chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Late/missed menstrual cycle; This is a spontaneous report from a contactable healthcare professional, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via intramuscular route of administration in the left arm on 09Feb2021 at 15:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and factor 5 heterozygous.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included beclometasone dipropionate (QVAR), pantoprazole (MANUFACTURER UNKNOWN), cannabidiol (CBD OIL) and mentha x piperita oil (PEPPERMINT OIL)(IB GARD); all for unknown indication from unknown start date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0142) via intramuscular route of administration in the left arm on 19Jan2021 at 15:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient previously took cefaclor (CECLOR) and experienced drug allergy. On 12Feb2021 the patient experienced late/missed menstrual cycle. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event late/missed menstrual cycle was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
This case was reported by a consumer and described the occurrence of vasculitis in a female patient who received FLULAVAL QUADRIVALENT (batch number 7754S, expiry date 1st June 2016). Co-suspect products included FLULAVAL QUADRIVALENT (batch number A3AD2, expiry date 1st May 2017). On 16th October 2015, the patient received the 2nd dose of FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 15th September 2016, the patient received the 3rd dose of FLULAVAL QUADRIVALENT (intramuscular) .5 ml. In October 2015, 6 days after receiving FLULAVAL QUADRIVALENT and FLULAVAL QUADRIVALENT and not applicable after receiving FLULAVAL QUADRIVALENT, the patient experienced vasculitis, rash, skin discoloration and joint pain. In September 2016, the patient experienced vasculitis, rash, skin discoloration and joint pain. On an unknown date, the outcome of the vasculitis, rash, skin discoloration, joint pain, vasculitis, rash, skin discoloration and joint pain were unknown. It was unknown if the reporter considered the vasculitis, rash, skin discoloration and joint pain to be related to FLULAVAL QUADRIVALENT. It was unknown if the reporter considered the vasculitis, rash, skin discoloration and joint pain to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. On 16th October 2015 01:12, the patient received 2nd dose of FLULAVAL QUADRIVALENT and on 15th September 2016 10:12, the patient received 3rd dose of FLULAVAL QUADRIVALENT. In 2015, 2016, and 2017, the patient had the flu vaccine, 6 days after each dose, the patient experienced vasculitis. The patient experienced severe rash on legs and trunk which lasted about a month, with some residual discoloration on legs and also experienced joint pain.
This spontaneous prospective pregnancy report was received from a currently 20 year old female patient. The patient had no concomitant medications, pertinent medical history, drug reactions or allergies. On 08-AUG-2018, the patient was vaccinated with the second dose of GARDASIL 9 per intramuscular route, for prophylaxis (dose, lot number and expiration date were not reported). The patient became pregnant with last menstrual period of 13-JUN-2018 and estimated date of delivery of 20-MAR-2019. At the time of the report, the patient was 8 weeks pregnant. The patient did not seek medical attention. She did not received any treatment and no laboratory test were performed.
This case was reported by a consumer and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included egg allergy. On 28th December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced headache, stomach pain and general body pain. On an unknown date, the outcome of the headache, stomach pain and general body pain were not recovered/not resolved. It was unknown if the reporter considered the headache, stomach pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX the patient experienced worst headache, stomachache and body aches from the study and asked how long would the side effects last.  The patient had egg sensitivity allergy and was recommended by her doctor to take the shot anyway and the patient was considering not taking the second shot.
I began experiencing vertigo/dizziness within 1 week following my booster (Moderna).  No prior history of these symptoms, including after my first 2 doses (Pfizer).  The dizziness occurs daily (still unresolved) with certain motions: sitting up, standing up from a low position, head movements while laying down.
shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 27-JUL-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a healthcare provider at a community health center for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to inoculation with zoster vaccine live (ZOSTAVAX), the pt was treated by a healthcare provider at a community health center for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
I got pericarditis; rare heart disease and this set me up bsically for failure; Inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 13Jul2021 (Lot number: EW0191) at the age of 23 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, SINGLE (Lot Number: EW0196) administered in left arm.), administration date: 03Mar2021, when the patient was 23 years old, for COVID-19 Immunization.  The following information was reported: PERICARDITIS (hospitalization, disability), outcome "not recovered", described as "I got pericarditis"; CARDIAC DISORDER (hospitalization, disability), outcome "not recovered", described as "rare heart disease and this set me up bsically for failure"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 13Jul2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered ". The patient was hospitalized for pericarditis, cardiac disorder (hospitalization duration: 1 day(s)). The events "i got pericarditis" and "rare heart disease and this set me up bsically for failure" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Mar2022) negative, notes: Unknown. It was unknown if therapeutic measures were taken as a result of pericarditis, cardiac disorder.  Additional information: The patient got pericarditis. The patient has not gotten better since the second shot. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination.
My arm was sore by that evening. The next day, I got swelling in my armpit. There was no indention from my armpit when I raised my arm. It looked different from other arm (completely). It was very swollen. No doctor visit. I took Advil after taking the pharmacist and she told me to take Advil. That helped with the swelling.
Steven Johnson syndrome x 2 wks-inpt tx required. Discharge summary states rash.
night of 2nd dose triggered menstrual cycle (occurs every ten days), body temp fluctuating, sweating
BREAKTHROUGH COVID: FULLY VACCINATED COVID POSITIVE. 63-year-old male who presented to ER following a minor MVC. He has a PMHx of PNA with Sepsis in 2019. Pt required 3L of O2. Upon arrival no complaints of h/a, N/V/D/C/I. Suspected d/t aspiration pna, no clear evidence of COVID PNA however cannot rule out this is contributing - cont steroids, no hypoxia so no remdesivir, cont cefepime - stop vanco.
presents today for sharp stabbing headache x2 days.  Patient states that the headache is constant and has not gotten better.  Patient states that she has never had a headache or migraine in the past, patient states that pain is located on the right temporal side and is sharp and throbbing with a 10 out of 10 pain. She did have the vaccine for COVID-19 on Saturday and is unsure if that is what is causing her headache.  Patient has been taking Tylenol for the headache which has not provided any relief.  Patient states that she was going to go to the ER but did not want to go and wait so came to the immediate care.  The pain does not radiate to any other area besides her head.  Patient denies any nausea, vomiting, syncope, palpitations, fever, change/loss of vision.  Patient denies any history of migraines.  Patient was driven here today by her son.
second dose wasn't administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 91-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23rd September 2019).   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 second dose, which led to incomplete course of vaccination. The reporter consented to follow up
He got his vaccine, had pain on the side of the injection and from there it grew to feeling aches and pains and then the shivers the next day.  He has had chills/sweating, fever that comes and goes, difficulty breathing as his nostrils block up, and has wheezing and when he gets up he's light headed and feels like he is going to pass out.  At night the symptoms seem to get worse, and thought that he had the flu.  He has bought everything for the flu and nothing has helped.  He then thought that he may have allergies and bought stuff for that and nothing has helped.  He has lost his sense of taste, he is extremely thirsty and could drink a gallon of water and his stomach hurts from drinking but his mouth is extremely dry and his throat is so dry as well.   He also has a nasty bad headache that is persistent and at night it gets to the point that he cannot seen and had lost his vision and could no see anything out of his right eye.  He called 9-1-1 and refused to go to the ER as he has no insurance and could not afford that kind of bill.  Yesterday his headache was so bad that he could not see out of the left eye, he has a fever of 101.5 right now and his head is killing him.  He has taken all of his medications that he has, medicated and nothing is helping the pain.  His nose is also extremely dry and he has no appetite, and ate last at 5:00 PM yesterday.   He also has vomiting, diarrhea, nausea, sweats/chills.  He watches his diet carefully due to the diabetes, but has not measured it.     He is very concerned about his vision and his fever and headache was so bad that he could not see, and he's worried about that.   He also has brain fog as well, and cannot remember things, pounding, pulsating water.
flu; Initial information was received on 27-Oct-2021 regarding an unsolicited valid non-serious media case from a consumer/non-healthcare professional.  This case involves a female patient (unknown age) who had flu (influenza), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "This case has been received from Media, the following potential adverse event has been found on a public post for Flu Shot. Since this is a public post on the Sanofi flu shots, we are assuming the consumer is referring to the Sanofi flu vaccine. wife got it, i did not, she got the flu, I did not. so, no thanks, I will pass!!!"  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the lot number for this case.
Patient called the pharmacy today with complaints of a red, raised area around the injection site. The adverse event occurred right after vaccination on 09/23/17. She also complained of an itchy nose. She had done some gardening after getting the flu shot, but already had the reaction on her arm at that point. She took a dose of Benadryl on 09/23/17. I suggested she continue to take Benadryl and monitor for signs of worsening reaction and report any worsening symptoms to her physician.
Very lethargic / exhausted. Similar to the feeling when I had covid-19. Lasted for approximately 24 hours. This was my second shot. I experienced no adverse effects after first dose.
Initial unsolicited report received from a health-care professional on 13-Oct-2017. This case involves a patient of unknown demographics who was vaccinated with dose of FLUZONE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On unknown date, following the vaccination, patient experienced full body rash, not hives. Lab data and Corrective treatment were unknown. The event outcome was unknown at the time of reporting. List of documents held by sender: none.
This is a spontaneous report from a contactable pharmacist communicated to a sales representative report for a female patient. A female patient of an unspecified age and ethnicity received PREVNAR 13, (Lot # unknown, Expiry Date unknown, NDC # unknown) at single dose in her left arm on 11Jan2018 for immunization. There were no concomitant medications, other medical conditions or relevant investigations to provide. She developed swelling in her left hand on 11Jan2018. She started itching the day after receiving the vaccine, on 12Jan2018. On 13Jan2018, 2 days after the injection, she developed redness and the injection site was extremely hot. She stated her skin felt like it was cooking and was painful on 13Jan2018. There was a 6-9 inch ring around the injection site and it started to spread on an unspecified date. The patient was sent to her physician. The outcome of the events was unknown. The information on the batch number has been requested.
Hive at injection site with erythema extending about 5cm in diameter around the hives. No resp. distress. Benadryl 3/4 tsp given and pt observed for 30 min. No other lesions developed.
8 days post injection, increased swelling, red bumps and Itchiness R deltoid area.
Information has been received from a physician concerning a 12 year old female with attention deficit/hyperactivity disorder who on 06-FEB-2008 was vaccinated 0.5mL with her first dose of GARDASIL (lot #659655/1486U).  On 06-FEB-2008 the patient fainted 2 minutes after receiving her vaccination.  Reporter noted they were not sure if it was a seizure because they did not witness the fainting.  The patient recovered on the same day and went home.  Additional information has been requested. 07/08/08 Follow up information received 24-MAR-2008 stated after the patient received the vaccination (approximately 3:30PM) she stiffened and passed out (approximately 3:40PM). It was reported the patient was taken to an exam room and examined by physician. The patient blood pressure measurement was 94/68 lying down and 88/62 sitting up. The patient's blood glucose was 88. Subsequently, the patient recovered on the same day. Additional information has been requested.
The evening after receiving the immunization, pt reported to son and daughter that arm was swelling and red.  Pt was taken to urgent care the next day. Pt was prescribed Prednisone taper for 6 days.
Legs felt heavy; Left arm was sore; felt tired, fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Legs felt heavy), VACCINATION SITE PAIN (Left arm was sore) and FATIGUE (felt tired, fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Migraine since an unknown date.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced LIMB DISCOMFORT (Legs felt heavy), VACCINATION SITE PAIN (Left arm was sore) and FATIGUE (felt tired, fatigue). At the time of the report, LIMB DISCOMFORT (Legs felt heavy), VACCINATION SITE PAIN (Left arm was sore) and FATIGUE (felt tired, fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Patient presented to ED from home with a complaint of Covid symptoms weakness and shortness of breath. Patient had covid symptoms was tested positive for Covid on 1/1/22 with an at home test. Patient experience reported increased weakness and shortness of breath. Patient had cough and states feeling somewhat short of breath. He notes no additional complaints. Patient has dementia and is a poor historian. Patient was febrile and hypoxic. He has a known history of COVID-19. Patient had IV established and lab work was done including blood cultures and lactic acid was sent. Patient?s pulse oxygen level improved on nasal cannula. Patient's labs consistent with COVID-19. Urine showing no signs of UTI. D-dimer was positive. CTA was ordered and results were consistent with COVID-19. Patient's fever improved with Tylenol. patient was given IV hydration. Patient was given Decadron while in the ED and patient was admitted to Hospital. Did not receive any addition information regarding length of stay or discharge.
shaking, violently shaking; chills; sweating; very hot; forehead was cold; hardly walk; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 78-year-old male patient received bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number: EN6202 and expiry date was not reported), via an unspecified route of administration, on 23Feb2021 at 11:40 PM (age at vaccination: 78 years), as a dose 2, single for COVID-19 immunization. The patient's medical history includes allergic to penicillin and bee stings. The patient's concomitant medications were not reported. The patient's previously received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number: EM9810 and expiry date was not reported), via an unspecified route of administration, on 02Feb2021 as dose 1, single for COVID-19 immunisation and after the first dose the patient did not have anything, other than his arm was a little sore. On 24Feb2021, at 3 AM that day the patient was having chills, and then sweating and very hot. It was also reported that last night the patient woke up at about 3 AM and he couldn't get warm he was shaking, violently shaking. The patient also stated that he added 3 more blankets he could not keep warm. He took a sleeping pill and an hour and a half later he finally went to sleep at about 4:30 PM. It was reported that when he woke up his forehead was cold but he was sweating and the patient wants to know is that anything to be concerned about. Reportedly last night when he started with the chills and shaking, it was bad, he felt like he was going to freeze to death, he could hardly walk he was shaking so bad. It was reported that the patient also took pain pills. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Technician  gave Patient an incorrect dose of 1 ml undiluted children's Pfizer Vaccine at 1345. No adverse events were observed 15-20 minuties after vaccine administration.  As a follow up, she was contacted at 1830. She was doing well without any symptoms.
A report was received from a healthcare professional on 15 October 2003 concerning a group of approximately 15 vaccinees who experienced injection site reaction, with redness, swelling and itching a few minutes after receiving Fluvirin on an unspecified date. On an unspecified date the vaccinees experienced injection site reactions with redness, swelling, and itching.  The vaccinees recovered on an unspecified date without treatment. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 22 December 2003. A follow up report was received from a healthcare professional concerning a 35 year old female vaccinee who experienced redness, swelling and severe itching at the injection site on the same day as receiving Fluvirin on 10 October 2003. On 10 October 2003, the vaccinee experienced redness, swelling and minor itching at the injection site after receiving Fluvirin 0.5ml.  The symptoms lasted for a duration of 30 minutes, and had resolved at the time of follow up report. No follow up pending.
Few scattered, small hives on upper chest, lower back, and upper arms and thighs. Occurred 10 min after MMR. We observed for 45 mins. No meds, VSS and faded. Follow-up Information 01-JUN-2006: Quick onset of urticaria within 5min. Man gave EPI-PEN dose. Monitored in office for 1 hrs post injection.
Sore Throat, Fever Chills, Some headache, minor cough  Covid breakthrough infection  antibiotic for sore throat, albuterol puffer