chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Henoch Schonlein Purpura. Joint pains in lower extremities developed 8-10 days after immunizations, purpura buttocks and lower extremities developed 5-6 days after onset of joint pains.
On 8/28, 12 days after vaccination, patient sufferd a non STEMI.
Pt did not devel a titer p/vax series; a booster dose was given;
Pt stated the next day after the Flu shot pt had a seizure - called MD but has underlying seizure disorder.
Narrative:  62 yo with GBM (brain cancer) died on 11/21/21 at inpatient hospital hospice unit (non-clinic hospital) due to clinic hospital was full & on diversion. Pt had received covid vaccines on 2/13/21 & 3/15/21. This death is not related to the vaccinations as pt died of brain cancer in hospice care.
Four days after vaccine, had a cortisone shot in the same arm that vaccine was given; The next day arm started to swell and and turned red and purple from armpit to wrist. Went to urgent care and was given cephalexin, doesn't seem to be working well.
Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Lot number: EL1284), in right arm, on 19Jan2021 as dose 2, single (Lot number: EJ1686), in left arm and on 05Oct2021 at 17:00 as dose 3 (booster), single (Lot number: 301458A) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: BLISOVI 24 FE, start date: 01Jun2021; BUPROPION, start date: 01Sep2021; CETIRIZINE, start date: 01Mar2019. Past drug history included: Fluconazole, reaction(s): "known allergies;Fluconazole - mild rash"; Fluconazole, reaction(s): "mild rash", notes: known allergies; Fluconazole - mild rash. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: BrCa1 gene: Positive; SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient received other medications in two weeks.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of covid-19 and drug ineffective.
Urgent need to have bowel movement; diarrhea/ loose, watery stool; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Mar2021 09:45 (Lot number: EN6199) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's disease" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Bnt162b2 (dose 1, single, administration time: 10:00 AM, lot number: EN5318, vaccine location: right arm), administration date: 02Mar2021, when the patient was 50 years old, for COVID-19 immunisation. The following information was reported: DEFAECATION URGENCY (non-serious) with onset 23Mar2021 17:45, outcome "unknown", described as "Urgent need to have bowel movement"; DIARRHOEA (non-serious) with onset 23Mar2021 17:45, outcome "unknown", described as "diarrhea/ loose, watery stool". Therapeutic measures were not taken as a result of defaecation urgency, diarrhoea.  Additional Information: The vaccine was administered at a Workplace clinic. The patient has no known allergies. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Events reported were not persistent. Since vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site discomfort (1st dose received on an unknown date, refer case US2019029586). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain, diarrhea, stomach cramps and chills. On an unknown date, the outcome of the injection site pain, diarrhea, stomach cramps and chills were recovered/resolved. It was unknown if the reporter considered the injection site pain, diarrhea, stomach cramps and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain at the injection site that took a little longer to resolve, diarrhea, stomach pain and cramps and chills lasted for about 7 days. The reporter did not consent to follow-up.
Initial unsolicited report received from literature on 21 October 2015 and additional information received on 23 October 2015. OBJECTIVE: To assess the association between influenza vaccination status and hospitalization for community-acquired laboratory-confirmed influenza pneumonia. Results: Forty-six percent of patients enrolled in the study (2342/ 5109) were excluded for the following reasons: age younger than 6 months (n 342, 7 percent), enrollment outside of the influenza season (714, 14 percent), children with partial vaccination (300, 6 percent), vaccination within 14 days of disease onset (115, 2 percent), self reported vaccination (518, 10 percent), self-reported vaccination with unknown vaccination date (52, 1 percent), unknown vaccination status (210, 4 percent), and unknown influenza infection status (91, 2 percent). After exclusions, 2767 patients were included in this study. Conclusions: Among children and adults hospitalized with community acquired pneumonia, those with laboratory-confirmed influenza-associated pneumonia, compared with those with pneumonia not associated with influenza, had lower odds of having received influenza vaccination. 162 influenza-associated pneumonia cases, 28 (17 percent) were vaccinated compared with 766 of 2605 (29 percent) influenza negative controls. The adjusted odds ratio comparing the odds of prior vaccination among those with influenza-positive pneumonia (cases) with the odds of prior vaccination among those with influenza-negative pneumonia (controls) was 0.43 (95 percent CI, 0-28-0.68; estimated vaccine effectiveness, 56.7 percent; 95 percent CI, 31.9 percent-72.5 percent). This case involves 28 patients [age and gender unknown] who were vaccinated with a [route and dose in series were not reported] dose of Influenza Vaccine (batch number, expiry date and site of administration were not reported) on an unspecified date. On an unspecified date following the vaccination, patients diagnosed with pneumonia tested positive for influenza. On an unspecified date patients were hospitalized. Laboratory investigations included RT-PCR which was positive for influenza. Corrective treatments were not reported. Outcome of the event was not reported. Documents held by sender: none.
WE GAVE THE PATIENT 2ND DOSE TOO EARLY. SHOULD BE 4 WEEKS APART FROM THE FIRST DOSE, BUT WE DID IT 2 WEEKS APART
Chest and Shoulder pain, shortness of breath, extreme pain when inhaling, Pulmonary Embolism diagnosed at hospital after ct scan and blood tests showed several lung infarctions, given xarelto for 6 months and follow up with gp. and tylenol for pain
Nose bleed. Disrupted sleep. Screaming. Fussing. Leg pain.
Initial report received on 6/21/2006 from health care professional. A 5 month old male child patient, prematurely born, experienced hypotonic-hyporesponsive episode 30 minutes following the first primary intramuscular diphtheria, tetanus and acellular pertussis vaccine (Pertacel), lot number C1973AB administration in the thigh on 04/10/2006. The above mentioned event persisted until 2 hours after the vaccination. The child cried persistently for 2 hours just after the vaccination and he had also developed nodulus at the site of administration 12 hours following the vaccination. The mother went to an emergency hospital 30 minutes after vaccination and the physician administered Prednisolone liquid-Prelone. The patient received antithermic drug one hour before vaccination, and the nurse declared that it is an usual procedure in her clinic. The patient has already recovered and the mother reported this event to the nurse two months after the vaccination, when the patient went back to the clinic to received the booster. The patient recovered at the time of the report. The cases of hypotonic hyporesponsive response and persistent crying were observed in the clinical trial of CPD15T vaccine. The onset 30 minutes post vaccination is consistent with the definition of HHE in relationship with vaccination (48 hours post immunization). It has to be confirmed that the duration of HHE was less than 48 hours. Nodule is though an unlisted event following CPDT vaccination. Medically important condition (OMIC).
Pt experienced a full body rash 15 days post vax. (non-pruritic)
RUNDOWN; TIRED; This spontaneous report received from a consumer concerned an 87 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: Unknown) dose was not reported, administered on 09-APR-2021 18:00 for prophylactic vaccination. The batch was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced rundown. On APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired and rundown was not reported. This report was non-serious.
IMMEDIATELY HAD METALLIC TASTE IN HIS MOUTH AND BEGAN TO SWEAT PROFUSELY.  WAS PALE AND FELT DISORIENTED.  AFTER SEVERAL MINUTES  OF A COLD CLOTH AND WATER HE BECAME CHILLED.  HE LEFT WITH HIS WIFE AFTER 30 MINS AND NOW SAID THAT HE FEELS BACK TO NORMAL AGAIN.
Headache - Fever - 100 - TYLENOL. Pain, swelling at injection site.
Developed rigors, fever, pneumonia (+) Influenza A, as well as L thigh swelling, redness pain c/w cellulitis -> hospitalized for pulmonary status as well as IV Abx.  11/17/09:  Discharge Summary recieved for dates of service 11/4/09 to 11/7/09.  Final Dx:  Influenza A-Rule out H1N1, Bronchitis with clinical right middle lobe pneumonia, asthma exacerbation-improved, resolving chest pain, possible LVH on echocardiogram-r/o LVH, boarderline diabetes mellitus, left thigh cellulitis, leukocytosis with left shift-sepsis ruled out.   Assessment:  Dx. in office with viral syndrome and frontal sinusitis and treated with Zithromax for 7 days and prednisone for 5 days. Returned to the office with c/o two weeks of congestion, chills, HA, productive cough RUQ and LUQ abdominal pain, decreased appetite and sore throat and diagnosed with bronchitis with decreased apical breath sounds and probable influenza. On date of admission presented with c/o substernal chest pain and SOB, fever, headache, neck and back stiffness, fatigue and nausea. Rigors, decreased R sided breath sounds and a respiratory rate of 34 were noted.  Cultures obtained and pt. placed on IV fluids with Levaquin IV and Tamiflu, Advair, Singulair and ceftin.  Nebulizer tx. Q 6 hrs, increased to Q 4 hrs.  SpO2 remained 98-100% on room air.   Temp. ranged from 98.0 to 102.8. Lungs with RML rhonchi and crackles. Prednisone therapy initiated.  C/o increased L thigh pain at injection site of Pneumovax with erythema and warmth to touch.  Rocephin and warm compresses initiated.  Discharged on 11/7 on 2500 kcal ADA diet, warm compresses to L thigh 3 x daily.
10/19/16 This 78 year old male presents for evaluation of the following problem(s): Hives x 6 days. Patient had the high dose flu injection on 10/11/16. A few days later he started to develop hives. The hives are located on the arms and legs. He also has some mild swelling around his eyes and lips. The hives are non-pruritic. He did see Cardio 2 days ago who advised that he take some ZYRTEC which he did start ZYRTEC-D then. He thinks that the hives have subsided some on the arms. Besides the flu injection he cannot think of any other thing that would have caused this reaction. No new medications, foods, or soaps/detergents. High Dose lot # UI679AA exp: 4/9/16.
This is a spontaneous report from a contactable other hcp (nurse). A 4-decade-old (at late 30s) male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 intramuscular on 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 intramuscular on 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient's wife reported she tested positive for COVID-19 after receiving both doses of the Moderna COVID-19 vaccine. She reports she was indirectly exposed to a patient who had not been vaccinated on Friday and swabbed the same day. The PCR test results came back positive for COVID-19 yesterday, 01Aug2021. Patient who was also fully vaccinated with the Pfizer vaccine, was directly exposed to an unvaccinated patient and also tested positive for COVID-19 via PCR testing (medically significant). The reporting HCP states she tested positive after exposure, but was completely asymptomatic, while the patient experienced a dry cough and a little headache for one day, the patient underwent lab tests and procedures which included sars-cov-2 test positive on 30Jul2021. Declined to provide any identifiers other than initials, age, and gender. No additional information obtained. Safety team follow-up consent provided for reporter. The clinical outcome of event headache and dry cough was recovered on 31Jul2021 and for all other events outcome was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded.
he was sick all night; threw up once or twice; he said his head is aching; aches all over; This is a spontaneous report from a non-contactable consumer (patient's spouse). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose number unknown, single, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient was sick all night and threw up once or twice. His head was aching, then aches all over. He woke up this morning and spouse gave him 2 Tylenol. Outcome of the events was unknown.
Pt had a 30 sec-1 min seizure. Temp 100.7. Taken to medical center, still there. This morning doctor observed pt had ear infections. Follow-up: H fever 100.7 degrees F. Febrile seizure at 12AM, approximately 9 hours after immunization with routine initial 2 month series.
day 1: none day 2: woke at 0530 with chills, general malaise & body aches, took ibuprofen, went to work, continued with same signs/symptoms, afebrile at 1430 - 98.0 degrees, sent home at 1500 day 3: woke feeling better
patient describes passing out within 5 minutes of shot.  typical syncope symptoms of light headedness, weakness, low blood pressure and high heart rate.  After recovering, patient describes having elevated HR off and on for 2 days post-shot and light headed as well, also noticed a dramatic skipping of beats of her heart. This lasted for around 2 days as well, patient had to miss work because of this.
Initial case received 30 January 2013 from a healthcare professional, (physician) who is also the grandfather of the patient. A 1 year old female patient, date of birth not reported, with no reported medical history or concomitant medications, received a DPT vaccination, about thirty years ago, date not specified. The manufacturer, dose, route, site and batch number were not reported. The patient developed a hearing deficit "almost complete deafness" several weeks after vaccination, date not specified. Laboratory tests and treatment details were not reported. The reporter had no further details and refused to be contacted. The outcome was reported as not recovered. No further details were available at the time of this report. Documents held by sender: None.
This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable Other-HCP on behalf of physician reported similar events for 3 patients. This is the 3rd of 3 reports. A patient of unspecified age race/ethnicity and gender received four doses of PREVNAR 13, all on an unknown date, at single dose, for immunization. Lot number of the fourth dose was 918245; while lot numbers of the other doses were not reported. Relevant medical history and concomitant medications were unknown. It was reported that the four doses did not immunize the patient. Possible 5th dose will be required. Clinical outcome was unknown at time of this report. The information on the lot numbers has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018129036 Same reporter/drug/event, different patients; US-PFIZER INC-2018129213 Same reporter/drug/event, different patients.
Experienced chills about 2 am, tested for fever at 3:30 pm (101 degrees F), pain in right arm and inability to raise arm without pain. All symptoms abated by 12/24/2021.
This case was reported by a nurse via call center representative and described the occurrence of shingles in a 76-year-old female patient who received SHINGRIX (batch number T4952, expiry date 18th June 2021) for prophylaxis. On 12th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 14th February 2019, 2 days after receiving SHINGRIX, the patient experienced shingles and rash. In February 2019, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved and the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the shingles, rash, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The reporter stated that about two days later receiving SHINGRIX, the patient started having a rash. The reporter had a patient in their office with significant redness and swelling at the site as well as what appears to be a shingles outbreak on her hand, thigh and stomach. The patient came to the physicians' office today 18th February 2018 and was diagnosed with shingles. The physician seeing her would like to know if he could or should prescribe VALTREX.
Phantom smell of cigarette smoke throughout the day.  Exact onset not known but approximately around the time of vaccine #1.
Patient received expired Moderna booster vaccine. Patient exhibits no adverse signs or symptoms.   Patient evaluated and instructed to report any issues. He verbalized his understanding. No treatment given.
COUGH WITH DEEP INSPIRATION; GENERAL TIREDNESS; MUSCLE ACHES; FEVER; FIBROMYALGIA; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Concomitant medications included naproxen for rheumatoid arthritis. On 10-MAY-2021, the subject experienced cough with deep inspiration. On 10-MAY-2021, the subject experienced general tiredness. On 10-MAY-2021, the subject experienced muscle aches. On 10-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.5 F. On 11-MAY-2021, Laboratory data included: Body temperature (NR: not provided) 100.2 F.  On an unspecified date, the subject experienced fibromyalgia. The action taken with covid-19 vaccine  was not applicable. The outcome of the general tiredness, muscle aches, cough with deep inspiration, fever and fibromyalgia was not reported. This report was non-serious.
Pt c/o redness, swelling of about 3 inches.  Slight itchiness.  Slightly sore.
Patient came in with 1 day of chest discomfort and tachycardiac 18 day post-COVID vaccine (Pfizer 1st dose). Patient tested COVID negative (via antigen) and also has household contact who where COVID positive. Blood work upon admission - high sensitivity troponin at 10,898 and pericardial rub on auscultation, abnormal EKG only for nonspecific T-wave abnormalities. No respiratory symptoms consistent with COVID-19 and a normal chest X-ray.  Enchocardiogram was carred out and pt has a ejection fraction of 71% with normal segmental wall motion and all other parameters appearing normal
Severe chills, rigors and muscle aches for 12 hours;  Resulting weakness and dehydration for 3 days following; Significant increase in resting pulse;  50-year old female has normal resting heart rate between 62 and 65 bpm as confirmed via annual physical including 2 months prior to vaccination with Moderna.  Resting heart rate following second dose Moderna is now 100 bpm and rises to 122 bpm upon walking.  Condition continues 10 days out from second dose;  Heart palpitations;  Difficulty breathing--cough upon taking deep breath.
Fever and chills onset around 8:00pm following injection. Continued fever (102.9*)and chills along with malaise  still current.
Extreme Migraine, fatigue, nausea, body pain for experienced daily, three to four weeks post-vaccination
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 14-NOV-2015 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 09-DEC-2016, the patient was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
lose weight, dx SEP98 w/juvenile diabetes-insulin dependent-MPH & Hemolog x 3;feverish, not feeling well, loss of appetite;