chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu like symptoms; severe headache; Had similar but not quite as severe reaction to dose 2; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 49-year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 14Feb2021 16:50 (Lot number: EL8982) as dose 2, single for covid-19 immunisation. Relevant medical history included: "PCOS", start date: 1986 (ongoing), notes: History of PCOS; "Penicillin Allergy" (unspecified if ongoing), notes: PCN allergy. Concomitant medication(s) included: ESTRADIOL taken for menopause, start date: 12Sep2021 (ongoing); PROGESTERON taken for menopause, start date: 12Sep2021 (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Time 7:00 PM, Site and Route of injection: Anatomical site of injection: Left Deltoid, Route of Administration: Intramuscular, Batch/Lot number: EL3249,), administration date: 27Jan2021, for COVID-19 Immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Flu like symptoms"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "severe headache"; ADVERSE EVENT (non-serious) with onset 2021, outcome "recovered" (2021), described as "Had similar but not quite as severe reaction to dose 2". Therapeutic measures were taken as a result of influenza like illness, headache.  No follow-up attempts are possible. No further information is expected.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: PATIENT RECEIVED HER FIRST DOSE OF MODERNA TODAY ON 8/8/2021 AND AFTER 5 MINUTES HAD A RASH/ITCHING SO PHARMACIST TOLD HER TO WAIT FOR 30 MINUTES AND GAVE HER BENADRYL. PATIENT FELT BETTER AND DECIDED TO LEAVE. PATIENT CALLED PHARMACY BACK AND STATED AFTER 90 MINUTES LEAVING THE PHARMACY THAT SHE FELT A TIGHTNESS IN HER CHEST AND DIFFICULTY BREATHING. SHE WENT TO URGENT CARE LIKE THE PHARMACIST TOLD HER TO IF NEEDED. THE URGENT CARE GAVE HER A DOSE OF EPIPEN AND SHORTLY AFTER SHE LEFT.
The spontaneous information was received from a physician regarding 22 patients of unknown age and unkonwn gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 05-MAY-2014 was vaccinated with PROQUAD (Merck) lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F), (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
achy; joint ache; injection site soreness; Chilling; low grade fever of 99.4F; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (achy), ARTHRALGIA (joint ache), INJECTION SITE PAIN (injection site soreness), CHILLS (Chilling) and PYREXIA (low grade fever of 99.4F) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 immunisation.     The patient's past medical history included Arthritis. Concomitant products included DICLOFENAC from 27-Jan-2021 to 27-Jan-2021 for Arthritis.   On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN (achy), ARTHRALGIA (joint ache), INJECTION SITE PAIN (injection site soreness), CHILLS (Chilling) and PYREXIA (low grade fever of 99.4F). At the time of the report, PAIN (achy), ARTHRALGIA (joint ache), INJECTION SITE PAIN (injection site soreness), CHILLS (Chilling) and PYREXIA (low grade fever of 99.4F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Body temperature: 99.4 f (abnormal) The patient had a low grade fever..     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 treatment medications were reported.
immed area of inj site was hot & swollen;the next day;7/12/99 feverish, stomach-cramped & became very fatigued;knot in arm is still there;
Pt presented to clinic for a pediatric well child check where he received Menactra, Bexsero, & Moderna from nursing staff. Pt then presented to Pharmacy 4 weeks later where he received the second Moderna vaccine. Pt reported experiencing no significant side effects with first dose of COVID vaccine. Adverse events unknown at this time.
Bright red rash appeared on over 50% of back on the evening of the day of vaccination, and gradually darkened over the following days.  Patient also reported feeling hot/sweating over time.
About 4 P.M.  I started swelling in my lips, tongue and throat area. Went to hospital for care.
no medical records on this patient; COD:  acute drug toxicity complicating COVID 19; PCR post-mortem COVID test showed "probable"; ME reviewed autopsy report and considered COVID death; if had not had COVID, the pt likely would not have died
within an hour of receiving the vaccine I became so fatigued I could not stay awake. I slept for six hours. My arm hurts both at the injection site and radiates down my arm as well. Within 12 hours I am experiencing body aches, chills, a fever, headache, and nausea-induced vomiting.
Pt awoke during night around 2AM needing to go to bathroom. Legs were paralyzed, because could not move pt wet the bed. Tried to roll to edge of bed but could not get up. In the morning could move fine and had achy bones and generalized aches which went away by dinner time. Advised to inform Primary Care Physician.
Patient came to the vaccination site to receive a dose of the Jynneos vaccine. The dose was administered at 16:50 on his left arm. Nurse administered the dose without checking vaccination history, resulting in giving an additional dose (second dose) before the recommended time frame. Based on the system, first dose was given on 7/17/22. Patient was observed for 30 minutes post-vaccination before leaving, no reaction or adverse reaction reported on site.
Mom noticed his legs changing color about 1500 today, she states that his lower legs were purple and the underneath tips of toes were purple, along with swelling, the discoloration lasted about 1 hour and resolved.  Now he has a rash to his upper and lower legs.
Left arm and shoulder very sore, swollen, difficult to move arm or shoulder. Site reddened, swollen raised, warm to touch for several days.  4/28/09 Received hospital medical records of 3/24-3/27/2009. FINAL DX: sigmoid diverticulitis; LUE cellulitis & dermatitis secondary to Pneumovax. REcords reveal patient experienced cramping abdominal pain.  Surgery & interventional radiology consults done.  Tx w/IV antibiotics, improved & d/c to home on continued oral antibiotics.
Pt received flu vaccine on 1/11/18. On 1/12/18 pt (L) arm became red swollen warm to touch at the vaccine site (L) delt. Pt came in to office on 1/13/18 and given AUGMENTIN. Pt returned to office today for a flu appt. Pt s/sx have greatly improved.
when she sneezed she then became dizzy; developed a headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (when she sneezed she then became dizzy) and HEADACHE (developed a headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included Sinus disorder NOS. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), SPIRONOLACTONE, DULOXETINE HYDROCHLORIDE (CYMBALTA) and CARVEDILOL for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (developed a headache). On 16-Mar-2021, the patient experienced DIZZINESS (when she sneezed she then became dizzy). On 16-Mar-2021, HEADACHE (developed a headache) had resolved. At the time of the report, DIZZINESS (when she sneezed she then became dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Case number PHEH2015US026892, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 24 year female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 13 Oct 2015 which was stored out of recommended temperature range (temperature excursion at 34 degrees). Reporter did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. Reporter checked the temperature before she left for the day, and when she arrived the next day and the temperature was fine. It was a new refrigerator, and there have not been any problems since the temperature excursion. No further information provided. No adverse event was reported following this medication errors.  Follow up information received from Nurse on 26 Jan 2016: Added reporter comment.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  No treatment medications were provided.  First dose vaccine administered after 1 day from first puncture of vial and second dose administered after 3 days from first puncture of vial.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received contains no new information
The patient has a history of dementia. She was seen int he ED on 7/20/23 for evaluation of altered mental status. The patient's memory care facility reported the patient has not been able to communicate or answer questions appropriately. In the ED, the patient was found to have O2 sats at 90% on room air, so was placed on supplemental O2 via nasal cannula. A COVID PCR test done in the ED result positive. Ultimately, the patient was admitted 7/20/23 - 7/24/23. On admission, she was febrile with a temperature of 102.3. As she was on supplemental oxygen, she was started on IV Decadron. Her O2 improved and she was able to be weaned to room air prior to discharge. Discharge diagnoses included SIRS due to viral COVID-19 infection and sepsis due to acute E.coli UTI, among other diagnoses. Of note, the patient has received the primary COVID vaccine series and two boosters.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On an unknown date, the patients were vaccinated orally with doses of ROTATEQ (lot # K006457, expiry date 03-SEP-2016; strength, dose, frequency were not reported), which were exposed to temperature outside of the recommended range. There were no concomitant therapies reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
pt called clinic & stated had a red, itchy rash on forehead & cheeks;this turned into hives on upper chest;c/o arthralgias & malaise;denied SOB & tachycardia; recommended DPH;
Had shot and Dr, missed it/suspected vaccination failure; Shingles; pain in left arm; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included chest pain (for past 10 years). Family history included shingles (patient's wife got shingles a couple of months later on her face and immediately got on an antiviral and left with one spot on her lip but no pain).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shot and Dr, missed it/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain in arm (Verbatim: pain in left arm). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was reported by a patient's wife via interactive digital media. The reported that the patient received Shingles vaccine. The patient still having pain in his left arm. The reporter stated that at that time the physician missed the shingles so the patient did not received an antiviral. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore shoulder) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 021B21A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS), ATORVASTATIN CALCIUM (LIPITOR), CALCIUM and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (sore shoulder). At the time of the report, ARTHRALGIA (sore shoulder) outcome was unknown.            No Treatment information was reported.   This case was linked to MOD-2021-074969, MOD-2021-074969 (Patient Link).
soreness in arm at injection site; headache; forehead feels a little warm; a little of the fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received bnt162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: EW0150, Expiration Date: 31Jul2021) at the age of 63 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "gastro issue" (unspecified if ongoing), notes: Her gastro issue was not effected by the vaccinations.; "Migraines" (unspecified if ongoing), notes: Her migraines were not effected by the vaccinations.; "Fibromyalgia" (unspecified if ongoing), notes: She has fibromyalgia and it was not effected by the vaccinations.; "Dry eyes" (unspecified if ongoing), notes: Her dry eyes were not effected.; "Tonsil" (ongoing), notes: She still has tonsil and appendix; "Appendix" (ongoing), notes: She still has tonsil and appendix. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "a little of the fatigue"; FEELING HOT (non-serious) with onset Apr2021, 1 day after the suspect product(s) administration, outcome "unknown", described as "forehead feels a little warm"; HEADACHE (non-serious) with onset Apr2021, outcome "unknown"; VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "soreness in arm at injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain.  Additional information: Caller reported that she was experiencing "soreness on her arm at the injection site, has a little bit of a headache, and her forehead feels a little warm, however the rest of her body doesn't feel warm." Caller stated all the covid vaccines that she has received have been from Pfizer in which she "believes her reactions are normal and thought she experienced them with the prior administrations. She believes she experienced the same things with the previous ones. She has had a total of 5 vaccinations during Covid period and all were Pfizer. Prior to 05Apr2021 when she got first vaccination she had never got flu shot and never got the flu. She still has tonsil and appendix.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 04-MAY-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M039067 with expiration date of 18-APR-2018; strength and dose were unknown; location was also reported as "2", dose number was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse sated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014144:
My face went numb but wasn't like a full numbness it was kind of like having numbing shots and a few hours later I could feel it but not fully. I did go to my PCP they looked at me and basically told me to let them know if it was still bad the next day. It did clear up within 24 hours.
Drenching night sweat on April 4 and then happening every few nights and sometimes every night throughout April and May.  Also, starting early April, just feeling ill, aching all over, several nights of extreme anxiety which was not normal, extreme tiredness to the point (mid April) of almost going off the road driving.
Soon after vaccinations my son developed a raised rash over his body and head. We took him to the pediatrician who then dismissed this as ezcema however his skin was perfect prior to 2 month vaccinations. We eliminated any kind of allergen and he still maintained rash. Son was not taken back for anymore vaccines and skin has slowly cleared. I was told if it was ezcema he would likely have it throughout his childhood however it cleared as soon as we stopped his vaccine schedule. This was a raised rash all over his head and body.
Rash on the face and arm; Rash on the face and arm; swelling in the legs, feet, ankle and knees; Fever 103f; severe chills; A spontaneous report was received from a consumer (patient's mother) which concerns a 39 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced fever of 103f, severe chills, rash on the face and arm as well swelling in the legs, feet, ankle and knees.  The patient's medical history was not provided. No concomitant product use was reported.  On an unknown date ??-Jan-2021, the patient received first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.  On an unknown date on ??- Jan-2021, the next day after receiving the vaccine, the patient experienced a fever 103f and severe chills. The patient also experienced a rash on the face and arm as well swelling in the legs, feet, ankle and knees. The patient's chills and fever have lasted for 4 weeks. The patient had to visit 2 internists, an endocrinologist, and a rheumatologist. The patient experienced Kawasaki disease as a child and the reporter felt the symptoms were similar.   The patient was prescribed an antihistamine meloxicam to relieve her side effects.  Action taken with mRNA-1273 was unknown.  The outcome of all the events was unknown.  No further information was provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Intense body aches, fever, inability to move, constant throwing up, inability to keep down food or water, popped blood vessels in eyes, swollen face,  slurred speech and extreme dehydration
I received my 1st dose January 29,2021, Approximately February  20, 4:00 PM I started to notice a b!otchy rash.   On my lower thigh front of legs Above and below my  knees and on my elbows above and below and below both elbows. To very large blotches on each elbow, and Several Medium On my legs, Totally about 14.
8 hrs after receiving 3rd DTaP, Hib and pneumococcal vaccine the child developed fever of 102.6, irritability and increased sleepiness. He also developed mild cold symptoms not noticed at physical. lasted 72 hrs.
COVID-19 symptoms started on 01/01/2022, tested positive on 01/03/2022. I had a headache and was stopped up with runny nose and I didn't have any fever and that was it. The headache was gone after 1 day and I was still having a runny nose when I went to the Doctor. I didn't feel bad except for my head and chest stopped up and a minor cough. I felt like I had a head cold. I told my doctor if I wasn't retired I probably would've went to work. I stayed in the whole week until that went away.