chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It started about 3:30AM, I got up to use the restroom. The room was spinning and I fell. I thought it was Vertigo. I went back to bed. I thought it would go away and it didn't. I took some Tylenol. By 7AM, my husband took me to the ER. They did a CT scan to make sure I wasn't having a stroke. It ended up being Vertigo. They did an EKG for my heart. It was off and on for about a month. I have not had any issues since. I went in to see my doctor later for a sinus infection and I did mention it to him, but I didn't require any treatment. When I went to my chiropractor and she told me that I was the 5th person that she had seen that had gotten Vertigo after having the shot.
A day or two after his vaccination for shingles my father began experiencing periods of dizziness and vertigo when he stood from a sitting position or laid down on his bed.
have received Shingrix vaccines. Why am I still getting shingles?/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had received Shingrix vaccines and still got shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Diarrhea; Sore arm; Runny nose; Headache; Low grade fever; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 30Aug2021 at 08:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received cefaclor (CECLOR) for an unknown indication on an unknown date and experienced drug allergy. On 30Aug2021 at 13:00, the patient experienced runny nose, headache, low grade fever and sore arm within 8 hours of vaccine at 16:30. On 01Sep2021, day three after the vaccine, the patient experienced diarrhea. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 02Sep2021, the patient underwent polymerase chain reaction (PCR) test and the result was pending. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events runny nose, headache, low grade fever, sore arm and diarrhea was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
had a reaction to Shingrix; This case was reported by a other health professional via interactive digital media and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient had a reaction to Shingrix. The follow up was not required.
Seizure on 11/01/02, lasted 1 hour, intubated, Flown to Level III hospital. follow up report received 11/25/02 states  "Fever"
Information has been received from a nurse concerning a patient who was vaccinated with a dose of GARDASIL (Lot# not reported).  After receiving the dose of GARDASIL, the patient had fainted.  The outcome of adverse event was not reported.  It was not reported whether the patient sought medical attention.  This was one of several reports from the same source.  Additional information has been requested.
Four hour after injection I started to shiver almost uncontrollably.   My temperature around midnight spiked to 103 and my heart rate was constant at 150. I was dizzy.  Very little sleep.  Temperature broke at 4:00AM
her arm hurt with the previous doses too; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 83-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "her arm hurt with the previous doses too"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "her arm hurt with the previous doses too"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "her arm hurt with the previous doses too"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "her arm hurt with the previous doses too". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm hurt with the previous doses too". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300348067 Same patient, different vaccine dose number, different AE;
Arm is very sore and it hurts in the muscle, this is very sore in the spot where they give me the injection; I have a slight fever of a 100; I feel I am cold, I have the chills; Headache; joint pain; muscle pain unbelievable; nauseous; I was sick all day; symptoms felt like when you are getting the flu and when you get the flu vaccine; tiredness; sweating; This is a spontaneous report from a contactable consumer, the patient. This 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose  1, single dose via an unspecified route of administration on 05Feb2021 (at the age of 73 years-old) for COVID-19 vaccination. Medical history included Parkinson's disease, bulging disc in the back and shoulder, anxiety, thyroid, had very bad case of, was in the hospital for 12 days and they were just supposed to put her on the ventilator, but then started to recover a little bit, was hesitating on taking the shot. But when she called the doctors they said no you can take it, even the neurologist said that you can take it because she had this disease and should be taking it. Historical vaccine included unspecified reaction from an unspecified flu vaccine on an unknown date. Concomitant medications included dexlansoprazole (DEXILANT), levothyroxine, paroxetine for anxiety, carbidopa, levodopa for Parkinson's disease, metoprolol succinate (METOPROLOL ER ACTAVIS) 25 mg, one a day and vitamin D NOS. On 05Feb2021, the patient experienced slight fever of a 100, felt cold, chills, headache, joint pain, muscle pain unbelievable,  nauseous and was sick all day. On 06Feb2021, the patient's arm was very sore in the spot where they gave the injection and has no rash, it's not red in that area or any place else, It's just very sore and it hurts in the muscle, this is very sore in the spot where they gave the injection. On an unknown date in 2021, symptoms felt like when you are getting the flu and when you get the flu vaccine just a little more tiredness. Treatment to reduce the fever included acetaminophen (TYLENOL) and is sweating. Treatment was received for chills. The clinical outcome of slight fever of a 100, felt cold, chills was recovered on an unknown date. The clinical outcome of arm very sore in the spot where they gave the injection, headache, joint pain, muscle pain unbelievable, nauseous, sick all day, symptoms felt like when you are getting the flu and flu vaccine, tiredness and sweating was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Second dose outside of allowed time window; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose outside of allowed time window) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 03-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose outside of allowed time window). On 03-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose outside of allowed time window) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable
Patient finished Pfizer COVID vaccine in March and developed COVID-19 Pneumonia end of May 2021. Patient immunosuppressed on ocrelizumab for multiple sclerosis.
This spontaneous report as received from a consumer refers to her 13 year old daughter. The patient's pertinent medical history and drug allergies were none. On an unknown date, the patient was vaccinated with GARDASIL (dose, frequency and lot# were unknown) intramuscular. Concomitant medications were none. On an unknown date, the patient experienced shooting pain down her neck minutes after receiving the vaccine. The reporter notified the physician and sought medical attention. No treatment was provided for the event. The outcome of the events was reported as recovered/resolved (reported as went away the following day). The relatedness of the events with GARDASIL was not provided. Additional information has been requested.
Expiration date was 26Feb2023 and date the vial was initially stored in the refrigerator on 14Mar2023; No adverse event; expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26Feb2023 and date the vial was initially stored in the refrigerator on 14Mar2023) and NO ADVERSE EVENT (No adverse event) in a 54-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26Feb2023 and date the vial was initially stored in the refrigerator on 14Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26Feb2023 and date the vial was initially stored in the refrigerator on 14Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated) and PRODUCT STORAGE ERROR (Expiration date was 26Feb2023 and date the vial was initially stored in the refrigerator on 14Mar2023).    No relevant concomitant medications were reported.  It was also reported that there was potentially a second lot number that was expired on 28Feb2023 and was administered to patients on 3Mar2023, but HCP did not have any details on this event at this time.  Vial size was reported as 10 dose vials. The vial hadn't undergone any temperature excursions.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Two hours after injection, I began wheezing. Four hours after injection, the wheezing worsened, the inside of my mouth started itching, and I had abdominal pain, bloating, and diarrhea. These symptoms lessened the next day but continued for one week.   I did not report these reactions immediately, as I did not want them to prevent my receiving the second covid vaccine dose. Also, if the second covid vaccine dose started to cause the same type of reaction, I was prepared to use two Epi Pens and call 9-1-1. Fortunately, the second dose caused only a sore arm.
Jaundice, bilirubin in high risk zone; Slow weight gain; This spontaneous case was reported by a consumer and describes the occurrence of JAUNDICE (Jaundice, bilirubin in high risk zone) and WEIGHT GAIN POOR (Slow weight gain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030M20A) for COVID-19 prophylaxis.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Penicillin allergy and Drug allergy (Allergy to Sulfa).    No Medical History information was reported.   On 10-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) 1 dosage form. On 10-Mar-2021 at 8:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) dosage was changed to 1 dosage form. On an unknown date, the patient experienced JAUNDICE (Jaundice, bilirubin in high risk zone) and WEIGHT GAIN POOR (Slow weight gain). At the time of the report, JAUNDICE (Jaundice, bilirubin in high risk zone) and WEIGHT GAIN POOR (Slow weight gain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood bilirubin: in high risk zone.         26-March-21 Mother tested positive for Group B Strep.  Mother glucose tolerance and ultrasounds were found normal.  Prenatal medication was administered by parent from Aug 2020 , ongoing is Yes.   No concomitant medication provided.  No treatment information listed.   This case was linked to MOD-2021-013572 (Parent-Child Link).   See case MOD-2021-013572 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Upon internal review on 23-May-2023, significant corrections performed. Reporter, event and product details updated. Lab data added. On 22-Jul-2021: Follow-up received contain No new information
Received a telephone call today 10-14-09 from parent stating she had to rush child to ER after receiving vaccines. Mother states child broke out in hives all over body. Given Vistaril injection in ER and sent home with Oral Vistaril and Steroid dose pack. Mother states, bumps on lower legs look like chicken pox. Instructed mom to take child to PCP for evaluation and proper diagnosis.
Patient returned to clinic immediately after receiving vaccine c/o numbness creeping up arm, chest, left jaw.  Chest felt "funny" with a metallic taste in her mouth.  Give Benadryl 50mg at 12:05.  At 12:05, BP = 138/96 P = 65.  At 12:20, BP = 125/84.  By 12:24 PM, tingling feeling was leaving; mildly diaphoretic.  By 12:29 part of left tongue still felt swollen and numb.  911 was called since not completely resolved in 30 minutes.  At 12:45 PM BP = 130/86, R = 70 no longer nauseous. NOTE: Patient had not eaten anything for the day leading up to time of vaccination.
chest ache (not feeling well in chest area)/ chest was aching; Dull cramp in the chest; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number not reported) via an unspecified route of administration on an unknown date as dose 1, single for COVID- 19 Immunisation. Relevant medical history and concomitant medications was not reported. On an unknown date, the patient had her "first dose of the Pfizer COVID-19 vaccine and experienced chest ache (not feeling well in chest area) which felt like a dull cramp in the chest which was constant and did not go away". Further, the patient mentioned that she was feeling fine but her chest was aching." The patient wanted to know if this had been reported as a side effect with the Pfizer COVID-19 vaccine. The report was considered as non serious. The outcome of the event of dull cramp in the chest was recovered on an unknown date and other event of chest pain was unknown.  Lot number of the vaccine (BNT162B2) was not provided and will be requested during follow-up.
Pt felt lightheaded/dizzy after receiving the vaccine. She stated that she usually felt that way after receiving all kinds of vaccines. She stated that after consuming some sugary drinks, she felt better. She had the symptoms for about 15 minutes
Pt recv vax on 1/14/98; 4 hr post vax pt exp swollen face, difficulty breathing & swallowing, urticarial rash
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 41-year-old female patient (gravida 5, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol since 2000, Infertility and Allergy (allergy to poultry). Concomitant products included PROGESTERONE for Infertility, METFORMIN for Polycystic ovarian syndrome, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and FAMOTIDINE (PEPCID AC) for Pregnancy, CALCIUM LEVOMEFOLATE (METHYL FOLATE) for Prenatal care, MARIJUANA for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 16-Jul-2020 and the estimated date of delivery was 18-Apr-2021. On 14-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy.  On 14-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2020, Pregnancy test: (Positive) Positive. On an unknown date, Glucose tolerance test normal: normal (normal) normal. On an unknown date, Prenatal screening test: normal (normal) normal. On an unknown date, Ultrasound abdomen: (Inconclusive) no result.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details was reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 41-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Patient was contacted for AE follow-up, which is still pending.
one of three patients received an ACTHIB vaccine that was not diluted with the 0.4% Sodium Chloride with no reported adverse event; Initial information received on 19-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received an acthib vaccine that was not diluted with the 0.4% sodium chloride with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect HIB (PRP/T) VACCINE lot UJ575AAA expiration date 07-Oct-2022 via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event, "one of three patients received an acthib vaccine that was not diluted with the 0.4% sodium chloride with no reported adverse event" (product preparation error) (unknown latency) following the administration of HIB (PRP/T) VACCINE.  It was reported, "Caller stated that during inventory she noticed that there was an extra diluent in the box of ACTHIB. Caller stated that someone must have reconstituted a dose of ACTHIB with the incorrect diluent. Caller unsure of which patient would have received incorrect diluent. Caller asking what recommendations are and if they should revaccinate all potential patients who received this vaccine."  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  It was not reported if the patient received a corrective treatment for the event (one of three patients received an ACTHIB vaccine that was not diluted with the 0.4% Sodium Chloride with no reported adverse event).  At time of reporting, the outcome was Unknown for the event one of three patients received an acthib vaccine that was not diluted with the 0.4% sodium chloride with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fever, bicep swelling in arm that received vaccine, generalized skin sensitivity described as pain to any kind of touch.
Shingles diagnosed 5/9/21.  Very small area of the body, approximately 2" x 1".  Treated with 10 day course of oral acyclovir and resolved.  Other vaccines NOT within one month of COVID vaccine: Flu vaccine 9/29/20 Pneumovax 23 10/2/20 Shingrix vaccine 10/29/20 and 2/4/21  NOTE:  This is in response to voice mails from V-SAFE.
Significant exhaustion, headache, flu like symptoms, body and muscle aches, fever, chills