chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tingling pain in left leg (L3 Dermatome) Only happened on outer thigh; This non-serious case was reported by a physician via sales rep and described the occurrence of pain in thigh in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In SEP-2022, 7 days after receiving Shingrix, the patient experienced pain in thigh (Verbatim: tingling pain in left leg (L3 Dermatome) Only happened on outer thigh.). The outcome of the pain in thigh was resolved.   It was unknown if the reporter considered the pain in thigh to be related to Shingrix.     It was unknown if the company considered the pain in thigh to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-MAY-2023 In the 2022, the patient received Shingrix.   The tingling pain did not occurred after the second shot. The reporter was not sure if the event was related to the product.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 14th September 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 26th September 2018, 12 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles was recovering/resolving. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: After vaccination, the patient experienced a mild case of shingles on her right buttock. The patient reported that, the shingles had improved. The contact details of the physician was provided.
Information has been received from a physician concerning a female who was vaccinated in the past 3 months with a dose of GARDASIL. Subsequently the patient experienced fainted. Medical attention was sought. The patient's outcome was unknown. Follow up information indicated there were 6 patients who after vaccination with a dose of GARDASIL fainted and none of them needed resuscitation. Additional information has been requested.
This spontaneous report as received from a nurse refers to some patient. The nurse was reporting "some patients in the past have had negative antibody titers after receiving 3 doses of RECOMBIVAX HB". The nurse was unable to confirm the exact number or identities of the patients involved. The patients had sought medical attention by unknown type. The outcome of the event was unknown. The relatedness of the event with RECOMBIVAX HB was unknown.
Four days after vaccine,I Suffered an extreme head ache half blinded body ache nausea.
Not getting enough air; Felt like something stuck in her throat; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Not getting enough air) and SENSATION OF FOREIGN BODY (Felt like something stuck in her throat) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DYSPNOEA (Not getting enough air) and SENSATION OF FOREIGN BODY (Felt like something stuck in her throat). At the time of the report, DYSPNOEA (Not getting enough air) and SENSATION OF FOREIGN BODY (Felt like something stuck in her throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported.   No treatment information was provided.
Patient reported heavy left arm. Neuro assessment negative.  VS stable, refused transport to hospital.
No additional Adverse Event reported; PROQUAD was administered after a temperature excursion. No additional information provided. No additional AE reported. No PQC reported.; This spontaneous report was received from a health business professional, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 02-SEP-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) (product storage error), for prophylaxis (lot number W017570 has been verified to be valid; expiration date reported and established as 29-NOV-2023) (dosage, vaccination scheme, route of administration, and anatomical site of injection were not provided). The administered dose of the vaccine was stored at a temperature of 5.7 degrees Fahrenheit (F), during a time frame of 30 minutes. There was a previous temperature excursion reported as 6 up to 14 degrees F during a time frame of 1 hour and 6 minutes. There was no adverse effect reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1 , single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Sulfa meds" (unspecified if ongoing). Concomitant medication(s) included: CELEXA [CITALOPRAM HYDROBROMIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative, notes: Tested negative multiple days in a row; (12May2022) Negative, notes: negative for Covid on a rapid test; (21May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Started testing negative for Covid on a rapid test on 12May2022. Tested negative multiple days in a row. Tested positive on a rapid again today (21May).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient developed fever of 101.7 in addition to injection site redness, bruising, swelling and warmth.
moderate headache; Fever; This case was reported by a other health professional and described the occurrence of headache in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th July 2022 14:30, the patient received Shingrix. In July 2022, 13 hrs 30 min after receiving Shingrix, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were unknown.   The reporter considered the headache and fever to be related to Shingrix.  Additional Information: GSK Receipt Date: 28-Jul-2022. Reporter's Comments: The case was self-reported by the patient who was other health professional. After receiving the Shingrix and after going to sleep at 11:30 PM on the same day. The patient woke up on 28th July 2022 at 4:00 AM with moderate headache and fever. The reporter believed these were the side effects of the vaccine. The reporter consented to follow up. Additional Supportive Information: To reflect precise time to onset for the events, partial event onset dates were captured.
Patient called the next day and said there was no reaction at injection site but that arm was warm to the touch with swelling below the elbow. patient was referred to their doctor.
chills; headache; This is a spontaneous report received from a contactable reporter, Consumer, from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 03Mar2021 (Batch/Lot number: unknown) at the age of 68 years 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: CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "headache". Additional information: the patient was only 108 lbs and her sister was concerned that she may need to take a lesser dose of the vaccine due to her weight.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fatigue after the 1st dose. Extreme fatigue and development of vertigo soon after the 2nd shot. Went to the doctor several times, had therapy for the vertigo several times with little improvement. Wasn't able to walk stable until late May. Doctor ordered MRI and MRA (scans done 6 years prior completely clear)
This spontaneous report as received from a nurse refers to her 14 months old (currently 15 month old) daughter. In September 2014, when the patient was 13 months old, the patient was vaccinated with the first dose of M-M-R II (dose, route of administration, lot number, expiration date were not reported). In October 2014, on an unspecified date, the patient experienced a rash, which started on her legs and spread to her head. The rash was itchy but there was no fever. The nurse took her daughter to consult an unspecified dermatologist on an unspecified date in 2014. Approximately in 2014, blood titers tests for strep, rubella and varicella were performed. The dermatologist found that the child had increased levels of IGM for rubella. The outcome od the events was not reported. Relatedness between the events and vaccination with M-M-R II was not reported. Additional information has been requested.
Infant was given Hep B vaccination today. Was inadvertently administered adult formulation of vaccine at 10mcg  (1cc) versus pediatric 5mcg  (0.5cc), no adverse reactions occurred at time of administration.
Around the injection site was now swollen, like a ping pong ball, black and blue and  blistered; Around the injection site was now swollen, like a ping pong ball, black and blue and  blistered; Around the injection site was now swollen, like a ping pong ball, black and blue and  blistered; Arm was swollen black and blue and there was a blister the size of a table tennis ball; Arm was swollen black and blue and there was a blister the size of a table tennis ball; Arm was swollen black and blue and there was a blister the size of a table tennis ball; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0183), via an unspecified route of administration in right arm on 26May2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7533), via an unspecified route of administration on 05May2021 (at the age of 58-year-old) as a single dose for COVID-19 immunization. Patient stated she was calling about the Pfizer vaccine, COVID 19 vaccine. Patient states she received her 2nd Pfizer vaccine dose yesterday, 26May2021. The patient received the injection in her right arm and the area "around the injection site was now swollen, like a ping pong ball, black and blue and blistered on an unspecified date in May2021. Patient states they are "a lot of little blisters, the size of pen tip, all around the area also on an unspecified date in May2021." She denies pain and itching. She states it was starting to "drain and it looks gross." Enquired has this side effect been reported before and could you recommend any treatment for it. Patient asked was this was a common side effect. It was reported that, her arm was swollen black and blue and there was a blister the size of a table tennis ball on an unspecified date in May2021. The outcome of the events was unknown.
I had several positive pregnancy tests for about a week before and a week after my first vaccine dose on 4/15:21.  I currently have 6 children, all carried to full term, with no history of miscarriage or abortion. Being my seventh pregnancy, I am fully in tune with early pregnancy symptoms and generally know fairly early when pregnant.  My last period prior to getting pregnant began on 03/01/21; date of conception 03/17/21; estimated due date 12/08/21.  I cramped for about a week being after my first dose which was unusual and not typical.  It was a low grade lower abdominal cramp that was continuous for 1-2 weeks. I then started to have negative pregnancy tests about 2 weeks after my first dose. I would have been 7 weeks pregnant at my first dose.
This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The reporter stated she heard everyone was getting sick from the vaccine. When asked to clarify, stated heard patients reporting flu like symptoms. This case has been linked with US2018GSK152273, reported by same reporter.
Patient contracted covid 2 months after receiving the full vaccine series. He was admitted the hospital and subsequently passed away.  Variant testing was conducted (results are pending) and antibody testing was done. Antibody testing showed no antibodies were produced in response to the vaccine.
Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 2:16 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 2:16 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 45.61.  Concomitant products were not provided.  On 14-FEB-2021, Excursion time was reported at 9:00 A.M , 10:00 AM, 11AM, 2PM and 3PM with  temperature as 32, 32, 32, 35 and 35 degrees Fahrenheit, total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-FEB-2021, vial was moved to clinic on  13-JAN-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-MAR-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a  temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Extreme fatigue; Lower back pain is now moderate but currently ongoing; I had severe back spasms (lumbar region); Tightness in upper back; Hamstrings; This is a spontaneous report from a contactable (Patient). A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN 6203 and Expiration Date not reported) via an unspecified route of administration, administered in left arm on 05Mar2021 at 01:45 PM as single dose for COVID-19 immunisation. The patient medical history included suspected allergy of penicillin and allergic to wasps. The patient not received other vaccine in four weeks. The patient concomitant medications included loratadine (CLARITIN) and omeprazole. The patient did not have COVID prior vaccination. On 06Mar2021 at 08:00 AM (18-hours after the vaccination), patient had severe back spasms (lumbar region) along with tightness in upper back and hamstrings, followed by extreme fatigue after 48 hour (morning of 07Mar2021) lasting until Tuesday (09Mar2021). Lower back pain was now moderate but currently ongoing. The patient visited doctor or other healthcare professional office/clinic as a result of events. The patient received treatment with Ibuprofen and Acetaminophen and electrolytes. The patient not tested for COVID post vaccination. On 09Mar2021, the extreme fatigue was resolved. The outcome of all other events was recovering.   No follow-up attempts are possible. information about lot/batch number cannot been obtained.
dizziness; jittery; shaky; headache; fluid in her ears; wake up in the middle of the night; Weakness; chills; tired; This is a spontaneous report from a contactable registered nurse (patient). A 57-year-old female nurse received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) injection at single dose via an unknown route in the left deltoid on 20Jan2021 for Covid-19 immunization. Medical history included hypothyroidism. Concomitant drug included  ongoing levothyroxine sodium (EUTHYROX) started about 12 years ago as of 27Jan2021 at 75mcg once a day for hypothyroidism.  Patient had first dose on the 20Jan2021, Wednesday and the last two nights (as of 27Jan2021) patient had chills. Onset date of chills was 25Jan2021. She assumed it would be sooner than further out close to the second one getting side effects.  She also experienced weakness and was really really tired. Onset date of tired was 24Jan2021. She was unsure if she should get the second dose, or if she needs to contact her provider about this. She did not know if these are normal side effects or not. She looked at the side effect list, which said chills and headache, which she has experienced both. She also had dizziness. She used Flonase for the fluid in her ears. She thought the headache and dizziness was from fluid from pressure or something. The FLONASE helped with that. She had no fever. She was a week out from getting the dose and was wondering if she should still be having these side effects.  Headache/ dizziness and weakness started a few days after she got the vaccine. She thought the weakness started that Friday or Saturday. If she got enough sleep she was okay, but she would wake up in the middle of the night. She thought the chills were from the weakness. She was also jittery and shaky as part of the weakness. Patient was always being really really tired later in the day. She thought that if she were working full time she would be missing work and that was medically significant. Treatment included FLONASE and took paracetamol (TYLENOL) for the headache early on. The events (chills, weakness, tired, headache and dizziness) were reported as serious with seriousness criteria of other medically important condition. No Investigation Assessment performed. Outcome of the events chills, weakness, tired was not resolved. Outcome of headache and dizziness was resolved. Outcome of the other evens was unknown.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient was seen in clinic by PCP for a routine 6 month well child check exam on 12/23/20. The following vaccines were given at that visit: Pediarix, Hib, and Prevnar. Per mother of patient, later that evening child felt very hot, and dad was starting to give tylenol when patient had a 30 second total body stiffening with quivering and eyes rolled back. 911 was called, fire dept. responded and advised patient probably had a reaction to shots. Patient was taken to the ER in parents own car as the paramedics were 30 minutes out due to responding to COVID calls. While on the way to the ER patient had another 15 second generalized stiffening. Hospital ER notes pending. Per mom, child was lethargic at first while in the hospital, Motrin was given, child back to normal within 2 hrs, RSV and COVID tests done while in the hospital, both results negative per mom. Patient was home by the next day and appeared/has remained WNL.
Tiredness and fever started that night. Large,extreme redness, hardness at injection site Fever 103.8 with Shivering , headache, joint paint, body aches, stomach pain and nausea. Fever slowly decreased over 5 days
My daughter has an IUD and hasn?t had her period in nine months. With the first vaccine, her period started the next day. With the second shot, the same thing happened, next day. Second dose was 4-15/21. We assumed these odd occurrence was totally unrelated, but we?re seeing incidences of the same discussed online and felt we should report this.
pt recvd flu vax & exp stinging @ the site of inject; stinging lasted several days;
Gave the bivalent vaccine as second Covid vaccine dose for this patient. No adverse response reported.
Pfizer-BioNTech Covid-19 Vaccine EUA  Injection @ 08:25, waited @ facility 30 minutes @ 09:10 lips began tingling, tongue was tingly/numb, and throat felt fuzzy, symptoms persisted but did not worsen @ 09:37 Took 25mg of Benadryl @1030 symptoms 75% gone
Loss of language, eye contact, responding to name. No social interaction, was in his own world.