chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got sick after second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (got sick after second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to vaccine (allergies to other vaccines).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (got sick after second shot). At the time of the report, VACCINATION COMPLICATION (got sick after second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Shaking so much; Diarrhea; Rash; Unable to stand or walk; It also made him weak; This is a spontaneous report from a contactable consumer. This consumer re-ported for a 82-year-old male patient (reporter's husband) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EM9809 and expiry date: 01Jun2021), via an unspecified route of administration, in Arm Right, on 12Feb2021 (age at vaccination: 82 years), as dose 2, single dose for COVID-19 immunization. Vaccine was not administered at military facility. The patient's medical history included ongoing Diabetic (he was diagnosed in his 40s, Has had for years, takes medications for diabetes constantly). Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9262 and expiry date: 01May2021), via an unspecified route of administration, in Arm Right, on 22Jan2021 (age at vaccination: 82 years), as dose 1, single dose for COVID-19 immunization. The reporter was calling to report something for her husband (patient). The patient had severe shaking, it was with his nervous system. He also had diarrhea. The patient was shaking so much he was unable to stand or walk. It also made him weak on an unspecified date in Feb2021. They had no idea what it was. It went away as fast it came. It was not lasting. The patient also had a rash on the back which was something that had never occurred before. Shaking so much was a week after the last vaccination. The patient received the second dose 12Feb2021. At first they did not think it was all connected until told family of nurses who were familiar with the reaction. They told reporter (patient's wife) to report this to (Withheld). She tried to report to (Withheld), but they did not seem worried about it. She was calling us because she thought someone should know about it. She thought if more than one person had this reaction most likely a side effect and should be aware. The shaking so much lasted about 4-5 hours at a severe state. Then it got better, but it took close to 3-4 days for it to completely go away. However, after the shaking so much episodes the patient was extremely weak after that. He still has not gained his strength back. Diarrhea was began within ten minutes after the shaking started. It stopped within three days Rash was on his back and it started within a week of the second shot. It was all happening at the same time. Unable to clarify statement further. The adverse events did not require a visit to emergency room and physician office. The patient did not receive any vaccine prior vaccinations (within 4 weeks). The patient did not go to the Emergency Room or see a doctor about this. Outcome of the events shaking so much and diarrhea was recovered on an unspecified date in Feb2021, rash and unable to stand or walk was unknown and it also made him weak was not recovered.  Follow-up attempts are completed. No further information is expected.
20OCT vax given 1PM; high pitch scream, inconsolable onset 5PM x 3 1/2 hrs;21OCT ok daytime, appetite dec; cried x 1hr in evening, again high pitched;  22OCT cried on & off total time 30-45mins;
Phone call from client who was attending a health clinic. States arm was painful after the initial injection and is now sore, red, swollen and warm to touch. States it is difficult to put coat on w/out pain. Right arm is throbbing. Initially noted.
Ten days after receiving the Moderna booster, I woke up feeling very itchy all over my body. When I itched, the area would immediately turn red. Sometimes it would become raised. The rash would usually disappear within 30 minutes. Two days later my throat felt as it if something was lodged in my throat and I could not swallow it. I also experienced pain in my diagraphm. The rash continues to pop up in different parts of my body, but subsides when I take an antihistamine. The skin is very sensitive and reacts to heat, jewelry, itching and other substances. While I thought it was an allergic reaction to something in my environment, I have tested lotions, detergent, foods etc. and have been unable to find a solution, even though the rash persists.
Side effects lasting 4 weeks; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Side effects lasting 4 weeks) 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 (Side effects lasting 4 weeks). At the time of the report, VACCINATION COMPLICATION (Side effects lasting 4 weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided  Past medical issues were amplified.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2021 at 17:15 as dose 1, single (Lot number: EN6198), in left arm, on 21Mar2021 at 17:15 as dose 2, single (Lot number: GP7534), in left arm, on 24Sep2021 at 17:00 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 11Mar2022 at 17:00 as dose 4 (booster), single (Lot number: FK9896) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "degenerative disk disease" (unspecified if ongoing); "Known allergies: Sulpha" (unspecified if ongoing); "asthmatic" (unspecified if ongoing); "had high cholesterol" (unspecified if ongoing). There were no concomitant medications. The patient had "Paxlovid rebound" after 6 days of testing negative for COVID. The patient reported that on 25Oct2022, she tested positive for COVID and immediately took Paxlovid which helped with all the symptoms. After her isolation period, she flew home and was feeling well and strong, ready to come home. She even went swimming in the ocean that morning. She took her time flying home because she did not want to infect anyone on her flight, nor at home, including her animals. She had a comfortable flight and slept well. Upon arrival her home, she still felt well. However, as soon as she stepped out and exited the baggage claim area, she took one breath of the outside air, and felt her throat close and react to the air pollution. She could feel pollution particle stick to her throat. On the drive home, her throat and ears felt like they were having an allergic reaction to poor air quality. At home, she got sick again. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative; (unspecified date) positive; (25Oct2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Outcome of the events was not recovered.
Near-syncopal episode about 2-5 mins after vaccine, with pt becoming limp and less responsive, but not totally unresponsive. Back to normal after about 10 mins.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of GARDASIL 9 (lot # L043214, expiration date: 30-AUG-2017 and lot # M005714, expiration date: 03-OCT-2017) (strength, dose, route of administration and frequency were not reported). The nurse reported also GARDASIL 9 with lot# L040459, expiration date: 06-APR-2017 which was not valid for GARDASIL 9. However, lot# L040459, is valid for GARDASIL. Administered doses of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 1 hour; 34 degrees Fahrenheit for 5 hours and 33 degrees Fahrenheit for 17 hours. No adverse effects were reported. Additional information has been requested.
administered .5ml of Flublock Quad to a 3 year old,/ NO AE; Initial information received on 29-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse  This case involves a 3 years old female patient who was vaccinated with 0.5 ml dose of Flublock quad vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant therapy was given.   On 28-Aug-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1905, exp date: May 21, 2020, via unknown route in the right thigh.  It was a case of actual medication error due to Inappropriate age at vaccine administration.  At the time of the report, 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 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.  List of documents held by the sender: none.
Havrix given after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 2-year-old male patient who received HAV (Havrix) (batch number F7X23, expiry date 25th May 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st November 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 16-FEB-2023 Reporter's Comment: The reporter called to inform that a dose of Havrix that had been in a below temperature excursion and was not considered stable was administered to a patient. The reporter stated that below temperature excursion had happened in October 2022. The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The reporter called to inform that a dose of Havrix that had been in a below temperature excursion and was not considered stable was administered to a patient, which led to incorrect storage f drug. The onset date for incorrect storage of drug was earlier than vaccination date, so onset date was not captured in the case.  This was 1 of 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023026692:Same reporter US-GSK-US2023026693:Same reporter US-GSK-US2023026694:Same reporter US-GSK-US2023026696:Same reporter US-GSK-US2023026698:Same reporter
Approx. 3 hours after receiving tetanus shot donor states became congested and it lasted until he went to bed and the next morning got up feeling fine.
Intense itching and  redness in a 4 to 41/2 inch circle on upper left arm around injection site. Very warm to the touch.  Used Benadryl, Tylenol for first two days.  Also wet wash cloth on red area at frequent intervals.  After 2 days  redness began to disappear.
Localized cellulitis, increased redness 10cm. Treated /w Dicloxacillin (sp?) QID for 10 days & cold compresses.
Within 6 or 7 hours patient started to get severe muscle and joint aches, even throughout the night as her husband told her that she was complaining. The next morning she still hurt all over and about mid-day she noticed that her arm was reddened about 2 inches below the injection site on the left arm. It was red, warm and very large covering the front and side of her arm. She described it as a "lymphedema-like" reaction. Her muscle soreness began to improve the 3rd day, but the arm remained red and sore. Now 7 days later the redness is almost gone and the soreness is too. She did not apply any type of treatment for the redness.
I have developed joint pains first. It started with small pains in random joints. One day would be my elbow another day my toes another day my hands they started getting worse over time now the pain is so excruciating that most mornings I cannot walk I cannot stand up without crying.
Symptoms started 12 hrs after infection: 1-left deltoid pain, moderate intensity. 2-MULTIPLE symptoms that are known/listed, which are:  fatigue, headache, muscle pain, joint pain,  fever and chills, and nausea. Also lightheaded once. Treatment: OTC meds, ibuprofen 200mg every 6 hrs, acetaminophen ES 500mg in between ibuprofen every 6hrs; Outcome: started to feel improved by 18 hrs from onset of symptoms using meds; moderate improvement at time from over 24, 36 hrs, still noting  some fatigue, VERY minimal brief head pains, and mild left deltoid pain
Difficulty driving; A flared up injection site; Soreness in right arm; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Difficulty driving), VACCINATION SITE REACTION (A flared up injection site), VACCINATION SITE PAIN (Soreness in right arm), NAUSEA (Nausea) and PYREXIA (Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.   No medical history was provided by the reporter.  Concomitant products included METOPROLOL, POTASSIUM CITRATE, FAMOTIDINE, VITAMIN B NOS, VITAMIN D [VITAMIN D NOS], INSULIN DEGLUDEC (TRESIBA) and LIRAGLUTIDE (VICTOZA) for an unknown indication.  On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Difficulty driving), VACCINATION SITE REACTION (A flared up injection site), VACCINATION SITE PAIN (Soreness in right arm), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Difficulty driving), VACCINATION SITE REACTION (A flared up injection site), VACCINATION SITE PAIN (Soreness in right arm), NAUSEA (Nausea) and PYREXIA (Fever) was resolving.      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.  No treatment details were provided.
Pink, hot rash on thigh in which MMR booster was administered. Fever between 101-103.5.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency and route of administration were not provided) lot# N017700 and expiration date: 09-JUN-2019. The VARIVAX was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccine was stored in between 15 degrees Fahrenheit (F) to 46 F for 1 hour and 9 minutes. Previous temperatures excursions were in between 6 F 14 F for 76 minutes and in between 15 F to 46 F for 1 hour and 23 minutes. The digital data logger was involved in recording the temperature excursion.; Sender's Comments:  US-009507513-1711USA002012:
This spontaneous report as received from a pharmacy technician refers to an unspecified group of patients (demographic data not provided). The patients were vaccinated with VARIVAX (Merck) on an unknown date, after "some" vaccines were exposed to 43.1 for 29 hours on 03-MAR-2014. No adverse event was reported. This report is linked with case MARRS # 1405USA002815 (the same reporter link). Additional information has been requested.
Patient developed large bumps on Right arm (opposite injection site) and on both sides of the neck. She said they were hard and warm to the touch.
10/29/17-Pt was given FLUZONE HD in left deltoid, and PREVNAR 13 in rt deltoid. 11/1/17-pt reported redness, soreness, itching and swelling at the administration sites. Advised TYLENOL and ice. 11/3-spoke to pt. stating to resolve w/out treatment. Reported to PCP 11/1/17.
less than 1 hr p/vax pt became lethargic, c/o h/a, vomited; mental status back to nl w/in 1 hr; nl neuro exam p/return to office; fever, lethargy, hospitalized 24 hrs;
Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 10-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L041207 (dose, route and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever, chills, cough, sore throat, no appetite, general feeling of "feeling unwell", watery diarrhea, weakness, fatigue, malaise
Mother called clinic to report complaints of "headache" and said "spine hurt". Nurse advised mother to have son see private MD and watch for any other symptoms. I was asked to follow up on 2/26/07 but repeated attempts to reach family have failed.
Patient called pharmacy w/ symptoms of redness and swelling around injection site. Patient also came in person to pharmacy on 2/7 and pt was referred to ER where she received unknown tx. The patient called the pharmacy to inform that she had been diagnosed with a staph infection.
My daughter developed a huge red bump the size of a coffee mug on her leg where the vaccine was administered. Then she developed a fever for 4 days afterwards. She has also been very irritable.
felt ill for a day; This case was reported by a consumer and described the occurrence of feeling unwell in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient felt ill for a day. For tolerance of 2nd dose of Shingrix, refer case US2020AMR042566. This case has been linked to US2020AMR042554 and US2020AMR042562, reported by the same reporter.
Pt came in 9/2/13 (2 day after shot) complains of pain in injection site. Site was red pronounced bump, several inches in diameter. Recommended pt get doctor to look at site.
extreme letharge, sluggishness, felt like the flu, very bad headache, resolved after 24 hrs
FAINTED; HEAD SMACKED; WHOLE BODY HURT; This spontaneous report received from a patient concerned a 30 year old of unspecified 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: Unknown) dose, administered 1 total, therapy start date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported.  On an unspecified date, the subject experienced fainted while taking a pee 15 hours post-shot and smacked my head. Whole body hurt for 2 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fainted, body pain and head smacked was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210422129-COVID-19 VACCINE AD26.COV2.S-Fainted, Head smacked. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient described having a physician confirmed shingles case that started around his nose and continued up the left side of his face and the left side of the top of his head.  He said there was blistering and issues with "double vision".  He said that his vision has resolved for the most part, but he still has lasting nerve pain that is sensitive to touch on his face and top left part of his head.
No additional adverse events reported; 2 year old male patient received a partial dose of GARDASIL 9; 2 year old male patient received a partial dose of GARDASIL 9; This spontaneous report was received from a nurse referring to a 2-year-old male patient.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 16-NOV-2020, the patient was mistakenly vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, lot # and expiration date not reporterd) intramuscularly (IM) for prophylaxis (Product administered to patient of inappropriate age).  The vaccine was meant for the patient's sister, once the nurse realized the vaccine was not meant for the patient, she stopped administration and as a result, the patient only received a partial dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Incorrect dose administered). No additional adverse events were reported.