chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves unknown demographic patient who was two time vaccinated with a dose of FLUZONE QUADRIVALENT lot number and Exp. Date not reported via unknown route in unknown administration site on unspecified dates in last year. Patient was Immunosuppressed. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to extra dose administered. No information about adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
c/o visual disturbance - no change acuity- "bright white" everything;  acting dazed & confused - turning head side to side though able to answer appropriately & follow commands;  A&O x 3  (reported never doing well with "shots", anxious today as always - mask removed - car door opened- emotional support - waited 15 mins in observation X 1.5.  symptoms resolved - driven home by parent.
12NOV97 devel a fever of 102 w/APAP it came down to 101R;was taken to hosp;explained as a rxn to the shot;later that day devel vomiting & rash on trunk, arms, & neck;13NOV97 3AM threw up;T103 all day;devel rash;14NOV97 T102 in AM to hosp;
Patient presented to facility with SOB. Patient stated she was tested on 9/11/21 and was positive. She also stated that she was having fever, body aches, chills. cough and HA.
Information has been received from a physician concerning some patients who were vaccinated with a dose of GARDASIL. After receiving GARDASIL the patients fainted or had seizures. At the time of the report, it was unknown if the patients had recovered from the events. Upon internal review, seizures were considered to be an other important medical event. No further information is available.
ONE OF TWO PT'S WHO EXPERIENCED SYNCOPE (VASO-VAGAL RESPONSE) IMMEDIATELY FOLLOWING IMMUN; PT RECOVERED & NO TREATMENT WAS GIVEN;
he was wiped out and fatigued and had to lie down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) 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: FATIGUE (non-serious), outcome "unknown", described as "he was wiped out and fatigued and had to lie down".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had  s/p emergency cesarean for fetal bradycardia, acute blood loss anemia. Baby girl born 7 lb 11.8 oz. Hospital admission within 6 weeks of receiving the COVID vaccine.
Fever 103 degrees F, muscle aches, chills, hypotension, swelling and redness at site of injection.
EXPIRED JANSSEN COVID-19 VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 20 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 04-OCT-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 04-OCT-2021, the patient experienced expired janssen covid-19 vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired janssen covid-19 vaccine administered was not reported. This report was non-serious.
spotting; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (spotting) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.  On 05-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 19-Oct-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced INTERMENSTRUAL BLEEDING (spotting). At the time of the report, INTERMENSTRUAL BLEEDING (spotting) had not resolved.     Concomitant product use was not provided by the reporter.  Approx 2 weeks after receiving the 2023 Moderna vaccine, the patient began spotting. The patient was post menopause 66-year-old woman. It became slightly worse at 2.5 weeks after receiving the Moderna vaccine. It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not provided.
Patient felt "not right" and momentarily passed out after receiving vaccine, when she regained consciousness she vomited but was then ok, possibly due to sight of needle and blood, since she bled. Paramedics called and arrived, took over.
Pt had red swollen bump after vaccine was given. To our understanding, today there is still a "knot" at the injection site.
Patient reports that early the morning she was feeling fatigue and not well (unsure if food or hotel sleeping) She denies any fever/n/v or cold like symptoms.  She reports 1 hour after receiving the vaccination feelings of nausea. Later that day, she reports nausea and diarrhea.  Overnight it did not improve and she noted to have rash (eczema) exacerbated. She was seen at local  ER - Hospital for further evaluation.  She was prescribed Zofran. Symptoms improved and she was discharge for ER.  Day one after vaccination, symptoms improved but did not resolve., no fever/diarrhea/vomiting, still c/o nausea. Eczema improved as well.
Narrative: COVID infection following COVID vaccine series 04/05, Pfizer, dose #1 04/26, Pfizer, dose#2 09/17 pt cc: cough, diarrhea, fatigue, fever, headache, myalgias, rhinorrhea, dyspnea exposure: daughter 09/20 COVID swab, result: detected 09/20 SARS-COV-2 Variant Sequencing result: pending
3" diameter by 2" welt; Raised swollen skin that is extremely itchy.  Temp @99.3- Gave 50 Mgs Benadryl tablets, topical hydrocortisone cream 1%, 200 mgs ibuprofen.
Case number PHEH2014US002082 is an initial spontaneous report received from a nurse on 27 Jan 2014 with a follow-up received on 25 Feb 2014. This report refers to a 12-month-old male infant. His medical history and concomitant medications were not reported. He was vaccinated with 0.5 ml of FLUVIRIN (batch number: 13462P, expiry date: May 2014) intramuscularly into left thigh on 20 Jan 2014 at 16:50. Nurse reported that the patient under 4 years of age received FLUVIRIN. No adverse event was reported following medication error. Follow up received from health care professional on 25 Feb 2014: Site and time of vaccination updated. Reporter details updated.
Patient did not report any adverse reaction to vaccine and to date we remain in the knowledge that she is in normal health.  The event is such that she was erroneously administered the Moderna COVID-19 vaccine as the second vaccine when in fact she should have received the Pfizer COVID-19 vaccine per guidelines.  Patient's doctor office was advised of error.
Started 4 hours after injection, arm began to hurt and patient felt very tired so she layed down. Patient's arm hurt worse the next day and she work up with flu-like symptoms. Arm was very red and swollen from elbow up to shoulder and by the fourth day post-vaccination, it looked like she was severely sunburn and arm was sensitive to touch. Patient treated symptoms with rest and naproxen, but did not see a doctor. Patient is now 7 days post vaccination and arm redness and swelling has gone down, but is still tender/sore and patient still feels fatigued.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient had no pertinent medical history and no drug reactions/allergies. On 05-JUN-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# reported as 1002130, expiry date: 08-JUL-2016), 0.5 ml, subcutaneously. No concomitant medication was taken. On 06-JUN-2015, the patient experienced an injection site reaction described as "a swollen arm, redness, pain, and warmth to the touch." The patient sought medical attention via office visit and was prescribed an unspecified dose of ibuprofen and doxycycline 100 mg capsule twice a day as treatment. No lab diagnostic studies performed. The patient was recovered from the events in a few days (estimated as an unknown date in June 2015). Lot number 1002130 is an invalid lot number PNEUMOVAX 23. Additional information has been requested.
fluid filled blisters at vaccination site; have fluid filled blisters at injection site, they itch; have fluid filled blisters at injection site, they itch, red in area as well; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 17Jun2021 at 16:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. The patient was allergic to penicillin. Concomitant medications included ciprofloxacin (MANUFACTURER UNKNOWN), taken for an unspecified indication from an unknown date. The patient previously took emycin and clindamycin and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Jun2021, the patient had fluid filled blisters at injection site, they itched and the area was red. Therapeutic measures were taken as a result of the events and included treatment with benadryl. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events fluid filled blisters at injection site, itchy and red were not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
Information has been received from a physician concerning a 21 year old female who on 14-FEB-2008 was vaccinated with the first dose of GARDASIL. The patient became very tired approximately 3 hours after receiving her first dose of GARDASIL. Unknown medical attention was sought. Patient outcome was unknown. No product quality complaint was involved. Additional information has been requested. follow up 2/15/2010 -  medical attention was sought. no product quality complaint was involved. follow up information received from a physician indicated that the patient suddenly felt tired/dizzy/pre-syncopal episode about 3 hours after hpv vaccine (yeast). the episode lasted 10 minutes. the patient outcome was recovered.
Client reported edema & erythema at injection site which started a couple hours after vaccine injection and got worse over time.  Client used topical bacitracin on area with no relief.  Client reported reaction to PHN on 9/21/16 @ 11:20 AM.  Area on Right arm swollen and painful to touch.  Client reports itching around area and painful when she moves her arm. Induration measured at 3 inches with erythema.  Client advised to go to Urgent care immediately.  Client agreed.
immediately after injecting the vaccine, swelling occured at the site of the injection.  the lump was ridgid, protruded about 1/4 inch from skin surface, and was the diameter of a dime.  Just a drop of blood was expressed from the site of injection.  A cold press was applied for about 5 minutes and the swelling went down. The patient called back about 20 minutes later and reported that the swelling came back.  She was advised to seek assistance at an urgent care facility.  the patient reported no discomfort or unusual feeling in the arm.
Initial report received from a health care professional on 04 May 2011. A 20-year-old female patient received on 01 March 2011 the following vaccines (manufacturers and lot numbers not reported): YF VAX (first dose), POLIOMYELITIS Vaccine Inactivated (adult dose), oral TYPHOID vaccine, HEPATITIS A vaccine (first dose), MENVEO vaccine, and RABAVERT (first dose). On 09 March 2011, the patient received a second dose of RABAVERT. On 10 March 2011, the patient developed "tremors, diffuse headache and feeling dazed". On 11 March 2011, the patient had a physical exam of a neuro exam, gait, strength, vital signs all within normal limits, yet she did demonstrated mild tremors to her hands, arms and feet. Her symptoms began after the second dose of the rabies vaccine. It was determined by the CDC that it may or may not have been the RABAVERT vaccine that was the cause and encouraged the patient to complete the series but instead switch to IMOVAX for the last dose. When the patient returned for her follow-up appointment on 14 March 2011, her symptoms were resolved. The patient, on schedule, was switched to IMOVAX (lot number not reported) for the last dose which was given on 06 April 2011. The outcome was reported as resolved. Documents held by sender: None.
On 10-17 patient notified us of redness/swelling of upper right arm.  The discomfort began 2-3 hours shot..then redness. Notified her physician...physician advised her to give it 72 hours..apply ice and take tylenol.
Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and a 67-year-old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 11-JUL-2014, the patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On or about 27-APR-2016, the patient was treated by a physician at a medical office for the following injury resulting from the patient's ZOSTAVAX use: Shingles. The patient claims damages including: injury to herself, loss of services, loss of consortium and economic losses. The outcome of Shingles was unknown. Causality assessment for shingles was considered as related to ZOSTAVAX. Additional information has been requested.
This spontaneous report as received from a female patient of unknown age reporting of herself. Concomitant medications, medical history, drug reactions and allergies were not reported. In 2011, "3 years ago", the patient was vaccinated with ZOSTAVAX (dose, route, lot number were not reported) and ended up getting shingles (on an unspecified date). The outcome of getting shingles was unknown. Additional information has been requested.
It started with a runny nose and scratchy throat that turned into a sore throat. I started Paxlovid on 12/26 and I'm fine today. It lasted 4 days.
Nausea, chills, headache night of vaccine. 9/15 legs and hands swelling. Then developed rash on legs, overnight swelling worse. Myalgias, nausea, chest pain sent to ER and admitted to hospital 9/12. Duodenal ulcer. 9/24 Transferred to another hospital. Diagnosis vasculitis (leukocytoclastic vasculitis) skin biopsy.  10/19/09:  Discharge Summary received for date of service 9/16/09-9/22/09.  Dx:  Henoch-Schonlein purpra with bowel involvement.  Assessment:  Presented with nausea, vomiting, leg weakness and achy neck and shoulders, fever and chills.  C/o feeling weak, fatigued, lightheaded and dizzy, calves were tight and painful.  Pt. noted a rash that began at her toes and went up her legs.  Rash was very small, red, non-itchy and non-painful.  Paleness noted on exam.  Tenderness in LUQ, midepigastric area and RUQ.  Multiple red hemorrhagic petechiae from toes circumfrentially up her legs, around her abdomen up to the mid-trunk area anteriorly and posteriorly. After abnormal upper endoscopy made NPO and placed on Proton pump inhibitors.  P. had episodic diarrhea with occasional passage of blood.  Started on IV antibiotic therapy.  Pt. was transferred to a higher level of care.     11/03/09 Medical records and Discharge Summary received for DOS 10/24-10/27. Final DX: Angitis.   Patient transferred to second facility for further eval by rheumatology. CT angiogram for vessel vasculitis neg. H/O of H pylori possible cause for GI ulcer sx.CT  for bloody diar showed large ascites, dilated loops small bowel, concern for ischemic bowel and vasculitis. Also R & L pleural effusion. CXR abnormal.  Stool and C diff cx neg. Hep A and C neg. Steroid therapy at other facility. Most likely hypersensitivity vasculitis s/t tetanus vaccine. Continued steroid therapy. ABX therapy. Sx improved greatly by d/c.
Next AM fever, swollen arm, red, warm gradually became worse, getting better 11/3/15 and almost gone.
This spontaneous report was received from a healthcare worker refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot lumber-L018501, expiry date-22-JUN-2017 and lot number-L004754, expiry date-10-NOV-2016, dosing regimen unknown). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The reporter considered events to be not related to RECOMBIVAX HB. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Soreness around injection site. It is more severe on 3rd day (today) than day after injection. Did not notice any soreness day of or next day until the early evening.
Approximately 5 minutes after receiving the HPV vaccine, pt became diaphoretic, pale and stated to her mother that she was nauseated. No loss of consciousness. Throughout pt alert and oriented x4. Cranial nerves II-VII grossly intact. PERRL. Bilateral upper extremity strength 5/5. Mother at side. 11:50 BP 106/63 HR 62 O2 100% on room air, RR 14. Pt pale, diaphoretic. Pt layed on exam table flat. 11:55 BP 109/66 HR 65 O2 100% on room air, RR 14. Color improving. Pt still lying flat. 11:57 AM BP 120/81 HR 64 O2 100% on room air. RR 14. Facial color within normal limits. 12:05 PM BP 123/76 HR 68 O2 100% on room air. RR 14.
Caller said had a slight reaction on his right arm with the first shot which is a red circle with open area that has scabbed over and never healed which was 7 or 8 months ago; Caller said had a slight reaction on his right arm with the first shot which is a red circle with open area that has scabbed over and never healed which was 7 or 8 months ago; This is a spontaneous report from a contactable consumer (patient) via medical information team. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown), via unspecified route of administration, in right arm on 01Mar2021 as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On an unspecified date in 2021, the patient experienced a slight reaction on his right arm with the first shot which was a red circle with open area that has scabbed over and never healed which was 7 or 8 months ago. Patient queried if he should get the booster dose and if his reaction would count as a severe allergic reaction. In addition to that, patient also queried if his reaction that never healed was a reported side effect. The outcome for all the reported events was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. The nurse practitioner reported that in October 2011, the patient was vaccinated intramuscularly with her first dose of 0.5 ml GARDASIL (lot # and expiration date not reported) and in April 2012 received intramuscularly her second dose of 0.5 ml GARDASIL (lot # and expiration date not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. The outcome for the patient events is unknown. Additional information has been requested.
Mild Fever; Joint pain; Tiredness; Pregant;received both doses of Moderna COVID-19 vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregant;received both doses of Moderna COVID-19 vaccine), PYREXIA (Mild Fever), ARTHRALGIA (Joint pain) and FATIGUE (Tiredness) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was in September 2020 and the estimated date of delivery was 15-Jun-2021. On 05-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregant;received both doses of Moderna COVID-19 vaccine). On 02-Apr-2021, the patient experienced PYREXIA (Mild Fever), ARTHRALGIA (Joint pain) and FATIGUE (Tiredness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 05-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregant;received both doses of Moderna COVID-19 vaccine) had resolved. On 03-Apr-2021, PYREXIA (Mild Fever), ARTHRALGIA (Joint pain) and FATIGUE (Tiredness) had resolved.            No concomitant medication information was provided by the reporter.  No treatment information was provided by the reporter.
No adverse effects reported.; the patient was inadvertently administered a fourth dose of GARDASIL 9; the third dose of the GARDASIL 9 series on 19-FEB-2020. Nurse reported that on 01-DEC-2020, the patiens was inadvertently administered a fourth dose; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 19-FEB-2020, the patient received the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) series (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 01-DEC-2020, the patient was inadvertently administered a fourth dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # S023476, expiration date 26-MAR-2022 (dose, route of administration and anatomical location were not reported). No adverse effects were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S023476; expirationdate: 26-MAR-2022; 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