chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At around 11:30 on June 21st or midnight on the 22nd, I noticed that my right elbow was itchy. The skin felt rough, so I thought it might be my eczema acting up. I woke up and noticed quite a few lumps on my arm near my elbow. I thought they might have been mosquito bites or spider bites. Then I noticed them spreading around my forearm and up near my right armpit. I was scratching constantly and upon examining them, I didn't notice any points of entry in the lumps. So, they weren't bites, but hives. I have had hives in the past from medications and an allergic reactions to an influenza strain, so I knew I should take Benadryl, cover it in Aquaphor 1% Hydrocortisone cream, ice it occasionally to relieve itching and NOT SCRATCH. It caused me to have frequent meltdowns. I thought it was the Strattera, but upon further research, a nurse and I think it might be COVID Arm. It only stayed on the arm I was injected in and a website we consulted said they could appear weeks after the shot. I also had a really itchy scalp, but we don't know what caused that. I still have some of the hives today (7/1/21) but they are fading and only itchy sometimes.
had titers done/the titers were negative/Rubella (German measles) - negative; Information has been received from a 33 years old female pharmacist, who is also the patient,  referring to herself. The patient had no drug reactions/allergies. Information about concurrent condition, concomitant medication and medical history was not provided.  On unspecified dates as a child, the patient received two doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, dose, route, lot# and expiration date were not reported) for prophylaxis. Other suspect therapy included sterile diluent (STERILE DILUENT) (strength, dose, route, lot# and expiration date were not reported) for prophylaxis.  The patient reported she was pregnant (pregnancy gestation 36 weeks) at the reporting time, and had titers done on an unknown date in May 2019 (reported as approximately one and a half months ago), and was told by her unspecified physician, that the titers were negative. Rubella (German measles) was negative and unsure of the remaining results for measles and mumps (Rubella antibody negative). The patient followed by physician to seek medical attention. No treatment was given. Date of LMP was 01-NOV-2018, due date was 08-AUG-2019, date of conception was 15-NOV-2018. The pregnancy outcome was outcome pending.  The outcome of the event was unknown (present status was also reported as "no problems", unspecified). The event was considered to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). The causality between the event and sterile diluent (STERILE DILUENT) was not reported.
tired; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 Immunization. The following information was reported: Fatigue(non-serious), outcome "unknown", described as "tired".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1st dose: 1/2/2021 2nd dose 2/1/2021  First hives seen 1/10/2021  Went to allergist (does not think it is related to vaccine) but wanted to submit just in case it is since I have never had chronic hives in the past  Currently taking 2 Allegra and 1 Pepcid in morning and 2 zyrtec, 1 singulair and 1 pepcid at night
Pt presented for 2nd dose in series. Vaccine was administered after confirming vaccine given for 1st dose. Overlooked pt age of 15.
Pt experienced dizziness post vaccination (BP 113/68; HR 99; RR 20). Encouraged water intake. Pt stable (BP 114/66; HR 89; RR 18), released from vaccination site
The doctor told the patient to wait for 4 weeks after the therapy before getting the 2nd dose.; A spontaneous report was received from a Pharmacist concerning, a patient of an unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced event The doctor told the patient to wait for 4 weeks after the therapy before getting the 2nd dose. / Inappropriate schedule of product administration.  The patient's medical history was not provided. Concomitant medication includes antibodies and steroid.  On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date, patient was due for the 2nd dose of the Moderna COVID 19 vaccine today started a medication therapy of antibodies and anti-steroid yesterday. The doctor told the patient to wait for 4 weeks after the therapy before getting the 2nd dose. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was Unknown.   The outcome of the event The doctor told the patient to wait for 4 weeks after the therapy before getting the 2nd dose was resolved on an unknown date, at the time of this report.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Unknown) with no associated AEs.
Information has been received from a doctor of pharmacy concerning a 15 year old female patient who on 04/23/2003 was vaccinated in the arm with a dose of pneumococcal vaccine 23 polyvalent (Lot # 645249/1196M).  Within hours on 04/23/2003, the patient developed severe pain and swelling in the arm of the injection.  Unspecified medical attention was sought.  The reporter also mentioned three other patients that had adverse experiences post vaccination with pneumococcal vaccine 23 polyvalent (Lot # 645219/1196M) (WAES #'s: 0304USA02307, 0304USA02520, 0304USA02521).  The reporter expressed a concern with the lot.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional information has been requested.
After receiving the vaccine I developed frozen shoulder. I had to get a cortisone injection, and now I am in physical therapy.
My 2 year old started having a seizure at the local park. She fell backward from standing still then drooled profusely and threw up before convulsing for 90 minutes even with seizure medication from the ambulance and ER.
among pain and dizziness and heavy arm, I had a brain fog and an inability to think straight. Most of these symptoms faded with time but six months later I still can't think normally as I had before. I forget things I don't normally forget. I put my keys in places I would never put them in. At times I have felt that my cognitive ability has been damaged to the point of possibly putting me in danger while driving. I have to do everything slower just to try to be more careful of my lesser brain function ability.
within a minute, electrical like vibration and then tingling pains & needles, left side of tongue, then left mouth, face and down left side of body to foot.   Strong tingling, but no numbness - continued  ver 1 and 1/2 hrs -   never had that before   followed by sore arm Day 2-3, then gone  Since then have had 5-6  much milder, shorter episodes of vibrational electric impulses mostly left side, and mostly left neck to shoulder and legs.     Odd. Will fu with  PCP02/12/21
Bruise and severe pain.  Bruise and shoulder joint pain remaining after 14 days.
fever, chills, abdominal pain- band of tightness around abdomen, kidney pain
Evening of 5/27. arm pain On 5/28. abdominal pain, leg pain; tingling backs of legs & feet. Light headed, passed out in shower. Temp 100.8.
Day 1 - flushed, coughed a lot; Day 2-4 = hyperglycemia in the morning; Day 1-4 = constipation; Day 1-4 = rapid heart beat and palpitations, nearly continuously, worsening of some chronic conditions. Narrative:  Other Relevant History:
pt recv vax 9AUG96 & 14AUG96 pt presented w/rash, low grade fever & h/a;The reporter reported two patients w/the same exp;
Ringing in worsened; Dizziness worsened; This is a spontaneous report from a contactable nurse, the patient. A 28-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 in Sep2020, ringing in ears which was ongoing and dizziness which was ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took cefaclor (CECLOR) and amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. On an unknown date in Sep2020, the patient underwent SARS-CoV-2 test and the result was positive. On an unknown date, the patient experienced worsened ringing in ears and dizziness. It was reported that ringing in ears and dizziness developed after COVID-19 positive in Sep2020 and ringing and dizzy spells were improving, but worsened again after receiving vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event worsened ringing in ears and dizziness was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Macular erythematous patches lower extremity - blanching. Child alert/active/afebrile.
This spontaneous report as received from a licensed nurse practitioner refers to a 63 years old male patient who on 31-AUG-2012, was vaccinated SQ in the left arm with a 0.5 ml dose of VARIVAX (merck) (lot# 0973AA, exp 17-JUN-2013). It was reported that the patient was inadvertently vaccinated with VARIVAX (Merck) instead of ZOSTAVAX today "on 31-AUG-2012". No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Patient received flu vaccine at onsite vaccination clinic at his spouses employment.  After the injection he become concerned about appearance of injection site, which had a localized blister appearing bubble.
1/08/2022 I started feeling bad. I was running a little bit of fever. I was aching all over, more than normal. I had a little bit of a cough. I took 2 at home COVID-19 tests on 1/10/2022, they were negative. I still felt terrible, so I called my doctor and they told me to come see them. I tested positive for COVID-19. They put me on an antibiotic, Vitamin C, Vitamin D, Zinc and increased my fish oil. I stayed at home for almost a month, by myself. I felt bad the whole month. I started feeling a little better for about 2-3 days, then I started feeling bad again. I went back to the doctor I was diagnosed with the flu. Right now I am having stomach issues, not sure what is causing it.
This spontaneous report was received from a registered nurse, via a company representative, referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On an unknown dates, the patient received 3 doses of an unspecified form of GARDASIL (Lot# and expiration date were not reported). The second dose and the third dose were separated by "7 weeks". No adverse effect reported. It was unspecified if the patient received GARDASIL or GARDASIL 9, therefore the adverse event was filed for GARDASIL. There was no product quality complaint involved. Additional information has been requested.
no additional event; improperly stored varivax; This spontaneous report as received from an immunization coordinator refers to a patient of unknown age and gender.   The patient's medical history and concurrent condition were not reported. The patient's pertinent medical history and drug reactions/allergies were not reported. On 04-DEC-2019, the patient was inadvertently administered with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S020464, 02-JUL-2021) for prophylaxis.      The concomitant medication included sterile diluent which was reported to be stored properly. It was reported that the vaccine was exposed to a temperature of -2.1 Celsius for a time frame of 4 hours 30 minutes. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report. No additional adverse effect.  The outcome of product storage error and no adverse event was unknown.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 08Feb2021 as dose 2, single (Lot number: EL9262), in left arm, on 05Oct2021 as dose 3 (booster), single (Lot number: PF2589), in left arm and on 20Apr2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: If vaccine received: Yes, other medication in 2weeks: Yes. Patient received paxlovid on 10Aug2022 and stopped on 14Aug2022 for covid 19 treatment. Rebound symptoms 6 days after finishing a 5-day course of Paxlovid.  No follow-up attempts are possible. No further information is expected.
Information was received from a pharmacy technician concerning a patient of unknown age and gender. It was reported that on 09-MAR-2017, an expired dose of M-M-R II (lot # K021950, expiration date 10-NOV-2016) was administered to an unspecified patient (dosage and route of administration not provided). No adverse effects. No further information was reported. Additional information has been requested.
Next  morning 12/29/2020  body ache, lethargy  and runny nose lasting a couple of days.  Associate was able to come to work.
Big red swelling spot where injection was given.  Continued to swell until about 5 inches in diameter.  Very painful.
Patient reported a sore arm the same day of the injection on 2/20/21. Eight days later, patient woke up to a red, swollen, itchy arm on 2/28/21.
Initially my arm was sore for about 36 hours. Yesterday on day 7 after my shot, the injection site was increasing in tenderness. By today the injection spot is swollen and I am unable to lift my arm over my head. No fever, or chills. I do have body aches which originally I was thinking was from moving snow and ice.
pain, swelling, redness devel @ site of inj w/o evidence of infect;resolved w/in 72hr;
Neutrophils increased; Inflammation; White blood cell count increased; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of NEUTROPHIL COUNT INCREASED (Neutrophils increased), INFLAMMATION (Inflammation), WHITE BLOOD CELL COUNT INCREASED (White blood cell count increased) and ARTHRALGIA (Shoulder pain) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 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) 1 dosage form. In August 2021, the patient experienced ARTHRALGIA (Shoulder pain). On an unknown date, the patient experienced NEUTROPHIL COUNT INCREASED (Neutrophils increased), INFLAMMATION (Inflammation) and WHITE BLOOD CELL COUNT INCREASED (White blood cell count increased). At the time of the report, NEUTROPHIL COUNT INCREASED (Neutrophils increased), INFLAMMATION (Inflammation) and WHITE BLOOD CELL COUNT INCREASED (White blood cell count increased) had not resolved and ARTHRALGIA (Shoulder pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Neutrophil count: 3700. In January 2022, White blood cell count: 5.7. In 2022, C-reactive protein: inflammation marker at 56. In 2022, Neutrophil count: elevated at 8800. In 2022, White blood cell count: elevated at 10.7.         Concomitant Drugs Not Reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality with Humira for the event(s) of neutrophils elevated at 8800, inflammation and white blood count numbers elevated at 10.7 was not provided. The reporter's causality for the event(s) of right shoulder hurting with Humira(adalimumab) was no reasonable possibility.  Treatment Drugs Not Reported.  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
Redness, swelling, and soreness of an area about 1.5 inches in diameter at the injection site.  The injection was yesterday midday; the soreness started yesterday evening and has continued today.  After 24 hours, there is now a very slight febrile response (very mild shivering and feeling "off").   Symptoms haven't yet abated but are expected to do so within a few days.
Information has been received from a health care professional concerning a 27 year old female who on 7/6/99 (lot 0162J) and 10/8/99 (lot 0570J) was vaccinated with the 1st and 2nd dose of Hep-B, respectively in the left deltoid. Subsequently, immediately after both vaccinations, the pt experienced warmth, light-headedness and extreme fatigue. She reported that she went to bed and slept through until the next morning. The pt also reported feeling cold at times. She sought unspecified medical attention. The symptoms resolved the next morning. It was noted that the because of the pt's reaction, the pt and her health care professional decided not to vaccinate with the 3rd dose. No further information is expected.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided. No treatment given. The vaccines was stored in freezer and took out one to two vials and place in fridge each day as needed.
Employee received the Moderna vaccine in the left arm and noted numbness in the left finger tips approximately 20 minutes later. RN assessed patient and patient requested additional assessment by our Medical Assistance Team (MAT).  The MAT team transferred the patient to the Emergency Department for further care.  Patient released from ED.  Contacted the following day and stated he had an elevated heart rate in the ED and when it returned to normal, they released him with instructions to follow up with his PCP if the arm pain and tingling did not subside in 1-2 days.  He states his left shoulder is painful today (1/6/21 10:00 am) and his left fingers are still tingling.  Patient instructed to call Occupational Health for further guidance.
Fever of 102F Headache Stomach ache Muscle aches Unable to sleep Cough
Patient broke out with red bumps all over. They were itching and burning. They looked like hives. Patient's symptoms lasted about a week and a half. Patient was treated with ATARAX 25mg, CLARITIN 10 mg and was sent home with Epi Pen Jr.
This spontaneous report as received from a health professional refers to a 6 month old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-JUL-2015, the patient was inadvertently vaccinated with VAQTA 25/0.5 (units not provided) (dose, route of administration, injection site, lot# and expiration date were not reported) instead of RECOMBIVAX HB 5/0.5 microgram/ ml, although the lot number recorded in the patient's chart (lot # K006825, expiration date: 15-SEP-2016 corresponds to pediatric dose of RECOMBIVAX HB. The reporter stated that the national drug code (NDC) number (0006498101) recorded in the patient's chart corresponds to RECOMBIVAX HB pediatric dose. No adverse event was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Clnt experienced episode of syncope with mild seizure activity 1-2 minutes after vaccination. Fully recovered.
This spontaneous report was received from a health care worker refers to 3 unspecified patients of unknown demographics. No medical history was reported. The reporter stated that the 3 unspecified patient were administered RECOMBIVAX (dose, route and frequency unspecified) that was stored improperly. No concomitant medications were reported. Nurse was then placed on the line to answer additional questions regarding event. No adverse effects were reported. No further information was provided. This is one of the two reports received from the same reporter and linked to case (1407USA012797). All Telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
tACHYCARDIA AND CHEST TIGHTNESS. IMPROVED AFTER im BENADRYL