chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever started 4/26/05 ranged from 103 to 105 for 10 days. Ambulance was called about 1-1 1/2 weeks after Immunizations. Infant was able to take fluids at that point and she was not taken to hospital.
I had an infarction; chest pain; was not able to sleep; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 10:30 (Lot number: 330308D) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hyperlipidaemia" (unspecified if ongoing); "known allergies: pcn" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin"; Known allergies: vicodin, reaction(s): "Drug allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0164, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM), administration date: 21Apr2021, when the patient was 62 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left, Vaccine Administration Time: 10:45 AM), administration date: 31Mar2021, when the patient was 62 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021 10:30, outcome "unknown", described as "booster"; INFARCTION (medically significant) with onset 19Nov2021 12:15, outcome "not recovered", described as "I had an infarction"; CHEST PAIN (non-serious) with onset 19Nov2021 12:15, outcome "not recovered", described as "chest pain"; INSOMNIA (non-serious) with onset 19Nov2021 12:15, outcome "not recovered", described as "was not able to sleep". The events "i had an infarction", "chest pain" and "was not able to sleep" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: abnormal, notes: This time it was Abnormal, and it showed I had an infarction; normal, notes: Before the vaccinations my EKG was normal. Therapeutic measures were not taken as a result of infarction, chest pain, insomnia.  Additional information: The patient was experiencing chest pain the day of and the day after I received my booster. I was not able to sleep whatsoever. I went to the Doctor and an EKG was done. Before the vaccinations my EKG was normal However this time it was Abnormal, and it showed I had an infarction. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; 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), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Coeliac disease" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing). 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient used Paxlovid from 18Oct2022 to 22Oct2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a registered nurse concerning a female patient with a history of a negative titer before becoming pregnant with her child who was vaccinated with 2 doses of varicella virus vaccine as scheduled. Subsequently, her titer after vaccination was negative. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Vertigo within thirty minutes of immunization. One hour after immunization, chills, body aches. Headache, tightness and burning in ankles and calves, lower legs. Nausea. Tachycardia. Temperature of 101.4 degrees. In bed for twenty four hours. Redness noted in ankles and lower legs on 10/31/2013. On 11/01/2013 hot red areas on left ankle and lower leg, with swelling in left ankle noted. When red areas spread to upper calf I went to Urgent Care for treatment. Keflex prescribed.
vax given approx 1030AM, APAP administered @ 11AM; 4PM pt had dx; temp @ ER was 104; pt observed for 4 hrs, treated w/Motrin; 1FEB94 t102;
Pt described severe swelling from injection site to elbow, redness and pain. Began nite of injection has resolved some when spoke with 3 days after
Nasal congestion, runny nose....started about 1 week later and is still ongoing.
I do have; the vaccine (Unspecified Vaccine) information and the adverse effect information (Unknown if consumer experienced any adverse effect after administration of vaccine); I do have; the vaccine (Unspecified Vaccine) information and the adverse effect information (Unknown if consumer experienced any adverse effect after administration of vaccine); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Intermittent Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for asthma. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "I do have; the vaccine (Unspecified Vaccine) information and the adverse effect information (Unknown if consumer experienced any adverse effect after administration of vaccine)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Home quick view COVID-19 antigen test; Positive, notes: I started testing positive about day may be 9. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: I had a re-bound effect starting the Paxlovid, 10 days after taking the Paxlovid. I am very frustrated because over the weekend I filled out your form on your adverse event reporting on website and after filling out all the detail information you ask for which waste my 45 minutes, your website is crashed would not accept the submission. So, I captured a PDF of the filled out form so I would like to know where I can email it and get it in your system. When probed to spell first name, Consumer stated, "(withheld) (First name not appropriately clarified hence not captured in tab, initials clarified and captured as (withheld)). Reporter stated, "Whatever is in your packaging. Five days, twice a day and you take one pill and one there is two drugs, so each drug is one pill of single drug and all these two pills for the other drugs. Right. Consumer stated, So, the stop date was 09May. Actually, no its the 8, so that will be five days, 08May2022.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Rotarix reconstituted with sterile water/diluent; Rotarix reconstituted with sterile water/diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 35T34, expiry date 18th February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 27th July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 27th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were 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: 05-Aug-2022 Reporter comment: Licensed practical nurse reported that a patient received a Rotarix. The Rotarix was reconstituted with sterile water instead of using diluent. The GlaxoSmithKline vaccine representative filled an adverse event effect for Rotarix with limited information. The representative stated that a nurse from one of her accounts reported that a patient was given a dose of Rotarix with a sterile diluent used versus the accompanying GlaxoSmithKline diluent. The representative had no further information regarding the event, patient, or vaccine. The reporter consented to follow up with HCP. Additional Supportive Information: Rotarix reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The case US2022115896 was identified as duplicate of US2022115894. The case US2022115896 would be voided, and all the future correspondence would be added in this case US2022115896 which stands as a case of record for this patient.
headaches due to grinding of teeth/possibly the Moderna vaccine; pain and soreness near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches due to grinding of teeth/possibly the Moderna vaccine) and VACCINATION SITE PAIN (pain and soreness near the injection site) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Testosterone (Patient was prescribed testosterone therapy once a week).    On 23-Jan-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced HEADACHE (headaches due to grinding of teeth/possibly the Moderna vaccine) and VACCINATION SITE PAIN (pain and soreness near the injection site). At the time of the report, HEADACHE (headaches due to grinding of teeth/possibly the Moderna vaccine) and VACCINATION SITE PAIN (pain and soreness near the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication include testosterone therapy once a week.    Treatment details was not reported by the reporter.
Patient had bilateral pulmonary embolisms; This is a spontaneous report from a contactable physician. An elderly (also reported as 65+ years) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 02Apr2021 (Batch/Lot Number: EN6205) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient is not pregnant. The patient had no known allergies. Concomitant medication included apixaban (ELIQUIS); monascus purpureus (RED YEAST RICE); colecalciferol (VIT D3); calcium; all taken for an unspecified indication, start and stop date were not reported. The patient had bilateral pulmonary embolisms on 07Apr2021 and was hospitalized for 2 days. There are no other vaccines in four weeks, no prior vaccination and was not tested positive post vaccination. Anticoagulation therapy was given as treatment. The outcome of the event was recovering.; Sender's Comments: Considering a plausible temporal relation, a causal relationship between the reported event of Pulmonary embolism and suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as  part of Pfizer procedures for safety evaluation, including the review and analysis of  aggregate data for adverse events. Any safety concern identified as part of this review,  as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was upper GI bleed.
Patient attended Adult Immunization Clinic on 5/28/2008.  Patient requested MMR vaccine for employment purposes.  Patient appropriately screened for pregnancy and denied pregnancy.  Patient counseled regarding postponing pregnancy for 4 weeks following receipt of live virus vaccine.  Vaccine administrator notified on 6/17/2008 from a RN at patients medical provider, that patient is 6 weeks pregnant.  Vaccine administrator provided counselling regarding receipt of MMR vaccine during pregnancy, quoting 2007 Epidemilogy and Prevention of Vaccine Preventable Diseases - Pink Book.  Medical provider instructed to provide individual counseling to patient.  Otherwise, no adverse event or untoward symptoms have occured as of this writing.
Mom reports pt woke @ about 4PM, crying & felt warm; pt given APAP; pt was in daycare when caretaker reported sz activity, fever, irritability, & high pitched cry; Pt seen in offfice, admitted to hosp;
This spontaneous case was reported by a physician and describes the occurrence of SYNCOPE (I know other people who fainted after 2nd dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (I know other people who fainted after 2nd dose) (seriousness criterion medically significant). At the time of the report, SYNCOPE (I know other people who fainted after 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Treatment information was not provided by reporter. Company Comment : This spontaneous  case concerns a patient of unknown age and gender with no relevant medical history who experienced serious unexpected event of syncope. The event occurred  approximately 20 hours after the second dose of the Moderna COVID-19 vaccine. No further details regarding clinical course were provided. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Non Significant follow up received includes updated contact information and correspondence contact ticked for SO follow up.; Sender's Comments: This spontaneous  case concerns a patient of unknown age and gender with no relevant medical history who experienced serious unexpected event of syncope. The event occurred  approximately 20 hours after the second dose of the Moderna COVID-19 vaccine. No further details regarding clinical course were provided. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
Where injection was given red, swollen, warm to touch. Had a lump. Mother applied cool compresses and gave Tylenol.
facial rash; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of RASH (facial rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced RASH (facial rash). At the time of the report, RASH (facial rash) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-018362, MOD-2021-019193, MOD-2021-020875, MOD-2021-021039, MOD-2021-023812, MOD-2021-023822, MOD-2021-023827, MOD-2021-023846, MOD-2021-023852, MOD-2021-023858, MOD-2021-023865, MOD-2021-031172, MOD-2021-031182, MOD-2021-031228, MOD-2021-031235, MOD-2021-031238, MOD-2021-031247, MOD-2021-036084 (E2B Linked Report). This case was linked to MOD21-13071 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. MOD-2021-018362:Same reporter MOD-2021-019193:Same reporter MOD-2021-020875:Same reporter MOD-2021-021039:Same reporter MOD-2021-023812:Same reporter MOD-2021-023822:Same reporter MOD-2021-023827:Same reporter MOD-2021-023846:Same reporter MOD-2021-023852:Same reporter MOD-2021-023858:Same reporter MOD-2021-023865:Same reporter MOD-2021-031172:Same reporter MOD-2021-031182:Same reporter MOD-2021-031228:Same reporter MOD-2021-031235:Same reporter MOD-2021-031238:Same reporter MOD-2021-031247:Same reporter MOD-2021-036084:Same reporter
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had a headache, onset 2021, with outcome of not recovered and injection site pain, onset 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Within 4 hours of receiving the vaccine, I developed chills and an fever of 101.5. I had muscle aches, pains, stomach upset, and nausea. At night I had difficulty breathing so I had to take extra medicine for my asthma. My temperature had went down to 100. I had severe body pains, abdominal pains, and vomiting. I was told to take Tylenol and stay hydrated by my doctor. He sent me to ER on March 11th. I went to ER and they ruled out a Covid or flu infection and any other infections. They said it was caused by the vaccine. They administered IV fluids, pain medicines, and vomiting medicines. 9 hours later after waiting, I decided to leave the ER and continued with taking pain and vomiting medicines. The symptoms lasted for 16 days. I met with my PCP and decided to get the 2nd shot three weeks later. I got similar symptoms as 1st shot with 2nd dose. Off and on I have been having adnominal discomfort. I have been having a hard time swallowing and chewing food. June 2nd I seen my PCP, and he said there was a problem with food processing into my stomach. He sent me to a gastroenterologist on June 22nd and they are scheduling a procedure to take a look into my esophagus and stomach to see the issue.
The day after I received the first dose I started experiencing a tightness and intense pain. It is now almost a year later and the pain has not subsided. It travels throughout my left arm and into my shoulder blade. I have seen my doctor several times and an orthopedic doctor.  I received a cortisone shot, did not work. Prescribed flexeril, again did not work
tested + for covid  7-29-22  to ER with fever, chills , shortness of breath ,given remdesivir  which she completed, she was dc to home after she improved  but also had cellulitis that admission  deceased on 1-17-23
mom states sore all over, t101 APAP given, high pitched screaming/crying all noc per mom; 21SEP91 mom states temp went to 102; states called ER; c/o stiff all over;
My regular menses have completely disappeared when I had previously been regular and my hormone levels went from normal to menopausal levels. I had my levels taken only a month before getting the first vaccine.  I was fine after first dose and got very sick after the second dose and since that time have not had a menstrual cycle or ovulated.
Didn't feel good; started running fever, its spiking up to 101 deg F; Headache; Shooting pain above ears; Felt achy; Didn't sleep well; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA, MALAISE, PYREXIA (started running fever, its spiking up to 101 deg F), POOR QUALITY SLEEP, and HEADACHE in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO medical history information was reported.  Concomitant products included LEVOTHYROXINE and SIMVASTATIN for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced POOR QUALITY SLEEP. On 19-Jan-2021, the patient experienced MYALGIA. On 20-Jan-2021, the patient experienced MALAISE, PYREXIA, HEADACHE, and PAIN (Shooting pain above ears). The patient was treated with TYLENOL at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, MYALGIA (Felt achy), MALAISE, PYREXIA, POOR QUALITY SLEEP (Didn't sleep well), HEADACHE, and PAIN (Shooting pain above ears) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Pyrexia: 101 Degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was received via an unknown source (no reference has been entered for a health authority) on 22-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA, MALAISE, PYREXIA, POOR QUALITY SLEEP, and HEADACHE in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO medical history information was reported.  Concomitant products included LEVOTHYROXINE and SIMVASTATIN for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced POOR QUALITY SLEEP (Didn't sleep well). On 19-Jan-2021, the patient experienced MYALGIA (Felt achy). On 20-Jan-2021, the patient experienced MALAISE, PYREXIA (started running fever, its spiking up to 101 deg F), HEADACHE and PAIN (Shooting pain above ears). The patient was treated with TYLENOL at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, MYALGIA, MALAISE, PYREXIA, POOR QUALITY SLEEP, HEADACHE, and PAIN (Shooting pain above ears) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Pyrexia: 101 Degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt experienced a fever up to 102 for 36 hours post vax, decreased appetite, red throat, no rash. Pt vomited 2 time at 5 days post vax. 7 days post vax, she still has decreased appetite.