chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states that he has a lump of productive cough after getting the first Covid vaccine on April 13 and developed fevers in 12 hours and has been having fever, fatigue and generalized body aches since that time.
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 11-OCT-2018, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number N029888 with expiration date in 28-AUG-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001849: US-009507513-1907USA001848: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001808: US-009507513-1907USA001807: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
covid test date=Nov2021, covid test result=Positive; covid test date=Nov2021, covid test result=Positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 28Apr2021 as dose 1, single (Lot number: EW0176) and on 19May2021 as dose 2, single (Lot number: EW0179) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: PCN" (unspecified if ongoing). Concomitant medication(s) included: BISOPROLOL; FLECAINIDE; ZOLOFT. Past drug history included: Midrin, reaction(s): "Known allergies: midrin"; Dilaudid, reaction(s): "Known allergies: Dilaudid"; Tramadol, reaction(s): "Known allergies: tramadol".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "covid test date=Nov2021, covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2021) Positive.  Additional information: It was reported that patient had positive COVID test on Nov2021. It was also that patient received dose 3 on 13Aug2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2 cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300312003 same patient and different drug dose/events.;
Patient was given #5 Hepatitis B vaccine. Should have received #2 Hepatitis A vaccine.
pt recvd vax & w/in 7 days devel redness,hardness & swelling @ inj site (4-5cm);treated w/warm compress;sx resolved w/in 2 wks;
Sleepy; arm sore; This is a spontaneous report from Pfizer-sponsored support program via a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry was not reported), via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date in 2021, only problem the patient had was that his arm was sore, and he was sleepy the next day. He took the first dose of the COVID Pfizer vaccine but that the second one he forgot about. and due date was the 19Mar2021. He was given a card, but he was half sleep when he went over there and wants to know if it was ok to take the second vaccine this late. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
body aches; This is a spontaneous report received from contactable reporter, Consumer. The reporter is the patient.  A 53-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 15:00 (Lot number: EN5318) at the age of 53 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number =EN5318, administration time=09:30 AM,, vaccine location =Left arm., dose number=1), administration date: 02Mar2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 24Mar2021 11:00, outcome "not recovered", described as "body aches". Therapeutic measures were not taken as a result of pain. Additional information included the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient has been not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101790907 Same patient, different dose and event.
I24.8 DEMAND ISCHEMIA 10/18/2021 ACUTE ON CHRONIC RESPIRATORY FAILURE J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 10/18/2021 ACUTE ON CHRONIC RESPIRATORY FAILURE
Information has been received from a consumer concerning her daughter a 17 year old female with no known drug allergies/reactions and no pertinent medical history reported who on unspecified dates was vaccinated with the first and second doses of GARDASIL vaccine (yeast). On 18-AUG-2008, the patient was vaccinated with a third dose of GARDASIL vaccine (yeast) and experienced soreness at the injection site after receiving the vaccine. On 23-SEP-2008 the patient was vaccinated with a fourth dose of GARDASIL vaccine (yeast) 0.5 mL intramuscularly, and the patient's mother stated that the doctor's nurse accidentally administered the fourth dose. On 23-SEP-2008, soreness at the injection site reappeared after the 4th dose of GARDASIL vaccine (yeast). The patient sought unspecified medical attention. The patient recovered from soreness at the injection site on 23-SEP-2008. Additional information is not expected.
Hard and painful, slightly red lump under the skin of the left side of her neck at the base Narrative:
Expired dose was administered to a patient by error; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 42-year-old patient who received HAV (Havrix) (batch number EK59B, expiry date 26th February 2022) for prophylaxis.   On 1st March 2022, the patient received the 1st dose of Havrix. On 1st March 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received an expired dose of Havrix by error, which led to expired vaccine used. The reporter consented to follow up by postal.
Patient had extreme high blood pressure, up to 160/108. also had high bp with second dose, pt sat still until felt okay, on blood pressure meds,  told to take regular bp med and contact pcp
numbness across chest and in severe pain. pain in upper back, right leg, nausea. diagnosed with bells palsy, right eye developed breathing difficulties, left heart blockage diagnosed with lung sarcoidosis also in brain and heart
Pain, swelling, redness at injection site Body aches (myalgia) Headache, severe  Fever Heavy fatigue  Joint pain
Slight fever and nausea at first. 4 days later severe chills for 8 hours.  Two weeks later severe chills and dizziness feeling as though about to pass out like Vertigo. Since continue to experience dizziness when rising from prone position - daily.
This case was reported by a consumer (also the subject's mother) and described the occurrence of myalgia in a 14-year-old female subject who was vaccinated with HPV vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included epilepsy. Concurrent medications included DEPAKOTE, KEPPRA, Risperidone and Omeprazole. On 6 February 2012 at 13:15 the subject received 3rd dose of HPV vaccine (unknown route, right arm). On 7 February 2012, 1 day after vaccination with HPV vaccine, the subject experienced myalgia, "hurts to move her feet so barely ambulatory" (could not walk because of pain in foot), abdominal pain and hiccups. At the time of reporting the events were unresolved.
Pt became fussy and screamed after shots and had slight temp-lasted over 24 hours. Gave Levsin drops and Tylenol with good results.
12/5/07 PM: Pt rcvd vaccine and said during night he was shaking and chills and took Tylenol, felt better next AM, but felt weak.
Vein that goes up in his neck has a little knot in it; Vein is really puffed up andhave that knot in it where he got the shot, well same side he got the shot on; This is a spontaneous report from a contactable consumer. This female consumer reported for a 52-year-old male patient (fiance) that received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number and expiration date not reported) via an unspecified route of administration on 18Aug2021 (at the age of 52-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in Aug2021, the patient experienced vein that goes up in his neck had a little knot in it; vein is really puffed up and have that knot in it where he got the shot, well same side he got the shot on. Reporter assessed the event as non-serious. Patient did not receive any treatment for the event. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Satelite infection left shoulder 1 cm below vacination site, right shoulder, right upper back, and 2 on left upper back.
Patient presented to the on 4/26/2021 for cystitis, cellulitis. Patient hospitalized on 4/30/2021 for vulvar abscess and cellulitis. These visits are within 6 weeks of receiving COVID vaccination.
Expired Bexsero administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number M7455, expiry date 31st December 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th January 2023, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 10th January 2023, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 10-JAN-2023 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. Additional supportive information: On the day of reporting, the patient received an expired dose of Bexsero, which led to expired vaccine used.
Large red, raised, itchy rash developed evening of vaccine administration.  Patient has treated with Atarax and topical hydrocortisone cream.  Area today is about 6 inches long spread down toward elbow and around injection site.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 025B21A) for COVID-19 vaccination.     The patient's past medical history included Food allergy (Corn and gluten) and Allergy to antibiotic (azithromycin, penicillin and Sulfonamide).   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      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 medications: hypothyroidism medication   This case was linked to US-MODERNATX, INC.-MOD-2021-080118, US-MODERNATX, INC.-MOD-2021-080175 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080118:Husband's case crosslinked US-MODERNATX, INC.-MOD-2021-080175:
Long covid; Short of breath; Slightly anemic; Tired; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (Long covid), DYSPNOEA (Short of breath), ANAEMIA (Slightly anemic) and FATIGUE (Tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21P, 053E21A, 024M20A and 030L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (Long covid), DYSPNOEA (Short of breath), ANAEMIA (Slightly anemic) and FATIGUE (Tired). At the time of the report, POST-ACUTE COVID-19 SYNDROME (Long covid) and ANAEMIA (Slightly anemic) outcome was unknown and DYSPNOEA (Short of breath) and FATIGUE (Tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: (Negative) Negative. On an unknown date, SARS-CoV-2 antibody test: (Positive) Positive.         The concomitant medication was not reported by reporter. In Jan-2022 patient got tested and was negative. Patient did not quarantine with her husband, but did not experience any symptoms at the time. A few months later patient started getting short of breath. Patient went to a doctor who gave her an antibody test, which patient was positive for. Later, patient was also found to be slightly anemic. Patient had continued to feel short of breath and tired up until today. Patient had not taken any medications or treatments for her symptoms. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-650992 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-650992:same reporter
Difficulty swallowing, pain in the left neck, left shoulder, left hand, left lower quadrant, across lower back and left knee
pt recvd vax; pt devel erythematous arm rash; pt devel fever w/ t 105;
Developed Muscle weakness and fatigue in upper and lower extremities, numbness in hands and feet, Tremors in upper and lower extremities, some times all over the body. Was diagnosed with Guillain Barre Syndrome.
5-6 minutes after vaccine I became light headed 5-6 minutes after vaccine a very bad! headache heart rate was recorded at 125-129 bpm on  my Fitbit I returned to vaccine facility to have my BP checked and it was recorded at 150/85; 5-10 minutes later my BP was 136/xx.  I returned to work.... bpm  returned to normal within the next hour still having headache two hours after vaccine
On August 30 visit (33 days after vaccination) was seen in office and he complained of arm pain. He said he could not sleep on side due to pain. Patient was prescribed topical NSAID.
First dose - no side affects at all could not even tell I had a vaccine.  2nd dose - by mid-afternoon my arm was getting sore, headache and scratchy throat.  Arm progressively got worse. Took Tylenol and headache improved.  Went to bed abut 10:30 pm was doing ok except for arm pain.  Woke up at 2:40 AM with the chills (shaking really bad and very cold) got another comforter and went back to sleep woke up about 4:15 am  a little better but just kind of sore all over.  Laid in bed but couldn't sleep, got up and tried to log on about 8:45am for work.  Felt completely drained and couldn't concentrate, took PTO.  Took more tylenol and went back to bed, fell asleep about 11:00 am and slept until 2:00 PM.  Felt much better when I got up just still kind of drained.  By 8:00 PM that night (wednesday the 27th) my arm didn't hurt any more and I was basically back to normally.  Have had a mild sore throat off and on since then but really nothing more than an irritation.
Site of the injection very sore, enough to wake me in the night. Woke with a headache and moderate nausea.
hives & lightheadedness are reported in a pt who recvd 1 dose of flu vax on 18OCT93 & 5 mins later exp lightheadedness; approx 15-30 mins p/vax pt exp hives, rash w/itching all over body & ears became flushed; pt was treated w/DPH;
pt recv vax 7MAR97 & w/in 24hr devel a rash on upper body (freon & back(, & mult hives on upper arms & on legs;no itching accompanied these sx which are ongoing 10MAR97;
Myalgia Malaise, SoreThroat Narrative: Pain at injection site, sore throat
Patient received the 1st COVID vaccine (Pfizer, Lot #: EW0162, expiration date: 07/31/2021) at 1500. EMT made contact with the patient standing in the 30 minute observation area at 1507. Patient complained of ?blurry vision, headache, and slight tingling in the throat.? Patient reported the symptoms started ?10 minutes? status post vaccine. Patient denied chest pain, nausea, vomiting, or diarrhea and was presenting conscious, alert, and oriented to person, place, time, and event (AOX4). EMT assisted the patient to the zero- gravity chair for further evaluation. Nurse then responded and attended to the client and EMT. Baseline vitals were obtained by EMT at 1508, while patient was sitting: blood pressure: 150/88, respiratory rate: 14, heart rate: 80, pupils equal and reactive to light. EMT observed the skin to be dry, warm, and normal. Chief complaint was then reassessed and patient claimed his vision had improved and symptoms were subsiding. He stated the onset of symptoms were gradual and lasted less than 5 minutes.? Patient also reported his last oral intake was around 1300 with minimal fluid intake. Patient stated he has a history of headache and denied any past medical history or taking any current medication. Patient has allergies to seafood and shellfish. At 1515, a second set of vitals were obtained by EMT, while patient was standing: blood pressure: 154/90, respiratory rate: 14, heart rate: 85, pupils equal and reactive to light. EMT observed the skin to be dry, warm, and normal. Patient was negative for orthostatic pressures. Patient was advised by the EMTs to stay another 30 minutes in the observation area, totaling 45 minutes. At 1545, patient stated ?all symptoms have subsided.? Patient was released and ambulated on his own, out of the facility, with a steady gate. EMTs encouraged the client to sign up in order to document any additional symptoms.
Reports " the back of my tongue, throat and lower jaw started to feel numb"  Narrative:
Initial report was received on 05 October 2010 from a health care professional which involved a cluster of four patients who experienced adverse events after receiving FLUZONE, lot number UT3570DA. This report represents one patient and other three patients have been captured in case numbers 2010-05758, -05759, and -05760. An eight-month-old female patient had received a first dose intramuscular injection of FLUZONE, lot number UT3570DA on 21 September 2010, and an unspecified amount of time later on the day of vaccination, the patient developed a fever of 102 and was cranky. The patient had not previously received any INFLUENZA vaccinations. Outcome was reported as unknown. No additional information was provided at the time of the report. The reporter for this case is the same as for case number 2010-05761.