chrisvoncsefalvay/vaers-outcomes huggingface dataset:
JUST A BIG  KNOT IN ARM AT INJECTION SITE; DIARRHOEA; EXTREME LETHARGY; EXTREME FATIGUE; NAUSEA; FEVER/LOW GRADE FEVER; EXTREME ABDOMINAL PAIN 12HRS AFTER INJECTION; UPPER GASTROINTESTINAL GAS; BLOATING; CHILLS AND SHAKING VERY STRONGLY; VOMITING; This spontaneous report received from a patient concerned a 49 year old male. The patient's weight was 260 (unit not reported) and height was 73 inches. The patient's concurrent conditions included non alcohol user, non smoker, type 2 diabetes, hypertension, and pain, and other pre-existing medical conditions included patient had no history of allergy to vaccine, drug, or food. patient had no drug abuse. the patient had no family history of any disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered on left arm on 26-MAR-2021 10:01 for prophylactic vaccination. Concomitant medications included atorvastatin for cholesterol, dapagliflozin propanediol monohydrate for diabetes mellitus, metformin for diabetes mellitus, amlodipine for hypertension, atenolol for hypertension, irbesartan for hypertension, and capsaicin/menthol for pain. On 26-MAR-2021, the subject experienced extreme abdominal pain 12hrs after injection. On 26-MAR-2021, the subject experienced upper gastrointestinal gas. On 26-MAR-2021, the subject experienced bloating. On 26-MAR-2021, the subject experienced vomiting. On 26-MAR-2021, the subject experienced chills and shaking very strongly. On 26-MAR-2021, the subject experienced nausea. On 26-MAR-2021, the subject experienced fever/low grade fever. Laboratory data included: Body temperature (NR: not provided) 100 (unit not specified). On 27-MAR-2021, the subject experienced extreme lethargy. On 27-MAR-2021, the subject experienced extreme fatigue. On 28-MAR-2021, the subject experienced diarrhoea. On 29-MAR-2021, the subject experienced just a big knot in arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme abdominal pain 12hrs after injection, upper gastrointestinal gas, bloating, extreme fatigue, and nausea on 30-MAR-2021, vomiting, chills and shaking very strongly, and fever/low grade fever on 26-MAR-2021, and diarrhoea on 28-MAR-2021, and the outcome of extreme lethargy and just a big knot in arm at injection site was not reported. This report was non-serious.
Nickel sized lump at injection site still very noticeable 12 days after injection. On Sunday evening around 7, started itching and turning red and the lump was no longer noticeable. By 9 there was a ring of welts around the injection site, with a pale area in the middle about 4 cm in diameter. Red, swollen area was 12x14 cm, extending downward from the site in an L shape. Mild pain and stiffness, very warm to the touch. Took 25 mg of Benadryl  at 9 pm with minimal improvement to itching and no other changes to the site.  Had been taking my normal meds throughout the day for a migraine that started 1/16, last dose being 600 mg Motrin just before 9 pm 1/17. Given 10 mg IV dexamethasone by mouth around 10:45 pm. At 8 am 1/18, the site was less swollen, had not extended past markings, and was less warm to the touch. Still some mild pain. Prescriptions for Prednisone 20 mg daily x 5 days and Keflex 500 mg QID x 10 days provided.
This child broke out with the chicken pox. This patient transferred to the us, some of the information I am not sure of.
I had my vaccination in 07/2022. On 11/22/2022 I woke up with tingling on left arm from shoulder to fingers. I could not rotate my shoulder. The tingling and numbness is still present on 01/31/2023. I did physical therapy and I do take a pain reliever.
Walked out of room and 25 yards experienced a syncopal episode/hit head/unresponsive and large jerk one time for 30-40 seconds. Pale afterwards.
shivering; collapsing to the floor; losing control of her bladder; no strength; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 55 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OCREVUS; ATENOLOL. Past drug history included: Amoxicillin, reaction(s): "amoxicillin allergy"; Cipro, reaction(s): "Cipro allergy". The following information was reported: CHILLS (non-serious) with onset 14Apr2021, outcome "recovered" (2021), described as "shivering"; FALL (non-serious) with onset 14Apr2021, outcome "recovered" (2021), described as "collapsing to the floor"; BLADDER DISORDER (non-serious) with onset 14Apr2021, outcome "recovered" (2021), described as "losing control of her bladder"; ASTHENIA (non-serious) with onset 14Apr2021, outcome "recovered" (2021), described as "no strength".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
11/7 - 11/10/13 Pt. may have been exposed to Varicella. His IgG titer was neg. Pt. developed varicella on 11/26/13. Was sent to hospital. Pt was treated for a mild case of varicella with Acyclovir and returned to jail on 12/3/13.
Vaccine was expired on 25-Mar-2022 and was stored in freezer till 07-Apr-2022; Patient administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine) and PRODUCT STORAGE ERROR (Vaccine was expired on 25-Mar-2022 and was stored in freezer till 07-Apr-2022) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 25-Mar-2022 and was stored in freezer till 07-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine) and PRODUCT STORAGE ERROR (Vaccine was expired on 25-Mar-2022 and was stored in freezer till 07-Apr-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The pharmacist reported that they inadvertently administered an expired vaccine to the patient. The vial was taken from the freezer on the morning of 07-Apr-2022 and placed in the refrigerator for use on the same day.  The vial did not undergo any temperature excursions.  No treatment details were reported.   This case was linked to MOD-2022-537781, MOD-2022-537834, MOD-2022-537863 (Patient Link).
2 days of flu-like symptoms post 2nd dose; Post vaccination flare-ups; This is a spontaneous report from a contactable consumer (Patient spouse reported for his wife) via Medical Information Team. A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunisation. It was reported that the patient's spouse queried that had there been COVID-19 vaccine studies looking specifically on Epstein-Barr virus and Herpes II virus, and any related reactions, positive, perhaps lessened viral load, or no reaction. Reporter stated his wife has had post vaccination flare-ups (unspecified condition aggravated), and wondering if there are studies to find and share information. The reporter also stated they both had 2 days of flu-like symptoms post 2nd dose of COVID-19 vaccination on an unspecified date, that cleared. They were grateful and thankful for 'your' work. No product quality complaint was reported. The outcome of the event post vaccination flare-ups was unknown, and outcome of event 2 days of flu-like symptoms post 2nd dose was recovered on an unspecified date.  Information about the Lot/batch number has been requested.
Chills; Fever like 100.2 F; Body aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-May-2021 and was forwarded to Moderna on 13-May-2021.    This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills), PYREXIA (Fever like 100.2 F) and MYALGIA (Body aches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever like 100.2 F) and MYALGIA (Body aches). On 21-Feb-2021, CHILLS (Chills), PYREXIA (Fever like 100.2 F) and MYALGIA (Body aches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient underwent unspecified surgery in her left arm in the past. Concomitant medications were not reported. No treatments were taken  by the patient because she was allergic to Tylenol, so she took it easy and put cold compress in her head.     This case was linked to MOD-2021-135394 (Patient Link).
Initially I just had the tiredness for a couple of days and muscle aches and chills at night and then things seemed to get better. Then sometime in February I became very "spacey", it was hard to remember things that I usually readily knew. I could be talking and forget what I was saying, I am a mental health therapist and I have always been able to remember things that now I cannot recall things that happen the days before. I have a lot of trouble remembering day to day things - very forgetful. Don't seem to retain information well anymore. Slow cognitive functioning that lasted through April and then in May I started recognizing/feeling like it lifted. That fog was gone and I still feel a little spacey every now and then but it is not anything like it was before. I went to my DR about it and she prescribed for me (mid May) supplements that have helped with my energy. I am a very active person normally and I had no energy during this whole time. The fatigue and mental fog were the big things that I experienced. The supplements that she game me were medical grade multivitamin, B vitamins and some other things. With those I have gotten to pretty much normal. My friend that got the same vaccine as me experienced the same exact symptoms and process so I hope that is helpful as well. It lasted about three months for me.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Batch/Lot number: unknown), on 08Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 01May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: testing positive at day 14. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took nirmatrelvir; ritonavir (PAXLOVID) for COVID 19 treatment starting from 19Sep2022 to 23Sep2022. The patient's other medical history was reported as none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After day 2 my arm around the injection site began to burn and ache.  Over the next week it progressively has gotten worse and now , 12 days out, I'm having trouble carrying a coffee cup or stirring with my right hand.  My arm is extremely weak and I'm unable to raise it more than half way up.  Picking up items from above causes me to drop them.  Sleep is impossible.  I'm forced to sleep sitting up, laying on my back is painful.  It doesn't seem to be getting any better.   I will be seeing my family doctor the week of Nov 30th
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored dose of PROQUAD (lot # M017337, expiry date 05-OCT-2017) (dose and route were not reported). No adverse symptoms reported. No further information provided. This is one of two reports received from the same reporter. Additional information has been requested.
pt devel axillary lymphadenopathy coincident w/administration of flu vax;
Patient experienced soreness at the site of injection and the area was inflamed.  The ADR has subsided now that since she has applied ice and taken a pain reliever.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Additional Details: patient called in this morning (12/15/21) at 09:09 Am. He sataes that a has rash around he's neck and chest area ever since he got the pfizer booster dose. He's 1st and 2nd covid vaccine was Moderna vaccine. He took Benadryl and not helping him.
Given her history of large local reactions to the flu vaccine, we administered the doses according to a graded protocol as reported in the Guidelines. She received all doses with a 15 min observation after each dose. After her last dose she developed throat itching and clearing followed by eye itching and watering and then progressed to difficulty swallowing. She was given BENADRYL, steroids and epinephrine and sent to the ER for a 4 hour observation. The following day she continued to have a large local reaction larger than the day before. No systemic symptoms on day 2.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 47 years, in left arm 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 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Note:  I'm not sure if this adverse event is due to the vaccine, or due to actually getting Covid in July 2021 (breakthrough).  But I wanted to file report. Symptoms:  periodic fatigue and mild stomach ache every few months.  But then that led to acute inflammation of stomach (gastritis), and sinus infection, and tinnitus - all at the same time, starting Feb 2022.  Treated the sinus infection with antibiotics, and the stomach tended to recover.   Tried Prednisone for 10 days for the ears/tinnitus, but had no effect. Dealing with constant tinnitus now, with mild headache, slight runny nose, sinus pressure, and fatigue.  Never had this issue before.  Seems to be related to either getting Covid, or, the vaccines (J&J initial shot, and Pfizer booster).
serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.; serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.), POOR QUALITY PRODUCT ADMINISTERED (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.), POOR QUALITY PRODUCT ADMINISTERED (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.) and POOR QUALITY PRODUCT ADMINISTERED (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.) outcome was unknown.            Concomitant products were not reported.  It was reported that unknown number of patients where vaccinated in a mobile unit after a serious of excursions happened to some vials of Moderna COVID-19 Vaccine bivalent from 21-Nov-2022 to 8-Dec-2022. Age group was from infant to adults.  Treatment medications were not reported.
I did not experience anything until 12 hours later. Severe hard cramping in both of my legs and feet while I was sleeping. The next day the fatigue was normal but the leg cramping is worse. I still have the leg cramping. I did an ultrasound for blood clotting and blood work. It was a week after the vaccine and you were still feeling it. The tiredness went away but the cramping is still present. It skipped a period and you have had a very inconsistent cycle. My period seems to be normal now but that was after the vaccine was administered.
Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer (Office Staff). This case is linked to cases 2018SA393504 same reporter. This case involves a 6 months old male patient who received 0.25 mL dose of vaccine PENTACEL lot C54009AA, expiry date: 10-Oct-2019 via intramuscular route in the right arm on 07-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique and vaccine underdose. It was reported that 6 months old males were administered 0.25 ml, IM injections, of the powder part of the PENTACEL vaccine that were diluted with sterile water. It was unknown if any adverse event was occurred. 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 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. Documents held by sender: none.
had febrile convuls 9 days later febrile convuls in sibling;also rxn was probably not d/t vax as child devel gastroenteritis assoc w/fever several days subsequent to febrile convuls;
Patient came in for a well check and the parent requested the COVID-19 vaccine (Moderna) I had made an error I documented that the patient was 6yrs but the patient was 5yrs. So the patient got a dose of 0.5 mL instead of the normal dose which is 0.25 mL I had given the patient the 6yr-11yr Moderna series 1st dose. I should have given the 6 mon-5yr Moderna series instead. The parent was informed that the patient may have a very sore leg due to the higher dose.
Janssen COVID-19 Vaccine EUA Chills, fever and headache for approx 40 hours.  Controlled with Tylenol.  Fine after that.
Breakthrough COVID: 59-year-old male No known medical hx. Patient stated, ongoing right throat pain and increased mucus production that caused him to have decreased oral intake.  He stated this has been going on for months. In February for similar complaints and at that time he tested positive for COVID 19.  He was discharged to follow up with true Health and he has an appointment for March 9th.  He stated he has not received any treatment for COVID but denies fever, chills, shortness of breath, nausea, vomiting or headache.In the ED he was slightly tachycardic, afebrile, oxygen saturation 100% on room.  Soft tissue mass along the left hemichest wall causing destructive changes of the sixth rib. FIrst Dose 10/14/21.
Patient experienced erythema and swelling from his shoulder all the way down to his knuckles.  He said his shoulder was tender and he had a burning sensation.  When he came today (9-23-19), there was mild erythema with swelling;  the swelling near the wrist and hand was very pronounced.  The patient said he had the shot on 9-19-19 and the side effect occurred on 9-20-19.    He started an antibiotic on 9-21-19.   Today, he was evaluated by his pcp and they started him on a Medrol dose pack.  If his arm is not better tomorrow, he will be getting a Doppler done.
Extreme low blood pressure at 80/40, fainting, low grade fever, headache, mild nausea
1st dose a year ago, 2nd dose has not been administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 11th November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received the first dose of Shingrix a year ago and the 2nd dose has not been administered yet. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Tingling all over, eyes and lips felt itchy Tingling in L arm down to the #4/5 fingers Narrative: