chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles outbreak; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Oct2021 (Lot number: FE3590) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "known allergies: Sulfa meds" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Phizer, prev dose brand unknown=False, prev dose lot number=EN6205, prev dose lot unknown=False, prev dose administration date=, 18Mar2021, prev dose dose number=2, prev dose vaccine location=Left arm), administration date: 18Mar2021, when the patient was 68 years old, for COVID-19 immunization; Bnt162b2 (prev dose product=COVID 19, prev dose brand=Phizer, prev dose brand unknown=False, prev dose lot number=EN6201, prev dose lot unknown=False, prev dose administration date=, 24Feb2021, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 24Feb2021, when the patient was 67 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Oct2021, outcome "recovering", described as "Booster"; HERPES ZOSTER (non-serious) with onset 21Dec2021, outcome "recovering", described as "Shingles outbreak". The event "shingles outbreak" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of immunisation, herpes zoster.  Additional information: other vaccine in four weeks reported as no. AE treatment received with Antifungal RX. Covid prior vaccination reported as no and Covid tested post vaccination reported as yes.  Follow-up attempts are completed. No further information is expected.
pt turned very pale, head hung & bubbles came to the mouth;pt was unresponsive for awhile didn't really wake up for an hr or more;
This spontaneous case reported by a consumer, describes the occurrence of chills and pyrexia (fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 088D21A) for COVID-19 immunization. No medical history reported. On Aug 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 5, 2021, patient experienced chills and pyrexia (fever). Patient treated with Tylenol (paracetamol) for fever, at a dose of 325 milligram. At the time of the report, chills and pyrexia (fever) outcome: unknown. Diagnostic results: On an unknown date, body temperature: 101ºF (high) and 99ºF (high). The action taken with mRNA-1273 (Moderna COVID-19 vaccine):  unknown. Concomitant product information not reported. Patient stated symptoms were minor. Sender's comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Dizziness, headache, vomiting (unable to tolerate anything NPO for 24 h w resultant dehydration), fatigue and body aches lasting 40 h
Itchiness and redness from head to arms. Tingling sensation to tongue. TX Atarax 10mg i tab PRN  HS. Prednisone 20mg 1 tab qd x 3 days.
Severe hives all over legs come and go; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "TP/ait- no pancreas" (unspecified if ongoing); "TP/ait- no spleen" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: LYRICA (within two weeks of vaccination). Vaccination history included: Bnt162b2 (Dose 1, lot number unknown), for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious) with onset 03Aug2021, outcome "not recovered", described as "Severe hives all over legs come and go". The event "severe hives all over legs come and go" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of urticaria.  Additional information:No other vaccine in four weeks. No covid prior vaccination. The patient tested for covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
7/5 & 7/6 reports injection site was tender and slightly red then resolved. 7/14 reports site tenderness. 7/16 reported it to Employee Health.  Site with induration approx 3 in X 2 in, no increase in temp to touch, no redness but tender to touch. Medical Director notified.
This is a spontaneous report from a contactable nurse via Pfizer sales representative. This  nurse reported for herself that a 56-year-old female patient of an unspecified ethnicity started to receive PREVNAR 13, intramuscularly at left arm in Oct2016 at 0.5 ml, single for immunisation. The patient's medical history and concomitant medications were not reported. Patient received vaccination in left arm and stated it felt like a "frozen shoulder" and was unable to raise left arm for 4 to 5 days after use of product in 2016. The outcome of the events was unknown.
Patient started with paresthesia and weakness mid April.  He was ultimately diagnosed with Guillain-Barre syndrome via lumbar puncture on May 20th after 3 ED visits and 2 hospitalizations.
This spontaneous prospective pregnancy report as received from a registered nurse, for GARDASIL, a Pregnancy Registry product, refers to a 19 years old female patient with penicillin allergy. The patient was vaccinated with first, second and third dose of GARDASIL 0.5ml IM on 31-AUG-2007, 14-MAY-2010 and 17-JUL-2012. The third dose of vaccine's Lot number was 672233/1561AA. No other co-suspects were reported. No concomitant medications were reported. The patient became pregnant with an LMP on 25-MAY-2012 and an EDD of 01-MAR-13. The patient was exposed to GARDASIL during trimester 1. The patient has been having loss of appetite, stomach pain, nausea, and vomiting "for the past two weeks". The patient has been taking OTC antacid with no relief. The outcome of the events was reported as not recovered at time of the report. Urine pregnancy test was performed. The patient had sought medical attention via seeing the physician. Additional information has been requested.
Itching around the injection site; Patient developed red around the injection site; Swelling around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching around the injection site ), VACCINATION SITE ERYTHEMA (Patient developed red around the injection site) and VACCINATION SITE SWELLING (Swelling around the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 17-Feb-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching around the injection site ), VACCINATION SITE ERYTHEMA (Patient developed red around the injection site) and VACCINATION SITE SWELLING (Swelling around the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching around the injection site ), VACCINATION SITE ERYTHEMA (Patient developed red around the injection site) and VACCINATION SITE SWELLING (Swelling around the injection site) outcome was unknown.
It was reported that a 53 year old female "received IM injection of .50cc left deltoid, Friday 10/22/99. That evening pt complained of severe left-sided pain, back, shoulder, and neck pain with cramping. Pt became bedridden. Spoke with PCP. Treated with Vicodin with Valium. Denies asthma and GI symptoms. Left arm also hot to touch." From additional information received on 12/6/99, it was reported that the pt is "still recovering".
601 doses were given after expiration date; 601 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (601 doses were given after expiration date) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (601 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (601 doses were given after expiration date) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The vaccine was placed in refrigerator on 18 Oct 2021. There was no temperature excursion. No adverse event was reported.
Went into a coma, and died 5 days later; Feeling really bad; This case was reported by a consumer via interactive digital media and described the occurrence of coma in a 54-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, 1 day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced coma (serious criteria death and GSK medically significant) and feeling bad. On an unknown date, the outcome of the coma was fatal and the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the coma and feeling bad to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: This happened 2 years ago with the patient. Company started giving out free flu vaccines to the workers and their families. The patient was healthy. Right after getting the vaccine, she started feeling really bad, and the next evening when her husband came home, that night he had to call the squad. She went into a coma, and died 5 days later. This case has been linked to US2019AMR211990, reported by the same reporter.; Reported Cause(s) of Death: Coma
Fatigue; Headache; Swollen lymph nodes in armpit; feeling unwell; This is a spontaneous report received from a contactable consumer, the patient. A 22-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration in the left arm on 13Mar2021 at 15:30 (at the age of 22-years-old), as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD) and scoliosis. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to COVID vaccine. Concomitant medications included lisdexamfetamine dimesylate (MANUFACTURER UNKNOWN) and etonogestrel (NEXPLANON), both taken for unknown indication from unknown date. Since the vaccination, the patient had not been tested for COVID-19. On 14Mar2021 at 12:00, the patient experienced fatigue, headache, swollen lymph nodes in armpit and was feeling unwell. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of events fatigue, headache, swollen lymph nodes in armpit and feeling unwell were resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected
Pt received her vaccines around 10:30 am and then went home. Around 4pm she started seizing and presented at the ER with fever 102.6 and she seized for quite a while. Transferred to Medical center for admission. 11/7/06 Received medical records from hospital which reveal patient admitted to hospital 9/14/-9/20/06 after being transferred from outside hospital.  Patient was in PICU 9/14-9/16 & was initially intubated.  HPI: Patient seen by PCP on day of admit for vax.  Put down for nap in usual state of health.  Parent found patient staring at ceiling & briefly responsive, left side staring.  When picked up, head remained left as did gaze.  In transport, left side mouth twitching & drooling, left arm jerking & continued w/head & gaze left.  Gen tonic clonic seizure witnessed at outside hospital, tx w/valium, ativan & Pb.  Temp noted 101.3. ALLERGIES: significant in a 15 mo old for penicillin, cephalosporin & peanuts w/anaphylaxis to all 3. FAMILY HX: maternal aunt w/history of seizures.  Final Dx: Complex Febrile Seizure vs seizure disorder precipitated by febrile illness.  Also dx w/otitis media while hospitalized.  D/C home on Pb as precaution as dx unclear to be f/u in ped neuro clinic. Also received records from a 10/12-10/13/06 admission for fever of 104.6& acute bilat OM in patient with history of complex febrile seizures.  Fever responded well to ibuprofen; zithromax was continued for OM.  No seizure activity./ss
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications. On 08-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection, lot # M033214, expiry date 13-JUL-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all available information has been received. Sender's Comments: US-009507513-1611USA004113.
Expired dose administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In October 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. Patient reported that patient did not need to repeat the dose unless patient experienced any side effects.   No treatment medication information provided.
Delayed local reaction at injection site with pruritis, several cm area of erythema and swelling
Subject came to scheduled clinic, name not on list for clinic, but had vaccination card. She filled out prescreening form and marked, "NO" for recieving a vaccine in the last 14 days, and signed. Was vaccinated, and upon entering into ICARE patient only spaced first and second dose by one week, despite scheduling and reminder card given to subject with correct spacing date on it after first dose. Unknown if any adverse events occurred.
Patient reports that she started having "chest bone pain" on 3/9/2021  after first dose Pfizer Covid vaccine on 3/7/2021. States her heart rate became irregular and elevated on 3/16/2021 and that she developed left calf pain;  Patient was already on apixaban (DVT).  Patient went to Emergency Department 3/17 -  was ruled out for Pulmonary embolism; will have stress test 3/18 and see her cardiologist next week.
received another dose of Kinrix by mistake 10 months after the first dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number D947X, expiry date 25-JAN-2025) for prophylaxis.   Previously administered products included Kinrix (1st dose of kinrix received on 9-AUG-2022).   On 28-JUN-2023, the patient received the 2nd dose of Kinrix. On 28-JUN-2023, an unknown time after receiving Kinrix, the patient experienced extra dose administered (Verbatim: received another dose of Kinrix by mistake 10 months after the first dose). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-Jun-23 Nurse called to report a patient received another dose of Kinrix by mistake 10 months after the first dose. Consented to follow up via email. This case is linked to the case US2023089768, reported by the same reporter.; Sender's Comments:  US-GSK-US2023089768:Same reporter, same event, different patient (twin)
very sick/high fever/get weaker/diagnosed with double pneumonia; This is a spontaneous report from a contactable consumer (patient wife).  A 72-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot # EL3247, intramuscular in left arm on 15Jan2021 (at 1500 or 1600) at single dose to prevent covid. There were no relevant medical history or concomitant medications. There were no additional vaccines administered on same date of the BNT162B2. There was no prior Vaccinations (within 4 weeks). The reporter stated on 16Jan2021 the patient got very very sick. He started running a fever, a high fever a high temperature all day on 16Jan2021 through 17Jan2021. On 17Jan2021 night the reporter took him to the emergency room and they said it was from the covid shot. The patient began to get weaker on 17Jan2021 (not resolved) and still with a fever (resolved in Jan2021) and they said it was the shot. They went to a walk in clinic where they did a covid test on 17Jan2021 which was negative and they gave him medicine for possible pneumonia. But he didn't get any better. They went to another clinic where he had 3 more tests on 17Jan2021, "a covid test, a throat culture/ strep test and a flu test that all came back negative". On 18Jan2021 his family doctor advised him to go the hospital and he was diagnosed with double pneumonia which was resolving. The reporter stated that the event required a visit to Emergency Room and Physician Office. The reporter wanted to know if he will be able to get the second shot and asking if the first dose of the covid vaccine give him pneumonia. The medicine they gave him did not seem to be doing a lot of good, he was admitted for 3 days last week (since Jan2021 to Jan2021) and he received iv antibiotics. The medicine that was not doing good she clarified was oral pills of azithromycin (Lot: KJ9712, Expiration: Jan2022. NDC: 0781808926)that was to be taken at home. The outcome of the event was not resolved.
3 hours after Hepatitis A & B vaccine and Yellow Fever vaccine  - chest began to ache.  The aching got progressively worse, as well as breathing became painful.  12 hours after vaccine, breathing and chest pain was too severe to lie down.  Went to Emergency room where oxygen and blood pressure medications were administered following irregular EKG and high blood pressure readings. I was admitted to hospital.  Cardiologist had blood tests and thalium treadmill test to rule out symptoms were heart related, and he determined that the symptoms were caused by adverse reaction to vaccine, probably the Hepititis A.
Patient presented on 11/1/12 with bilateral upper arm redness and swelling. Referred patient to primary care doctor and he prescribed Methylprednisolone dose pak and Zpak.
Case number PHEH2011US011818 is an initial spontaneous report received from a pharmacist on 14 Dec 2011 with a follow-up received from a physician on 29 Dec 2011: This report refers to a 20-year-old pregnant female patient. She was vaccinated (vaccine given during pregnancy) with MENVEO vaccine (batch number: M10135B) intramuscularly on 14 Dec 2011. She was warm and was transferred to a patient registry. Physician stated that it was all right for the patient to have the MENVEO vaccine but was not the one who administered the vaccine. Reporter did not know where the patient received MENVEO vaccine and the patient did not report any reactions to their office. No additional information was provided. Follow-up received from a physician on 29 Dec 2011: Updated seriousness. 22 Oct 2012: Multiple attempts were made to obtain outcome of events without success. This case is considered lost to follow-up.
1. Cellulitis of left lower extremity - cephALEXin (KEFLEX) 250 mg/5 mL suspension; Take 7.5 mL (375 mg total) by mouth two (2) times a day for 7 days.  Dispense: 105 mL; Refill: 0 - mupirocin (BACTROBAN) 2 % ointment; Apply topically Three (3) times a day for 7 days.  Dispense: 22 g; Refill: 0 - Warm or cold compresses for comfort as tolerated - Tylenol/Motrin for pain - Monitor for worsening signs of infection including increased redness, swelling, purulent drainage, warmth to touch or increased pain. - Provided educational handout on cellulitis   2. Adverse effect of vaccine, initial encounter - Localized reaction measuring 6 inches x 3 inches, VIR completed - Believed to be a cellulitis and not an allergic reaction, at this time there is no indication that the patient would not tolerate a future influenza vaccine.
Rash at the injection site approximately the size of a tennis ball appearing on day 4.  Red and slightly raised.  Slight itching has started on day 5 with the rash slightly spreading.
pt devel hard red knot @ inj site the evening of vax;hives started around the bandaid area & spread down arm to wrist;mom called ER & was told to give DPH;hives last approx 24hr;mom denies allergy to bandaid;