chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EL9267), at the age of 78, via an unspecified route of administration, right arm, on Feb 22, 2021, at 13:15, single dose, for COVID-19 immunisation. Medical history included glaucoma from an unknown date. The patient allergic to latex and shrimp; all from an unknown date. Concomitant medications included warfarin, metoprolol and Crestor (rosuvastatin calcium); all for an unknown indication. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EL9265), at the age of 78, via an unspecified route of administration in the right arm on Feb 1, 2021, at 13:15, single dose, for COVID-19 immunisation. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 6, 2021, at 08:00, patient experienced bad stomach cramps for one day, irregular heart beat for 3 days; then severe headache for the next 4 days; and a sore right shoulder the entire time. 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 bad stomach cramps for one day recovered on Apr 7, 2021; irregular heart beat for 3 days recovered on Apr 9, 2021; severe headache for the next 4 days recovered on Apr 10, 2021; and a sore right shoulder entire time recovered on an unknown date in Apr 2021. No follow-up attempts needed. No further information expected.
Pt recvd the same day & next day had pain in rt chest, hypertension; seen by MD; hospitalized; pt had moved a heavy box on the day of the vax; tx heart catherization;
Pt had second Moderna Covid shot. On  May  18th,   One day later started to become confused.  I saw him on May 20. He was confused, no headache.   He had a large  acute left   Cerebral  ischemic infarct.    Three was an overlying  2.6 X  2.2  CM hemorrhagic infarct.    Blood pressure was elevated  at 170/130,  I controlled blood pressure with Cardene drip.
My son his paralyzed t12 and his left hip swelled up within 24 hours of injection, then he used a hand massager to loosen it up and the leg and knee became bright red, swollen even more, and the pain in the leg became unbearable he couldn't move without intense pain, he was taken to ER, where he was treated for possible infection, and they noticed his hemoglobin was dropping and his leg was getting larger, he received 3 units of blood during his stay, A hematoma developed and was growing in the left thigh. He was given Vancomycin, then Doxy. The blood stabilized day 6 and he was discharged day 7 to home to continued recovery.
This spontaneous case reported by a consumer, describes the occurrence of asthma in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient had asthma. Patient treated with prednisone for asthma; 1 dosage form. At the time of the report, asthma outcome: unknown. Concomitant product information not provided. Most recent follow-up information incorporated: On Jul 28, 2021: Follow-up received and contained non-significant information.
Mother states she noticed child's hands swelling about 4 PM and then found whelps on her back and arms. She also experienced swelling of face and feet later on. Mother gave Benadryl. Family was traveling and was seen at an ER and told this was allergic reaction and to continue Benadryl.
Sharp pain horizontal in L) deltoid. Pain with Range of motion. Shoulder seems to pop. Vaccination injection was 10/10/2017. No swelling, No bruise at the time. Has used occasional ibuprofen and heat with minimal response.
Approx. 45 -- 60 minutes following the vaccine, pat c/o lightheadedness, blurry vision, tingling in Left cheek, x 1hour, skin turned bright red heart rate 147 BP 147/80. Iced back of neck/forehead, sat for a few minutes. Heart rate down to 104, went back to work, but continued to feel flushed. Upon examination, her skin was normal in color but she stated that she still feels flushed & hot.
Hot Skin at Injection Site. 2 weeks later and still occcuring at Injection Site.
NEUROPATHY; SEVERE REACTION; This spontaneous report received from a patient via media via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number were not reported, expiry: unknown) 1 total, dose, start therapy date were not reported 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.  On an unspecified date, the patient experienced neuropathy, and severe reaction. The patient reported as "My first experience with the Johnson and Johnson vaccine was so bad I had a severe reaction with neuropathy".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe reaction and neuropathy was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220207510.; Sender's Comments: V0:20220207073- covid-19 vaccine ad26.cov2.s-Neuropathy. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
BLOOD CLOT IN LEFT LUNG, PATIENT WOKE UP IN HORRIBLE PAIN UNDER LEFT RIB, THURSDAY HE COUGHED UP A "CLOT OF BLOOD" PATIENT WENT BACK TO ER AND WAS THERE FOR 2 DAYS AND STARTED ON BLOOD THINNERS.
Pt reports after having flu shot that evening developed redness and swelling of upper arm, became more pronounced over next 2 days. Also had defined raised hive like rash .
Serum ejected out from syringe bottom, don't know how much was injected; Pt over 65 yrs. intradermal; A spontaneous report was received from a physician concerning 65-year-old male consumer, who received Moderna's COVID-19 vaccine and the serum ejected out from syringe bottom. The patient was also administered the vaccine intradermally.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On a date that was not reported, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 0112L20A) intradermally for prophylaxis of COVID-19 infection.     During, preparation of the of mRNA-1273 vaccine some of the serum ejected out from syringe bottom. The amount of serum lost is unknown, that same syringe was used to vaccinate the patient. The healthcare professional is unsure how much vaccine was injected. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the event, serum ejected out from syringe bottom and administered the vaccine intradermally, was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered and incorrect route of product administration (Intradermal) for mRNA-1273.  There were no reported adverse events associated with this case.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 10:36 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 10:36 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 31.98.  Concomitant products were not provided.  On 27-Apr-2021, Excursion time was 09 AM, temperature was 35, total doses given for the day was 42, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 27-Apr-2021. 8 vials were sent to clinic. Vaccine BUD date was 19-May-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Sep2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 06Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FJ5683) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "DJD" (unspecified if ongoing); "HBP" (unspecified if ongoing); "Reflux" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN. Past drug history included: Daypro, reaction(s): "Allergy"; Voltaren, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (Jul2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive, notes: Positive, Rapid Covid test on 13Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Recurrence of symptoms 5 days after finishing five days of Paxlovid (sinus, congestion, cough sneezing) Positive Rapid Covid test on 13Jul2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 (COMIRNATY) to the reported events Drug ineffective and COVID-19 cannot be ruled out.
Few minutes after vaccination-- pale, sweaty, lightheaded and passed out for a few seconds- responded after a few seconds- ems took vitals and all BP, O2 and bs were normal- breathing fine but threw up after about 20 minutes. Spoke to mom and doing fine so far- still dizzy but much better- will continue to monitor.
Large, red welts below injection site with swelling on left arm and tenderness to abduct arm from body.
I was having a normal healthy pregnancy, no high risk symptoms and was checked by my OBGYN the same day of the vaccine and everything was fine. My estimated due date was April 10, 2016. The day after my vaccine (less than 24 hrs later) I started bleeding vaginally (cervix was thin) and delivered my baby 3 days later at 3 lb and 7 oz.
Developed severe ongoing pain in left shoulder and arm which has persisted to current date. I had minor pain prior to second vaccination but beginning in the hours immediately following the second dose it became much worse. It migrates throughout the arm and shoulder throughout the day. I am taking prescription pain medication and muscle relaxers for the first time in my life. I could not go to work for 5 days, I now can make it through the day with heavy medication. I have also been prescribed physical therapy for 7 more weeks.
Daughter seen for a routine well checkup. Dr. administered vaccines GARDASIL, Hep A and TD. A few minutes after injections daughter became very pale. She was standing - almost fainted. she was placed on exam table - laid flat for 5 minutes. Did not return to school that day. remained pale for about 30 mins.
Pt recvd vax & 36 hrs post vax exp generalized flu-like sx & fatigue;
It started a couple days after the dose. I started getting really extreme shortness of breath. I was struggling to take good full breaths that were satisfactory. I was gasping for air sometimes every few minutes. It would happen a lot the first few days every few minutes and would get worse in the evenings. It slowly tapered off after a few weeks. I still have that shortness of breath every now and then. First dose I also got a large rash on my left arm. It happened 6 days after the 1st dose then went away. After I got my 2nd vaccine, my left arm started itching again and then it went away. Office visits that were follow up after the first dose doctor visits June 23. Shortness of breath is still there occasionally and lighter but recovered.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored VAQTA (lot # L015460, expiration date 20-JUL-2017, dose and route were unknown). Other suspect therapy included improperly stored GARDASIL 9 (lot# L045711, expiration date 07-MAY-2017, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reported to the doctors on the 23rd with red, swollen, painful arm.  Dr. told her to put a cold compress on it, use anti-inflammatories, and gave her an antibiotic in case needed.  Patient did not take antibiotic and redness was relieved with ice pack.
I was exposed on Sun the 17th to COVID-19. I tested on 7/18 and was negative. On 7/21 I was feeling bad and tested positive. I went to urgent care and was tested and was negative. They gave me an antibiotic shot and a steroid shot. I was given bebtelovimab and I was told to isolate for 5 days. The most severe was on Thursday where I kept sweating a lot yet I didn't have a fever either when I took it at home or at the urgent care the same day. Most issues was sweating, vertigo and dizziness. I'm also hoarse, dry cough, achy and feeling very tired with a bad headache. I would stay the symptoms lasted for about 4 days; today is my 5th day. I still have some of the sweating, sore throat, hoarseness and headache but they have lessened in intensity.
This case was reported by a physician and described the occurrence of maladministration (asymptomatic/ child too young) in a 1-month-old female subject who was vaccinated with HAVRIX, (GlaxoSmithKline).  There were no concurrent medications.  On 11 February 2009 the subject inadvertently received 1st dose of HAVRIX.  This was considered to be a maladministration (asymptomatic/child too young) as HAVRIX is not indicated for use in subjects under the age of 12 months.  An unspecified amount of time following vaccination with HAVRIX, the subject became fussy.  At the time of reporting the outcome of the events was unspecified.
Patient tested positive for COVID after the first dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested positive for COVID after the first dose of the vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient tested positive for COVID after the first dose of the vaccine). At the time of the report, COVID-19 (Patient tested positive for COVID after the first dose of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
low fever, chills, body aches, fatigue (kind of like milder flu symptoms) - felt better 72 hours after getting shot
Day of vaccine starting experiencing what has been diagnosed as psychogenic non-epileptic seizures. Beginning 10/18/19 - many episodes consisting of wooziness, unaware of surroundings, disoriented, fatigued. Beginning 12/31/19 - seizure-like episodes lasting 5-15 minutes. No pain, legs move involuntarily, extremities shake, labored breathing.
Information has been received from a physician concerning a 2 month old male who was vaccinated with a dose of Rotateq (lot number not available). Unspecified medical attention was sought and the patient was subsequently hospitalized and diagnosed with rotavirus. The patient was not recovered at the time of this report. There was no product quality complaint. Additional information has been requested.
Adverse symptoms: fatigue, muscle and joint pain, fever Treatment: ibuprophen Symptoms began upon waking the following morning and lasted approximately 24 hours
patient presented to pharmacy 9-23-19 concerned with reaction having after vaccine.  She reported and showed visible signs of left arm swelling, pain and hot to the touch of vaccinated arm.  She also reported experiencing itching to arm vaccinated and left side of upper back.  I counseled patient that she appeared to be having an adverse event from the vaccination and should see a doctor to confirm as well as get further possible treatment.  Patient was seen in office at urgent care, given steroid injection and prescription for 5 day course of steroids.  I phoned patient to follow up and she informed me that the doctor believed she was having an allergic reaction to the vaccine as well and informed me of treatment.  As of now her symptoms remain the same, patient only received injection a few hours ago.
Patient called 11:38 am 9/4/15 stating that his arm was slightly swollen and he had a low grade fever after getting a PREVNAR 13 and AFLURIA flu shot on 9/3/15 at 6:00 pm pharmacist on duty told patient to take ibuprofen and call MD if worsens.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 16-JAN-2012 at 7:30 and on 17-JAN-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 30-JAN-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671141/1267AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
No adverse event- patient presented full vaccine card with last dose (monovalent) given 5-2022 and then received Bivalent booster 1-17-23. Hours later patient presented an additional vaccine card with a Bivalent booster given 10/22. Only symptom is sore arm today.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021514881 same reporter/drug, event / different patient
arthritic pain in his shoulders, knees, toes, elbow, fingers and cheeks/jaw joint was aching.; "booster dose" given at full dose; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (arthritic pain in his shoulders, knees, toes, elbow, fingers and cheeks/jaw joint was aching.) and ACCIDENTAL OVERDOSE ("booster dose" given at full dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE ("booster dose" given at full dose). In September 2021, the patient experienced ARTHRALGIA (arthritic pain in his shoulders, knees, toes, elbow, fingers and cheeks/jaw joint was aching.). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Arthralgia, at an unspecified dose and frequency. On 26-Aug-2021, ACCIDENTAL OVERDOSE ("booster dose" given at full dose) had resolved. At the time of the report, ARTHRALGIA (arthritic pain in his shoulders, knees, toes, elbow, fingers and cheeks/jaw joint was aching.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: high (High) High Inflammation and High antibodies.         No concomitant medications were reported Symptoms: It was reported that the patient had experienced unspecified mild symptoms after the booster dose of vaccine.  Lab data: Blood tests were performed between 20-Sep-2021 to 10-Oct-2021
I was covid-19 positive; scratchy throat then bad headache; Fever and coach and that lasted about 48 hours.