chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US019589, is an initial spontaneous report from a pharmacist received on 29 Sep 2014. This report refers to a 46-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 1411201) intramuscularly two weeks ago on an unknown date. On 13 Sep 2014, she experienced tingling sensation at injection site. The outcome of the event was unknown. Seriousness and causality was not reported.
abdominal bloating/it looked like she was pregnant; pain in lower abdomen, almost like vaginal area; pain in lower abdomen, almost like vaginal area; arm pain; felt tired; fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (abdominal bloating/it looked like she was pregnant), VULVOVAGINAL PAIN (pain in lower abdomen, almost like vaginal area), ABDOMINAL PAIN LOWER (pain in lower abdomen, almost like vaginal area), VACCINATION SITE PAIN (arm pain) and FATIGUE (felt tired) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia and Inflammatory bowel disease.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced ABDOMINAL DISTENSION (abdominal bloating/it looked like she was pregnant), VULVOVAGINAL PAIN (pain in lower abdomen, almost like vaginal area), ABDOMINAL PAIN LOWER (pain in lower abdomen, almost like vaginal area), VACCINATION SITE PAIN (arm pain), FATIGUE (felt tired) and PYREXIA (fever). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. On 14-Mar-2021, ABDOMINAL DISTENSION (abdominal bloating/it looked like she was pregnant), VULVOVAGINAL PAIN (pain in lower abdomen, almost like vaginal area), ABDOMINAL PAIN LOWER (pain in lower abdomen, almost like vaginal area), VACCINATION SITE PAIN (arm pain), FATIGUE (felt tired) and PYREXIA (fever) had resolved.            This case was linked to MOD-2021-048119 (Patient Link).
A report has been received from a health professional via Medimmune concerning a 6 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that the patient received FLUMIST QUADRIVALENT twice this season which started on 07-OCT-2014. The outcome of the event of PATIENT RECEIVED FLUMIST QUADRIVALENT TWICE THIS SEASON is unknown. The report was considered to be non-serious.
Patient received first dose of Pfizer vaccine. Later in the day, patient experienced swollen arm, bubble at injection site and couldn't move arm. Patient went to ER where they gave meds at the hospital
About 5 hours after the shot I got up from a chair and immediately became dizzy and started sweating.  This lasted about an hour, sweating all the time to the point where my t shirt was completely soaked.  I was able to breathe normally and I drank cold water and applied cool cloths to my neck and face.  After about 2 hours I was  normal again and ate my supper.
Approximately 12 hours after vaccine administration on 08/10/2022, patient reported nausea/vomiting, migraine/headache, neck pain, body aches, and fever.  Patient reported they had poor results with verbal Neuro Screen conducted by provider at Urgent Care, MRI completed at visit. Patient reports "feeling better today," however still has minor swelling/redness with small, sporadic spots around injection site.
Redness, small lump, warm to touch & pain at injection site - treated for cellulitis w/ abx.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (went to see her daughter, and she and her husband  tested positive to covid19) and DRUG INEFFECTIVE (LACK OF DRUG EFFECT) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037c21a, 013a21a and 030m20a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced COVID-19 (went to see her daughter, and she and her husband  tested positive to covid19) and DRUG INEFFECTIVE (LACK OF DRUG EFFECT). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Chills, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Chills, at an unspecified dose and frequency. At the time of the report, COVID-19 (went to see her daughter, and she and her husband  tested positive to covid19) and DRUG INEFFECTIVE (LACK OF DRUG EFFECT) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.         Patient is on concomitant medications of blood pressure medicine.  chills is a symptom of COVID-19 hence not captured.  Company Comment-  This case concerns a 79 year-old, female patient with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. The event occurred approximately 8 days after the booster dose of mRNA-1273 vaccine and 8 months after the second dose of the vaccine. Vaccination schedule was administered correctly (first and second doses administered 27 days apart). Drug ineffective was considered as an additional event. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-392008 (Patient Link).; Sender's Comments: This case concerns a 79 year-old, female patient with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. The event occurred approximately 8 days after the booster dose of mRNA-1273 vaccine and 8 months after the second dose of the vaccine. Vaccination schedule was administered correctly (first and second doses administered 27 days apart). Drug ineffective was considered as an additional event. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient stated he had flu and PNEUMOVAX on 9/6/13 and they were both put in right arm side by side. He states he was nauseous, and had diarrhea all weekend. Also has a red rash by the site and redness the size of a fist some warmth to touch. No fever. Instructed to draw line on edge and to call back if redness goes outside line.
Back were sore/back pain is 1/4 of the way up from his waist between my waist and bottom of my rib cage; Exhaustion; chills; convulsions; shaking really bad, slightly shaky; neck sore; twitching; muscles were contracting uncontrollably and regularly, started in my right leg then went up my back; stinging when I go pee; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (convulsions) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2021, the patient experienced SEIZURE (convulsions) (seriousness criterion medically significant), TREMOR (shaking really bad, slightly shaky), NECK PAIN (neck sore), MUSCLE TWITCHING (twitching), MUSCLE CONTRACTIONS INVOLUNTARY (muscles were contracting uncontrollably and regularly, started in my right leg then went up my back), DYSURIA (stinging when I go pee), FATIGUE (Exhaustion) and CHILLS (chills). On an unknown date, the patient experienced BACK PAIN (Back were sore/back pain is 1/4 of the way up from his waist between my waist and bottom of my rib cage). At the time of the report, SEIZURE (convulsions), TREMOR (shaking really bad, slightly shaky), NECK PAIN (neck sore), MUSCLE TWITCHING (twitching), MUSCLE CONTRACTIONS INVOLUNTARY (muscles were contracting uncontrollably and regularly, started in my right leg then went up my back), DYSURIA (stinging when I go pee), BACK PAIN (Back were sore/back pain is 1/4 of the way up from his waist between my waist and bottom of my rib cage), FATIGUE (Exhaustion) and CHILLS (chills) outcome was unknown. Concomitant product was not provided by the reporter. Patient reported that he experienced chills, shaking really bad worse than he had hypothermia, his neck and back was sore, he had twitching and shaking, he also started convulsions he is craving Gatorade, with salt and sugar after receiving 2nd dose. He has yellow urine and continues to be slightly shaky. His back pain was 1/4 of the way from his waist and bottom of his rib cage. Treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-280138 (Patient Link). Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
HIGH BLOOD PRESSURE 180/115 MMHG; BLURRY VISION; NOT FEELING GOOD; HEADACHE; This spontaneous report received from a patient concerned a 44 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, non-smoker, and non alcohol user. The patient had no health conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190, expiry: 27-APR-2022) dose was not reported, 1 total administered on 11-FEB-2022 at about 10:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 11-FEB-2022, about 30 minutes after the vaccination, the patient's blood pressure had gone up to 180/115 mmHg and pulse rate was 125 {beats}/min. The patient also experienced blurry vision, headache, and was not feeling good. The patient wanted to know what he needed to do to lower his blood pressure. The patient was asked to contact his physician for medical advice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurry vision, and headache, and had not recovered from high blood pressure 180/115 mmHg, and not feeling good. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220229973-Covid-19 vaccine ad26.cov2.s-High blood pressure 180/115 mmHg. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
1 day after injection experienced severe shooting pain from upper arm to fingers for about 4 hours. Symptoms resolved spontaneously. At same time had somnolence symptoms regularly.
My lips were swollen, red, itchy, and sensitive to the touch. Almost a slight burning sensation as well. They became covered with tiny bumps that are not easily seen but feel scaley when I rub my lips together. I have been taking an antihistamine and using vaseline but nothing seems to be helping.
noticed swelling/my armpit, it is swollen and painful, it happened to me the last time; my armpit, it is swollen and painful, it happened to me the last time; Swollen lymph/ Swollen lymph node; pain went away; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 59-year-old female patient received bnt162b2 (BNT162B2), in Dec2020 as dose number unknown, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SWELLING (non-serious), outcome "not recovered", described as "noticed swelling/my armpit, it is swollen and painful, it happened to me the last time"; AXILLARY PAIN (non-serious), outcome "unknown", described as "my armpit, it is swollen and painful, it happened to me the last time"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph/ Swollen lymph node"; PAIN (non-serious), outcome "recovered", described as "pain went away". The events "noticed swelling/my armpit, it is swollen and painful, it happened to me the last time", "my armpit, it is swollen and painful, it happened to me the last time", "swollen lymph/ swollen lymph node" and "pain went away" required physician office visit. Therapeutic measures were taken as a result of swelling, axillary pain, lymphadenopathy, pain.  Additional information: Patient got the Pfizer vaccine 2 years ago (on her left arm), because it was required since she was a nurse and worked with COVID patients. With this first time she noticed swelling and she took Ibuprofen and pain went away but after some time, the doctors told there was still some swelling in armpit. Her armpit was swollen and painful, it happened to her the last time that she took the COVID Shot. She was asking if it had a long term side effect because the last time she went to do her and they said they saw a swollen lymph and the first time she experienced it was when she got the COVID Shot. Consumer stated, "When she took it the first time she was not suffering from hypertension it was just high cholesterol that was all. 2 years ago." Causality: Consumer stated, "Yes, it just happened every time she got it, she got this shot.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300334668 same patient, different dose/events;
This initial non-serious spontaneous case was received on 04-Oct-2017, from a nurse, concerning a patient of unspecified age and gender. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). It was reported that the patient was injected with last year's flu shot. The nurse enquired the duration after which the patient can receive the next dose. The reporter was unable to assess the seriousness of the event.
USAF officer experienced dysphoria and dizziness 15 min after Flu shot. 20 year history receiving same, no problems. Resolved within hours. No problems.
This spontaneous report was received from a pharmacist refers to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. The patient's concomitant therapy included sterile diluent (DILUENT MRK INJ). On 28-FEB-2018 the patient was vaccinated with a properly stored but expired dose of ZOSTAVAX (dose, units, frequency not reported) lot # M038350, expiration date: 06-DEC-2017 via subcutaneous route (expired product administered). The sterile diluent (DILUENT MRK INJ) used for reconstitution of ZOSTAVAX was properly stored. No adverse effects were reported (no adverse event). No further details were provided. No product quality complaint (PQC) was present.
A report has been received from a Health Professional via medical representative concerning an 11 years 26 weeks old, male patient. No medical history and concomitant medications provided. The patient received FLUMIST (intranasal), 0.2 millilitres, one time administration, nasally, on 03-Nov-2015 for vaccination. The patient was diagnosed on 14-Nov-2015 with influenza by the emergency room. FLUMIST was continued. The outcome of the event of diagnosis of influenza was unknown. The company physician considered diagnosis of influenza to be non-serious.
The case had an adverse reaction after receiving his first dose of Pfizer. He says he had a 5-week flare-up of his Epstein-Barr infection and experienced vertigo. He spoke with his PCP about it. He also tested positive for COVID-19 and experienced a prolonged symptoms for at least 2 weeks. Symptoms included nasal congestion, loss of smell/taste, cough, wheezing, and bronchitis.
Roughly 12 hours later I had very restless legs, profuse sweating, and a bad headache. The sweating and restlessness went away but then I got a 99.7 fever. That went back to normal and I developed a swollen chest lymph node and swollen arm pit gland and both are extremely painful.
induration, pain & swelling @ rt deltoid area around site of inj measuring approx 4 to 5 cms in diameter;Medrol dosepak given
Patient said on 5/23 that she has been having tingling, swelling and soreness since the day she received the immunization. Since then, more recently she has had sores develop on her arm.
Reddened neck and chest for 2 days.  No treatment, no other effects, resolved on its own
This is a spontaneous report from a contactable nurse via Pfizer Sales Representative. A elderly female patient (Age: Over 65-year-old) received PREVNAR 13, via an unspecified route of administration in the winter of 2017 single dose for immunisation, and influenza vaccine, via an unspecified route of administration in the winter of 2017 for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced flu-like symptoms after being vaccinated and went to the hospital, as a result. Outcome of event was unknown. Sender's Comments: Reported flu-like symptoms is not related to the use of PREVNAR 13 more likely representing an intercurrent medical condition. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pt immediately began to feel site itching after injection redness. Rash to arm, chest, Pt c/o of SOB, use PROAIR, lung clear, breathing improved.
I was awakened about an hour after going to bed with excruciating pain in my abdomen and couldn't get comfortable. When I stood up and walked around it was still there. It was so bad I considered calling the ambulance to go to the hospital. When I woke up it was still hurting but not the excruciating pain from earlier. I went to Urgent Care and by then the pain was still there, my whole abdomen was very tender and uncomfortable. They told me to go to the ER. They did tests and sent me home with referral to GI specialist.  I was placed on a clear liquid diet for 3 days - by Tuesday it was better but still painful in the upper abdomen. As the week wore on the pain dissipated. Tomorrow I will see the GI specialist. As the week progressed I progressed to a pancreatic diet.
Information has been received from a physician's assistant concerning a 23 year old female who on 08/30/2001 and 10/05/2001 was vaccinated with a first and second dose respectively of varicella virus vaccine live. It was noted that after the two doses the pt did not seroconvert. Unspecified medical attention was sought. Additional info has been requested.
unresponsive with tonic movements. no loss of urine or bowel. no biting of tongue
Sore arm (resolved), weakness, fatigue, racing heart, nasal congestion, swollen lymph nodes, severe sinus headache and pressure continuing past day 5.
Patient became very itchy. Her face was red and swollen and her scalp was itchy and red. She sounded like she was wheezing but was having no problem breathing. She came back the next day and said she threw up and had a low grade fever the night after she received both vaccines but felt back to normal the next day.
second dose of the Pfizer vaccine on 06Jan2021/had an antibody test performed on 14Jan. The results were negative; This is a spontaneous report from a contactable nurse. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 06Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 for COVID-19 immunization on an unknown date. Patient received the second dose of the Pfizer vaccine on 06Jan2021 (also reported as 06Jan2020) and had an antibody test performed on 14Jan2021. The results were negative for the presence of IGG. Patient asked if this was "normal" and if not, does it mean he do not have protection against SARS COV2. Patient was not immunocompromised nor was taking any immunosuppressive medications.  The outcome of the event antibody test/negative was unknown.   Information on lot/batch number has been requested.
had swelling of mouth, flushed face, treated with 50mg of diphenhydramine. symptoms resolved within one hour
Hurt during administration; Her arm bothered her when she rolled over on the injection site; Felt a tingling down her arm  for one second during administration; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain, injection site discomfort and tingling of extremity. On an unknown date, the outcome of the injection site pain, injection site discomfort and tingling of extremity were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site discomfort and tingling of extremity to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in right arm. The Shingrix vaccine was hurt during administration and she felt a tingling down her arm for one second during administration.  That night her arm bothered her when she rolled over on the injection site. It was sore and would cause her to wake up. This lasted for one day and then resolved. Unable to obtain additional details. The reporter did not consent to follow-up. This is 1 of the 3 linked cases reported by the same reporter.
fever 103; swollen glands in neck & face, bad cough, lasted about 3 days; pt was very sick;
Case number PHEH2015US018754, is an initial spontaneous report from a pharmacist received on 18 Sep 2015. This report refers to a 62-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1514701, expiry date: May 2016) intramuscularly on 18 Sep 2015. On the same day after vaccination, the patient bled a lot (required many gauze) and developed a quarter sized knot at the injection site. However the patient did not feel any pain. The patient recovered from the events on 18 Sep 2015. Seriousness and causality was not reported.