chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to an  unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with an unspecified number of improperly stored doses of ROTATEQ oral solution, lot # K020182 with expiration date 25-JUN-2016 and lot # K007246 with expiration date 17-MAR-2016 (doses were not reported). No information on patients concomitant medication was provided. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient received vaccine at approximately 10:50 AM. She proceeded to the observation area where she began to feel light-headed. On-site EMS from was summoned. EMS placed the woman on their gurney and began assessment (vitals and EKG). A copy of the PCR has been requested, but may not be available.
pt recvd DTP/OPV on 11FEB92 & 13FEB devel a rash from DTP inject site to knee; rash was raised, red, itching w/welts the size of a nickel/quarter; required office visit 13FEB; tx included DPH & pediaprofen; recovered; 15FEB welts re-appear
Persistent unbearable nauea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Persistent unbearable nauea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Persistent unbearable nauea). At the time of the report, NAUSEA (Persistent unbearable nauea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.   no concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
rt arm red, swollen, painful from inj site to top of shoulder down to elbow;no fever; started augmentin & swelling gradually dec;
Client called 11-22-2021 and stated that after receiving the injection and left the clinic started having some redness on her face with swelling in her face and neck.  She had a headache the next day and fever and chills for about 48 hours.  She felt better over the weekend and then at 3 am this morning she had vomiting and diarrhea.  She also stated that she has multiple cold sores in her mouth.
Administered expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 15-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 15-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD21-054673, MOD21-054574, MOD21-054744, MOD21-054746, MOD21-054749, MOD21-054751 (E2B Linked Report).; Sender's Comments:  MOD21-054673: MOD21-054574: MOD21-054744: MOD21-054746: MOD21-054749: MOD21-054751:
evening of immun devel urticarial rash all over body; taken to ER given DPH; was given grape flavored APAP afternoon of immun; p/ER visit had 2 additional episodes w/urticaria p/doses of grape APAP;
A raised rash was verbally diagnosed as urticaria by 2 pediatricians. No fever, the rash "moved" around his body, from 6/16/05 through 6/20/05. Unsatisfactory doctors visit with son pediatrician, on 6/16/05. She claimed that it was not caused by the vaccines injected on 5/19/05. Doctors visit at the same clinic on 6/17/05. Urticaria confirmed and Benadryl prescribed to ease the discomfort caused by the rash. The rash totally disappeared on 6/21/05 - 6/22/05.
w/in 4hr post vax pt exp shock waves every 5 minutes;now they occur every 5-10sec;pt hasn't slept for days;if there is no stimulation then pt is fine;can't even watch a TV now;described as adrenaline like kick, like when frightened but not
Extreme inflammatory response.  In ER/hospitalized 5 days post vaccine; Had Angiogram, found clot in Obtuse Marginal; This is a spontaneous report from a contactable consumer (patient).  A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 21Mar2021 12:00 (Lot Number: EN6207), age at vaccination of 54-years-old, as single dose for covid-19 immunisation. Medical history included cardiac failure from an unknown date and unknown if ongoing, connective tissue disorder from an unknown date and unknown if ongoing. Patient was not pregnant. Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) taken for an unspecified indication, start and stop date were not reported; isosorbide mononitrate (IMDUR) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; furosemide (FUROSEMIDE) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced hypersensitivity.   The patient experienced extreme inflammatory reaction on 24Mar2021 at 04:00 AM and clot blood on 24Mar2021; events were serious as resulted in Emergency room/department or urgent care, hospitalization (for 5 days), life threatening illness (immediate risk of death from the event). The patient had extreme inflammatory response; in ER/hospitalized 5 days post vaccine. Angiogram was performed and clot in obtuse marginal was found; unable to remove clot, surgeon was able to break it apart and balloon the vessel open. It was unknown if patient had COVID prior vaccination. Patient had no other vaccine in four weeks. Sars-cov-2 test was negative on 15Apr2021. The patient was considered to be recovering from the events.
Hard lump at inj site redness, painful to touch. Itching & swelling. Gave BENADRYL & told pt to call doctor.
Information has been received from a physician concerning a patient who on unspecified date was vaccinated with the dose of ZOSTAVAX (Merck) (LOT# not reported). On unspecified date, the patient experienced shingles. The physician did not report the patient's outcome at this time. It was unspecified if the patient sought medical attention. The physician stated that he did not consider the adverse experiences but considered them part of the 48% of patients who could potentially got shingles after receiving ZOSTAVAX (Merck). He said that no vaccine was 100% and that at least the cases of shingles that patients got after ZOSTAVAX (Merck) were milder. The physician reported that he could only remember one patient's name (had captured in WAES # 1009USA01617), stating that the patient for this report and other patient (WAES # 1008USA03480) were not his patients but were patient's of other people in the practice. Follow-up information has been received on 14-SEP-2010 from the physician who on 07-SEP-2010 reported that the occurrence of this episode of shingles occurred 1.5 to 3 years after ZOSTAVAX (Merck) vaccination so the physician did not consider this to be reportable adverse event. Follow-up inconsistently information has been received from the physician who stated that the patient had no adverse reaction. This is one of several reports from same source. No further information is available.
Cranky and crying per mother early AM on 7/25/03.  Motrin administered at 5:00 AM and 11:00AM.  Temp did reach 102.  Seizuer activity noted by parents on 7/25 soon after administering dose of Motrin at 11:00.  Seizure activity consisted of body jerking and vocalizing.  Seizure lasted approx. 4 min.  Child does have a hx of a febrile seizure as an infant. Child remained febrile and "cranky" for several days.  Had been exposed to an apparent viral illness in the community with GI sx & fever. This child developed no GI sx. Sibling also had seizure activity following his vaccine the same day.  His seizure took place 7/23.  He received same vaccines with addition of PCV7. He did have diarrheal illness prior to vaccine. Mother thought was d/t teething.  He also developed fever of 101 prior to seizure activity.
On day of initial vaccine, left arm ached especially on the underside. Numb sensation and swelling down to my finger tips and in my shoulder - reducing arm mobility and difficulty getting wedding ring off.   Since this initial dose, left arm periodically aches on the underside and arm / fingers swell with some aches down to fingers. At times, ache wakes me up at night. Left breast / underarm pit area sometimes aches at those same times.   I'll discuss more with my primary doctor during my Nov 18 physical.   2nd vaccine - in right arm - very minor response initially and do not have the symptoms I have from the first vaccine.
MENVEO ADMINISTERED 60 DAYS AFTER 1ST DOSE. THIS IS AN INVALID DOSE.
Patient started to feel nauseous and sat down in a chair. Shortly after sitting down he briefly lost consciousness (<5 min) and had minor jerking movements in his hands. He was sweating profusely and was pale and clammy. Upon arrival of paramedics his BP and glucose were normal. He was transported to the hospital for evaluation.
pt recv vax 12SEP90 & about 30 to 40min p/vax pt reportedly exp h/a, malaise, leg cramping where couldn't walk for half a day;rt arm still has a small boil @ the site of inj; short term/long term memory loss also present;
STOMACH VIRUS; FATIGUE/TIRED; ACHY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced achy. On 13-MAR-2021, the subject experienced stomach virus. On 13-MAR-2021, the subject experienced fatigue/tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy on 12-MAR-2021, and had not recovered from fatigue/tired, and stomach virus. This report was non-serious.
This spontaneous report as received from a registered nurse via a company representative refers to a 57 year old female patient. On 08-AUG-2013 the patient was vaccinated with ZOSTAVAX, (dose, lot number and expiration date not reported) intramuscular for vaccination. There was no concomitant medication reported. The nurse reported that the patient was inadvertently administered ZOSTAVAX intramuscularly on 08-AUG-2013. The patient developed localized itching immediately after receiving the vaccine. The itching lasted a few days (exact length of time unspecified). The patient sought for medical attention and spoke to the nurse. No treatment was given for the event. The localized itching recovered on an unknown date in 2013. Additional information has been requested.
Pfizer 12/23/20 and 1/13. Postiive on 11/30
soreness at injection site; pain in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 28Mar2021 10:30 (Lot number: ER8733) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Grapefuit allergy" (unspecified if ongoing); "chalazion" (unspecified if ongoing), notes: being treated with antibiotics (oral, ointment and eye drops). Concomitant medication(s) included: CEPHALEXIN [CEFALEXIN] taken for hordeolum; DOXYCYCLIN [DOXYCYCLINE] taken for hordeolum.  The following information was reported: INJECTION SITE PAIN (non-serious), outcome "unknown", described as "soreness at injection site"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in arm".  Additional information: The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient had not been tested post-vaccination. The patient had no medication allergy.   No follow-up attempts are possible. No further information is expected.
Rash-like symptoms on the chest and back. Discoloration similar to sunburn with no sun exposure. Texture of skin across breast and back have crepe appearance and has not changed since initial onset.
Migraine headaches; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Aug2021 17:45 (Lot number: FC3181) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hidradenitis suppurativa" (unspecified if ongoing), notes: Hidradenitis suppurativa; "PCOS" (unspecified if ongoing), notes: PCOS; "known allergies  Penicillin" (unspecified if ongoing), notes: known allergies  Penicillin. Concomitant medication(s) included: RIFAMPIN; CLINDAMYCIN; SPIRONOLACTONE. Past drug history included: Bactrim for Drug allergy. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, Lot number=FA7484, lot unknown=False, administration date=26Jul2021, administration time=05:45 PM, dose number=1, vaccine location=Left arm), administration date: 26Jul2021, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 20Aug2021, outcome "not recovered", described as "Migraine headaches". The event "migraine headaches" was evaluated at the emergency room visit. Therapeutic measures were not taken as a result of migraine.  Additional information: No other vaccine in four weeks. The patient started receiving continual Migraine headaches on the left side of her head. This had been going on a week after the last shot, and it had been continuing on a everyday bases. She had to go to the emergency to check her head and make sure nothing was wrong with her. She had a migraine as she typed this to you, so it had been going on for a month now. No covid prior vaccination. The patient had not tested covid post vaccination.   No follow-up attempts are possible. No further information is expected. Follow-up attempts are completed.
swelled up; had a knot, was red; had a knot, was red; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history included auto-immune disease and psoriatic arthritis. Concomitant medications included guselkumab (TREMFYA). Patient stated that with the first shot that she had a delayed reaction to her right arm and it did not pop up until week later. Stated that it swelled up, had a knot, was red and then went away. There was no product complaint to report. There was request for medical information. Patient wanted to know if this is from the vaccine or if she should go to doctor. Wanted to know if others had reported it. The outcome for the event was recovered.  Information about lot/batch number has been requested.
This spontaneous report as received from a nurse refers to a 4 month old patient of an unknown gender. On 09-FEB-2015, the patient was vaccinated with improperly stored ROTATEQ (lot # K007247 and expiry date: 17-MAR-2016 or lot # K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
73 y.o. female with a history of breast cancer, stroke, and hyperlipidemia who received her second dose of the Pfizer COVID-19 vaccine at an outside clinic. Within 10 minutes of receiving the vaccine she developed new numbness and swelling in her tongue, along with numbness in her extremities. She was given 0.3 mg epinephrine per protocol and was then advised to be seen in the emergency department. Her symptoms resolved once she arrived at the emergency department. She was observed for a period of two hours without worsening symptoms and was then discharged. presented to the ED following pfizer vaccine ingestion. received epinephrine IM prehospital for report of tongue swelling and and numbness at the time. She was improved at the time of presentation to the ED. Observed for several hours and discharged home without recrudescent sx. Although cannot find objective evidence of tongue swelling, administration of epi prehospital with report of improvement of symptoms is suggestive that this was a true anaphylactic reaction to the vaccine.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N026073, expiration date 20-SEP-2019 for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003063: US-009507513-1804USA003064: US-009507513-1804USA003065: US-009507513-1804USA002453: US-009507513-1804USA003067: US-009507513-1804USA003068: US-009507513-1804USA003069: US-009507513-1804USA003070: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA003074: US-009507513-1804USA003075: US-009507513-1804USA003062.
Rebound Covid; Rebound Covid; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Lot number: ELO140), on 26Jan2021 as dose 2, single (Lot number: EL3249) and on 17Aug2021 as dose 3 (booster), single (Lot number: FC3180) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Other medical history: HTN, RA, Hyperlipidemia; "Rheumatoid arthritis" (unspecified if ongoing), notes: Other medical history: HTN, RA, Hyperlipidemia; "Hyperlipidemia" (unspecified if ongoing), notes: Other medical history: HTN, RA, Hyperlipidemia. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17May2022, outcome "unknown" and all described as "Rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) positive; (25May2022) negative; (31May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had taken antiviral COVID 19 Treatment of paxlovid from 18May2022 to 23May2022. Patient had no known allergies.
Initial report received from a health care professional (medical assistant) on 23 Jun 2010: This patient was vaccinated with only the diluent portion of MENVEO (batch number: 090901), (dose: 0.5 ml) intramuscularly on 07 Jun 2010. The lyophilized portion was not reconstituted. The patient had not yet received additional dosing with MENVEO. No adverse event was reported following this administration.
Had influenza vaccine. Seen by MD for left outer arm 7 x 7cm erythema with warmth at site and 5 papules. Pt states, "received injection same arm", left deltoid area. Seen by MD 10/24/03.
On 12/08/2022, Patient called the pharmacy around 3:30 p.m, I had administered a Fluzone HD to her around 1:55 p.m. She asked about common side effects of the vaccine. Patient stated that during her drive home, she began feeling as if she were drunk or stoned. She stated that she felt off and mentally slow. She stated she felt unsteady and that she had difficulty making her drive home. She stated that her vision is off, that the lights are not as they should be. She stated that her taste and smell and the lights around her are exaggerated. She stated that her brain is not computing correctly. I told her that these are not frequent side effects of the Fluzone vaccine, but that they can occur. I asked if anyone was with her and encouraged her to seek medical attention. I told her that she needs to be seen by a doctor. She stated she did not want to be a bother. Over the course of the phone conversation and her answers to my probing questions, she seemed to be deteriorating, and I encouraged her to get to medical care. I told her that her symptoms seem severe enough to be seen by a doctor immediately. She stated she would call emergency services. Toward the end of the call, she asked who I was. She asked who she was speaking with and stated that she seemed to have forgotten who she called. I identified myself, the pharmacist. She decided she would call emergency services. I told her I was going to hang up the phone so she could call emergency services.