chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt presented to pharmacy for scheduled Covid dose 2 appointment. 1st dose was administered at a different pharmacy chain. Pt did not have CDC card from first dose. Pharmacist at intake verified Pfizer and immunizing technician verified prior to administration patient was receiving Pfizer vaccine. Patient was administered Pfizer vaccine at approximately 5/15/21 11am. Discovered when billing "manufacturer different than initial dose". Upon further investigation confirmed first dose was Moderna. Pharmacist contacted patient to inform her she received Moderna as her first dose and Pfizer as her second dose today. At this time no additional vaccination is recommended. Pharmacist to inform patient's primary care provider, and relay any direction back to patient if necessary. Counseled patient that both are mRNA vaccines and there is not evidence of any increased risk of side effects due to interchange, that interchange is not recommended. Pt did not express concern or have any questions at time of follow up 5/15/21 at 5:41pm. No adverse effects to report at this time.
Got shot, got shingles anyway/Suspected vaccination failure; Got Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's Comment: This case was reported by a patient's friend via interactive digital media. The patient did a shingles vaccine and he got shingles anyway. The reporter stated that his doctor told him 51 percent who got shingles vaccine got shingles anyway. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule ,time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR034659, reported by same reporter, for different patient.; Sender's Comments:  US-GSK-US2023AMR034659:Same reporter
Fever 103 degrees F for few hours on the night of vaccine administration at 4 months.
stomach is off; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach is off), FATIGUE (fatigue) and HEADACHE (headache) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach is off), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, ABDOMINAL DISCOMFORT (stomach is off), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.            No Concomitant information was reported. No treatment information was reported.
Myalgia fatigue, chills, feverish, pain Narrative:  Treated with OTC tylenol 1000mg, capsaicin gel. Event occurred 2/2-2/4.  Other Relevant History:
all over body rash; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Concurrent medical conditions included immunodeficiency (the patient was immunocompromised.).   On 2nd October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. In October 2019, less than a week after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was not recovered/not resolved.   It was unknown if the reporter considered the generalized rash to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not provided. The reporter stated that, the patient was immunocompromised and received dead dose of influenza vaccine and experienced rash all over body. The reporter did not know, what flu vaccine the patient got. There was discrepancy in outcome of generalized rash reported in source document(recovering and resolving) and in database (Not recovered and not resolved).
Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); This is the spontaneous report received from a contactable other health professional. This other HCP (patient) reported for herself that a 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) at the age of 30-years, via an unspecified route of administration in left arm on 19Mar2021 13:00 at single dose for COVID-19 immunization, in hospital. Medical history included PTSD, anorexia, chronic migraines, bradycardia. Patient was not pregnancy at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included propranolol, atorvastatin (LIPITOR), prazosin, alprazolam (XANAX). On 19Mar2021 13:15, the patient experienced allergic reaction-characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling). After medical treatment, hives continued for 3-4 days. The events result in doctor or other healthcare professional office/clinic visit. The patient received high dose diphenhydramine hydrochloride (BENADRYL) and epinephrine (EPIPEN). Outcome of the events was recovered in 2021. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Allergic reaction, Anaphylactic reaction. The case will be reassessed once new information is available. 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
Headache, fever, chills, bones ache; 1 wk p/shot;
<24 hours after H1N1 injection broke out in hives. They have continued intermittently for 2 weeks. Not yet resolved. Injection received at school.
NEw onset atrial flutter with rapid ventricular response resulting in SOB and ? CHF ADmitted to hospital 12/3/2021  for treatment (TEE CV )
overheating, vertigo, tinnitus, eyes get white cobwebs,  profuse sweating. had to start metoprolol due to testing of heart condition.
Received vaccine 5/27/2009 and seen 5/29/2009 with red very swollen arm treated with BENADRYL, ice, Hydrocortisone 1% cream for itching.
Recieved the 2nd dose of Covid on  1/21/2021 at 8am the symptoms started that night around  9pm. Fatigue, achy, and nausea. Wake up at 11pm with fever 104.8, ears pounding, dizziness, swollen elbow and hand pain on same arm of injection. Fever over the next 24hrs went to 105.9. Nausea  and extreme jaw pain and joint pain. fever resolved after 26hrs. Still having dizziness, arm around injection site is warm to touch, swollen, and joint painful. headache and neck pain still. treating with motrin and tylenol that was started 26hrs after the injection.
pt recvd vax 2OCT95 & devel pain, soreness & a 2 inch red area on arm;this is one of three pts from this site to report adverse reactions;pt is recovered;
ARM PAIN; SHORTNESS OF BREATH; DIARRHEA; CHEST PAIN; FATIGUE; STOMACH PAIN; JOINT PAIN; FEVER; HEADACHE; MUSCLE PAIN; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced stomach pain. On 06-MAR-2021, the subject experienced joint pain. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced muscle pain. On 06-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced shortness of breath. On 07-MAR-2021, the subject experienced diarrhea. On 07-MAR-2021, the subject experienced chest pain. On 07-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced arm pain. Laboratory data (dates unspecified) included: COVID-19 rapid POC test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, stomach pain, headache, muscle pain, nausea, chest pain, fatigue, shortness of breath, arm pain, and joint pain, and the outcome of diarrhea was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
A report received from a health professional on 10/22/2002, concerning an 11 month old female vaccinee who inadvertently received the Fluvirin vaccine on 10/11/2002. The vaccinee experienced no adverse event. There was insufficient information to determine the reporter's causality assessment.
About 2 weeks after 2nd dose Istarted having significant pain in hands; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (About 2 weeks after 2nd dose Istarted having significant pain in hands) 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, the patient experienced PAIN IN EXTREMITY (About 2 weeks after 2nd dose Istarted having significant pain in hands). At the time of the report, PAIN IN EXTREMITY (About 2 weeks after 2nd dose Istarted having significant pain in hands) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, X-ray: normal (normal) normal.No Concomitant product use was reported.No treatment information was provided.The patient reported that about 2 weeks after they got the 2nd dose, they started having significant pain in their hands. They told their Doctor, and they took X-Rays of the patient's hands, but they didn't find anything wrong.Reporter did not allow further contact.
hypovolemic( confusion & limpness) episodes on 30JAN98;gen tonic clonic sz on 31JAN97 lasting less than 15min resolved;adm to hosp for 48hr sepsis work up
3 inch red mark below injection site, feel slightly warm and tender, per patient report by phone to pharmacy on 10/16/2020, 2 days later. Advised patient to see urgent care right away.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe
I had what is considered the normal side effects i.e. body aches, joint pain, pain redness and swelling around injection site (both my 3/12 Lot# EN6208 & 3/31 Lot# ER8737 where done in the left arm), low grade fever, fatigue, headache, chills but I think they were all except for headache & fever at a higher degree since I already have issues that cause many of these symptoms.  I feel that they triggered a reaction of my existing conditions.  After the 3/12 dose, it was 4-5 days before I felt better.  I also had on day one a tightness in my chest that I had not had before with the 1st dose where it felt harder to breathe, and a had an intermittent cough.  I am today on the 3rd day after the shot, and I'm still having side effects.  Fatigue, body aches, joint pain, and I've a new one which is a rash on the center of my chest that feels like it may go up under my chin but I'm not sure yet as it hasn't yet as its right under the hollow of my throat.  I have also had very painful areas around my clavicle, in the back of my neck, and I believe I can feel some of my lymph nodes. Since I've had the shot, it is very difficult with these areas of pain despite my normal stretching routine are not releasing. I am hoping that these side effects will resolve like the first dose did in a couple more days.
Breakthrough COVID-19 case with symptom onset 8/24/2021:  Fever >100.4,  Muscle or body aches,  New loss of taste or smell,  Runny nose/Congestion,  Sore throat,  Cough (new onset or worsening of chronic cough),  Shortness of breath or difficulty breathing,  Chest pain,  Fatigue or tiredness,  Nausea or vomiting, Loss of appetite, extreme chest tightening. Hospitalization. Admitted for dehydration and lack of appetite. Went to hospital on 9/1 but not admitted until 9/2. They did a heart catherization because they thought he had blockages based on an EKG on 9/3.
2 days of mild soreness at injection site; swollen lymph nodes under jaw/sore throat and fatigue for 4 days after injection --everything was better after a week.
No additional AE; the vaccine was administered after a temperature excursion; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided.  On 18-JAN-2022, after a temperature excursion, the patient was vaccinated with a varicella virus vaccine live (oka/merck) (VARIVAX), lot # U022321, expiry date 15-JUL-2023, 0.5 milliliter (route and site of administration were not reported) for prophylaxis. The administered dose of vaccine experienced the temperature excursion of -14.1 degrees Celsius for 12 minutes. There was no previous temperature excursion reported. No additional adverse event was reported.
BLOOD CLOTS; HURT ALL OVER MOSTLY LOWER BACK; This spontaneous report received from a patient via a company representative via social media (J and J Corporate) concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: Graves disease (under control). The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse event following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient also received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The drug was associated with off label use (off label dosing frequency, dose number in series 2). The outcome of off label dosing frequency was not reported. The patient additionally received first booster of covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots and was on thinners but hurt all over mostly lower back (Dose number in series 3). Reporter stated that, "I have Graves under control had 2 j j vac and 1 booster now blood clots on thinners but hurt all over mostly my lower back". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots and hurt all over mostly lower back was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20221245467 (dose number in series 2).; Sender's Comments: V0: 20221242050-Blood clots. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Pt came into pharmacy for flu vaccine. About 5 minutes post-vaccination, pt started feeling lightheaded, sweaty & nauseous. I called the ambulance & they arrived around 1:30 PM & took pt's vitals. Pt refused to be taken to the hospital. Pt felt better around 1:40 PM & left the pharmacy.
7/27/21: Patient came to ER due to acute onset chest pain and was found to have a STEMI, patient tested positive for COVID on 7/27/21. He underwent successful PCI s/p placement of DES in RCA.  Patient was CP free after PCI. No COVID-related symptoms noted. 7/28/21: Patient was discharged home  Note: patient previously was vaccinated with the Pfizer COVID-19 vaccine; 2nd dose administered in April 2021.
No Adverse Event; bivalent booster (0.5 ml) instead of the 2nd primary dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (bivalent booster (0.5 ml) instead of the 2nd primary dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No Adverse Event) in a 49-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jan-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 23-Jan-2023,  after starting , the patient experienced WRONG PRODUCT ADMINISTERED (bivalent booster (0.5 ml) instead of the 2nd primary dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (bivalent booster (0.5 ml) instead of the 2nd primary dose of Moderna COVID-19 vaccine) 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 WRONG PRODUCT ADMINISTERED (bivalent booster (0.5 ml) instead of the 2nd primary dose of Moderna COVID-19 vaccine).    Patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medications were not reported.  No treatment information was provided
I got out to my garage to pick up drinks for 5 min and my left leg got a lot of a big spots red   cirles and my right leg got  an spot in dark colour. I am trying to apply aloe vera but it doesnt work.
On  the evening of 4/15 I noticed a sore spot on my left pinky. But I thought maybe my ring finger ring might have been placing too much pressure on it during activities that day. The following morning of 4/16 that sore spot was larger and more tender and I also had several other little red bumps that felt like itchy blisters on the inside of my skin. They were not raised or fluid filled externally. They looked like red spots on various fingers on both hands. They were mostly on the palm sides but I had a few on my right index finger and thumb that were on the backside of the fingers. That day I put some hydrocortizone cream during the day and took Benadryl at night. It felt like it was subsiding  but then flared up again the evening of 4/17. I went into the doctor on Monday, 4/19. I explained that the only thing that was odd in my behavior recently was a miscarriage that began on 4/02 and that I had received the Moderna vaccine on 4/05. Dr. said that it looks like contact dermatitis of some sort and prescribed  Mometasone Furoate ointment USP 0.1%. I place some on my hands on the night of 4/19. The blisters haven't fully gone away, though they haven't flared up or gotten itchy. But on the morning of 4/20 I noticed a soreness on the bottom of my heels. I saw a light red sore spot that feels like a blister on the bottom of my heel. One on each heel. They feel like tender blisters but are not raised
On 10/24 at 2200 patient could not feel his legs, there was a period of paralysis of his legs then spreading to his arms over the 12 -24 hours after administration with symptoms relieving and patient just sleeping thereafter for 2 days
pt recv vax & devel bloody mucous diarrhea w/lot of pus cells 15 days p/vax;bacterial & viral stool cult were negative;rotazyme was positive;
Information has been received from a physician's office. The physician's office reported that they read an article about GARDASIL (MSD) and at the end of the article there was a disclaimer which stated the author's son received MMR II. After receiving MMR II, the author's son developed leukemia. Upon internal review, leukemia was determined to be an other important medical event. This is one of several reports from the same source. No further information is available.
3x5 cm erythematous warm plague. Raised, non pruritic. Location: L deltoid area
Pt. presented to clinic on 2/3/2011 c/o pain in L shoulder, L shoulder blade, and down length of L arm.  Also c/o tingling in L fingers, worse with picking objects up.
No adverse affects for 8 days. Today, major redness, itching, large hard bumps at injection site. Spread to 3 inches in the last 3 hours. The site is very hot to the touch.
07/09/2005 - right thigh swollen - red, hot, temperature 100.3 - gave Motrin, Benadryl and ice to thigh.  07/10/2005 right thigh swollen from inner to outer thigh - swollen hot and hard - to Er, given Keflex.
This spontaneous prospective pregnancy report was received from a physician and refers to a 34 year old pregnant female patient. The patient had no concomitant medication, pertinent medical history, drug reactions or allergies. On 20-SEP-2017 (at which time she was 7 weeks pregnant) the patient was vaccinated with GARDASIL 9, (lot # N012093, expiration date: 13-JAN-2020), (dose, route of administration were not provided). The patient Last Menstrual Period (LMP) was estimated as 02-AUG-2017 (calculated using gestation period at the time of vaccination), estimated Date of Conception: 16-SEP-2017 and estimated Date of Delivery (EDD) was 09-MAY-2018. The exposure to GARDASIL 9 occurred in the first trimester of patient's pregnancy. The pregnancy outcome was pending at the time of the report and the fetal outcome was unknown.