chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling sensation in her lower arm and hand.; A sensitive spot on her arm that resembled a half inch circle; Rough bumps on it but it did not cause any other problem besides that.; Nausea and fatigue the day after; Nausea and fatigue the day after; Two dots on her skin; Felt pain initially as well.; Drop of the vaccine splash on her skin in between the administrations.; Vaccinator initially injected the needle in then took it out and then reinserted the needle in again upon recognizing that she hadn't given the patient the full dose the first time around.; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Two dots on her skin), PAIN (Felt pain initially as well.), PARAESTHESIA (Tingling sensation in her lower arm and hand.), SENSITIVE SKIN (A sensitive spot on her arm that resembled a half inch circle) and VACCINATION SITE MASS (Rough bumps on it but it did not cause any other problem besides that.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Feb-2021, the patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced RASH MACULAR (Two dots on her skin), PAIN (Felt pain initially as well.), UNDERDOSE (Drop of the vaccine splash on her skin in between the administrations.) and DEVICE CONNECTION ISSUE (Vaccinator initially injected the needle in then took it out and then reinserted the needle in again upon recognizing that she hadn't given the patient the full dose the first time around.). On 19-Feb-2021, the patient experienced FATIGUE (Nausea and fatigue the day after) and NAUSEA (Nausea and fatigue the day after). On 20-Feb-2021, the patient experienced PARAESTHESIA (Tingling sensation in her lower arm and hand.), SENSITIVE SKIN (A sensitive spot on her arm that resembled a half inch circle) and VACCINATION SITE MASS (Rough bumps on it but it did not cause any other problem besides that.). On 18-Feb-2021, UNDERDOSE (Drop of the vaccine splash on her skin in between the administrations.) and DEVICE CONNECTION ISSUE (Vaccinator initially injected the needle in then took it out and then reinserted the needle in again upon recognizing that she hadn't given the patient the full dose the first time around.) had resolved. At the time of the report, RASH MACULAR (Two dots on her skin), PAIN (Felt pain initially as well.), PARAESTHESIA (Tingling sensation in her lower arm and hand.), SENSITIVE SKIN (A sensitive spot on her arm that resembled a half inch circle), VACCINATION SITE MASS (Rough bumps on it but it did not cause any other problem besides that.), FATIGUE (Nausea and fatigue the day after) and NAUSEA (Nausea and fatigue the day after) outcome was unknown.            No Concomitant medications were provided No Treatment information provided
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL dose 1. The time gap between first and second dose was not reported. The patient received the second dose on 31-MAY-2013 and third  on 26-JUL-2013. No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 31-MAR-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M025871, expiration date: 24-MAY-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained. Sender's Comments: US-009507513-1611USA004113.
Moderna Covid-19 vaccination EUA       1st dose, 8 days later injection site raised, red,  swolen,  painful rash, treated with antihistamine and cortisone cream. Redness still visible on 11th day after shot. Read: "Covid Arm".
Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced NAUSEA (Nauseous). At the time of the report, NAUSEA (Nauseous) outcome was unknown. Not Provided          The patient's medical history was not provided.  No relevant concomitant medications were reported. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OSTEOPOROSIS (non-serious), outcome "unknown", described as "osteoporosis".  No follow-up attempts are possible. No further information is expected.
He is been running a fever about 100 degree, 101 degree; My son has headache for almost 2-4 days; This is a spontaneous report from a contactable consumer (Patient father).  A male patient received BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as single dose (Dose number unknown) for COVID-19 immunization. Medical history and family history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient has headache for almost 2-4 days. He has been running a fever about 100-degree, 101-degree. Outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information was expected.
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 31-MAR-2015, patient received improperly stored (Oka/Merck) VARIVAX dose 1, from batch/lot # K007982(expiry date, dose units, route and anatomical location were not specified) (incorrect product storage). Concomitant medication were not reported. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provided 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
After my first dose of the Moderna vaccine, my senses of smell and taste changed slightly. However after my second dose, my senses shifted entirely. Everything smelled wrong. I could not tell what gas or bleach even smelled like. I went to multiple doctors who insisted that the vaccine would not cause that but that is what I have been experiencing. My doctor referred me to an ENT doctor who did not find anything, but advised that I should try to retrain my senses. After my third dose of the vaccine, things seem to have shifted back a bit, but things still aren't back to normal by any means.
VARIVAX was administered following a supported temperature excursion; This spontaneous report was received from a healthcare business professional referring to a 4-year-old male patient. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 13-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T038830 with an expiration date on 17-NOV-2022) for prophylaxis, following a supported temperature excursion on 28-JUN-2021 (product storage error).         The dose of varicella virus vaccine live (oka/merck)(VARIVAX) was exposed to a temperature excursion of 8.4 degrees Fahrenheit (°F) during a time frame of 1 hour, 30 minutes, and 0 seconds. There was no prior temperature excursion.
This spontaneous report was received from a register nurse, reporting a 49 year old female patient with drug reaction/allergies to CELEXA. The patient's medical history included recent appendectomy. On 03-SEP-2014, the patient was vaccinated with a single dose of PNEUMOVAX 23 lot # K004281, expiration date 22-MAR-2015, intramuscular route. Concomitant therapies included XANAX, bupropion hydrochloride and hydrocodone. The nurse reported the patient developed severe pain in the right arm, from shoulder to elbow, a few hours after administration of PNEUMOVAX 23 on 03-SEP-2014. The nurse added that the severe pain in the right arm makes it difficult for the patient, who recently had an appendectomy, to re-position her self. At the time of the report the outcome was reported as not recovered. No lab diagnostics studies were performed. Severe pain in the right arm, from shoulder to elbow makes it difficult for the patient, who recently had an appendectomy, to re-position her self was considered by reporter to be disability. Patient call to the office for medical attention. This is one of several reports from the same source (MARRS 1409USA003160 and 1409USA002618). Additional information has been requested.
2 day after injection, had headache, rash papulous on cheeks and both lower arms, redness of eye, took ~= TYELONL and CLARITIN,  LASIX, took 3-4 days to recover, took some meds every day until better.
PATIENT HAS DEVELOPED INVOLUNTARY JERKING MOTIONS AND VOCALIZATIONS WHICH HAVE BEEN OCCURING SINCE MARCH 2021.  PATIENT HAS BEEN DIAGNOSED WITH TICS/CONVERSION DISORDER.  MOTHER STATES PATIENT RECEIVED THE GARDASIL VACCINE ON MARCH 12, 2021.  PATIENT BEGAN TO EXPERIENCE INVOLUNTARY  MUSCLE SPASMS AND VOCALIZATIONS ON MARCH 30, 2021.  PATIENT HAS NOTED IMPROVEMENT OF INVOLUNTARY MOTIONS, HOWEVER STATES SHE CONTINUES TO EXPERIENCE EPISODES OF SPORADIC LOW MUSCLE TONE WHICH CAUSES HER TO FALL. SHE CONTINUES TO EXPERINCE INVOLUNTARY MOTIONS AND VOCALIZATIONS.  SHORT TERM MEMORY LOSS.  DAILY EPISODES WHERE PATIENT APPEARS ZONED OUT PER MOTHER AND WILL NOT RESPOND TO STIMULUS.  EPISODES LAST  LESS THAN SEVERAL MINUTES.  AUDITORY CHANGES NOTED AND STATES THINGS INTERMITTENTLY SOUND FAR AWAY AND NOTICES INTERMITTENT BLURRING OF VISION.
This spontaneous report as received from a other health professional (registered nurse) refers to a unspecified number of patients of unknown age. Current conditions and medical history was not reported. Since 05-NOV-2014, patient were administered with ROTATEQ injection (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On 05-NOV-2014, ROTATEQ was exposed to temperatures (9 degree for 6 hours) out of the recommended range and administered to unspecified patients. It was reported that the nurse was not aware of any adverse effects. At the time of the report, the excursion has not ended. It was reported to nurse that as per stability assessment data, ROTATEQ would not be adversely affected by this specific temperature excursion. Product quality complaint was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report received from a pharmacist refers to an unspecified patient of unknown age and gender. On 12-FEB-2018, the patient was vaccinated with an expired dose of ZOSTAVAX (19400 PFU Vial) lot # M038350 and expiration date 31-DEC-2017, via unspecified route for prophylaxis. Both the ZOSTAVAX and the sterile diluent (unspecified lot and expiration) used to reconstitute the ZOSTAVAX were properly stored. No adverse effects noted. No additional information provided. No product quality complaint involved.
severe overall headache; nasal congestion; This is a spontaneous report from a contactable consumer (self-reported). A 77-year-old female patient (who was not pregnant at the time of vaccine) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9261), via an unspecified route of administration, at Left Arm on 03Feb2021 13:30 at single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM 11), hypertension and hypothyroidism. Concomitant medication included metformin, levothyroxine sodium (SYNTHROID), hydrochlorothiazide, triamterene (DIU) and blood pressure medication (unspecified). The patient previously took ibuprofen and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination, included; blood pressure Med, metformin, synthroid, DIU. The patient was the not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. On 04Feb2021, the patient woke up at 3 AM with severe overall headache and nasal congestion. At 6: 30 am took Tylenol tabs 2. Had head and nasal congestion as well and no treatment was taken for nasal congestion. Symptoms did not clear up for nearly 10 hours. Outcome of the events was recovered on an unknown date in Feb2021.
Pt. reports onset of hives, primary on arms (both). Injection received in left arm, but hives predominantly in right arm. Some swelling. Pt. used topical hydrocortisone OTC. Reported reaction Monday following injection. Reaction has subsided since Saturday.
Pt presented with raised, swollen blisters on left arm 5 days after vaccine administered. Rash was from wrist up to mid arm MD was contacted and prescribed halobetasol crm BID x 7d. On the 6th day when came to get prescription the rash had migrated to right arm. No pain or itching reported.
Patient received PNEUMOVAX 23 and FLUZONE HD on 1/22/18. Later that night he had fever and local injection site swelling/redness. By the next morning the fever had subsided, but the injection site reaction continued to spread down his arm stopping about 3 inches above elbow. Patient reported to the pharmacy on 1/24 and was advised by pharmacist to take BENADRYL and monitor closely for any worsening or new symptoms, and seek immediate medical attention if so.
household had someone who is positive for covid and he is now symptomatic for covid; coughing; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COUGH (coughing) and SUSPECTED COVID-19 (household had someone who is positive for covid and he is now symptomatic for covid) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 21-Mar-2021, the patient experienced COUGH (coughing). On an unknown date, the patient experienced SUSPECTED COVID-19 (household had someone who is positive for covid and he is now symptomatic for covid). At the time of the report, COUGH (coughing) and SUSPECTED COVID-19 (household had someone who is positive for covid and he is now symptomatic for covid) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: Event coding correction and narrative update. On 07-Jul-2021: Outcome updated to recovered.
Case number PHEH2013US014363, is an initial spontaneous report received from a nurse on 02 Jul 2013, and with a follow up report received from nurse on 05 Aug 2013. This case refers to  11 year old female patient. Her medical history included Osgood-Schlatter's disease. Concomitant medication included Albuterol for use when needed. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: M12025), intramuscularly without being reconstituted with men A Component on 28 Jun 2013. On the same date he concomitantly received ADACEL (batch number: unknown). No adverse reaction was reported following this administration error. Follow up report received from nurse on 05 Aug 2013. Updated patient demographics, medical history, concomitant drugs and vaccination date.
Fever x 3 days 102.1 (highest temp) , chills, headache.   Swelling of hands and feet with rash/redness on hands and feet.  That started on Jan 27 2021 x2 days after vaccine.  Hasn't subsided yet.
On 4/5/11 GM of child stated while leaving the clinic that day that her grandchild noted above received shot some months ago & about a week later was playing, then sat down in a chair and began to seizure, his eyes rolled back, appeared to be choking & loss consciousness. 911 was called per mother of child, parents were instructed to hold hand and don't let him swallow his tongue. Child was transported to ER with temp of 102-103, grandmother not sure of exact temp, child was treated in ER & released after temp went down.
Hives; This case was reported by a physician via call center representative and described the occurrence of hives in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 7th September 2020, unknown after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Physician reported that the patient had a reaction after receipt of Shingrix at a pharmacy. The patient developed hives. Physician stated that the patient received vaccine at a pharmacy not his office.
After receiving the vaccine I had swelling of my face and swelling of my left arm. I went to the doctor two days later. Now the swelling has gone down.
Approximately 6 hours after my vaccination I experienced the following: Fever (103 degrees), Chills, Body Aches and slept for about 18 hours and after I woke up I still felt disoriented. I recovered after 60 hours.
This case was reported by a lawyer and described the occurrence of neuropathy in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (LYMErix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMErix (unknown). At an unspecified time after vaccination with LYMErix, the subject experienced joint pain and swelling, fatigue, headaches, memory loss, muscle pain, stiffness and weakness, limited head movement, back pain, neck pain, knee pain, elbow pain, sleeping disorder, numbness, dizziness, sinus problems, neuropathy, decreased activities of family life, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-modiated, or other mechanism, all reportedly caused by vaccination with LYMErix. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by mfr. This info was received via a Statement of Injuries.
After two hours of putting the first dose, I experienced headache, pain in the joints of the feet and hands, abdominal pain in the lower part of the back. A little fever at night and nausea. I took acetaminophen for the fever and the pain subsided quite a bit in my symptoms.
6 days after receiving the RSV vaccine  suddenly felt strange and then a few seconds later my  Apple Watch alarmed that I was in atrial fib.  Check my pulse and I was in atrial fib at a rate of 80 bpm.  Had no chest pain and had no SOB.  Soon my pulse rate increased and I  called 911 and when the Paramedics arrived my heart rate was 150 in atrial fib.  Taken to Hospital. Had blood work drawn, IV started and several EKGs.  Spent about 9 hours there.  Highest B/P was 180/106.  Never had hypertension or atrial fib before.  Over the hospital course my heart rate slowly came down but was in atrial fib.  Went to CAT scan with contrast and was found to have 3 pulmonary emboli.  Started on Eliquis 10 mg BID for 7 days then 5 mg BID for the rest of my life and also started on Metoprolol 50 mg qd which 2 days later was back at ER with bradycardia of 48 and very lightheadedness. Had multiple labs done and then sent home with Metoprolol dose reduced to 25 mg qd
Diarrhea, Nausea, muscle and joint pain, headache.... Flare up of Celiac Autoimmune disease
VERY SICK; TEMPERATURE OF 102; This spontaneous report received from a patient via a company representative concerned a 19 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.. No concomitant medications were reported.  On an unspecified date, the subject experienced temperature of 102, and very sick. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature of 102 and very sick was not reported. This report was non-serious.