chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On 25th February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient called in to notify them that she developed a potential (no definitive diagnosis) case of Shingles. The rash was said to be on her face and the patient was going to an ophthalmologist at the time of call. The patient has not completed the series at the time of report. The pharmacist stated that she did not want to do double work by providing GlaxoSmithKline with the data. She also stated that she was waiting for an update from the patient.
NO ADVERSE EVENT. NURSE GAVE A 3RD SHOT OF MODERNA WITHOUT KNOWING PT HAD ALEADY RECEIVED BOTH DOSES IN SERIES.
pt recvd vax;devel skin redness & swollen arm;md reported that pt also had a hot & tender arm; md did not have any oth info concerning pt;
Patient experience short duration seizure after receiving his 2nd dose of Pfizer vaccine. Per patient, no reaction in his 1st dose. Seizure lasted less than 30 seconds and patient recovered fully. Patient denied calling 911 for help.
Approximately 2 hours after receiving the shot the patient's arm that she had the injection in and that same hip hurt.  She also had migraines.  This lasted for 24-48 hours post vaccination.  She had no pain or swelling at injection site.  She self treated with aspirin and reported the event on 10/11/13.  She has had no other problems and is fine at this point.
Dizzy; HOT FLUSHES FACIAL; ELEVATED BLOOD PRESSURE; This spontaneous report received from a pharmacist concerned a 40 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known medication and food allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 14:03 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021 14:15, the subject experienced dizzy. On 10-APR-2021 14:15, the subject experienced hot flushes facial. On 10-APR-2021 14:15, the subject experienced elevated blood pressure. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) elevated, and Oxygen saturation (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure, had not recovered from dizzy, and the outcome of hot flushes facial was not reported. This report was non-serious.
normal arm soreness; 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 48 year-old female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) at the age of 48 years 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "normal arm soreness".  Additional Information: The patient reported that with the first time after the shot it was just like the patient had the shot normal feeling, so that night the middle of the night other than the normal. The patient received the second dose on 31Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
high blood pressure, amloditimeeesylate, head stretching feeling, dizzy spells,
vertigo and extreme nausea 05/20/2021 since , can't work, can't get out of bed, i can hear my eyes move   body aches, can't care for sick family. extreme anger!!!  need to go back to the doctor or hospital! no one seems to be able to help, medicine prescribed make me sleep which stops the vertigo and my life
Received her IM typhoid vaccination on February 4, 2004. The following day she developed whole body muscle pain that she rated 8/10. She also experienced chills and felt as if she had a fever(subjective) . She took Tylenol 1 gram but it was not effective. The next day she awoke with severe abdominal cramps (rated 8/10).  The myalgias continued and she also felt nauseated and vomited twice. The following day (day 3), she felt worse and reported to the emergency room. During her four-hour length of stay, she received IV fluids, Zofran 4MG and Toradol 30MG by IV, and Motrin 800MG by mouth. Urine analysis done: ketones 80, sp grav 1.031 otherwise normal UA. Symptoms resolved after 6 days.
4 days after receiving 2nd injection, I had my regular cancer tests done which included a CT and ultrasound of thyroid area. It was noted that there was an enlarged lymph node under the left arm at this time. The next day, there was a swelling in the thyroid area (thyroid completely removed 3 yrs earlier). This "swelling" to date has not gone down in the thyroid area. Unknown if lymph nodes are still enlarged at this time. Scheduled for cancer tests on Aug 4th at MD office.
current_age: 15; Headache; chest pain; fatigue; This is a spontaneous report received from a non-contactable consumer. A 15-year-old male patient reported for himself that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in Left Arm on 13May2021 16:00 (at the age of 15-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any known allergies. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14May2021 at 16:30 the patient experienced Headache, chest pain, and fatigue. The patient received Tylenol as treatment for the events. The reporter stated that events as non-serious. The outcome of the events was reported as recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt recv vax on 3/25/99; on same day pt exp red/swollen/ hard knot at vax site
Information has been received from a physician (the patient) concerning a 35 year old female with asthma and allergies to aspirin and codeine who in 1996 was vaccinated with 2 doses of Varivax (lot#'s not reported). On 23-NOV-2004 (lot# 647534/0625P) and 07-FEB-2005 (lot#649644/1050P) the patient received 1 dose of Varivax. Concomitant therapy included albuterol and pre-natal vitamins (unspecified). Sometime in 2004, the patient experienced a negative titer after receiving the 2 doses. In November 2005, the patient again experienced a negative titer after receiving 2 doses. Unspecified medical attention was sought. The outcome was not reported. No product quality complaint. Additional information has been requested.
This spontaneous report was received from a physician via a company representative concerning a 10 year old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 subcutaneously, as prophylaxis (Strength, dose, frequency, lot # and expiration date were not reported). No adverse effects were noted.
Flu-like symptoms (expected), but then developed erythema at injection site all the way down to the elbow, happening 3 days after injection.  Improving with levocetirizine.  Determined she may have allergy to polyethylene glycol as she does not tolerate certain colonoscopy preps.
Sudden onset flushness w/ slight hoarseness lasting approx. 3-5 min.130/70-84-18-97%. No stridor or drool. Resp. unlabored and even. No adventitious lung sounds noted. States PMH: HTN,, diabetes (diet controlled). hgA1c-6.9., "leaky valves". Meds-Lisinopril, Omeprazole. 1300-Water provided. Monitoring continued. Remains asymptomatic. 1320- 134/76-80-16-98%. Pt. stable. All symptoms resolved. Pt states "I want to go home, I'm fine".
Local reaction on left thigh upper 3/4 cm of redness and knot a little tender not much is getting better.
This spontaneous report was received from a nurse and refers to a small amount (unspecified total) of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L016428, expiration date 30-JUL-2017 (dose and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Bad chills; coughing; dizziness or light headed; This is a spontaneous report from a contactable consumer (patient) via a regulatory authority. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left on 28Feb2021 09:45 (lot number: EN6202; expiry date: unknown) as dose 1, single for Covid-19 immunisation. Medical history included high blood pressure, diabetes 2, high cholesterol, and obesity. Concomitant medications included atenolol and rosuvastatin calcium (ROVASTIN) taken for unspecified indications, start and stop date were not reported. The patient previously received procaine (NOVOCAINE) and experienced allergies. The patient was not pregnant at the time of vaccination. The vaccine was administered in the hospital. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient has not been tested for COVID-19 since vaccination. On 02Mar2021 at 15:00, the patient experienced bad chills, coughing, and dizziness or lightheaded. The patient did not receive treatment for the events. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
This case was reported by a nurse via sales rep and described the occurrence of skin warm in a adult patient who received FLUARIX TETRA. Co-suspect products included FLULAVAL TETRA. On an unknown date, the patient received FLUARIX TETRA at an unknown dose and FLULAVAL TETRA at an unknown dose. On an unknown date, unknown after receiving FLUARIX TETRA and FLULAVAL TETRA, the patient experienced skin warm, local swelling and pain localized. On an unknown date, the outcome of the skin warm, local swelling and pain localized were unknown. It was unknown if the reporter considered the skin warm, local swelling and pain localized to be related to FLUARIX TETRA and FLULAVAL TETRA. Additional details were received as follows: The age at vaccination was not reported. It was reported that the sales representative was not sure if the patient received FLUARIX or FLULAVAL vaccine. The sales representative was not aware of which flu vaccine there was an adverse event associated with. The patient who was an employee had local reaction to flu vaccine as hot to touch, swelling and soreness. The sales representative had not other information and stated that someone could reach out to the nurse to obtain more information on the adverse event. The sales representative would also like the event to be emailed to him if possible. This case has been linked with case US2017GSK162192, reported by the same reporter.
at 8:40 am patient felt dizzy and flushed, she asked for extra attention and indicated she felt embarrassed, but denied difficulty breathing, no trouble speaking in full sentences, no rash, no change of vision;  BP was 158/108 with pulse of 95 and then patient was brought to a more quiet area and seated in a wheelchair.   She was able to ambulate, a nd speak normally, but she said she felt very strange and shaky.  she was visibly tremulous.  She was seated, and vitals reassessed and her shakiness increased and she felt panicky.  She was taken by stretcher to the Emergency room for further observation .   in the emergency room, her symptoms gradually subsided.  She was able to return to work after an hour of observation.
Information has been received from a medical assistant(also reported as office manager) referring to a 5 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 08-MAY-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program (VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. Sender's Comments: US-009507513-1704USA014784:
blister; Chills; fatigue; upset stomach; generally feel miserable; This case was reported by a consumer and described the occurrence of blister in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th February 2021 14:00, the patient received the 1st dose of Shingrix. In February 2021, 14 hrs after receiving Shingrix, the patient experienced blister, chills, fatigue, upset stomach and feeling unwell. On an unknown date, the outcome of the blister, chills, fatigue, upset stomach and feeling unwell were unknown.   It was unknown if the reporter considered the blister, chills, fatigue, upset stomach and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient was reporting case for herself. On 26th February 2021, at 4 am, 14 hours after receiving Shingrix, the patient woke up with a blister. The patient also had chills, fatigue, upset stomach and generally felt miserable. The patient wanted to report this and asked if she should be concerned.
no symptomatic adverse event was reported; TE for ROTATEQ and VAXNEUANCE; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 26-JUL-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection (0.5 ml/once, lot#: X005583, expiration date: 10-DEC-2024; strength and route of administration were not provided); and Rotavirus vaccine live, pentavalent (ROTATEQ) oral liquid (2 ml/once, lot#: 1933911, expiration date: 18-APR-2024; strength was not provided) orally, both for prophylaxis. The vaccines administered experienced temperature excursion (TE) at 9.6 degree Celsius for 16 minutes (product storage error). No adverse event (AE) was reported (no adverse event).
At 1200 it was noted resident had a small emisis. Resident responded minimally to this writer verbally and does track writer with his eyes. Respirations are noted to be labored. Respirations 32. Mouth cleaned, no obstruction noted. Oxygen applied via nonbreather at 5L. Temp 91.3, pulse weak and thready, BP 98/50 on R)arm, Pulse 90. Resident is very weak, pale diaphoretic. Resident shaking and jerking. Initially unable to obtain pulse ox. Emergency services contacted. At 1212PM BS 135 BP to R)arm 108/68, Sats 99% on 5L nonrebreather, respirations are even and unlabored 18. Resident is noted to open eyes and communicate. Dr.is notified and okays sending resident to ER. Wife notified of pt condition by staff she will meet at ER. EMS arrives and transports resident to ER 1223 and RN gives report to the ER.
Breakthrough case admission after 3 vaccines Pfizer 3/31/21 Lot# ER8730;  Pfizer 4/21/21 Lot# Ew0162; Pfizer 11/21/21 Lot# FH8027
Subsequent to receiving one dose of varicella virus vaccine live the pt developed atopic dermatitis. There were no complications or pain. Subsequently, the pt recovered.
The patient had a seizure on 03/14/2001 that lasted 3 minutes. The patient did not have a fever prior to the seizure. The patient had several seizures on the following days. The seizures were petit mal. The patient was started on Depakote on 04/13/2001.
07:40 patient reported to mother that he was "lightheaded and dim vision" then mother witnessed syncope. Nurse assessed patient LOC but breathing was recorded at approximately 1 minute with pallor, cool, and clammy skin. ED was notified of patient transport. Vitals were obtained BP - unobtainable, HR - 44 faint and thready, Resp -10. Patient regained consciousness and informed nurse that he had "white coat syndrome and history of fainting with blood drawn and doctor visits" he apologized for not notifying nurse prior to vaccination. 07:43 patient has second witnessed syncopal episode after reporting "dim vision", patient was lowered to floor with assistance from 3 nurses and bystanders. Vitals obtained - BP - 117/76, HR - 46 Resp - 12. LOC lasted 30 seconds, patient was pallor, skin was cool and clammy. Patient regained consciousness and was alert and oriented x 3. 07:48 patient was assisted to sitting position and then assisted to W/C and escorted to the ED with a nurse, CNA and family for examination and further treatment. Upon leaving patient had pink color, skin was warm, but diaphoretic. Pt entered ED at 07:55 VS  BP - 141/83 MAP - 102 HR - 66 RR- 20 SPO2- 96% Temp - 97.9. Pt was observed in ED for an hour and was provided food and liquids after report of not eating or drinking since previous night.
Tingling in arms and hand 5m after shot. Fatigue for the remainder of the day. Flu like symptoms with chills and body aches since midnight.
Sore arm. Resolved 2/24 (about 48 hours after vaccination).
This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 31Mar2021 at 18:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, aortic valve replacement and allergy to statins. Concomitant medications include metoprolol (MANUFACTURER UNKNOWN), desipramine (MANUFACTURER UNKNOWN), esomeprazole magnesium (NEXIUM), ezetimibe (MANUFACTURER UNKNOWN) and acetyl salicylic acid (ASPRIN). The patient previously received amoxicillin (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not 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 01Apr2021 at 15:00, the patient experienced severe headache, muscle aches, chills, sweats and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of events severe headache, muscle aches, chills, sweats and fatigue were resolving at the time of report. No follow-up attempts are needed. No further information is expected.
Bottom side of lower arm turned blue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID=19 mRNA VACCINE, solution for injection) (Lot number: EN6200) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "Bottom side of lower arm turned blue".  No follow-up attempts are possible. No further information is expected.
01/08/2021 PT REPORTS FACIAL/NECK/TORSO RASH POST RECEIVING PFIZER COVID 19 VACCINE. ROUTE RN ADMINISTERED BENEDRYL 50 MG IM. RASH STOPPED AND BEGAN TO CLEAR. PT ADVISED TO SEEK MEDICAL ATTENTION IF ANY OTHER AE OCCURED AFTER LEAVING SITE. PT VERIFIED UNDERSTANDING.
3/5 ? 3/9 Swelling, pain and redness 2?x4? at injection site Headaches Fatigue Mild achiness  3/12 ? current Return of swelling, redness and pain with new onset of rash and itching to injection site.  3?X6? with induration. Improving.
Red and swollen area below injection site appeared the day after booster shot. Still inflamed, swollen and itchy.
Body aches and joint aches; Backache; joint aches; Fatigue; Severe chills/ shivering; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches and joint aches), BACK PAIN (Backache), ARTHRALGIA (joint aches), FATIGUE (Fatigue) and CHILLS (Severe chills/ shivering) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Pfizer (COVID-19 Vaccine). Past adverse reactions to the above products included No adverse event with Pfizer (COVID-19 Vaccine).    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Body aches and joint aches). an unknown date, the patient experienced BACK PAIN (Backache), ARTHRALGIA (joint aches), FATIGUE (Fatigue), CHILLS (Severe chills/ shivering) and NAUSEA (Nausea). At the time of the report, PAIN (Body aches and joint aches), BACK PAIN (Backache), ARTHRALGIA (joint aches), FATIGUE (Fatigue), CHILLS (Severe chills/ shivering) and NAUSEA (Nausea) outcome was unknown.            Concomitant medication was not reported.  The patient got 3rd COVID-19 Booster shot and 2 days later started having the normal things like just like body aches, fatigue while in the next day severe chills, nausea, joint aches and then the previous day she felt pretty fine last night. The 3rd one she had done Moderna Booster (COVID-19 Vaccine) and the first time she had for the Pfizer (COVID-19 Vaccine).  Treatment medication was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.