chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician and refers to a 12 year old female patient with attention deficit/hyperactivity disorder. On 02-SEP-2015 the patient was vaccinated with the first dose of GARDASIL 9, second dose on 03-DEC-2015. The patient received third dose of GARDASIL 9 on 25-FEB-2016, lot # L028082, 0.5 ml, intramuscular. Concomitant therapies included FOCALIN. On an unknown date in February 2016, within 12 hours of receiving the third dose, the patient developed a fever of 102 Fahrenheit. The patient received treatment with TYLENOL in the morning and ibuprofen in the afternoon but nothing had brought the fever down. The patient sought medical attention with physician on 26-FEB-2016 and received an additional TYLENOL in the clinic for her 102.6 Fahrenheit fever and her fever had still not come down. The outcome of pyrexia was reported as not recovered. The reporter did not assess the causality of the event with GARDASIL 9. Additional information has been requested.
one inch and a half knot under the injection reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (one inch and a half knot under the injection reaction) in a 75-year-old female patient who received mRNA-1273 (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On an unknown date, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE MASS (one inch and a half knot under the injection reaction).        The action taken with mRNA-1273 (Intramuscular) was unknown.
Patient tested positive for COVID on 11/10/2022, hospitalized and died on 12/2/2022
hands are very swollen right now; This is a spontaneous report from a sponsored program . A contactable consumer (patient) reported that a 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation; methotrexate sodium (manufacturer unknown) at an unspecified dose and tofacitinib citrate (XELJANZ) at 5 mg both via an unspecified route of administration from an unspecified date for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 in Jan2021 (mid-January) for COVID-19 immunization (went off Xeljanz 5mg for three days and things got very bad very quickly). The patient took Xeljanz 5mg and Methotrexate who stated her hands were very swollen right now. Stated that she got the Covid vaccine and stopped Methotrexate a week before the vaccine. Stated that it has been a week since the vaccine she and was hoping that she can go back on Methotrexate so that things can go back to normal. Stated that this was her second dose of the Covid vaccine. The action taken in response to the event for methotrexate sodium was post-therapy and tofacitinib citrate was unknown. Outcome of the events was not recovered.   This product is a marketing authorization holder of methotrexate sodium in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of methotrexate sodium has submitted the same report to the regulatory authorities.  Information about lot/batch number has been requested.
Patient states her cycles have been irregular, heavy,  and painful since March post COVID vaccine. Patient states she is having  bleeding every 4-5 days with at least 10 bleeding days per month and saturating  through overnight pads every 2-3 hours. Cycles prior were normal every 28-32 days with mild cramping.
Within 2 hrs. I began to feel ill, weakness, chest pain, nausea, extreme headache, body aches, chills and fever, sores in mouth. Very ill for several days. Went to ER on 10/20, again on 10/25. Temperature at that time was 104.5, BP 200+. Stayed overnight. As of 11/15/07 still have not regained strength or appetite.  12/10/2007 MR received for o/n stay10/24-25/2007 with DX: Acute Febrile Illness, assoc with malaise, myalgias, and arthralgias.  Probably a systemic viral illness.  Essential HTN.  Mild dehydration.  Chronic headaches.  Allergies to Stadol, Demerol, and Inderal.  Remote hx of melanoma.  S/P appendectomy.  Post-menopausal osteoporosis. Pt presented to ER with several day hx of fever, feeling poorly, with generalized myalgias, arthralgias, and malaise.  Pt also reports some non-exertional chest tightness. PE (+) for decreased skin turgor and dryness. Admitted for hydration and anti-pyretics with DX High fever, no obvious source, recent influenza vaccination.
Swelling and itching around injection site started today. Took a Benadryl. Seems okay, just weird. I googled it and results I came up with said to report it, so I am. This is less of a full circle but more of a crescent shape, red and surprisingly firm.
COULD NOT BARELY MOVE OUT OF BED; BARELY WALK; BLOOD CLOTS IN BOTH LEGS; This spontaneous report received from a patient concerned a 40-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, smoker (vapor about 10 -15 times a day), and non-alcohol user, and the patient had no known allergies. He did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 07-AUG-2021) dose was not reported, 1 total, administered on left arm on 25-JUN-2021 for prophylactic vaccination. Concomitant medications included metoprolol succinate tablet for high blood pressure.  On 30-Jun-2021 (5-6 days after receiving the vaccine), the patient started feeling pain in both legs. He had no other symptoms no fever, no aches. He climbs in a machine at his job, but he knew he didn't twist it. On 16-JUL-2021, he visited his physician because the pain lasted for 3 weeks. His physician ordered X-rays and Ultrasound. On 19-JUL-2021, he was notified that he had blood clots in both legs. He stated that it was worse and he could not barely move out of bed and barely walk. Physician prescribed him Eliquis (apixaban) for blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots in both legs, and the outcome of could not barely move out of bed and barely walk was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210743268- Covid-19 vaccine ad26.cov2.s- Blood clots in both legs. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
does she still need to take the second Pfizer Covid-19 vaccination if she tested positive for Covid after her first vaccination?; This is a spontaneous report from a contactable consumer. A 65-Year-old consumer (female) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch no and expiration date: unknown) via unspecified route of administration on 05Feb2021 as a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 10Feb2021 patient got COVID-19. Patient questioned that she still need to take the second dose of Pfizer Covid-19 vaccination if she tested positive for COVID-19 after her first vaccination. The outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
some swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced some swollen lymph node on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included weight: 170 or 165 (probably 170 or165, something like that). The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
ACTHIB diluent only was administered to the patient. Patient's mother was notified and asked to bring the child in to have the vaccination done again.
Throwing up constantly, bad headache, lifeless until 8pm. Today 3/29 I don't have an appetite and my stomach feels nausea. I took a few bites for breakfast & a nice dinner but I feel weird.
Cold like symptoms; chills; tiredness; sleepiness; runny nose; sore/red throat; sore/red throat; complete body ache and pain during night but was gone the next morning; This is a spontaneous report from a contactable Other HCP (patient). A 75-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3249) via unspecified route of administration in left arm on 19Jan2021, at 15:00 (at the age of 75-year-old) as a single dose for COVID-19 immunisation. The patient medical history included vertigo, mild heart attack and glaucoma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included glaucoma eye drops, dorzolamide and latanoprost. The patient didn't receive any vaccine within four weeks prior to vaccination. The patient previously took Fosamax and experienced light headedness (after 2 years). On an unknown date in Jan2021, the patient experienced (Night after vaccination), complete body ache and pain during night but was gone the next morning. On 01Feb2021, at 13:15 the patient had cold like symptoms starting 12 days after vaccination, chills, tiredness/sleepiness, runny nose, sore/red throat. The patient didn't receive treatment for the events. The outcome of the events complete body ache and pain during night but was gone the next morning was recovered on Jan2021 while for other events was recovering.
THE AFTERNOON AFTER BEING INJECTED A RED MILDLY RAISED RASH DEVELOPED AROUND INJECTION SITE. 1 12 INCH BY 1 INCH IN SIZE. THE AREA FELT ITCHY. THE PATIENT REPORTED TO THE PHARMACY THE FOLLOWING DAY AND WAS INSTRUCTED TO COVER THE AREA. SHE MAY APPLY VASELINE AND TAKE BENADRYL AS NEEDED FOR ITCHING. IF RASH BECAME WORSE SHE SHOULD CONSULT HER DOCTOR.
Pt c/o nearsyncope shortly after vaccination.  no loc.  no vertigo.  hx afib that is rate controlled w/o meds.  sx pr to assessment.    BP and blood glucose wnl.   HR=75-80 irreg irreg.  12-LEAD:  AFIB RATE:78  NO ST/T CHANGES. PT REMAINS ASYMPTOMATIC AFTER 30MIN monitoring. pt and daughter declined transport to hospital for further eval.   ems refusal signed
Left ear diminished hearing, echo's, ringing in the ears. Severe vertigo, nausea and dizziness starting the Friday after the shot and continues still today. Went to clinic Saturday the 28th of October. My ear showed no sign of infection or fluids. He gave me Meclizine. I went to the Neurologist 11-1-17 and was ordered an MRI/MRA of the Brain and IAC's.
Patient was calling to inform her got extremely sore and hard to move but not until 10 days after vaccination.  She was unsure if it was related but wanted to report it could be a possible reaction.
Lt arm swollen and red-11-2-18 9:00AM started PRELONE 10x10cm area of redness, swelling-not tender, moves arm well.
Screamed 2 1/2 hrs p/receiving first set of immun DTP/OPV/HIB;
I noticed about a week after my second COVID19 (Moderna) shot that I had a hissing/ringing in my ears, more noticeable at night when sitting or lying quietly. Also, I noticed that my heart rate was running between 90 - 128 while sitting still, when it is normally around 75. My resting heart rate over time has also gone up from around 60-75 to around 80. I know it's not a huge difference, but it is not normal for me to run a heart rate of over 100 for a greater part of the day.  It can jump around, too, between high 70's to 128 or more while I'm sitting during the day. Note this is not while I am exercising or moving around.
Staff requested a first dose of the covid vaccine for this patient.  We later realized it was his third dose.  First dose was given 2/23/21 and second dose was given 3/23/21.  Therefore this should have been a 0.25ml dose of Moderna, instead a 0.5ml dose was given.  No problems or reactions to the vaccine were reported.
fever & rash w/sz (comples febrile sz) occuring 10 days p/vax; pt also had upper resp sx w/OM 7 day p/vax;
Severe vertical double vision after second dose lasting three days.; Blotchy facial redness and puffiness, almost like hives, after both doses lasting two days.; Blotchy facial redness and puffiness, almost like hives, after both doses lasting two days.; Blotchy facial redness and puffiness, almost like hives, after both doses lasting two days.; This is a spontaneous report from a contactable consumer (patient), Reported for himself.  A 43-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, batch/lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 30Apr2021 14:30, as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store (Age at vaccination: 43 years). The patient medical history included high blood pressure and depression from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE), cetirizine hydrochloride (ZYRTEC ALLERGY) and propranolol hydrochloride (INDERAL LA) all were taken for unspecified indication, start and stop date was not reported. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient had past drug Wellbutrin and (Allergies: Wellbutrin) on an unknown date. Patient previously received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, batch/lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 08Apr2021 at 14:00 (at the age of 43-years-old), as DOSE 1, SINGLE for COVID-19 immunization and experienced blotchy facial redness and puffiness and almost like hives. On 01May2021 08:00, the patient experienced severe vertical double vision after second dose lasting three days and blotchy facial redness and puffiness, almost like hives, after both doses lasting two days. The patient did not received treatment for the events. The outcome of event Severe vertical double vision after second dose lasting three days was recovered on 04May2021, while the outcome of other events was recovered on 03May2021.  No follow-up attempts are possible. No further information is expected.
TESTED POSITIVE FOR COVID AFTER TAKING VACCINATIONS; BROKE OUT IN HIVES AT THE INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (TESTED POSITIVE FOR COVID AFTER TAKING VACCINATIONS) and INJECTION SITE URTICARIA (BROKE OUT IN HIVES AT THE INJECTION SITE) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (TESTED POSITIVE FOR COVID AFTER TAKING VACCINATIONS) and INJECTION SITE URTICARIA (BROKE OUT IN HIVES AT THE INJECTION SITE). At the time of the report, SARS-COV-2 TEST POSITIVE (TESTED POSITIVE FOR COVID AFTER TAKING VACCINATIONS) and INJECTION SITE URTICARIA (BROKE OUT IN HIVES AT THE INJECTION SITE) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   The reporter's causality for the event of tested positive for covid after taking vaccinations and broke out in hives at the injection site was not provided.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  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.
Patient called 12/9/02. Injection site red, swollen. Tried ice and Benadryl and did not help. Seen at ER; was given Medrol dose pack and Zithromax for Cellulitis
This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 12-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. K007263; expiration date 09-JUN-2016) "SDV; 10 pack", (Route of administration and anatomical location were not reported). There was no concomitant therapy reported. On an unspecified dates, the RECOMBIVAX HB had two temperature excursions: one of 16 hours and 480 hours. The lowest recorded temperature was 33 F (0.555555556 Celsius) and the highest recorded temperature was 34 F (1.111111111 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On 08-OCT-2014, unspecified number of patients were vaccinated with a dose of GARDASIL (lot # K001631, expiration date:06-NOV-2016), 0.5 ml, intramuscular that underwent post supported temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Swelling at site of injection...Cephalexin 500 mg #15...One capsule 3 times daily. Medrol Dospak..As instructed by pkg..Diagnosed as allergic reaction..Site is much better today.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 2:29 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 2:44 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 28-Feb-2021 at 2:29 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. On 28-Feb-2021, Excursion time was 09 AM and 01 PM, temperature was 27 and 26, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021. On 28-Mar-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021. On 28-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: Unknown, 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM: 37, 3 PM: 43, 4 PM: 45 and 5 PM: Unknown. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Initial sore arm; Fever; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Initial sore arm), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Initial sore arm), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Initial sore arm), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.            No concomitant medication information was reported. It was reported that patient was received second booster dose. No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2022: Follow-up received and contains no new information.
BEHAVIORAL CHANGES MANIFESTED BY TEMPER TANTRUMS, WAKING UP CRYING IN THE NIGHT, SEEMINGLY INCONSOLABLE LASTING FOR 3 DAYS.
24 hours post vaccine developed heavy fatigue, chills, body aches, headache, and weakness for 8 hours, then slight headache and weakness continued an additional 12 hours.
Soreness to right deltoid, injection site of pneumovax vaccination. Mild nausea starting 6pm of 10/28/08. Chills starting 4pm 10/29/08. 8:45am 10/30/08 only injection site soreness remains.
Pfizer-BioNTech COVID-19 Vaccine EUA  Muscle spasms in right arm, shoulder and neck. Limited use of right arm with severe pain.
Very Soar Arm and tired first day.  Second day, Soar Throat when swallowing, Swollen Eyes in the morning when I woke up, increased blood pressure at times and not as stable when walking.  Very Tired.  Took Benedryl on second day, one in morning and one at night.  Seemed to calm symptoms.  Soar Throat lasted two days and much better today (day 3).  Left Arm also less soar today and stability when walking seems better...
CHILLS, FEVER 101, DIZZINESS, LOSS OF APPETITE, FATIGUE MOST SYMPTOMS GONE IN 36 HOURS. FATIGUE LASTED 50 HOURS