chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Called the pharmacy on 9/6/2018 stating that her arm was red and swollen around the injection site starting on 9/5/18 and the area affected got larger. She did not complain of any fever or other symptoms. Told her to put a cold compress on the area. Called her on 9/6/18 to check her symptoms. The area affected (swelling and redness) was reduced and a small bruise was forming. She is doing fine and is getting better.
Patient tested positive for Covid19 after being vaccinated with Pfizer vaccine EUA 4/07/2021-4/22/2021
Migraine; Chest pain; Pain in arm; Sometimes it feel like very sharp pain like something is bursting; This is a spontaneous report received from a contactable Consumer or other non HCP. The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administration date 30Aug2021 (Lot number: FC3182) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "thyroid disease" (unspecified if ongoing), notes: I do see a doctor and I came out of pocket but he is my specialist for my thyroid disease. Concomitant medication(s) included: CYTOMEL; SYNTHROID. The following information was reported: MIGRAINE (non-serious) with onset 2021, outcome "unknown", described as "Migraine"; CHEST PAIN (non-serious) with onset 2021, outcome "unknown", described as "Chest pain"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Pain in arm"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Sometimes it feel like very sharp pain like something is bursting". The events "migraine", "chest pain", "pain in arm" and "sometimes it feel like very sharp pain like something is bursting" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of migraine, chest pain, pain in extremity, pain.  Additional information: Consumer stated that she is pretty sure she has some kind of reaction to the first COVID Vaccine, the first dose. She had a Pfizer vaccine, ever since she had the vaccine, she has been having migraine and she has been having chest pain and pain in the arm and then sometimes it feel like very sharp pain like something is bursting. It is not that she is having a question. She was told to report it.  No follow-up attempts are possible. No further information is expected.
21 weeks pregnant via IVF. Estimated date of delivery = dec 28th.  Around 11:45pm, developed fever and severe chills with bad indigestion. Proceeded to vomit multiple times.
flu-like symptoms with fever,nausea,vomiting,loose stool over a weekend period. pt visited medical center e.r. pt was treated and released same day.
This spontaneous report was received from a health care worker (office manager) refers to 3 unspecified patients of unknown demographics. No medical history was reported. The reporter stated that the 3 unspecified patients were administered ROCOMBIVAX (dose, route and frequency unspecified) that was stored improperly. No concomitant medications were reported. Nurse was then placed on the line to answer additional questions regarding event. No adverse effects were reported. No further information was provided. This is one of two reports received from the same reporter and linked to case. All Telephone attempts to obtain follow up information have been unsuccessful. Follow up has been received from the office manager. The office manager stated this temperature excursion was supported and the vaccines were out of range for approximately 3 hours. The office manager was unable to provided patient identifiers and dates of administration at this time, but was able to provide lot numbers and expiration dates for RECOMBIVAX: lot#0384AE; expire date 02-NOV-2014. Additional information has been requested.
Scratch after itching begin to break out red rashes and then it became dark brown, now it is becoming black on both feet; looks like blood getting out of his skin; Scratch after itching begin to break out red rashes and then it became dark brown, now it is becoming black on both feet; looks like blood getting out of his skin; Scratch after itching begin to break out red rashes and then it became dark brown, now it is becoming black on both feet; looks like blood getting out of his skin; Scratch after itching begin to break out red rashes and then it became dark brown, now it is becoming black on both feet; looks like blood getting out of his skin; Scratch after itching begin to break out red rashes and then it became dark brown, now it is becoming black on both feet; looks like blood getting out of his skin; This is a spontaneous report from a contactable consumer.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated that the patient had taken the Pfizer Covid-19 Vaccine and about 2 weeks after he started to scratch and after itching began to break out red rashes and then that became dark brown, now that had become black on both feet. Reporter also queried to know what to do and where to go (treatment) because the patient had visited several Doctors who had not really given other diagnosis or reason why the patient got that rash on his feet. Reporter also stated, that looked like blood got out of his skin. Reporter stated that they do not know the product details (expiration date, NDC number and UPC number, pharmacy details and treatment). The outcome of the events was not recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received the covid vaccine on 01/06/2021.    C/o bodyache, temperature of 99.6, fatigue, and sore arm (no swelling or redness). Denies any ocular, respiratory, or GI symptoms  She is breast feeding her infant without any issue.
Wife stated that about a week after patient received the 2nd dose of pfizer vaccine, the patient started to voice his speech. and now it is to the point where she can just barely understand him at times. Wife stated that she has been to PCP, and several other doctors and no one is able to help.
did, too, but still got them/Suspected Vaccination Failure; got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: did, too, but still got them/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22MAR2023 The case  was received from the patient via interactive digital media. The patient stated that he/she did too, but still got them. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
No adverse effects were reported; during administration the patient jerked her leg and some of the vaccine came out of the needle causing the patient to not get the full dose of MMR II and some of the vaccine to get on the patient's leg; during administration the patient jerked her leg and some of the vaccine came out of the needle causing the patient to not get the full dose of MMR II and some of the vaccine to get on the patient's leg; This spontaneous report was received from a nurse referring to a 12 months and 1 week old female patient. Information about medical history, concurrent conditions and concomitant therapies were not provided.   On 07-AUG-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) (lot # R030809 and expiration date 24-OCT-2020), which was reconstituted with sterile diluent, subcutaneously for routine vaccination. However, during administration, the patient jerked her leg and some of the vaccine came out of the needle causing the patient to not get the full dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) and some of the vaccine to get on the patient's leg (incorrect dose administered and exposure via skin contact). No adverse effects were reported.
received only the HIB powder portion of PENTACEL with no reported adverse event; PENTACEL that was diluted with normal saline with no reported adverse event; Initial information received on 17-Nov-2021 regarding an unsolicited valid non-serious case received from other healthcare professional and non-healthcare professional via phone via Global Medical Information (GMI) (Reference number- 00862445).  This case is linked to case 2021SA388591(CLUSTER).  This case involves a 4 months old male patient (date of birth: 9-JUL-2021) who received only the haemophilus influenzae type b (HIB) powder portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (product preparation issue) and that was diluted with normal saline (product preparation error).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  On 16-Nov-2021, the patient received a (second, 0.7 ml) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (once, lot number: UJ580AAA and expiry date: 10-SEP-2022) via an intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error due to inappropriate reconstitution technique and wrong solution used in drug reconstitution (same day).  It was reported "Caller asked if this would count as a valid ACTHIB dose for these patients or if they required re-vaccination with PENTACEL. Caller asked if the Safety department would attempt to contact the patients prior to the doctors in the practice having the opportunity to address the situation with the patients' families. Caller asked for information regarding the HIB portion of PENTACEL not counting as a valid dose if administered with any diluent other than 0.4% NaCl saline solution. Caller states that the diluent used on the two patients were from vials containing 0.7 ml normal saline."  Caller states that after checking the refrigerator to see how many doses of the DTAP-IPV liquid portion of PENTACEL and HIB powder portion of PENTACEL were remaining, it was determined that two patients on 16NOV2021 received only the HIB powder portion of PENTACEL that was diluted with normal saline by a nurse in the facility.   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 by the regulatory authorities. 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.
Evening after injection complain of sore arm with muscle soreness radiating across mid chest. Rash around injection site down to elbow area at 28 hrs after injection - continued to have rash down arms & legs, chest & back - Given steroid shot.
100.9 fever, horrible migraine (can't touch chin to neck), chills, sweats, stomach hurts, shivering, body aches, brain zaps, bad neck pain, nauseous   Took Tylenol
pt recv vax & exp neck stiffness;As of 22OCT97 stiffness persisted;
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On multiple unspecified dates, the patients were vaccinated with PEDVAXHIB (lot #: L030871, expiry date: 10-JUN-2018) (route of administration: intramuscular) that had been improperly stored at a temperature of 47 F for a time frame of 74 hours. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Information has been received from a pharmacist concerning a patient greater than 38 years old, who on 31-JAN-2002 finished the Varivax series. Subsequently the patient had a titer value of 0.58. It was reported that a value of less than 0.91 is considered negative. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Patient was given KINRIX earlier date. Recommendation of age for vaccine is 4-6 years old. Spoke with manufacturer GlaxoSmithKline Pharmacist stated that this is a valid dose for patient. And does not need to be repeated.
covid-19 positive; covid-19 positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EL3247), on 16Mar2021 as dose 2, single (Lot number: EL3247) and on 03Nov2021 as dose 3 (booster), single (Lot number: EW0217) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jun2022, outcome "not recovered" and all described as "covid-19 positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
extreme swelling around injection site  --size of  tennis ball--- pain  ---redness  and feverish commencing on  july 19th in pm  continuing all night. at this time -july 20--some sweeling aleiviated  but area very hot and painful
Suspected Vaccination failure; Shingles aggravated; blisters; Pain; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister and pain. On an unknown date, the outcome of the vaccination failure, shingles, blister and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, blister and pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient had several out breaks of shingles since received both shots. They were coming more often than before the shots. The patient wanted to know is there anything else that could be done to prevent the shingles out break or put on the blisters to make them less painful. This case was considered as suspected vaccination failure as time to onset for the event unknown at the time of reporting.
This spontaneous report as received from a health care worker refers to about a dozen of unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with a series of hepatitis B vaccine (recombinant) (manufacturer unknown) (Lot number, expiry date, route and dose were not reported) as a children. On unspecified dates, the patients had the titers drawn that had resulted negative. The outcome of the reported event was unknown. This is one of the two reports received from the same reporter Link (MARRS#1308USA010407). Additional information has been requested.
immunocompromised patient received first dose of Pfizer COVID-19 vaccine on 1/25. Received second dose on 2/18. Around 3/10, patient was exposed to his son with COVID-19 and developed a fever and cough. Diagnosed with COVID and patient was approved to receive monoclonal antibody infusion, which he received on 3/10.  Confirmatory nasopharyngeal swab obtained 3/11 at 1330. Coronavirus PCR test resulted positive later that evening.
6 hours after shot Injection site swollen and red and hot to the touch. Also very itchy and painful. Two days later lumps have formed in my neck and under my armpit. They are painful and movable. I am having an ultrasound in a few days on them.
Information has been received from a physician concerning a 12 month old male with no allergies who on 19-APR-2007 was vaccinated with a subcutaneous dose of ProQuad Lot # 656941/0227U) in the right thigh. There was no concomitant medication. On 30-APR-2007 the patient developed a varicella-like rash at the injection site. There were no laboratory or diagnostic tests performed. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Rash, hives, itching, facial swelling, severe nausea, T 98.4.
Rash began 2 days ago. Rash on left axilla, right shoulder and neck.
Clouded mental state, very "foggy".  Trouble communicating verbally. Muscle weakness, trouble moving and standing.  Very tired. Got better after a long night's sleep, mobility retuned as did mental capabilities.
Sore in arm of injection (about 1 day)  Body ache, tiredness
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Some people have told me that the adverse reactions to the  Moderna Covid-19 vaccine dose are worse after the second moderna Covid-19 vaccine dose than) and VACCINATION SITE PAIN (Several patients who received the Moderna Covid-19 vaccine and they have sore injection site arms.) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Some people have told me that the adverse reactions to the  Moderna Covid-19 vaccine dose are worse after the second moderna Covid-19 vaccine dose than) and VACCINATION SITE PAIN (Several patients who received the Moderna Covid-19 vaccine and they have sore injection site arms.). At the time of the report, VACCINATION COMPLICATION (Some people have told me that the adverse reactions to the  Moderna Covid-19 vaccine dose are worse after the second moderna Covid-19 vaccine dose than) and VACCINATION SITE PAIN (Several patients who received the Moderna Covid-19 vaccine and they have sore injection site arms.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant product use was reported. No treatment information was provided. The reporter stated that some people had told them that the adverse reactions to the Moderna Covid-19 vaccine dose were worse post the second Moderna Covid-19 vaccine dose and the reporter knows of several patients who received the Moderna Covid-19 vaccine and had sore injection site arms. Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: New event Vaccination site pain was added.
This is a spontaneous case, initially received from other health professional on 11-Feb-2019, concerning a female neonate patient. The mother was 39-year-old female, with a history of two previous pregnancies in which first pregnancy was full term live birth and second pregnancy was elective abortion. The mother had no family history of offspring with major congenital malformation. No relevant maternal and paternal medical history with major congenital malformation. The mother did not use tobacco, alcohol and illicit drugs during pregnancy. The mother's current condition included asthma and urinary tract infection (since an unspecified date). The mother's concomitant medications included Vitafol one (ascorbic acid, betacarotene, colecalciferol, cupric oxide, cyanocobalamin, folic acid, magnesium oxide, nicotinamide, omega-3 fatty acids, polysaccharide-iron complex, potassium iodide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide) for healthy pregnancy and Macrobid (nitrofurantoin) for urinary tract infection (from 18-Sep-2018 to 24-Sep-2018). The mother's last menstrual period (LMP) date was 02-Jun-2018. On 04-Sep-2018, non-invasive prenatal test and first trimester screening test were performed, and no congenital malformations were noted. On 08-Oct-2018, at gestational age of 18-weeks (second trimester of pregnancy) the fetus was exposed to FLUCELVAX QIV [dose, batch number: 252232, route of administration: transplacental, anatomical location, and expiry date: not reported] for an unknown indication (explicitly coded as fetal exposure during pregnancy). 4 months after vaccination, the mother delivered a premature female neonate at 35.9 weeks gestation through caesarean. At the time of delivery, no pregnancy complications were reported. The neonate's birth weight was 2722 grams, head circumference was 33.5cm and body length was 47cm. The APGAR scores were 9 (one minute), 9 (five minutes) and there was no data for 10 minutes. There was no major congenital malformation was noted. The outcome of the events was unknown. The mother's estimated delivery date (EDD) was reported as 09-Mar-2019. This case is linked to 201805976, the corresponding maternal pregnancy report and 201901533, the corresponding report for the other baby.; Reporter's Comments: A female neonate patient was delivered at 35.9 weeks of gestation (preterm birth), 4 months after maternal receipt FLUCELVAX QIVc, at 18 weeks of gestation (considered as fetal exposure during pregnancy). Time to onset is considered implausible for the event preterm birth. Twin pregnancy, advanced maternal age (39 years) and maternal obstetrical history (multigravida) provide more plausible explanation rather than suspect vaccine. Hence, causality assessed as not related to suspect vaccine. The decision to administer a vaccine during pregnancy is related to medical decision made by the mother and her physician and is not related to any property of the medication. Hence, the event fetal exposure during pregnancy assessed as not related considering the intended use of the vaccine. The company assessed this case as serious (medically significant).
Pfizer vaccine was placed in Freezer instead of Refrigerator for storage.  Was thawed and administered.