chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Crohn's flare up; Pain after both pfizer covid vaccinations; Pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4326321-00.  A 33 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 33 years as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: CROHN'S DISEASE (medically significant), outcome "unknown", described as "Crohn's flare up"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain after both pfizer covid vaccinations"; PAIN (non-serious), outcome "not recovered", described as "Pain". The action taken for adalimumab was dosage permanently withdrawn.  The reporter's causality for the event(s) of pain after both Pfizer covid vaccinations with humira (adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of crohn's flare up and pain was not provided.   The reporter's assessment of the causal relationship of the Crohn's disease,  VACCINATION SITE PAIN, PAIN with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
pt had flu shot 22OCT93 & 29OCT93 c/o achiness w/fever; did not take temp APAP seemed to help sx; 1NOV93 called to say still ached, c/o head cold & swollen tender lymph nodes on rt side of neck; referred to MD:
Patient noticed no pain in the left arm the day after vaccination. She says the swelling, redness, and itching began about 2 days after the vaccination and it has been slowly spreading through the upper arm. Today when she came to the pharmacy, the upper arm was red and slightly swollen near the injection site. I told her that redness and swelling are fairly common side effects (up to 30% of patients) and advised that she seek medical attention this evening or tomorrow morning and to take Benadryl and/or use hydrocortisone cream  in the meantime to help with the itching/swelling/redness. She stated that she would return to the pharmacy in the morning to follow up.
increased fussiness, decreased PO intake, began becoming hypotonic and was evaluated in the ED. Currently intubated in ICU and undergoing further workup. Concern for possible botulism, though no exposures known. Symptoms began day after the vaccine was administered.
ACUTE DVT OF RIGHT FEMORAL VEIN 5/20/2021 HX OF DVT
4Mar91 pt developed "hive type" rash /w 102 T seen by MD 5Mar91 & a positive Strep test - on Benedryl, a pink antibiotic & Tylenol. Fever to 104 T, irritable
trouble in her stomach; been feeling "weak and had headaches".; been feeling "weak and had headaches".; immune system might be "weakened"; gastritis and reflux; vomited; diarrhea; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunization. The patient medical history was reported as none. The patient's concomitant medications were not reported. On 13Feb2021, the patient vomited and had diarrhea and felt a bit better 14Feb2021. On an unspecified date, the patient explained she had trouble in her stomach and specified being known for gastritis and reflux for which she took pills every day. The patient added she had been feeling weak and had headaches. The patient added she vomited and had diarrhea yesterday and felt a bit better today. The patient said maybe she ate something that bothered her. The patient then said her immune system might be weakened as a result of her recent symptoms. Therapeutic measures taken for events had trouble in her stomach and gastritis and reflux. The patient mentioned she has the second dose of the Pfizer-BioNTech COVID-19 vaccine tomorrow and asked if it is ok to receive it. The outcome of the events diarrhea and vomited was recovering and other events were unknown.  Follow-up attempts are completed. No further information is expected..
7 days post vaccine, swelling of left leg down to ankle with discomfort 9 days post vaccine, swelling and pain at injection site, with redness and hives.  Increase swelling in left leg and ankle.  Elevated blood pressure
Given Varivax at medical center. Left office and returned with emesis approx 10 min after shot Emesis -> urticaria-> 25 mg Benadryl given. VSS throughout. D/C with rash. Completely resolved by A.M.
The wife of a 45 year old male reported that her husband received an injection of influenza virus vaccine. The next day, he experienced numbness and tingling of his feet extending into the pelvic area. The pt was seen by a physician who sent him to an ER. The pt was also seen by a neurologist.
this is one of four pt from this site to devel a lump@ the inject site after recv vax.
Lump size 3" x 3" and itchy. Lasted since injection until now.
Rash, itching, hives.  Started in groin area, then moved to triceps, then on both sides of trunk, then behind knees.  Redness and flushing  of face but no swelling/rash/hives/itching.  As rash has subsided, low grade fever came on (100 degrees F).
In January 2023, I was admitted to the hospital to be treated for multiple pulmonary embolisms. On 1/27/2023, I was transferred to a rehabilitation center. While I was at the rehabilitation center, I was exposed to COVID-19. On 2/11/2023, I developed a stuffy, runny nose. I was still in the rehab center, and they administered a rapid antigen test, which yielded a positive result. They told me that if I wished to receive antivirals, I would have to travel back and forth between the rehab center and the hospital daily to receive them. I didn't want to go through that hassle, so I decided not to get the antivirals. While I was at the rehabilitation center, I was given guaifenesin. Overall, my symptoms were mild. I didn't develop any symptoms besides a stuffy, runny nose, which lasted for only about three days. I quickly recovered from the COVID-19 and was released from the rehab center on 2/21/2023 or 2/22/2023.
no additional AEs; first dose on 25-JUL-2020 and second dose on 06-JUN-2021; This spontaneous report was received from a pharmacist via a company representative referring to a 39 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 25-JUL-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, frequency, route, lot# and expiration date were not reported and on 06-JUN-2021, the patient was vaccinated with the second dose. The reporter confirmed that did not have any additional data to provide. No additional adverse events were reported. The reporter was inquiring about the dosing schedule for the suspect therapy for the patient.
This report is due to administration of expired vaccine. Patient was given a vaccine that had a Beyond Use Date of 12/1/21. The vaccine itself expires on 1-29-22, but due to being in the refrigerator from 11/1/21, it expired on 12/1/21 and this was missed.
I had neck and face stiffness (I couldn't move my head and face after the shot for a few minutes), then I had nausea, diarrhea, severe headache and vomiting. Then I took Tylenol and stayed home for a few days until I could recover and which I eventually did.
Itching and hives arm bands on arms. Itching all over pelvic area bright red.
Woke up @ 2AM (12/3/19) with body aches, frontal headache, photophobia, some chest pain, throat pain. Initially tachycardic with WBC 16.6 -ceftriaxone 1 gm given with Imitrex. All other tests were normal. Symptoms more likely related to elevated immune response secondary multiple IZs.
12 hours after receiving my second Pfizer vaccine, I woke up shaking and unable to stop. It went away after a minute or two but over the course of the next 2 hours, I had muscle spasms and shaking that I could not control. It slowly faded away. I am a healthy 20 year old with no other health issues and this had never happened before. After 30 minutes of off and on shaking, I went to the ER, and they monitored me for a little before telling me it was fine to go home once it subsided.
The next day, developed mild peri-orbital edema. No other symptoms. It resolved in one week. He received the second dose in the series. The same thing happened.
I tested positive for Pneumonia in February 2023 I experienced Chest congestion; cough; sinus congestion; I was prescribed Prednisone and antibiotics for my symptoms.
I had fatigue, fever, mild cough, and chills on and off. We were on vacation and when we got back home, I took a COVID-19 test at home and tested positive. I took doxycycline that I already had at home, and it helped to break fever.
Pt previously received the J&J single dose vaccine and came in as she said she was directed to get the other mfg.  Pt did not disclose at the time of the vaccination and was not noticed until the second dose when we looked the pt up in the due to other pt's trying to get booster doses.  No adverse effects reported and only one dose of Pfizer given.
My husband had both shots and still got shingles / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient had both shots and still got shingles. This case was considered as suspected vaccination failure, as information about laboratory test confirmation for shingles infection and time to event onset was unknown. The follow-up would not possible, as no contact details were available.
The night of the shot I only had mild soreness in my right arm around the injection site. Upon waking up the next morning my arm was more sore than the previous day and I had trouble extending or flexing at my right shoulder. A couple hours later at around 11:45 AM I began experiencing a headache that progressively has gotten worse. I also began experiencing muscle and joint aches and chills. I believe now at 2:30 in the afternoon I have a fever. There was a decent amount of fatigue the night after getting the shot but the fatigue has been much worse today.
Information has been received from a physician concerning a 15 month old female who was vaccinated on 03/11/04 with a 0.5ml dose of varicella virus vaccine live. One week later, on 03/18/04, the pt has a low grade fever and 10 lesions to her trunk. The reporter also mentioned that the father of the pt who was a
STORAGE IN REFRIGERATOR ( 2°C - 8°C ) UP TO 30 DAYS. (VACCINE USED AFTER 10/16/2021 )
Body aches and pains, fever, headache, and inability to stay awake. 18-24 hours.
It started out with just fatigue, and then I went into nausea, and I vomited once. Then headaches, and this whole time I had fatigue. I also developed severe diarrhea. I've had a little shortness of breath. Just over all not feeling good. But very fatigued. My arm swelled and it had a big 3-inch x 2 inch welt that was so hot to the touch. It was radiating heat and it was very hot. It was also very sore, not hot anymore, but still sore. I talked to the doctor yesterday and she stated that she was getting several calls regarding that. She recommended Tylenol, severe flu over the counter, and I'm taking CORICIDIN with acetaminophen. I was also running a temperature of 100 yesterday, and I turned on my AC and my temperature went down within an hour.
3 days of dyspnea on exertion, dry cough and right thigh pain. CT chest with acute submassive pulmonary emboli, saddle PE across main pulmonary arteria. Right lower extremity DVT. Echo - mild RV dilation and reduced RV systolic function.
Ear infection; COVID-19 Positive; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (Ear infection) and COVID-19 (COVID-19 Positive) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced COVID-19 (COVID-19 Positive). On an unknown date, the patient experienced EAR INFECTION (Ear infection). The patient was treated with AMOXICILLIN for Ear infection, at an unspecified dose and frequency. At the time of the report, EAR INFECTION (Ear infection) outcome was unknown and COVID-19 (COVID-19 Positive) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported
Headache, Bradycardia, FLUSHING, TINGLING OF LOWER EXTREMITIES, GENERALIZED WEAKNESS Narrative:
Suspected vaccination failure; outbreak of Shingles; pain; rash on the back; two dses were given only one month apart / Dse #1-Feb. 2020 & Dse #2-March 2020; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 2nd dose of Shingrix. In February 2020, the patient received the 1st dose of Shingrix. In March 2020, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too short. In March 2021, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and rash. On an unknown date, the outcome of the vaccination failure, shingles, pain, rash and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingrix and Shingrix.  Additional details were reported as follows: This case was reported by medical assistant. The age at vaccination was not reported. The patient stated to the reporter that the two doses were given only one month apart, which led to shortening of vaccination schedule. Approximately one year after receiving the 2nd doses of Shingrix, the patient experienced an outbreak of shingles and initial symptoms were pain, followed by a rash on the back. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. The reporter consented to follow up.
6/25/05-Pink spots appeared on stomach.  6/29/05-Rash now appears on face, upper back and upper chest-almost solid in apperance on that date.  Seen by MD who feels it is rash associated with MMR.
Urticarial rash vs fixed drug eruption (R) arm, not at injection site. Tx'ed with topical BENADRYL and topical steroid cream resolved in 1 week.
Roughly 5 minutes after vaccination patient said he started to feel lightheaded, patient started to pass out but we got him to a laying flat position fast enough that I'm not sure if he fully passed out. Patient immediately could verify his name, DOB, what just happened etc. Declined any symptoms that would indicate any form of allergic reaction. Said he felt dizzy/lightheaded/sweaty. Sat patient up after a couple minutes and took a blood pressure. It read 103/52. Patient then informed me he does pass out after shots. He says he doesn't get vaccines because of his fear of needles but in the past when he had a shot for a medication he has passed out. Took another blood pressure about 10 minutes later which read 126/86. Patient also informed me he hadn't ate/drank anything all day and did work all day prior. Got patient a pop to help with any low blood sugar. Patient had a friend pick him up, didn't want an ambulance, said he felt fine after 30ish minutes passed by besides a minor headache.
A 21 year old received the pediatric dose of Engerix-b; A 21 year old received the pediatric dose of Engerix-b; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 21-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.     This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: It was reported that the 21 year old patient received the pediatric dose of Engerix b, which led to underdose and adult use of a child product.  No side effects were reported. The reporter consented follow up via email.
Within 24 hours arm started to swell, became tender and sore, cold/flu symptoms, a change in the voice, and congestion. Healthcare professional advised not to get 2nd dose of vaccination.
Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, 42 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The customer stated that one of his friends received the first dose of the Shingrix vaccine. About 6 weeks after receiving Shingrix, the patient was diagnosed with shingles. Additional information not provided.  Address not provided.  The reporter did not consent to follow-up.
Left deltoid pain - inhibiting range of motion and function; Left deltoid pain - inhibiting range of motion and function; Headache; This is a spontaneous report from a contactable consumer (patient). A 45-years-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 22Feb2021 09:30 (at the age of: 45-years-old) as dose 1, single for covid-19 immunization. Medical history included sulfa allergies. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine with in 4 weeks prior to the covid vaccination. List of any other medications the patient received within 2 weeks of vaccination was reported as None. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Feb2021 12:00 the patient experienced left deltoid pain- inhibiting range of motion and function and headache. The patient did not receive any other treatment as a result of events. The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Pain, pruritis, Swelling and warmth in left deltoid muscle (injection site.) Treated with diphenhydramine and acetaminophen.
sore arm; Body aches; exhausted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 18:30 (Batch/Lot number: unknown) at the age of 35 years as dose 2 (initial pfizer dose), single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), administered in arm left, administration date 29Oct2021 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: "known allergies : Adhesive" (unspecified if ongoing); "penicillin" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "arthritis" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "known allergies". Vaccination history included: J&j (Dose Number: 1, Batch/Lot No: Unknown. Obscured by other product labelling,Location of injection: Arm Left,Vaccine Administration Time: 02:00 PM), administration date: 09Apr2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Oct2021 07:00, outcome "recovering", described as "sore arm"; PAIN (non-serious) with onset 30Oct2021 07:00, outcome "recovering", described as "Body aches"; FATIGUE (non-serious) with onset 30Oct2021 07:00, outcome "recovering", described as "exhausted". Therapeutic measures were not taken as a result of pain in extremity, pain, fatigue.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and did not received any other medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not tested for COVID-19.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected. .