chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has not received the 2nd vaccine (First dose received on 05FEB21); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not received the 2nd vaccine (First dose received on 05FEB21)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not received the 2nd vaccine (First dose received on 05FEB21)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not received the 2nd vaccine (First dose received on 05FEB21)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
1505: RN x 2 responded to vehicle 2 to pt c/o increase in HR  pulse checked and is 82, Denies SOB or any other sx. Monitored in lot X 15 minutes. at above average HR. Feeling better left at lot @ 1520 in no acute distress. Spoke to pt by phone @ 1626. Is home and doing well. No further complaints
her right arm and her whole body was very painful; right shoulder injury; her whole body was very painful; neurological head pain; allergy; muscle twitching all over her body for the whole day; nausea; loss appetite/ no appetite; sick; dizziness; fatigue; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had experienced severe events right after her first dose which included nausea, loss appetite/ no appetite, sick, dizziness, and fatigue. The patient then mentioned that the next morning after the first dose (on 12Mar2021), she experienced muscle twitching all over her body for the whole day. A couple of days later (unspecified date), her right arm and her whole body was very painful. The patient took lots of medication after her first dose of the vaccine for her right shoulder injury (unspecified date) and she added that she was taking antibiotics as well. The patient took the following medications after her first dose of the vaccine: ethambutol, erythromycin, rifabutin and Bactrim. The patient then stated that she took topiramate for neurological head pain, thyroid pill, birth control pill, muscle relaxant (unspeciifed) and omeprazole for allergy on an unspecified date. The outcome of the events was unknown.  Information on batch/lot number has been requested.
Flu shot provided. Grandmother comes in for an appointment the next day and states he had a rash all over his body that evening. It went away after she gave Benadryl but it returned the next morning.  Rash/hives noted to torso, arms, neck and face. No respiratory stress or throat swelling/irritation noted. Lungs CTA all lobes. Child does not appear to be in distress.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 17-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M000996, expiry date 07-JAN-2018, dose, strength, vaccination site, route unspecified). The vaccine was exposed to a temperature of 6.5 Fahrenheit (F) for 80 hours. Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received fro the same reporter. Additional information has been requested.
Severe splitting headache (starting in left temple and proceeding to encircle my head).  It felt like a vice tightening around my head.  This was followed by nausea and eventually lead to projectile vomiting for about an hour.  Extreme weakness.
The patient experienced 5/10 bilateral frontoparietal headache and nausea 4 days after receiving the vaccine. On the 7th day, CBC revealed low platelet count. The patient was subsequently admitted, vomiting and fever occurred during stay, platelet count monitored, given IV antibiotics. Symptoms resolved, platelet gradually went up, and the patient was discharged after 5 days.
This spontaneous report as received from an unspecified healthcare worker refers to a 12 year old patient (patient # 3819) of an unknown gender. No information on patient's medical history, concurrent conditions or concomitant medications was provided. On 03-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, Lot# L000610 with expiration date 31-JAN-2017, Current Procedural Terminology (CPT) 90651 (dose and route of administration were not provided). No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Employee reported onset of high fever up to 103 degrees, body aches, severe headache, chills and sweating. States as of this date (10/26/12) symptoms are slowly improving.  Was prescribed Tamiflu by his primary care provider.
Redness and swelling from left groin to the knee. Tx Keflex x 10 d. Warm compress with leg elevation.
Hospitalized with COVID 19, weakness , small PE of undetermined significance and ground glass opacities on CT chest Remdesivir x 5 days.  Pt had Pfizer 3rd dose 9/28/2021 lot number  FC3183
Red welt on back of left arm. Approximately 3 inches in diameter at ZOSTAVAX injection site.
A report has been received from a Health Professional concerning a 3 year old, female subject, who has been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 26-Oct-2013. The patient experienced FLU A which started on 14-Dec-2013. The outcome of the event of FLU A is unknown. The report was considered to be non-serious by the reporter.
07/24/2006 greater than 500 lesions, sever disease (Varicella) on 07/24/2006, secondary lesions infection, KEFLEX 1000 mg twice a day for 10 days by 08/03/2006 lesions gone.  Patient's father died of Varicella resulted in pneumonia (diagnosed approximately 07/25/2006).  On 07/15/2006 patient tested (+) strep throat, treated Amoxicillin 500 mg twice a day for 10 days.
No adverse event; Patient received booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y instead of the Bivalent Booster; Vial caps and labels for Monovalent and Bivalent look too similar; Vial caps and labels for Monovalent and Bivalent look too similar; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar), PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar), PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Patient received booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar).    Concomitant product use was not provided by the reporter.  Patient received 0.5ml of Monovalent Moderna COVID-19 vaccine 6M-5Y, instead of the Bivalent Booster.  Reporter was complaining that the vial caps and labels look too similar, and reporter was requesting that Moderna to do something about the vial similarities.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2022: Live follow up received included quality complaint number was added.
Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Apr2021 at 15:30 (at the age of 27-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Apr2021, the patient experienced tiredness. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event tiredness was recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Received influenza vaccine on 10/7/22.  No pain initially.  One week later approximately on 10/14/22 noticed that her left arm was sore.  Soreness increased throughout the weeks, and now is complaining of decreased range of motion- cannot raise arm higher than 90 degrees, also if crosses arm across body it shoots pain to her neck.  She cannot sleep on her left side as it causes pain in her left arm.
Vomiting, Swollen lips, rash with onset 6-8 hours after Varivax and Prevnar vaccines. Paramedics felt had allergic reaction, gave epinephrine with resolution of symptoms. Observed overnight at hospital with no recurrence of symptoms.
Rash at site of injection and L upper arm. Hydrocortisone cream for itch.
Baby was fussy, developed loose stools and had 1 diaper w/small amount if blood seen in it.
Patient had vivid dreams 12 hours after receiving second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 29 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty, for COVID-19 Immunization. The following information was reported: ABNORMAL DREAMS (non-serious), outcome "unknown", described as "Patient had vivid dreams 12 hours after receiving second dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
whole arm was swollen; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a patient of unknown demography who experienced whole arm was swollen (peripheral swelling), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history included Food allergy. The patient's past medical treatment(s), vaccination(s), concomitant medication(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 not reported via unknown route in unknown administration site.  On an unknown date, following the vaccination the patient experienced whole arm was swollen (peripheral swelling).  (Other relevant tests included no lab data.)  Final diagnosis was swelling arm.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown at the time of reporting.  Information on the batch number was requested.
Fever. Chills. Intense pains throughout body, including hip and a place in left hand where I have a pin from a precious ligament tear. Abdominal cramps.  Night sweats. Brain fog. Debilitating fatigue. Shallow breathing and chest tightness.
This spontaneous report was received from a Certified Medical Assistant referring to an unknown number of patients of unknown age and gender. Pertinent medical histories, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with incorrectly stored doses of RECOMBIVAX HB (Lot#L018501. Expiration date 22-JUN-2017). Dose, route and anatomical location were not provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
On 2/9/00, the pt presented to a pediatrician with a case of full blown chickenpox. Follow up states no additional information is expected.
low grade fever 29MAR95 up to 101 gradaully inc to 102.4 & swelling of lymph nodes began 30MAR95; 31MAR95 remains w/swelling, more lt side than rt temp 99-100; taking APAP PRN; has sore throat/difficulty swallowing;
PATIENT CALLED THE FOLLOWING DAY AFTER INJECTION AND COMPLAINED  OF TOTAL ARM  PAIN AND LIMITED RANGE OF MOTION. PATIENT FELT INJECTION WAS "TOO HIGH". SHE WAS ADVISED TO USE IBUPROFEN  OR TYLENOL. FOLLOW UP CALL PLACED TO PATIENT 3RD DAY AFTER INJECTION BUT WAS  UNABLE TO REACH PATIENT FOR OUTCOME
herpes zoster infection of the trigeminal ophthalmic branch 40 days after the second dose of bnt162b2. Smaller break out same 10 days after first shot; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 07Jun2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable physician (patient) from a Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscularly, administered in the right arm on 16Feb2021 at 12:00 (Batch/Lot number was not reported) as a single dose, and then dose 2 intramuscularly, administered in in the right arm on 09Mar2021 at 12:00 (Batch/Lot Number: EN6199) as a single dose for COVID-19 immunisation. There were no prior vaccinations. The patient's medical history included hyperimmune from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 26Feb2021 at 12:00, the patient experienced herpes zoster ophthalmic (medically significant); described as: herpes zoster infection of the trigeminal ophthalmic branch 40 days after the second dose of bnt162b2. Smaller break out same 10 days after first shot. The event required a visit to a physician office after the second instance of the herpes zoster. On 26Feb2021 at 12:00, the patient experienced herpes zoster ophthalmic which did not require treatment and was recovered with sequel on 10Apr2021 (as reported). On 17Apr2021 at 08:00, the patient had herpes zoster infection of the trigeminal ophthalmic branch 40 days after the second dose of bnt162b2. The clinical course was reported as follows: After the first dose, the patient who was hyperimmune, contacted Pfizer to ask if the second COVID vaccine dose should be delayed or reduced due to the "major reactions to the first dose." Upon follow-up information received on 07Jun2021, the patient reported: had a "herpes zoster infection of the trigeminal ophthalmic branch 40 days after the second dose of bnt162b2. Smaller break out same 10 days after first shot. Never experienced zoster before Pfizer vaccine. Second breakout required medication (antiviral) for two weeks." The patient did not undergo lab tests. Therapeutic measures were taken as a result of herpes zoster ophthalmic which included acyclovir for 14 days (for the 17Apr2021 instance). The clinical outcome of the event, herpes zoster ophthalmic, was recovered on 30Apr2021 (as reported).; Sender's Comments: Based on the information available and temporal relationship, a causal association between BNT162B2 and the reported herpes zoster ophthalmic cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Patient was a patient on hospice, had terminal dx of frontal lobe dementia.  NP visited with patient on 03/10/2021, notable decline/flank pain, fever 101.   Patient passed away on 03/12/21, Medical Director wanted this reported to VAERS d/t the vaccination was within 72hrs of the pts death.
CHILLS; SLIGHT FEVER; HEADACHE; EXHAUSTION; This spontaneous report received from a patient concerned a male 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On an unspecified date, the subject experienced chills, slight fever, headache, and exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, slight fever, headache, and exhaustion. This report was non-serious.
It was reported that a 44 year old male patient received a Fluzone SV vaccination Lot # UO694AA administered on 11/05/01. Twelve hours later reported the patient developed chills, shaking, aching and sweating. Patient did not return to office for further evaluation.
The pt experienced about 2-3 rash. The rash appeared more like hives than chickenpox. The pt subsequently recovered and the rash disappeared. No further information is available.
hypothermia; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (reported as 48, unknown unit) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced hypothermia after receiving the 1st dose of the COVD-19 vaccine last 15Jan2021. She wanted to check if there are reported cases for hypothermia, coldness of hands and feet and recorded body temperature was 95.7 F; all on an unknown date in Jan2021 and unknown outcome. The patient was advised that there was no information available about hypothermia after getting the 1st dose.  Information on Lot/Batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported hypothermia cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Started as severe head & neck pain. Diagnosed as subarachnoid hemorrhage. Onset of pain was instant. Spent 7 days in ICU
One day after my first dose, I started spotting despite not being due for my period for 2 weeks. I now have been bleeding for over a week and experiencing other period symptoms (cramps, fatigue, bloating, nausea).
Started feeling sick 5/18; sniffles, coughing, stomach hurting, headache and chills, checked temperature around 4 pm that day and temp was 100.5 started feeling better on 5/21 except then I started losing my voice, 5/22 I had a dry cough but couldn't really talk but could whisper, hurts to swallow to a certain point, 5/23 still dry cough, some very compacted mucus, no voice and hurts to whisper, hurt to swallow
Pt recvd vax & exp nausea & vomiting a few hrs later;
lost 3 pounds; chills; Sheets were soaking wet, she kept having to urinate; Kept having to urinate; Diarrhea; Getting very hot and cold; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose, lot number: EL9262, via an unspecified route of administration on 07Jan2021 at a single dose in the upper part of left arm for COVID-19 immunization. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1686, expiry Mar2021, on 07Jan2021, she had no reaction or anything. The patient had no medical history. The patient's concomitant medications were not reported. The patient was calling about the second shot, Pfizer asked if there were side effects on the second one, and there were, she can't say what went on yesterday, it was that bad. She was a volunteer at the hospital. She lost 3 pounds in the last few days from this. She was in no condition to talk to anyone yesterday, and in fact, she was getting hot now. Yesterday (26Jan2021) was the worst, she doesn't know how to describe, but her sheets were soaking wet, she kept having to urinate, and she's ashamed, she almost couldn't make it to the bathroom, her aide said to not be ashamed, and she had a lot of diarrhea. It was around 2am she noted her sheets were soaking wet, and it started going away at 5AM. She was still having effects from the shot: she was still getting very hot and cold. Getting very hot and cold started 12:00PM Monday (25Jan2021) night. Getting hot and cold was like the chills. She has 27 chronic illnesses but doesn't think they have anything to do with the shot. She was grateful she got the shot and hopes everyone at Pfizer was able to get the shot. The outcome of the event 'sheets were soaking wet, she kept having to urinate' was recovered on 27Jan2021, diarrhea and getting very hot and cold was recovering, lost 3 pounds and chills was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Pt recvd 3 doses of Engerix-B vax 3DEC90, 4JAN91, & 3JUN91 & 10DEC91 titer was checked & found to be neg; pt recvd 1 booster;