chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received from a health care professional on 09Oct03 concerning two vaccinees of unk demography who experienced fever, night sweats, stiff joints and headache on 07Oct03 after receiving Fluvirin vaccine on 07Oct03. On 07Oct03, two vaccines received Fluvirin and later that evening they both experienced fever of 101-102 degrees F, night sweats, stiff joints and headache. The vaccinees symptoms improved on 09Oct03. There was insufficient information to determine the reporter's causality assessment. No follow up pending as the reporter will not collect any further information. Update 1, 17Dec03. A follow up report was received from a health care professional concerning a male vaccinee, of unspecified age who experienced fever, night sweats, stiff joints, headache and achiness all over on 07Oct03 after receiving Fluvirin vaccine on the same day. On 07Oct03 the vaccinee experienced fever, night sweats, stiff joints, headache and achiness all over following Fluvirin vaccination. No follow up pending as the reporter will not collect any further information. Cross Reference with PJP200300788.
Fatigue, shortness of breath,  digestive issue, headache.  Symptoms took 10 days to mostly go away. Still have shortness of breath. Took Tylenol and got lots of sleep.
Two days after the shot I had a really bad cold, during the cold, I noticed that my lip and tongue felt funny. A day after I was over my cold (no more symptoms) My eye began to water by itself and I could see a stye on my inner lid. The next day (Today) I noticed I couldn't purse my lips around a straw, and my right side isn't moving at all. My eye won't blink unless I force it, and my lip won't move.
I have had leakage in urine and like I normally can control it but it seems like it just came out, just ripped out, it was enough that my penis got wet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: URINARY INCONTINENCE (non-serious) with onset 09Dec2022, outcome "unknown", described as "I have had leakage in urine and like I normally can control it but it seems like it just came out, just ripped out, it was enough that my penis got wet".  Additional information: Patient received last COVID shot (clarified as Pfizer COVID-19 Vaccine) on 09Dec2022 (reported as yesterday) and patient really did not have any side effects at all. So far it was only been about 24 hours but one thing patient noticed was, patient took a lot of prescriptions (unspecified medication). So, patient drank a lot of water but it seemed like for the last day patient had not been able to hold urination, it was twice in 24-hour period. Patient had leakage in urine and like patient normally could control it but it seemed like it was, patient did not know how to explain it, it just came out you know, just ripped out. It was not a lot but it was enough that patient's penis got wet. Only twice because patient usually urinated maybe up to 10 times per day. So, patient drank a lot of water with all the medication that patient took. Patient inquired if it was a common thing or was it, of any concern to patient because of the shot. It never happened before. The report was not related to a study or programme.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Neighbor shared that after her son had the 2nd dose, he developed severe symptoms described as "an electric current" constantly running through his body.; may not be able to resume normal activities for a while; This is a spontaneous report from a contactable consumer (Pfizer employee). An adult male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date in May2021 as dose 2, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient been tested for COVID-19. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date in May2021, the consumer reported that, after her son had the second dose, he developed severe symptoms described as "an electric current" constantly running through his body. While improving, he is still experiencing symptoms and may not be able to resume normal activities for a while. The reporter classified the events as non-serious and stated the events result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events. The outcome of the events was resolving.  This follow-up is being submitted to notify theta the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
persistent crying for 24hrs;fever 102 R for 48hrs;seen in ER 9FEB96 late evening w/above sx & also some vomiting & loose bowel movements;
Received call from pt 10/28/03 08:00: reports miserable night. Extreme pain in leg, hard to bear weight, nausea and emesis. Did report going home and gardening till early evening when felt increased pain. Took narcotic pain reliever which she uses for other health problems. Had emesis and increased pain through night and next 2 days off work.
From initial information received on 4/13/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 19 year old male patient received his second dose of IMOVAX RABIES, lot number X0581, route and site of administration not reported on 3/31/04. Within 48 hours of vaccination, the patient experienced dizziness, weakness, nausea, and vomiting as well as subjective feeling of fever. The patient previously experienced arm soreness and tenderness after receiving his first dose of Imovax rabies. Reportedly, the symptoms persist but are improving. The patient had not yet recovered from these events. From additional information received on 5/10/04 from the initial reporter, the patient was seen by a physician and recovered from the adverse events on an unspecified date. He returned to work on 4/19/04. It was also reported that the patient received his third dose of IMOVAX RABIES on 4/21/04. No adverse events were reported following administration of the third dose. No further information is anticipated, this case is considered closed. The reporter of this case is the same reporter of case 200401511.
4 1/2 hrs with administrations vaccine c/o cough nausea; fever; chills; HA -better after 24 hours.
light headed, dizzy after 15 to 20 minutes,  lasted for 30 minutes.
Sore throat (difficulty swallowing), swollen glands, joint pain, low grade fever (99.8), sore arm, for 7 days. Day 9 delayed COVID arm with 8 x 8cm outer ring, and inner bullseye of 4cm x 3cm hot to touch, pain on site, swollen . Returned low grade fever on Day 15.
COVID vaccine breakthrough case Pfizer 4/15/21 EW0158, 5/6/21 EW0179 and boosted 5/16/22 FJ4989
pt recv vax & devel an inj site rxn characterized by erythema & induration;also exp fever (degree unk) chills, muscle aches, & arthralgias;tx w/DPH & recovered;
No adverse event; First dose on 06-Feb-2021 and second dose on 02-Mar-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 06-Feb-2021 and second dose on 02-Mar-2021) and NO ADVERSE EVENT (No adverse event) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 13A21A and 024M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Overweight and Borderline diabetes.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 06-Feb-2021 and second dose on 02-Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 06-Feb-2021 and second dose on 02-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Oct-2022, SARS-CoV-2 test: (Positive) Positive. On 11-Oct-2022, SARS-CoV-2 test: (Negative) tested negative at night. On 14-Oct-2022, SARS-CoV-2 test: (Positive) tested positive at night. No concomitant medications were reported.   The patient received Moderna dose 3 (Batch/Lot No: 033F21A) on 02-Nov-2021 and dose 4 (Batch/Lot No: 054A22A) on 06-Jun-2022.  On 05-Oct-2022, the patient experience symptoms and was tested positive on 06-Oct-2022. He received unspecified steroid shot and started Paxlovid treatment on the same day. The patient did not have major symptoms aside from slight cough and phlegm and was tested negative on 11-Oct-2022 at night. He continued to have slight cough and phlegm, tested positive on 11-Oct-2022 at night. The patient was not taking any medications/products within 2 weeks of starting COVID-19 treatment.   No treatment details were reported for event inappropriate schedule of vaccine administration.
Information has been received from a physician concerning a 4 month old female with no past medical history and no known drug allergies who on 8/22/01 was vaccinated with haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast). Concomitant medications included 4 other vaccines from other pharmaceutical companies. Within 24 hours, the pt had petechiae on her extremities. Unspecified medical attention was sought. No further information was provided. Additional information has been requested. The follow up states within 24 hrs the pt had petechiae on her lower extremities, away from the site of the injection, on both legs. The site of the injections was without swelling, petechia or erythema. The pt was considered recovered. Unspecified medical attention was sought. No other info is expected.
Information has been received from a physician concerning a female with reflux who was vaccinated with the first dose of ROTATEQ.  Concomitant therapy included PREVACID.  It was reported that the patient had intussusception.  The patient had inconsolable crying episodes and fussiness 1 day after receiving her 2 month immunizations.  The patient had a normal bowel movement on the morning of 12-Jun-2008 but had episodic crying and later had 3 small bowel movements with specs of blood with a low grade fever.  There was no vomiting and the patient was on breast milk.  The patient was admitted to the hospital on 12-Jun-2008 and discharged on 13-Jun-2008.  It was reported that the patient had fluoroscopy for barium enema.  It was reported that the patient recovered from these events on 13-Jun-2008.  The reporter considered intussusception, inconsolable crying episodes, fussiness, low grade fever, 3 small bowel movements with specs of blood and episodic crying to be other important medical events.  Unspecified medical attention was sought.  No product quality complaint.  Additional information has been requested.  9/15/2008 D/C summary received for DOS 6/12-13/2008 with D/C DX:  Intussusception.  Pt presented with inconsolable crying and 3 BMs with blood. PE WNL except for crying. Barium enema done with no residual IS identified. It was felt that the IS was resolved.  Pt admitted for observation, had no pain o/n and was able to advance diet. Pt had a slightly heme (+) stool post-procedure.
PAINS IN MY LEGS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, 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, the subject experienced pains in my legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pains in my legs was not reported. This report was non-serious.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 02-NOV-2012 at 12:41, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
COVID 19; COVID 19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) and in Jun2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), in Oct2021 as dose 1, single (Batch/Lot number: unknown) and in Feb2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown). The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Allergy: Sulfa antibiotics" (unspecified if ongoing); "Allergy: mussels" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Sep2023) negative, notes: Positive COVID-19 rapid antigen test result on 19Sep2023. Test result was negative on morning of 18Sep2023; (19Sep2023) Positive, notes: Positive COVID-19 rapid antigen test result on 19Sep2023. Test result was negative on morning of 18Sep2023. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300305354 same reporter/patient, different dose/AE;
He was given the wrong shot.  The DTaP and polio combination shot that was labeled for 4 to 6 year old was given instead of the 4 month old. Also the hib was not mixed so he was only given the water instead of the vaccine.
new onset cutaneous lupus erythematosus; This is a literature report.  A 70-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. History of autoimmune was none. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: CUTANEOUS LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "new onset cutaneous lupus erythematosus".  Clinical course: After 2nd dose Erythematous plaques noted as symptom. History of autoimmune was none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event 'new onset cutaneous lupus erythematosus' and the use of suspect product BNT162b2 cannot be fully excluded.The case will be reassessed once further information is available 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.
4 hours after vaccination patient had severe dizziness and vomiting that he had to call an ambulance and be admitted
Information has been received from a pharmacist referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L019128 with expiration date of 27-MAY-2017; strength, dosage, frequency and route unspecified). No adverse effects were reported. There was no previously temperature excursion. Temperature was 42 F and time frame was 48 hours. Additional information has been requested.
mom called office 24OCT96-states pt has chicken pox on face, trunk, legs & vaginal area; noticed about 4AM-today;some have the water blisters;
The injection was administered high on the shoulder of the left arm.  It caused extreme pain, more than is normal.  Pain continued at a level 4 for 2 days and diminished to a level 2.  After 2 weeks patient still could not raise her arm without pain.  Injection site continued to be painful.  Sleeping on the left side cause pain in left arm and shoulder.  Patient saw doctor on December 4, 2019 at which time he prescribed oral steroids and physical therapy.   He said he had never heard of SIRVA.
12 week old received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received DTPa-IPV (Kinrix) (batch number PX27D, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th October 2022 10:00, the patient received Kinrix (intramuscular). On 26th October 2022, the patient started Kinrix Pre-Filled Syringe Device. On 26th October 2022 10:00, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 26-Oct-2022 Reporter's comment: Nurse reported that 12 week old patient accidentally received Kinrix in right thigh on the day of reporting around 10 am. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received Kinrix vaccine at inappropriate age, which led to inappropriate age at vaccine administration.
I started noticing tinnitus in both ears, and never had that before. I was not subject to any loud noises, and this came on rather quickly.
Pain at site - and swelling.   Swelling to upper arm. Should not be a common side effect after vaccine. This is not normal. Very tender and painful.  Tiredness.  Was told to report back for eval.  Outcome pending.
Covid monitoring documentation. PT admitted 1/15/22 documented to have positive covid. PT received Pfizer 2/28/21 Lot EN6198 for dose 1. Dose 2 was Pfizer given on 03/21/21 Lot EN6199.
5 days p/vax began having rash all over body-burning sensation w/rash; rash raised papules primarily on trunk; severe itching rash cont x 2 wks;
mild headache for 36 hours; exhaustion for 36 hours; sensitive to cold,unable to get warm for 36 hours, shivering a lot; vomited once after 22 hours after the injection. No fever.
Paresthesias following Gardasil #2 beginning within a few days of administration. Intermittent sting, tingle and pain in various areas of body. Labs negative. B12 trial not helpful.
Day one achy and nauseous. Day 2 sore arm swollen armpit temperature and nauseous.Took Tylenol and went away third day.Temperature up to 101.9F.
This spontaneous report as received from a Doctor of pharmacist refers to a 72 year old male patient, with no pertinent medical history and no drug reactions/allergies. On 19-NOV-2012, the patient was vaccinated with ZOSTAVAX (lot # H013945, expired on 25-OCT-2013), subcutaneous. No concomitants medications were reported. The reported stated that on an unknown date after administration of ZOSTAVAX in 2013 or 2013, the patient began to experienced generalized pruritus. No rash was present. The patient sought medical attention by calling the pharmacy. The outcome of generalized pruritus was reported as not recovered. No treatment was given. The causality between ZOSTAVAX and generalized pruritis was unknown. Additional information has been requested.
This case was reported by a consumer and described the occurrence of diarrhea in a 1 year old male subject who was vaccinated with Pediarix for prophylaxis. The reporter is the mother of the pt. A physician or other health care professional has not verified this report. Medical history included developmental delay and speech problem ("...[he] has almost no frenulum which interferes with his speech"). Family history included one brother with autism. There were no concurrent medications. On 17 June 2005 the subject received 1st dose of Pediarix (lot number not specified). "In the evening" on 17 June 2005, less than one day after vaccination with Pediarix, the subject experienced "severe diarrhea". At the time of reporting, on 28 June 2005, the diarrhea was unresolved.
1 day after shot, the thigh, where it was administered, got red, swollen about 13cm.  (+) pain, circumferential around injection site.
I became ill with flu-like symptoms 8 hours after receiving the second vaccination. I had a fever of 101.5, cold chills, body aches, headache, fatigue, and queasy stomach. These symptoms lasted for 48 hours. On March 28 I developed a very sore and swollen lymph gland near my left collarbone. Today is March 29, and the swollen lymph node is visible to the naked eye and is very sore to the touch.
Usual Chills and aches after second shot. Tinnitus started a could of days later and has gotten progressively worse
Mild Chest pain shortness of breath 24 hrs after shot. Went way with Tylenol and rest. Returned next day worse. Emergency room tests ruled out heart, lung issues, and blood clot. Following up with primary care.
Came back to office after immunizations with swollen eyelids, conjunctiva and red and swollen cheeks. Rx'ed Benadryl.