chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaginal fistula; Vaginal discharge; Post procedural complication; Post procedural fistula; Skin rash; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4381812-00 (Company).  A 51-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at cf, subcutaneous for psoriatic arthropathy, psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VAGINAL FISTULA (hospitalization), outcome "not recovered"; VAGINAL DISCHARGE (hospitalization), outcome "unknown"; POST PROCEDURAL COMPLICATION (non-serious), outcome "unknown"; POST PROCEDURAL FISTULA (non-serious), outcome "unknown"; RASH (non-serious), outcome "not recovered", described as "Skin rash". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of vaginal fistula. Clinical course: On unknown dates, the patient experienced Fistula She was hospitalized after developed a fistula. Surgery was preformed to remove the fistula. Then, she developed vaginal leaking and another fistula. She was scheduled to have the surgery done again. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient had rashes on both elbows, that she and her physician hoped the Humira would clear up, but it had not.   The reporter considered "vaginal fistula", "vaginal discharge", "post procedural complication", "post procedural fistula" and "skin rash" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.  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.
No adverse event; accidentally got two updated boosters/Moderna bivalent booster on 28Sep2022 and 22Dec2022 (lot number 011H22A); This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (accidentally got two updated boosters/Moderna bivalent booster on 28Sep2022 and 22Dec2022 (lot number 011H22A)) and NO ADVERSE EVENT (No adverse event) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Dec-2022, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .5 milliliter. On 22-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (accidentally got two updated boosters/Moderna bivalent booster on 28Sep2022 and 22Dec2022 (lot number 011H22A)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (accidentally got two updated boosters/Moderna bivalent booster on 28Sep2022 and 22Dec2022 (lot number 011H22A)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (accidentally got two updated boosters/Moderna bivalent booster on 28Sep2022 and 22Dec2022 (lot number 011H22A)).    It was reported that patient did not receive any vaccine four weeks prior to covid-19 vaccine and had no information about Covid-19 vaccination dose.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.  It was reported that the pharmacist states the patient did not have her previous vaccinations at her pharmacy, so she doesn't have the records. She does not have an email address, so consent was given for safety to contact the pharmacist by phone.
Loud constant ringing in ears; A bit of vertigo; Muscles were so painful and got worse everyday; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 14Apr2021 at 11:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included interstitial cystitus, pseudo tumor cerebri, ebstein barr virus (EBV), gluten sensitivity and allergy to dairy products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included metformin hydrochloride (GLUMETZA), thyroid (ARMOUR THYROID) and alprazolam (MANUFACTURER UNKNOWN); all from an unknown date for an unspecified indication and unknown if ongoing. The patient previously received tetracycline (MANUFACTURER UNKNOWN) and sumatriptan succinate (IMITREX) from an unknown date for an unspecified indication and experienced drug allergy. On 15Apr2021 at 08:00, the patient experienced loud constant ringing in ears, a bit of vertigo, and her muscles were painful and getting worse every day. Patient stated that the ringing in ears started morning of 15Apr2021 same with the vertigo, and muscle pain was progressively getting worse. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events loud constant ringing in ears, a bit of vertigo, and muscles were painful and getting worse every day were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium, Additional Details: Patient fainted after receiving 1st Pfizer COVID 19 vaccine. Paramedics were called and patient came to fairly quickly. He did bite his tongue and had some bleeding. Heart rate and pulse were elevated.
A medical student reported that a 6 month old female received her third dose of Prevnar (lot # 474730) on 9/11/01. On 2/7/03, at 23 months of age, the child was seen by the physician for temperature and cough. She was seen again on 2/12/03, with rapid respirations and was sent to the hospital. Lab tests were performed and a bacterial blood culture obtained on 2/11/03 yielded strep pneumonia, serotype 19. The child was diagnosed with pneumonia and empyema. The reporter indicated that the patient came down with the serotype infection that was contained in the vaccine. The child was discharged to home taking ampicillin for three additional weeks and recovered. At present the child is being followed by an infectious disease specialist.
4 hours after immunization patient developed bilateral conjunctivitis that was fairly severe and accompanied with conjunctival ulceration.
Body aches; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), HEADACHE (Headache) and PYREXIA (Fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to molds, Dust allergy, Drug allergy (Allergy to botox), Drug allergy (Allergy to Celebrex), Drug allergy (Allergy to Combid), Drug allergy (Allergy to Flagyl), Drug allergy (Allergy to Librax), Drug allergy (Allergy to Bentyl), Seasonal allergy, Irritable bowel syndrome since 1973, GERD since 2004, Headache (Headaches9tension, vestibular.) since 1973, Diverticulitis since 2010, Drug allergy (Allergy to Iodylpropynl butylcarbamate), Reaction to flavouring (Allergy to balsam), Drug allergy (Allergy to phenylenediamine), BPPV (occasionally), Osteoarthritis of cervical spine, Osteoarthritis of lumbar spine, TMJ syndrome (TMJ disorder), Myalgia and Arthralgia. Concomitant products included MECLOZINE HYDROCHLORIDE (ANTIVERT [MECLOZINE HYDROCHLORIDE]) for BPPV and Headache, FAMOTIDINE (PEPCID [FAMOTIDINE]) and PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) for GERD, ATROPINE SULFATE, HYOSCINE HYDROBROMIDE, HYOSCYAMINE SULFATE, PHENOBARBITAL (DONNATAL) for Irritable bowel syndrome, ALPRAZOLAM (XANAX) for Irritable bowel syndrome and TMJ syndrome, AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE (DYMISTA), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA ALLERGY) for Seasonal allergy, BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for Tension headache, ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 14-Jan-2021 at 2:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced MYALGIA (Body aches), HEADACHE (Headache) and PYREXIA (Fever). In January 2021, MYALGIA (Body aches), HEADACHE (Headache) and PYREXIA (Fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided.   This case was linked to MOD-2021-386996, MOD-2021-387042 (Patient Link).
Fatigue, arthralgia's, fever, weakness vomiting, swelling at site of injection.
Swelling of cheek and eye area.  No hives or difficulty breathing.  Patient stated it lasted about 3 days then stopped.
Diarrhea (2 days),  sore throat (several days),  headaches (2 days),  dizziness (2 days),  loss of sleep (14 days) cough (7 days)
Red, round, raised rash around injection site. Didn?t appear until 10 days after injection
1/5/2021 0718 Pt received 2nd COVID vaccine 1/4/21. Oral temp 100.6, near syncope, muscle aches and head aches. Per EMS NSR, denies SOB, and chest pain. 500 ml bolus received in route. In ED, Pt c/o nausea. Pt anxious, sweating and uncomfortable. 0855 Pt resting comfortably, reports decease in pain/body aches 4/10. 1043 Discharge disposition: home.  Accompanied By: self.  Mode:  walk.
Skin discoloration/redness and site painful over course of 1 day. No s/s inf. noted. Outline of redness marked to monitor progress. Advised to monitor closely and administer ibuprofen as needed.
Initial report was received from a health care professional on 13 January 2012. A female patient (age and date of birth not reported) had received an injection of FLUZONE HIGH-DOSE, sanofi pasteur Inc. (lot number, route, site and date of administration not reported) and an unspecified amount of time later, the patient developed numbness and tingling in the extremities. The patient has had ongoing complaints for the past several months. The patient saw a neurologist and the doctor told her that was the side effects were a result of the FLUZONE HIGH-DOSE. Past medical history and concomitant medications were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Employee calling to report a reaction after receiving a COVID-19 vaccine.    Vaccine Name -  Pfizer  Vaccine Lot # - EK5730  Vaccine Date and time  - ?12/18/2020 @ 5:30pm    Is this your first or second dose? First  Date and time of symptom onset - ?12/22/2020 @ 9:00am    Symptoms - ? mild dizziness, feeling hot but no fever, very mild sore throat, intermittent cough, fatigue  Last day of work and shift - ?  12/22/2020 7a-3p  Home remedies?  none  Any improvement? -  n/a  Recommendation?  Employee asked her manager to go home early because of her symptoms. She wanted to be tested cause her family from out of states are coming over for the holiday. Advised to continue monitoring at home & call us back if symptoms worsen.  Employee voiced understanding Employee of information ? yes  Employee voiced any concerns ? no    Employee?s questions answered to employee?s satisfaction - yes
Only 5/5: rash (small, red spots) initially seen on left arm. By Fri 06/21, rash had spread to right arm, face, and chest. Rash became confluent. No treatment.
9 days after the second shot I experienced whAt had been diagnosed as an ocular migraine by 2 separate physicians, an urgent card and retinologist. Three days later an mri diagnosed a 2 mm finding in my thalamus.
General lousy feeling; fever started sometime p/shot; tongue feels like its burning, throat feels like its burning; has lost 10 lbs;
Pfizer 11/5/21, 11/26/21, 3/26/22. Positive on 6/11/22
Patient developed proteinuria and alkaline urine pH (it was 9.0) 3 days after her vaccine was administered.
Received pneumonia vaccine R deltoid. Few cm below injection site-red raised hot to touch 25 cent size now but approximately 50 cents on Mon 11/18. Area sore has gradually ? H/A all over head, photophobia, occ. blurred vision, heart racing 1 1/2 hr felt weird.
A itchy rash starting day 3 or 4 , increasing in size and intensity, continuing through day 14 (today. ) about 3 cm  now
Information has been received from a 71 year old female with allergy to morphine and a history of previous stroke who in December 2008, and on 19-JUN-2009 was vaccinated with the first and second dose of ZOSTAVAX (Merck) (injection, dose and lot# not reported). Concomitant therapy included simvastatin (MSD), minerals (unspecified) (+) CENTRUM SILVER, Fish Oil and COSAMIN DS. On 19-JUN-2009 the patient had a rash and had severe pain around her chin area and up to her ears. The patient was having difficulty breathing and could not speak. The patient was taken to the hospital and was hospitalized. In June 2009, the patient recovered. No lab diagnostics study was performed. Additional information has been requested.
Patient received the vaccine and about 3 minutes after she described a warm flushing feeling when it was injected, and tingling. No shortness or breath or chest pain, patient was removed from cell and taken to the observation area, her chest  was red and  flush. her blood pressure at 1145 was 178/122 and heart rate 89 and pulse ox 95% in her let wrist, patient was placed on litter and laid down, she was observed . Follow up blood pressure at 1208  on her left wrist was, 167/112, HR 87, pulse ox was 99 on room air. Blood pressure check in her right wrist was 175/99 . Patient stated that her symptoms were resolving with additional observation. Patient was then placed on the edge of the bed for additional time and patient was released from observation at 1215.
Doctor self disclosed that he administered patient 0.1 ml IM of Moderna vaccine .  Patient was notified via telephone and instructed to return to the site were she received a full dose (0.50 ml) of the Moderna vaccine as instructed by HCP. No side effects reported by patient after administration or during resting period of 15 minutes. Supervisor notified and all vaccinators reminded that 0.5ml is the recommended dose for the Moderna vaccine.
Right thigh at injection site developed deep red indurated plaque about 5" within 24 hours of vaccination. Treated with cool compress and Benadryl.
redness; soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2018, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 15th September 2018, 6 hrs after receiving Shingrix, the patient experienced pain in arm. On 16th September 2018, the patient experienced erythema. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm and erythema were recovered/resolved.   It was unknown if the reporter considered the pain in arm and erythema to be related to Shingrix.  Additional details were received as follows: The patient presented with arm sore and the next morning she had some redness.  In 2018, the symptoms resolved after a couple days.  The reporter did not consent to follow up. For tolerance to next dose, refer case US2018GSK220697.
arthritis flared up; rash; headache; muscle pain; dizzy; tired; cold; warm; ringing in her left ear; lethargic; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (arthritis flared up), FEELING COLD (cold), FEELING HOT (warm), TINNITUS (ringing in her left ear) and LETHARGY (lethargic) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tinnitus since 03-Feb-2021, Rash since 03-Feb-2021, Headache since 03-Feb-2021, Muscle pain since 03-Feb-2021, Dizzy since 03-Feb-2021 and Arthritis.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced FEELING COLD (cold), FEELING HOT (warm), TINNITUS (ringing in her left ear), LETHARGY (lethargic), MYALGIA (muscle pain), DIZZINESS (dizzy) and FATIGUE (tired). On 28-Jan-2021, the patient experienced ARTHRITIS (arthritis flared up), RASH (rash) and HEADACHE (headache). On 28-Jan-2021, ARTHRITIS (arthritis flared up), FEELING COLD (cold), FEELING HOT (warm), TINNITUS (ringing in her left ear) and HEADACHE (headache) had resolved. On 30-Jan-2021, MYALGIA (muscle pain) had resolved. On 01-Feb-2021, RASH (rash) had resolved. At the time of the report, LETHARGY (lethargic), DIZZINESS (dizzy) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced PYREXIA (Low grade fever). At the time of the report, PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.   No treatment drug was reported.
Bad reactions to covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Bad reactions to covid-19 vaccine) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and Panuveitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced IMMUNISATION REACTION (Bad reactions to covid-19 vaccine). At the time of the report, IMMUNISATION REACTION (Bad reactions to covid-19 vaccine) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       The patient had last surgery on hand. She was recovering from surgery and stitches. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter. 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.
Lymph nodes in armpit of arm of injection site.  Constant, throbbing pain in right armpit that is now radiating to the back of my right arm.
Pemphigoid/it was Bullous, it was Pemphigoid; Has horrible blisters on her skin which are infected, swollen and leaking; Affecting immune system; Stressed out; This is a spontaneous report received from a contactable reporter(s) (Consumer) from medical information team. The reporter is the patient.  A 50-year-old female patient received bnt162b2 (BNT162B2), in 2021 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: PEMPHIGOID (medically significant), outcome "unknown", described as "Pemphigoid/it was Bullous, it was Pemphigoid"; SKIN INFECTION (medically significant), outcome "unknown", described as "Has horrible blisters on her skin which are infected, swollen and leaking"; IMMUNE SYSTEM DISORDER (medically significant), outcome "unknown", described as "Affecting immune system"; STRESS (medically significant), outcome "unknown", described as "Stressed out". The events "pemphigoid/it was bullous, it was pemphigoid", "has horrible blisters on her skin which are infected, swollen and leaking", "affecting immune system" and "stressed out" required physician office visit. Therapeutic measures were taken as a result of pemphigoid, skin infection. Clinical course: Patient stated that she had the Pfizer covid vaccine two years ago and it was affecting her immune system. She had been diagnosed with pemphigoid. She had horrible blisters on her skin which were infected, swollen and leaking. She had seen her primary doctor and two dermatologists and had been given creams and antibiotics. They all thought it was related to the vaccine. She read on the internet that pemphigoid and autoimmune arthritis had been reported with the vaccine. She had an appointment to see a specialist in 3 weeks but she was calling Pfizer to find out what to do about it. She was so stressed out. She wanted to talk to a medical doctor at facility because she had Pemphigoid from some immune system disease, rash whatever on her skin that was infected that she could not get help from any doctor. When paraphrased the above concern, she stated that it was not a rash it was Bullous, it was Pemphigoid, one of the side effects from Pfizer Vaccine.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Mild erythema and edema at injection site 2 days after immunization. Low grade temp 99 degrees F. Treated with anti-inflammatories and anti-histamine.