chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/27/2021    was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  Reports itching to the upper chest..   Assessment : Time of assessment 0945. Urticaria. No visible signs of rash or hives noted, complained of itching to upper chest.   Actions taken:  Vitals sign taken  VAERS form obtained and completed by RN.   VS at 0945- BP- 140/101, P- 65, 99%, recheck at 0959- BP- 139/83, P- 61, O2- 99%, 1015- BP- 125/88, P- 63, O2- 98%, water given, reports itching has stopped at 0959.   Medications administered: Loratadine (Claritin) 10 mg  by mouth. Time: 0949. Administered by RN. Famotidine (Pepcid) 20 mg by mouth. Time: 0949. Administered by RN.   Disposition: Reports no further symptoms of adverse reaction after observation for 45 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/27/2021  9:29 AM 0.3 mL 2/25/2020 Intramuscular   Manufacturer: Pfizer, Inc
pt last recvd tetanus vax yrs ago, greater than 10 yrs ago; 9SEP93 given Td  IM (lt deltoid area sore 10SEP-12SEP93; severe pain lt auxilla, 14SEP93 pain persisted, t100, tenderness over deltoid;
This case was reported by a physician via call center representative and described the occurrence of anaphylactic shock in a female patient who received TWINRIX adult. Co-suspect products included PNEUMOVAX. On an unknown date, the patient received TWINRIX adult and PNEUMOVAX. On an unknown date, less than a year after receiving TWINRIX adult, the patient experienced anaphylactic shock (serious criteria GSK medically significant), angioedema (serious criteria GSK medically significant and clinically significant/intervention required) and eczema. The patient was treated with Adrenaline. On an unknown date, the outcome of the anaphylactic shock, angioedema and eczema were unknown. The reporter considered the anaphylactic shock, angioedema and eczema to be related to TWINRIX adult. Additional details were reported as follows: In 2012, the patient received TWINRIX adult with PNEUMOVAX. After vaccination, the patient got eczema and angioedema after injection. She visited a pharmacy thereafter, where she got adrenaline via syringe as the pharmacy suspected that the patient had got anaphylactic shock. This was the story told by the patient to the reporting physician. The reporting physician did not seen any medical records or notes from this event but anticipated that he would get it. The reporter considered the anaphylactic shock, angioedema and eczema to be related to PNEUMOVAX. This was all the available information.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender, an office staff person. On an unknown date, the patient was vaccinated with, .5 ml PNEUMOVAX 23, IM (site of administration and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. ON an unknown date, the patient experienced injection site swelling, a raised knot and the site was warm to the touch. No treatment was commenced. The events went away in 3 days. The patient sought unspecified medical attention. It was reported that PNEUMOVAX 23 was not reintroduced. No lab diagnostic studies were performed. The relatedness for injection site swelling, site was warm to the touch and raised knot is unknown for PNEUMOVAX 23. This is one of several reports from the same source. Additional information has been requested.
Patient reports experiencing headaches, fatigue, and hair loss in the last two weeks since receiving her first moderna vaccine. Hair loss on scalp measures 3.5cm by 4.5cm. Recommended that the patient be seen at urgent care for further evaluation and workup.
she has Alzheimer's and dementia; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Jul-2023 and was forwarded to Moderna on 26-Jul-2023.    This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA ALZHEIMER'S TYPE (she has Alzheimer's and dementia) 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 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 DEMENTIA ALZHEIMER'S TYPE (she has Alzheimer's and dementia) (seriousness criterion medically significant). At the time of the report, DEMENTIA ALZHEIMER'S TYPE (she has Alzheimer's and dementia) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered DEMENTIA ALZHEIMER'S TYPE (she has Alzheimer's and dementia) to be related.    Reporter had to watch the demise of his grandmother. Patient had Alzheimer's and dementia, and she never had that in her life. Reporter told her that she should not get the Covid-shot. And now the doctor told that, wish they should never gave it to  because your actual issue that you're had was vaccine related Dementia. Concomitant medications were not reported.  No treatment information was provided by the reporter. Company comment: This spontaneous case concerns a female patient of an unknown age, with no medical history reported, who experienced the unexpected and serious (medically significant) event of DEMENTIA ALZHEIMER'S TYPE after vaccination with an unspecified dose of mRNA-1273.222 vaccine. The vaccination date and the onset of the event were not reported; hence, latency to vaccination could not be properly assessed. No details of other doses were provided. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-734472, US-MODERNATX, INC.-MOD-2023-734863, US-MODERNATX, INC.-MOD-2023-734864 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734472:Invalid case (Patient 1 - MOD-2023-734472) & Grandmother case (MOD-2023-734538 - Patient 2) US-MODERNATX, INC.-MOD-2023-734864:Grandmother case (MOD-2023-734538 - Patient 2)  & Patient 4 (Fatal - MOD-2023-734864) US-MODERNATX, INC.-MOD-2023-734863:Grandmother's case (MOD-2023-734538) & MOD-2023-734863- Patient 3 (Fatal outcome)
Covid infection; Covid infection; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jan2023, outcome "recovering" and all described as "Covid infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jan2023) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical Information: Patient received other vaccine in 4 weeks. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. Prior to vaccination, was the patient diagnosed with COVID-19 was unknown. Since the vaccination, the patient has been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported COVID-19 positive after BNT162b2, BNT162b2 omi ba.4-5 immunization is considered ineffective of BNT162b2, BNT162b2 omi ba.4-5, and the Company cannot completely exclude the possible causality between the reported events and suspect product.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received SHINGRIX for prophylaxis. On 19th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced a deep, long painful arm.
Initial information received on 26-Feb-2019 regarding an unsolicited valid serious case received from a nurse. This case involves a 16 years old patient who was vaccinated with a 0.5 mL dose of FLUZONE QUADRIVALENT on an unknown date and another 0.5 ml dose of it (lot: UJ069AA, expiry date: 30-Jun-2019) via unknown route in the right arm on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENACTRA for Immunisation. It was an actual medication error due to extra dose administered as FLUZONE QUADRIVALENT accidentally given twice to 16 year old. The patient had no 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 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. List of documents held by sender: none.
ear infection; got first dose on spring of 2021 and still has not received 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (ear infection) and PRODUCT DOSE OMISSION ISSUE (got first dose on spring of 2021 and still has not received 2nd dose) 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.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EAR INFECTION (ear infection) and PRODUCT DOSE OMISSION ISSUE (got first dose on spring of 2021 and still has not received 2nd dose). At the time of the report, EAR INFECTION (ear infection) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (got first dose on spring of 2021 and still has not received 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       As reported patient was taking antibiotics.
Leg pain on right side. Vaccine given in right arm. Loss of sleep for 2 nights due to pain. While awake, it's OK. His doctor prescribed Salsalate for the pain.
Initially with back pain followed by dysesthesias, numbness, and paresis in a stocking glove distribution of both legs. Fell on few occasions because of lower extremity weakness.  Soon diagnosed with Guillain-Barre syndrome in addition to paroxysmal atrial fibrillation.  Treated with corticosteroids and antiarrhythmic medications.
RED RAISED RASH THAT DOES NOT ITCH ON RANDOM SPOTS AROUND THE BODY.  PATIENT CLAIMS THIS HAS HAPPENED BEFORE WHEN HER IMMUNE SYSTEM IS "TAXED"
08/22/2003: Patient called today to report reaction.  Received PPV on 08/20/2003.  Stated she felt "Lightheaded" approximately 4-5 hours after dose.  On 08/21/2003 developed rash around injection site, extreme tenderness around injection site, fever up to 104, flu-like symptoms.  States she feels better today.  Fever 101.  Arm not as painful.  Rash gone.  Instructed to see PCP.  Patient chose not to for now.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unspecified number of patients of unknown age and gender. Medical history and current conditions were not reported. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX 23 (dose, frequency, route of administration, lot# and expiration date were not reported) all of which underwent a supported temperature excursion on an unknown date. No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd DTP/MMR/OPV/HIB on 29OCT92 in AM very cranky all PM, no fever, on AM of 30OCT balance off, eyes glassy, nostagmus both eyes; 31OCt to MD cont sx; 3NOV to neuro sx persist 13NOV92;
I got Bells Palsy - it was on the left side of my face - I went to the ER that Friday (9th). They gave me prednisone. It's getting better. I still experience little pain in the jaw area on my left side; a little weakness still on the left side of my cheeks. I am still taking the prednisone.
Was administered a dose of VARIVAX by intramuscular injection instead of subcutaneous; No adverse effects reported; This spontaneous report was received from a pharmacy student and refers to a 12 month old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S003448, 1 dosage form, by intramuscular injection instead of subcutaneous injection, for prophylaxis. No adverse effects were reported.
previously reacted to Moderna/immediate reactions, to the Moderna COVID-19 Vaccine/worse side effects; feeling funky; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (previously reacted to Moderna/immediate reactions, to the Moderna COVID-19 Vaccine/worse side effects) and FEELING ABNORMAL (feeling funky) in a 75-year-old female patient 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 third 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 IMMUNISATION REACTION (previously reacted to Moderna/immediate reactions, to the Moderna COVID-19 Vaccine/worse side effects) and FEELING ABNORMAL (feeling funky). At the time of the report, IMMUNISATION REACTION (previously reacted to Moderna/immediate reactions, to the Moderna COVID-19 Vaccine/worse side effects) and FEELING ABNORMAL (feeling funky) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2022-662621 (Patient Link).   Reporter did not allow further contact
feeling tired and lazy; Headache; aches all over; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling tired and lazy), HEADACHE (Headache) and MYALGIA (aches all over) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (feeling tired and lazy), HEADACHE (Headache) and MYALGIA (aches all over). At the time of the report, FATIGUE (feeling tired and lazy), HEADACHE (Headache) and MYALGIA (aches all over) 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.  It was reported that the patient is in her 60's age.
dizzy; Then I passed out; Headache; Nausea; Arm soreness 2 hours after injection.; Chills for well over 12 hours; stomach pain; big bump on my head where I hit the tile floor; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received the first dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in the left arm on 05Mar2021, 16:30 as a single dose for covid-19 immunisation. The patient's medical history included allergies to Sulfa based meds from an unknown date and unknown if ongoing. The patient had Covid prior to vaccination. Concomitant medications included cranberry; colecalciferol (D3), fish oil, and multi-vitamin taken for an unspecified indication, start and stop date were not reported. On 05Mar2021 at 18:30, the patient experienced headache, nausea, arm soreness 2 hours after injection. Chills for well over 12 hours. Most concerning, patient got up in the middle of the night. Used facilities. Washed hands, and was having stomach pain. Then she passed out. she came to, and have a big bump on her head where she hit the tile floor. Sunday Morning (07Mar2021) she was dizzy. Maybe from the bump on her head. The patient did not received treatment for the events. The outcome of the events was recovering at the time of the report. The has not tested positive for Covid-19 post vaccination.
I was given a FLUZONE HIGH-DOSE influenza vaccine. Since then I have been consistently more fatigued and my asthma is worse, coughing phlegm up more.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown. Not Provided      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.   This case was linked to MOD-2021-103666 (Patient Link).
Guillain-Barre Syndrome/ He was paralized/ He had no balance; his hands were left in a claw like position; he passed away from a different illness; Information has been received from a lawyer and the patient's wife concerning an approximately 78-year-old male patient (pt), regarding a case in litigation. The pt's concurrent conditions, medical history, and concomitant medications were not provided. On 10-DEC-2012, at 78 years old, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, route of administration, anatomical location of the injection, lot number and expiration date were not reported) as prophylaxis. In January 2013, he suffered Guillain-Barre syndrome (GBS). He was in the hospital and rehabilitation for almost 15 months, he was completely paralyzed for most of the time. With intense physical therapy he was able to walk with the help of a walker as he had no balance; also, his hands were left in a claw like position (hand deformity). The pt's wife reported that the pt lost his small business, and both of them lost eight years of their retirement years; she had to become his caregiver, but it was too much for her to get him in and out of the car. She mentioned the pt had to claim bankruptcy for his business and personnel. The pt's wife stated that when treating physicians asked about any vaccines received prior to GBS, she and her husband did not make an association to zoster vaccine live (ZOSTAVAX) (reported as "we never put two and two together"). In January 2020, the pt passed away from an unspecified illness, not GBS, it was unknown if an autopsy was done. The outcome of the events GBS and hand deformity was considered as not recovered. The events GBS and hand deforemity were considered as related to the vaccine. The causality between the pt's death and the vaccine was not provided. The events GBS and hand deformity were considered as disabling events.  Upon internal review, the event GBS was determined to be medically significant.  Additional information was received on 07-SEP-2022 via pharmacy records, regarding a case in litigation. On 10-DEC-2012, the pt received a dose of zoster vaccine live (ZOSTAVAX) injection, single dose vial (dosing information was not provided), administered at a pharmacy.; Reported Cause(s) of Death: passed away
Chest pains, shortness of breath and rapid heart rate. Went to the hospital at 10:30 PM. They did two EKG's, Catscan, chest xray, and blood work. They tried to lower her heart rate with medication, but that did not help.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were provided are as follows: The age at vaccination was not applicable for this report. The caller reported that he knew a lot of people that had sore arm after receiving Shingrix. No patient identifiers were known. No specifics were known. The caller declined to provide health care professional information. The caller did not consented to follow-up. The case has been linked with with case US2021172435 reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021172435:same reporter - reporter´s case.
immediately felt super warm, dizzy, lightheaded, nauseous jaw pain and lower neck pain clammy hands and weakness,  EMT eventually checked my vitals while in the waiting room, extremely high blood pressure and rapid heart rate transferred me to the ED via ambulance
My daughter received the series of rabies vaccines after a cat bite. Her side effects included headache/fever, dizziness, stomach pain, pain at the site, general malaise and weakness.
In the morning I had a scratchy throat and a dry cough. Once in a while, it was not even that often. Around the evening, the cough had progressed a bit heavier but was not constant. I did not think of it as anything more then maybe I was coming down with a cold. When I got home, I was just conscious of it since I never get sick and took a home test and it showed positive, but the test was expired so I did not believe it. The next day I called my pharmacy to get my medication and got more Covid tests, and this time it showed positive again. I called my doctor, however the only symptom I had was a bit of a scratchy throat, runny nose, and a light cough, but he prescribed Mulvania and Benzoate for the cough. The only thing that lingered beyond a week was the runny nose.