chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hard to sleep; right arm sore; left side near his ribs started hurting; pain returned and it started to radiate from his left arm into his neck down his shoulder on the inside near his spine following the muscle; stiff neck; pain returned and it started to radiate from his left arm into his neck down his shoulder on the; injection site hurt; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck), NECK PAIN (pain returned and it started to radiate from his left arm into his neck down his shoulder on the), INSOMNIA (hard to sleep), PAIN IN EXTREMITY (right arm sore) and MUSCULOSKELETAL CHEST PAIN (left side near his ribs started hurting) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044a21a and 032b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection site hurt). On 17-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck) and NECK PAIN (pain returned and it started to radiate from his left arm into his neck down his shoulder on the). On 19-Mar-2021, the patient experienced ARTHRALGIA (pain returned and it started to radiate from his left arm into his neck down his shoulder on the inside near his spine following the muscle). On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (right arm sore) and MUSCULOSKELETAL CHEST PAIN (left side near his ribs started hurting). On an unknown date, the patient experienced INSOMNIA (hard to sleep). On 17-Mar-2021, VACCINATION SITE PAIN (injection site hurt) had resolved. On 19-Mar-2021, MUSCULOSKELETAL STIFFNESS (stiff neck) had resolved. At the time of the report, NECK PAIN (pain returned and it started to radiate from his left arm into his neck down his shoulder on the), PAIN IN EXTREMITY (right arm sore) and ARTHRALGIA (pain returned and it started to radiate from his left arm into his neck down his shoulder on the inside near his spine following the muscle) had resolved and INSOMNIA (hard to sleep) and MUSCULOSKELETAL CHEST PAIN (left side near his ribs started hurting) outcome was unknown.
Client present to drive thru flu clinic for annual flu vaccine and Pfizer bivalent booster.  After vaccinations administered it was found that client was given Pfizer primary series dose instead of bivalent.  Client notified of error and given instruction to return in 2 months for correct Pfizer bivalent booster.  Client verbalized understanding and denies side effects at this time.
It was reported that a 13 year old female patient received a Typhim VI vaccination on 02/26/01.Reportedly 48 hours after vaccination, the patient developed a migraine headache and lose of vision in one eye for 20 minutes. These symptoms repeated again in 24 hours. Further information is requested.
Information has been received from a medical assistant referring to a patient of unknown age and gender. On 10-JUN-2016 the patient was vaccinated with improperly stored GARDASIL (lot # M014929, expiration date 27-MAY-2017, dose was not reported) intramuscularly. The lowest storage temperature of the vaccine was 29.3 Fahrenheit and the cumulative excursion time was 136 hours. Data logger had been involved. No adverse effects were reported. This is one of several reports received from same source. Additional information has been requested.
My arm was hurting a lot. The pain lasted two days. I also had a high fever that lasted one day. I took Tylenol and the fever went away.
Patient was admitted from ED due to 1 day history of shortness of breath and altered mental status. Pt was intubated upon arrival to ED and later admitted to ICU. Pt had a hx of COPD, CKD3, hypertension, obesity, and was a former smoker. Pt was admitted to Hospital on 08/06/2021 and expired on 08/19/2021. Patient was fully vaccinated.
COULD NOT RAISE ARM; SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (COULD NOT RAISE ARM) and PAIN IN EXTREMITY (SORE ARM) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Ulcerative colitis.    No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced JOINT RANGE OF MOTION DECREASED (COULD NOT RAISE ARM) and PAIN IN EXTREMITY (SORE ARM). At the time of the report, JOINT RANGE OF MOTION DECREASED (COULD NOT RAISE ARM) and PAIN IN EXTREMITY (SORE ARM) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Enzyme level test: Enzyme level abnormal and Enzyme level resolved.         Concomitant medication was not reported.  On an unknown date, patient experienced enzymes level was abnormal. On an unknown date, enzymes level was resolved. Patient had sore arm and was not able to raise the arm. Treatment details were unknown.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
101.4° fever for 24 hours then 100.8° Fever for 24 hours. muscle pain arms and legs for 5 days fatigue and lethargy for 7 days.  Treatment rest and  fluids.
Fever (up to 100.4), severly painful arm where injection was given, pain up into L side of neck.
Temperature began rising with no other symptoms. Appropriate dose of Tylenol was administered at 5:00 pm. By 11 pm temperature rose to 105.9 axillary Tylenol was administered by 11:45 pm patient began to seize. Her eyes rolled back in her head and her limbs began to violently jerk it lasted for approximately one minute.
arm  pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm  pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm  pain). At the time of the report, PAIN IN EXTREMITY (arm  pain) had not resolved.            No concomitant medications were provided by the reporter.  Treatment information was not provided.
Pt. stated she felt nauseous 10 Minutes after getting vaccinated.  She also stated she suffers from migraines and when she is about to get a migraine she feels nauseous.  She stated she has her migraine medication at work and she will take it as soon as she gets there.  At 9:30am she stated she feels better.  At 9:33am pt. stated she was ready to go.
Patient received immunizations on 08/21/02.  She started to have reaction on leg DTaP given. Pt had redness, warm to the touch on left leg, app. 8 cm in size, Pt. was given 10 days course of Keflex- reaction vs cellulitis, symptoms resolved
Got vaccines on 2/28/2006. Right leg started to get red and swollen on 3/1/06. On 3/2/06 mom states leg edema was increased and redness spreading also seems to be painful when touched.
Case number PHEH2014US005623 is an initial spontaneous report received from a health care professional on 18 Mar 2014 and with a follow up information received on 11 Apr 2014. This case was initially reported as a multiple patient case, but upon follow up receipt the identifiers were reported. This case refers to 12 year old male child patient. His medical history and concomitant medications were not reported. He received meningococcal polyvalent vaccine (unknown manufacturer, batch number: not reported), influenza vaccine (unknown manufacturer, batch number: not reported), hepatitis A vaccine (unknown manufacturer, batch number: not reported) and HPV vaccine (unknown manufacturer, batch number: not reported) on unknown dates. He was vaccinated with first dose of MENVEO (batch number: M12100) intramuscularly in right deltoid on 06 Mar 2014 at 8:30. It was reported that MENVEO had been stored below the recommended temperature at 1.9 degrees Celsius approximately for two hours (vaccine not frozen or not reconstituted). No adverse event was reported following this administration error. The patient was called for revaccination. Follow up information from the other health care professional on 11 Apr 2014: Reporter type, reporter information, patient identifiers, vaccination history, vaccination date and time, anatomical site of vaccination, temperature of storage of vaccine was updated.
Got a blood clot that went to his brain and died; This is a spontaneous report from a contactable consumer (patient's friend) based on information received by Pfizer, on behalf of Moderna (Case: MOD21-136450). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 2, single for COVID-19 immunization. Medical history included Hashimoto's disease. The patient's concomitant medications were none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. On an unspecified date, the patient got a blood clot that went to his brain and had died on an unspecified date after 16-18 days of being fully vaccinated. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Got a blood clot that went to his brain and died
Fell asleep on stairs then unable to talk - started with severe stammering and stuttering which has not resolved. Physician notified. Now in speech therapy twice a week.
I got a faint positive result on a rapid test, but a PCR test the next day came back a few days later as negative so it was a false positive
pt recvd vax 14AUG95 & subsequently had fever 12hrs & sore arm 2-3 days; prev vax records unavailable but hx indicates that pt had more than one vax;
Pneumococcal polysaccharide vaccine administered in left arm on 10-21-10 about 11:15am. About 2 hours later arm started to hurt. Then I lost all range of motion and called the nurse who said to take ibuprofen, notify someone that I was having a reaction to a vaccine, and be seen if arm got hot. Slept little that night and by noon of 10-22-10 my arm was red from shoulder to elbow. I called the doctors office and was told to go to convenient care. By this time I had some fever and periodic sweating (esp. at night). The convenient care doctor suspected an allergic reaction to something in the vaccine but was concerned about cellulitis. Dr. prescribed cephalexin 500mg cap. for three days. by 10-25-10 my symptoms were gone.
Information has been received from the mother concerning her 15 year old daughter with no previous medical history or any known drug allergies, who in approximately November 2007, was vaccinated IM with a 0.5 ml first dose of Gardasil.  There was no concomitant medication.  The day after the vaccination, the patient experienced generalised rash.  Unknown medical attention was sought.  After 3 weeks of vaccination the patient recovered from generalised rash.  The mother decided to discontinue the dosing schedule.  No product quality complaint was involved.  Additional information has been requested. Information and follow up information has been received froma mother and the physician concerning her 15 year old daighter who had right shoulder pain at the time of the vaccination, who on 05-DEC-2007, was vaccinated IM in the left arm with 0.5 ml first dose of HPV vaccine (lot # 657868/05230). On 05-DEC-2007 the patient developed a full body rash from head to toe, papular rash which was mildly pruritic. The rash lasted at least 9 days. The patient recovered from a papular rash on 15-DEC-2007. The patient was seen in the office on 15-DEC-2007 and started oral steroids. Antihistamines did not improve the symptoms. The mother decided to discontinue the dosing schedule. No product quality complaint was involved.
Pt received vaccines x4 on 01/29/04.  Swelling, redness noted on 01/30/04 night.  No form.  Pt was seen on 01/31/104 with left deltoid 9x9cm area induration left upper injection site, no fluctuence or discharges but (+) erythema and mildly tender.
Injection site soreness; low-grade fever (100-101); headache; fatigue; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP6955 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 25Mar2021 10:30 (at the age of 62-years-old) at dose 2, single for covid-19 immunization. Medical history included known allergies to CT scan dye. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY); calcium citrate; ergocalciferol (VIT D); ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER +50). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 03Mar2021 12:45 (at the age of 62-years-old) at dose 1, single for covid-19 immunization. The most recent vaccine was administered at Workplace clinic. The patient experienced injection site soreness, low grade fever, headache and fatigue on 25Mar2021. No treatment was given for the events. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021240148 Same patient and drug, different event separated in time, similar events
About an hour after  vaccine administration, I experienced nausea/lightheadedness that persisted throughout the morning. I also had a terrible headache with sensitivity to light/sound that did not go away until I woke up this morning.    My nightgown and sheets were soaked with sweat as well.   Today I am exhausted with very little energy.   The shot itself did not hurt at all.  The injection site this morning is only minorly tender.
Narrative:  Patient reported body aches, extreme fatigue and weakness, brain fog, and nausea after receiving his first COVID-19 vaccine. Symptoms resolved after approximately 8 days.
Newly onset Type 1 diabetes; This is a spontaneous report received from a contactable Consumer. The reporter is the patient.  A 24 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 (Lot number: EP6955) as dose 1, single and administered in arm right, administration date 13Apr2021 (Lot number: EW0150) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: ALLEGRA. Past drug history included: Cedax, reaction(s): "Known allergies: Cedax"; Augmentin, reaction(s): "Known allergies: augmentin". The following information was reported: TYPE 1 DIABETES MELLITUS (disability, life threatening) with onset 2021, outcome "not recovered", described as "Newly onset Type 1 diabetes". The event "newly onset type 1 diabetes" was evaluated at the physician office visit. Therapeutic measures were taken as a result of type 1 diabetes mellitus with Daily T1D treatment. Clinical course: event resulted in life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient had not covid prior vaccination. The patient was tested for covid post vaccination.
Is overdue for her 2nd SHINGRIX vaccine; This case was reported by a consumer via other manufacturer and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 20-SEP-2022 Reporter's comment: The patient self-reported this case. The patient was overdue for her 2nd Shingrix vaccine. The patient had declined for providing her address or physician demographics. No additional information was provided. The reporter had denied to provide further contact details. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
She received the vaccine, had a terrible migraine and laid in the bed for 2 days.  Had a fever, felt like she had the flu about 24 hours after she received the vaccine.  These symptoms went away and around the 3rd day was fine.   Then a week after that she developed shingles on her left butt cheek.  It started off as a shingles red rash, and now has lesions that she has to go to a wound clinic.  She developed a fever, and now has nerve pain due to the singles.  It is only on the side that she received the vaccine on, the left side.   She did a telemed appointment on 2/24/21, no 2/25/21 went to a respiratory clinic as they were concerned about COVID.  She then went back to the dr. last week as the lesion on her buttock is not healing, and now being referred to hospital to go to the wound clinic.
Severe vertigo and pressure/pain in the head, often debilitating leading to difficulty in walking, concentrating and performing daily activities including work-related
8-12-10 Tdap (BOOSTRIX) administered then information received from previous provider that on 5-5-06 Tdap (ADACEL) was administered. 8/17/10 spoke to mother - no adverse reaction reported.
Sore arm; Shoulder pain a little bit; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6200), via an unspecified route of administration, in left arm on 18Feb2021 (at the age of 72-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. Historical vaccine included flu shots, shingles vaccine, pneumonia vaccine and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9262), via an unspecified route of administration, in left arm on 28Jan2021 as dose 1, single for COVID-19 immunization after which the patient experienced painful arm, shoulder pain, vaccination site pain and incorrect product administration duration. The patient experienced sore arm on 18Feb2021 and shoulder pain a little bit in Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. The outcome of event sore arm was 18Feb2021 and event shoulder pain a little bit was recovered in Feb2021.   No follow-up attempts needed. No further information is expected.
Narrative:  Product storage and handling error lead to expired produce being administered to 31 patients. Expired vaccine that was administered 8/19/2021 was transferred from -70 freezer to -20 freezer on June, 30, 2021 according to Pharmacy Supervisor. With the manufacturer 14 day expiration in the -20 freezer, vaccine would have expired on 7/13/2021. Vaccine was removed from -20 freezer and placed in refrigerator to be prepared for administration. The administration happened after 14 day shelf-life from -20 freezer had expired. Storage requirements from -70C to -20C freezer are different, including different shelf-life based on labelled expiration dates. Affected individuals information is being pulled. This information will be reported when available. There were 31 patients affected in this product handling and administration error. LLT Code 10063973 EXPIRED VACCINE USED PT Code 10074902 EXPIRED PRODUCT ADMINISTEREDL LLT Code 10079843 PRODUCT STORAGE ERROR PT Code 10079843 PRODUCT STORAGE ERROR
immediate after this vaccination for COVID-19 prevention, pt. developed lightheaded and dizziness she says.  on questioning if BP was checked, she said BP was not checked.   Denies ever getting lightheaded or dizziness with other types of vaccinations or immunizations so probable not vasovagal.   Headaches she also reported arm aching at this vaccination site.  initially said in 1/2 hour later she says 2 hours.  She looked at the vaccination site on her arm for first time 8 hours after this vaccination.  Found redness and blisters first time   treated with diphenhydramine 5 mg. barely move arm next day.  swelling arm lasted 2 days. photos of arm vaccination site she sent were reviewed. had video visit with Family Medicine Physician and later with video visit with Allergy Physician
Typical reactions at first (sore arm and fatigue for 2 says) Day 3 developed an itchy throat.   Which continued and became a cough   Due to my immune history, I spoke to my pharmacist  on day 5 and determined taking additional allergy medication to reduce my reaction was the best course of action.  Medication reduced the itchy throat but Cough continued for 2 additional days.  I got a covid test just to be safe. It was negative.     All symptoms were gone approx 13-14 days following injection.
Began with thunderclap migraine (patient has no history of headaches), abdominal pain, extremely high blood pressure. ER ordered CT scans of head, neck, chest and abdomen, labwork and ekg. All normal. Treated with migraine cocktail. Sent home, blood pressure still very high. Returned to ER on 10/4 with another migraine and extremely high blood pressure. Treated with another migraine cocktail. Returned to ER on 10/8 with spontaneous, hand-sized, very dark bruise in spleen area. Ordered another CT scan and referred to neurologist. Between 9/29 and 10/20, patient experienced burning on chest area, issues with memory, speech, balance, vision, brain fog, fatigue. Symptoms disappeared over last 3 weeks.