chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received 2nd shot 4/16/21 SARS-COV-2 (COVID-19/PFIZER) mRNA BNT162B2 (PF) IM (LNP-S) EUA, beginning of May patient started to become OCD with her purse and wallet, on 5/12 she put ravioli that was to be boiled into the microwave and started a fire. After she did so, she realized it was wrong and said "how stupid" "why did I do that".  I proceeded to make dinner for her and her meals for the next day, I advised her that I was going to take her to the hospital on Friday 5/14 for a Mental Health check as she began to decline.  She returned home from but had her stay with me didn't trust her to stay alone.  I followed up with her CP, Neurologist and Cardiologist, during her visits she struggled with words but was aware something was wrong as she stated "i just want the old me back".   From 5/15 thru 6/1 her mental health only worsened, she had no cognitive functions (phone, tv, computer) unable to eat on her own and shower.  We placed her in a Memory Care Facility on 6/2, she fell the next day and was hospitalized with a broken hip, she is now in rehab.  The current reports are she is not eating well, put on a puree diet since she is having swallowing issues, cannot talk and attention span is minimal,  The PET Scan determined Alzheimer's with Picks Disease.  She showed absolutely no signs of decline prior to the 2nd vaccine.
soreness in arm; Felt pin prick; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm) and PAIN (Felt pin prick) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN (Felt pin prick). On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm). On 22-Feb-2021, PAIN (Felt pin prick) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided  Treatment medication was not provided   This case was linked to MOD-2021-056939 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant follow-up, event outcome updated.
Arm pain; Nausea; lightheadedness; This is a spontaneous report from a contactable healthcare professional (patient).  A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration on the left arm in Jan2021 at SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history included hypothyroidism. It was reported that the patient had allergies with sulfa and trimethoprim / sulfamethoxazole (BACTRIM). Concomitant medications included levothyroxine sodium (SYNTHYROID), ergocalciferol (VIT D), levocetirizine dihydrochloride (XYZAL).  It was stated that the patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. In Jan2021, the patient experienced arm pain after 10 hours of getting the vaccine. It was also reported that nausea and lightheadedness the following day. No treatment received for the adverse events. The patient recovered from the events in Jan2021 (reported as feeling passed after 2hrs)  Information on the lot/batch number has been requested.
temperature excursion; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 02-NOV-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (strength, dose, frequency and route of administration were not provided) for prophylaxis (lot number S035110 was verified to be valid, expiration date reported and established as 03-MAY-2020).   The administered dose of vaccine experienced a temperature excursion of -14 Celsius degrees to -10 Celsius degrees (-13.9 Celsius degrees) for 30 minutes, -14 Celsius degrees to -10 Celsius degrees (-14.2 Celsius degrees) for 15 minutes, -14 Celsius degrees to -10 Celsius degrees (-14.7 Celsius degrees) for 20 minutes and -14 Celsius degrees to -10 Celsius degrees (-14.6 Celsius degrees) for 5 minutes. Digital Data Logger was involved.
11 year old consumer to receive Pentacel and not the Adacel that was prescribed, no AE; 11 year old consumer to receive Pentacel and not the Adacel that was prescribed, no AE; Initial information received on 27-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2019SA272344 (same reporter).  This case involves a 11 years old female patient who received 0.5 ml dose (booster dose) of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ019AAA, expiry date: 09-Oct-2020) via intramuscular route in left deltoid instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] that was prescribed on 23-Aug-2019.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  It was reported that 11 year female patient old consumer to receive Pentacel and not the Adacel that was prescribed.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
is_pregnant:Yes/gestational_period:35; Certain foods have Foul and slightly sweet taste. Cant pinpoint a particular ingredient that is causing it. Smell the exact same way; Certain foods have Foul and slightly sweet taste. Cant pinpoint a particular ingredient that is causing it. Smell the exact same way; Certain foods have Foul and slightly sweet taste. Cant pinpoint a particular ingredient that is causing it. Smell the exact same way; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 14:00 (at the age of 27-years-old) (maternal exposure during pregnancy- third trimester) as a single dose for COVID-19 immunisation. The patients gestation period was 35 weeks. Medical history included COVID-19. Concomitant medications taken within two weeks prior to the vaccination included sertraline hydrochloride (ZOLOFT), promethazine (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN); all from unknown date for unknown indication. The patient did receive other vaccines within four weeks prior to the vaccination, which included tetanus vaccine toxoid, diphtheria vaccine toxoid, pertussis vaccine acellular (TDAP) on 24Feb2021 for an unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021 the patient experienced certain foods had foul and slightly sweet taste (the same taste). The patient could not pinpoint a particular ingredient that was causing it. Things also smelled the exact same way (foul and slightly sweet). Toothpaste, mouthwash, soda, peanut butter, tea, chocolate, mint, all tasted this way. All deodorant, soap, shampoo, etc had this smell. Feces also smelled the exact same way. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events certain foods had foul and slightly sweet taste (the same taste), things also smelled the exact same way (foul and slightly sweet), toothpaste, mouthwash, soda, peanut butter, tea, chocolate, mint, all tasted this way, all deodorant, soap, shampoo, etc had this smell, faeces also smelled the exact same way was not resolved at the time of this report.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient had collapsed, seized, 20 seconds. Was observed in clinic for 30 mins then released to go home.
I got the second dose on 1/25/2021. I did IVF on 1/17/2021 and tested positive on 1/26/2021. I had low pregnancy hormone when tested and then had some breakthrough bleeding a week after the second dose. I had an ultrasound which confirmed the Ectopic pregnancy on 2/5/2021. I was given the first dose of Methotrexate 2/9/2021 and 02/12/2021 and third dose on 02/15/2021. I had tiredness with cramping which may have been a side effect of the medication. I did not need surgery and when my Period started. I was given a HSG 04/05/2021 and the results were normal. Due-10/05/2021 Pregnancy- Second
Large amount of swelling/redness around injection site within approximately 1 day of injection, lasted several days, did prednisone to treat.
Patient reported significant fatigue starting 5 to 6 hours after receiving vaccination and resolving about 24 hours after receiving vaccination. Patient reported no other symptoms. Did not sleep well the night after receiving vaccination.
This case was reported by a healthcare professional and described the occurrence of looking pale in a 11-year-old male subject who was vaccinated with Boostrix, for prophylaxis. Concurrent vaccination included Menactra given on the same date as Boostrix. On an unspecified date the subject received 1st dose of Boostrix (unknown), Following an unspecified date the subject received 1st dose of Boostrix (unknown). Following vaccination with Boostrix, the subject became pale, his blood pressure dropped and he began to wheeze. He required breathing treatments at the facility and was then released to home. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified.
Lymph node swollen/'supraclavicular' lymph nodes swollen; I just want to report that I had a side effects from COVID booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 14Oct2021 (Lot number: FF2590) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, The LOT# was LOX EN6198.), administration date: 26Feb2021, when the patient was 65 years old, for COVID-19 immunization; Bnt162b2 (2d dose, LOT# was EN6207.), administration date: 19Mar2021, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Oct2021, outcome "unknown", described as "I just want to report that I had a side effects from COVID booster"; LYMPHADENOPATHY (non-serious) with onset 17Oct2021, outcome "unknown", described as "Lymph node swollen/'supraclavicular' lymph nodes swollen". Therapeutic measures were taken as a result of lymphadenopathy.  Additional information: Expiry date of COVID-19 Vaccine: unknown. Patient History and Investigation Assessment: No. Anatomical site of vaccine administration: Reporter stated, "It was high on the left shoulder." It was reported as patient was not taken any vaccination 4 weeks prior to the COVID 19 Vaccine.  Follow-Up (24Nov2021): Follow-up attempts are completed. No further information is expected.
eczema-skin reaction; Eczema; This case was reported by a consumer via call center representative and described the occurrence of skin reaction in a 64-year-old 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 skin reaction and eczema. On an unknown date, the outcome of the skin reaction and eczema were unknown.   The reporter considered the skin reaction and eczema to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient asked if Shingrix vaccine could cause eczema. The patient thought the skin reaction might be from the vaccine.
Bad reaction (throwing up, not feeling well, and very tired); Bad reaction (throwing up, not feeling well, and very tired); Bad reaction (throwing up, not feeling well, and very tired); This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Bad reaction (throwing up, not feeling well, and very tired)), VOMITING (Bad reaction (throwing up, not feeling well, and very tired)) and FATIGUE (Bad reaction (throwing up, not feeling well, and very tired)) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included MS.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Bad reaction (throwing up, not feeling well, and very tired)), VOMITING (Bad reaction (throwing up, not feeling well, and very tired)) and FATIGUE (Bad reaction (throwing up, not feeling well, and very tired)). At the time of the report, MALAISE (Bad reaction (throwing up, not feeling well, and very tired)), VOMITING (Bad reaction (throwing up, not feeling well, and very tired)) and FATIGUE (Bad reaction (throwing up, not feeling well, and very tired)) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant mediations were reported. It was reported that on an unknown date patient experienced bad reaction (throwing up, not feeling well, and very tired). No treatment medications were reported.
Patient fainted after receiving the shot and he was unresponsive and then rouse slowly. Epipen was refused by father. 911 was contacted.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 21Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 12Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic bronchitis" (unspecified if ongoing). The patient had no known allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxloid from 14Feb2023 to 19Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tickle at base of throat, ringing/ear pressure, mild headache, slight dizziness.  Occurred about 5-10 min after. Didn't get worse so just waited. Dizziness resolved first after a few minutes. Tickle in throat resolved after about an hour. Ear pressure and headache lasted for the rest of day
No adverse event; administered a vaccine past the expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a vaccine past the expiry date) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 044H22A) for COVID-19 prophylaxis.     Patient did not report relevant medical history/conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis).     On 14-Jun-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 14-Jun-2023 at 2:48 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a vaccine past the expiry date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered a vaccine past the expiry date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered a vaccine past the expiry date).    Patient did not received any other vaccine 4 weeks prior to Covid-19 vaccine.  Concomitant product use was not provided by the reporter.  On 05-Mar-2021 patient received his first moderna covid-19 vaccine (lot number: - 013A21A), on 02-Apr-2021, patient received his second moderna covid-19 vaccine (lot number: - 046A21A), on 03-Jan-2022, patient received his third moderna covid-19 vaccine (lot number: - 013H21B) and on 26-Jul-2022, patient received his fourth moderna covid-19 vaccine (lot number:- 055A22A). Expiry date of the suspect vaccine fifth dose was reported as 10-Jun-2023. Time of fifth dose vaccination was reported as 14:48 (2:48 P.M).  Treatment information was not provided.
hot flash from head to toe; sweating to the point where my clothes are wet; running a fever; chills; joint ache; headache; very tired; nausea; no appetite; soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), HOT FLUSH (hot flash from head to toe), HYPERHIDROSIS (sweating to the point where my clothes are wet), PYREXIA (running a fever) and CHILLS (chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm). On 06-Apr-2021, the patient experienced HOT FLUSH (hot flash from head to toe), HYPERHIDROSIS (sweating to the point where my clothes are wet), PYREXIA (running a fever), CHILLS (chills), ARTHRALGIA (joint ache), HEADACHE (headache), FATIGUE (very tired), NAUSEA (nausea) and DECREASED APPETITE (no appetite). On 06-Apr-2021, HOT FLUSH (hot flash from head to toe), HYPERHIDROSIS (sweating to the point where my clothes are wet), PYREXIA (running a fever) and CHILLS (chills) had resolved. On 08-Apr-2021, PAIN IN EXTREMITY (soreness in arm) had resolved. On 09-Apr-2021, NAUSEA (nausea) and DECREASED APPETITE (no appetite) had resolved. At the time of the report, ARTHRALGIA (joint ache), HEADACHE (headache) and FATIGUE (very tired) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took advil in the first evening for the arm pain and Stayed hydrated
Patient went to his HR department and showed his arm area were shot was given. He described it as red, swollen, warm to touch. I myself did not see it.
Red arm on vaccination area and spreading to underarm - tried BENADRYL/and ibuprofen. Breast hurting.
COVID breakthrough. Patient presented to the hospital on 11/28/2021 with worsening SOB and difficulty walking for three days. She was initially afebrile. Once admitted to the floor she spiked a fever of  100.5 which prompted COVID testing that came back positive.
36% After receiving vaccine, mild swelling and tenderness of left upper arm / L axilla.
Large red circular rash around injection site.  It was itchy and a little sore .  This developed 9 days after my shot.  The shot was on 3-4-21 and I noticed the red spot on 3-13-21.
stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 OMI ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose number unknown (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: Covid-19 vaccine (Primary immunization series complete; Unknown manufacturer), for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 24Sep2022, outcome "unknown", described as "stroke".  Clinical Course: Event took place after use of product. The patient felt the incidents were related.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient's left arm is swollen, reddened with a small welted area where the influenza vaccine was given. Patient is experiencing a little bit of discomfort in the area, but denies itching, warmth or fevers.
This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (a little upset stomach) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The patient's past medical history included Cigarette smoker (for 25 years but has stopped 6 months ago which at the time, he also received the Moderna Covid vaccine). On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (a little upset stomach). At the time of the report, ABDOMINAL DISCOMFORT (a little upset stomach) outcome was unknown. No concomitant medications were reported. No treatment medications were reported. Reporter did not allow further contact.