chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent. A 17 year-old male patient received bnt162b2 (BNT162B2), administration date 10Apr2021 (Lot number: EP6955, Expiration Date: 30Jun2021) at the age of 16 years as dose 2, single and administration date 20Mar2021 (Lot number: EP6955, Expiration Date: 30Jun2021) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Apr2022, outcome "unknown" and all described as "tested positive for COVID-19"; OROPHARYNGEAL PAIN (non-serious) with onset 31Mar2022, outcome "unknown", described as "a severe sore throat"; MALAISE (non-serious), outcome "unknown", described as "generally not feeling well". The patient underwent the following laboratory tests and procedures: investigation: (31Mar2022) positive; sars-cov-2 test: (03Apr2022) positive, notes: on a home test; (31Mar2022) negative, notes: (rapid and PCR). No follow-up attempts are possible. No further information is expected.
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  They accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage. No adverse event was reported for any of the patients.  Treatment medications were not reported.  This case contains information for patient 15 out of 25.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2023: Live significant follow-up received contains patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:master case
This spontaneous report was received from a nurse practitioner concerning to a unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On an unspecified date, PEDVAXHIB was exposed to temperatures of 14.0 C for 4 hours and 30 minutes. At the time of the report, it was unknown if the vaccine was applied to patients. This is one of several reports from the same source. Additional information has been requested.
Hives on neck, chest, abdomen, arms, and thighs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Nov2021 14:38 (Lot number: FK5127) at the age of 6 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset 10Nov2021 16:00, outcome "recovered", described as "Hives on neck, chest, abdomen, arms, and thighs". Therapeutic measures were taken as a result of urticaria.  Additional information: If other vaccine in four weeks: No. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: None. Other medical history: None. Family Medical History: Father has hx of Fever / vomiting from childhood vaccines and had adjusted dose schedule. Relevant Tests: None. Specific Relevant Tests: None. Treatment Details: Benadryl/Cloritin. (Withheld) developed hives from neck to knees starting approximately 2 hours after administration. Patient received alternating doses of 25mg Benadryl and 10 mg Cloritin g/2 hours for approximately 3-4 days after then hives/itch no other sequalae.  No follow-up attempts are possible. No further information is expected.
This is a prospective pregnancy case. This 16-year-old female subject was enrolled in an open label study titled BEXSERO pregnancy registry: an observational study on the safety of BEXSERO exposure in pregnant women and their offspring. The subject received BEXSERO on 11th January 2019, for prophylaxis. Co-suspect products included MENVEO for prophylaxis. The subject received BEXSERO during the first trimester of pregnancy. On 1st February 2019, 21 days after receiving BEXSERO, the subject developed vomiting blood. Serious criteria included GSK medically significant. Additional event(s) included vaccine exposure during pregnancy. The outcome of vomiting blood was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. It was unknown if the investigator considered the vomiting blood to be related to BEXSERO. Other possible cause(s) of the vomiting blood included Men A Conjugate - CRM 197, Men C Conjugate - CRM 197, Men W Conjugate - CRM 197, Men Y Conjugate - CRM 197. Additional details were provided as follows: This case was reported by the patient's mother. The age at vaccination was not reported but the patient could be 15 or 16 years old. The patient was about 6 weeks pregnant (estimated delivery date unknown) and received two meningitis vaccines but could not say with certainty if the vaccines were MENVEO or BEXSERO and the patient's provider did not know at the time she was pregnant. The reporter wanted to know if the vaccines could have harmed her daughter or the pregnancy and reported that at the morning of date of reporting the patient had to be taken to the hospital due to vomiting up blood. The patient was only seen as an outpatient and they released her with some medication to coat her stomach. The reporter provided permission for the Registry to share this information with GSK and for a representative to contact her directly. The reporter was advised that the Registry was closed to enrollments, but that her information would be shared with GlaxoSmithKline (GSK) and a representative would be in touch.
Obsessive compulsive disorder, encephalopathy, sensory processing disorder, Autism Spectrum Disorder, Pediatric acute-onset neuropsychiatric syndrome (PANS).
She has been afraid to get her second dose; sweating like she is in the sauna; Dizziness; Weakness; Difficulty breathing; couldn't hardly talk, had to whisper; fast heart beat; swelling of throat; shaking really bad; swollen face; she feels hot like she's in a sauna; severe allergic reaction; This is a spontaneous report from a contactable consumer or other non-health care professional. A 58-years-old female patient received bnt162b2 (BNT162B2solution for injection, Batch/Lot number was not reported) via intramuscular route of administration and administered in left arm on 23Apr2021 12:00 as single dose for COVID-19 immunization. The patient didnt had any another vaccines on 23Apr2021. The patient didnt had any another medications prior four weeks. Medical history included angina pectoris from 2006 and ongoing She takes Diltiazem 180mg once daily by mouth. She has been on it for years. Concomitant medications included diltiazem (DILTIAZEM) taken for angina pectoris. On 23Apr2021 at 12:00 patient had a severe allergic reaction to the Pfizer Covid-19 vaccine. Her side effects were difficulty breathing, difficulty swallowing, fast heartbeat, dizziness, weakness, and she feels hot like she is in the sauna. Confirmed details with caller, who said she did not have difficulty swallowing, but did have swelling of her throat and couldn't hardly talk, she had to whisper. She also said she was sweating like she was in the sauna instead of she feels hot like she is in the sauna. Immediately after the Covid-19 injection she had all these symptoms. Within two hours she was completely back to normal. Her mom came to get her in a wheelchair because she was shaking really bad. She used a wheelchair which was provided to her by them. This occurred half an hour after the injection. An emergency medical technician (EMT) came and the caller's symptoms started to dissipate by the time they got there. She said they took her vitals and was told that they were all fine. She does not remember what vital signs were taken or what the results were. She did not get nothing after getting the vaccine for her side effects. The EMT was going to give her an epi-pen but she declined it. She did not take anything for her symptoms. Caller thought she was supposed to wait a month, which was a couple of days ago. She was listening to the automatic thing and was told she was supposed to wait three weeks. She has been afraid to get her second dose of the Covid-19 vaccine. Her doctor said it was ok to get. caller reports that the EMT did a blood sugar test on 23Apr2021 and initially stated the result was 23. Clarified with caller result is 123. She also had her vitals taken, but does not know the results, she was so out of it. Has regular medications that she has been taking for a long time but doesn't feel that they are relevant. Caller provided no further product names. The patient underwent lab tests and procedures which included heart rate: fast, investigation, physical examination on 23Apr2021.The outcome of events was recovered and outcome of event she has been afraid to get her second dose was unknown.
This spontaneous report was received from a pharmacist, referring to an adult male patient of unknown age. The patient's pertinent medical history and current medical conditions were not provided, neither information about any historical and concomitant medication taken by him, drug reactions or allergies. The pharmacist mentioned that during his childhood, on unspecified dates, the patient was vaccinated with the first and second dose of (wistar ra 27-3) M-M-R II for prophylaxis (route and anatomical site of administration, lot number and expiration date were not provided). It was reported that as an adult, on an unspecified date, the patient had an antibody titer drawn for measles, mumps and rubella, which resulted negative. Therefore, on an unspecified date, the patient was vaccinated with the third dose of (wistar ra 27-3) M-M-R II as part of a routine vaccination to get a new job (route and anatomical site of administration were not provided, lot number and expiration date were unknown by reporter). The pharmacist stated that after being vaccinated with the third dose of (wistar ra 27-3) M-M-R II the patient had, on an unspecified date, an antibody titer drawn for measles, mumps and rubella, which resulted to be negative. No treatment was given for the events and the patient did not seek medical attention. Further information was not provided. The outcome of measles, mumps and rubella antibody titers resulting negative was unknown by the time of reporting, and the pharmacist did not provide any causality assessment for them in regards with (wistar ra 27-3) M-M-R II vaccination.
Pain in chest, fast heartbeat and shortness of breath. Pain began 6-28-21 at 5pm and has persisted  through today 6-29-21.
Baby had been crying while waiting for vaccinations, during Rotavirus vaccine administration, and during injections. As soon as the last injection was given, the baby stopped crying, her eyes were fixed and staring, her arms went stiff and straight out from her body, she was not breathing and she was turning pale in the face with bluish lips.
dry mouth; tongue felt lazy; trouble swallowing; light headed/Felt faint; Starting tingling; itching; Face broke out with a rash; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER, formulation: solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Right on 09Mar2021 15:15 (at the age of 51-years-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism, hypertension, pituitary tumour benign, drug hypersensitivity and food allergy from an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. The patient did not have covid prior vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 09Mar2021, the patient experienced dry mouth and tongue felt lazy for 8-10 minutes, lightheaded/felt faint for 10-12 minutes, itching for 30 minutes, trouble swallowing, tingling and face broke out with a rash. Therapeutic measures were taken as a result of the events. The patient was treated with Benadryl for these allergic reactions. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Vaccine administered on 7/28 (ZOSTAVAX). 2 to 3 inch diameter red area appeared 7/30 (R arm); per nurse - reaction to ZOSTAVAX. Area also hard...(erythema, induration).
Was given Pentacel and IVP, MMRV and Varicella vaccines resulting pt getting two IVP and two Varicella at the same time. Discuss with Vaccine unit. 06/21/2019 Father reports pt limping and not wanting to eat. No site reactions reported
Vaccine injured following two moderna vaccines; Cognitive issues; Nerve pain throughout body; Racing heart palpitations; Trouble sleeping; Debilitating; Can no loger drive; Memory loss; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccine injured following two moderna vaccines), COGNITIVE DISORDER (Cognitive issues), NEURALGIA (Nerve pain throughout body), PALPITATIONS (Racing heart palpitations) and INSOMNIA (Trouble sleeping) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced COGNITIVE DISORDER (Cognitive issues), NEURALGIA (Nerve pain throughout body), PALPITATIONS (Racing heart palpitations), INSOMNIA (Trouble sleeping), ASTHENIA (Debilitating), IMPAIRED DRIVING ABILITY (Can no loger drive), AMNESIA (Memory loss) and HEADACHE (Headaches). On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccine injured following two moderna vaccines). At the time of the report, VACCINATION COMPLICATION (Vaccine injured following two moderna vaccines), COGNITIVE DISORDER (Cognitive issues), NEURALGIA (Nerve pain throughout body), PALPITATIONS (Racing heart palpitations), INSOMNIA (Trouble sleeping), ASTHENIA (Debilitating), IMPAIRED DRIVING ABILITY (Can no loger drive), AMNESIA (Memory loss) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Weight decreased: low (Low) Lost weight.         No information was provided on concomitant medication. Treatment information was not provided by the reporter.
extreme sleepiness-recv vax 12noon on 16MAY96 slept from 5PM that day until 1PM the next day-only brief nursings when wakened by parent
The patient said that 12 hours after she got the vaccine, she had fever, chills and body aches that lasted around 12 hours. She got the vaccine at 3:15pm and said the symptoms started around 3am the next morning and lasted until around 3-4pm the next day. Her son got the same vaccine at the same time, same lot number, and had no adverse effects.
Ringing in my ears started just after the two shots were administered, and has persisted for three (3) weeks.
None reported. Pt received her Moderna COVID vaccine on 6/18/21 as the first vaccine and received Pfizer as the second dose. No reactions reported
no additional AE; administration of a pediatric dose of PROQUAD to an adult patient; This spontaneous report was received from a medical assistant and refers to a 46-year-old patient of an unknown gender. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 02-MAY-2023, the patient was inadvertently vaccinated with a pediatric dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD) injection, 0.5 milliliter, lot #W028565, expiration date: 06-MAR-2024 (administration site, and route of administration were not provided) for prophylaxis (product administered to patient of inappropriate age). The reporter inquired about the need for revaccination and what the timing/schedule would be. No additional adverse event (AE) was reported (no adverse event).
Patient given 0.2 ml of Pfizer-Gray Top, which is the adult dose. Lot #: FJ6369 that Exp: 05/31/2022 to his left deltoid. Patient was given the wrong immunization and should have been Pfizer age 5-11 years. I reported this to both my Practice Manager and the PCP Dr. I then spoke with our pharmacist at L and he reports that he has no physical concerns for this patient and stated that he may even have a stronger immune response to this. Patient and his step father both advised of this. I advised the step father that I would call this patients mother, and advise her as well. Step father advised me that things happen and that he had no worries or concerns regarding this mishap. I advised the step father that if needed, they could call the on-call doctor with any questions or concerns over the weekend if this patient developed any symptoms.  VM left with mother to call me back at the office so I could advise her as well.
pt noticed redness & swelling @ Td site & saw MD;ultrasound revealed abscess & a drain was placed;the fluid was cultured & pt started on oral & IV ATB w/daily aspiration of fluid through the drain;
I received the vaccine on Monday at 4:30, around 5:30 I noticed my tongue feeling weird, no difficulty swallowing, no resp issue and no rash. I took 25 of Benadryl and went about my evening. Tuesday around 12:00 I had that same sensation but a little stronger, I would call it a tongue swelling but no resp issues or swallowing problems. I called my PCP and he recommended me to take Zyrtec (which I take 1 daily) BID and Benadryl prn. I took 3 doses of Benadryl Tuesday and a Zyrtec Tuesday night and one Wednesday and  around 8:15 had the same sensation, tongue swelling but milder. I immediately took 50 mg of Benadryl and called my Dr again and he recommended a steroid pack and Benadryl prn and to not take the 2nd dose.
Muscle tightness, which lead to joint popping and pain; Muscle tightness, which lead to joint popping and pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Apr2022 at 01:15 as dose 4 (booster), single (Lot number: FK9893) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood cholesterol increased" (unspecified if ongoing), notes: Other medical history: High cholesterol. Concomitant medication(s) included: LOVASTATIN. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline", notes: Known allergies: Tetracycline; Actonel, reaction(s): "Known allergies: Actonel", notes: Known allergies: Actonel. Vaccination history included: Covid-19 vaccine (Dose: 1, Primary immunization complete, manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose: 2, Primary immunization complete, manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose: 3, First booster dose.), for Covid-19 Immunization.  The following information was reported: ARTHRALGIA (non-serious), MUSCLE TIGHTNESS (non-serious) all with onset 30Apr2022, outcome "not recovered" and all described as "Muscle tightness, which lead to joint popping and pain". Therapeutic measures were taken as a result of arthralgia, muscle tightness.  Additional information: patient was not received any other vaccine in four weeks. Patient did not had covid prior vaccination nor covid tested post vaccination. Treatment for the events included Myofascial release massage and regular massage.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a female who on 29-MAY-2007 was vaccinated with Gardasil.  On 20-JUN-2007, lab work was done as part of a regular check-up, and transient elevated liver enzymes was noted.  It was reported that the rest of the lab work was normal, and there was no elevation in bilirubin.  The patient was re-tested 3 weeks later, and all results were normal.  The patient was reported to be fine.  Additional information has been requested.  This is one of two repots from the same source.
Patient complains that he has cramps in his right leg, his back, hip and his chest.