chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered around 6PM on 5/13; Patient reports experiencing fever, headache, body aches, and nausea beginning on 5/14. Patient reports fever of 101F on 5/14. The patient self treated with Tylenol to reduce the fever. Fever got down to 100F by the evening of 5/14. The patient contacted the pharmacy on 5/15. She reported that the fever was gone by that point. She also reported that headache, body aches, and nausea had improved by 5/15. The patient was concerned if her experience was out of the ordinary and if she should see further medical attention.
Information has been received from a consumer concerning one of her children who was vaccinated with a dose of MMR II on an unspecified date. Subsequently the patient had a rash and a fever. The patient also had autism, but it was not reported if the autism started before or after the vaccination. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Upon internal review, autism was considered to be an other important medical event. This is one of several reports received from the same source. Additional information is not expected.
bad reactions; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reactions) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (bad reactions). At the time of the report, VACCINATION COMPLICATION (bad reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.                   No treatment medication was reported.
Moderna COVID-19 Vaccine EUA Adverse Events: (one day later) Severe back pain & general muscle fatigue Nausea & Vomiting Bloating stomach  Took full strength Asprin pills 2 times, and slowly recovered the next day.
Swelling after 1 day led to extremely pain (no rash) for 7 days. Also fatigued loss of appetite, thought of suicide, disrupted sleep.
I had symptoms next Saturday and tested positive two days ago on Wednesday; I had symptoms next Saturday and tested positive two days ago on Wednesday; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Nov2022, outcome "unknown" and all described as "I had symptoms next Saturday and tested positive two days ago on Wednesday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Nov2022) Positive, notes: tested positive two days ago on Wednesday. Clinical course: Patient mentioned that he never had COVID the whole pandemic for 3 years, he was very careful, always wear a mask, keep social distance, hygienic, so he was really surprised. "I've known of 4 cases where people turn up positive COVID tests after the booster, myself, two patients, one received it last Thursday and then had COVID like symptoms throughout the week. I am waiting her to call me about the results. I also spoke to a patient this morning a friend also got a bivalent the day after. Personally, I did some research and found an article news where someone also got the booster on 04Oct and got very sick and tested positive for COVID test in the past week. It seems unusual the frequency of people reporting COVID".   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.,Linked Report(s) : US-PFIZER INC-202201296629 same reporter/drug/event, different patients;US-PFIZER INC-202201296628 same reporter/drug/event, different patients;US-PFIZER INC-202201296630 same reporter/drug/event, different patients;
This spontaneous report as received from a registered pharmacist refers to a 66 year old female patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route, and lot # not reported). The pharmacist reported that the patient experienced an injection site reaction with redness swelling and inflammation (no vesicles or blistering) about 4 inches in diameter accompanied by a tingling feeling from the elbow to the finger tips and fever that occurred recently (date unspecified). The exact onset of any symptoms was unspecified. Ibuprofen was given for the events. At the time of reporting, the outcome of the patient was unknown. It was unspecified whether the patient sought medical attention. Additional information has been requested.
developed cellulitis after receiving the shot of Prevnar 20/information on where the cellulitis was: left arm at the injection site, in the deltoid; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  An 86-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, 0.5ml single (Lot number: GN1898, Expiration Date: Sep2024), in left deltoid for immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE; MIDODRINE; POTASSIUM; TAMSULOSIN. The following information was reported: VACCINATION SITE CELLULITIS (intervention required), outcome "unknown", described as "developed cellulitis after receiving the shot of Prevnar 20/information on where the cellulitis was: left arm at the injection site, in the deltoid". Therapeutic measures were taken as a result of vaccination site cellulitis. Additional information: Reporter was wondering if something was wrong with a batch of Prevnar 20 (see lot number below). She has two patients that developed cellulitis after receiving the shot. LOT: GN1898. NDC: 0005 2000 01. Added information on where the cellulitis was for each patient: left arm at the injection site, in the deltoid. Nurse stated, "Our management team had suggested to call as we had 2 patients that actually had developed cellulitis after receiving Prevnar 20. So, my doctor was actually little concerned that there is actually something wrong with the batch because we have given this out numerous times but all of a sudden two patients within a week apart developed cellulitis."  The reporter considered "developed cellulitis after receiving the shot of prevnar 20/information on where the cellulitis was: left arm at the injection site, in the deltoid" associated to pneumococcal 20-val conj vac (dipht CRM197 protein).; Sender's Comments: A possibly contributory role of PREVNAR 20 in triggering the onset of vaccination site cellulitis cannot be fully excluded, considering the temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product 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,Linked Report(s) : US-PFIZER INC-202300204006 Same reporter, drug, event and different patient;
she is in a lot of pain; pain is in her RIGHT arm; right upper back pain that burns and goes numb and tingly; right shoulder blade pain; back / goes numb and tingly; back / goes numb; This case was reported by a consumer and described the occurrence of pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 15th January 2021, 1 hr after receiving Shingrix, the patient experienced pain, pain in arm, upper back pain, shoulder blade pain, tingling and numbness. On an unknown date, the outcome of the pain, upper back pain, shoulder blade pain and tingling were not recovered/not resolved and the outcome of the pain in arm and numbness were unknown.   It was unknown if the reporter considered the pain, pain in arm, upper back pain, shoulder blade pain, tingling and numbness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. 1 hour after receiving Shingrix patient experienced lots of pain. The patient received Shingrix in left arm and experienced pain in right arm and in upper back area, back pain burns and tingling and numbness. The reporter did not consent to follow up.
4/19/22: Lower left sided back pain, radiating to left leg 4/23/22: Seen at Urgent Care. Urgent care prescribed NSAID and Tizanidine 4 mg. 3x/day Advised follow up with PCP in 2-3 days of no improvement. 4/26/22:  No improvement of symptoms. Saw PCP's nurse practitioner. Started on Medrol dose pack, Naproxen 500 mg 2x/day, Acetaminaphen 1000 mg 3x/day. Ibuyprofen discontinued as well as Tizanidine discontinued. 5/2/22: Improvement noted. Medrol dose pack completed. Remain on Naproxen  and Acetaminaphen. Still not totally painfree.
received Moderna  vaccine at one location around 4:30 PM by 1:00 AM I broke out in Hives and went to Urgent care at another location
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with RECOMBIVAX HB (dose and route of administration was not provided). No concomitant therapy was reported. On an unknown date the patient had Hepatitis B titers drawn following administration of vaccine which exhibited "false negative" responses to the vaccines. The outcome of the event was unknown. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Intense headaches , Severe leg cramps, Heart palpitations, Severe Back rash, Nausea , Diarrhea, Joint pain
Patient's hair started falling out a few months after her last shot. The patient has lost 60% of her hair and is still losing hair, though it is growing back in some areas.
Severe front middle headache with vision blurriness.  Eyes started getting worse, hard to focus. Severe eye pain and vision loss. Tried to wait and see if it would go away. It did not. Went to the ophthalmologist June 3rd. The vision in my left eye changed dramatically and the vision in my right eye was worse as well.  New prescription for glasses didn?t help. Still have very bad eye pain, sensitivity to light and vision blurriness. Hard to read and can?t focus for long. Now I am having broken blood vessels under my skin on my arms. Never had that before. Tiny pinpoint bruising. Saw my PCP recently as I had hoped things would stabilize but they didn?t. So she advised me to report what happened after my vaccine.
pt recvd vax; swollen, erythema of Lt deltoid down to 1" above elbow for 72 hrs; no tx required;
inflammation at site of injection; rash at injection site which spread to upper arm; body aches; chills; nausea; fever of 103; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (inflammation at site of injection), VACCINATION SITE RASH (rash at injection site which spread to upper arm), MYALGIA (body aches), CHILLS (chills) and NAUSEA (nausea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (inflammation at site of injection), VACCINATION SITE RASH (rash at injection site which spread to upper arm), MYALGIA (body aches), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever of 103). At the time of the report, VACCINATION SITE INFLAMMATION (inflammation at site of injection), VACCINATION SITE RASH (rash at injection site which spread to upper arm), MYALGIA (body aches), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever of 103) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 103 (High) (103).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment reported was antibiotics.
(reporting as I read about other inflammatory conditions in another that caused adverse events). It might not be related - I contracted a very bad case of Shingles on June 21st with slight nerve symptoms occurring through today (July 18th). With the rash showing by June 25th at 8p.  End result, on June 26th ~2P,  I went to urgent care and was prescribed Valacylovir for 10 days to help reduce severity of symptoms
patient given expired fluzone with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and other health care professional via Medical Information (Reference number- 00759590) and transmitted to Sanofi on 08-Sep-2021.  This case involves 23-year-old female patient given expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (expired product administered).  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 07-Sep-2021, the patient received 0.5ml (total, 1X(once)] dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot: UT7073LA and expiry date: 30-Jun-2021) (Frequency = once) (Strength = standard) via intramuscular route in unknown administration site for prophylactic vaccination (expired product administered).  It was reported,"Caller stated that she needs guidance on if they need to revaccinate a patient, If so, what is the time frame she needs to wait?"   This case was an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse 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 immediately turned red and swelled upon administration of Zostavax. Swelling and redness began to decrease within 10 minutes. Symptoms were gone within one hour. Patient was not concerned and did not report any other problems.
Patient received 1st dose of vaccine at 1100 and waited for 15 mins with no adverse s/s. Pt started having tremors and palpitations around 1700 and called campus police from her dorm room. Security notified and was brought back to vaccine location to be evaluated and EMS was already notified and in route. Pt first set of vitals were BP 158/78, HR 136-150, )2 98%, Resp 22. Patient stated she was not short of breath. Pt was transferred and was being monitored when a second patient was having a severe reaction as well. 2nd nurse RN remained with patient to reassess condition until EMS arrived. Patient was noted at 1723 to start having more trouble with irregular heart rate.
Administration error. Vaccinator gave client Moderna (047A21A) today (3/13) as the client stated that they had received Moderna for their first vaccine. However the client's vaccine shot card stated she received Pfizer (EN6201) on 2/20/21. which was given to the vaccinator prior to Moderna vaccine was given.  After the client received the Moderna vaccine the situation was brought to my attention. The vaccinator had shown the card to a Nurse who went to confirm the vaccine and in the meantime the vaccinator gave the Moderna vaccine.  I confirmed in the state immunization data base that the client did received Pfizer on 2/20/21 as written on her shot card.  Client remain in holding for 30 minutes without and adverse events.
I experienced towards mid July 2022, 4th dose. I was feeling tingling, cold bringing sensation on the plantar surface of my toes. I had no cramps when ambulating but did have some numbness on my toes. I had a Q-cert test in November 2022 and diagnosis was small fiber neuropathy was likely. I can say I have not recovered to this day from my symptoms.
large local reaction with redness and swelling of the deltoid and ipsilateral neck starting the day after injection
Reconstituted with sterile water for injection and not the diluent provided; Reconstituted with sterile water for injection and not the diluent provided; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's Comment: The reporter reported that the patient was administered Menveo which was reconstituted with sterile water for injection and not the diluent provided. The reporter did not have any information about patient or vaccines. The reporter consented to follow up. Additional Supportive Information: The patient was administered Menveo which was reconstituted with sterile water for injection and not the diluent provided, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
About 5 mins after rec'vg all imm. appeared fine; started to stand then fainted x 20-30 secs. Revived w/cool water compress & light stimulation. Remained lying then sitting x 15 more minutes then home w/mom. Sustained no injury.
body is swelling up; Arm is still sore; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (body is swelling up) and PAIN IN EXTREMITY (Arm is still sore) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 SWELLING (body is swelling up) and PAIN IN EXTREMITY (Arm is still sore). At the time of the report, SWELLING (body is swelling up) and PAIN IN EXTREMITY (Arm is still sore) outcome was unknown.            No concomitant medications were provided by reporter.  No treatment details were provided by reporter.   Reporter did not allow further contact
I became pregnant shortly after receiving the first dose receiving the first dose, despite being on hormonal birth control I have come to understand vaccine raises estrogen levels temporarily in women which can cause them to become pregnant.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: Patient was told to be seen same day at a higher level of care.
Flu like symptoms; Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and PSORIASIS (Psoriasis flare-up) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PSORIASIS (Psoriasis flare-up). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and PSORIASIS (Psoriasis flare-up) was resolving.            No concomitant medication information was provided. The patient still got flair ups, she had caused mild flu like symptoms for a day. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was 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.
Info has been received from a health professional concerning a 47 month old white male, with no medical history and no allergies, who on 10/28/02 was vaccinated with a 1st, SC, dose in the left leg of varicella virus vaccine live (lot "02707"). There was no illness at the time of vaccination. It was noted that the pt's mother had shingles "two weeks prior", in 10/05. On 10/20/05, at 10:00 AM, the pt experienced breakthrough chickenpox with many papules and few vesicles. Subsequently, the pt recovered on 12/28/05. There were no lab or diagnostic tests performed. Medical attention was not sought. Additional info has been requested.
Developed hives early 8/25/11 about 8 AM. One hive on face, a couple on legs and arms. As of this moment, hives are still present will fade, then reappear. No respiratory distress. No treatment thus far - ok to give BENADRYL.
Pt experienced atypical chickenpox subsequent to receiving one dose of varicella virus vaccine live. Additional information has been requested.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 11/09/2021. PATIENT FULLY VACCINATED ON 09/25/2021.
Diffuse swelling of (R) thigh progressively worse over 3 days. Prescribed abx, Motrin, Benadryl.