chrisvoncsefalvay/vaers-outcomes huggingface dataset:
not feeling that great; his arm hurts where he was given the shot/left arm sore; two nosebleeds; headache; sneezed; medical history included: real bad arthritis and adrenal insufficiency; medical history included: real bad arthritis and adrenal insufficiency; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via intramuscular route of administration on 19Jan2021 at 14:30 in the arm left at a single dose to prevent covid. The patient's medical history included high blood pressure from Feb2019, cancer (three times, for clarification), real bad arthritis and adrenal insufficiency. Also, the patient had lost a kidney, two adrenal glands, and part of his prostate. Concomitant medications included hydrocortisone (strength: 10 mg) for adrenal insufficiency, amlodipine (strength: 5 mg) for high blood pressure, colchicine (strength: 0.6 mg), irbesartan (strength: 150 mg), and fludrocortisone (strength: 0.1 mg) for adrenal insufficiency. The patient previously took a flu shot in Oct (as reported) and experienced sore arm. Patient goes to the doctor to get the flu shot each year. On 20Jan2021, the patient had two nosebleeds and headache. He has never had a nose bleed and could not remember the last time he had a nose bleed. The first nose bleed was worse and was concerning. He sneezed and that is what started the second nose bleed. The first nose bleed was worse than the second one. He asked if nosebleed was one of the side effects of the vaccine. It was not listed as side effect on the website when he looked it up. He also stated that his arm hurts where he was given the shot/left arm sore and was not feeling that great on an unspecified date. His height was 5'10'' or 5'11'' on an unspecified date. The outcome of the events two nosebleeds and  headache was recovered on 21Jan2021; events not feeling that great and his arm hurts where he was given the shot/left arm sore was recovering; while unknown for the other events.
During injection the needle became detached from the syring.  Approximately half the dose went in and the other ran down the arm of the person being vaccinated.  Per vaccine manufacturer guidelines, a full dose was repeated in the other arm.
3 1/2 hrs /p vax, pt woke up & was very quiet,eyes appeared "glassy" she would seem to be dozing off & would startle awake, legs would tremble like seizure, mom gave Tylenol, Seen by MD, DX:somnolenscent start & advised no more pertussis.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Patient complained of fever a few hours after receiving MENACTRA. Took "Theraflu" complained of headache the following day. Took "immune booster". Fever gone after 48 hours. Still has headache today. States arm red, swollen and sore. No drainage: Advised to seek MD advise. *Advised to stop taking Theraflu - take Tylenol of Motrin instead.
GOT COVID-19; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose not reported, 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 patient experienced got covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid-19 was not reported. This report was non-serious. This report was associated with product quality complaint: 90000218330.     .
No additional AE reported.; an expired dose of ROTATEQ was administered to the patient on 6SEP2022; This spontaneous report was received from a registered nurse (R.N.), concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions and concomitant medications were unknown.  On 06-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliter, lot #1741381, expiration date 04-SEP-2022, administered orally for prophylaxis (expired product administered). The patient did not experience any adverse event.  The reporter stated that the vaccine had not been involved in a temperature excursion through the date of administration. No additional information provided.
Headache, Arthralgia, weak, hurts to walk, chills, cough  Narrative: took Tylenol and Benadryl
Patient got small blood clot show on skin 4 days after shot, it went away lighter red in 1.2 week, blood pressure went up and down suddently. Sunday was fine, Monday the 26 was fine, went to bed at 9:00 PM.  Was not able to wake up, went to ER around 8:30 AM on 4/27 AM by daughter call 911. In ER for 28 hour and found out she got stroke. Pnewnewmia. ER gave antibootic around 3:00 PM, transfer to intensive care, MRI around 7:00 PM 4/27/2021 due to CT scan shown stroke. Lost Vision on right side and parcial on left side due to stroke.
NOTE:  I filed this report at the direct request of a CDC staff person who called me and recommended that I file this report.  Likely this call was initiated by my participation in VSafe.  This reaction is similar to the reaction I had to Moderna #2 & #3.  I am a nurse practitioner and do reports for patients at my organization so my name may come up for other cases in addition to my own.   6/13/2022:  2 pm Migraine headache, mental fog, injection site pain, missed 1/2 day of work 6/14/2022:  Moderate to severe headache, moderate to severe injection site pain, to Dr. office for treatment, missed 1/2 day of work, Tylenol every 4 hours 6/15/2022:  headache better, moderate to severe injection site pain radiating to left neck, missed 1/2 day of work, felt better after a nap, nausea without vomiting all dayTylenol every 4 hours 6/16/2022:  moderate to severe injection site pain, Tylenol every 4 hours.  Able to work a full day, nausea without vomiting today.
Extreme pain at injection site, preventing movement of arm above heard, swelling at injection site, redness at injection site, hot to the touch at injection site
Patient had a syncopal episode after receiving the J&J vaccine. Patient stated before getting vaccinated that she passes out with shots and blood draws. Did ok right after the vaccine but few minutes later she had a syncopal episode for less than a minute and came back to. Laid her down in exam room 8 and checked vital was 125/83. Stayed in the room with her and did start to feel better was given a cool towel and a juice to drink. Patient was slowly moved to a sitting position and was able to ambulate after 20 minutes.
pruritus, erythemic area large & fever x 2 days p/12; presumptive allergic react, local;
Booster after being contacting COVID and being treated with remdisivir; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Booster after being contacting COVID and being treated with remdisivir) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Booster after being contacting COVID and being treated with remdisivir). The patient was treated with REMDESIVIR for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Booster after being contacting COVID and being treated with remdisivir) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Company Comment: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected event of COVID 19. The event occurred on an unknown date before the third dose of mRNA-1273. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.Concomitant medications was not provided by the reporter.; Sender's Comments: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected event of COVID 19. The event occurred on an unknown date before the third dose of mRNA-1273. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Within 5 minutes of receiving vaccine, pt developed nausea, vomiting, flushing, lightheadedness and diaphoretic. Lungs clear, face pale and diaphoretic. Given 0.3cc epi (1:1000) with good response. Observed for one hour without further reaction.
Tingling around the mouth and throat, sensation of swollen lips, but not visible. Started around 25min after vaccination, did not last more than 1 min.
Pt noticed red swelling 2 days after shot. No other symptoms. Pt's husband noticed the swelling on pt's arm. Could have been there same day of shot.
This spontaneous report as received from a licensed nurse practitioner refers to unspecified number patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored VARIVAX (dose and route were not reported) lot # L017142 and expiry date: 13-MAY-2017. No concomitant medications and no adverse events were reported. The call was due to a data logger. No further information was available. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Fever to 101, chills, myalgias, plus 2-3cm induration at injection site.
Papules and suggestion of vesicles on scattered lesions on trunk and face. Low grade fever.
1st dose on 29mar21 and 2nd dose on 04may2021; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 29mar21 and 2nd dose on 04may2021) and VACCINATION SITE PAIN (Soreness at injection site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Tecfidera), Multiple sclerosis (No new lesions or growth in brain between last year's MRI and this year's MRI.), Depression, Anxiety and Post-traumatic stress disorder. Concomitant products included HYDROXYZINE for Anxiety, BUPROPION for Depression, FINGOLIMOD HYDROCHLORIDE (GILENYA) for Multiple sclerosis, GABAPENTIN for Pain, PRAZOSIN for Post-traumatic stress disorder.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site). On 04-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 29mar21 and 2nd dose on 04may2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 29mar21 and 2nd dose on 04may2021) had resolved and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.            The following day of first dose of vaccine, 30-Mar-2021, patient experienced weakness in limbs and stiff, painful joints.  Pushed through and did stretches throughout day to try and keep from locking up.  On March 31, 2021, woke to my right side feeling normal but my left side unwilling to function. Left hand would not enclose and right arm would not raise when desired. Left leg would not tolerate weight and foot had to be watched for footing placement when trying to move. Forced self to move and do things even though exhaustion came quicker. On April 1, 2021, regained function of Left side ligaments but still heavily fatigued. On April 2, 2021, symptoms weren't present and those that were, did not effect daily functions.   This case was linked to MOD-2021-091272 (Patient Link).   Reporter did not allow further contact
Information has been received from 66 year old female patient concerning herself. The patient's medical condition included hypertension and allergy to aspirin and penicillin. On 05-NOV-2014, the patient was vaccinated with ZOSTAVAX (route, dose and strength unknown). Concomitant therapies included Lisinopril (manufacturer unknown), LEVOXYL and CRESTOR. On 10-FEB-2015 (also reported as unspecified dates), the patient experienced internal lesions, numbness in my vaginal area, constipation and pain in the back part of my thigh after receiving the ZOSTAVAX injection. She also said she had to be rushed to Emergency Room on unspecified date because she could not urinate after receiving ZOSTAVAX as well. Unspecified lab work was performed and the result was not provided. It was unknown if the patient had to be admitted. Her physician diagnosed her as having "Herpes Simplex Virus Type II". She was treated with VALTREX and did not currently have an outbreak. The outcome of the events was unknown. Additional information has been requested.
pt recv vax 22JUL97 & 24JUL97 pt exp itchy lumps on hands & legs;
This spontaneous report as received from a physician refers to a 3 months old (at the time of second vaccination) and currently 5 year old male patient. On 20-MAY-2008 the patient was vaccinated with the first dose of RECOMBIVAX HB injection, 0.5 ml, intramuscularly (lot number and expiration date not provided). The second dose was administered on 31-JUL-2008 and the third dose was administered on 13-MAR-2009. The reported stated that on an unknown date a titer for Hepatitis B were drawn and the titer resulted negative. No treatment was given for adverse event. The outcome of Hepatitis B titer negative was unknown. This is one of 10 reports from the same source. Additional information has been requested.
Injection site became red; This is a spontaneous case initially received from a physician on 22-Feb-2019, concerning a female patient of an unspecified age.  It was reported that, the patient had no erythema with the flu vaccine in the past.  On 18-Feb-2019, the patient was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported) for active immunization against influenza.  On the same day after vaccination, the patient developed redness at the injection site. The patient applied ice packs and took an unspecified antihistamine as treatment.  On 22-Feb-2019, it was reported that the injection site redness was recovering.  The reporter assessed the case as non-serious.  Case re-opened for completion of full data entry: 22-Feb-2019.  Non-significant case amendment (22-Feb-2019): Added medical history in narrative.; Reporter's Comments: A female patient of an unspecified age developed injection site redness on the same day after receiving Flucelvax QIVc. The company assessed the causality of the event as related due to site specific occurrence and plausible temporal relationship between the event and the suspect vaccine.
About 3 hours after getting the vaccine, he developed a severe headache, followed by vomiting an hour later.  He had several episodes of vomiting, and received IV fluids at the hospital
Swollen lymph nodes and tenderness on left side, starting within 24 hours and persisting for 14 days (and counting) after vaccination. Not resolved Pain and stiffness in left arm, shoulder and neck starting after vaccination and persisting for 14 days after vaccination. Not resolved Headaches, temporarily resolved by OTC treatment (Advil, Tylenol) but recurring.
w/in min of vax pt became hypotensive & appeared to have circulatory problems;pt was taken to ER & was adm to hosp for 1 day of observation;
Initial report received from a healthcare professional on 15 September 2012. A 54-year-old female patient, whose concomitant medications not reported, had received FLUZONE (batch number UH747AB) intramuscularly in left deltoid on 13 September 2012. The patient was allergic to Latex, NEOSPORIN and SUDAFED. The patient had received NAPROSYN, ZOFRAN and Birth control pills in the past. The patient had TMJ (Temporomandibular Joint) disorder, hyperlipidemia and anxiety. The patient had no acute illness at the time of vaccination. The patient experienced her usual symptoms the day after receiving flu shot. The patient reported that she experienced heartburn, nausea, "dizziness" and ear pain on 14 September 2012. Laboratory investigations and corrective treatment were none. The patient did not seek physician evaluation or treatment. The outcome at the time of report was unknown. Documents held by sender: None.
Within a few days of the vaccination, pt. began to throw temper tantrums every day screaming at the top of her lungs.  She will not listen.  She starts to scream as soon as you begin to say anything to her.  She screams hateful and selfish things.  Since we are unable to reason with her, we just stay nearby occupying ourselves with a soft smile on our faces.  We occasionally walk over and give her a little kiss or a small hug, just to let her know we  still love her even though she is acting so hateful.  She will scream for 20 minutes up to an hour and then she will cry and say she loves us and say she is sorry.  We hug her and kiss her and then she does whatever it was we had asked her to do and then she is fine.  She has always been a sweet and obedient little girl.  This started suddenly and it is not like her.  I know she can't control the flood of emotions, so I do not get angry with her and she still has to obey.  Also, since the shot she has been getting welts on her legs from her underwear and pull-ups every day.
The next day post vax, the pt developed fever at the injection site which lasted 72 hours. The pt recovered without treatment. This is one of four pts from this facility who had an injection site reaction following receipt of vax.
11 days post injection large red raised welt appears at injection site. Area is itchy swollen and red
My arm hurt right after at injection site and lasted for 5 days. Yesterday shoulder started hurting and now can hardly move it. In pain! When the shot was given to me it felt fine until the vaccinator pushed the medicine in. It felt like it went too deep and hit a bone or something.
On 11/8/15 spoke with client. Stated left arm (upper) became reddened around shot site. Left upper arm very sore. States redness and soreness resolved on its own within 3 days. Did not see practitioner. Received influenza vaccination 10/20/15.
pt recvd vax 25oct94;noted some local gum bleeding eve 4nov;gum bleeding all night of 7nov; hosp 8nov;platelet count of only 4000/ml; bone marrow test shows production okay;preliminary dx IPT;placed on predisone;count rebuilding 16,000/ml;
Approx 1 hour after immunizations, pt's eyes were swollen (right eye extremely swollen), heart rate normal, B/P normal, O2 normal. Pt was playing as if he was fine, except for swelling.
acute respiratory distress syndrome/ acute respiratory failure with hypoxia; pneumonia of the lower lobe; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not reported. On or about 15-NOV-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered acute respiratory distress syndrome, requiring hospitalization and intubation. He remained hospitalized for 16 days and was diagnosed with acute respiratory failure with hypoxia and pneumonia of the lower lobe. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to vaccination. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of pneumonia of the lower lobe and acute respiratory distress syndrome/ acute respiratory failure with hypoxia were determined to be disabling.  Upon internal review, the events of pneumonia of lower lobe and acute respiratory distress syndrome/ acute respiratory failure with hypoxia were considered to be medically significant.
severe brain bleed which left me disabled and crippled; This is a spontaneous report received from a contactable reporter(s) (Physician), Program ID. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), in Dec2021 as dose number unknown (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, Batch/lot number: ER2613), administration date: 25Mar2021, for covid-19 immunisation; bnt162b2 (DOSE 2, SINGLE, Batch/lot number: EW0175), administration date: 11Aug2021, for covid-19 immunisation. The following information was reported: CEREBRAL HAEMORRHAGE (disability, medically significant), outcome "unknown", described as "severe brain bleed which left me disabled and crippled". Severe brain bleed which left patient disabled and crippled- lost medical practice and career plus any ability to perform any physical activity or have a job. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event (CEREBRAL HAEMORRHAGE) and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300257445 Same patient/vaccine, different dose/event;
In May, 1999, on an unspecified date, and on 5/26/00, the pt received her 1st, 2nd and 3rd doses of Lymerix, respectively. On 5/26/00, the pt notified her physician that she was approximately 6 weeks pregnant. Her last menstrual period was in April, 2000, the date of the positive pregnancy test was in May, 2000, and the estimated delivery date is January, 2001. The most recent information, received on 5/31/00, reports the condition of the vaccinee as ongoing.
Per mom, she has a lump at injection site, soreness, unusual behavior-hyper, weakness.