chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 10Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 16Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "IgA deficiency" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim", notes: Known allergies: Bactrim. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Apr2022) apparent much high viral load, notes: apparent much high viral load as indicated by a much deeper, thicker t line; (09May2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Weakness-Mild
Pt received Hep-B vaccine on 6/20/00. The next day, the pt complaining of a headache and face (jaw area) was swollen. No treatment given. Pain and symptoms subsided on 6/25/00.
Patient walked out of immunization room and fell down about 10-20 sec. after shot. Pt. was alert but didn't feel well and nauseated. She knew the day and where she was at. 911 called and transported. She stated didn't have breakfast.
The night of the vaccine (01/07/2021) I got severe muscle aches, no relief from a heating pad or ibuprofen/Tylenol. Woke up 01/08/2021 with muscle aches still, headache, fever of 101.8 and fatigue, loss of appetite, brain fog, palpitations. Symptoms lasted all day 01/08/2021 with no relief from OTC pain medications or fioricet for headaches or my Xanax and propranolol for palpitations. Felt about 75% better 01/08/2021 night. Completely better 01/09/2021
one week after covid #2 vaccine developed fevers, neck pain, headaches and vomiting, treated for lymphadenitis with oral antibiotics with continued fevers now x 9 days
sick; aching; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick) and pain (Verbatim: aching). The outcome of the sickness and pain were not reported.   It was unknown if the reporter considered the sickness and pain to be related to Shingles vaccine.     It was unknown if the company considered the sickness and pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR087210   Additional Information: Additional Information: GSK Receipt Date: 17-JUN-2023 The patient self-reported this case. This case was reported by a patient via interactive digital media. The patient received the dose of Shingles vaccine however, it made the patient sick and aching. The patient was glad after having the dose. For tolerance of 2nd dose refer case US2023AMR087210.; Sender's Comments:  US-GSK-US2023AMR087210:first dose case US2023AMR086707, same patient
11:05- lightheaded, nausea, chills. Laid on the ground for probably an hour recovering. Once home, I noticed my chest feel a deep sore, achey. I chalked it up to the side effects, until i went mountain biking and had to turn around after there was so much resistance and pressure in my chest. I'm glad I turned around when I did. It continued to be a deep constant pressure for over a week after the shot. Eventually the pressure subsided but I also didn't do any physical activities after the mountain biking experience.  As i tld the Dr.s this same story they told me I should have gone to the emergency room... Of course I didn't know, so I went about my life just reducing physical activity. I went in for my second shot today and was informed of the new possible linkage between myocarditis and vaccines. What the Dr.'s described (I had two in the room this time because of the way I reacted to the first shot) was exactly what I felt after the first shot. If I was having the same symptoms, as recently discovered, but only after the first one, I wasn't going to try and find out if I would die from this second one or how much worse the inflammation would be.  I will disclose, pertinent or not, that I am a small individual at 5'7, 120.
Mom reports that child got a lump on right thigh immediately after shot was given and has persisted & enlarged over last couple of months. Now has come to a head & copious amounts of purulent drainage was expressed. Cultures sent & placed on antibiotics.
had my Moderna booster 70 days after my second dose; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had my Moderna booster 70 days after my second dose) in a 57-year-old patient of an unknown 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 an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had my Moderna booster 70 days after my second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had my Moderna booster 70 days after my second dose) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  patient was in good health.  No Treatment information was provided.
Pt recv vax on 4/15/99; 15 min post vax pt exp pink area at vax site
(I completed a form before this one with a previous reaction to the flu shot in 2019) The reaction this time around was allergy like symptoms, swelling and red rash around the face that spread within a few hours to the whole body. The rash was very hot and itchy and her temperature got to 101 at home. This is a head to bottom of feet rash that covers her whole body. (we have pictures from both occasions). The reaction started 10 days after the vaccine and we took her in to the er on the 24th of October. We tried to control it with the medications we were sent home with from the last visit but it was not working. She was tested for Covid and other viral infections. IV. She was sent to the hospital for the night. Neither time was anaphylactic. The first time they used an epi pen (I forgot to mention) that worked in making her comfortable for 45 min but then it came back worse. She had diarrhea and vomiting both times.
Patient reported that she started to feel unwell immediately after the vaccine with some nausea.  She presented to the Emergency Department where she was treated by myself approximately 17 hours vaccine administration.  She was having vomiting, diarrhea, diffuse rash, and throat discomfort.  She was successfully treated for anaphylaxis and was able to discharge to home.
Very bitter mouth taste Tastes like quinine or some other bitter bark or fruit; Diarrhea started on Thursday 5/12 around midday and has gotten progressively worse: increased frequency/urgency and more liquid; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSGEUSIA (Very bitter mouth taste Tastes like quinine or some other bitter bark or fruit) and DIARRHOEA (Diarrhea started on Thursday 5/12 around midday and has gotten progressively worse: increased frequency/urgency and more liquid) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 05/F21A, 0212B21A and EXP001B21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 treatment.    Concurrent medical conditions included Asthma, Anxiety (General) and Sulfonamide allergy (sulfa antibiotics). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) from 20-Mar-2022 to 10-May-2022, MIRTAZAPINE, LORATADINE, NIMODIPINE (NORTON), ACETAMINOPHEN from 10-May-2022 to 13-May-2022 and FLUTICASONE PROPIONATE from 10-Apr-2022 to 10-May-2022 for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2022, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 13-May-2022, received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, the patient experienced DYSGEUSIA (Very bitter mouth taste Tastes like quinine or some other bitter bark or fruit) and DIARRHOEA (Diarrhea started on Thursday 5/12 around midday and has gotten progressively worse: increased frequency/urgency and more liquid). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) in May 2022 for Diarrhea, at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (Very bitter mouth taste Tastes like quinine or some other bitter bark or fruit) and DIARRHOEA (Diarrhea started on Thursday 5/12 around midday and has gotten progressively worse: increased frequency/urgency and more liquid) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient took any other medications/products within 2 weeks of starting COVID-19 treatment.  Patient previously received a COVID-19 Vaccine. It was reported that Hospitalization prolonged was reported as NO. It was reported that very bitter mouth taste started with second dose in the morning of 5/11 and has gotten more prominent. In peaks around 3-4 hours post-dose, then declines till right before the next dose (though still perceivable). Device Date: 13May2022.
Patient presented with red, erythematous rash approximately 3.5 inches x 3 inches in size on left arm around injection site. The center of rash was slightly raised and slightly lighter in color.
Headache, Fever, chilla Narrative: called to report adverse effects after receiving her first dose of Moderna vaccine on 7/14/21. Employee complains of fever, headache, and chills. Employee called to report symptoms on 7/15/21.
* hours after vaccine patient had trouble breathing . lasted 3 days. went to the ER on April 9 and was admitted for 5 days and dianosed with Lung cancer
FAINTED; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in MAR-2021, the patient fainted approximately after 35 hours of being vaccinated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted on MAR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:covid-19 vaccine ad26.cov2.s-fainted. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
On 09/26/2001, Mother in for 12 month immunizations. Client had come to clinic in May 2001 for IPV. Returned approximately one week later stating daughter had developed rash or hives on abdomen one day after receiving vaccine. Discussed possible allergies to foods or soaps. Client sought medical attention when rash did not resolve after changing brands of laundry soap. Mother states rash increased in size and extended to arms and lower extremities. PMD suggested possible reaction topreservative in IPV. Client given Benadryl. Rash subsequently resolved.
Initial report received on 18 May 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3436AA received on 05 January 2010, lot number not reported received on 08 March 2010, lot number not reported received on 10 May 2010 and 1 dose of DAPTACEL; lot number C3191AA received on 07 February 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 18 April 2012, approximately 14 months after the last dose. On 21 April 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 27 April 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 27 April 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 02 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Company Medical Assessment: No vaccine protects 100% of individuals against infection. Because this case was solicited from an electronic database, medical records are not available so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. This is one case out of a cumulative total of 67 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 18 May 2012. These 67 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Fatigue hit within a couple of hours; So tired and this was fall in to bed and be out. I slept for awhile - I rested all day the second day. I was getting dizzy and; muscle pain; a lot of joint pain (normally I'm not in a lot of pain and never this tired). I needed a cane to walk I went to work on Wednesday and I had to leave early (11:30). Wed - horrible diarrhea Started getting a little confused and  still had dizziness and joint pain was bad. Couldn't take care of patients. Went to work on Thursday and I had to leave earlier yet that day - by 9:00 am - Started having chills  but didn't have fever and still had other symptoms and was getting confused.   Had an excruciating headaches and nausea (no diarrhea but extreme nausea) and that day started light and sound sensitivity - so bad. Was getting scared driving home - and had very slurred speech. Couldn't drive for a week after that(. My sister was on the phone with me helping me stay alert and drive safely on the way home from work on that Thursday.) Thursday when I got home. - had Telemed visit - Set up appt for a rapid COVID test - and a flu test so my sister drove me and I slept the whole way there. My sister said my speech was slurred; confused in my speech and I felt like that for three days. Both (Covid and flu) tests came back negative. Times when my sister couldn't understand what I was saying and I slept more than I was awake (Thursday - Saturday was like this). Took Imodium for diarrhea when I had that. For joint pain - I treated it by tramodal 50 mg and I can take it as needed and I usually don't need it but took it consistently during this time.  What scared me the most was I could feel my Hip Implant  - ball and socket joint from bone all the way to my femur( I had Right implant on Hip on May 2019) - which is healed completely but I felt it at this time. I still can't lay on my right side without pain - like a deep bone pain.  I was going to call my surgeon today.  January 4th visit with my Dr - for check-in - He gave me a clearance to go back to work on Wed the 6th. I work two days a week; I'm on disability and so have been able to work since then. Right hip pain is still  a lot and bouts of dizziness and still have joint pain. Have to take a minute and a couple of breaths to stand up. Some days I do have to use may cane. Chills are gone.
Patient felt light-headed after 5 minutes of vaccination, experienced dizziness, syncope, and was required to lay down. After 15 minutes she experienced shaking that continued until 5:50 PM. Patient was alert the entire time, no problems breathing, some problems speaking. We called 911 after 10 minutes; however, patient refused EMT transport, and had family members pick her up at 5:50 PM.
Rash on inside of arm and stomach, muscle soreness, headache x1-2 days. Resolved by day 3.
Swelling around shot area; Ill for a few days; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Swelling around shot area) and ILLNESS (Ill for a few days) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included Avascular necrosis (The severity changes due to weather, use (heavy activity) causes swelling in hips and knees.. The Moderna vaccine alleviated swelling and pain.) on 15-Mar-2006. Concurrent medical conditions included Pollen allergy, Dust allergy and Allergy (Mold). Concomitant products included CHLORAZEPATE for Anxiety, LISINOPRIL for Blood pressure, BUPROPION for Depression, OXYCODONE HYDROCHLORIDE, PARACETAMOL (OXYCODONE AND ACETAMINOPHEN) for Pain, PROPRANOLOL for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (Swelling around shot area) and ILLNESS (Ill for a few days). At the time of the report, INJECTION SITE SWELLING (Swelling around shot area) and ILLNESS (Ill for a few days) outcome was unknown. Not Provided          Past medical history include Patient had 6 surgeries: both hips replaced, both knees replaced, and both shoulders repaired via surgery for tearing and repair.  Treatment information was not reported.   This case was linked to MOD-2021-024754 (Patient Link).
No adverse event.  Medication administration error.  The Moderna vaccine is licensed for ages 18 years and older.  This patient is only 16 years old.
inappropriate schedule of vaccine administered; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no medical history was reported no concomitant medication were reported no treatment medication were reported   Reporter did not allow further contact
Received Varivax 07/27/2000.  3-4 Varicella blisters.  11/03-whole class ill.
Patient stated she had chills and was unable to move her legs for 24 hours after the vaccine.
Left arm numbness and pain; Left arm numbness and pain; headache; nausea; stiff neck and back; inability to stand for more than a few seconds without becoming weak; inability to stand for more than a few seconds without becoming weak; Patient received BNT162B2/ breastfeeding; Patient received BNT162B2/ breastfeeding; This is a spontaneous report from a contactable other healthcare professional (patient herself). This other healthcare professional reported information for both mother and baby. This is the mother report. A 25-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9265), via an unspecified route of administration in left arm on 01Feb2021 at 13:00 (at the age of 25-year-old) as a single dose for COVID-19 immunization. The patient's medical history included hypothyroidism, ongoing breastfeeding, allergies to medications, food, or other products: Hydrocodone, Vicodin, dialaudid, morphine. Concomitant medications were none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. Patient received BNT162B2/ breastfeeding on 01Feb2021 at 13:00. The patient experienced left arm numbness and pain, headache, nausea, stiff neck and back, inability to stand for more than a few seconds without becoming weak on 01Feb2021 at 19:00. It was unknown whether the treatment received for the adverse events or not. The events were considered as non-serious by the other healthcare professional. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021125300 baby case