chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching mostly on face and scalp.; This is as spontaneous report received from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264) via unspecified route of administration in the right arm on 11Feb2021 at 01:00 PM (at the age of 76-years-old) as a single dose for COVID-19 immunization. Patient's medical history included glaucoma, dry eye and allergy to tetracyclin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included hydrochlorothiazide, omeprazole, alendronate and latanoprost. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Restasis, dorzolamide thymol, PredMild, Rhopressa, Latanoprost, Artificialtears, Night gel, Biaxin and expereinced allergy. On 12Feb2021 the patient had itching mostly on face and scalp. No teatment was given to the event. Outcome of event was resolving.
Received flu shot 10:16 AM on 11/16. Denied pain or discomfort. Noted redness the following AM on arm upon removal of BANDAID (10/17/17 at 0600). Small ecchymotic area at injection site reported as of 10/19/17. Now reported as resolved.
pt recv vax & devel clinical varicella but never devel antibodies;2 patients were reported;
The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter)  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, 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 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.
This spontaneous report received from a patient concerned a 51 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total, first dose administered on 09-Apr-2021 for prophylactic vaccination. Age at time of vaccination 51 years old. The patient had headache, psoriasis flare-up and vaccination site pain following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient had not recovered from plaque psoriasis flare up/ plaques on shins. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total, second dose administered on 29-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. No adverse events reported following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2). The patient additionally received non-company suspect vaccine included tozinameran (Pfizer biontech covid-19 vaccine) (Dose number in series 3) (form of admin unknown, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, booster dose, administered on 01-APR-2022 for covid-19 vaccination. On an unspecified date, the patient experienced muscle ache, and fatigue (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of the muscle ache and fatigue was not reported. This report was non-serious. This case, involving the same patient is linked to 20220307805 (Dose number in series 1).
Diagnosed with polio in '63. In 2002 post polio syndrome started and has gotten progressively worse since then. Complains of extreme fatigue, muscle weakness, muscle atrophy (left leg) lack of appetite, migraines, leaky valve on heart, dry throat which causes problems when swallowing, high cholesterol, severe depression.
BLOOD CLOT IN LEG; SMALL BLOOD CLOT IN LUNG; SUSPECTED COVID-19 INFECTION; SICK; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient caught covid then she got a blood clot in her leg, the a small one in her lung they put a screen in her neck. Patient had gotten sick and been sick for 4 weeks now she had a cough that she got rid of. Reporter stated that, "My whole family got these shot I never got them I never stayed during the lock down, my sister had caught covid then she got a blood clot in her leg the a small one in her lung they put a screen in her neck. I got covid one day all I had was the chills and a fever. Now my sister had gotten sick and been sick for 4 weeks now she has a cough that she get rid of and now my brother inlaw has that cough too. I am glad my daughter and my grandson did not get them covid shot plus like 10 people could be more has a cough that they can get rid of. Vaccines takes year and years to develop a good vaccine but the government and these medicine company just so happen to come up with a vaccine to stop covid 19 they swear up and down that they figure it out the only thing they did Johnson and Johnson mederma and Pfizer really messed up this world that just my opinion shame on you guys Less". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and sick, and the outcome of blood clot in leg and small blood clot in lung was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20221258060. This case, from the same reporter is linked to 20221258150. This report was associated with product quality complaint: 90000264811.  It was determined that Manufacturer Case Number 20221258060 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20221258056.; Sender's Comments: V0- 20221258056- Blood clot in leg- The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  V0- 20221258056- Small blood clot in lung- The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, strength and frequency not reported, lot # L013826, expiry date: 21-APR-2017). No adverse effects were reported. This case is one of several cases received from the same source. Additional information has been requested.
12/19/17 Vaccine given at 1:30pm. At 3:30pm, son complained of nausea and leg pain, HA. By 4:30pm, son w Extreme HA, body aches, nausea, vomiting, temp 103 oral, sensitivity to light, shaking/ chills. MD called. Recommended Tylenol or Motrin w food. Unable to keep water or food down. By 6:15pm, he could tolerate ice chips and took Tylenol. 7:30pm temp 102 PO, still w body aches, nausea, HA. Slept through night, but still w nausea, HA. 12/20/17 Wednesday 9AM nausea w vomiting,temp 101 po, HA, body aches, taking soda and ice chips. Refuses Tylenol. 2:30 PM Feeling less nausea, so Tylenol Temp 99.4 at 10:30PM. Thursday temp 98.6 and HA, body aches nausea gone.
approx 5 weeks p/vax pt devel intussusception which was successfully treated surgically
Double black and blue marks in shape of a snowman. on upper left arm at injection site. White in each center of black marks. Still have marks on March 23, 2021.  Right hand turned  red black and blue on base of hand down to my wrist and up to my pointing finger, base of middle finger and thumb. Color is fading now but still visible at base of my hand.
pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Nov2021 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: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "pain at the injection site".  Additional information included: Customer Verbatim: I received my booster shot in Nov2021 and still have pain at the injection site. I don't believe 5 months would be considered normal. I am trying to find the right doctor to assess, but wanted to reach out to first inform of this side effect and to see if you may offer some guidance.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Two days post vax, pt developed numbness in the fingertips of his left hand. The numbness progressed to involve his fingers and sometimes the entire left hand.  On 12/28/1999 he was seen by a physician who noted numbness mostly involving the fingertips of the left hand.  EMG and nerve conduction studies performed 02/02/2000 revealed borderline prolongation of median motor distal latency consistent with mild left carpal tunnel syndrome. The final dx was carpel tunnel syndrome due to repetitive work using the left hand.
1/3/21: SWOLLEN, SORE LYMPH NODES TO LEFT AXILLA, INJECTION SITE ITCING, SWELLING, WARMTH, REDNESS & department visit TENDERNESS
Side effect / YES; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect / YES) 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.    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 VACCINATION COMPLICATION (Side effect / YES). At the time of the report, VACCINATION COMPLICATION (Side effect / YES) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. No treatment drugs are not provided by reporter.
This is an administration error. patient received pediatric moderna booster as opposed to the Bivalent Moderna booster
Severe local reaction with induration erythema, warmth and swelling. Right upper arm 20x16cm around injection site.
Narrative:  Patient received Pfizer COVID19 vaccination on 3/23 and 4/13. Presented to PCP appointment on 5/19 and reported itching after second dose. No documentation of treatment.
Redness and swelling in both thighs, fever started at 8PM with 102 degree F. Non stop cry, shrill, high pitched for 2-3 hrs. Given Tylenol at 4:45 PM and give Q 4 hrs throughout night. No tolerate cool clothes or bath to cool legs.
anxiety; Extremely debilitating; Severe vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Oct2021 16:45 (Batch/Lot number: unknown) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, 09:00 AM, left arm), administration date: 04Oct2021, when the patient was 28 years old, for Covid-19 Immunization. The following information was reported: ASTHENIA (medically significant) with onset 28Oct2021, outcome "not recovered", described as "Extremely debilitating"; VERTIGO (medically significant) with onset 28Oct2021, outcome "not recovered", described as "Severe vertigo"; ANXIETY (medically significant) with onset 28Oct2021 05:00, outcome "not recovered", described as "anxiety". The events "extremely debilitating", "severe vertigo" and "anxiety" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of asthenia, vertigo, anxiety included "meclizine and buspar". Neither was helping. Clinical course: Didn't have any anxiety before until after the second shot. Vertigo started about 3 days after the vaccine. Anxiety started about 5. Extremely debilitating. Have been to the hospital 3 times over the vertigo and anxiety. The lot number for bnt162b2 was not provided and will be requested during follow up.
Initial injection site pain, headache, myalgias, and fatigue. NOV20-22.  Left lower leg paresthiseas (sensorineural) which continue to present (28NOV2021). NOV22.  Left carpal tunnel symptoms, which continue to present. NOV23.  Right lower leg paresthesias (sensorineural) which continue to present.
First dose had made me spot some between periods, too; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Apr2021 13:30 (Lot number: ER8731) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Known Allergies: Penicillin and all derivatives" (unspecified if ongoing), notes: Known Allergies: Penicillin and all derivatives. Concomitant medication(s) included: ACETAMINOPHEN. Past drug history included: Erythromycin, reaction(s): "drug allergy", notes: Known Allergies: Erythromycin; Epinephrine shot, reaction(s): "Drug allergy", notes: Known Allergies: Epinephrine shot. The following information was reported: INTERMENSTRUAL BLEEDING (non-serious) with onset Apr2021, outcome "not recovered", described as "First dose had made me spot some between periods, too". The event "first dose had made me spot some between periods, too" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of intermenstrual bleeding.  Additional information included: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Acetaminophin within 2 weeks of vaccination. Reported Event: Her menstrual cycle was now 3 weeks+ long flow and never really stops. Cramps, spotting, clotting, the whole nine yards almost all month, every month since her second dose. First dose had made her spot some between periods, too. Yet she also still get heavy flow on what would normally be her'time of the month'. If she was lucky she might get up to a week after her 'time' flow-free, but never more and often less. She cannot go even one day without wearing a pad at least or she would be bleed through clothing. Tired, headache, cramps, even a bit of bloating throughout every month since vaccination. This sucks, it affects her daily life to detrimental proportions. This did not result in prolongation of hospitalization. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Seizure w/fever 8 days after getting Immunizations for MMR Varicella and Hep A.
Pt has a history of CAD s/p CABG, type 2 IDDM, and a history of colon cancer.  Pt was admitted due to sepsis and COVID-19 pneumonia.
Was not communicated on her admission that patient had a prior vaccine and so was given the 2nd dose of  the Vaccine 14 days after 1st dose.   No adverse outcomes at this time.
allergic reaction; swelling of her hands and feet; swelliing of feet; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-May-2021 and was forwarded to Moderna on 04-May-2021.    This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING (swelling of her hands and feet), PERIPHERAL SWELLING (swelliing of feet) and HYPERSENSITIVITY (allergic reaction) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALBUTEROL [SALBUTAMOL], AMLODIPINE, ATORVASTATIN, EMPAGLIFLOZIN (JARDIANCE), FAMOTIDINE (PEPCID AC), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), GABAPENTIN, INSULIN, METFORMIN, NAPROXEN, MULTIVITAMIN & MINERAL and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling of her hands and feet) and PERIPHERAL SWELLING (swelliing of feet). On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction). On 12-Apr-2021, PERIPHERAL SWELLING (swelling of her hands and feet) and PERIPHERAL SWELLING (swelliing of feet) had resolved. At the time of the report, HYPERSENSITIVITY (allergic reaction) outcome was unknown.        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.   The patient took Benadryl to treat the swelling.
Pt presented to pharmacy for influenza and shingrix (dose #2) vaccinations. Patient reported severe pain for 2 months after shingrix dose #1 (administered 11/25/19 per WIR). Pharmacy intern administered influenza vaccine to R Deltoid first, without complication. Pharmacy intern then administered shingrix vaccine to L Deltoid, and upon placing bandage noted swelling and induration. Pharmacy intern advised patient of concern for reaction and called for supervising pharmacist. The patient was observed for 20 minutes after reaction and denied any symptoms of anaphylaxis. After 15 minutes of observation, the patient opted to self-administer a dose of Benadryl and Tylenol from her own personal supply. She was educated on the signs and symptoms of infection and instructed to follow-up as needed. Pharmacy intern and pharmacist will followed up with patient 24 hours after the event. Patient reported that the swelling resolved overnight but that the pain persists. Denied any signs or symptoms of infection.
This spontaneous case reported by a consumer, describes the occurrence of constant headache in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch#  041C21A) for COVID-19 immunization. No medical history reported. On Apr 11, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 11, 2021, patient experienced constant headache. At the time of the report, constant headache outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications provided. Treatment: Tylenol and cranial work taken to alleviate the symptoms experienced.
Received PFIZER DOSE on 6/30/21, but his first dose was Moderna Given on 6/2/21. Client remain asymptomatic and stayed 15 minutes for observation.
Apnea spell with feeding, mom initiated CPR, EMS transported to ER (shallow respirations & unresponsive to painful stimuli on EMS arrival). At ER arrival shallow respirations & occas. weak cry. Admitted to pediatric unit. Dx: apnea of prematurity with hypoxia, anemia of prematurity.
Chills, then fever (101-103F) from approximately 1:30 am to 6:00 am.  Awakened around 1:30 am nauseous and hot to touch.
On 2/9/22 at approximately 7p, I suddenly developed severe dizziness followed by whole right side paralysis, aphasia, & confusion.  The symptoms lasted about 5 mins. EMT arrived at my home and transported me to the ER. While in route to the hospital via ambo, the dizziness, paralysis, aphasia, and confusion started again. This was all observed my medics. I was hospitalized from 2/9/22 - 2/11/22. I had an extensive work-up done which was all negative. I continue to feel dizzy after my hospitalization. The dizziness increased to several times a week to several times a day. I went back to the ER on 3/16 for the dizziness ( all diagnostic test and labs were negative). I have since started vestibular physical therapy and is awaiting to see an ENT specialist scheduled later in April 2022.
Breakthrough case admission after 3 vaccines Pfizer 3/3/21 Lot# EN6198;  Pfizer 3/24/21 Lot# EN6208;  Pfizer 11/4/21 LOt# FE3590
Thought she was having a heart attack. All muscles hurt (whole body). Terrible indigestion.
Headache, chills, fatigue, fever (highest 103.2 F). These symptoms lasted 4-5 days. Still had headache 8/18/08.
Swelling of throat, bruise at injection site, rash on opposite forearm. Patient did not seek any medical attention, returned to pharmacy today.
Fever started about 4 hours after receiving vaccines. Fever was the highest at 103. Baby was very fussy and did not want to eat. She did not sleep well last night.