chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 14 year old daughter who on 11-JUL-2007 was vaccinated with her first dose of GARDASIL vaccine (yeast). On 01-AUG-2007, 20 days after receiving the first dose, the patient "came down with what was labeled a summer virus by her doctor". Her symptoms included fever of 103 which lasted a full 6 days accompanied by extreme achiness throughout her body and blisters which lined her throat. On 20-SEP-2007 the patient received her second dose of GARDASIL vaccine (yeast). On 02-OCT-2007, 12 days after receiving the second dose, the patient came down with the exact same symptoms she had in August. At the time of the report she was into the third day of symptoms with no relief. The reporter indicated that "the vaccination is the only common denominator in both instances. I spoke with my daughter's doctor regarding the possibility of my daughter's condition being a result of a reaction to the GARDASIL vaccine (yeast). She explained that because the drug is so new, there are not enough documented cases yet by which to make a conclusion and suggested, rather, that it is purely coincidence. They advised that if my daughter came down with the same symptoms after her third shot this coming January, it would most likely be attributed to the (vaccine) and would have to be reported. I am not certain I want to wait and experiment in such a way with my child's health. This virus or whatever it is she has really knocks her off her feet. Her throat is so sore that I have to coax her to eat mashed bananas.. She really suffers with it and, therefore, I am considering not going through with the third shot. I understand that all three shots are needed in order for the vaccination to be effective, but at this point, I am more concerned about the suffering my child has had to endure as a possible result of the vaccination. Additional information has been requested. Follow-up received 04/16/2008 indicated that the consumer received the third dose of the vaccine on 26-JAN-2008. The consumer's sister also had a similar reaction to GARDASIL (WAES#0710USA03615). Additional information has been requested.
High fever (103.1F), difficulty urinating and sever chills within 12 hours of vaccination.  Maintaining 100F fever 24hrs post vaccination
Tongue soreness; Anxiety; This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an intramuscular route of administration in the left arm on 22Feb2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications were not reported. On 22Feb2021, the patient experienced tongue soreness and anxiety. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events tongue soreness and anxiety was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected
Painful shot, difficult to lift arm for 2 days, shivers, 102 degree fever, fast hearthbeat within a couple of hours lasting till morning weakness, tired, no appetite (might be sick but wasn't) lasted for about 1 1/2 weeks.
Fever up to 101.8 before taking Tylenol at 2:30 pm on January 30, 2021. Fever started at 6:30 am that morning. Intense fatigue and moderate headache. I had joint and body aches. I experienced lightheadedness when I got up when fever was 101.8 at 2:30 pm.  I had to lay down again and apply a wet towel. Once I felt able to walk (about 10 minutes later) I ate a popsicle and then proceeded to take two 325 mg of Tylenol. Within 30 to 45 minutes fever subsided. I then ate soup, crackers and an orange and drank cranapple juice. I went back to bed and slept some more. I woke up at 5 pm and had a cup of soup, a quarter of an apple and gatorade. At 9 pm I took two more Tylenol to be safe and when to sleep. Sunday I was fine. My arm, never was swollen only a little sore.
Information has been received from a physician concerning the patient who was vaccinated with the first dose of GARDASIL. She asked "what is the incidence of rash after GARDASIL? should patient receive second and the third doses?" A follow-up voice mail received from the physician stated that the reporter did not have any questions about the GARDASIL and/or rash. Additional information has been requested.
Headache, Fever, FATIGUE SWELLING Narrative: Seen on 12/23/22 at facility EH
From correspondence received at manufacturer on 12/4/01 it was reported that a 48 year old female patient received a Fluzone SV 2001-2002 vaccination administered on 11/20/01. Within 6-9 hours that patient developed aching joints and dull ache at the injection site--unresolved.
Shortness of breath; Really bad runny nose; Cough; It was like a drum on back of ear drum; Racing in chest; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), RHINORRHOEA (Really bad runny nose), COUGH (Cough), TINNITUS (It was like a drum on back of ear drum) and PALPITATIONS (Racing in chest) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003F21A, 003A21A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced DYSPNOEA (Shortness of breath), RHINORRHOEA (Really bad runny nose), COUGH (Cough), TINNITUS (It was like a drum on back of ear drum) and PALPITATIONS (Racing in chest). On 21-Nov-2021, DYSPNOEA (Shortness of breath), RHINORRHOEA (Really bad runny nose), COUGH (Cough), TINNITUS (It was like a drum on back of ear drum) and PALPITATIONS (Racing in chest) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that he had a bunch of concomitant medications which were not provided. Treatment information was not provided.  Patient stated that there was no cardiac history or diagnosis of Myocarditis/ Pericarditis until the day of report. And stated that the heartbeat slowed as of 21-Nov-2021 morning.
Right anterior thigh-whole leg swollen (diffusely) treated with Keflex.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included cold sores (usually in winter). On 28th February 2019, the patient received SHINGRIX (intramuscular). On 28th February 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 5th March 2019, the patient experienced cold sores. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the cold sores was not recovered/not resolved. It was unknown if the reporter considered the pain in arm and cold sores to be related to SHINGRIX. Additional details were provided as follows: The patient experienced sore arm for couple days and also developed cold sores after receiving SHINGRIX vaccine.
Pulmonary Embolism - desaturating to the 70's on admission, requiring 4L NC oxygen supplementation and heparin gtt
Red rash developed gradually increasing:  beginning back of upper left arm (site of injection), increasing in size and itching over next 4 - 5 days to include back of right upper arm, chest, shoulder area, face (mask appearing) to tope of scalp.  Seen by medical provider.  Declined Benadryl capsules.  Rash persisted 10 - 14 days.  Gradually subsided by 3 weeks.  Treatment:  increased water intake.
sweating; Fever of 99; Stomach is upset; Doesn't feel well; his back hurts; Left arm is sore; violent chills; dose of bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EM9809; Expiration Date: 30Jun2021), dose 1 via an unspecified route of administration, administered in Arm Left on 20Feb2021 as DOSE 1, SINGLE for covid-19 immunisation (age at vaccination 68 years). Medical history included pre-diabetes, vitamin d deficiency, borderline for high blood pressure (The patient won't let his doctor put him on a blood pressure medication. Clarified caller has not yet been prescribed a blood pressure medication), EHD, Covid-19 from an unknown date and unknown if ongoing. Caller stated that he got COVID shot on Saturday, 20Feb2021. Had multiple reactions to it. Left arm is sore of course, which is no big deal. Each night for the last two nights, has woken up around midnight and has been violently chilled. So chilled that he couldn't even open a bottle of Tylenol. He took some Tylenol and then was sweating profusely about an hour later. He is not allergic to anything. He got a fever today of 99 and of course doesn't feel good. Reported all symptoms on online report except for fever of 99, stomach is upset, and didn't feel well. Patient is normally an energetic person. Fever of 99 Started at 5AM, 22Feb2021. Was sweating profusely. Noticed he wasn't feeling well yesterday when he got out of bed after violent chills. Chills kept him up in the night. Night before Saturday, he got up late after he finally had some Tylenol. Took some Tylenol and the violent shaking stopped hours later. He was able to get a little bit of rest. Same thing happened last night. He shook so hard his back hurts. Left arm is injection arm. His arm was sore. Feels like when he was a kid and the neighborhood bully pounded on him. It began 15 minutes after the COVID shot and has been that way. He took two different types of Tylenol. He took capsules the night before last and is not sure he can read the print on the packaging. It is small print on the pill. His girlfriend left him a handful red and blue gel capsules with powder in the middle. He used those last night. He used the hard pills the night before. Has heard the second COVID shot is worse than the first. If it is worse, he is not sure he wants the second COVID shot. Asked if having COVID impacts his physiology of getting a shot for COVID. Asked if it make any difference in getting the COVID shot. The outcome of the event left arm is sore was recovered and outcome of other events was unknown.   Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Pt received 2nd dose Moderna vaccine 0.5 ml. @ 1234 PT reported feeling itchy legs vs 155/103 100%on RA hr 92. Observation pt has patchy redness on bil face. PT reported as new. Pt given Benadryl po x1 and transported to urgent care. In transport pt began coughing worsening in route to urgent care. Report given to urgent care triage RN who routed pt to ER. Pt transported to ER report given to ER triage RN who accepted pt.
07/03/2021- trouble breathing and dry mouth.  Two weeks after I went to see my doctor. He gave me a steroid. I was diagnosed with sleep apnea 3 weeks, about 04/04/2022. I did not have that problem before the vaccine. I was given a  folic acid prescriptions, I have to fill once a month and I was put on a CPAP machine.  I have to  visit my doctor every 90 days and they do blood work so they can get me off of the folic acid prescription.
Moderna COVID-19 Vaccine EUA; Booster; Warm reddish around injection site size tennis ball not swollen.
Passed out; Sweats; Lightheaded; Fatigue; Chills; Nausea; Vomit; Headache; A spontaneous report was received from a consumer concerning herself, a 68 year old female patient who experienced passed out/loss of consciousness, sweats/hyperhidrosis, lightheadedness/dizziness, fatigue/fatigue, chills/chills, nauseas/nausea, vomit/vomiting, headache/headache.  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received her first of two planned doses of mRNA-1273 on unknown date for prophylaxis of Covid-19 infection.  On 01-Mar-2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (Batch number 014M20A) intramuscularly into her left arm for prophylaxis of Covid-19 infection.  On 02-Mar-2021, the patient stated she "passed out", she also experienced sweats, lightheadedness, fatigue chills, nauseas, vomit, and headache.    No other treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The events, passed out/loss of consciousness, sweats/hyperhidrosis, lightheadedness/dizziness, fatigue/fatigue, chills/chills, nauseas/nausea, vomit/vomiting, headache/headache.was considered unknown.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Fatigue, chills vomiting, headache and nausea are consistent with the known safety profile of the vaccine
This spontaneous report was received from a physician refers to a male patient of unknown age. The patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23. On an unknown date, the patient experienced high fever of 104 degrees, aches and pain, dizziness and excruciating pain in the armpit area after receiving the vaccination. The outcome of the events were unknown at the time of this report. This is one of the several reports received by the same reporter. Additional information has been requested.
This is serious spontaneous case, initially received on 26-Jan-2018 from a male patient (physician) of unspecified age. On an unspecified date, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location, batch number and expiry date: not reported). On an unspecified date, after the vaccination (reported as later this season), the patient developed flu. This case was associated with product quality complaint, hence quality assurance investigation (QAIR) had been requested and the corresponding QAIR reference number was 1028319. It was reported that, as the batch information was unknown for the complaint, a detailed batch level review was not performed. A holistic review of the manufacturing process was performed and based on the investigation performed, it was concluded that, there were sufficient controls in place (in the manufacturing process of both multi-dose vials and pre-filled syringes) to ensure that FLUCELVAX vaccine was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the lack of efficacy complaint was the result of the manufacturing process (fill finish and bulk). Therefore, no internal root cause was confirmed. At the time of this report, the outcome of the event flu was not reported. Non-significant follow-up received from quality assurance department on 01-Mar-2018: The QAIR number (1028319) was updated. Follow-up received from the quality assurance department on 12-Apr-2018: It was reported that, as the batch information was unknown for the complaint, a detailed batch level review was not performed. A holistic review of the manufacturing process was performed and based on the investigation performed, it was concluded that, there were sufficient controls in place (in the manufacturing process of both multi-dose vials and pre-filled syringes) to ensure that FLUCELVAX vaccine was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the lack of efficacy complaint was the result of the manufacturing process (fill finish and bulk). Therefore, no internal root cause was confirmed.
immediately following my left arm got a hot sensation, my hand went numb, and my fingers tingled.  1 hour later I was nauseated and I had flu like symptoms, body aches, chills and a horrific headache.  By 4th hour I needed to go to bed.
Received rabies immunization on 06/27/2006 at 18:40.  He states about 1 hr after shot he started diaphoresis that lasted 1 week.  He states he also had joint pain and swelling, intermittent nausea and vomiting, and soreness at injection site starting 06/23/2006 and lasting 3-4 days.
symptoms of COVID; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (symptoms of COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION COMPLICATION (symptoms of COVID). On 02-Jan-2021, VACCINATION COMPLICATION (symptoms of COVID) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Rash, ErythemaMultiform, p vaccine day 1-3 soreness. 1/11 rash, redness and lump at injection site, warm to touch and bothersome. Narrative:  p vaccine day 1-3 soreness. 1/11 rash, redness and lump at injection site, warm to touch and bothersome. Taking benedryl and aleve PRN. Enouraged to contact PCP if symptoms worsen or it is not relieved past day 10 p vaccine.
Information has been received from a pharmacist concerning his 33 year old wife with no medical history and no drug allergies who was vaccinated with a dose of MMR II as a child. There was no concomitant medication. Recently a measles antibody test performed which showed that the patient was found to have a low measles antibody titer. At the time of the report, the patient had not recovered. No further information is available.
minor sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 2, Single), administration date: 01Apr2021, when the patient was 60-year-old, for Covid-19 immunization, reaction(s): "Atrial fibrillation", "heart palpitations", "some very slight lesser functioning on the left side of her heart"; Bnt162b2 (Dose 1, Single), administration date: Mar2021, when the patient was 60 years old, for Covid-19 immunization; Bnt162b2 (Dose 3, Single), administration date: Sep2021, when the patient was 61 years old, for Covid-19 immunization, reaction(s): "minor sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "minor sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller female, her and her husband are both over 60 and are both vegan. When possible, they try to avoid products derived from animals. That is one of the reasons they went with the Pfizer BioNTech Covid 19 vaccine. Each of them has had 6 shots of the Pfizer Covid vaccine, two of the initial and 4 boosters. She only had a reaction after the second shot, not the boosters that are spaced out for 6 months. She suspects because of the closeness of the time table, just the three weeks instead of 6 months. And its not definite, she can't tie it all together but she experienced heart palpitations for the first time. She had no bad reactions other of the Pfizer Covid vaccines other than minor sore arm with any of the subsequent boosters. 3rd, 4th, 5th, and 6th doses: Dates was Unknown at time of call, that information is at home on vaccination card, but thinks all doses were given 6 months apart, 3rd dose was probably late Sep2021, then 4th dose given 6 months after, so each time like late Sep and maybe late sometime in Apr.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289194 same patient and event, different dose;
large blisters around mouth after recently receiving a fourth dose of the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ORAL MUCOSAL BLISTERING (large blisters around mouth after recently receiving a fourth dose of the Moderna vaccine) in a female patient of an unknown age 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 fourth 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 ORAL MUCOSAL BLISTERING (large blisters around mouth after recently receiving a fourth dose of the Moderna vaccine). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, ORAL MUCOSAL BLISTERING (large blisters around mouth after recently receiving a fourth dose of the Moderna vaccine) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not reported.  It was reported that patient had no problem at all with her previous Moderna shots.
Chicken pox spots appeared on the left thigh (site of varicella immunization) 6 days after injection. Family was told to keep child away from daycare or anyone who is immunosuppressed.
On March 22 I had flu symptoms headache achy and tired the next day on the 23rd I was at work teaching an exercise class I got a severe stomach pain and was unable to continue working this lasted for 11 days and it lasted 7-9 hours everyday and every time I ate it got worse I got an appointment was in April but my husband took me to the ED and because of the location of the pain between my ribs they wanted to rule out a heart attack. When that was ruled out they did a CT of the abdomen and they saw 4 inch blood clot I was transferred to a different hospital better equipped I was hospitalized there and later sent me home on blood thinners. At home the pain continue and on April 9th my husband took me to the clinic and they said the medicine needs time and to give it time but on April 13 my doctor sent me again to the ED and they did a angio CT and found my gallbladder is very bad and needs to come out but it has to take 3 months of blood thinners now the blood clots are gone and now my gallbladder was removed and everything is going back to normal. In November I have anther angio CT to make sure everything is still normal.
Gave Moderna 6mo - <6y BIV 10mg/0.2ml instead of Moderna BIV 25mcg/0.25ml