chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tripped over a speed bump and was taken to ER and given Naproxen for a broken rib; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) of an unspecified age received bnt162b2 (BNT162B2, Pfizer-BioNTech COVID-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient was walking into the hospital for her 2nd dose of the COVID vaccine and tripped over a speed bump and was taken to Emergency room and given Naproxen for a broken rib. Caller then went and took her 2nd dose and is now hearing that Naproxin could decrease the efficacy of the Covid vaccine. Relayed information and transferred. Faxing to Pfizer for AE that she tripped after getting first covid shot from Support CEP 159558. The outcome for event rib fracture was unknown. Treatment was received as result of AE includes emergency room visit and treated with Naproxen. The outcome for event rib fracture was unknown.  Information on the lot/ batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Swollen lymph nodes left side of neck. 12:00 pm  03/12/2021 Headache pain in left temple  12:00pm , 03/18/2021 Treated at clinic 03/21/2021  Swollen glands (Parotitis). 4:15PM  03/22/2021. Treated at clinic on 03/ 23/2021.
Fever, muscle aches, restlessness, headache, chills, neck pain, fatigue
left arm pit really swollen; feeling really cold and with body aches; feeling really cold and with body aches; hot flush-wave on the back; some sweating; arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HOT FLUSH (non-serious) with onset 23Mar2021, outcome "unknown", described as "hot flush-wave on the back"; HYPERHIDROSIS (non-serious) with onset 23Mar2021, outcome "unknown", described as "some sweating"; PAIN IN EXTREMITY (non-serious) with onset 23Mar2021, outcome "unknown", described as "arm soreness"; SWELLING (non-serious) with onset 24Mar2021, outcome "unknown", described as "left arm pit really swollen"; FEELING COLD (non-serious), PAIN (non-serious) all with onset 24Mar2021, outcome "unknown" and all described as "feeling really cold and with body aches".  Additional information: Clinical course: Yesterday 23Mar2021 a hot flush-wave on the back, some sweating, arm soreness. Today noticed left arm pit really swollen during morning shower. A couple of hours later started feeling really cold and with body aches. No fever yet.   No follow-up attempts are possible. No further information is expected.
Pt recvd 1st dose Engerix-B 15OCT91 & 16OCT91 pt exp rash around inject site, swelling, itching & pain; MD visit was required; pt was treated w/meds; 24 hrs p/inject exp fever @ site, itching, burning; poss allergic reaction;
Flu like symptoms, headache, muscle aches, low grade fever, sore chest wall, injection site pain, nausea
This spontaneous report was received from an unspecified reporter via an online article published and Vaccine Adverse Event Reporting System and refers to 236 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of quadrivalent HPV vaccine (manufacturer unknown) (route, dose, lot # and expiration date not reported). On unknown dates, the patients experienced death. It was unknown whether the autopsy was performed. The relatedness between death and quadrivalent HPV (manufacturer unknown) was not reported. This is one of several reports received from the same reporter. Additional information is not expected as no contact details were provided.
This spontaneous report was received from a pharmacist referring to a 27 year old patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date in February 2018, the patient was vaccinated with GARDASIL 9 (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. No adverse effects were reported (Drug use in unapproved age group).
Breakthrough bleeding/spotting menses; soreness at injection site; fatigue; muscle aches; This is a spontaneous report from a contactable other Healthcare Professional (patient). A 35-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 23Dec2020 10:00 at single dose in Left arm for COVID-19 immunization. Medical history included Alports, Alopecia Areata, eczema, all from an unknown date and unknown if ongoing. There were no known allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC), lisinopril. There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination. The patient experienced Breakthrough bleeding/spotting menses, soreness at injection site, fatigue, muscle aches on 23Dec2020 20:30. No treatment received for all reported events Breakthrough bleeding/spotting menses, soreness at injection site, fatigue, muscle aches. The patient underwent lab tests which included blood test for covid-19 which named SARS-COV-2 IGG on 09Jun2020 was with result Negative and covid-19 test which named SARS-COV-2 BY PCR (2019-NCOV) via Nasal Swab post vaccination on 30Dec2020 was with result Negative. The outcome of the events was recovered on an unspecified date.
Shingles - painful, sensitive skin, followed by severe rash on and around the left hip.
20JUL93 nausea 5PM, h/a 6PM, hot/cold flashes & felt warm during evening; pain in lower back & shooting into thighs; cried a lot; seen in ER told was allergic react & soreness @ inject site;
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-OCT-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 single dose: 0.5 ml (lot # L013428, expiration date: 03-FEB-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius) for 48 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
very weak; Joint aches; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very weak), ARTHRALGIA (Joint aches), NAUSEA (Nausea) and VOMITING (Vomiting) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Mar-2021, the patient experienced ASTHENIA (very weak), ARTHRALGIA (Joint aches), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN ACTAVIS) at an unspecified dose and frequency. On 07-Mar-2021, ASTHENIA (very weak), ARTHRALGIA (Joint aches) and NAUSEA (Nausea) had resolved and VOMITING (Vomiting) outcome was unknown.            No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
another co-worker of mine took Pfizer and she had a brain aneurysm and died instantly; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTRACRANIAL ANEURYSM (death, medically significant) with onset 2022, outcome "fatal", described as "another co-worker of mine took Pfizer and she had a brain aneurysm and died instantly". The patient date of death was unknown. Reported cause of death: "another co-worker of mine took Pfizer and she had a brain aneurysm and died instantly".  Clinical course: Term highlighted by the reporter as yes, highlighted by the reporter as serious, resulted in death was reported as true and no information on life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect, other medically important condition. Report not related to a study or programme. Reporter is an independent filmmaker, and doing this story on vaccines, specifically the Pfizer vaccine and just wondering if you had any updates in severe side-effects. reporter never took the Pfizer vaccine and never got COVID before and was healthy as you can be. Co-worker of reporter took Pfizer and she had a brain aneurysm and died instantly (Event captured in tab). Are you hearing anything about any of this kind of stuff going on I am seeing it all over around me and also on the news. People are dying suddenly from Pfizer, but they are still poisoning people with the shots. Can you tell me what you think about this". On paraphrasing the concern, Reporter stated, "People are dying (further clarifications unavailable), getting sick, they are having all sort of, mostly heart problems. Now the reporter never took it, and reporter's sister never took it. They are healthy as it can be. They never wore those face diapers, those wave masks, they never wore them. You know, that, "he said at first, nobody should be wearing a mask, that is ridiculous and then all of a sudden, he says where 2 or 3 masks and take your shot" and shut up and reporter just wondering why Pfizer is killing the people. It is depopulation. People are dying suddenly everywhere from the shots, but Pfizer still keeps pushing. Is it about money maybe. This is going to affect the whole world. This is causing unbelievable amounts of pain and death (further clarifications unavailable) and then Pfizer is busy taking all their money and getting rich and then all of my friends and family, this is disgusting. reporter seeing them dying suddenly (further clarifications unavailable) and seeing what is happening, "Pfizer is laughing at it. It is killing us, it is disgusting."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: another co-worker of mine took Pfizer and she had a brain aneurysm and died instantly
Stored beyond use date. Moderna analysis revealed possible reduced effectiveness. A third dose recommended to patient.
flu for a long week; Initial information was received on 17-Nov-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional (under reference number: US-SA-SAC20211124000688).  This case involves an adult patient with an unknown gender who experienced flu for a long week  (influenza) after receiving INFLUENZA VACCINE.  The patient's past medical treatments, concomitant medications, vaccinations, and family history were not provided.   The patient had no medical history, concomitant disease, or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu for a long week (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Always gives me the week long flu."  It was unknown if the patient experienced any additional symptoms/events.   There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of event was reported as unknown.  There will be no information on lot number for this case.
Initial report received on 10 April 2008 from a consumer, who is also the patient, in the USA. A 60 yr old female patient with no medical history received on 04 April 2008 an intramuscular left arm injection of ADACEL (lot # unknown). There was illness at the time of vaccination. On 06 April 2008, 2 days post-vaccination, the patient experienced itching at the injection site and insomnia. At the time of the report, 10 April 2008, the patient had not recovered.
Narrative: 90 yo m with hx of cad s/p cabg '91 and stent thereafter, b12 deficiency, oa, rt knee, htn & hld died on 11/24/2021. No info given on cause of pt's death. Most of pt's care outside of facility. Pt had received covid vaccines on 1/22/21 & 2/19/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
I was tested positive for COVID 19 last year in January the vaccine flared up my autoimmune disease and I was diagnosed severe joint pain Arthritis, the joint pain is unbearable.
Few minutes after receiving vaccine, patient began to say she felt dizzy with a headache and unable to hold her head up. Code Assist called. Patient evaluated/tx by code assist team. Paramedics called, patient transferred to hospital via 911.
Mom states during the wk following immun pt had inc temp of 101 & 1x sz episode; mom states sz episode lasted aprox 30-45 second; paramedics were call, pt saw MD;
This spontaneous report was received from a consumer refers to an unknown age female patient. On an unspecified date the patient developed shingles after vaccination with a dose of ZOSTAVAX (lot # unspecified), route, dose and location unspecified. The outcome of shingles was unknown. Additional information is not expected.
late second dose /first dose/March 16th 2020.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 16th March 2020).   On an unknown date, the patient received 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 details were provided as follows: The age at vaccination was not applicable. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No information about lot number from first dose was reported. The pharmacist confirmed that the first dose was given in that pharmacy. The reporter consent to follow up.
As soon as tdap was injected, pt experienced an injection site reaction. Area where immunization was injected swelled to size of gumball and after 5 minutes pt reported feeling slightly itchy around the injection site.
muscle pain & stiffness,unable to raise arm following Td vax;tx w/heat,cyclobenzaprine,ibuprofen,physical therapy
Rash on both arms and neck. Rash disappeared within 15 mins. without treatment. Pt. was given a prescription for BENADRYL.
suspected vaccination failure; get the after pain every so often take  a nerve endings for a few days; pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had 4 times). Previously administered products included Shingles vaccine (received 1st shot on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), post herpetic neuralgia (Verbatim: get the after pain every so often take  a nerve endings for a few days) and pain (Verbatim: pain). The outcome of the vaccination failure, post herpetic neuralgia and pain were not reported.   It was not reported if the reporter considered the vaccination failure, post herpetic neuralgia and pain to be related to Shingles vaccine and Shingles vaccine.     It was not reported if the company considered the vaccination failure, post herpetic neuralgia and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 28-FEB-2023 The case  was received from the patient's wife via interactive digital media. The patient had 2 Shingles shot and had to pay for them.. The reporter stated that they were kind of costly for each one. The patient still got the after pain every so often took a nerve endings for pain for a few days. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This case is linked with US2021AMR111381, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR111381:same reporter
Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves female patient (age not reported) who experienced large red and swollen area day after injection, while she received vaccine FLUZONE QUADRIVALENT. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and Exp. Date not reported) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious large red and swollen area after injection (inflammation) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Details of lab data not provided. Final diagnosis was large red and swollen area after injection. It was not reported whether patient received any corrective treatment. The event outcome was not reported. List of documents held by sender: none.
This spontaneous report as received from patient's mother refers to a male patient of unknown age. Patient's concurrent conditions and relevant medical history was unknown. On an unknown date the patient was vaccinated with RECOMBIVAX HB (dose and route unspecified). Concomitant medications were unknown. On an unknown date the patient developed autism. The outcome of autism was unknown. The causality of the event with RECOMBIVAX HB was not reported. This is one of several reports received from the same reporter.  Additional information has been requested.
Symptoms: Acites in joints, chills, diarrhea, shoulder pain- Symptoms appeared on Wednesday- shot given on Monday.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    Patient ID was reported. Concomitant medications details were not reported by the reporter. It was reported that 60 doses received to several patient from Lot AS7148B. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment details were not reported by the reporter.
Dizziness. BP 156/74 (pulse 90), 99% O2 sat. Given orange juice. F/u BP 145/75, pulse 92, O2 sat 98%. Patient stabilized
3 episodes of pain in upper epigastric, lower chest, each lasting about 10 minutes, at 23 mins, 25 1/2 mins, 30 mins after administration of DT vaccine. No vomiting, cough, difficulty breathing. No fever Concomitant redness at site of shot.
This case was reported by a pharmacist via call center representative and described the occurrence of ophthalmic herpes zoster in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the ophthalmic herpes zoster and incomplete course of vaccination were unknown. It was unknown if the reporter considered the ophthalmic herpes zoster to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced shingles in eye. The patient had not received 2nd dose within recommended 2 to 6 months later, which led to incomplete course of vaccination. The reporter did not have further detailed information.