chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SEVERE MIGRANE HEADACHE; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP7534) on an unknown date in Mar2021 at 07:30 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient was not aware of any known allergies to medications, food or other products. The patient had no concomitant medications received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6199) on an unknown date in Mar2021 at 08:00 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 06:00, the patient experienced severe migraine headache 3 days in a row after receiving the second dose of vaccine and the patient remained in bed in the dark room for 3 days. Treatment was not taken as a result of migraine headache. The clinical outcome of the event migraine headache was not recovered.   No follow-up attempts possible. No further information expected.
Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022; Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2022 at 4:49 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Feb-2022 at 4:49 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.  Vaccine went into 2-8 C thaw state on or about 24-Dec-2021. On 09-Feb-2022 at 04:49:01 PM, the patient took booster dose.  No treatment information was reported.
severe body aches, hot and cold, stiffness,  headaches, severe shortness of breath.
Received flu shot 11-22-10 & applied ice immediately because of previous reactions. (L) upper arm became hot, red & swollen within several hrs, painful arm & headache; examined 11-24-10. (L) upper arm warm with 2 cm x 3 cm induration; using ice & ibuprofen 1200 mg q d.
Patient reports symptoms occurred within 24 hours of receiving the vaccine. She noticed when she woke up the next day that she had small blisters across her nose. Once they popped open, the blisters felt like lumps or knots. The blisters then popped into open sores. She has been applying Neosporin topically to her nose once every other day. Today she has purchased Eucerin ointment and will be applying it to her nose topically to prevent it from drying.
NEUROLOGICAL ISSUES: Hands not working properly, hand weakness, left foot tingling/foot weakness, internal vibrations. OTHER ISSUES: Joint pain in wrists, ankles, lower back, hands, elbows, shoulder.
Onset within 15 minutes with generalized erythema with wheals, involving about 50% of surface area. No respiratory distress.
syncope instance; getting close to passing out; Dizzy; Pain; pain in the shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of syncope in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 9277N, expiry date 27th June 2021) for prophylaxis.   The patient's past medical history included shoulder operation (previously had a shoulder surgery).   On 14th March 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th March 2019, 1 hr after receiving Shingrix, the patient experienced syncope (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), dizziness, pain localized and shoulder pain. On an unknown date, the outcome of the syncope, passed out, dizziness, pain localized and shoulder pain were unknown.   It was unknown if the reporter considered the syncope, passed out, dizziness, pain localized and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the same arm where she had previously had shoulder surgery and had ended up with pretty bad side effect and was taken to emergency room. About an hour or two after receiving Shingrix, the patient experienced very dizzy and had a syncope instance and got close to passing out.  She also had a lot of pain in the area and an extreme pain in the shoulder.  In the emergency room she got X-rays and everything was normal. It was reported that nothing was noted while administering the vaccine.  The emergency room visit did not feel it was related to the vaccine itself, but the pharmacy decided not to administer the second dose of Shingrix and referred her to the physician.
Fever; Couldn't eat; Nauseous; Arm swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), DECREASED APPETITE (Couldn't eat), NAUSEA (Nauseous) and PERIPHERAL SWELLING (Arm swelled up) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), DECREASED APPETITE (Couldn't eat), NAUSEA (Nauseous) and PERIPHERAL SWELLING (Arm swelled up). At the time of the report, PYREXIA (Fever), DECREASED APPETITE (Couldn't eat), NAUSEA (Nauseous) and PERIPHERAL SWELLING (Arm swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Rash, shortness of breath, weakness, tingling of hands and feet, light headed, increased heart rate, extreme fatigue.
Felt great after the vaccine. Eight days after vaccine I woke up with a sore right arm.  Thought something had bitten me, but then realized was my injection site.  Continued to get bigger and redder as day went on.  No pain but the itching was terrible.  After 3rd or 4th day, it subsided. Now a few days after that, I am feeling like I have a bad cold and am lethargic.  (Could this be from a vaccine I got 2 weeks ago, on March 20?)
Pt developed pruritic, erythematous macular patches on both legs 01/08/2002, 5 days after vaccination. Otherwise, feels well. Treated with PO Benadryl.
Pt's arm was red and she wanted to know what to do. RPh on duty, saw it and suggested she go to dr to get a steroid shot. Pt went to MD office.
Mother describes hives as generalized over entire body approx. 5 hours, post vax. She gave Benadryl at that time. Mom denies that child had then or since, any symptoms of distress.
pt recvd vax 18AUG93 & broke out in rash/whelps over entire body; 20AUG93 went to ER 22AUG93; treated w/DPH which relieved some; rash & itching cont again w/DPH;
swollen lips, no difficulty breathing, no airway compromise, resolved with benadryl 1/30  Narrative:
First at 12:30 AM was extremely swollen upper arm at injection site with extreme pain and itching at site. Went to bed. When I woke up at about 6AM my whole body hurt terribly at every joint. Felt like I had been hit by a bus. I took Tylenol and went back to sleep. When I got up later, everything still hurt terribly and continued for most of the day until evening, when it started subsiding. Third day was much better - except I still have pain in left thumb joint and right heel of hand. (P.S. In the past since the 80's I have had Herpes cold sores once every few years (rarely)  - but since I had Covid in December 2019 and/or the vaccines, I have had 8 outbreaks, one after another; I have one now.)
Pt was waiting 30 minutes due to history of anaphylaxis.  Started to feel "muscle tightness" in the back of her neck. She was immediately brought to an observation bed where she began to shake uncontrollably and complain of abdominal pain. Airway was patent. Pt developed hives on face, neck, and chest.  EMS was initiated and Pt was given epinephrine 0.3 mg. An IV was started and diphenhydramine 50 mg IV given. Hives began to dissipate 3 minutes after Epi and diphenhydramine. Pt was handed off to EMS and transported to closest Emergency Department.
102.7 Fever, felt completely freezing, significant body aches, so tired it was hard to open my eyes.  Took Tylenol Extra Strength and put ice on forhead  Hour later fever came down to 101.7  Body kept switching between sweating and freezing entire night  24 hours later at 7:30AM the next day, i was still very tired, sweating, but fever was gone.  48 hours later - i'm still a bit foggy and have a light cough
Started coughing, signficant nasal congestion, then 15 minutes later scratching at scalp, hives on arms and chest, redness at site of injection.
This spontaneous case was reported by a health care professional and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and FEELING HOT (felt warm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and FEELING HOT (felt warm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat) and FEELING HOT (felt warm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No relevant concomitant medications were reported. The patient visited her daughter the weekend before the second vaccination and found out on Friday 07May2021 the day after vaccination that her daughter was positive for COVID-19. This case was linked to MOD21-089454, US-MODERNATX, INC.-MOD-2021-123426, MOD21-089473 (E2B Linked Report).; Sender's Comments: MOD21-089454: US-MODERNATX, INC.-MOD-2021-123426:Mother. MOD21-089473:
Case number PHEH2014US024302, is an initial spontaneous report received from a nurse on 02 Dec 2014 and with a follow-up from a nurse received on 21 Jan 2015. This report refers to a 45 year old female patient. Past medical history and concomitant medication were not reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar2015) left deltoid intramuscularly at a dose of 0.5 ml on 05 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow-up from a nurse received on 21 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe). On 01-Dec-2021, PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant informations were reported.No treatment informations were reported.
had a case of break-through covid, confirmed today via rapid test at home.; had a case of break-through covid, confirmed today via rapid test at home.; fever up to 100 degrees; running nose; exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old male patient received bnt162b2 (BNT162B2), administration date 26Nov2021 (Batch/Lot number: unknown) at the age of 8 years as dose 2 (tris), single and administration date 05Nov2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jan2022, outcome "not recovered" and all described as "had a case of break-through covid, confirmed today via rapid test at home."; PYREXIA (medically significant) with onset 07Jan2022, outcome "not recovered", described as "fever up to 100 degrees"; RHINORRHOEA (medically significant) with onset 07Jan2022, outcome "not recovered", described as "running nose"; FATIGUE (medically significant) with onset 07Jan2022, outcome "not recovered", described as "exhaustion". The events "had a case of break-through covid, confirmed today via rapid test at home.", "had a case of break-through covid, confirmed today via rapid test at home.", "fever up to 100 degrees", "running nose" and "exhaustion" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (07Jan2022) upto 100 degree; sars-cov-2 test: (07Jan2022) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, pyrexia, rhinorrhoea, fatigue. Consumer reported that, the patient received any other vaccines within 4 weeks prior to the COVID vaccine and patient received any other medications within 2 weeks of vaccination was unknown. Consumer stated that, the patient did not diagnosed with COVID-19 prior to vaccination and patient had been tested for COVID-19, since the vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
I started with a sore throat and I took Tylenol  and water and I was on a river cruise. Came back on 19 or 20 Sep22. That evening, we did a self test and was positive.  The next morning I did a PCR test and I was positive .The sore throat went away  I was sneezing, coughing and dripping. I called my doctor and was told to quarantine. I would have not got to the doctor as it felt like a normal cold, Friday on 23Sep22 at 4pm afternoon, I had a terrible pain in the stomach. I did not throw up and had saliva and finally went I threw up the pain remained for a while. The doctor asked me to use Prilosec . I did not any temperature.
Upon the delivery of Pfizer gray cap vaccine on 2/15/2022, pharmacy has kept the vaccine in the freezer (average temperature at -23.9 C) for 3 days before the administration. There were no adverse reactions reported after the administration. Pfizer has provided temperature excursion data to determine that the vaccine was still viable.
patient was given two doses of Shingrix one month apart - (16Jun2023 and 17Jul2023); This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 22M3K, expiry date 04-AUG-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 17-JUL-2023, the patient received the 2nd dose of Shingrix. On 17-JUL-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: patient was given two doses of Shingrix one month apart - (16Jun2023 and 17Jul2023)). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2023 The reporter reported that a patient was given two doses of Shingrix one month apart. The patient was not Immunocompromised per healthcare professional. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Severe back, muscle, body pains, low grade fever, feeling cold, progressed to headache, green black phlegm coming from nose and lungs.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOXIA 10/13/2022,  10/29/2022,  12/8/2022 -- RECURRENCE OF SAME SYMPTOMS
COVID+, s/p mRNA vaccine x 1 on 9/1/21; hospitalized for resp distress.
Information has been received from a Registered Nurse (R.N.) concerning a 20 year old female patient who on 16-FEB-2007 was vaccinated IM in the deltoid muscle with a dose of Gardasil vaccine (yeast), lot # 655617/1447F. The patient recently noted a small lump in her deltoid muscle at the injection site, also described as a bump in her arm at injection site. Unspecified medical attention was sought. The patient was recovering as of the report day. Additional information has been requested.
12/18/2021  I began having Shingles. Went PCP 3 days later. Prescribed medication. I did not have no new outbreaks after that.  The ones I already had ,remained.  it took at least a month, gradually, for all to disappear. Spoke with my dermatologist, Dr on February 8, 2021.  Because of the work she has been doing to keep track of adverse events, she was interested.
Pt recvd 3 doses of Hep B vax on 8JUL92, 13AUG92, 8JAN92 & pt lost 60lbs; lab eval on 13MAR92 showed no detectable Hep B surface antibody; on 26MAR92 & 28MAY92 recvd 4th & 5th dose of vax; lab eval on 23OCT92 was neg for Hep B surface antib
Cellulitis at injection site, vomiting, diarrhea, fever, chills, migraine
PATIENT RECEIVED 2ND PFIZER VACCINE, WHILE WAITING IN THE VACCINATION AREA, ABOUT 10 MINUTES AFTER THE VACCINE, HE STARTED TO FEEL DIZZY AND SWEATING PROFUSELY. PATIENT WAS ALSO COMPLAINING ABOUT STOMACH CRAMPS. HE SAT ON THE FLOOR FROM THE CHAIR AND RESTED HIS HEAD ON THE CHAIR, WHEN I ASKED HIM IF HE WANTS US TO CALL EMERGENCY SERVICES; HE REPLIED YES. HE WAS THEN TAKEN TO THE HOSPITAL FOR FURTHER EVALUATION
one hour of chills and violent shaking, followed 2 hours later by about 50 minutes of sweating
about 3 minutes after the shot she had a sharp pain to her left arm down to her fingertips, and when she clenched her fingertips to move them it went away in about 10 seconds; low grade fever; her temperature was raised by one degree, it is normally one degree below normal, and it was one degree higher; This is a spontaneous report from a contactable consumer (patient) via medical information team.   A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6200), via an unspecified route of administration, administered in arm left on 24Feb2021 at 13.30 (age at vaccination was 76 years) as dose 1 single for covid-19 immunisation at clinic. The patient's medical history and concomitant medications were not reported. Historical vaccine included second vaccination for shingles over two months ago, but she thought that was far enough away. No further details provided about her shingles vaccinations. The patient reported that she had not had any other recent vaccinations or started any new medications. On 24Feb2021, the patient experienced about 3 minutes after the shot she had a sharp pain to her left arm down to her fingertips, and when she clenched her fingertips to move them it went away in about 10 seconds. On an unspecified date in Feb2021, (exactly one week later after vaccination) the patient experienced low grade fever and her temperature was raised by one degree, it was normally one degree below normal and it was one degree higher. The patient stated that she had her first shot and she had a minor reaction at the time, then exactly one week later she had a low grade fever on and off for the next week. She had the low grade fever for 2 days, then it was gone for 2 days, and then it came back again. The patient asked if it was possible that would be from the shot a whole week later. Her temperature was raised by one degree, it was normally one degree below normal, and it was one degree higher, which she had two for days then it went away for two days after she took Tylenol. She said that it came back yesterday. She clarified that she took Acetaminophen and not Tylenol ES, she took one in the daytime and two at night. Caller said that there was no barcode on the bottle it must have been on an outer package that was discarded. Lot: 9DE31078. She just realized that it expired in Jan2021. The patient reported that the other reaction she had seemed strange; about 3 minutes after the shot she had a sharp pain to her left arm down to her fingertips, and when she clenched her fingertips to move them it went away in about 10 seconds. The patient received treatment for temperature was raised by one degree. The patient underwent lab test and procedure included body temperature: raised by one degree then one degree below normal and again raise on unspecified date in Feb2021. The outcome of the event sharp pain to her left arm down to her fingertips was recovered on 24Feb2021 and outcome of other events was unknown.  No follow up attempts were possible. No further information was expected.
Patient was given  pediatric dose of Hep A by medical assistant. Patient didn't report any symptoms or reaction from receiving the dose of Hep A.
One week following second dose, I experienced a urticarial reaction to a meal. I have never had allergies prior to this type of reaction. Upon allergy testing after this event on 2/19/21, an allergy to shrimp was noted. This report is intended to document a brand new food allergy that occurred one week after receiving second dose of COVID vaccine. Treated with one tablet of Benadryl and reaction subsided thereafter.
Urticaria on left side of face and neck; mild. No action taken. Self-limited.  - started 7-10 minutes after vaccine - resolved within 2 hours
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and Lot# not reported). The reporter stated that the patient experienced an "adverse event" with ZOSTAVAX. The outcome was not reported. Additional information has been requested.