chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to unspecified number of unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route of administration, lot # and expiration date were not reported). The vaccine underwent a temperature excursion of maximum 46.9 degrees Fahrenheit for 15 minutes and minimum 34.9 degrees Fahrenheit for 2 hours (6 cycles). It was reported that Digital Data Logger was involved. There were no previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
2 itchy painful lesions appeared close to injection site. Large red patch surround injection site was warm to the touch.
Hives started 9/21/16. Seen in office 09/22/16 for widespread hives, edema of arms and purpleness of lower extremities. The patient is a 4 year old child presenting with widespread hives for 1 days. He is accompanied by maternal grandmother. Parent/patient had tried BENADRYL and ibuprofen- last doses today at 10:15am.
mom called office stating child had sz en route to home p/vax on 21AUG98;
Pt with prior vasovagal reactions to blood draws had syncopal episode and noted to be hypotensive shortly thereafter. placed in trendelenberg, recovered to baseline shortly thereafter.
Chills, headache, muscle aches all over, injection site sore, and 2 in diameter circle around injection site is red and very hard.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a adult female patient who received Flu unspecified (Flu vaccine) for prophylaxis. The patient's past medical history included chickenpox (had history of chicken pox). On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced general body pain and headache. On an unknown date, the outcome of the general body pain and headache were unknown. It was unknown if the reporter considered the general body pain and headache to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not provided. The patient stated that she had received flu vaccines (unknown manufacturer) in the past and after receiving them, she has experienced body soreness and headache the patient stated that the soreness that she felt after the flu vaccine was different than the body aches that she experienced following the SHINGRIX vaccine (Refer case US2018179223). The patient stated that she had not received a flu vaccine in at least 5 or 6 years. The patient did not have any additional details regarding the adverse reactions that she experienced after receiving the flu vaccines. This case has been linked with case US2018179223 reported by the same reporter for the same patient.
RPH advise pt to sit for 15 minutes after the vaccine. No allergies were listed or vocalized during the registration period. Ten minutes after administration of Pfizer Ped first dose, Dad came to let RPH know his Daughter had fainted. RPH rushed to pt, she was awake by then.   No rash or any type of allergic reaction signs of symptoms were visible. Parents stayed with daughter through out the time along with RPH. Pt stated she was feeling fine and was ready to leave after 30 minutes. Rph consulted on signs and symptoms of allergic reaction and to follow up with Pediatricians if there are still concerns.
PCR nasopharyngeal swab positive; PCR nasopharyngeal swab positive; This is a spontaneous report from a contactable nurse. A 28-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in deltoid left on 30Dec2020 (Lot Number: EH9899) as first single dose, dose 2 intramuscular, administered in deltoid left on 20Jan2021 (Lot Number: EK9231) as second single dose for covid-19 immunization. Medical history included lung disease. The patient's concomitant medications was none. The patient was not taking any medications routinely prior to the event being reported. No prior vaccination. The patient experienced PCR nasopharyngeal swab positive on 29Mar2021 with outcome of recovered on 01Apr2021. Seriousness criteria was reported as not serious. On 29Mar2021 PCR nasopharyngeal swab positive at CVS- results back 31Mar2021, on 31Mar2021 negative PCR nasopharyngeal swab, on 01Apr2021 negative PCR nasopharyngeal swab. The patient was not hospitalized or admitted to an Intensive Care Unit. The patient did not display clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The patient did not receive any additional therapies for COVID-19. The event did not require the initiation of new medication or other treatment or procedure. No pre-existing diseases worsened during the SARS-CoV2 infection. The patient has not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination.   The reporter consider the bnt162b2 had a causal effect to the adverse event.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the known safety profile, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Vaccination Failure and Covid-19.
About 7 minutes after receiving the vaccine she starting her numbness and tingling of the mouth and lips and swelling of upper lips. NP gave her epinephrine at 3:19 and called 911 and patient was transported to ER (I think Hospital patient will know more). NP did follow  up  with patient later that 4:42 PM and patient said she was feeling better and received Benadryl and Solumedro.    **follow up with patient for missing information as reporter does not have access to it**
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-SEP-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date later in 2014, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving zoster vaccine live for long-term prevention of shingles, 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.
Shingrix of 14July2018 confirmed; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14th July 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's Comment: The case was self reported by the patient. The patient reported that he was unaware of whether they only received one or two doses, they only found the date for one dose. The reporter was also unsure of whether this was the first or second dose of Shingrix. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Swollen face, redness in face, numbness in entire face,  (took Benadryl and felt numb for about an hour) on and off numbness/tingling in arms/legs, muscle/joint pain, chills, nausea, dizziness, fatigue, migraine (all still continued today)
Severe twitching of the right eyelid, causing vision issues . Began about 6 hours after shot. Continued high intensity for 4 days, then began to taper off in  frequency . Stopped on Oct. 2. Did the same thing after second shot. But it has never completely stopped. Only happens a couple times a day, but some days twitches all day with strong intensity.
nausea, sl h/a, dizziness, dry mouth, low grade temp, shaking;
Approximate 2 minutes after receiving vaccines:  I passed out. Right after I woke up I started throwing up and the Rn clinic was unable to stop it and they transfer me the emergency Room.
Patients complains of persistent pain and swelling in arm since vaccination, he has seen and is seeing doctors to treat symptoms.
Two days after getting shot, I started developing join pain all over my body.  In my elbows, knees, hands, shoulders, feet.  I called my doctor 2 weeks later, and another doctor on duty prescribed Ibuprofen 600 mg for the pain.  I requested an appointment with my rheumatologist, since I suffer from Scleroderma and Reynaud's Disease.  On October 31, 2008 the rheumatologist prescribed Prednisone for inflammation and pain in my joints.  Condition has not improved.  It is getting worse, pain has not gone away, hands are swollen and puffy.  It is getting so difficult to do daily activities, since I am very weak and fatigue.  I believe Dr. should not have ordered to get the shot in the first place, since my immune system was compromised already.
0940: Patient presented 40 minutes post vaccination complaining of rash and itching.  Patient stated she had a rash approximately 60 hours post first dose of the Moderna vaccine.  She began treating it with benadryl and claritin then switched to Pepcid and Allegra and two weeks on that regimen the rash subsided.  She pretreated with Pepcid and Allegra today, but feels as though she is beginning to have a reaction.  Patient escorted to "procedure room 2" for observation.   Vitals:  0942: HR 85, BP 187/101 SpO2:99% on RA Patient resting on they gurney.  Patient talking to Dr on site. Provided patient water. 0952 Rechecked VS: HR 80, BP: 145/86, 99%RA. Patient reports feeling itching on her posterior neck.  No rash noted.  Skin clear and pink. 1000: Patient discharged from vaccine clinic with instruction to seek treatment if any progressive signs of allergic / anaphylaxis reaction.
The morning after the vaccine she had a fever for 1/2 the day, a headache for two days, and body aches for two days.  Then, on Thursday, May 27th she had a swollen and painful armpit on the arm that the injection was in.  The pediatrician thought it was probably swollen lymph nodes, but just did a teleconference with her, so she didn't see the swollen armpit. Patient took ibuprofen for the pain and swelling, put heat compresses on it occasionally, but it still stayed that way for All of Thursday and through the weekend.  The swelling began to go down on Monday, May 31.  Then on the morning of June 1 she had a sore throat, later developing a fever, headache, and congestion that lasted two days.  She is a bit improved today, June 3rd, just still congested and has a cough but all other symptoms are gone.
102+ temp, chills, muscle aches, muscle spasms, headache, injection site sore, nausea
This spontaneous report as received from a other health professional refers to patients of unknown age. On unknown dates the patients were vaccinated with VARIVAX lot # N009767 for prophylaxis. Concomitant therapies included sterile diluent. On unknown dates the patients experienced incorrect product storage. No adverse event was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA010487.
vaccine was expired, no temperature excursion occurred and Moderna determined the vial "maintained the activity necessary to protect against eh SARS CoV-2 virus at the time of administration".  Patient reported no adverse reactions.
Patient report nausea, vomiting and diarrhea that started approx 5 hours after immunization administered.
Watery diarrhea; chills; fatigue; body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Watery diarrhea), CHILLS (chills), FATIGUE (fatigue), MYALGIA (body aches) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Watery diarrhea), CHILLS (chills), FATIGUE (fatigue), MYALGIA (body aches) and PYREXIA (fever). At the time of the report, DIARRHOEA (Watery diarrhea), CHILLS (chills), FATIGUE (fatigue), MYALGIA (body aches) and PYREXIA (fever) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No Relevant concomitant medications was reported.  Treatment information included drinking fluids.
Presented to the ED w/ AMS and auditory hallucinations. Due to pt's extreme agitation and O2 pt was intubated in the ED. Pt admitted for acute encephalopathy d/t ETOH intoxication, and acute hypoxic/hypercapneic resp failure d/t COVID-19 pna; tx w/  O2, steroids, abx; Dc'd home on O2.
Kidney involvement, nerve inflammation: numbness, tingling, burning, facial and head neuralgia, migraine-like headaches (It began with nerve pain at the sight of the shot) and then accelerated; endocrine system affected, high inflammation level) still under treatment with neurologist. 3/16/09 Received ER medical records of 12/3 & 12/29/2008. FINAL DX: atypical chest pain; palpitations; myalgias; left side tingling Records reveal patient experienced intermittent left groin, left arm, left neck & chest pain when see 12/3 w/onset 3-4 days prior w/positional lightheadedness.  D/C to home w/PCP f/u.  Returned to ER 12/29 w/feeling unwell x 4-6 weeks.  Treated recently for UTI & was on oral antibiotics.  Had intermittent tingling/numbness on left side, fatigue, muscle aches, pins & needles sensation of head.  Exam & labs WNL.  D/C to home w/PCP f/u.   3/19/09 Received PCP medical records of 1/8-1/22/2009. FINAL DX: suspected allergic or autoimmune reaction to experimental anti-aging lotion started 11/08. Records reveal patient experienced persistent symptoms previously seen in ER for on 12/3 & 12/29.  S/S present on 1/8: burning sensation in head, neck & shoulders; facial pain; paresthesias.  Tx w/neuropathic pain meds.  Follow-up: 1. Partial numbness in toes of both feet. 2. Diagnosis of Gastroparesis. 3. Diagnosis of inflammatory neuropathy - peripheral nerve pain. These symptoms have been very debilitating and have greatly altered my quality of life. I had to retire from my position as substitute teacher and curtail my performances as a professional musician. It was necessary to hire someone for gardening and yard work.
Fatigue; a back pain around kidney areas; chills to hot to chills; headaches; joint pain; muscle pain; Up all night; This spontaneous case was reported by an other health care professional and describes the occurrence of BACK PAIN (a back pain around kidney areas), FEELING OF BODY TEMPERATURE CHANGE (chills to hot to chills), INSOMNIA (Up all night), HEADACHE (headaches) and ARTHRALGIA (joint pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced INSOMNIA (Up all night). On 01-May-2021 at 11:00 PM, the patient experienced BACK PAIN (a back pain around kidney areas), FEELING OF BODY TEMPERATURE CHANGE (chills to hot to chills), HEADACHE (headaches), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). On 02-May-2021, the patient experienced FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency. On 02-May-2021 at 7:00 AM, BACK PAIN (a back pain around kidney areas), FEELING OF BODY TEMPERATURE CHANGE (chills to hot to chills), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) had resolved. At the time of the report, INSOMNIA (Up all night) outcome was unknown and HEADACHE (headaches) and FATIGUE (Fatigue) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The action taken with the drug was not applicable.
This spontaneous report was received from a healthcare worker (medical assistant) reporting on unspecified number of patients of unknown age and genders. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of (Oka/Merck) VARIVAX that underwent a temperature excursion (dose number, lot number and expiration date were not reported), 0.5 ml, subcutaneous. Co-suspect and concomitant therapies were not reported.   Follow up information has been received from a medical assistant who stated that on 19-AUG-2014 a 14 month old patient received (Oka/Merck) VARIVAX (lot # J014402, expiration date 13-NOV-2015). No further information was available at the time of the report. This is one of several reports from the same source. Additional information has been requested.
Fever; Lethargy; Generally just felt bad; Missed one day of work; This case was reported by a consumer and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fever, lethargy, feeling unwell and activities of daily living impaired. On an unknown date, the outcome of the fever, lethargy, feeling unwell and activities of daily living impaired were unknown.   It was unknown if the reporter considered the fever, lethargy, feeling unwell and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the Shingrix 3 months ago and missed one day of work because of fever, lethargy, and generally just felt bad.  The patient need the 2nd vaccine, just trying to figure work schedule.  The reporter asked should expect the same reaction or should reaction be milder.
temp & lethargic max measured t104; 21JUN92 thru 24JUN92; T lasted thru 26JUN92;
Urticaria started within 30-45 min after administration of 4 mos vaccinations (DTaP, Prevnar, IPV, Hib). Benadryl given in office, urticaria cleared within 20 min.
patient came in two days after with a welt about 2 inches under the injection site. States could be unrelated to vaccine but it started the day after she received her shingrix vaccine. Had treated with benadryl.
Child received H1N1 vaccine at school 5 days ago. Since then mother reports "drastic" behavior changes. Some anger, some sadness. Was hitting his brother "more than usual", "disrespectful and rude". Child is new pt to practice, per mom no underlying medical conditions. Child with no observed behavioral problems in office.
24 hours after injection, rash appeared on outer right arm 3" below Pneumovax site. Grew over next 24 hours to 4" diameter semi-disk, swollen, reddened and itchy, especially at lower margins. Applied 2% topical diphenhydramine. At 72 hours after injection, was mostly resolved, still red.
After Administring the first injection (Hep A) to patient she then said she feels sick and wanted to go to the rest room. I asked if she could wait she said yes. I proceeded and administered Varicella patient then dropped her head as if she was going to faint. The physician was notified and then began to evaluate patient. Patient was given a breathing treatment @ 6:04pm.
Started to feel chills and not well in the evening.  Took some cold medicine and was feeling better in the morning but had developed a rash on chest and back.  He has been taking benadryl.
Vaccination: 14OCT2020 @ 12:30 PM.  Patient noted sore, reddened left tricep area, about 5cm in diameter at about 18:00 that evening.  On the morning of 15OCT2020 - Patient's entire left tricep area was sore, swollen  and reddened.  Patient presents at the Occupational Health Clinic on 16OCT2020 AM complaining of continued soreness and redness of the left tricep area. Left tricp - slight induration, erythematous, warm to the touch 12cm X 12cm, somewhat reduced in size from the previous evening. B/P 124/68, Pulse 92, Temp 98.5F. Referred to PA for further evaluation and documentation.
Started to have body aches, head aches and neck pain from next day morning and keep on progressing the symptoms even after 4 weeks. So tested for Covid on 2/23/21 and was positive. Also tested positive on 11/2/2020 and recovered in 3 weeks. My allergies increased in frequencies and intensity during last 12 weeks and had a severe anaphylactic shock 3 weeks ago which required calling 911 and ER treatment for stabilization. Till today, I have body aches, neck pain, insomnia and head aches and I am doing everything in my knowledge to improve my health. Multiple doctors and specialist appointments, are still continuing for treatment .
Patient's right arm was "red" and described as being "hot"; patient saw her physician and was prescribed an antibiotic.
R41.82 - Altered mental status I63.9 - CVA (cerebral vascular accident) (CMS/HCC) D70.9 - Neutropenia (CMS/HCC)
High fever 103F Body aches Cough with junk in lungs Congested Symptoms lasted 3 days until Dr notified.  Urine test neg Blood test good Phenomena chest xray neg Flu test unknown
pain on the injection site; a small lump; congested; upper respiratory issue; feeling tired; watery eyes; colds and sneezing; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported for herself that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 06Mar2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took dose 1 of bnt162b2 for COVID-19 immunisation. On an unspecified date, the patient was experienced pain on the injection site with slight redness, a small lump with a size of a dime, congested, upper respiratory issue, feeling tired, watery eyes, colds and sneezing after the second dose last 06Mar2021. "PRIVACY" was asking if it was normal to have those side effects and if can use antibiotics. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.