chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rec'd second vaccine on 4/15/21. Recalls about 2 days later started to have cough, congestion. Change in vocal quality, hoarse voice, family felt maybe slurring speech.  Cough, congestion persisted about 4 weeks. During this time also had stiffness, weakness of R hand. Significant decline in use of R hand. She saw orthopedic specialist regarding the R hand in June, 6/28/2021, Doctor. He confirmed Dupuytren's, but felt she was having upper motor neuron signs, did nerve testing, not carpal tunnel. Consulted with Doctor. Nerve testing did confirm multifocal motor neuropathy, recommended she see neuro. Was referred to neuro per PCP. She saw ENT regarding the vocal quality, no acute findings with that.
No adverse event  reported manufacture changed the expiration date   and was notified  after the  administration  of the vaccination
Information has been received from a physician concerning a 30 year old female who, about 4 weeks ago, on approximately 10Mar2003, was vaccinated with a first dose of varicella virus vaccine live. Subsequently the patient developed about 30 varicella-like lesions and a fever. Unspecified medical attention was sought. Additional information has been requested.
Chills causing shivering lasting a couple of hours during the night after injection. Sore arm from injection.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EL1284), in right arm, on 29Jan2021 as dose 2, single (Lot number: FL3302), in left arm, on 26Jul2021 as dose 3 (booster), single (Lot number: FF0894), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: IRBESARTAN oral. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Positive, notes: Positive test 26May2022 treated with Paxlovid; (09Jun2022) Positive, notes: antigen testing 09Jun2022 positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient took Paxlovid from 27May2022 to 31May2022, orally for COVID 19 treatment. Other medication in 2weeks taken was reported as concomitant drug. Adverse event reported as Positive test 26May2022 treated with Paxlovid x 5 days antigen testing 09Jun2022 positive. Patient had no Known allergies.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure cannot be ruled out.
Vaccine under constituted with 1.3mLs of dilutent ie 5mcg/1.3mLs
Fever, chills, muscle and joint aches, headache - all lasted about 12-24 hours of onset Treated with ibuprofen to reduce fever and alleviate muscle and joint aches
Headache, caused him to be dizzy and throw up, couldn't function,; Headache, caused him to be dizzy and throw up, couldn't function,  captured together, after first vaccine; Headache, caused him to be dizzy and throw up, couldn't function,; He got sick; Massive headache, constant, after first vaccine; Joint pain, after first vaccine; This is a spontaneous report from a contactable consumer or other non hcp.  A 56-years-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 20May2021 18:00 (Age at vaccination 56 years old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing hypertension (High Blood Pressure Caller states he was diagnosed in the late 1990's) , ongoing back pain (Low back pain Caller states he was diagnosed originally in 1995 or 1996) , spinal operation from an unknown date and unknown if ongoing (adds that he has had 4 back surgeries). Concomitant medications included metoprolol taken for hypertension and loratadine taken for back pain from an unspecified start date and ongoing. Caller states, the day after (21May2021, early in the morning when he woke up, at 5 AM. ), the patient woke up with a massive headache and joint pain that his headache got so bad, he was dizzy and threw up. he has had both effects, ever since that time. his doctor told him to take Aleve and Advil, but the medications, did not relieve the headache. his headache was constant, and his joint pain was terrible. he has no idea what to do, was there anything that he can do, for his effects? his doctor said the effects will wear off, but they have been constant. Headache and the patient got sick. The patient missed second dose, afraid of what the effects will be: 47 days from first dose, 20May2021. Outcome of events was not recovered.  Information on lot/batch number has been requested.
Rash behind ears and bottom of hairline and after a few days spread to shins and feet
Was administered flu vaccine indicated for 65 years and older when should've been given flu vaccine for <65. A hot red confluent rash developed below injection site 24 hours later. It wasn?t itchy and did lessen with a dose of OTC Claritin. Otherwise no other complaint other than mild soreness of my deltoid.
Diarrhea, fever 103.8 Fri, Sat temp 105.2 evening. Sunday temp unspecified. Monday increased appetite increased achy, afebrile, still diarrhea. 12/4 normal exam.
started to feel a little lightheaded like my blood sugar was low; started to feel a little lightheaded like my blood sugar was low; tongue started tingling, which then progressed to lips, face, and then halfway back the scalp; tongue started tingling, which then progressed to lips, face, and then halfway back the scalp; tongue started tingling, which then progressed to lips, face, and then halfway back the scalp; some mild numbness of my tongue, face, and scalp; some mild numbness  tongue, face, and scalp; some mild numbness  tongue, face, and scalp; headache; This is a spontaneous report from a  contactable physician (patient).  A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3248), via an unspecified route of administration on 21Jan2021, on 15:45 as single dose for covid-19 immunisation .  The patient medical history was not reported.  Concomitant medications included multivitamin. No other vaccines  were given within 4 weeks prior to the COVID vaccine.  The patient previously took amoxicillin and experienced allergies, amoxicillin and experienced urticaria.  on 22Jan2021, at 17:30, the patient started to feel a little lightheaded like my blood sugar was low, tongue started tingling, which then progressed to lips, face, and then halfway back the scalp, some mild numbness of my tongue, face, and scalp and  headache; the events were reported as non-serious. The events were elaborated as follows: the patient  indicated started to feel a little lightheaded like her blood sugar was low. About 15 minutes after, she  had initially started to feel lightheaded, her tongue started tingling, which then progressed to her lips, face, and then halfway back of her scalp. The paresthesias were intermittent in those areas and then some mild numbness of the tongue, face, and scalp followed. All the symptoms subsided after about 30-40 minutes.  She said she may have had a mild headache afterwards. No motor symptoms were noted. Purely sensory and it seemed in the trigeminal nerve distribution. The outcome of the events was 22Jan2021; no symptoms have occurred since the 22Jan202.   Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19.
symptoms similar to COVID/ got really sick; symptoms similar to COVID/ got really sick; This is spontaneous report from contactable consumer, the patient. A 66-years-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose and then received her second dose of BNT162b2, via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) (at the age of 66-years-old) as a single dose; both for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she had her first shot previously and they kept her there an hour instead of 15 minutes. She got her second one yesterday on 06Apr2021 and she got really sick today on 07Apr2021 as she was in bed with symptoms similar to COVID. The outcome of event, symptoms similar to COVID/ got really sick, was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The shot was administered on Monday 7/20/2020.  The Patient (my 82 year old mother) had redness, swelling and pain at the injection site for several days.  She reported having body aches and joint paint throughout the entire body.  There has been no fever.    Since the day the shot was given (Monday) she reported feeling extremely tired,  weak and faint and dizzy.  Could not participate in her daily chair yoga class on Zoom, nor carry on normal household chores and activities, because of feeling dizzy and generally ill.  I am happy to report that as of mid-Morning on Friday she seemed a little more perky and less 'out of sorts'  .  On Friday 7/24/2020 she reported feeling better, although still tired.
DID NOT COMPLETE HER IMMUNIZATION ONE WEEK PRIOR TO TRAVEL/ TOOK THIRD DOSE ON DAY 6; TOOK VIVOTIF WITH ANTIBIOTIC; A spontaneous case report was received from a consumer on 02-Jun-2019 for two consumers.  Based on the information obtained from the consumer, 2 individual case safety reports PVX201907-000560 (PVX2019-1729; female) and PVX201907-000561 (PVX2019-1729, male) were created and cross-linked in the database.  This case describes a 19-year-old male consumer who "did not complete her immunization one week prior to travel/ took third dose on day 6" (PT: Inappropriate schedule of vaccine administered) and "took Vivotif with antibiotic" (PT: Labelled drug-drug interaction medication error). He was receiving Vivotif for a foreign travel and amoxicillin (for 7days) for wisdom teeth removal.   Case report: The consumer took the first and the second dose of Vivotif on 26-Jun-2019 and 28-Jun-2019, respectively. He lost the remaining two doses. He obtained a new pack and took the next dose on 01-Jul-2019 along with a dose of amoxicillin in the evening. He took another dose of amoxicillin on 02-Jul-2019 in the morning for his wisdom teeth removal. The procedure was planned before Vivotif was started. He had a planned travel on 08-Jul-2019.  Action taken with Vivotif and amoxicillin with respect to the events was not applicable.  The clinical outcome of the events was unknown.  Company's Comment: The causality of the event "did not complete her immunization one week prior to travel/ took third dose on day 6" and "took Vivotif with antibiotic" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not complete her immunization one week prior to travel/ took third dose on day 6" and "took Vivotif with antibiotic" was considered as not applicable. US-PaxVax Berna GmbH-PVX201907-000560:
no adverse event; HCP reported that GARDASIL 9 was administered to a patient on 12/23/2022 after a Temperature Excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  On 23-DEC-2022, the patient was vaccinated with improperly stored dose (Product storage error) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, syringe, lot #W000189 (verified to be valid lot number), expiration date: 10-AUG-2024, administered for prophylaxis (exact dose, dose #, route of administration, and anatomical location were not provided). Administered dose of vaccine experienced the temperature excursion of above 47 degrees Fahrenheit (F) (52.9 F) for 2 hours 22 minutes and 0 seconds. No further information was provided to further clarify any details. No additional adverse events (AEs) (No adverse event) were reported.
12/24/2021 onset of petechia over entire body. 12/25/2021 onset of oral mucosal/gingival bleeding and recurrent epistaxis.
Pt received vaccine on 3/25/13 seen on 03/26/13 with c/o edema, induration, erythema, warmth, and pruritus. Tx with BENADRYL. Ice to area and OTC steroid cream. F/U on 04/10/13 local reaction resolved, back to normal.
I tested positive for COVID-19 on 10/07/2022. I had body aches, congestion, and I had a hard time breathing, I had altered taste, but I didn't lose my sense of smell. I called my doctor, and she told me to treat my symptoms with over-the-counter medication. I took ALKA-SELTZER PLUS, and ROBITUSSIN. She didn't call in PAXLOVID. I am feeling much better now.
Received vaccine at 10:55 am. Within 15 min vomited once, had back and body pain, and hypertension. She received oral benadryl and had vitals monitored every 15 minutes for an hour. Glucose was normal. Vitals stable, no further events, she was hungry, felt better and wanted to go home in care of her son. At 7:30 pm son brought her to ER for fever, multiple episodes of vomiting, lethargic, some confusion throughout the day. On admission 39.2, HR 116, BP 106/57.  That night she subsequently became hypotensive refractory to fluids, likely shock secondary to anaphylaxis and was transferred to the Intensive Care Unit.  Patient required pressor support and was treated with antibiotic.  She had an extensive workup that was largely unrevealing and was finally discharged on day 6 of hospitalization to home.
Site: Pain at Injection Site-Medium, Systemic: pain around the breast and underarm area-Medium, Additional Details: Called patient on 0814 to remind her to get 2nd dose of pfizer shot,Per pt ,she refused to get 2nd dose due to the side effects associated with first shot, she is currently seeing her dr regarding the pain around the breast and underarm area, Ultrasound has been ordered by her doctor, dr. thinks it probably is " swollen of lymph node" , no confirmed diagnosis yet.
Migraine headaches  Thumping in  both ears Chronic ringing in both ears
The patient reports that minor headache started approximately one day after vaccination and was relieved using Tylenol. However, the patient reports an itchy, isolated rash on the wrist, which also arose after about one day after receiving the vaccination. The patient believes the rash is a result of the vaccination, but no other symptoms of allergic rxn are present (swelling, fever, hives, etc.).
Information has been received from a physician concerning a 4 year  month old male, with no previous allergies, or medical conditions who on 25-JUN-2007 was vaccinated with PROQUAD . There was no illness at the time of vaccination. Thirty hours after being immunized, on approximately 27 JUN 2007, the patient developed redness and swelling at the injection site, on the thigh. The area around the injection site measured 10 -12cm edema with 6-7 mm erythema. The patient was afebrile. The site was non tender. Unspecified medical attention was sought. No outcome was reported. There was no product quality complaint. Additional information is not expected.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: patient got moderna covid vaccine in consultation room and she complteley walked fine outside. She was sitting in waiting area for 15 minutes observation and she started shaking in 2 minutes while sitting on chair and non responsive on chair for 2 minutes. She started feeling nauseated and threw up while she was sitting on chair after becoming consious. I called 911 and emeregency room people took her to ER. She was talking while they took her to ER.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 11Jan2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 03Feb2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 11Nov2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VIT C, start date: Apr2022, stop date: May2022; VIT D [COLECALCIFEROL], start date: Apr2022, stop date: May2022; BABY ASPIRIN, start date: Apr2022, stop date: May2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Positive, notes: Still testing pos 10 days after treatment. Therapeutic measures were taken as a result of covid-19 with Paxlovid. Patient also received MULTIVITAMINS as concomitant medication, start date: Apr2022, stop date: May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sore arm; Tired; 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, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (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), for COVID-19 Immunization, reaction(s): "tired", "Sore arm"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "tired", "Sore arm"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "tired", "Sore arm"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "tired", "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "Tired".  Additional information: Patient had all vaccines and all of then had been Pfizer and patient had no issues other than may be sore arm and been tired.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300352612 same patient, different dose/event;
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received SHINGRIX. Concomitant products included CRESTOR and Vitamin D3. On 18th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th February, less that a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The patient reported that she had a dose of SHINGRIX in her right arm. This case is linked with case US2018GSK078961, reported by the same reporter.
Mom states that baby choked during adm of ROTARIX. And since adm pt had a "horse voice".
This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB for prophylaxis (lot #, expiration date, dose, route and site of administration were not reported). The temperature and time frame of excursions were unknown by reporter. There were also previous unspecified temperature excursions. The Data Logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA010657: US-009507513-1707USA000439: US-009507513-1707USA000440: US-009507513-1707USA000441: US-009507513-1707USA000443:
fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Guillain-Barre Syndrome(GBS)" (unspecified if ongoing); "shingles" (unspecified if ongoing); "Peripheral neuropathy in her feet" (unspecified if ongoing); "Exposed 2x to COVID 19" (unspecified if ongoing), notes: Caller has been Exposed 2x to COVID 19 and never got it. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown".  Additional information: She stated she has had the Pfizer COVID vaccine primary series 1&2 and 2 previous booster doses from Pfizer. She had no side effects from the 1st dose and with the 2nd dose she Had a sore arm (where the injection site was) and the 2nd booster dose she experienced fatigue. She called her neurologist after her first dose of Pfizer. There was news that the J&J covid vaccine was said to cause GBS, she was panicky and looked up info, mostly males. So she continued with the Pfizer vaccines. Caller has been Exposed 2x to COVID 19 and never got it.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201356556 same patient, different dose/event;
Vaccine given past best use date (BUD). BUD for this vaccine was 10/29/2023 and vaccine was administered on 11/03/2023.