chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 71-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6199), in left arm and on 26Mar2021 as dose 2, single (Lot number: ER8732) at the age of 70 years, in left arm for Covid-19 immunisation; coviD-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), on 04Dec2021 as dose 3 (booster), single (Lot number: 024C21A) for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NYQUIL, start date: 11Apr2022, stop date: 14Apr2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset 11Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 11Apr2022, outcome "recovering" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Apr2022) Positive, notes: home test; (16Apr2022) mildly positive, notes: home test; (24Apr2022) highly positive, notes: home test. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Symptoms of Covid began about 10Apr2022. The patient first tested positive using a home test on 11Apr2022 and began taking Paxlovid on 11Apr2022 and after five days the patient had no symptoms, but still tested mildly positive for Covid using a home test. About five days later on 22Apr2022 the patient had a resurgence of mild symptoms - nasal congestion, a cough and fatigue. Two days later the patient tested highly positive using a home test. Nasal congestion and fatigue have persisted for five days but appear to be receding. The patient had no known allergies. No follow-up attempts are possible. No further information is possible.
she felt sick; Booster; metapneumovirus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2, Solution for injection) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "she's on chemo" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 immunization; Bnt162b2 (DOSE: 2), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "she felt sick"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; METAPNEUMOVIRUS INFECTION (non-serious), outcome "unknown", described as "metapneumovirus".  Additional information: The patient said that she was on chemo and received 3 doses of the Pfizer covid-19 vaccine. The patient said that after the booster shot, she felt sick and doctor said that it was due to a certain type of virus (metapneumovirus) that they don't know much about. She wanted to know if that virus was caused by the Pfizer vaccine.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I had a sore throat, and I was feeling really weak which made me test myself which I was in fact positive with COVID-19.
arthritis has flared up; 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 ARTHRITIS (arthritis has flared up) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (arthritis has flared up). At the time of the report, ARTHRITIS (arthritis has flared up) outcome was unknown.            Action taken with mRNA-1273 in response to the event was reported as not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Treatment information was not  reported.
Nurse reporting expired dose of Engerix-B was administered on 07/24/2023. Dose expired on 07/03/2023.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 72-year-old female patient who received HBV (Engerix B) (batch number F73DG, expiry date 03-JUL-2023) for prophylaxis.   On 24-JUL-2023, the patient received Engerix B. On 24-JUL-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Nurse reporting expired dose of Engerix-B was administered on 07/24/2023. Dose expired on 07/03/2023.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-JUL-2023 Nurse reported patient was administered with expired dose of Engirix B vaccine. The vaccine administration facility was the same as primary reporter. The patient received an expired dose of Engirix B vaccine, which led to expired vaccine used. The reported consented to follow up for safety team.
fluttering of the ear; feels hot; feels like static and is painful; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (fluttering of the ear), FEELING HOT (feels hot) and EAR PAIN (feels like static and is painful) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     Concomitant products included PHENTERMINE for Weight loss.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced EAR DISCOMFORT (fluttering of the ear), FEELING HOT (feels hot) and EAR PAIN (feels like static and is painful). At the time of the report, EAR DISCOMFORT (fluttering of the ear), FEELING HOT (feels hot) and EAR PAIN (feels like static and is painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications provided by the reporter.
On 10/6/14 rec'd flu vaccine in (L) deltoid. By noon was having slight tenderness, swelling and redness. Sought evaluation at office. Was told she strained muscle in neck - had complaint of intermittent burning in left trapezius. Has follow up appointment. Has since had symptom resolution. Not taken off work. No other treatments given.
Information has been received from a 66 year old male with a long history of dermatitis herpetiformis, gastroesophageal reflux disease and hypercholesterolemia who about 3.5 weeks ago was vaccinated with 10 vials +/- monthly of MMR live as treatment for laryngeal HPV. Suspect therapy included dapsone. Concomitant therapy included atorvastatin calcium, glucosamine and omeprazole. Laryngeal HPV was noted about 3 years ago and he has undergone 15 surgeries in a matter of about 2 years, each including massive doses of MMR injected around his vocal cords and IM. To date he had received over 70 vials of MMR. On 6/7/06 the patient experienced increasing fatigue, shortness of breath, joint pains, and generalized weakness. He turned yellow and went to the ED where significant drop in hemoglobin was noted (baseline 15-16, result 6). Dapasone was discontinued and he was transfused 2U PRBC, one each on 6/7/06 and 6/8/06. Prednisone 80mg daily was started for dermatitis herpetiformis flare and he was advised to pursue a gluten-free diet. Multiple radiographic studies and an MRI only revealed a distended bladder. There was no blood in his stool. Follow up hemoglobin from 6/13/06 was 11.5. The patient resumed dapsone with 100mg on 6/13/06 and 50mg on 6/14/06 with rapid relief of dermatitis herpetiformis. Prednisone was decreased to 40mg with the intent to continue a rapid taper. He was to follow up with serial CBCs with his hematologist and was advised to pursue upper GI endoscopy and biopsy. It was reported that the event seemed unlikely to be secondary to dapsone. Re-introduction of dapsone was ongoing. It was reported that the possibility of MMR-related serum sickness should be considered. The patient's adverse events were considered to be other important medical events (OMIC). Additional information has been requested.
pt recvd flu vax in SEP or OCT90; w/in 1 day of vax pt devel shoulder pain; also devel various rashes, the last of which believes is shingles; in addtion pt was dx w/degenerative arthritis which was attributed to flu vax;
big blood clots; heavy menstrual cycle for two times a month; heavy menstrual cycle for two times a month/ Very heavy bleeding. Much heavier than ever before; Started getting much more severe cramping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2022 as dose 3 (booster), single (Lot number: RJ5683) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Fiber, reaction(s): "Known allergies: Fiber"; Penicillin, reaction(s): "Known allergies: Penicillin". Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0168), administration date: 06May2021, when the patient was 16-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0151), administration date: 15Apr2021, when the patient was 16-year-old, for Covid-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "not recovered", described as "big blood clots"; MENSTRUATION IRREGULAR (non-serious), outcome "not recovered", described as "heavy menstrual cycle for two times a month"; HEAVY MENSTRUAL BLEEDING (non-serious), outcome "not recovered", described as "heavy menstrual cycle for two times a month/ Very heavy bleeding. Much heavier than ever before"; DYSMENORRHOEA (non-serious), outcome "not recovered", described as "Started getting much more severe cramping". The events "big blood clots", "heavy menstrual cycle for two times a month", "heavy menstrual cycle for two times a month/ very heavy bleeding. much heavier than ever before" and "started getting much more severe cramping" required physician office visit. Therapeutic measures were not taken as a result of thrombosis, menstruation irregular, heavy menstrual bleeding, dysmenorrhea. Clinical course: After the first vaccine. Patient Started having heavy menstrual cycle for two times a month. Each lasting 10 days. Only getting 10 days off in between periods. Would start having ovulation symptoms in the middle of period. Nothing was able to be found on lab work and ultrasounds of pelvic and uterus. Everything comes back as normal. Period had never been this bad until first vaccine. Has stayed like this until now (17Apr2022). Very heavy bleeding. Much heavier than ever before. Started getting much more severe cramping and getting big blood clots that would not even dissolve in water. Patient did not tested for covid post vaccination. patient did not experienced covid prior to vaccination. Patient did not get administered with other vaccines in 4 weeks.  No follow-up attempts are possible. No further information is expected.
It started with lots of ringing in my ears to the point that it took over my hearing,  then came the tingling in left arm that traveled down to the tips of my fingers, changes in ability to walk, extreme muscle pain throughout body, some sort of feeling like a not in my left arm, then came the sever migraine on the left side of my head accompanied with lots of pressure with loss of touch on the top of my head, sever nose bleed in the middle of the night and included what appeared to be clots and dark red in color, disorientation, the inability to focus, regular noise levels seemed to became louder and slurring with loss of feelings in the left side of my face.
My first Covid Moderna vaccine shot was on 2/25/21. I started having excessive migraines/headaches on 3/1/21. I have had migraines for years and have never experienced this many migraines constantly. I had 34 days of migraines/headaches in 64 days. My second Covid Moderna vaccine shot was on 3/25/21. I called my dr on 4/1 and was subsequently put on 3 different medications to stop the constant migraines. I went into the dr's off on 4/15 for a Urgent dr appt and was given a Ketorolac injection. The 3rd medication started to work after about 10 days. I was on that medicine for 2 months and stopped it about 2 weeks ago. My migraines have increased since so I may need to contact my doctor and go back on that medication. I can't stress enough how unusual it was for me to have the constant migraines and for them not to stop.
Redness at injection site; Itching at injection site; Injection site swelling; Small bumps on skin at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE MASS (Small bumps on skin at injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE MASS (Small bumps on skin at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE MASS (Small bumps on skin at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Benadryl.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
The patient developed a fever of 101.7F with a sudden onset of lethargy, vomiting and perioral cyanosis. These symptoms occurred within 52 hours post vaccination. There was no specific treatment.
dizzy; maternal exposure during breast feeding; headache; Bruising; redness; itchiness; warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruising), ERYTHEMA (redness), PRURITUS (itchiness), FEELING HOT (warm to the touch) and DIZZINESS (dizzy) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced CONTUSION (Bruising), ERYTHEMA (redness), PRURITUS (itchiness), FEELING HOT (warm to the touch), MATERNAL EXPOSURE DURING BREAST FEEDING (maternal exposure during breast feeding) and HEADACHE (headache). On 17-May-2021, the patient experienced DIZZINESS (dizzy). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 14-May-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (maternal exposure during breast feeding) had resolved. At the time of the report, CONTUSION (Bruising), ERYTHEMA (redness), PRURITUS (itchiness), FEELING HOT (warm to the touch), DIZZINESS (dizzy) and HEADACHE (headache) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: TCR received on 18-jun-2021 contains Consent declined to Follow-up.
Patient was experience nausea, dizziness, vomiting, weakness, headache, and chills. It started around 7am on March 3rd, when she woke up. The symptoms lasted almost all day, and he started to feel better around 6:30pm on the same day, March 3rd. He was able to eat and drink at this time without feeling nauseous. On March 4th, he  experienced mild headache and was feeling a little dizzy, but much better. She is able to eat and drink, and move around the house now.
Guardian of PT states that she experienced a very high fever, doctor stated to give TYLENOL.
Recently admitted 8/10 - 8/12/2022 for respiratory failure with hypoxia due to COVID-19 infection. Treated beginning 8/10 with dexamethasone 6 mg remdesivir.  Was requiring 2 L oxygen on 8/10 presentation, was tapered off during hospitalization.  Was not discharged on oxygen, and dexamethasone as well as remdesivir were discontinued on discharge.   Presents again 8/14/2022 for recurrent hypoxia. Requiring 2L O2 again in ER. No other changes in patient status or other symptom D-dimer: pending. Was 1.03 on discharge 8/12 CRP: pending. Was 3.4 on discharge 8/12.
Episode of syncope and collapse at school; hit head, followed by 4-5 episodes of vomiting the following few hours.
Patient called pharmacy today and said she had a rash about 2x3" around the site of injection. Non-painful rash. Informed pt to contact MD if rash spreads or fever develops. Also told pt she could take BENADRYL to help reduce reaction.
Developed numerous bruises on my arms, blood blisters in my mouth and one nose bleed. I waited until I received my second Moderna dose on February 21, 2021 before contacting my hematologist.  I went in for blood work and tested low on platelets at 4,000.  I was admitted to the hospital and was there for 6 days.  I was treated with intravenous dexamethasone, platelets, IVIg therapy and finally 4 weeks of Rituxan.  Platelets finally went up to normal range at the end of March and have remained in the normal range
Developed fever to 103 and vomitted and at 2 months old, developed rash all over (consistant with atopic dermatititis) after PEDIARIX, HIB, PREVENAR, ROTATEQ
Pfizer-BioNTech COVID-19 Vaccine EUA: Shortly after receiving the vaccine patient stated they had chest pain, shortness of breath, nausea, back pain, and sweating. On evaluation a mild systolic murmur and irregular heartbeat were noted. Patient was transferred to the emergency department where initial vitals were within normal ranges except for blood pressure 145/104 mmHg. No wheezing, vomiting, respiratory distress, or anaphylaxis noted. Patient administered aspirin, morphine, acetaminophen, diphenhydramine, ibuprofen,  and ondansetron and symptoms resolved. Repeat vitals were within normal ranges and patient discharged to home stable.
injection site hard; injection site warm to touch; injection site red in a perfect square; injection site started itching; bruising at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Jan-2021 and was forwarded to Moderna on 14-Jan-2021.    A spontaneous report was received from a consumer (United States) concerning a 22 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed bruising, itching, redness, warmth, and hardness at the injection site.   The patient's medical history and relevant concomitant medications were not reported.   On 04 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient experienced bruising at the injection site on 05 Jan 2021.  On 07 Jan 2021 the patient developed itching at the injection site and on 08 Jan 2021 the patient developed warmth, redness, and hardness at the injection site.  A doctor prescribed an anti-inflammatory medication and the patient was advised to treat the events with a cold compress and diphenhydramine.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events bruising, itching, redness, warmth, and hardness at the injection site were not reported.  Reporter causality for the events was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Headache, sensitive eyes, fever for over 18hours, fever over 104. Have a photo of fever 104.1, but it was over that.  Weakness, disorientation, loss of appetite.
reaction to Moderna; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction to Moderna) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (no reported medical history).    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, the patient experienced VACCINATION COMPLICATION (reaction to Moderna). At the time of the report, VACCINATION COMPLICATION (reaction to Moderna) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment details were provided.
tested positive for Covid after getting three vaccines; tested positive for Covid after getting three vaccines; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group for a Pfizer sponsored program. The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administration date 15Aug2021 (Lot number: EW0198) at the age of 73 years as dose 3 (booster), single, administration date 01Mar2021 (Lot number: EN6203) as dose 2, single and administration date 06Feb2021 (Lot number: EM98001) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (ongoing), notes: Diabetes, diagnosed about 30 years ago. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Mar2022, outcome "unknown" and all described as "tested positive for Covid after getting three vaccines". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Mar2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The clinical course was reported as follows: He has had three shots, 2 shots and a booster, last booster was 5-6 months ago. He tested positive for Covid last Thursday, 24Mar2022, states he started the Paxlovid the same day, finished the Paxlovid on Monday this week, 28Mar2022.
Both Knees and Feet have burning and tingling sensation that radiates from knees to toes
Urticaria several weeks following administration of last of three doses of anthrax; urticaria continues and is kept under control by Zyrtec; miscarriage may have been caused by vaccine.