chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose of Shingrix back on 1/26/2023 and it is over the 6 months for the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26 Jan 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose of Shingrix back on 1/26/2023 and it is over the 6 months for the second dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date 24 August 2023: The pharmacist called to inquire whether the patient had to restart the Shingrix series over?  The pharmacist reported a patient received the first dose of Shingrix back on 26 Jan 2023 and it was over the 6 months for the second dose, the patient was currently at 7 months.  The reporter asked if they could we administer the second dose?  The reporter did not consent to follow-up.  Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination.
Extremely irritable, not sleeping or napping at all, screaming and holding head, hives all over abdomen and blisters and welts all over thighs, butt, pelvis and lower stomach. Started 3 days after shot was given and lasted 3-4 days. More than a week later child is still angry, not sleeping and in pain.
3/19/21 body aches, flu like symptoms began at 2130; red sunburn like rash on lower chest 3/20/21 used Benadryl 12.5 mg twice; 3/21 mid back itching and red rash, 3/22/21  fatigue and rash continues - called Moderna and physician there told her allergic reaction and to go either to ER or personal physician whichever faster, ER physician told her not allergic reaction but immune response.  Advised Cortisone which has been helpful.  Improved 3/23/21.  Missed work 3/22 and 3/23, will return 3/24 if improvement continues.
This case was reported by a nurse and described a 25 year old female patient who received Hepatitis A vaccine and subsequently tested positive for Hepatitis A IgM antibody.  The patient's past medical history was notable for exposure to fecal contamination on 06/28/2004.  The nurse reported that it is unknown if the fecal contamination was infected with Hepatitis A.  On 06/29/2004, the patient received the first dose of Hepatitis A vaccine.  On 06/29/2004, a Hepatitis A IgM antibody test was positive.  The patient was seen at a physician's office.  The reporter stated that the patient shows no signs or symptoms of Hepatitis A and their liver function test was normal.  The nurse considered the event to be related to vaccination with Hepatitis A vaccine and considered the event, an appropriate immune response.
Injection side of arm has rash, red oval shape 2 inch red amp. hard. headache.
Arm red; Arm swollen; Arm warm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Arm red), INJECTION SITE SWELLING (Arm swollen) and INJECTION SITE WARMTH (Arm warm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Arm red), INJECTION SITE SWELLING (Arm swollen) and INJECTION SITE WARMTH (Arm warm). At the time of the report, INJECTION SITE ERYTHEMA (Arm red), INJECTION SITE SWELLING (Arm swollen) and INJECTION SITE WARMTH (Arm warm) outcome was unknown. Not Provided   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   Concomitant medications were not reported.  No treatment information provided.
Vaccine administered, patient appeared to tolerate well. Upon checkout process , patient stated she felt faint, lost color in face and had to be lowered to the floor where feet were elevated. She stayed in this position on the floor for 5-10 minutes before slowly sitting up and then standing. She reported to be feeling fine upon leaving the office.
Left arm was swollen and red from shoulder to hand, had the appearance of cellulitis; Left arm was swollen and red from shoulder to hand; Left arm was swollen and red from shoulder to hand; Chills; Fever; A spontaneous report , was received from a Healthcare Professional concerning a unidentified patient, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, fever, red, swollen arm from shoulder to hand, and had the appearance of cellulitis .  The patient's medical history or concomitant medications were not provided.  On 01-FEB-2021,  the patient received their first of two planned doses of mRNA-1273 (batch number: 013L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 02-FEB-2021, the patient experienced chills, fever.   On 04-FEB-2021 the patient experienced red, swollen arm from shoulder to hand, had the appearance of cellulitis .  Laboratory reports were not provided. Treatment information included antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.   The  outcome of the events were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a health care worker/medical assistant refers to a currently 25 year old female patient. On 10-MAY-2013 the patient was vaccinated with first dose of GARDASIL (0.5 ml once, intramuscular, lot # reported as: 01073AA and expiry date reported as: 11-OCT-2013). The reporter stated that the patient was in office to receive second dose of GARDASIL on 23-APR-2014, reported also as "today". Lot number 01073AA is an invalid lot number for GARDASIL. Additional information has been requested.
My lower back hurt for several days, prohibiting movement. I am still feeling  some back pain.
Fifteen minutes after receiving the vaccine I felt dizzy. They asked me to stay for fifteen more minutes to see if there were any changes. After the 30 minutes were up, I felt even worse. They brought another chair over for me to recline my legs. They started monitoring my blood pressure every few minutes. It was good. It raised a little, maybe up to 166. They called the doctor who told me that I need to go to the hospital. I did not want to go. They called the EMT over and when I stood up, I almost fell over. They brought me to Hospital. I have been admitted since 10/02. I have been experiencing dizziness and headaches. I'm not able to stand straight from my bed. I need to call for help to get up from the bed to go to the restroom.
Booster; I became positive from another person who had three shots from Pfizer; I became positive from another person who had three shots from Pfizer; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "I became positive from another person who had three shots from Pfizer". The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-202101873713 same reporter/drug/AE, different patient;US-PFIZER INC-202101870449 same reporter/drug/AE, different patient
This is a breakthrough case who died, but the causality is not clear. There are unusual circumstances, in that the positive test was done post-mortem since the patient was an organ donor, thus the delay in identifying this as a breakthrough case.   The patient was vaccinated on 04/02/2021.  On 04/24/2021, he suffered a presumed cardiac arrest while exercising at home, and he subsequently passed away on the same day.  Per policy, the organ/tissue donation facility ran a routine COVID-19 test on a sample taken on 04/25/2021 which came back PCR-positive on 04/27/2021.   Per follow-up with the surviving spouse, the patient had been experiencing fatigue in the week prior to death, but no other possible COVID-19 symptoms that they were aware of. The case had also previously been COVID-19 positive in October 2020.
Area of injection site became inflamed, red, itchy  Remains so as of today although less red.
Pt recvd vax 9SEP91 between 230PM-330PM evening of 9SEP91; c/o soreness; 10SEP91 c/o inc soreness, low grade temp, & inc redness, soreness, arm, & neck became edematous; 11SEP91 rash, could not move neck due to swelling; Taken to ER;
SWEATING MORE AT NIGHT; A BIT OF PAIN ON MY ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-NOV-2021 for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 23-NOV-2021, the patient experienced sweating more at night. On 23-NOV-2021, the patient experienced a bit of pain on my arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a bit of pain on my arm and sweating more at night was not reported. This report was non-serious.
patient was administered only the liquid component (DTaP-IPV) component of the Pentacel vaccine with no reported adverse event; Initial information received on 16-Dec-2021 regarding an unsolicited valid  non-serious case received from a physician via Agency number: 00901359.  This case involves a four months old female patient who experienced patient was administered only PREVNAR and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation issue).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE.  On 16-Dec-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number:  UJ551AAA (carton) and expiry date: 05-AUG-2022 via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date,  she also received a dose of the same vaccine  lot number: U6990AB and expiry date: 05-AUG-2022 via unknown route in unknown administration site and a dose of suspect PREVNAR not produced by Sanofi Pasteur lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination respectively.  It was case of an actual medication error due to inappropriate reconstitution technique (latency: same day).  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
brachial plexus neuritis/Parsonage Turner syndrome; This spontaneous report was received from a consumer, who was reporting on himself as a 52-year-old male patient. His concurrent condition included seasonal allergy. No information regarding the patient's pertinent medical history, drug reactions and concomitant therapies was provided. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, he experienced vaccine reaction-brachial plexus neuritis (Parsonage Turner syndrome). The outcome of the event was unknown. The reporter considered neuralgic amyotrophy to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).
The pt developed red, warm to touch, swollen, painful to move left arm for 48 hrs. Treated with Tylenol alternating with Motrinl and Benadryl.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 13-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # and expiration date unspecified) (dose and route unspecified). The pharmacist reported that the patient received a dose of improperly stored ZOSTAVAX. The vaccine was given to the patient after it was exposed to 70 F for 48 hours and then refrigerated for 24 hours. No adverse effect reported. Follow up information was received from pharmacist who stated that the ZOSTAVAX was only exposed to 70 F for 64 hours. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Neck pain and right Supraclavicular lymphadenopathy. About 10 hours after I got the shot, I felt flu like syndrome-malaise, mild headache and low grade fever. So, I started ibuprofen 400mg two times a day. Neck pain was started 24 hour after the injection. Since last nigh, about 48 hours after vaccine administration, I found a1x1 painful lymph node in my right supraclavicular area.
TINNITIS R EAR CONSTANT, SINCE 9/22/2021. NO TREATMENT AS OF YET.
Narrative:  zoster vaccine given 5/10; the following was noted on presentation to ER w/ subsequent admission on 7/11: pt c/o progressive weakness x3-4 weeks; note that date of event is estimated based on patient's report
BODY ACHES; WOKE UP SWEATY AND DRENCHED; THOUGHT HE HAD THE FLU; GROGGY; COULD NOT RELAX; LETHARGY/OUT OF IT ALL DAY; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 185 pounds, and height was 155.75 centimeters. The patient's past medical history included drug abuse, and concurrent conditions included seasonal allergy, alcohol user, and non smoker, and other pre-existing medical conditions included no illness at the time of vaccination. no past history of similar event. no adverse event after any previous vaccination. no history of allergy to vaccine drug, or food. no pre-existing acute illness 30 days prior to vaccination. no history of hospitalization in last 30 days with cause. no family history of any disease(relevant to vaccination) or allergy. no pregnant at the time of vaccination. no currently breastfeeding. no event is covid-19 infection, was it confirmed by test. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced body aches. On 23-MAR-2021, the subject experienced woke up sweaty and drenched. On 23-MAR-2021, the subject experienced thought he had the flu. On 23-MAR-2021, the subject experienced groggy. On 23-MAR-2021, the subject experienced could not relax. On 23-MAR-2021, the subject experienced lethargy/out of it all day. On 23-MAR-2021, the subject experienced chills. On 23-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, woke up sweaty and drenched, lethargy/out of it all day, chills, and headache on 24-MAR-2021, and was recovering from thought he had the flu, groggy, and could not relax. This report was non-serious.
It was reported that a patient  (1 of 2) received a Tripedia vaccination (Lot # UO536AA), administration date not specified). Reportedly, sometimes after the vaccination, the patient developed a severe local reaction with 5-6 cm swelling and erythema. Linked case U2001-001194
Entire left upper thigh was red, swollen, "on fire" and red bumps on 4/12/01. On 4/17/01, has 1.5cm-2cm firm, non-tender, movable mass on left anterior lateral thigh, no femoral adenopathy. No treatment.
pt recv vax & was crying constantly did not want bottle, cried off & on;a few hr was pale, listless, fever went to 102.6;taken to ER was seen by MD examined pt did not recommend hosp or tx did recommend no more pertussis;
nurse accidentally forgot to mix the HIB portion, so the 4-month-old child only got the DTAP/IPOL mix but did not receive the HIB with no reported adverse event; Initial information received on 07-Jul-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old of unknown gender patient whose nurse accidentally forgot to mix the hib portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)], so the 4-month-old child only got the dtap/ipol mix but did not receive the hib with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Jul-2023, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (with an unknown strength, expiry date and lot number) via unknown route in unknown administration site for immunization.  On 06-Jul-2023, the nurse accidentally forgot to mix the hib portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)], so the 4-month-old child only got the dtap/ipol mix but did not receive the hib with no reported adverse event (product preparation error) (Latency:same day).  It was reported, Clinic supervisor called to get information on incident that occurred yesterday 06Jul2023 with a PENTACEL vaccine. Caller reports that a nurse accidentally forgot to mix the HIB portion, so only got the DTAP/IPOL mix but did not receive the HIB. Does the child need to be re-vaccinated with PENTACEL or can the remaining vial of HIB be mixed with a diluent and given? This situation is reported as a medication error due to--not giving the medication together as intended.  Action taken: not applicable.  At time of reporting, the outcome was Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
At 17:00 on 3/21/02, she received MMR and Tetanus vaccination. About 12 hours later (05:00 on 3/22/02), she died and was brought back. 05/01/2002 patient expired after being transferred to hospital in Budapest. Records from San Clemente Hospital: Diagnosed with severe anoxic brain injury, probably alpha coma, seizure disorder, staphylococcus aureus bronchitis, ventricular fibrillation arrest, tachycardia, elevated liver enzymes.
Blood clot in lung; Shortness of breath; Felt tired; Slight headache; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201), dose 2 intramuscular, administered in Arm Right (also reported as "injected intramuscularly in right arm") on 23Feb2021 13:00 (at the age of 79years) as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EL8982) on 02Feb2021 (at the age of 79years) for Covid-19 immunization. Medical history included high blood pressure (diagnosed prior to 10 years ago), respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities including diabetes, diagnosed allergies, compromised immune status, and obesity (Little on the heavy side but she does not think she is obese); all from an unknown date and unknown if ongoing. Concomitant medication included lisinopril taken for high blood pressure at 20 mg once daily, started at least 10 years ago. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient had received the two doses, she had shortness of breath in the morning around 08:30 on 08Mar2021 and went to her doctor. They did blood work and she was put in the hospital because the doctor found out she had blood clots in her lungs (11Mar2021, 13:00). The patient was hospitalized for blood clot in lung from 11Mar2021 to 13Mar2021. She doesn't know if it came from the vaccine or not. She was sent home on Eliquis for 6 months to get blood clots from her lungs. She also has oxygen for when she needs it and mostly for when she is ambulatory. It was further clarified that when she went to her doctor's office, they did blood work. When they got results, they called her at home and told her that she had to call the ambulance and go the hospital in the ambulance, so she did; Ambulance to ER (hospital) on 11Mar2021. There was also a problem with the left ventricle of her heart (12 Mar2021 12:30). She stated whichever part pumps blood into the pulmonary vein, something is wrong there. She was going to have an echocardiogram to check that out again on 29Apr2021. She does not know the outcome of that yet until she gets that done. They gave her Eliquis as a blood thinner and oxygen.  She has not really needed the oxygen around the house.  But if she goes outside, she may. She took it to the grocery store with her and if she needed it, she used it.  She also had a headache after second dose on 24Feb2021 09:00. She felt tired on 24Feb2021 21:00 and stuff (as reported). The outcome of event blood clot in lung was unknown; the outcome of other events was recovering.
On October 5th I had a fever, chills, sore arm, swelling  at injection site, before going to bed. Woke up at 2:00am with strong heart palpitations, chest pain, increased pulse rate, very light headed and dizzy. Contacted my dr and made an appointment, he did chest x-ray and blood test for cardiac  markers such as triponin etc. suspected pericarditis and started a course of steroid to reduce inflammation. After several  days on steroids it had not improved much so I went to the ER and they did ct scan looking for blood clots and re checked blood work. No clots and labs were all good. Symptoms appear to be consistent with postural orthostatic tachycardia syndrome.
Fever or Chills  Muscle or body aches  Headache  Sore throat  Congestion or running nose