chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported to clinic on 10/28/2011 and stated on 09/28/2011 had influenza vaccine and immediately had left shoulder pain where had influenza vaccination. Pain is waking patient up at night and cannot lay on left arm at night. Also is stating has limited range of motion. Arm swelled per patient and was red at that time. Has been taking Advil and Advil pm due to pain. Pt has had some chronic pain in other shoulder and went ahead and is seeing orthopedic surgeon on 11/1/11 due to this issue.
hepatic injury; This literature-study case was reported in a literature article and describes the occurrence of LIVER INJURY (hepatic injury) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Publication    No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIVER INJURY (hepatic injury) (seriousness criterion medically significant). At the time of the report, LIVER INJURY (hepatic injury) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered LIVER INJURY (hepatic injury) to be related.    Treatment and concomitant medications were not reported  Company comment: This is a  literature-study case concerning a  66-year-old female  patient with no medical history reported, who experienced unexpected event of liver injury. A multicenter cohort of patients with liver injury following COVID19 vaccination was reported, cohort includes 16 total patients aged25 to 74, who presented between 5 to 46 days following their first vaccine dose (Pfizer 12, Moderna 4). Notably 75% of patients presented after their second vaccine dose. Six patients had a history of chronic liver disease including 4 with autoimmune hepatitis in treated remission. The majority of cases demonstrated a hepatocellular pattern of liver injury (peak alanine aminotransferase: 96 to >5,000 U/L). Of the remaining 3 cases, 1 was cholestatic and 2  were mixed. Acute liver injury (ALI, defined as international normalized ratio >1.5) occurred in 3 patients; no patients developed acute liver failure. Treatment details were not disclosed in the abstract. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-419558, MOD-2021-419608, MOD-2021-419609.; Sender's Comments: This is a  literature-study case concerning a  66-year-old female  patient with no medical history reported, who experienced unexpected event of liver injury. A multicenter cohort of patients with liver injury following COVID19 vaccination was reported, cohort includes 16 total patients aged25 to 74, who presented between 5 to 46 days following their first vaccine dose (Pfizer 12, Moderna 4). Notably 75% of patients presented after their second vaccine dose. Six patients had a history of chronic liver disease including 4 with autoimmune hepatitis in treated remission. The majority of cases demonstrated a hepatocellular pattern of liver injury (peak alanine aminotransferase: 96 to >5,000 U/L). Of the remaining 3 cases, 1 was cholestatic and 2  were mixed. Acute liver injury (ALI, defined as international normalized ratio >1.5) occurred in 3 patients; no patients developed acute liver failure. Treatment details were not disclosed in the abstract. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient states that he has a red, hive-like rash on his scalp.   The rash is described as a red, raised, itchy, blotchy hive-like rash that migrates from area to area on his head.  It has not appeared on any other area of the body.  He has tried Benadryl but that has done nothing for the itching.  At this time, the rash does not seem to be improving.
This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283) solution for injection, intramuscular on right arm 14Jan2021 12:30 at a single dose for Covid-19 immunization. Medical history included chronic sinusitis due to allergies, asthma; allergies to corn, wheat, Penicillin, Sulfa, and cephalosporins. The patient was not pregnant. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (AUROVELA FE 1/20), and salbutamol (ALBUTEROL HFA). The patient experienced hives - full body on 14Jan2021 17:00 (as reported), experienced it approximately 4-6 hours after receiving vaccine. It was resolved with Benadryl. Patient stated that to be fair, she has a lot of allergies and she does occasionally experience full body hives on days when she has not received a vaccine or changed her diet/detergents. Patient did not have COVID prior vaccination. Patient has not been tested for COVID-19 after receiving the vaccine. Outcome of the events was recovered.  No follow-up activities are needed. No further information is expected.
Mild to moderate fevers for four weeks, approx. eight days after the vaccines.  Ear infection 2 weeks later.  Rolling around in pain most of the day and night.  High blood count, but no diagnosis.
Lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Lightheadedness). At the time of the report, DIZZINESS (Lightheadedness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment information not reported.   Reporter did not allow further contact
Immediately following IM administration of MENACTRA, the patient's eyes dilated, she became stiff and passed out for less than 15 seconds. We moved her to the floor and she immediately recovered.
I was fall two or three times a day and I have been admitted to the hospital at this poin.
Tiredness, headache, muscle pain, chills (severe) joint pain, nausea
inj was given 11OCT95 & 12OCT95 pt came in w/red rash to site of inj, warm to the touch
12 year old child has a 102 fever; This is a spontaneous report from a contactable consumer (patient's mom). A 12-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as 1st dose, single, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. This 12-year-old child had a 102 fever on unspecified date, 1 day after receiving her first shot. Patient had no symptoms on the day of vaccination. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Developed tingling to his  buttocks down to his ankles/feet a few days after receiving the Covid pfz  vaccination  Currently he states no previous trauma, no overuse, no redness, no swelling, no  skin discoloration, minimal pain, "mostly a tingling feeling...it's not  bad...it's like I ran a marathon "   No issues ambulating, no weakness, no other symptoms
- Increasing balance and walking problems since 9:00pm (10/13)  Increasing fatigue since 9:50pm Pain in joints, lower back, and neck  Bad headache by 10:10pm  *Seizure* with 103.6 Fever around 11:20pm Muscle pain Difficulty walking  --took Tylenol (650mg)--  *105.8* Fever around 1:30am (10/14) Heart fluttering Chills  101.3 Fever around 8:15am 10/14. 99.5 temperature by end of 10/14.  Significant fatigue, muscle pain, and walking problems persisted to 10/15.  Muscle pain persisted to 10/16.  All resolved by 10/17.
sore throat, headache, congested and feeling super tired  Narrative:  Patient called with complaints of feeling super tired last night around 6:30pm and this am, around 7am, she started to have a sore throat, headache and congestion. She states she is going home today. She states she has not taken any medications for her symptoms today. Advised patient to call with any  questions/concerns and to follow up with her primary care provider if any worsening symptoms and or report to the ER. patient voiced an understanding.
pt recvd vax 17AUG94 & 24AUG94 about 3AM awoke screaming & felt hot; t106 R; tepid bath; nodules in back lt neck;
8 days post vaccine, a small (quarter sized) red, hot, firm and swollen spot appeared at the site of the injection. This grew in size day to day. It was thought to be an infection (cellulitis) and I was prescribed antibiotics (bactrim) for 7 days. Approximately 48 hours after starting the bactrim, the swelling and redness subsided but a red, raised and itchy ring around the site continued to grow for several days, and was approximately 6 inches in diameter by day 6 when I was prescribed an antihistamine. After taking the antihistamine for 2 days the red ring disappeared slowly over 24 hours and was completely resolved by 1/21/2021.
Patient started experiencing rapid heart rate around 4AM on 3/26/2021, she had reported to the pharmacist she also has had some dizziness and has stayed in bed.  She did have some of the other usual side effects of the vaccine - chills, mild headache, tired. The rapid heart rate has not subsided or worsened. She doesn't have a primary care doctor.  The pharmacist recommended she call 911, which is recommended, just in case it is an allergic reaction and it can be treated quickly.
Eternal pleuritic type chest pain no other cardiovascular symptoms . No nausea. Settled within 10-15 minutes.
Approximately 9 hours after the shot was administered, I developed body aches, chills, and a headache. I went to bed and had difficulty sleeping because I felt so hot. When I woke up the next day, I had a fever of 99.7. I took Tylonol, but still had body aches, chills, a headache, fatigue and some nausea, as well. I slept most of the day, ate bland foods and continued to take Tylonol every 4-5 hours. I began to feel better around 6pm the day after the shot.
Cleft palate; Foetal exposure during pregnancy; This is a spontaneous case, initially received from other non-health professional via Med Communications (reference number: SEQ18-02462) on 13-Sep-2019, concerning a neonate patient of unspecified sex.  The mother was an adult, female patient, whose medical history and concomitant medications were not reported.   On an unspecified date, the patient's mother was administered Afluria Quadrivalent [influenza vaccine; dose, route of administration, anatomical location, batch number and expiry date: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for an unknown indication.  On 09-Jul-2019, the mother delivered neonate through caesarean delivery. The neonate was born with cleft palate. It was also reported that the neonate did not have any other problem, and there were no problems during delivery. No further details regarding neonate were provided.   At the time of initial reporting, the outcome of the event cleft palate was not reported.   This case is linked to 201905290, the corresponding mother case.  Company Comment: Reportedly, the neonate subject of unspecified sex was delivered with cleft palate after foetal exposure during pregnancy with the suspect product Afluria Quadrivalent. Chronology is unclear but plausible. No medical history and concomitant medications were provided. Foetal exposure during pregnancy is assessed as not related. For event cleft palate, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reporter's Comments: Reportedly, the neonate subject of unspecified sex was delivered with cleft palate after foetal exposure during pregnancy with the suspect product Afluria Quadrivalent. Chronology is unclear but plausible. No medical history and concomitant medications were provided. Foetal exposure during pregnancy is assessed as not related. For event cleft palate, causal role of the suspect product cannot be totally excluded and is assessed as related.
Swelling/erythema L deltoid 5 x 6 inches. Monitor clinically, ice, elevation, TYLENOL, rev 2d
Patient had received 3 doses of monovalent COVID vaccine already, which was documented but not the internal medical record. Patient received monovalent COVID vaccine as a booster when, per CDC recommendations, he should have received bivalent COVID vaccine.
suffers stroke during game; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional via social media.  This case involves a 23 year old male patient who suffered stroke during game while receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(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, dose, frequency, expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination. Information on batch number was requested.  It was reported that the patient was a baseball player and on an unknown date, the patient suffered stroke during game (cerebrovascular accident) (unknown latency) following the administration of influenza vaccine. This event was assessed as medically significant. The reporter commented that the list went on and on and it was happening every where. It is unknown if the patient experienced any additional symptoms/events.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (suffers stroke during game).  At time of reporting, the outcome was Unknown for the event suffers stroke during game.; Sender's Comments: Sanofi company comment dated 03-Feb-2022: This case concerns a 23 year old male patient who suffered stroke during game, after vaccination with Influenza Vaccine. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, medical history, concomitant medication, would be needed to rule out any alternative etiologies. Based on the reported information, the role of an individual vaccine cannot be assessed.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 as dose 5 (booster), single (Lot number: GJ6742) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient is not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "recovering", and all described as "Treatment of COVID-19". Symptoms of COVID-19 includes fever, sore throat, congestion, and cough. Therapeutic measures were taken (Paxlovid from 28May2023 to 01Jun2023) as a result of drug ineffective, covid-19.
Pt received Hep B vaccine on 9/08/2014, first dose. Pt. received a second dose of Hep B on 9/26/2014.
Fatigue and transient fever (99.9) starting about 5-6 days following vaccine. Fatigue and brain fog persists on day 6.
asthma; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "Covid-19"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "Covid-19". The following information was reported: ASTHMA (non-serious), outcome "unknown".  Additional Information: It was reported that the patient received Pfizer primary series and first booster. Then got COVID-19 in Jul2022. Suspects to have developed asthma following the infection.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient developed hive from hair line to waist, pt went to urgent care and was instructed to take diphenhydramine  and given steroid cream to treat hives
This spontaneous report was received from a patient of unknown age and gender via a company representative concerning on  theirself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 06-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot number M043987, expiration date 30-JUN-2018 (strength, dose and route of administration were not reported) to prevent pneumonia. On the same date, later that evening, the injection site was warm to the touch and the area was blotchy and red. At the time of the report, the patient had not recovered from the events. The causality assessment between the events and therapy with PNEUMOVAX 23 was not reported. This is one of two cases from the same reporter.; Sender's Comments: US-009507513-1711USA003938:
Client made an appt for pfizer and nurse mistakenly gave 0.25 ML. of Moderna in place of Pfizer. Client noticed sticker on vaccination card was a Moderna sticker. She indicated to the site administrator that she was ok and then left.  When  Nursing staff became aware they noticed that client needed another 0.25 mls. of Moderna to make a full dose of Moderna at this time client was contacted and a nurse was sent to clients home to administer another 0.25 ml. dose of Moderna to equal one full dose for clients first dose of Moderna.
4 1/2? x 1 1/2? red , warm and tender area - left upper arm area below injection site.   Still there as of 7:00 pm 2/16/2021.
Erythema multiforme; conservative treatment with diphenhydramine and topical hydrocortisone.
Cannot even stand; Dizzy; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Cannot even stand), DIZZINESS (Dizzy) and NAUSEA (Nauseous) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced MOBILITY DECREASED (Cannot even stand), DIZZINESS (Dizzy) and NAUSEA (Nauseous). At the time of the report, MOBILITY DECREASED (Cannot even stand), DIZZINESS (Dizzy) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant was not provided. Treatment was not provided.   Reporter did not allow further contact
Sore throat and swelling, (gave penicillin) Found later tonsils were swollen and was given  Dextromethadone for it.  The swelling went down immediately but came back after two days and then went down again over the course of a week.
chills, night sweats, chest pain, body aches, nausea, anorexia, back pain now, 16 lb weight loss, cough when sitting up and moving, peripheral neuropathy,  - chest pain resolved but other issues are persistently bad,  adv some of the initial symptoms could have been related to the shot, such as initial body aches and chills, but persistent and worsening issues are NOT expected this far out. I adv HCF eval given likely unrelated persistent symptoms, consider ED if effects are severe and worsening. He will likely go in tonight but he isn't sure where he will go. I adv try not to drive yourself call back if issues. PCC will FU tomorrow with patient at home.  4/11-Patient positive for Covid per MD at hospital Follow up call - Patient feeling better today, went to ED at hospital , was prescribed Flexeril, Ibuprofen and ondestron. Second vaccination is next week.
muscle pain from neck down  arms. all joints, headaches with no relief with tylenol or aleve, lower  extremities, nausea nausea  LE swelling joint pain rash:  2nd, 3rd, 4th fingers (spots)  Both palms - pink spots (L) arm above elbow - violaceous  papule/nodule.
No memory of injection, racing heart, HBP. No memory of EMS arriving by @ 11:30  nor transport to ER. No memory of treatment at ER.Unable to provide info in ER. No memory of ER stay. Hospital, admmitted4/12/21, discharged 4/14/21
Wife phoned agency reporting husband missed work last night "because of the shot". Reports husbands sx: achy, diarrhea, cold sweats, swelling of left arm "the size of an onion or index finger". Advised to apply ice for 20 minutes every hour x 4 hours and to seek MD assessment if no improvement.
Fever, jerking, vomiting, very cranky and diarrhea, very will. Trying to keep calm for 5 days after 8/5/98. Green stools.
The lot number used for this vaccination (006M21A) expired on 9.15.22, however, the dose was given on 9.28.22. No adverse reaction occurred, logging due to expired vaccine given.
Patient was administered the Pfizer 5-11yr monovalent vaccine. Patient should have received the 6month-4yr Pfizer monovalent vaccine.
Initial report was received 28 September 2010 from a health care professional. A 4-year-old patient had received an injection of IPOL (manufacturer sanofi pasteur), DTAP, MMR and Varicella vaccines (manufacturers not reported). Routes, sites and dates of vaccine administration were not reported. An unspecified amount of time after vaccination, the patient experienced seizures. Outcome was not reported. No further information was provided at the time of the report. Documents held by sender: None.
Partial Dose was given due to the vaccine leaked out of the injection site. No leaking from the syringe.
Tachycardia, arrhythmia. Noted around 1130am the day after receiving the first vaccine.
Pink generalized papular rash started 5/4/07; developed fever to 101.5 - 102 on 5/5/07 with generalized urticariall rash w/ some target lesions consistent with erythema multiforme
About ten days after the vaccine, I started to have waves of dizziness. I then started to get intense shooting pain in the back of my skull. It woke me up during the night with it a few times. It lasted for about two months. Some days nothing happened and then other days it would happen several times during the day. It is a very intense pain like an electric shock that lasts for a few seconds. It has not happened for about a month. The dizziness came and went for that long as well. It was there for a short period of time.  There was no pattern and no way to tell  when it would happen. The scans were not done for this problems.