chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No reported side effects at this time; Nurse called stating that a patient who is on HUMIRA was accidently given the MMR-II vaccine and should not have been due to the HUMIRA making the patient immunocompromised and MMR-II being a live vaccine. AE filed for MMR-II (live vaccine) that was; This spontaneous report was received from nurse, referring to a unspecified patient of unknown gender and age. The patient's medical history was not reported. The concurrent conditions included  immunocompromised. Concomitant medications included adalimumab (HUMIRA).   On an unknown date, the patient immunocompromised was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous product quantity 1, administered for prophylaxis (strength, dose regimen, lot #, expiration date, and route of administration were not provided) (contraindicated product administered). No reported side effects at this time (no adverse event).  This is non-valid report due the lack of patient's identifiers.  Follow-up information was received from the nurse/vaccine provider on 17-FEB-2023 referring to a 36-year-old female patient. The patient's information was updated. The patient's concurrent conditions included ulcerative proctitis with rectal bleeding and dysthymia. The patient's concomitant medication included mesalazine (MESALAMINE).   On an unknown date, the patient started therapy with adalimumab (HUMIRA) pen pnkt 40 milligram (mg)/0.4 milliliter (mL) (40 mg, route was reported as injection, frequency, lot# and expiration date were unknown) for ulcerative proctitis. The reporter reported adalimumab (HUMIRA) as a suspect therapy.  On 22-NOV-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status recombinant human albumin (rHA)) (M-M-R II) subcutaneous injection (lot# W007181, expiration date 01-MAR-2024) subcutaneously (subq) in a medical center. The operator was trained. The patient was on adalimumab (HUMIRA) and should not have received this vaccine. The reporter called the doctor's office to ask what they should do. A certified nurse practitioner (CNP) spoke with the reporter and also called the patient. The CNP asked if the patient became symptomatic to prevent to emergency room (ER) for evaluation. The patient was not symptomatic at the reporting time (reported as to date). The outcome of the event contraindicated product administered was reported as recovered. It was unknown if the experience required prescription drug treatment. This adverse event had also been reported to manufacturer. There was no product quality complaint.
Received his 2nd dose 44-46 days after his 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received his 2nd dose 44-46 days after his 1st dose) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LAMOTRIGINE and ESCITALOPRAM OXALATE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received his 2nd dose 44-46 days after his 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received his 2nd dose 44-46 days after his 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided. Concomitant medications were not provided.
lymph node swelling in axilla in arm of injection site started with 6 hours after vaccination.  Fatigue, fever as high as 101 , chills, nausea started approx. 12 hours thereafter.  Ibuprofen was used to treat systemic symptoms.  Systemic symptoms resolved after 12 hours.  Lymph node swelling resolved after 7 days.  Patient
Symptom onset 1/12 itchy, 1/13 arm is swollen, painful and red, hard, hot to touch 1/14- was given abx for site infection
bad reaction to a live vaccine; This spontaneous report was received from a 66-year-old female patient reporting on herself, via Pfizer (manufacturer control # 2020239584). The patient's medical history and concurrent conditions were not reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose number, route, lot # and expiration date were not reported). Concomitant medications were not reported.  On an unknown date (reported as "a number of years ago"), the patient experienced a bad reaction to the "live vaccine" pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(vaccination complication.)   The outcome of vaccination complication was unknown.    The reporter considered vaccination complication to be related to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23).
I received my second Moderna COVID vaccine on 1/31 ( lot: 028L20A, exp 7/29/21) .   The next day  2/1 I had a severe  reaction with temps to 103, chills, rigors, nausea and vomiting.   I was in the bathroom vomiting and passed out, and fell and hit my head on the tub. On 2/8  for two weeks and had residual  fatigue but no other symptoms.  2/24 around 7 pm I had sudden onset of paraesthesias  ( pins and needles)  in both  feet, over 30 min it progressed up to my knees and my legs and feet were numb.  The next morning I went to the ER and was admitted.
This report is being submitted per request of the Department of Health to submit all patients who tested positive for COVID19 after receipt of the COVID19 vaccine. No other adverse reactions were reported. This patient tested positive for COVID19 on  12/27.
Information has been received from a nurse prescriber referring to an unspecified number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L048237, expiration date 08-MAY-2017; dose, dose number and route were not reported). No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose: 01/10/2021 ,pfizer,Lot#012L20A 2nd dose: 02/07/21,Pfizer,Lot# 012M20A Diagnosed covid positive:07/09/21 Exposure:unknown Symptoms:Fatigue, bodyaches,runny nose,headache.
fast/hard heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast/hard heartbeat) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation. Concomitant products included RIVAROXABAN (XARELTO) for Atrial fibrillation, METOPROLOL, ALLOPURINOL and OMEPRAZOLE for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced HEART RATE INCREASED (fast/hard heartbeat). On 13-Feb-2021, HEART RATE INCREASED (fast/hard heartbeat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.   Reporter did not allow further contact
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 11:00 (Lot number: FG3527) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Uncontrolled Severe Asthma" (unspecified if ongoing); "Erythema Multiforme" (unspecified if ongoing); "Hives" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR; VENTOLIN; TRELEGY; FLONASE ALLERGY RELIEF; ZYRTEC ALLERGY; BENADRYL. Past drug history included: Penicillin, reaction(s): "Allergy", notes: Penicillin(Hives) 'CHR(38)' GSK Hep B Vaccine (developed Erythema Multiforme). Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL8982, Location of injection: Arm Left, Vaccine Administration Time: 05:45 PM, ), administration date: 25Jan2021, when the patient was 56 years old, for COVID-19 immunization, reaction(s): "weakness", "joint pain"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EK9231, Location of injection: Arm Left, Vaccine Administration Time: 05:45 PM), administration date: 04Jan2021, when the patient was 56 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Oct2021 11:00, outcome "unknown", described as "booster"; ARTHRALGIA (non-serious) with onset 29Oct2021, outcome "unknown", described as "After 3rd shot, entire body was aching w Severe DEEP pain in most of joints"; INSOMNIA (non-serious) with onset 29Oct2021, outcome "unknown", described as "I could not sleep much"; JOINT SWELLING (non-serious), MOVEMENT DISORDER (non-serious) all with onset 30Oct2021, outcome "unknown" and all described as "lateral part of Left Wrist (swollen & could not rotate at all)"; LYMPHADENOPATHY (non-serious) with onset 30Oct2021, outcome "unknown", described as "left side of Thyroid area swollen & very tender to gentle touch"; DYSPHAGIA (non-serious), SENSATION OF FOREIGN BODY (non-serious) all with onset 30Oct2021, outcome "unknown" and all described as "felt a lump in my throat on the left, which resulted in difficulties in swallowing"; ASTHMA (non-serious) with onset 30Oct2021, outcome "unknown", described as "Worsening Asthma symptom"; TENDERNESS (non-serious) with onset 30Oct2021, outcome "unknown", described as "Externally: left side of Thyroid area swollen & very tender to gentle touch". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of asthma. No follow-up attempts are possible. No further information is expected.Additional Information:Patient took Prednisone (Rx from my pumonologist, for asthma, filled before moving from PA to CA), but left wrist is still in pain esp. during supination over 1 month after 3rd shot. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  Follow-up (14Dec2021): Follow-up attempts are completed. No further information is expected.
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jan2021 16:00 (Lot number: EL3246) at the age of 47 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Niacin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (DOSE 1, Batch/Lot No: EK5730, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 23Dec2020, when the patient was 46 years old, for COVID-19 Immunization, reaction(s): "complete loss of menses". The following information was reported: DRUG HYPERSENSITIVITY (disability) with onset 16Jan2021, outcome "not recovered", described as "severe allergic reaction"; MENOPAUSE (disability) with onset 16Jan2021, outcome "not recovered", described as "complete loss of menses". Therapeutic measures were not taken as a result of drug hypersensitivity, menopause. Clinical information: The patient reported complete loss of menses to date with NO previous signs of menopause. No other medications were taken in two weeks. No other vaccine was taken in four weeks. No Covid prior vaccination. No Covid tested post vaccination. Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the Drug hypersensitivity 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.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by a physician for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
On (L) deltoid notice redness, swollen and fever on 8/2/10 she had fever 101. But has improved on fever. Today she has slight swollen 4 1/2 cm x 4 cm. Advise mom to apply ice.
Patient came to the pharmacy to inform us that she had small rash on her right forearm. Pt believes that it was a result of her 2nd SHINGRIX shot she received from us on 01/11/2019. Upon further discussion with the patient, she described rash as small water filled pimples, itchy, but not painful. She indicated that rash appeared about 10 days after the shot. She showed me the picture of the rash that she took on 01/25/19. She applied Hydrocortisone for approximately two weeks and the rash went away. She indicated that she did not had any adverse reaction to the 1st SHINGRIX shot.
February 26 or 27th - I had a routine blood test - which showed my potassium had dropped down to 2.9. I had always been normal before. They put me on medication - Potassium CL Micro 10 Meqer tabs -  and it is back up to  normal. I continue to take the medication once a day. They are keeping a watch now. My doctor sent me to a cardiologist and kidney specialist. I have to have another blood test in two weeks.
ear ringing/ my husband started complaining of Tinnitus; Dose 3rd was administered 05Oct2022; Dose 4th was administered October it's says but I feel like it was week later than that 2022; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Lot number: GJ3277) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE), administration date: 06Jan2021, for COVID-19 immunisation; bnt162b2 (DOSE 2, SINGLE), administration date: 27Jan2021, for COVID-19 immunisation; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/lot: FF2587), administration date: 05Oct2022, for COVID-19 immunisation, reaction(s): "Wrong vaccine administered". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset Oct2022, outcome "unknown", described as "Dose 3rd was administered 05Oct2022; Dose 4th was administered October it's says but I feel like it was week later than that 2022"; TINNITUS (non-serious), outcome "unknown", described as "ear ringing/ my husband started complaining of Tinnitus ". The event "ear ringing/ my husband started complaining of tinnitus " required physician office visit.  Additional Information: Reporter's husband and reporter both had four of the Pfizer COVID-19 Vaccination, Immunizations and she was a very big vaccine protonate. Reporter stated that in January her husband started complaining of Tinnitus. They both had, she no way related it to the immunization at first. They were showing doctor and somebody when she was saying that they had Tinnitus, they were like, got it from shot. Apparently there was small percentage of people that were reporting tinnitus which of course they could not say for sure they said maybe it just a correlation but there was nothing else that could happen. Reporter stated they had all the same series of shot, all of the same lot and everything. Reporter stated, all four were COVID Pfizer 19 mRNA. When asked if husband also received Pfizer COVID-19 Vaccine, reporter stated, they took the exact same thing. Reporter stated, They (Lots) were the exact same as reporter's and like she said when she would call back with her information she would have his ready as well but his were the same because they took one after the other. It was clarified that husband received the same LOT# as FF2587. She would call later for her husband.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300302160 Same patient/different dose/AE;US-PFIZER INC-202300302176 Same reporter/drug/AE, different patient;US-PFIZER INC-202300302191 Same reporter/drug/AE, different patient;
Constant pain in shoulder of the arm the flu vaccine was injected, also sometimes limited range of motion in that shoulder which becomes worse with use.
This case was reported by a physician via call center representative and described the occurrence of leukocytoclastic vasculitis in a 22-year-old female patient who received ENGERIX B (batch number X9F7Y, expiry date 16th April 2019). Concomitant products included Hepatitis B vaccine and Hepatitis B vaccine. On 30th June 2017, the patient received the 3rd dose of ENGERIX B (intramuscular) 1 ml. On 30th June 2017, unknown after receiving ENGERIX B, the patient experienced drug dose administration interval too short. On 3rd July 2017, the patient experienced leukocytoclastic vasculitis (serious criteria GSK medically significant and other) and rash. In July 2017, the patient experienced headache and joint pain. On an unknown date, the outcome of the leukocytoclastic vasculitis, rash, headache and joint pain were not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the leukocytoclastic vasculitis, rash, headache and joint pain to be related to ENGERIX B. Additional details were reported as follows: The patient's concomitant medications also included birth control medication. The patient received 1st dose of hepatitis B vaccine on 21st April 2017. The patient received 2nd dose of hepatitis B vaccine on 22nd May 2017. No symptoms were documented after the first 2 doses. The manufacturer of the first two shots are unknown because they were given at a different facility. On 30th June 2017, the patient inadvertently received 3rd dose of ENGERIX B in left deltoid, which led to shortening of the vaccination schedule. The patient developed a rash and was diagnosed by a dermatologist via skin biopsy to have Leukocytoclastic vasculitis. Less than a week after vaccination, the patient also reported headaches and joint pain. The symptoms started shortly after the 3rd dose. The patient was now being followed by a rheumatologist and a dermatologist. The patient was treated with corticosteroids to ameliorate the symptoms and prevent further worsening of the rash.
Pt was waiting in 15 minute waiting area. Was doing fine then went unconscious-fainted, went to the floor slowly from the chair. Woke in about 15 seconds. Negative for head injury. Slightly nauseated, -HA, + shaking. Recovered, then -HA, -Shaking. HR was lower than his normal HR. Offered food/drink and patient was able to do this. Patient reported feeling better. Offered to call for a ride home, but patient denied, reporting that he felt "100% better".
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 26-MAR-2013 the patient was vaccinated with ZOSTAVAX (lot # 672476/1605AA, expiry date 13-JAN-2013) (subcutaneous, 0.65 ml). Pharmacist reported that this was an expired dose. No adverse effects were reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Information has been received from a physician concerning a female who was vaccinated with the second dose of Gardasil. Subsequently the patient experienced genital warts. Additional information has been requested.
Muscle twitching all over body from head to toe for a couple of seconds, does not hurt but continues on every day.  Also, paresthesia in lower lip and chin area Also, hurts to smile and talk for long periods.
Ichy rash on trunk of body and derriere crack, also under arm pits, and neck, so far. Have had for 3 days now and still driving me nuts with the itching.
It started with sore throat, head cold and loss of taste and smell. I had a really bad headache and started losing my breath and getting winded really bad on Oct 12, I went to ER they sent me home with oxygen and an inhaler. My O2 was 74. I was officially taken off the oxygen Nov 18, I still get fatigued and have brain fog really bad.
This case was considered medically important (OMIC). Information regarding Prevnar was received from a consumer, the mother of a male child. Information was verified and clarified by a healthcare professional on a follow up call to the child's pediatric office. The child received a dose of Prevnar in 9.01. Additionally, the patient received other childhood vaccines from 6/27/00 to 9/01, including Acel-Imune and Hib-TITER, Varivax, Infanrix, Recombivax HB, MMR II, Pedvax-HIB, IPOL, Comvax, and Hepatitis B vaccine. The child was diagnosed with autism in December 2003. The patient has a past history of being a normal newborn (reported as full term normal newborn also having a 6 year old sister with no medical problems). Indication for all vaccines was immunization. Dose regimen was 1 dose. Prevnar was administered in August 2000, October 2000, January 2001, and September 2001. Acel-Imune was administered in August 2000, October 2000, and January 2001. Hib-TITER was administered in October 2000, and September 2001. Additional suspect vaccines administered between 6/27/00 and 9/01 included; Varivax, Infanrix, Pedvax-HIB, Comvax, MMR II, IPOL, Recombivax HB, and Hepatitis B vaccine. Concomitant medications were not reported. A consumer, the mother of a male child, reported that her son at the age of 3 was diagnosed with autism after receiving Prevnar and other vaccines. The mother stated that she first noticed her son's symptoms, described as no eye contact and too quiet, when he was approximately one year old. An auditory screening, given at one year of age, did not show any hearing problems. Over the next two years, the mother observed that her son became less interactive, had hearing and speech difficulties and did not play with other children. The child was evaluated in a clinic in December 2003 and was diagnosed with autism. As of 8/12/04, the mother indicated that all events were unresolved and the pediatrician was aware of all events. Her son was attending a special needs school and was receiving speech therapy.