chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After I received the shot I felt achey, muscles and a headache, which I usually do after a flu shot and it usually resolves within a day. I continued to feel poorly for a few days and I began feeling fatigued and I did not know why. Sunday night (10/7) I could not sleep due to a very itchy rash that was causing me pain on the right side on my body. I went to my dermatologist 10/8 who diagnosed me with Shingles and started me on medication, which is now helping me improve. I believe the flu shot "confused" or put a strain on my immune system causing me to  come down with Shingles. I did not currently have stress, which is a common cause. So, I do not know why else I got Shingles and I suspect it was the flu shot.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-SEP-2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-JUL-2016 the patient was treated by a physician/MD for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Moderna COVID-19 Vaccine EUA - Approx 17 h post vaccine pt became dizzy and lost consciousness, fell, hit head. Awoke shaking & confused, generalized strong tingling sensation for 45 min post. Severe headache immediately post vaccine, had resolved. Febrile at 100.7F with ibuprofen. Called PCP who determined symptoms to be vagally mediated, pt recovered at home with no evident sequelae.
Redness and swelling at injection site. Headache and chills. Some itching.
An MD reported that a child receiving a complete series of Prevnar subsequently developed bacteremia. This event was considered medically important. No further info was available at the date of this report.
Metal taste in mouth about 10 minutes after receiving immunization lasting 10 to 15 minutes. Relieved after drinking juice and taking eating something. She had the same symptom after the first injection, lasting 1/2 hour.
Patient contacted telenurse today to inform us that he feels he had  a reaction to the H1N1 flu shot that he recently received. States the day  after he received it he felt very achy "Just like I have the flu" and has been weak and tired ever since. Feeling slightly better today than he did yesterday, will contact telenurse if symptoms increase, worsen or change.....Pt did not call back.
ring finger felt like slammed in door; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (ring finger felt like slammed in door) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (ring finger felt like slammed in door). At the time of the report, PAIN IN EXTREMITY (ring finger felt like slammed in door) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Severe headache (worse than a normal migraine) Nausea Diarrhea
Pt presented to clinic on 8/8/19 with mother. Pt reported itching of right deltoid same day of vaccination. Mother gave patient Benadryl at home as well as ibuprofen and ice pack for pain. Pt exhibits edema (Right upper arm : 18cm up from olecranon process is  34 cm on right and 31 cm on left). Mother was advised to continue Benadryl as needed as well as cool compresses. Advised to contact office if no improvement.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 21Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: Treatment for covid-19 test; (2022) Postive, notes: Treatment for covid-19 test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received treatment of paxlovid start date from 31Jul2022 to stop date 01Aug2022. It was reported that after 5 days of isolation, patient got a negative test. 5 days after that he tested positive. Patient took paxlovid for 1 day but stopped it because it made me feel too bad.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
04/03/2022 vaccination. 07/08/2022 evening, I felt unwell. I started to have a sore throat, congestion and headache. It wasn't that bad. I didn't think much of it. I did take a COVID-19 x2; negative (I was at the airport). 07/09/2022 Felt the same that evening; not well. Felt like a little cold. 07/10/2022 I felt ok. 07/11/2022 Monday morning I felt sick. My whole nose hurt, uncomfortable at the top. I had a headache across my forehead, was coughing that night and felt 'heavy' and exhaustion. I tested COVID-19 positive, called my doctor and anyone I was near those few days. My PCM prescribed PAXLOVID 5 days worth. 07/13/2022 was the worst day in regards to exhaustion. Too much energy to move. 07/14/2022 I don't feel great but my head feels more clear and I have a little more energy.
Breakthrough COVID infection. Patient fully vaccinated 2/11/2021. Pt received boosted on 11/9/2021. Patient tested positive for COVID Jul 14, 2021.
Patient complained of dizziness approx. 1-2 minutes after vaccine administered. Patient then momentarily was not responsive to verbal stimulation. Once responsive patient stated increased anxiety prior vaccination and that she had not eaten yet. Pt given snack after incident advised increased fluids.
This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (Floaters and flashing on the eye) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VITREOUS FLOATERS (Floaters and flashing on the eye). At the time of the report, VITREOUS FLOATERS (Floaters and flashing on the eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided by reporter.  Treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: NNI. TCR document/ No consent to further follow up
Woke up 12 hours after injection with body aching, fever, and nausea.  Lasted until I woke up the next morning.
Initial report was received from a health care professional on 12 December 2011. A 40-year-old male patient received an intramuscular injection (dose 1) in the left deltoid of MENACTRA, sanofi pasteur Inc., lot number U4249AA on 08 December 2011 at 2:30 PM. On 11 December 2011 at 6:00 AM, the patient vomited one time and had numbness from the tip of the tongue to the right ear and from the right hand to the forearm and elbow. The patient had no illness at the time of vaccination, allergies or past medical history. The patient did not take any concomitant medications. No other vaccinations were given within four weeks prior to 08 December 2011. The patient's wife had shingles. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Redness and warmth, pain chills. 13x10 cm LUE.
Low grade fever; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the unspecified anatomical site on 15Mar2021 at 13:45 (at an unspecified age), as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not provided. On an unknown date, the patient had fatigue and low-grade fever. The clinical outcome of fatigue and low-grade fever was unknown.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to unspecified patients of the age over 26 years. On an unknown date, the numerous (exact number unspecified) patients over 26 years were vaccinated with GARDASIL (lot# not provided). No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. The nurse did not wish follow up for the purpose of safely report. Additional information is not expected.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 as dose number unknown, single (Batch/Lot number: unknown) and on 30Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 23 years for covid-19 immunisation; coviD-19 vaccine Janssen (COVID-19 VACCINE JANSSEN), on 12Apr2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PLAQUENIL S. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Adverse event: Tested positive for Covid 07Jun2022 & started paxlovid. Finished meds on 11Jun2022, w/a negative test. Tested negative everyday after that. Tested positive 22Jun2022  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
I gave the patient a pediatric dosage instead of an adult dosage. The only difference was a .1ml difference.
WHEEZING  SHORTNESS OF BREATH  FULLNESS IN THROAT  RAPID PULSE  PT WAS GIVEN ALBUTEROL, EPI PEN, TRANSPORTED TO ED DEPARTMENT
I was 31 weeks pregnant, estimated date of delivery is January 16, 2019. The vaccine was given on Thursday and in the middle of Friday night I woke up to stomach aches, mild fever of at least 100.3 (by the time my temperature was taken), headache, tiredness, nausea, vomiting, diarrhea, chills, sore joints, body aches.
Localized redness, warmth and swelling. Non tender - Full ROM hip and knee - No fever - Onset 7-22-10.
Janssen COVID-19 Vaccine EUA, extremely tired and weak, chills, pains in chest
Fever, drooling, vomiting, lethargic couldn't hold her head up, swollen eyes.
Same problem with the rash after several weeks; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Same problem with the rash after several weeks) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Same problem with the rash after several weeks). At the time of the report, RASH (Same problem with the rash after several weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment medication was provided.
Report received from a consumer on 13-Jan-2010. A 3.5 male patient received H1N1 vaccine (lot unknown) for immunization on 11-Jan-2010. The patient had a medical history as follows: Diagnosis of specific antibody IgG4 deficiency. The patient vomited, developed rapid blinking, head shaking and exhaustion, difficulty walking, disorientation and decreased appetite on 9-JAN-2010 after Vivaglobin use. Past IVIG use over 8 hours in 2007 and over 6 hours in 2008 without adverse event; allergic reactions to many antibiotics (unspecified); mild autism; loss of appetite resulting in gastrostomy feeding tube placement in 2008; history of tumor in kidney requiring treatment with chemotherapy and radiation (2007); Right nephrectomy/tumor removal. Concomitant medications: Vivaglobin started on 9-JAN-2010 at 16 ml weekly in 3 sites over 1.5 hours for the treatment of specific antibody IgG4 deficiency, BACTRIM; ZANTAC; PERIACTIN; ZYRTEC; NASONEX; Hepatitis A vaccine on 11-Jan-2010. On 12-Jan-2010 the day after the administration of PANVAX, and after receiving formula feeding via a g-tube (gastrostomy feeding tube), the child 'threw up'. It appeared as though the stomach did not digest the food judging by the appearance of the regurgitated food. Treatment details and event outcome unknown. For Vivaglobin case, see case number 2010021878. Additional information has been requested. The company considered events to be possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product.
pt was vaccinated using Janssen vacine on 5/19/21 (Lot 204A21A). S/O 08/27/21, tested + 8/28/2021
Next day post vax, the pt developed vomiting which lasted 24 hours, arm pain and arthralgia.
This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (throat aching), FREEZING PHENOMENON (freezing), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills) in a 63-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (throat aching), FREEZING PHENOMENON (freezing), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills). At the time of the report, OROPHARYNGEAL PAIN (throat aching), FREEZING PHENOMENON (freezing), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided .
This spontaneous report was received from a 66 year old male patient with VICODIN allergy and codeine allergy who was reporting on himself. There was no patient's medical history. On 06-OCT-2014 the patient was vaccinated by a pharmacist with a dose of PNEUMOVAX 23 (injection, in the left arm, lot number: K009107, expiry date: 21-JAN-2016, dose number and route of administration were not reported). Concomitant therapies included influenza virus vaccine (unspecified) (reported as Flu shot) (manufacturer and dose unknown) (given on the same day but administered in the right arm), SPIRIVA and morphine sulfate (manufacturer and dose unknown). On 06-OCT-2014, after receiving the PNEUMOVAX 23, the patient experienced injection site pain. No treatment was given for adverse event and no lab diagnostic was performed. The patient did not seek medical attention. The outcome of the event was reported as not recovered. The relatedness between PNEUMOVAX 23 and the event was not reported. Per instructions from the pharmacist, the patient was requesting a lot check for PNEUMOVAX 23. Additional information has been requested.
the patient received a dose of MMR II via the intramuscular route on 2/18/2020; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 18-FEB-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), intramuscularly (dose, lot # and expiration date were not reported), for prophylaxis (Inappropriate route of vaccination). Concomitant therapies included sterile diluent. The outcome of the event was unknown.
30JAN-31JAN pt had fever 105 & seizures; pt had a sz & fever was 102 or more for 2 days; hospitals did blood work, bathed pt & sent home;
5/21 @ 10:00 pm - 3:00 am extreme chills  5/22 @ 3:00 am  - 5:00 am burning up, muscle aches 5/22 @ 5:00 am  - 9:00 pm dull headache, nausea 5/22 @ 5:00 am - 6:00 pm diarrhea  5/22 @ 11:30 am - 5:00  pm vomiting
15 people in her immediate family who are experiencing adverse effects from the vaccine; 5 people who have had the vaccine and got COVID, and their COVID is worse than if they did not have the vaccine.; 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 VACCINATION COMPLICATION (15 people in her immediate family who are experiencing adverse effects from the vaccine) and COVID-19 (5 people who have had the vaccine and got COVID, and their COVID is worse than if they did not have the vaccine.) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (15 people in her immediate family who are experiencing adverse effects from the vaccine) and COVID-19 (5 people who have had the vaccine and got COVID, and their COVID is worse than if they did not have the vaccine.). At the time of the report, VACCINATION COMPLICATION (15 people in her immediate family who are experiencing adverse effects from the vaccine) and COVID-19 (5 people who have had the vaccine and got COVID, and their COVID is worse than if they did not have the vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Gave flu shot, waited 5 minutes, gave pneumonia shot, 5-10 minutes after second shot, patient became flushed and complained of lower back and upper leg pain. Called 911, arrive in 10 minutes. Patient taken to E.R. but was non-symptomatic as he entered ambulance
Constipation. Normally baby pooped at least one big poop daily, and has only had small harder bowel movements since the vaccines.
This spontaneous report as received from a healthcare worker via company representative refers to a 71 year old male patient. On 19-FEB-2015 the patient was vaccinated with PNEUMOVAX 23, .5 ml, 1 injection (lot no. K016295, expiry unknown). On 19-FEB-2015, the patient developed vaccination site reaction immediately after receiving PNEUMOVAX 23. The patient had vaccination site pain and vaccination site erythema. The patient did not receive any treatment for the events. The outcome of vaccination site reaction, vaccination site pain and vaccination site erythema was reported as recovered on an unknown date. The causality of events was not reported. This is one of two reports from the same reporter. Additional information has been requested.
red, itchy spots under the breast and now it is radiating to the neck and belly button Narrative:
Pt came in on 9/20/17-area around flu vaccine site was raised and warm to touch. Site was left arm. Pt was given Cephalexin 250 mg/5 ml oral suspension 10 ml 3 times a day for 10 days.
11-6-08 evening: soreness and itching at site. 11-7-00 AM: malaise, 2" diameter reddened raised area at injection site. 11-7-08 afternoon: chills. Self treatment with TYLENOL PM/ ibuprofen/ ZYRTEC.
Case previously recorded as MA2009-4225. Initial case report received from a Nurse via agency, on 11 NOV 2009. Patient below 4-year-old was vaccinated with 0.25 mL of FLUVIRIN (batch no. 102046P1) i.m. on 10 NOV 2009. Company assessment: Seriousness criterion: not serious. Causality: Not applicable. Expectedness assessment according to foreign and local label. Off label use is unexpected with FLUVIRIN. No change in benefit-risk-ratio. No measures necessary. Reference no.: NA09-008010.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed rash that resembled herpes zoster and was seen by a physician. It was noted that on presentation to the physician, the pts rashes had crusted over. Additional information has been requested.
Per patient. This is a 48 year old female with no relevant PMH who presents to the ED for evaluation of chest pain and palpitations after COVID 19 vaccination.  The patient reports that approximately at 8:45 AM she received the first shot of the Pfizer coronavirus vaccine.  Within 15 minutes she began to develop palpitations a flushed feeling, tickling in the back of her throat.  There is no itching or rash.  There is no difficulty handling secretions.  The patient has never had an adverse reaction to vaccine in the past.  Her only allergy is of ibuprofen, which causes hives.  Patient reports ongoing palpitations since this started.  No difficulty handling secretions. No leg swelling. No hx of cardiac disease.
Patient reports received Twinrix #3 dos e on 05/16/2007 around 3:30 Noted that evening Very tired.  Had experienced some allergy type symptoms prior to the vaccination consisting of clogged sinus, runny nose.   awakened this am and noticed continued fatigue, swelling in throat, need to use asthma inhaler.  Was sent home from work. Called Public HEalth.  Recomending contact PCP and report to Public HEalth findings.
Severe chills/shaking of my entire body for about 2 hours.  The tremors woke me up from a sound sleep and I couldn't fall back asleep for 2 hours.
I awoke at about 5:00 am with severe abdominal pain.  I was hospitalized for several days with a working diagnosis of acute kidney injury with unknown cause. Upon my release, I awoke the next morning with the same symptoms.  I was hospitalized again for several days with the same diagnosis.
Pt recvd MMR vax on 10FEB88 & SEP91 lab eval revealed pt's MMR titers were low;
Headache, Myalgia & Fever Narrative:  fever; severe myalgia ha