chrisvoncsefalvay/vaers-outcomes huggingface dataset:
seizure; Body soreness; Inability to sleep/stay asleep; Loss of memory/confusion; Loss of memory/confusion; This is a spontaneous report from a contactable consumer. A 26-yearsold male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 29Apr2021 13:00 (Lot Number: EW0161) via an unspecified route of administration, administered in Arm Right as single dose for covid-19 immunization (Age at vaccination: 26 years). Medical history included High blood pressure. Concomitant medication included marijuana. The patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right arm (lot number: EW0150) on 08Apr2021, 10:00AM for covid-19 immunization (Age at vaccination: 25 years). The patient experienced seizure, body soreness, inability to sleep/stay asleep (initial insomnia), loss of memory/confusion on 30Apr2021 07:00. The events were assessed as life-threatening by the reporter. The patient was not diagnosed with COVID-19 prior vaccination and the patient has not been tested with COVID-19 since the vaccination. Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
(L) arm red, warm to touch, painful afebrile. Pt given warm compress, sling and KEFLEX
Headache, Muscle tightness, Nausea I have not gone to my dr.  Im resting and taking Ibuprofen
Fever; Chills; Vommiting; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), VOMITING (Vommiting) and HEADACHE (Slight headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20F) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), VOMITING (Vommiting) and HEADACHE (Slight headache). On 20-Feb-2021, CHILLS (Chills) and VOMITING (Vommiting) had resolved. On 21-Feb-2021, PYREXIA (Fever) had resolved. At the time of the report, HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
On 9-26/2019 I received the first Shingrix 50mg vaccine at 8 am. Through the day I continued to feel light headed and migraine type headache, during the night I battled chills, sweating and headache. At 7:30 am on 9/27/2019 I went to Urgent Care could not sit up do to light headiness and nausea. They measured my BP 85/60 I was sent in ambulance to ER for EKG hydration and given ondansetron 4mg and prochlorperazine 5 mg intravenously and released 4 hours later. I still felt light headed slept the rest of the day. It took until 3pm 9-28-19 where I felt I was myself again.
genital warts; HPV positive; This spontaneous report was received from a nurse referring to a currently 20 years old female patient. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unknown date in 2012, the patient was vaccinated with the first and second doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (it was stated that it could not confirm which of the products was involved) (strength, dose, route, frequency, lot# and expiration date were not provided), both for prophylaxis.  In 2013, the patient received one dose of HPV rL1 16 18 VLP vaccine (baculovirus) (CERVARIX).   On an unspecified date in 2019, the patient reported to the nurse that she went to an unspecified physician for an exam and she was found to be "papilloma viral infection (HPV) positive". The patient also told the nurse that she thought she had genital warts. The nurse then referred the patient to an unspecified gynecologist for follow-up. The outcome of anogenital warts and papilloma viral infection was unknown by the time of reporting. No further information provided by the field representative.  The causal relationship between the events of anogenital warts and papilloma viral infection and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Early menstrual cycle by one week, prolonged cycle extended to multiple days. Cycle used to start on the 24th of each month, has now started on the 16th or 18th of the month since April. Second cycle since the last dose has now last a week when it used to be 4-5 days.
Pharmacsit stated daughter has only recieved 2 doses of GARDASIL 9 at age of 17 and did not complete 3rd dose. Inquring if revaccination is neccssary; No AE/PQC reported.; This spontaneous report has been received from a pharmacist, concerning her/his 17-year-old daughter. Information regarding the patient's concurrent conditions, medical history, and concomitant medications was not reported.   On unknown dates, the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (strength, lot #, expiry date, and route of administration were not provided) administered as prophylaxis. The pharmacist stated that the patient did not complete the 3rd dose (Inappropriate schedule of product administration) and inquired if re-vaccination would be necessary. No adverse event (AE) or product quality complaint (PQC) were reported.
During afternoon/evening of 9/11/02, became feverish with back ache, headache, stiff neck. Called health services for evaluation. Temperature 102, pulse-96 in obvious discomfort. Sent to ER for evaluation where they determined vaccine reaction. No labs done. Given Motrin and sent home. Re-evaluated at health services where she spent 9/12. Still with fever and aches. Follow up 9/13--slightly better with fever of 101.
I noticed significant handfuls of hair falling out when ever I brushed my hair or washed it, then randomly it would fall out throughout he day until decided to go  sea a  Doctor. After the fourth vaccine stating at the end of 07JUL2022 I contracted COVID-19 as well along with a major oral surgery on 20JUL2022.
reaction to tetanus shot; Initial information received on 30-Mar-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 60 years old female patient who experienced reaction to tetanus shot ,while receiving vaccine TETANUS TOXOID and while treated with PALBOCICLIB [IBRANCE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Dec-2021, the patient started taking IBRANCE (PALBOCICLIB) Capsule at a dose of 125 mg daily oral followed by 125mg daily oral (with an unknown batch number) for an unknown indication.  On an unknown date, the patient received a  dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported at an unknown dose via unknown route in unknown administration site as Prophylactic vaccination.  On an unknown date ,the patient developed a non-serious event "reaction to tetanus shot" (drug hypersensitivity) (unknown latency) following the administration of TETANUS TOXOID.  It was reported"I had a tetanus shot and i had a reaction to it. It was the TDAP. I just sent my immune system into overdrive. I was miserable, I thought i was coming down with covid or the flu. It only lasted about 18 hours."  Action taken with TETANUS TOXOID (TETANUS TOXOID) was not applicable and no action taken for another suspect drug   It was not reported if the patient received a corrective treatment for the event (reaction to tetanus shot).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event reaction to tetanus shot.
Woke up in the middle of the night of the 2nd day after 2nd covid vaccine with body aches, chills, fatigue, slight nausea overall felt yucky....lasted for 3-4 hours.
Fever onset about 7am 100.1, up to 102.8 at 1pm; chills; Tylenol given at 8pm; night sweats; body aches; extreme fatigue; nausea; headache;   7am next day no fever; continued body aches, fatigue and headache
25 wker now 11 wks old received 2 mos vaccinations and one day later experienced apnea, brady's, desats resulting in intubation.
PT RECIEVED TDAP ON 5/27/11. STATES HER ARM STARTED GETTING RED AND PAINFUL 5/29/11 AND DID NOT GET ANY BETTER. CAME TO CLINIC 6/1/11 FOR HEP A INJECTION AND THIS NURSE NOTICED REDNESS, SWELLING AND INCREASED TEMP AT INJECTION SITE IN LEFT DELTOID. PT ALSO HAD PALPABLE LUMP AT SITE. CHECKED BY CFNP. RX FOR BACTRIM DS - PO PH BID X 10 AND RECHECK ON 6/3/11. ADVISED WMP AND NO HEP A TODAY. PT WENT TO URGENT CARE AFTER LEAVING HERE.  UPDATE: PT IS TEACHER GOING OUT OF COUNTRY. REASON FOR BACTRIM, INJ. SITE LOOKED INFECTED. FOUND OUT PT WAS ALLERGIC TO SULPHA, REASON FOR URGENT CARE VISIT.
Patients received the vaccination after a temperature excursion.; Patients received the vaccination after a temperature  excursion; had a temperature excursion in the freezer, DDL was not recording; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature  excursion), PRODUCT STORAGE ERROR (had a temperature excursion in the freezer, DDL was not recording) and NO ADVERSE EVENT (No Adverse Event) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature  excursion), PRODUCT STORAGE ERROR (had a temperature excursion in the freezer, DDL was not recording) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature  excursion), PRODUCT STORAGE ERROR (had a temperature excursion in the freezer, DDL was not recording) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature  excursion) and PRODUCT STORAGE ERROR (had a temperature excursion in the freezer, DDL was not recording).    No concomitant medication was reported.  The facility had a temperature excursion in the freezer. They had an inspection and saw that their DDL was not recording the temperatures. At the time of the excursion vaccine was in frozen storage. Unbroken Cartons with vial size of 2.5 mL and 5.5 mL. Maximum or minimum temperatures reached was unknown, only had manual twice a day recording. The excursion duration was unknown. The vials were returned to the freezer at the time of reporting. Upon visual inspection vaccine state change was still frozen. No treatment information was provided by the reporter.
Symptoms were first noted on 12/22/2020 in 15 minutes after getting the Covid Pfizer vaccine. He had numbness of his face and right hand. It resolved in two hours. He did have soreness for two days after the vaccine.  He did not have any other symptoms like rashes or difficulty breathing. He could lift his arm.  It made him a little nervous. It was bad enough that he pulled over from the freeway and rested for a few  hours.  He used an ice pack that helped the soreness, but this was after then numnbness resolved.
reactive arthritis; joint pain; I developed a rash that eventually covered most of my extremities; Pfizer-BioNTech COVID-19 vaccine on 11Jan2021 and the second dose on 28Jan2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 28Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (I received the Pfizer-BioNTech COVID-19 vaccine on 11Jan2021), administration date: 11Jan2021, for COVID-19 immunization.In May2021 patient developed joint pain and was eventually told by the physician that she probably had reactive arthritis. The following information was reported: ARTHRITIS REACTIVE (medically significant) with onset May2021, outcome "unknown", described as "reactive arthritis"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Jan2021, outcome "unknown", described as "Pfizer-BioNTech COVID-19 vaccine on 11Jan2021 and the second dose on 28Jan2021"; ARTHRALGIA (non-serious) with onset May2021, outcome "recovered" (Nov2021), described as "joint pain"; RASH (non-serious) with onset Approximately two weeks after the second vaccine on unknown date in Feb2021, outcome "not recovered", described as "I developed a rash that eventually covered most of my extremities". The rash had subsided with the onset of the joint pain and in Nov2021 the joint pain subsided, but the rash resumed. The patient enquired if it was safe for her to get a COVID booster?  The lot number for bnt162b2 was not provided and will be requested during follow up.
nausea, vomiting, facial swelling, hoarseness within 24-48 hours.
03/19/2018 04:35 Pt. complained of pain in left arm where vaccine given. Was slightly red and painful to the touch. Swelling noted. TYLENOL and cold packs given. 03/19/18 11:30 Pt. seen in rounds by nurse practitioner. Left upper arm and elbow cellulitis. Erythema and swelling from middle of upper arm to elbow. Outlines in marker and KEFLEX ordered. Pt. being discharged routinely. Instructed to monitor and if redness or swelling extend beyond the outlined area to be seen immediately by PCP or in ED. Pt. has appt with PCP for 3/23/18.
Fever of up to 100.9, severe body aches, severe chills from 6:00am through 8:00pm.  Treated with Tylenol which eased symptoms.  All symptoms went away at 8:00pm.
I?ve always had tinnitus but after the third shot it is so high pitch and constant. I?m having trouble sleeping and concentrating.  My right ear.
Skin burning, yet shivering while wrapped in multiple blankets and clothing, nausea, severe headache, shortness of breath; symptoms lasted for about 12 hours
Soreness at sight of injection for over 10 days. Red skin discoloration and swelling increased daily, starting at day 3 and continuing, becoming worst on day 8 and 9. Red swollen site grew from 3 inch diameter to 7 inch diameter. Had to apply benadryl ointment and take an antihistamine for several days to lessen the discomfort and swelling. Also had fatigue from day 1 to day 4. After 13 days, swelling and redness at injection site is lessening.
a 61 year-old female patient received expired Tenivac without adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional (Nurse) via Agency (Reference number- 00379109) and transmitted to Sanofi on 02-Dec-2020.    This case involves a 61 years old female patient who received a dose of 0.5 ml expired suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (produced by unknown manufacturer, lot number LU6101AA, expiry date 23-Oct-2020) vaccine via intramuscular route in an unknown administration site for prophylactic vaccination, on 02-Dec-2020 (Expired product administered).    The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.    This was an actual medication error case due to expired vaccine used (latency same day).    At the time of reporting, no adverse event was 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.
The first vaccine caused pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Jun2021 14:00 (Lot number: EW01A1) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic fatigue" (unspecified if ongoing); "tinnitus" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; MONTELUKAST; ATORVASTATIN; ZOLPIDEM. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Jun2021, outcome "recovering", described as "The first vaccine caused pain at the injection site". The event "the first vaccine caused pain at the injection site" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site pain. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Tramadol and Pregabalin for the pain for the adverse event as treatment. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination.  Follow-Up (28 Sep2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
numbness leg; tingling; A spontaneous report  was received from a healthcare professional concerning a 35-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypoesthesia (numbness leg) and paresthesia ( tingling).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced numbness in leg and tingling.  Treatment details included No.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events  was unknown.
Appear to have contracted Shingles two days after 2nd dose. of Pfizer.  Used Benadryl believing it to be a rash.  Sent my Doctor photos on Day 9 after the 2nd dose.  I was told via a telehealth visit that it was too late for Steroids but she would give me an antiviral medicine for 1 week.   I got my 1st Shingles Vaccine on 4/7/2016.  Tomorrow morning I will begin the medicine my doctor gave me (Valacyclovir HCL, 500mg tablet) by mouth 3 (three) times daily for 7 days.
Patient received the second dose on day 23; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose on day 23) and NO ADVERSE EVENT (No adverse event) in a 22-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1412B) for COVID-19 vaccination.     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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose on day 23) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose on day 23) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose on day 23).    No concomitant medications was reported. It was reported that first and second dose had the same LOT numbers. No treatment drug details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-643391 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-643391.
This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 16-year-old female patient received TRUMENBA, intramuscular in the deltoid at a single dose for the prevention of meningococcal B disease and MENACTRA via an unspecified route of administration at unknown dose  for immunization both administered on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient experienced fainting. It was also reported that in the morning of the event, the patient did not eat. The outcome of the event was recovered on an unspecified date. Information on the batch number has been requested.
I got one shot and never got the second one; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: I got one shot and never got the second one). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 13-Mar-2023 Years ago, the Shingles vaccine was using a live culture.  The patient was advised not to get it because of his/her immune problems.  Now it was not a live culture.  The patient got one shot and never got the second one.  The patient wonder if he/she could get it years later or have to take both again. He/she did not know what it would hurt.  The physician advised him/her not to take it when they used a live culture because of his/her immune problems.  Later when they did not, got one of them and never got the second one.  It had been years, but reporters wonder if he/she could just get the second one now or do he/she had to get both again. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Patient states that she developed 102 fever and gum swelling with pain. Also complains of submandibular lymphadenopathy.
Mild flu like symptoms starting around 9 hours after dose - cold sweats, muscle aches, nausea.