chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fourteen weeks after the second dose of the vaccine I woke up one morning and my right hand was very swollen. I was given an antibiotic. A few days later I woke up and my left arm and leg were very swollen and extremely painful. I was hospitalized and after discharge the symptoms returned with extremely swollen legs that are very painful. This time it was in both and both arms. It was very painful in my muscles. I could not walk, and I was hospitalized again. I have seen Neurologist, Orthopedist, Rheumatologist, and a Cardiologist. All tests were negative. I have just had a Muscle Biopsy. I have never had any of these problems before.
Right arm where Dtap was administered is red, swollen, tender to touch and warm. Had 7x6cm area noted on exam of redness and swelling.
Information has been received from a physician concerning a male pt who on 05/21/2002 was vaccinated in the right upper quadrant of the buttocks with the second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Concomitant therapy that same day on the other side included unspecified vaccines. Subsequently the pt developed a bump 9" x 6" in diameter. It was noted that the first measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) vaccination caused no problems. Unspecified medical attention was sought. Additional info has been requested.
It is very itchy; She started with a red circle about 2 inches big at injection site on her left arm; Patient had a sore left arm on next day after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Patient had a sore left arm on next day after receiving 1st dose), VACCINATION SITE PRURITUS (It is very itchy) and VACCINATION SITE ERYTHEMA (She started with a red circle about 2 inches big at injection site on her left arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included PANTOPRAZOLE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Patient had a sore left arm on next day after receiving 1st dose). On 26-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (It is very itchy) and VACCINATION SITE ERYTHEMA (She started with a red circle about 2 inches big at injection site on her left arm). At the time of the report, PAIN IN EXTREMITY (Patient had a sore left arm on next day after receiving 1st dose), VACCINATION SITE PRURITUS (It is very itchy) and VACCINATION SITE ERYTHEMA (She started with a red circle about 2 inches big at injection site on her left arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-059974 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: Non significant On 11-May-2021: Event outcome updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-059974:Case for husband
expired PENTACEL was administered to a patient with no reported adverse event; Initial information received on 22-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 4 months old female patient who was administered expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination (Immunisation); and rotavirus vaccine live oral 1V (Rotarix) for Prophylactic vaccination (Immunisation).  On 21-Sep-2023, the patient received a standard expired dose 2 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection at a dose of 0.5 ml total (lot UJ788AAA, expiry date- 18-SEP-2023) via intramuscular route in the left vastus lateralis for Immunization with no reported adverse event (expired product administered) (latency- same day). Caller asks what should they do? She asks how they should document the expired dose in the chart?   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
ARM BECAME RED, ITCHY, SWOLLEN W/MIGRATION DOWN TO ELBOW, AND ABOUT 4 INCHES IN DIAMETER SHE REPORTED. PT. USED HYDROCORTOSONE CREAM AND NOTHING ELSE BY MOUTH. CONTACTED US ABOUT A WEEK LATER.
facial rash - forehead/nasal area/ lips red and decreased swelling. Denies SOB.
Local irritation at the injection site. Redness, itchiness, warmness to the touch.
Fatigue, Low grade fever and feeling unwell on next day . On 4th day large red rash that is Itchy and hot to the touch has apearred on my left arm near injection site .
2/15/21 2pm Covid Pfizer Vaccine #1 administered 2/15/21 5pm developed tongue swelling, Took Benadryl 75mg at 5p and again at 9pm with resolution
According  to patient's caregiver, patient presented with symptoms of fever (101.6 F) and purple blotches all over the body within an hour. Since patient was in hospice , caregiver called Hospice and a pharmacy and was told to give patient Benadryl and Tylenol. Patient was given both medications and the fever subsided in a few days but the purple blotches never went away. Patient passed away at the facility a week later.
Information has been received concerning a 22 year old female with no medical history or allergies who on 09-APR-2007, was vaccinated with a first 0.5ml dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On approximately 09-MAY-2007, a month after receiving the vaccine, the patient developed small clear blisters on top of her hands. NO medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. . In follow-up it was reported by the patient's mother, concerning her white, 22 year old, student, daughter with no illness at the time of vaccination, whose reported weight was 170 pounds and whose reported height was 71 inches, who on 09-APR-2007, was vaccinated into the left deltoid muscle with the first 0.5ml dose of Gardisil (lot # 656051/0244U). It was reported that on 11-APR-2007, the patient's mother noticed small blister-like pimples on the top of the patient's hand. On 16-APR-2007, the patient recovered.This is one of two reports from the same source.Additional information is not expected.
A short time after receiving shot, my arm began to  feel itchy.  At bedtime I noticed my arm was red from the site of the shot down toward my elbow.  No trouble sleeping. Tuesday and Wednesday itching continued, and arm is still pink, so I thought perhaps I should mention this for information.
Hives entire body. Onset - 3 hrs after MMR vaccine. 2/23/15 - playful child and exam: skin - hives maculopap urticar lesion.
flu; Initial information received on 01-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength, dose and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event of flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, I still got the flu.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
she took a Tylenol 1 hour before her covid vaccine; This is a spontaneous report from a contactable consumer via the Pfizer Sponsored Program.  A 67-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 27Jan2021 as a single dose for COVID-19 immunization. Medical history included ear infection.  The patient's concomitant medications were not reported. The patient reported that she got the COVID-19 vaccine on Wednesday 27Jan2021. The Prior Sunday she developed inner ear infection, so she took Tylenol about an hour before the vaccine. She heard taking a pain reliever could lessen effectiveness if taken before shot. She took Tylenol about an hour before the vaccine, she inquired if that is okay. The clinical outcome was unknown.   Information about Lot number has been requested.
she had a seizure; having a fever of 103 Fahrenheit; high pitched crying for hours; Initial information received on 13-Aug-2020 regarding an unsolicited valid serious case received from a physician (Pediatrician).  This case involves a 15-month-old female patient who experienced high pitched crying for hours (high-pitched crying), fever of 103 Fahrenheit (pyrexia) and had a seizure (seizure), while she received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included HIB VACCINE CONJ (TET TOX) (ACT-HIB) for prophylactic vaccination.   On 10-Aug-2020, the patient received 0.5 ml fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5624AA and expiry date 10-Jun-2021) via intramuscular route in the right thigh for prophylactic vaccination.  On an unknown date, the patient developed non-serious high pitched crying for hours (high-pitched crying) and fever of 103 Fahrenheit (pyrexia) unknown latency following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  On an unknown date, the patient had a seizure (seizure), unknown latency following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant.  No other laboratory data was reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome of the events was not reported (it was reported that the patient had seizure until fever went down).; Sender's Comments: This case involves 15 month old female who experienced high-pitched crying, pyrexia and seizure following the vaccination with DAPTACEL. The time to onset was compatible. Medical history, concurrent condition, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Concomitant vaccine is a confounding factor. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
9 days after getting second moderna, started itchy posterior scalp and upper back and the next day noticed bumpy, itchy large area of reddness which persisted for 6 weeks with extreme itching and large amt swelling with any scratching of area...also flare ups of back of neck and upper back with itchy bumpy rash. flare ups of all itching usually occured late evenings, nightly.  took benadryl and symptoms resolved.  as of half week ago arm raised, leathery rash greatly improved, but nightly flare ups of itching persist on back of neck.  again, improves with benadryl.  generally i have never had any skin issues in the past
1 week after the vaccine I started to develop inflammation at the injection site, a round large red circle and it felt very warm and the red circle got bigger. It is still warm to the touch and it has been two days. It itches slightly. I guess this is called "Covid Arm"
Pt recvd vax & immediately p/inject had tingling fingers & shoulder soreness 48 hrs p/3rd inject had face numbness;
Dry heaves; Loose yellow bowels; Rash on left arm, stomach, under breast; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (Dry heaves), DIARRHOEA (Loose yellow bowels) and RASH (Rash on left arm, stomach, under breast) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult Crohn's disease).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RETCHING (Dry heaves), DIARRHOEA (Loose yellow bowels) and RASH (Rash on left arm, stomach, under breast). At the time of the report, RETCHING (Dry heaves) and RASH (Rash on left arm, stomach, under breast) had resolved and DIARRHOEA (Loose yellow bowels) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Treatment information was not provided.  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.
Mom called and stated patient was breaking out in a rash since he was given his imms earlier today.  She took him to the ER and they treated him with Benadryl and he was doing better.  I asked mom to keep me posted on his condition, and also gave her the information of which imm was given where.
Itchy scabs on left hand, both elbows erythematous, warm, itchy, indurated nodules.  Also developed scabs/itching on backs of legs and toes.
INCREASED DIAPHORESIS, INCREASED IRRITATION, NEW SEIZURE ACTIVITY AFTER 2 WEEKS OF VACCINE
Body aches; Did not sleep well; feeling woozy; BURNING AT INJECTION SITE WHICH STUNG; fever; Headache; very tired; Joint ache; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included arthritis, pre-diabetic, alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies, the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 04ZAZ1A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 11:30 on right arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced joint ache. On 06-APR-2021, the patient experienced body aches. On 06-APR-2021, the patient experienced did not sleep well. On 06-APR-2021, the patient experienced feeling woozy. On 06-APR-2021, the patient experienced burning at injection site which stung. On 06-APR-2021, the patient experienced fever. On 06-APR-2021, the patient experienced headache. On 06-APR-2021, the patient experienced very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning at injection site which stung on 06-APR-2021, had not recovered from fever, body aches, headache, and did not sleep well, and the outcome of joint ache, feeling woozy and very tired was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Expired vaccine administered to patient. Expiration date: 21JUL2022. Patient, 6hr post administration, is not feeling any adverse reactions.
The following day after my second dose of the Moderna vaccine, I experienced numbness and limited movement on the right side of my face. I had Bells Palsy in my teens and it felt similar to that but cleared up by the next day.
redness has gone down near the elbow/ the upper part is not as red but the bottom part is still red; redness has gone down near the elbow/ the upper part is not as red but the bottom part is still red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 96-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "redness has gone down near the elbow/ the upper part is not as red but the bottom part is still red". Therapeutic measures were taken as a result of erythema, pruritus. Additional information: Patient was given penicillin.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 13-OCT-2015, the patient was vaccinated with improperly stored GARDASIL 9 (strength, dose and route of administration were not reported, lot # L007560, expiration date: 15-JUN-2017). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a nurse concerning a 12 year old female who on 14-MAY-2007 was vaccinated with the first dose of GARDASIL (Lot#653735/0688F). On an unspecified date post vaccination the patient developed plantar warts. The patient's plantar warts perisited. The patient sought unspecified medical attention. At the time of the report she had not recovered from the event. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/12/2007. Initial and follow up information has been received from a nurse concerning a 12 year old female who on 24-MAY-2007 was vaccinated with the first dose of GARDASIL (Lot#651735/0688F). Other vaccinations that day included DTP. On 04-SEP-2007 the patient developed plantar warts. The patient's plantar warts persisted. The patient sought unspecified medical attention. At the time of the report it was not known if she had recovered from the event.
feeling pain; chills; fatigue; This case was reported by a physician via sales rep and described the occurrence of pain in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain, chills and fatigue. On an unknown date, the outcome of the pain and chills were recovered/resolved and the outcome of the fatigue was recovering/resolving.   It was unknown if the reporter considered the pain, chills and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient described feeling pain from the Shingrix shot, chills and fatigue. The doctor called GlaxoSmithKline to inquire about the adverse event experienced by the patient and was told it would pass in 2-3 days. On the fourth day after the patient received the shot the doctor called the patient to inquire if the adverse event still persisted.  The patient said he felt better on the second day itself and he did not experience adverse event any more.
Hand/Arm/muscle tremors and hand incoordination. I am noticing that I am now struggling with muscle coordination in my hands/fingers/arm muscles. There is also a lot of brain for or loss of thought after receiving the vaccination.  There was also some  arm soreness but that was expected.
marked urticarial (total body) rxn 24hr p/hep A vax;no prior h/o any allergies;no family h/o urticaria or allergies;
Skin lesions in different stages from papules to blisters. No significant symptoms except for itchness.
During mass flu school clinic mom stated "previous flu shot" RN gave H1N1 nasal spray- child told mom, mom then stated "previous flu shot" was really nasal mist seasonal. Child was sent back through vaccination line was given H1N1 injection and seasonal injection.
pt exp pruritic rash all over including arms, face & head on 25ARP92 following Engerix-B; pt seen in ER & given DPH & Medrol & sent home; called questionable allergic reaction to HB vax by ER MD;
Within 24 hours post vax pt developed an injection site reaction characterized by redness, warmth and swelling.
About 5 minutes after receiving Pfizer bivalent vaccination patient approached counter and reported not feeling well. She looked very pale and with assistance sat down and then laid down to the floor(fainted). She may not have completely lost consciousness but closed her eyes. She was able to talk with me and gradually came around over 5 to 10 minutes where she was then able to sit up. Patient was picked up at  the store after about 25 minutes of observation.
Obtained the SHINGRIX vaccine and had severe reaction necessitating Urgent Care center visit for cortisone, anti nausea, fever and chills, and severe pain from head to base of spine...needed multiple injections. Was sick for 4 days after.
runny nose; sneezing; This is a spontaneous report from Medical Information Team. A contactable consumer (patient) reported that a 41-year-olf female received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot: EW0185) via unspecified route of administration on 13May2021 on 14:30 as single dose in left arm for COVID-19 immunization in Hospital. Medical history and concomitant medications were not reported. the patient previously took first dose of bnt162b2 (Lot Number: EW0169) on 22Apr2021 13:00 in left arm and experienced smell and taste it feels weird, I can't taste food, food taste like something different and smell you know feels something different. She felt like she was having an allergic reaction, clarified she wakes up with a runny nose and sneezing and has never had this before. The runny nose and sneezing started third or fourth day after the second dose of the vaccine, it was a little better. No treatment was received in response to the events. Outcome of the events was recovering.  Follow up needed, further information has been requested.