chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tender/numbness on left side of body; Chest pains; Nausea; Fever; Chills; Muscle pains; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8727) via an unspecified route of administration in the left arm on 19Mar2021 at 08:15 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient has no known allergies to food, medications or other products. Concomitant medications included birth control pills. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 00:00 the patient experienced tender/numbness on left side of body, chest pains, nausea, fever, chills, muscle pains and headaches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tender/numbness on left side of body, chest pains, nausea, fever, chills, muscle pains and headaches were recovered with lasting effects. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8729) via an unspecified route of administration in the left arm on 09Apr2021 at 13:00 (at the age of 22-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
This spontaneous report has been received from a healthcare worker (certified medical assistant) referring to a patient of unknown age and gender. The patient's concurrent condition and medical history were not provided. On 04-MAR-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (lot# not provided, 0.5ml, subcutaneous), which had been improperly stored. No adverse effects were reported. It was unspecified if the patient had sought any medical attention. Additional information is not expected because the reporter refused additional contact.
Headache, Myalgia, Sore arm Narrative: Received 2nd dose of COVID vaccine 1/26/21. Arm became sore 8 hours after dose, and unable to raise arm. Noted soreness in ankles and hips that worsened the next day. Also noted headache on 1/27/21. Symptoms lasted mid-late afternoon on 1/27/21. Missed work x 1 day. No known prior covid infection.
started feeling better; still a little washed out; vaccination site pain; chills; fever; put me on the couch all night; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain), CHILLS (chills), PYREXIA (fever), FATIGUE (put me on the couch all night) and FEELING OF RELAXATION (started feeling better) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain), CHILLS (chills), PYREXIA (fever) and FATIGUE (put me on the couch all night). On 23-Apr-2021, the patient experienced FEELING OF RELAXATION (started feeling better) and FATIGUE (still a little washed out). On 24-Apr-2021, VACCINATION SITE PAIN (vaccination site pain), CHILLS (chills), PYREXIA (fever), FATIGUE (put me on the couch all night), FEELING OF RELAXATION (started feeling better) and FATIGUE (still a little washed out) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-076249 (Patient Link).
I felt my throat begin to close; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 14:00 (Lot number: EW0158) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "complete hysterectomy" (unspecified if ongoing); "orthoscopic knee surgery" (unspecified if ongoing); "bunionectomy" (unspecified if ongoing); "rotator cuff surgery" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN; CALCIUM. The following information was reported: THROAT TIGHTNESS (disability) with onset 15Apr2021 17:00, outcome "not recovered", described as "I felt my throat begin to close". The event "i felt my throat begin to close" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Feb2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of throat tightness.  Clinical information: Patient did not receive other vaccine in four weeks of vaccination. Patient receive Simvastatin, Multivitamin, Calcium other medications in two weeks of vaccination. Patient was diagnosed with COVID, prior vaccination. Patient had been tested for COVID, post vaccination. No Known allergies.
STABLE ANGINA ANGINA, UNSPECIFIED 2/6/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
became blind; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (became blind) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLINDNESS (became blind) (seriousness criterion medically significant). At the time of the report, BLINDNESS (became blind) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Developed blisters all over his leg, arms, hands and ankles. They started popping up within a few hours after receiving his vaccines. Took him into his dr and she stated she ahs never seen anything like it so she can't say if its from the vaccine or not. Then stated she will just say its hand foot and mouth since she hasnt seen anything like it. He still has blisters popping up all over his legs. I took him into the ER and they also stated they have not seen anything like that and to just hope it goes away in a week. The leg that has the blister is where he received 2 vaccinations. He only received one vaccination in his other leg and has no blisters on that one, but they are on both arms.
A report was received from a health care professional on 10/26/01 regarding a female patient (age not reported) who experienced brachial plexitis on 10/19/01 after receiving Fluvirin vaccine on 10/16/01. Three days after vaccination in the left deltoid muscle, the patient presented with weakness and clumsiness in the left arm extending from the elbow down to the hand, diagnosed as brachial plexitis. No treatment was administered to the patient. According to a neurologist, it is thought that the patient experienced a neurological immune reaction. At the time of reporting, the patient's condition was slowly improving. The reporter has assessed the relationship of study medication to the event as unrelated. the patient has received influenza vaccine in the past years. Following internal review, on 1/21/02, this case was upgraded to serious, and following clarification on 1/25/02, the reporter's causality was amended to possible. (OMIC)
This is a spontaneous report from a contactable consumer (patient). A 22-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 22, via an unspecified route of administration, in the left arm, on Apr 12, 2021, at 08:30, single dose, for COVID-19 immunisation. Medical history not reported. Concomitant medications included Loestrin (ethinyl-estradiol/norethisterone acetate) for birth control from an unknown date and unknown if ongoing. Prior to the vaccination, patient was not diagnosed with COVID-19. On Apr 14, 2021 (1 week since she got the shot), patient reported two, 24-hour periods. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, patient has not tested for COVID-19. The clinical outcome of two, 24-hour periods (in 1 week since she got the shot): unknown (at the time of this report). No follow-up attempts required. Information about batch/lot number cannot be obtained. No further information expected.
2 days after administration of Td, patient developed 5cm x 2.5cm area on left upper arm (deltoid area). Redness, edema, tenderness and warmth appreciated.
Patient reported to us on 11/30/2020 that she has felt a lingering "pinching pain" located approximately 1 inch below the injection site (specific vaccine unknown) that started within 1 day of recieving the Fluzone Quad vaccination and Energix-B vaccination in her left arm.  She has had no such symptoms in her other arm (right) in which she received the Boostrix vaccine.  Her primary care provider initially told her to treat pain with over-the-counter NSAIDS.  She reported that they have helped with the pain but it continues to return if she stops taking them.  She says she is going to follow-up with her primary care provider about the ongoing issue because it showing no signs of improvement over a month after receiving the vaccine.
Starting around 6 pm the following day, awoke with fever of 103 degrees.  Significantly compromised muscle weakness and gross motor coordination.  Had difficulty sitting up and walking.  Compromised speech and altered mental status.  Took Tylenol at advice of GP administered by husband.  By 10 pm fever down to about 99 degrees.  Speech and mental status recovering.  By the next day, still felt quite weak and shaky, but fever 99, speech and mental status basically recovered.  A week later, still feel slightly weak and shaky
Vaccinator inserted needle into pt's arm. Mother did not have a good hold and pt moved. Needle came out before vaccinator was able to inject.  Pt was  then vaccinated with full dose.
Fatigue, sharp pains in my head, headaches, not walking, fainting, heavy head, tingling in my feet.
tingling, pins and needles, itching all over body intermittently for 4 weeks. took Benadryl as recommended by doctor. Symptoms were very intense for 2 weeks, slowly got less frequent. It seemed to be completely gone about a week ago but then came back strongly for 2 days. Now about 80% better.
I received my booster shot on 11/5/2021. On 11/14/2021 I woke up in middle of night with my scalp, neck and wrists itching. Next day on 11/15 a hive appeared on my face. As the week progressed, I became itchy and if I touched where it itched on my body a hive appeared and spread. this continued and getting progressively worse, and I saw a doctor on 11/18/2021. I told her nothing had changed (no new soaps, shampoos, detergents or foods) and the only thing new within this time period was Wellbutrin prescription and my booster vaccine. She felt that since my booster was on 11/5 this may not likely be the case and could be attributed to cold weather or stress. The hives continued since that appointment and only mildly controlled with Allegra, Benadryl and cortisone only to reappear. I took a vacation in warmer weather, no stress, and the hives continued to get worse and daily, multiple times a day. I only feel the link is to the booster and have since heard of others getting hives days after their vaccine. I get hives multiple times throughout the day. If I feel an itch and lightly touch it the area will then spread with a hive. Hives on scalp, face, neck, chest, back of thighs, wrists, arms. No previous history of ongoing hives pre-booster.
An expired Covid-19 pfizer vaccine was administered to the patient on 4/18/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke with patient on 5-9 and she will consider getting revaccinated.
huge flare with her Ulcerative Colitis; This is a spontaneous report from a contactable pharmacist via medical information team.   A female patient of an unspecified age received first dose of BNT16B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date: UN-KNOWN), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included adalimumab (HUMIRA), 160 mg (Then in 2 weeks will go down to 80 mg dose) taken for an unspecified indication from year 2021 and ongoing.   On an unspecified date of Jun2021, the patient experienced huge flare with her ulcerative colitis. Re-porter was concerned about the immune response the patient will receive and her immunity to Covid-19 after her second dose while on the immunosuppressant therapy, or should the patient wait to receive her second dose until she was at her maintenance dose in 4 weeks time. Therapeutic measures were taken as a result of the event with steroids. The outcome of the event was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event ulcerative colitis (relapse) and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021707940 Same reporter,patient/ different event, dose
6 hrs p/vax pt exp pallor, hyporesponsiveness, strange forced cry lasting 5-10 mins; also had fever all day;
COVID 19 Treatment; COVID 19 Treatment; Dose 1: Moderna/ Dose 2: Moderna/ Dose 3: Moderna/ Dose 4: Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 35 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Mar2021 as dose 1, single (Lot number: 047A21A), in left arm, on 18Apr2021 as dose 2, single (Lot number: 046B), in left arm and on 27Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: Aug2020; QULIPTA, start date: Jun2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Sep2022, outcome "not recovered", described as "Dose 1: Moderna/ Dose 2: Moderna/ Dose 3: Moderna/ Dose 4: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Sep2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Sep2023) Positive; (11Sep2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included received Paxlovid from 06Sep2023 to 10Sep2023. Clinical courses: Covid symptoms and first positive covid test developed 6 days after known covid exposure. The patient's only symptom was still loss of voice with NO sore throat.   No follow-up attempts are possible. No further information is expected.
The pt experienced anterior thigh redness, swelling of approximately 10 x 8 cm at the site. No tenderness. No treatment was necessary.
EE developed symptoms of rhinorrhea, congestion, and itchy eyes on 4/17/2021 and tested positive for Covid on 4/19/2021.
This spontaneous report was received from a registered nurse referring to a 12 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 07-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored (incorrect product storage). This is one of several reports received from the same source.; Sender's Comments:  US-009507513-1709USA008666:
Was doing great after back surgery then the day after 2nd. vaccine, 10/27/21, woke up and could not stand or even walk. Felt extremely hot and weak. Did not take  temp. Gave him two Tylenol.  after a few hours he could stand  and needed a lot of help to take any  steps. Today 10/29/21 is improving but not as good as before vaccine.
Tinnitus increased within a few hours after injection and still has not gone away.  Had strong headache, mild fever and felt achy for 36 hours after vaccine.
This spontaneous report as received from a Registered Nurse concerning a 6 month old patient who on 01-NOV-2013 was vaccinated with an expired dose of ROTATEQ lot # 0579AE, exp date reported 27-OCT-2013, oral (dose not provided). No adverse effect was observed. This is one of several reports received from the same source. Additional information has been requested.
Lethargic; Shoulder area above the injection site hurts; Injection site was swollen and painful; Injection site was swollen and painful; Tired; Right arm has not felt normal; Feels like her joint is stiff; Can't grip on things; Can't sleep on her right arm; Can't lift her right arm like she used too; she has adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), VACCINATION SITE REACTION (Right arm has not felt normal), JOINT STIFFNESS (Feels like her joint is stiff), GRIP STRENGTH DECREASED (Can't grip on things) and VACCINATION SITE DISCOMFORT (Can't sleep on her right arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced VACCINATION SITE REACTION (Right arm has not felt normal), JOINT STIFFNESS (Feels like her joint is stiff), GRIP STRENGTH DECREASED (Can't grip on things), VACCINATION SITE DISCOMFORT (Can't sleep on her right arm), HYPOKINESIA (Can't lift her right arm like she used too) and VACCINATION COMPLICATION (she has adverse reaction). On an unknown date, the patient experienced LETHARGY (Lethargic), ARTHRALGIA (Shoulder area above the injection site hurts), VACCINATION SITE PAIN (Injection site was swollen and painful), VACCINATION SITE SWELLING (Injection site was swollen and painful) and FATIGUE (Tired). At the time of the report, LETHARGY (Lethargic), VACCINATION SITE REACTION (Right arm has not felt normal), JOINT STIFFNESS (Feels like her joint is stiff), GRIP STRENGTH DECREASED (Can't grip on things), VACCINATION SITE DISCOMFORT (Can't sleep on her right arm), HYPOKINESIA (Can't lift her right arm like she used too), VACCINATION COMPLICATION (she has adverse reaction), ARTHRALGIA (Shoulder area above the injection site hurts), VACCINATION SITE PAIN (Injection site was swollen and painful) and FATIGUE (Tired) had not resolved and VACCINATION SITE SWELLING (Injection site was swollen and painful) was resolving.            Concomitant medications were not reported. Treatment medications were not reported   This case was linked to MOD-2022-455427, MOD-2022-455416 (Patient Link).
Four days after my booster I developed double vision, blurred vision, facial numbness, and a heavy/restless/weak feeling in my right leg that?s progressing quickly and no one can seem to help. I don?t know if this is directly related to the vaccine but thought it?s worth making sure the proper people know.
09/10/04: Pt presents with signs and symptoms reaction to "Hepatitis B" #3 vaccine. Vomiting, chills, fever, deafness in right ear, blisters in vaginal area.  No menses in 3 months all since 05/18/04-reports "4 heart attacks after having 1st full 2nd shot in series of Hepatitis B.  Reports "vomiting continuously since 3rd shot". MD advised her to come report to health department in July but its just now coming back. Taking Lasix 40mg daily, Methimah 5mg three times a day, Aldatone 25mg twice per day. Has begun all these meds for several years but did not report them to RN at time of vaccination. Saw MD on 07/21/04.  He ran "blood tests", she got no answer. Renewed meds because of fluid (doubled Lasix prescription). Pt was in presence of RN x40 minutes. No vomiting occurred. RN advised pt to see gastroenterologist for continual problems. Also needs to be seen in STD clinic.  09/10/04: Telephone call with MD who concerns with advise if RN to see Gastroenterologist MD.
This spontaneous report was received from a physician refers to a currently 21 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 09-APR-2012, the patient received a pediatric dose of VAQTA (lot number4 and dose were not reported) intramuscular. ON 21-MAY-2013, the patient received adult dose of VAQTA (lot number and dose were not reported) intramuscular and on 29 MAY 2015, the received pediatric dose of hepatitis a (lot number and dose were not reported) intramuscular. No adverse events were reported.  Additional information has been requested.
Pt said rash started on right shoulder (Prevnar was administered on that side) and worked itself down to spead all around waist.
The pt experienced swelling of her face and hands as well as itching of her eyes. The pt took over the counter Benadryl. No further information is available at this time.