chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Tuesday, October 1, 2019 at approximately 7:00p, I experienced  mild itching. The following morning, I noticed swelling in my face & hives on my arms, belly, back &  ankle area. Late afternoon, around 1:00p on Wednesday, October 2nd, the swelling went away without treatment. By 3:00p Wednesday, I started to feel excruciating lower back/tailbone pain. The rashes/hives was treated with Benadryl on Wednesday evening but was not resolved until Friday afternoon on October 14th. On Thursday, October 10,  I reported the incident to my employee health worker & was prescribed Naproxen for 5 days.  I took the Naproxen as prescribed & it did not help. As of today, I am still experiencing lower back/tailbone pain that radiates down both legs intermittently. I am being followed by an employee health physician.
No Adverse reaction. Resident received 4th dose 1.5 months after receiving 3rd dose.
pt states lt arm, back & buttocks broke out in whelps w/itching; pt did not return to office for f/u;
Received vaccines HPV and Tdap at 1400. 1405 pt. felt like she was going to pass out. Became pale, diaphoretic, clammy and cold. BP 68/40, HR 49. C/O blurred vision. With monitoring after 10 minutes BP increased 74/52 then 94/62, O2 Sat remained at 99%. Pt. could se without difficulty. Ambulated without difficulty and stated felt "fine".
I contracted COVID-19 twice; the first was in early November with mild symptoms. I didn't even know I had COVID-19 for about 3 days. I had a tickle in my throat, cough and congestion. I had body chills for one night very briefly. I took an at-home COVID-19 on 11/07/2022 which came back negative. I went to work the next couple of days assuming I just had a cold. I took another test on 11/09/2022 which came back positive. I called my doctor who prescribed me PAXLOVID on 11/10/2022; I isolated myself and tested again on 11/14/2022 to come back negative. Months later, on 03/05/2023 I started having a tickling sore throat again. I caught body chills and aches that disappeared the next day. I took an at-home test on 03/06/2023 which came back negative so I followed normal routine and went to work. I started developing significant body aches and chills again in the day. By evening time, I had a persistent cough and felt lethargic. I took another test that same evening which came back positive. I'm currently home and isolating again for the rest of the week as I'm taking PAXLOVID and cough medication which was prescribed for current treatment again.
Developed small spots and rashes in different places on her body (hands, ankles, and shoulders); Developed small spots and rashes in different places on her body (hands, ankles, and shoulders); Itchy; Rather small areas that are very itchy, red when scratched; Sometime little red bumps that itch not all a whole rash; I am very tired; This is a spontaneous report from a contactable consumer. A 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 09:50 (age at vaccination 83 years) as dose 1, single for covid-19 immunisation. Medical history included osteoporosis, Allergies (Verbatim: She has sensitive skin States it is thinner than it was before at 83 years old. She has to watch what soaps she uses. When she showers, she uses something she gets from the health food store, Spouts; something gentle with aloe, tea tree oil. Tries to use natural products), thyroid, blood pressure. Concomitant medication(s) included amlodipine besilate (AMLODIPINE (ALS BESILAAT) SANDOZ) taken for blood pressure measurement; levothyroxine sodium (SYNTHROID) taken for thyroid disorder, start and stop date were not reported, PROLIA (denosumab) for osteoporosis. The patient previously took flu and experienced malaise (she felt kind of icky; no fever or anything. Vaccine/Brand Name: Flu Shot/Brand Name, NDC, Lot, Expiry Date Unknown), prolia for osteoporosis (17Feb2021 had a Prolia shot for Osteoporosis, Right Arm). On 13Mar2021 the patient experienced developed small spots and rashes in different places on her body (hands, ankles, and shoulders, and just in different places), itchy, rather small areas that are very itchy, red when scratched, sometime little red bumps that itch not all a whole rash, she was very tired. Reporter stated, Patient not visited emergency room, physician office. noticed events at night 5-6 days after vaccine. She wants to know if this was a normal reaction or if anyone else has reported the same type of side effect. she is due for her second dose on 29Mar2021, and she is wondering if the side effects will be worse after the second dose. Rash occurred 5-6 days after vaccination. Small patches, some are just little bumps, they are very itchy. Has no specific time just that she noticed it at night and tried to ignore it. Patient states that it is persisting, she gets a new spot every once in a while, and that it has not improved, she confirms it is persisting. Patient received treatment for reported events, just putting cream. got some lotion called Curel for itching skin. It's over the counter Curel but it only helps temporarily used different lotions, creams to keep moist, found that Curel Itch Defence for Dry Itchy Skin helps. The outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse refers to a 10 months 23 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
chronic condition due to Epstein- bar virus; got very sick; didn't get to get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC ACTIVE EPSTEIN-BARR VIRUS INFECTION (chronic condition due to Epstein- bar virus) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHRONIC ACTIVE EPSTEIN-BARR VIRUS INFECTION (chronic condition due to Epstein- bar virus) (seriousness criterion medically significant), ILLNESS (got very sick) and PRODUCT DOSE OMISSION ISSUE (didn't get to get the second dose). At the time of the report, CHRONIC ACTIVE EPSTEIN-BARR VIRUS INFECTION (chronic condition due to Epstein- bar virus) and ILLNESS (got very sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (didn't get to get the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.  The caller was a patient who received the first dose of the Moderna COVID-19 Vaccine on the right arm,  and didn't get to get the second dose as it got very sick. The patient had a chronic condition due to Epstein- bar virus ( the episode happened after the first dose).  Company Comment: Very limited information regarding these events have been provided at this time. No further information is expected.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected
Hep A vaccine administered with an expiration date of 12/4/2022. Provider notified and pts mother notified. Provider plans to re administer at next visit.
PT REPORTED TO CLINIC AFTER RECEIVING LETTER IN MAIL ABOUT GETTING PNEUMONIA SHOT. PT DID NOT BRING HIS MEDICAL RECORD OR SHOT RECORD TO CLINIC.  PT WAS ASKED IF PREVIOUSLY VACCINATED, PT WAS UNSURE. SHOT WAS GIVEN. PT REPORTED TO CLINIC THE FOLLOWING DAY WITH LOCAL REACTION TO SITE. MD WAS NOTIFIED, PT DID NOT HAVE SIGNS OR SYMPTOMS OF ANAPHYLAXIS. PT WAS ADVISED IF SYMPTOMS WORSENED TO REPORT TO  ER FOR TREATMENT.
Local reaction; Redness on the injection site; Swelling on the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of LOCAL REACTION (Local reaction), VACCINATION SITE ERYTHEMA (Redness on the injection site) and VACCINATION SITE SWELLING (Swelling on the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOCAL REACTION (Local reaction), VACCINATION SITE ERYTHEMA (Redness on the injection site) and VACCINATION SITE SWELLING (Swelling on the injection site). At the time of the report, LOCAL REACTION (Local reaction), VACCINATION SITE ERYTHEMA (Redness on the injection site) and VACCINATION SITE SWELLING (Swelling on the injection site) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.  Patient stated that symptoms lasted for 3-4 days then got better and also reported of taking antihistamines for allergy   This case was linked to US-MODERNATX, INC.-MOD-2021-068997, US-MODERNATX, INC.-MOD-2021-008799 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068997:1st dose US-MODERNATX, INC.-MOD-2021-008799:
A 15 year old female who has completed a 15-minute observation period with the following signs and symptoms of an adverse reaction: loss of consiousness. Pfizer-BioNTech COVID-19 vaccine # 2 in series administered.  Per mother, patient started shaking and passes out Action(s) taken: Transferred to higher level of care.  ED. 911 called Allergy to COVID-19 vaccine documented in Allergies activity: no
Received PPD, IPV 4, DTaP 4, and MMR 2. Selected stickers as reward after shots - about 1-2 minutes after shots turned pale, eyes rolled up in head, body stiffened, then went limp and unresponsive. Laid flat with legs elevated, MD in to eval, by which time pt responding appropriately to questions. HR 70, POX 97-98%. Rested and observed x 15 minutes with no further episodes. D/C home alert and playful. HR 98-100s, POX 94%, BP 90/50.
joint pain in neck & shoulders started over past weekend;rash on trunk, face, arms;The patient experienced flu symptoms.
slight cough and said her skin was itchy on her neck but no rash was observed.  After 30 minutes she said that she was fine.  She had a rescue inhaler in her car, but didn't feel like she needed it.  I offered to walk her to her car to get it, but she said that she was fine and didn't need it.  she waited an additional 10 minutes and left.  O2  and blood pressure were taken and were with in normal range.
Rebound in COVID after taking Paxlovid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound in COVID after taking Paxlovid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    No Medical History information was reported.   On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 24-May-2022, the patient experienced COVID-19 (Rebound in COVID after taking Paxlovid). At the time of the report, COVID-19 (Rebound in COVID after taking Paxlovid) had not resolved.            The patient did not took any other medications or products within 2 weeks of starting COVID-19 treatment.  The patient previously received a COVID-19 Vaccine. Company comment: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 186 days after administration of third dose of mRNA-1273, there was no information provided regarding the initial two doses. On May 16, 2022, patient was started on treatment regimen of Paxlovid to which the patient experienced rebound symptoms of COVID-19. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 186 days after administration of third dose of mRNA-1273, there was no information provided regarding the initial two doses. On May 16, 2022, patient was started on treatment regimen of Paxlovid to which the patient experienced rebound symptoms of COVID-19. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Inadvertently both Pentacel and HIB where given. At the time I (the administering nurse) was thinking I was giving a combo vaccine containing DTaP, Hep B and IPV. Double doses of HIB were given in opposite limbs and no Hep B was administered. Parents to be called and informed, including the need for a hep B that was missed. At this time no adverse side effects have been noted.
Intense Lower back pain and mild headache. Began day after and still ongoing 3 days later.
Have been feeling short of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Have been feeling short of breath) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Have been feeling short of breath). At the time of the report, DYSPNOEA (Have been feeling short of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.  The patient had received vaccine 3 weeks ago and felt shortness of breath since vaccine.  The treatment information was not provided.   Reporter did not allow further contact
Itchiness, small hives that flare up throughout the day, worse at night and sometimes only become red when itched. These hives move (wrist, hairline, scalp, eyebrow, above eye, neck, back, hips, groin, arm, shoulder, back of thigh, etc.) every 1 or so. No rhyme or reason and no exposure to new foods, products, chemicals. No other symptoms aside from skin reaction.
HCP called to report that she accidentally gave the patient an extra dose of VARIVAX. No additional AE/PQC; HCP called to report that she accidentally gave the patient an extra dose of VARIVAX. No additional AE/PQC; third dose of VAQTA on 6/21/2022; fourth dose of MMR II on 4/19/2022; third dose of MMR II on 1/12/2022; This spontaneous report was received from a registered nurse and refers to a 7-year-old male patient with milk protein and soy allergies, neonatal abstinence syndrome, neonatal stroke, attention deficit hyperactivity disorder (ADHD), and autism. His medical history was not reported. Concomitant medications included sterile diluent (STERILE DILUENT), diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP) and hepatitis b vaccine (HEP-B-VAX). He had no adverse event following prior vaccination.  On an unknown date, the patient was vaccinated with the third dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U030162, expiration date: 28-SEP-2023, administered subcutaneously in right arm (dose was not provided). On 12-JAN-2022, he was administered with the third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, lot #T033815, expiration date: 05-OCT-2022, administered subcutaneously in right arm (extra dose administered). Then, on 19-APR-2022, he received the fourth dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, lot #T034392, expiration date: 08-OCT-2022, administered subcutaneously in right arm (extra dose administered). On that date, the patient was also administered with polio vaccine. On 21-JUN-2022, the patient received the third dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #U024505, expiration date: 15-OCT-2022, administered intramuscularly in left deltoid (extra dose administered). The HCP said the patient went to a different pediatrician in 2022, and the pediatrician was unsure of the patient's vaccination history. So, due to the unknown vaccination history (incomplete and inaccurate vaccine documentation), the patient received these extra doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and hepatitis a vaccine, inactivated (VAQTA) in 2022. On 06-APR-2023, the patient was accidentally vaccinated with the fourth dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W024335, expiration date: 01-AUG-2024, administered subcutaneously in left arm (extra dose administered). All vaccines were administered for prophylaxis. No adverse events were reported.
350pm pt with a history of COPD/emphysema uncontrolled, on oxygen and nebs at home.  about 15 minutes after recieving covid vaccine #1 pt began c/o sob and chest tightness.  stated was having a hard time breathing.pt appeared to be having a hard time breathing and catching breath.    RNs asisting pt. BP 110/88 P 110 SA O2 95% Called for Dr. per Dr-pt was tight with decreased air exchange.  pt with increased work of breathing 353pm V.O Dr  epi 1mg IM now Solumedrol 125mg/2ml IM now Albuterol neb 2.5mg/ml now  354pm  gave Epi 1mg IM R arm. ................................................................... RN  March 22, 2021 5:10 PM 355pm started Albuterol neb 2.5mg/3ml PO ................................................................... RN  March 22, 2021 5:10 PM 358pm gave Solumedrol 125mg/2ml IM R arm ................................................................... RN  March 22, 2021 5:11 PM pt states she is starting to feel better.  not havign as much sob breath.  is not having to work as much to breathe.   407pm P 107 SA O2 95% pt states she is feeling alot better.  feels a little shaky however denies sob and states can breath alot easier now.  albuterol neb is still running. Pt appears to be more comfortable. 410pm albuterol neb is complete BP136/84 P 106 SA O2- 95% PT states feels alot bettter.  denies sob, dizziness, swelling of throat or tongue, itchiness or rash, dizziness, hand/fett tinglling or numbness.  pt states that she is much more comfortable now and her breathing is alot more easire now.  pt appears to be more comfortable now.  per Dr- pt has better air exchange now with no wheezing. pt advised to use rescure inhaler and nebs at home.  given ER precautions.  Pt verbalized understanding.  Walked out of clinic on own will to dial a ride. ...................................................................RN  March 22, 2021 5:17 PM
Headache, Nausea Vomiting, FATIGUE, MUSCLE ACHES, CHILLS/SWEATS Narrative:
Information has been received from a published article, title as stated above. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient #2 of 32, a 36 year old female. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 36 year old female on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (lot number, route and site not reported). Concomitant therapy included levothyroxine sodium. On an unspecified date, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The patient also experienced symptoms of arthritis, optic neuritis. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB (WAES #1004USA01716, WAES # 1004USA02328 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
PT returned to clinic c/o difficulty breathing was retracting and exhaling forcefully. O2 sat 98% coarse BS. Given albuterol TX with improvement in exam few minutes later c/o inability to blow nose. Nasal passages were swollen shut. Given one dose of Benadryl with some improvement. Referred to children's emergency for observation. O2 sat remained 95 - 99%. Pt has a completely normal exam 15 min prior to episode before vaccine given.
Pt had TWINRIX #1 3/24/10, no prob. RTC for TWINRIX #2 3/31/10. states woke up 4/1/10 w/ back pain & b/l knee stiffness. Back pain has resolved, knee discomfort unchanged. No significant PMH.
03/25/23 presents to ED for "fever and Afib w/RVR". PMHx of "atrial fibrillation on coumadin, cardiomyopathy"
I day after I received my vaccine I had extreme muscle aches and pains, an extremely dry mouth. The joints hurt all over my body, I felt as if I had a bad case of the flu. I had chills so bad that I could not get warm (it was 116F outside and I could not get warm). I experienced a headache that is very unusual for me. I did take a Tylenol on July 22, 2022 because I was still feeling achy. I do feel a bit better.
Severe swelling from shoulder to elbow on back of arm. Moderate pain at injection site. Itches. Hot to touch.
A 13-year-old male patient, whose medical history and concomitant medications were unknown, received a dose of MENACTRA vaccine sanofi pasteur Inc. (lot number unknown) intramuscularly in the right arm on 22 AUGUST 2012. On 22 August 2012, 10 minutes after vaccination, the patient presented with nausea, headache, arm pain and redness at the injection site about 4 cm diameters on right arm. Correct medications and laboratory investigations were not reported. The patient's outcome was not recovered. List of documents held by sender: None.