chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My son first reported a headache at 5 PM and gave him 200MG of MOTRIN and he kept saying he didn't feel well. The MOTRIN did not help his headache. At 7pm, his eyes started looking puffy so we gave him 25mg of BENADRYL. At 7:15 his eyes swelled shut and his face was swollen, he said it was difficult to breathe and his chest hurt. We gave him an albuterol nebulizer and took him to the ER at 7:30 pm. Between 7:30 and 7:45 his facial swelling started to go down and his breathing became easier. He complained of chest pain for approximately 2 hours. While at the ER, he was given a double dose of steroids and the swelling came down to about 25% and we were discharged with instructions to continue BENADRYL every 6 hours for swelling, nebulizers for breathing difficulty and continue steroids at home.
November 14th I started with a headache. 15th I started to have the normal body aches and fatigue. 16th I woke up with an excruciating headache, 160/110 blood pressure, took my meds and tried to relax. Headache kind of went away and blood pressure 170/90 for the rest of the week. 22nd woke up with worse headache, blood pressure was 190/120. I went to ER, they gave me head CT and medication. 178/100 blood pressure when I got to ER. When discharged blood pressure was 156/98. On 11/23 woke up with headache and blood pressure was 140/100, called doctor and they added a new blood pressure medication. Before they were having me double my Lisinopril, but blood pressure top was still elevated. Never in 12 years since on Lisinopril has blood pressure ever gone up that high. Only thing that has changed was the shot. I had a physical in month October and blood pressure was fine.
Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was received to date  and noted the vaccine expired 1 day prior.   Notified  Vaccine program Administrators.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministerd.  An email was sent from Pfizer with the following info to verify that there is 2 additional days for expire time but the vaccine over all expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured  to the vaccine receipent (patient) and all staff have met and will place visible expire labels on each box upon recieving and monitor expire dates daily to prevent further occurances.
Throat fullness/epigastric pain x 24 hours Urticaria - 3+days
Information has been received from a registered nurse referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (lot # M031943, expiration date: 27-DEC-2017; lot # M029595, expiration date: 10-DEC-2017; lot # L046509, expiration date: 17-MAY-2017; dose and route were unknown)(rHA) for prophylaxis. No adverse effects reported. The temperature for the vaccine stored was 10 Fahrenheit degree with 35 minutes time frame. Previous temperature excursion was reported as exposure to 35.6 Fahrenheit for 8 hours and 53 minutes, 13.3 Fahrenheit for 3 hours and 22 minutes, 32.9 Fahrenheit for 24 hours and 34.5 Fahrenheit for 24 hours (cumulative 60 hours and 15 minutes). Data logger was involved.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA006776:
Painful arm day after injection. 2nd day after injection fatigue, pounding headache, cold sweats, upset stomach, nausea  and diarrhea.
No additional adverse effect reported; patient received a dose of improperly stored ROTATEQ; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 10-FEB-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose detail were not reported) (lot # 1660112, expiration date 18-OCT-2020) orally for prophylaxis, which was reported as improperly stored (temperature below 2 degrees Celsius (1.28 degrees Celsius) multiple excursions, time frame was 2 hours and 30 minutes) (product storage error). There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. No PQC was reported.
Fever of 103, body aches, profuse sweating, early onset of menstruales (regular 27 day cycle, onset at day 19. 24 hours after 2nd covid injection)
Left arm swelling with hive; Left arm swelling with hive; left hand fingers numb; Fever; headache; Right Arm tingling; This is a spontaneous report from a contactable consumer reporting for himself.   A 65-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 11Feb2021 14:00 (Batch/Lot Number: EL9267) at the age of 65 years as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included colectomy Colon resection 14 years ago. The patient's concomitant medications were not reported. On 11Feb2021 22:00  the patient experienced left arm swelling with hive, left hand fingers numb, fever, headache, right arm tingling all with outcome of not recovered. Therapeutic treatment: Tylenol.  No follow up attempts are possible. No further information is expected.
REDNESS OF LEGS FROM KNEES DOWN; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's past medical history included past history of cancer (15 years) that has recurred, and concurrent conditions included cancer.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 13:30 for prophylactic vaccination on Left arm. Concomitant medications included enzalutamide for cancer, gabapentin for cancer, rosuvastatin for cancer, ipratropium for drug used for unknown indication, leuprorelin acetate for drug used for unknown indication, loratadine for drug used for unknown indication, megestrol acetate for drug used for unknown indication, meloxicam, and metoprolol. On 24-MAR-2021, the subject experienced redness of legs from knees down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from redness of legs from knees down. This report was non-serious.
COVID vaccinated patient who admitted to hospital with complications of COVID. Provider discharge note below:  "Reason for Admission: Patient is a 89 YO year old female with past medical history of HTN, SVT s/p remote ablation, hypothyroidism, chronic bronchitis admitted with COVID viral infection. She is fully vaccinated against COVID. Brief Summary of Hospital Stay: The patient remained relatively asymptomatic other than a mild sore throat. She had no hypoxia or respiratory compromise. She did not meet criteria for active treatment, and our hospital does not have Paxlovid available for inpatients. She did experience a brief episode of atrial fibrillation, likely due to her active infection and some agitation at night. This has not recurred and she remains on her home metoprolol and Rythmol. Given history of falls the risk of anticoagulation outweighs the benefits. Nevertheless an event monitor has been ordered to monitor for further events".
on 1/28/21 patient experienced a retinal artery occlusion. Pt reported normal blood flow after 24 hours
Initial report received on 04 April 2008 from a nurse in the USA. An unreported number of patients (no individual identification provided) developed a black dot at the injection site after having received, on an unspecified date, an intramuscular dose of IPOL (lot number, dosage and site not reported). The reporter claimed that a large practice of 20 offices has found black dots occurring in patients who have received IPOL from a multi dose vial. The black dot did not seem to be subsiding. No other symptoms occurred in the patients. The practice was monitoring the situation. At the time of the report (04 April 2008), the patients had not recovered.
After received the COVID-19 booster shot arm became very swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (After received the COVID-19 booster shot arm became very swollen) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Chronic lymphocytic leukemia.    Concurrent medical conditions included Chronic lymphocytic leukemia.   On 10-May-2019, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On 16-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (After received the COVID-19 booster shot arm became very swollen). At the time of the report, VACCINATION SITE SWELLING (After received the COVID-19 booster shot arm became very swollen) had resolved.            No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. 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.
headache; muscle pain; tender at the injection site; nausea; chills; dizzy; weak; couldn't walk; sore throat; This is a spontaneous report from a contactable Consumer. This (Age:65; Unit: Unknown) female Consumer reported for herself.  A 65-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FL9269, Expiration date: unknown), via unspecified route, administered in left arm on 08Feb2021 (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Hypertension from unspecified date to unknown ongoing and thyroid disorder from unspecified date to unknown ongoing and concomitant medications were not reported but mentioned as taking for thyroid and hypertension. On an unspecified date, after the vaccination, the patient experienced headache, sore throat, the muscle pain. The patient tried to get up off the couch to walk and the patient was so dizzy, the patient was going to fall over. Then the patient got nausea and chills. the patient had the chills so bad; it was that bad that her whole body shook. Now the patient due to get the second shot. She is terrified because most people who got the first shot said all they had pain in the injection area and maybe a slight headache, but they did not have any symptoms like she had. So, if she had those symptoms like that, they say the second shot is worse than the first. The events assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (01Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
6/16/2021 =  - URGENT CARE:  COMPLAINING OF ABDOMINAL PAIN, COUGH, CHEST PRESSURE, TIRED, BODY ACHES, FATIGUE, TROUBLE DIGESTING FOOD, FEELING FULL, EXCESSIVE GAS, HEADACHE, CHILLS, MUSCLE ACHES, BACK PAIN, BRAIN FOG
Headaches, seizures, strokes, swelling of the brain, blood pooling in the brain, brain dead, repetitive speech, fainting, tachycardia, fever, lethargic, emotional, bradycardia, incontinent.
Pain in the armpit the day before, then hardness/swelling and itch on injection site the next day. A rash on the injection site can also be seen.
Site discomfort, red warm, chills. Took TYLENOL/ADVIL - ice to site.
Tightness in his chest; Difficulty breathing; Slept a lot; Body aches; Pain in arm; Low grade fever; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness in his chest), DYSPNOEA (Difficulty breathing), HYPERSOMNIA (Slept a lot), PAIN (Body aches) and PAIN IN EXTREMITY (Pain in arm) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Anxiety.  No concomitant medication reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced CHEST DISCOMFORT (Tightness in his chest), DYSPNOEA (Difficulty breathing), HYPERSOMNIA (Slept a lot), PAIN (Body aches), PAIN IN EXTREMITY (Pain in arm), PYREXIA (Low grade fever), NAUSEA (Nausea) and FATIGUE (Fatigue). The patient was treated with ALBUTEROL [SALBUTAMOL] ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, CHEST DISCOMFORT (Tightness in his chest), HYPERSOMNIA (Slept a lot), PAIN (Body aches), PAIN IN EXTREMITY (Pain in arm), PYREXIA (Low grade fever), NAUSEA (Nausea) and FATIGUE (Fatigue) was resolving and DYSPNOEA (Difficulty breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Initially developed fatigue, myalgias, and headache after vaccine administration.  On 5.3.2021 developed "brain fog" where patient had difficulty focusing, completing tasks, and subsequently developed anxiety symptoms.
very low grade fever which did not last more than a few hours.  did not get above 100.  Severe body aches which lasted about 24 hours.  Just took some Tylenol which did help with the aches.  Was a little nauseous throughout the day after the shot.
Left thigh swollen/warm to touch (twice the size of other thigh) and pain. No redness locally at either injection site
Fever ranging from low grade to as elevated as 104 over course of 3 days post vaccination.  Also had arthralgia, fatigue, joint pain, back pain and malaise. Nausea but no emesis and no diarrhea.  No redness or inflammation at site. Did consult PCP and lab work done revealing normal CBC but elevated liver enzume, AST 73 ALT 88, Alk Phos 128.  Urine was negative.  PCP will cont. to f/u w/ patient re: labs.  Patient is gradually recovering.  Afebrile as of 07/28/05
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Follow up information has been received from the medical assistant on 02-JUL-2015 regarding the patient of an unknown age and gender who on 04-JUN-2015 was vaccinated with a dose of oral, ROTATEQ (lot number K016313) (dose and route were not provided). There were 87 hours excursion. This lot number was received on 08-APR-2015. Additional information is not expected as all correspondence was received.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. Patient medical history and current condition was not reported. On 2-DEC-2014 date the patient was vaccinated with expired ZOSTAVAX, of dose 0.65 ml via subcutaneous route (frequency reported as once). Expiration date for the ZOSTAVAX was reported as JULY-2014. No adverse events were reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient received Tdap on 07-31-09. Presented first on 08/03/2009 with fever 99.8 and local site erythema, induration and mild soft tissue swelling. Fever was reported higher by the dorm advisor 2 nights later. Local ice, ibuprofen 400 mg  every 4 hours advised.  Seen again on 08/06/09 still with local reaction.  Added local itching when touching the arm. (Tdap/Adacel by Sanofipasteur)  Received PPD skin test 0n July 29 and read on the 31,2009
I developed shortness of breath and pulse rate of 140-160 on February 5th, 2021. Went to Urgent Care. Found to have Pulmonary Embolism and Atrial Flutter. Hospitalized overnight. Started on blood thinners. Had cardiac ablation on April 9th.
administered a Hib vaccine with the wrong diluent (non-supplied GSK) mixed; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a female patient who received Hib UNK (Hib vaccine) for prophylaxis.   On 18th October 2022, the patient received Hib vaccine. On 18th October 2022, unknown after receiving Hib vaccine, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 19-OCT-2022 Reporters comment:  The medical assistant called to inquire about any available information. The medical assistant reported that employee's grandchild was administered a Hib vaccine with the wrong diluent non-supplied GSK mixed yesterday (one day before the day of reporting). The reporter stated that they were not the ones who given the vaccine and it had nothing to do with their office and called to get something for the employee so did not had worry. The reporter mentioned not able to provide any details on vaccine brand, lot, expiration or patient details. The reporter did not consent to follow-up  Additional Supportive information: The grandchild was administered a Hib vaccine with the wrong diluent non-supplied GSK mixed, which led to wrong solution used in drug reconstitution.
Caller states she received her vaccines 9 days ago. 2 days ago she developed a rash under her right arm that is described as fine bumps that are itchy. The rash has now spread to both thighs. She denies other symptoms. She is going to call her PCP for appointment or instructions.
headaches and some diziness ocurring.  Blood pressure has been checked on several ocassiions and has been normal.  Headaches sppear after lunch and remain until bedtime.   Dizziness comes and goes, usually with quick head movements.  Ibuprophen and Naproxyn taken on ocassion and seem to help.  I am putting up with it for now.
Information has been received from a physician concerning a now 13 year old male with no drug reaction/allergies and no pertinent medical history, who on 01-OCT-1998 was vaccinated with a first dose of VARIVAX (Merck) (dose, route and lot # not reported), a dose of DTP (unspecified) and dose MMR II (MSD). On 22-AUG-2008 the patient was vaccinated with a second dose of VARIVAX (Merck) (dose and route not reported, lot # 660671/0430X). After receiving doses of VARIVAX (Merck), the patient presented with a case of shingles. On 14-FEB-2011 the patient visited the office for this case and was given oral prednisone. No diagnostic laboratory tests were performed. At the time of the report, the patient's outcome was unknown. According to the reporter the patient's shingles was considered to be disabling with "a significant pain". Additional information has been requested.
High fever, achy all over body and nauseated. Discussed possible reaction versus onset of viral illness. To treat fever and push fluids. If not better by next day, to be seen. To call if they have any questions.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 16 months old child patient of unknown gender. On 21-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J015437, expiration date 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Case number PHEH2014US019836, is an initial spontaneous report received from a consumer (health care professional) on 30 Sep 2014. This report refers to a 64 year old female patient. She was vaccinated with FLUVIRIN (batch number: 1410701) intramuscular on 29 Sep 2014. On the same she developed red blotch at injection site. Outcome of the event, seriousness and causality assessment was not reported.
Headache, vomiting, 102 temp. Mother took son to MD 01/15/2010. Back at school 1/18/2010
vomited on and off for 15 hrs; This is a spontaneous report from a contactable consumer. A child patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After receiving the second dose of COVID vaccine the patient vomited on and off for 15 hrs. The patient recovered from the event on an unspecified date.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Fever to 101.9 all day on 6/2/21,  red painful circular rash around injection site on 6/3/21
Injection site pain (lasted for 6 days) Extreme fatigue (lasted for 2 days) Flu-like symptoms/body aches ( lasted 4 days)
1. Chills (Started immediately after injection around 5 pm on date of injection and is still going ongoing)2.Nausea (2hrs) 3. Gas (Flatus and flatulence)(12 hrs) 4. Nose Bleed ( once) 5. Vomiting (once) 6. Diarrhea (Started at 7 pm on date of injection & is still ongoing) 7. Body aches (started at 2 am the early morning after injection and still ongoing at time of reporting) 8. General malaise (woke up with it at at 7 am on the day after injection.)
Pt vaccinated with DTaP and IPV. Received vaccine calmly. Stood to put on jacket. Fainted and collapsed to ground, within 3 minutes of vaccine. Stiff tonic posture about 30-60 seconds. Then recovered quickly. Somewhat dazed. Postictal for 10-15 minutes vs normal.
Swelling, tenderness, welts, pain at injection site and 15 cm surrounding area.
Fever, Chills, weakness, Headache. Fatigue. Onset symptoms 12/17/2020 to 12/18/2020. Highest fever 101.8.