and 5 cm wide, and was described as "huge". It was reported that the patient was still recovering as of 17-JAN-2009. No further information is available.
got sick in between doses so he missed his 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A male patient received bnt162b2 (COMIRNATY), administration date 2021 (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: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "got sick in between doses so he missed his 2nd dose".  Additional information: Patient who came in to receive his 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine. He said he received his 1st dose sometime around January or February 2021. His supervisor told him that he needs to get two more doses because it has already been 6 months since his 1st dose. He said he got sick in between doses so he missed his 2nd dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Elevated heart rate on Day 2 (between 24 - 48 hours). Elevated heart rate remained for 8-12 weeks. Normally, resting heart rate is 65 and while active in the 120s. Woke up on Day 2 with heart rate over 100. Walked from one side of the house to the other and HR was 150.
headache/ head was pounding/ bad headache; dizziness; wondering could the patient has been exposed to COVID again; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 07Apr2021 (Lot number: ER8732) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "exposed to COVID" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "not recovered", described as "headache/ head was pounding/ bad headache"; DIZZINESS (non-serious) with onset Apr2021, outcome "not recovered", described as "dizziness"; SUSPECTED COVID-19 (non-serious) with onset Apr2021, outcome "not recovered", described as "wondering could the patient has been exposed to COVID again".  Additional information: It was reported that the patient experienced the normal side effects that Pfizer listed, every single one of them and then the patient had the headache for probably 48 hours and then it was all last. On 22Apr2021 (previous night), the patient woke up in middle of night with same side effects, same things happened to the patient. It was mentioned that the patient was not a person who normally get sick and was wondering could the patient has been exposed to COVID again.   No follow-up attempts are possible. No further information is expected.
upset stomach; sore throat; Runny nose; Sinusitis; missed dose; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (Runny nose), SINUSITIS (Sinusitis) and PRODUCT DOSE OMISSION ISSUE (missed dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (Runny nose), SINUSITIS (Sinusitis) and PRODUCT DOSE OMISSION ISSUE (missed dose). On 12-Mar-2021, PRODUCT DOSE OMISSION ISSUE (missed dose) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) and OROPHARYNGEAL PAIN (sore throat) was resolving and RHINORRHOEA (Runny nose) and SINUSITIS (Sinusitis) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient taking sinus medicine to treat. No concomitant medication were provided.
Severe body aching, pain level 8, fever of 100.7, diarrhea and severe nausea, headache, chills and shaking
Several minutes after receiving the vaccine, the patient felt dizzy, went in and out of consciousness, and lost sense of sight and hearing. 911 was called by the pharmacist while the patient was taken care of by the pharmacy technician and patient's accompanying person. The ambulance arrived quickly and the patient claimed to have recovered and felt well enough to go home. EMS allowed her to leave.
pt recv vax 18DEC96 & that afternoon pt devel a lemon-sized knot on arm, & exp general malaise & arm pain;
received a extra dose 12-JAN-2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number G9N2M) for prophylaxis.   Previously administered products included Kinrix (On 10th February 2022, received dose). Additional patient notes included the patient was asymptomatic..   On 12-JAN-2023, the patient received Kinrix. On 12-JAN-2023, an unknown time after receiving Kinrix, the patient experienced extra dose administered (Verbatim: received a extra dose 12-JAN-2023). The outcome of the extra dose administered 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: 13-NOV-2023 The reporter reported that the patient received extra dose of Kinrix, which led to extra dose administered. The patient was asymptomatic. The reporter consented to follow up.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C  on or about 24-Dec-2021; Received vaccine past its 30-days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2022 at 12:52 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Mar-2022 at 12:52 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.                   Concomitant medications were not reported. Treatment information was not reported.
Pt c/o pain in L leg behind knee on Day after vacc. Pt waited, hoping for it to feel better. On Tues. 4/13/21, pain was worse and pt had difficulty walking. Pt went to ER, dx with DVT. Treated with Eliquis
Information has been received from a registered nurse (R.N.) concerning a patient who on 15-SEP-2010 was vaccinated with a dose of VARIVAX (Merck) (lot # unknown) instead of ZOSTAVAX (Merck) due to human error. No adverse effect was reported. Follow-up information has been received from a registered nurse BSN who reported that the 75 year old retired patient on 15-SEP-2010 afternoon was vaccinated subcutaneously into the left arm with the first dose of VARIVAX (Merck) in the afternoon. ZOSTAVAX (Merck) was to be given. No adverse events. No further information is available.
This spontaneous report was received from a registered nurse referring to a female patient of unknown age. Information on patient's pertinent medical history and drug reactions/allergies were not reported. On 28-JUN-2018, the patient was vaccinated with one dose of Oka/Merck VARIVAX (strength, dose and route of administration were not reported) (lot # N026071 and expiry date: 20-SEP-2019) for prophylaxis (product storage error). The administered dose of Oka/Merck VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # and expiry date were not reported) (concomitant therapy). The vaccine was stored in the range -9 °C (degree Celsius) to 8 °C (maximum -6.0 °C) for 9 hours 44 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1807USA007149.
approx. 4 hours after injection, I had severe chest pain and pressure. I went to the emergency department for evaluation and testing. All tests were normal. One week post injection I still have chest pain, pressure and tightness.
Chills late evening of the shot 6/18.  Fever and chills upon awakening the following day 6/19/2019.  Fever topped at 101.6 in early afternoon.  Took ibuprofen.   Started feeling better late that evening.  Fatigue 6/20/2019.  Fully recovered 6/21.
I received one flu shot and one pneumonia shot, both in my right arm.  I was given no documentation by my doctor's office.   After arriving at work around 1 PM, I started feeling pain near the injection sites.  By the time I left work around 8:30 PM on October 9th, I  was having difficulty lifting my arm over my shoulder.  The following morning, my right bicep was red and warm, and I was suffering from a massive headache, dizziness and a rapid heartbeat.  As the day progressed, I began having chills, a fever, sweats, nausea, lack of appetite along with the previous symptoms.   The symptoms continued on Friday, October 11, as I continued to suffer from fever, chills, nausea, sweats, dizziness, lack of appetite, rapid heartbeat, and headaches.  On Saturday morning, the fever seemed to finally break, but my right bicep is still red, warm and sensitive to the touch.
pt recv vax & MAR96 pt exp h/a which persisted @ the time of the report;no further details were provided;
No additional AE; Product was administered to patient after an excursion; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.       On 29-NOV-2021 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine Live recombinant human albumin (rHA)(PROQUAD) (lot # U015479 expiration date reported 13-NOV-2022) after an excursion for prophylaxis (product storage error).   The temperature of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored had been between 14F to 46F (31.8F) for 5 hours 30 minutes for lot U015479. No additional adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA001166: