chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BOOSTER DOSE WAS NO LONGER IN THEIR SYSTEM; This spontaneous report received from a pharmacist concerned a patient of an unspecified age, sex. Initial information was processed along with the additional information received on 20-JUL-2022. The patient's height, and weight were not reported. The patient's past medical history included: transplant, and concurrent conditions included: immunocompromised. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose 1, primary dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. On an unspecified date, the patient experienced primary dose was no longer in their system following vaccination with primary dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose 2, booster dose, dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced booster dose was no longer in their system (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of booster dose was no longer in their system was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000242725. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20220735351.; Sender's Comments: V0:20220742370-covid-19 vaccine ad26.cov2.s-  booster dose  was no longer in their system. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY (immunocompromised), SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Information has been received from a literature article concerning a 18 year old female patient developed uveitis following administration of GARDASIL. The patient had as a pre-existing conditions hypertension, diabetes mellitus and arthropathy. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476); time to onset was unknown in 1 case; the time to onset in this case was of 30 days from vaccination. There was one reported rechallenged of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccine and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.
Extreme weakness in legs for 3 wks starting 1 week after Menactra severe head and neck pain for 13 days starting 1 week after Menactra-Elevated PTT (6.8) (normal PT and normal LFT's) 05/02/07-records received from physician for DOS 3/5 and 3/8/07. C/O 9 days headache, body ache, arthralgia. Questionable myositis. 05/02/07-records received from rheumatologist. PMH: Several years with aches pains Raynaud's phenomenon. Osteoarthritis of right thumb. December fell from a truck or car and her left foot was bothering her attributed to that injury. Several years with low platelet counts recently at 140,000.  Right epicondylitis. Problems appear to be early connective tissue disease with arthritis, thrombocytopenia, leukopenia and Raynaud's phenomenon which has been symptomatic.
Slight swelling, about quarter size erythema area to left arm.  Pt. complain affected area is itchy.
A non-serious, spontaneous report of flu and fever of 104 has been received from a physician concerning her six-year-old female daughter, one day subsequent to FLUMIST. Neither medical history nor concomitant medications were reported. The patient received FLUMIST on the afternoon of 29-Sep-2010. Around 7:30 PM on 30-Sep-2010 the patient experienced symptoms of influenza including fever of 104, chills, body aches and lethargy. On 01-0ct-2010 all reported symptoms resolved.
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 05-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA004059:
About a month after the second dose she had issues with her GI track and was diagnosis with IBS which has ever been an issue in her life. She is still having some issues today, has even changed her diet to help. She said she has spoken with others that have also had GI issues after having the vaccine.
Patient had redness and warmness. She started Itching and felt a little off. She took diphenhydramine 50mg. Her blood pressure was 161/107 and Heart rate was 100. Her temperature was fine. She had water and food and waited about an hour. The itching and rash went away. Her blood pressure came back down to 125/89 and heart rate 93. She left to continue working and has reported no other events since at 4PM.
No adverse effect reported; a patient received expired GARDASlL 9; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On 09-AUG-2019, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot # M040412, expiration date 30-JUN-2019 (dose and route of administration were not provided) for prophylaxis. No adverse effect was reported.
got the flu; Initial information was received on 11-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves an unknown demographics patient who got the flu while receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (strength, formulation, dose, batch number and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had got the flu (influenza) (unknown latency) following the administration of Influenza Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event influenza  Outcome: unknown
4-5 hrs p/immunization limpness/paleness noted. T 103 & very irritable responded hyper to any stimulation. Taken to ER for eval. Sent home from ER
pt recv vax 13OCT97 & stated itched all over told to come to med office & had reddened area all over body w/itching & rt deltoid are where vax given reddened;
No adverse event, patient was not 12 years old yet. Actual age is 11 years and 11 months old
Developed right facial eyebrow sagging, inability to close eye, disappearance nasolabial fold, drooping corner mouth, and decreased tearing; onset 4/8/21; diagnosed with right Bells Palsy
first dose in 2020, not received second; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter had no information regarding patient (initials, gender, or date of birth).  The reporter did not have lot number or expiry date, route and date of administration, and dose for the first shot of Shingrix. The reporter consented to follow up with herself.
The day following vaccination, onset of fever of 103 degrees, the pt has chills. Temperature decreased without medication to 99.8. Pt did not seek medical advice. Temperature 99.8 degrees on 6/16/10. Also had c/o's body aches.
BRUISING ALL OVER BODY; VAGINAL BLEEDING; PAIN; PAIN IN ARM; MUSCLE ACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On APR-2021, the subject experienced bruising all over body. On APR-2021, the subject experienced vaginal bleeding. On APR-2021, the subject experienced pain. On APR-2021, the subject experienced pain in arm. On APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bruising all over body, vaginal bleeding, muscle ache, pain and pain in arm was not reported. This report was non-serious.
This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received INFANRIX (batch number UNK, expiry date unknown). On an unknown date, the patient received INFANRIX. On an unknown date, an unknown time after receiving INFANRIZ, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information received: INFANRIX was administered to a 7 year old patient.
I had pain in my upper arm, shoulder area after the shot to the point that I could not lift my arm or sleep on my left side. The pain was immediate and never subsided. I am currently attending physical therapy.
This retrospective pregnancy case was reported in a literature article and described the occurrence of preeclampsia in a 40-year-old female subject who was vaccinated with DTPa (with small D + P), manufacturer unspecified). The subject had multiple previous pregnancies. On an unspecified date, the subject received unspecified dose of DTPa (with small D + P) (unknown route and injection site). Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine during unspecified trimester. At an unspecified time after vaccination with DTPA, the subject experienced preeclampsia. On an unspecified date, after 36 weeks of gestation, the subject gave birth to a preterm neonate by unspecified method of delivery. No congenital anomaly was reported. The subject was hospitalised.
This spontaneous report was received from healthcare worker concerning a male patient of unknown age. The patient's medical history and drug reactions/allergies were not reported. Recently in 2012, the patient was vaccinated with PNEUMOVAX23. Dose and route were not reported. Lot number H209826 (in validation). No other co-suspects were reported. No concomitant medications were reported. In 2012, the patient experienced severe reactions as fever of 102 F and cellulitis at the injection site. No treatment information was reported. The outcome of fever of 102 F and cellulitis at the injection site was unknown. The relatedness for fever of 102 F and cellulitis at the injection site was unknown for PNEUMOVAX23. This is one of two reports received from the same source. Additional information has been requested.
Flu vaccine given 11/17/04.  Developed rash over most of body on 11/19/04. Pt received Enbrel injections on 11/18/04 and 11/26/04.  On 11/19/04, physician diagnosed pt with Erythema Multiforme and treated with Valacyclovir HCl 1 po bid X 1 wk. Follow up on 12/3/04 revealed Erythema Multiforme Improved.  Pt moved from area a few days later and has been lost to further follow up.
CRAMPS; BODY ACHES; WARM TO TOUCH; FEELS WIPED OUT; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 54 year old female. 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: 1802070, expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced cramps. On 03-MAY-2021, the subject experienced body aches. On 03-MAY-2021, the subject experienced warm to touch. On 03-MAY-2021, the subject experienced feels wiped out. On 03-MAY-2021, the subject experienced nausea. On 03-MAY-2021, the subject experienced fever. On 03-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, cramps, body aches, nausea, headache, feels wiped out, and warm to touch. This report was non-serious.
vaccine was administered on 11/10/2022 after the 30 day window beyond use date. no adverse event.
Pt received immunizations on 5/31/11, states on the next day she noted raised red rash on (L) arm and her top lip was swollen, states lip still swollen some today 6/2/11 & redness to (L) arm noted. Pt advised cool compresses, go to ER if cond worsens or any s/s of SOB/etc.
Recumbivax-Adult was administered.  At time of next dose, noted that this client was 18 y/o not the required 20y/o
skin raised and a hive presented; Redness appeared at the injection site; site of the injection became very warm to the touch.; raised again and became hard to the touch/swelling; skin raised and a hive presented/raised again and became hard to the touch; This case was reported by a nurse via sales rep and described the occurrence of hives in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA418A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo (intramuscular). On an unknown date, less than a day after receiving Menveo, the patient experienced hives, injection site erythema, injection site warmth, swelling and skin induration. The patient was treated with benadryl (nos) (Benadryl) and non-drug therapy (Cold Compress). On an unknown date, the outcome of the hives, injection site erythema, injection site warmth, swelling and skin induration were unknown.   It was unknown if the reporter considered the hives, injection site erythema, injection site warmth, swelling and skin induration to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine in left arm and the nurse noticed his skin raised and a hive presented itself. Afterward it went down and then raised again and became hard to the touch. The redness appeared at the injection site and the site of the injection became very warm to the touch. The patient was treated with 50mg of Benedryl intramuscular and placed a cold pack on it to relive the swelling. The consent to follow-up was granted.
Renal pain, throbbing like calculi, intermittent, recurring.  today is Feb, 21 and it is still happening.   I am pushing fluids and taking Tylenol.
pt recvd vax 1130AM 21NOV95 & mom noticed red, warm area approx 1 1/2"diameter @ inj site on lt deltoid;APAP given & pt went to school;pt c/o arm sore, but is using it
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (DILUENT MRK INJ). On 07-MAR-2018, the patient was vaccinated with expired dose of ZOSTAVAX (dose, units, frequency and route not reported) (lot # N009777 and expiration date: 08-JUN-2018). No adverse effects and no additional information was provided. No product quality complaint was involved.
Patient was administered the incorrect dose for age. Dr. Pediatrician contacted parents, explained the situation and answered all questions. Dr. made a plan for second dose.
Had shot on thursday at 6pm had a very sore arm and back all day friday.  saturday about 8 am my wrist started to itch n so did the inside of my elbows.  i went to the bathroom n i was completly covered in hives i was beet red n my neck face eyes hands were completly swollen and i threw up.  i took two benadryl and it helped alot took three more throughout the day n i was fine.  sunday am about 8 again same thing only much more intense itching oh and my heart was beating very rapidly both days took benedryl again and it helped but then went to urgent care because my face was still swollen n wouldnt go down n since it happened twice i was not going to go through that again.       ch
This spontaneous report was received from a Registered Nurse (R.N) regarding two unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 22-DEC-2015, the patients were vaccinated with two doses of VARIVAX, Lot # K026385, (dose and route of administration not provided), which were improperly stored. There were no concomitant medications reported. There were no adverse effects reported. This is one of several cases from the same source (MARRS # 1601USA011654, 1602USA002863, 1602USA002864 and 1602USA002865). Additional information has been requested.
Approximately 2 days post vaccine, Left deltoid/Upper arm became Red, Swollen, Inflamed. Area Painful to touch and with  movement.. On day 4,  swelling and inflamation decreased, skin transitioned to pink raised rash, remained tender with slight itching. Area treated with cold compress, topical 1% hydrocortisone cream, tylenol and benadryl.
This spontaneous report was received from a nurse regarding multiple patients of unknown demographics. Information on pertinent medical history and concomitant medications were not reported. On unknown dates, the patients received improperly stored VAQTA lot#N005796 with expiry date of 26-MAY-2018 for prophylaxis (dosing details not reported). Temperature was 47F to 77F (46.8 F). Time frame of the excursion was 62 hours 45 minutes. There was no previous excursion. The call was because of data logger. No adverse effects were reported. This case is linked to 1707USA009781 due to the same reporter. Additional information has been requested.
Lump on left side of neck.  Diagnosed in hospital as swollen lymph node side effect from shot; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 04Apr2021 at 10:30 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 17:00, the patient experienced lump on left side of neck. It was diagnosed in the hospital as swollen lymph node as a side effect from the shot. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event swollen lymph node and included treatment with pain medicines (Unspecified). Since the vaccination, the patient had been tested for COVID-19. On 12Apr2021, the patient underwent COVID-19 Nasal swab test and the result was negative. The clinical outcome of the event swollen lymph node was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient complains of soreness in the upper arm. Deep ache. Constant dull pain.
PATIENT PRESENTED WITH REDNESS AT SITE OF INJECTION ON RIGHT DELTOID WHRE Tdap was admistered. AREA LOOKS RED AND IS SLIGHTY WARM TO THE TOUCH AND ITCHES, BUT PATIENT DOES NOT REPORT ANY PAIN. THERE IS NO SWELLING.
Expired Dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Dose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Dose). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided Concomitant medication were not provided.
Redness and swelling at injection site. BENADRYL cream and TYLENOL provided to patient.
fever 103 w/sz on 2AUG98;taken to ER 733PM;
Mother reports 6 small red spots on shoulder, head, neck, forehead, knee and abdomen<.7cm, 2 weeks after immunizations. otherwise well