chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received first dose of Pfizer Covid vaccine on 11/22, and has had persistent complaints since then. She felt fatigue and headache the next day, and had a fever. Since that time, she has felt like her stomach is "squeezing" off and on throughout the day. Feels like "constriction." No nausea/vomiting. Also stating that legs are sore - everywhere on her legs except her anterior lower legs. Able to walk ok, but soreness comes and goes during the day. Having headaches on and off as well since then, which is unusual for her. She then had a fever about two weeks after vaccination, which resolved in one day. At time of last evaluation, about 4 weeks since vaccination, has had persistent lower leg myalgias and fatigue. Headaches and abdominal pain have improved.
Started with minor site pain and muscle ache. By evening, heart rate increased substantially and fever began. Spent next two days sleeping, sweating and aching. Had severe (and alarming) genital swelling after one day, lasting 12 hours.
Mid day, day after vaccine: fatigue.Entire week following the second day: Foggy brain, minor headache, felt like a head cold, tired.; Very mild Headache/minor headache; Entire week following the second day: Foggy brain, minor headache, felt like a head cold, tired.; Entire week following the second day: Foggy brain, minor headache, felt like a head cold, tired.; This is a spontaneous report from a contactable physician. A 66-years-old non-pregnant adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot Number: EL9264) via an unspecified route of administration, administered in Right Arm on 23Feb2021 at 12:00(at the age of 66years) as 2nd Dose, Single Dose for COVID-19 immunization.The patient's medical history included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Right Arm on 02Feb2021 at 12:00 as 1st Dose, Single Dose for COVID-19 immunization, Known allergies: Sulfa drugs (mouth ulcers).The patient had taken Estradiol patch, Levothyroxine 112mcg, Calcium sup within in two weeks of vaccination. The patient did not take any other vaccine within 4 weeks of vaccination. On 24Feb2021 at 12:00,the patient experienced fatigue, very mild headache/minor headache, feeling abnormal, head cold. No Treatment was received for the events. The outcome for the events was recovered/resolved.
PATIENT WAS FEELING DIZZY ,SO i AND MY TECHNICIAN HELPED HER TO LIE DOWN ON THE FLOOR. WE GAVE HER WATER AND GAVE HER ICE PACK. SHE WAS TALKING TO US AND WITH IN 5-7 MINUTES ,SHE WAS COMPLETELY OKAY , SHE WAKS OUT OUR CLINICAL ROOM AND SET ON CHAIR. WE OBSERVE HER FOR ANOTHER 30 MINUTES , SHE WAS FINE AND I ALSO CALLED HER AFTER 6 HOURS ,SHE WAS FINE . SHE MENTIONED THAT SAME SITUATION HAPPENED IN PAST WHEN SHE HAD TATTOO DONE.
11MAY91 poss seizure seen by MD; 18MAY91 poss sz x 5; resp arrest, admitted to Hosp, EEG, CT scan, full neurological workup-neg; 23MAY91 d/c on sz meds & ATB for URI;
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter stated that, they had a group of 13 pharmacies and administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware that in some of the freezers there was a temperature excursion that their data logs showed. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials had been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised. Moderna date ordered was found to be 01-Nov-2021 and 15-Nov The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021. No treatment medication was provided.
Pt reported that they developed a rash, throat swelling/closure after the first dose.  Pt was presenting for second dose on 6/22. Unknown time course for development/resolution of reaction. Pt also has an allergy to Peanut butter flavor (SOB) and Egg (rash)
Several hours after I got the COVID-19 vaccine I got a sore throat; next day started getting sinus headaches with congestion, next I  started feeling it in my chest; Still having what feels like a constant sinus infection with headache and ear aches; My Tinnitus has become a lot worse;  Got so severe that I contacted my Doctor and was prescribed an Albuterol Inhaler; Amoxicillin; Benzonatate; Codeine with Guaifenesin; Took a Home COVID-19 test, negative.
second dose is past 36 day mark; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second dose is past 36 day mark) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-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 (second dose is past 36 day mark). At the time of the report, PRODUCT DOSE OMISSION ISSUE (second dose is past 36 day mark) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.
get redness five inches beyond the injection site with swelling; felt discomfort at the injection site; flu like symptoms; red; tingling; uncomfortable; area hurt / she felt pain during the injection; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 21st September 2021) for prophylaxis.   On 23rd September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd September 2019, less than a day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site discomfort, influenza-like symptoms, erythema of extremities, tingling, discomfort and injection site pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the extensive swelling of vaccinated limb was unknown and the outcome of the injection site discomfort, influenza-like symptoms, erythema of extremities, tingling, discomfort and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site discomfort, influenza-like symptoms, erythema of extremities, tingling, discomfort and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. After vaccination with dose of Shingrix, the patient experienced discomfort at the injection site and flu like symptoms, and on Monday afternoon, the arm was swelling, red and felt tingling and described it as an uncomfortable reaction. The patient stated that, did not experienced pain during injection with 1st dose, but felt pain with 2nd dose of Shingrix and it was uncomfortable. As the area hurt, the patient took Tylenol as an treatment medication. On 25th September 2019, the patient got redness five inches beyond the injection site with swelling and discomfort again. The reporter consented to follow up.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756498A, A075600 - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (FLUA320 and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and FLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Gave our Patient a Dose of Heplisav-B Which Expired; Initial report received on 30-Oct-2023.  A pharmacist reported that a 59 year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine had expired.  No relevant medical history was reported. No known drug allergies were reported.    No relevant concomitant medications were reported.    On 27-Oct-2023, the patient received a dose of HEPLISAV-B (Lot #937228, expiration date 30-Aug-2023, and NDC # 43578000301) intramuscularly in the right deltoid.   On 27-Oct-2023, the patient was vaccinated with HEPLISAV-B which expired on 30-Aug-2023. The patient did not report any side effects.  No additional information was reported.   Company Comment:  The company considers the event as non-serious.; Sender's Comments: The company considers the event as non-serious.
Itchiness at injection site; delayed red patch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (delayed red patch at injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PANTOPRAZOLE and ATORVASTATIN for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (delayed red patch at injection site). On 03-Mar-2021, VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (delayed red patch at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided by the reporter.   This case was linked to MOD-2021-053051 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Initial additional TCR - patient said all events resolved, no more phone calls and doesn't want to provide email id.
Little nausea; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore) and NAUSEA (Little nausea) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm sore). On 03-Feb-2021, the patient experienced NAUSEA (Little nausea). At the time of the report, PAIN IN EXTREMITY (Arm sore) and NAUSEA (Little nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not provided by the reporter. Treatment details was not reported by the reporter.
Severe ongoing chest pain for weeks, still have chest pain to date not as severe pain all the time, Pericarditis. Thought I had a heart attakcFirst hospital visit 6/13/21 had chest x ray, ultra sounds, blood work, ct scan. Have had probably 10 EKG ?s all abnormal since then during many dr visits. Still have chest pain
Pt recvd 3rd dose of Engerix-B vax & it was determined that pt did not seroconvert; 4th dose of Engerix-B was administered;
Swollen & painful arm Facial swelling  Joint and muscle pain/weakness  Exhaustion  Fever Shortness of breath  Headache  Nausea  Confusion  Feeling more depressed
Caller also received 2nd dose and no side effects other than sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Caller also received 2nd dose and no side effects other than sore arm) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Caller also received 2nd dose and no side effects other than sore arm). At the time of the report, VACCINATION SITE PAIN (Caller also received 2nd dose and no side effects other than sore arm) outcome was unknown.            No concomitant products were reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-041170 (Patient Link).
Severe pain in all my joints starting two to three weeks after the second vaccination and continuing to get worse. Also headaches and disorientation at times
2am onset (12/30/20)  fever to 103, chills, aches. Severe Headache. All symptoms lasted until 8am on 12/31/20 when all symptoms went away except for fatigue that lasted for the next 24 hours.
Patient arrived to  vaccine clinic for her 1st Pfizer vaccine.  She received her vaccine at 1606.  She was then walked out to the waiting room to wait her 15-20 minutes that is strongly recommended after receiving the vaccine.  Approximately 5 minutes later, she alerted the reception staff that she was having some sort of reaction.  I was then notified immediately and patient was brought back to a private exam area.  Patient complained of chest tightness, numbness in fingers and a racing heartbeat.  She also felt that she was having difficulty breathing.  Vital signs at that time were 96.3 temperature, RR 36, blood pressure 170/100 and a heart rate of 174.  Patient received (1) epipen  and 911 was simultaneously notified.   2 liters of oxygen via nasal cannula were applied.  Shortly after epipen was given and oxygen applied, patients heartrate decreased into the 130s.  Oxygen remained stable at 99-100% on 2 liters nasal cannula.  Ice pack applied to base of neck for comfort.  EMS arrived and report given as patient will be taken to the emergency department for further evaluation.
He had slight fever and chills, diarrhea, muscle weakness, arrhythmia asserted itself. Home health nurse came out and checked on him and put him on bed rest.
20JUN04 cranky & irritable; 22JUN94 t102, fine red rash upper torso; 24JUN94 temp WNL appears to be feeling better per mom;
Dizziness, Headache, Myalgia, Fever, CoughWheeze, 1/5-chills, sinus drainage; 1/7/21-102.5 temp, nausea; 1/12/21-injection site red, raised warm Narrative:  Employee rec'd flu vaccine Flurarix ot# 5332L by Glasko Smith Kline from outside source on 12/2/20. Tested positive for COVID-19 on 1/6/2021.
Sore arm in evening. Next day early in AM shaking and chills and pain, headache, fever 101.6, fatigue ; PM loose bowel movement and vomit (1x)
Non-Responder to 9 Doses of a Previous Hepatitis B Vaccine Responded to Heplisav Series; Initial Report Received on 08-Nov-2021  Heplisav-B in prior hepatitis B vaccine nonresponders: a case series. Military Medicine.  24 September 2021.  In a case series by (2021), patients with documentation of 6 doses of a standard hepatitis B vaccine, received 2 doses of Heplisav-B, and results of post-vaccination tests were collected from existing health records within the system.    Patient ID 1 received an initial hepatitis B series at 20-year-old and a second hepatitis B series at 24-year-old.   A total of 9 doses of the standard hepatitis B vaccine were administered. The patient was considered a non-responder.  At 28-year-old, the patient received the initial dose of Heplisav-B.   The patient completed the Heplisav-B series (details not specified).   On an unspecified date, at least 1 month after completing the Heplisav-B series, the hepatitis B surface antibody was positive.   No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Covid19 breakthrough.  1st vaccine received on 04/27/2021.  60 y/o with PMHx of prostate CA with bone mets, AAA, HTN, GERD, Depression, Chronic pain, CAD, PTCA with stents x2, HLD, Type 2 DM presents to ED from oncologist's office with c/o Hypotension.  Room air sats 89%, CXR-increased hazy alveolar density edema or infection.  Initial Covid test negative on admission 2/3/2022.  During stay pt with increasing SOB and productive cough, tested again on 2/7/2022 and test now positive.  Pt currently on IV ABx and steroids, now to be started on Remdesivir.
Vasovagal Syncope  Patient was monitored and provided support so that he does not fall down. Patient was layed down slowly on the floor so that he does not fall. His breathing was monitored constantly. He came back to conciousness within few seconds. He had a orientation within few minutes. He was provided glucose cracker and water.  He mentioned that he did not have any reaction during the first dose. He was monitored for 45 minutes. He was constatnly being monitored. His alterness was being checked by talking to him.
Followed up with patient 3 days post-vaccination and patient reports feeling fine and experiencing no side effects.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of improperly stored ZOSTAVAX, 19400 plaque forming units injection, lot # M038350 with expiration date on 06-DEC-2017 (also reported as unknown) (dose, route and site of administration were not reported), reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT), lot # M044950 with expiration date on 30-MAY-2019. The vaccine experienced temperature excursion of 6-14 degrees Fahrenheit for 1 hour and 15 minutes. Previous excursion of 6-14 degrees Fahrenheit for 1 hour was also reported. Digital data logger was used to record the excursion. No adverse effects were reported. There was no product quality complaint involved in this case. Additional information has been requested.
Right axillary and cervical gland swollen and painful.  Low grade fever.  Infected wound around small pox innoculation site.
Arm pain (especially after 2nd dose); This non-serious case was reported by a physician via sales rep and described the occurrence of pain in arm in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Arm pain (especially after 2nd dose)). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-APR-2023 The doctor reported that the patients that he had vaccinated with Shingrix had arm pain especially after the second dose of Shingrix. The reporter did not agree to follow up from GlaxoSmithKline.
Patient was administered improperly diluted covid vaccination without adverse event at the time. Plan to revaccinate.
HD influenza vaccination was administered to the patient after patient received an influenza vaccination four months prior at another pharmacy.
Patient received 1st dose of the Moderna covid-19 vaccine on 4-6-21. Patient unable to get 2nd shot with the 4-6 week time frame due to overseas travel. Patient received 2nd dose of Moderna covid-19 vaccine on day 60. Patient denies any adverse events from 1st dose.
chills, body aches, tired, headache,  sore arm, swollen, red,
Heart Racing/ elevated heart rate- several times a day. History of panic/anxiety attacks, but feels completely fine, so the heart rate is concerning.