chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Lot number: EW0158) and in May2021 as dose 2, single (Lot number: EW0173) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 31May2022 as dose 4 (booster), single (Lot number: 037A22B) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications which include birth control medication. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (17Jul2022) Negative; (21Jul2022) Positive. Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 13Jul2022 to 17Jul2022  Clinical course: The patient had no known allergies. After receiving the treatment, tested negative and asymptomatic by Day 5, but then tested positive and symptoms resurfaced on Day 9.  No follow-up attempts are possible. No further information is expected.
Experienced a round red area at injection site within 24 hours of injection.  Site was painful and itchy at times.  Now, 2 weeks later, redness has faded but is still present and site itches at times.
DEC. 30TH, 1:30PM, WHILE MOM WAS BATHING HER, NOTICED RED, SWOLLEN AREA THE SIZE OF A SILVER DOLLAR ON R UPPER ARM.
Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from consumer (Office Staff). This case involves six-months-old patient who was vaccinated with 0.5 ml of FLUZONE QUADRIVALENT (batch number, expiration date, route and site of administration was not reported), on 11-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to overdose (six month old patient received 0.5 ml FLUZONE QUADRIVALENT. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
sneeze, cough, wheeze, red eyes; sl cyanosis of lips occurred w/in 15 minutes; 320PM proventil areosol tx & DPH given PO;
Woke up at 4AM on  03/05/2021 with shaking chills, feeling very cold, couldn't get warm.  Shaking so bad I couldn't get whole sentences out.  Body aches and stiffness, affected my walking.  Did not take temperature at that time.  Got back into bed with 2 blankets and a comforter and still couldn't sleep.  Got up a 7AM - temp 102.2, shaking less but still  feeling cold, body was hot to touch.  I had a bad headache and body aches and stiffness were still there. I noticed at that time  that I had a bright red flush on both cheeks and my nose that was hot to the touch.  Took 600mg of Ibuprofen.  Went back to bed feeling terrible.  At 12 noon I got back up and temp was down to 99.7.  Headache, body aches, stiffness, and "red flush" still on cheeks and nose.  Went back to bed.  Took more Ibuprofen at 7pm - temp was down to 98.7.  Headache was better, body aches improved.  Flushed hot face was still present.  Went to  sleep at 11:30PM  and slept for 10 hours.  Today, 03/06/21, all symptoms improved, no fever, redness of face is still present but less.
Onset after shot on right deltoid on 10/05/04 per mother got worse over last 2 days with increased redness, swelling and warmth. No fever. Treating patient for cellulitis 10/7/04
After about 30 minutes, my cheeks and lips started to tingle/go numb.  It was on the surface of my skin, not inside of my mouth.  It slowly spread on my face, and then about a hour later, subsided.; After about 30 minutes, my cheeks and lips started to tingle/go numb.  It was on the surface of my skin, not inside of my mouth.  It slowly spread on my face, and then about a hour later, subsided.; This is a spontaneous report from a contactable consumer (patient herself). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number EM9809 and expiration date unknown), via an unspecified route of administration in Right Arm on 04Feb2021 at dose number unknown, single for COVID-19 immunization. The patient's medical history included Cancer in 2000, chemo and radiation. Concomitant medication included Apple Cider vinegar for Immunity vitamins. Patient previously took codeine for which she was experienced with allergies. It was reported as patient stated that on 04Feb2021 after about 30 minutes her cheeks and lips started to tingle/go numb. It was on the surface of her skin, not inside of her mouth. It slowly spread on her face and then about an hour later it was subsided. Patient did not receive any treatment. Outcome of events was recovered on 04Feb2021.
Parent called to schedule meningitis vaccine for school as she received a letter from school nurse stating he required it to start school Sept 2022. One staff nurse scheduled visit, patient was new to practice and was awaiting transfer of previous office records. Upon visit to office for injection a second staff nurse gave vaccine without looking up history, after it was found that patient received Menveo one year prior in 7.2021.
No adverse reactions Reported. In November 2022 our State Immunization VFC program did our every-other-year audits in both our offices. It was discovered at that time, that some Covid vaccines were administered outside of the 10 week expiration date (which is calculated from the date the vaccines were received from the State).
Body Aches; Vomits; Fever; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body Aches), VOMITING (Vomits), PYREXIA (Fever) and HEADACHE (Headaches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039H20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (Body Aches), VOMITING (Vomits), PYREXIA (Fever) and HEADACHE (Headaches). At the time of the report, PAIN (Body Aches), VOMITING (Vomits), PYREXIA (Fever) and HEADACHE (Headaches) had resolved.            No concomitant medications were provided No treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Followup received and updated event outcome and action taken.
rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L2DA) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included NIFEDIPINE and METOPROLOL for Blood pressure management.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE RASH (rash at injection site). At the time of the report, VACCINATION SITE RASH (rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Maternal exposure during pregnancy; No adverse event; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved 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 MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy).    Concomitant and treatment medications were not reported.  Index number was reported as MONU2257.  Company comment: This is a spontaneous case concerning a 31-year-old female patient with no medical history reported, who experienced the unexpected non-serious events of maternal exposure during pregnancy and no adverse event. The events occurred after the fourth dose of mRNA-1273.222 vaccine. No information disclosed about diagnostic tests performed or treatments received. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report. Events seriousness assessed as reported.     Reporter did not allow further contact; Reporter's Comments: This is a spontaneous case concerning a 31-year-old female patient with no medical history reported, who experienced the unexpected non-serious events of maternal exposure during pregnancy and no adverse event. The events occurred after the fourth dose of mRNA-1273.222 vaccine. No information disclosed about diagnostic tests performed or treatments received. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report. Events seriousness assessed as reported.
Covid vaccine documentation: PT admitted 12/13/21.   POC SARS COV2 ANTIGEN POS 12/13/21. PT documented to have had covid, symptoms began last week. presented to ED with syncope for assessment. PT had experienced a non-traumatic syncopal episode 12/12 after completing half of their peritoneal dialysis session. PT currently admitted. Pfizer dose 1 given 5/14/21 Lot EW0170. Pfizer dose 2 given 6/4/21 Lot EW0172.
Pt had a syncope episode.  Nausea, fatigue. Monitored for one hour.  Walked out of clinic with parent.  Parent did not disclosed that the patient reacted to the 1st dose of series has vomiting for 24 hours.
Pt had immediate allergic reaction to flu vaccine - hive at site & itching redness = 2 inches - 3 inches in diameter.
CHEST TIGHTNESS; This spontaneous report received from a parent 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced chest tightness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chest tightness was not reported. This report was non-serious. This case, from the same reporter is linked to 20220419225.
Pericarditis.  Symptom onset 4/7/03 of dyspnea on exertion, chest pain worse with lying down, better leaning forward accompanied by night sweats and chills but no measured fever.  Seen by physician and treated with non-steroidal anti-inflammatory agents, symptoms improving as of 4/16/03.
Uncontrollable shaking, inability to walk, inability to talk, hands hot to the touch, incontinence, inability or desire to eat -  all began 4:30pm on the day after first vaccine given (Tuesday 2 Mar 2021) . Patient had to sleep in a reclining chair for 3 nights  and was prompted to drink water and was given one Tylenol 650mg. During this time patient needed INCREASED  assistance with toileting and could not have a shower with assistance (instead was given a sponge bath). Symptoms lessened over the three days and patient returned to her baseline by Saturday 6 Mar 2021.
Confusion; Balance was off; Aggravation; Sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion), BALANCE DISORDER (Balance was off), CONDITION AGGRAVATED (Aggravation), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M2A) for COVID-19 vaccination.     Concomitant products included METOPROLOL TARTRATE, SERTRALINE, NAPROXEN, ALPRAZOLAM (XANAX) and AMITRIPTYLINE for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced CONFUSIONAL STATE (Confusion), BALANCE DISORDER (Balance was off), CONDITION AGGRAVATED (Aggravation), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue). At the time of the report, CONFUSIONAL STATE (Confusion), BALANCE DISORDER (Balance was off), CONDITION AGGRAVATED (Aggravation), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not provided,
Severe vomiting, diarrhea, irritability, chickenpox rash, fever of 102. Symptoms lasted 9 days. Spoke with nurse on 03/11/2000.
I was having pain from my neck all the way to my ear, temple, upper/lower jaw bones, right eye, really bad pain in my neck. I went to the Chiropractor and the neck calmed down but the rest of the pain did not stop in the other areas. The pain was so bad in my jaw bones and I could not talk. After going to the Chiropractor without getting any relief the following day I made medical appointments with my Dentist and Doctor. My Doctor said that said that she was glad that I tried to rule the pains out by going to the Chiropractor. Dr. ordered a series of X-rays on my jaws on 06/07/2021 and the X-ray clinic took them on 06/10/2021. I was diagnosed with trigeminal neuralgia and ruled out any structural thing or anything else going on with me (no way that there was any way that I was causing tension by turning my head and if the nerves were following where my pain was occurring). I have to let one of my colleagues takeover after talking too long because it starts to get stiff or sensitive. I'm adjusting around it right now.
Was unable to sleep due to severe pain in left arm, fever feelings, body aches, headaches, and stomach ache. Took tylenol to sleep. was unable to work the next day due to continuation of the same symptoms.
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 26-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 28-Apr-2021 at 9:01 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 9:01 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 26.95  Concomitant products were not provided.  On 28-Apr-2021, Excursion time was 9AM temperature was 33 total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 28-Apr-2021. 4 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  On 28-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: Not provided, 9 AM:33, 10 AM: 36, 11 AM: 40, 12 AM:41, 1PM: 41, 2 PM: 39, 3 PM: 41, 4 PM: 40 and 5 PM: Not provided.  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 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.
Pt arrived due to fever and altered mental status.  He was found to have COVID and viral sepsis.
blood clot; This is a spontaneous report from a contactable consumer. A 93-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, consumer stated that she found out that 2 other people she knew were having the same symptoms. Consumer clarified that they had a blood clot, stated that she did not ask them if they were having any other symptoms. Later, consumer stated that her neighbor who was 93 years old got a blood clot 3 days ago. The other person who got a blood clot was much younger and got it right after getting the vaccine. Consumer verified that these were the same 2 people she was talking about earlier and they both got the Pfizer Covid vaccine. The outcome of event was unknown. Information about Lot/Batch number has been requested
This spontaneous report as received from an office manager via a company representative refers to an 8 year old male patient. The patient's concurrent conditions and medical history were not reported. On 07-JUN-2015, the patient was vaccinated with the first dose of GARDASIL 9 (Lot #, expiration date, dose and route were not provided). Concomitant therapies included DURA-TAP/PD and MENVEO. The reporter stated that at the age that the patient was vaccinated was other than indicated in the prescribing information. It was also reported that no treatment was given. Additional information has been requested.
Terrible pain in hands and ankles with immense swelling, heat, and redness.  Muscle pain through body.  All which has continues weeks after vaccination.
Temperature excursion. Unmixed vaccine was exposed to a temp of 1.3 degrees higher than the recommended storage max range for up to 6 hours prior to administration.; POOR QUALITY VACCINE ADMINISTERED; This is a spontaneous report from a contactable Nurse. A 49-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an intramuscular route of administration in the right arm on 24Feb2021 at 07:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. It was unknown if the patient was pregnant at the time of the vaccination. It was unknown whether  the patient was diagnosed with COVID-19, prior to the vaccination. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 24Feb2021 at 07:00, the patient experienced temperature excursion. Unmixed vaccine was exposed to a temperature of 1.3 degrees higher than the recommended storage maximum range for up to 6 hours prior to administration. It was unknown whether the patient received any treatment. The clinical outcome of the events temperature excursion and poor-quality product administered was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Mother noticed redness (half dollar size) around 6:00 AM on 5/24/2007 arrived home from school around 4:00 pm with large swelling/redness/pain fell asleep. No fever. Today with 83 cm x 83 cm swelling, redness - no pain, no fever to LT deltoid
My left leg started hurting from my foot all the way up to the top of my thy was swollen painful.. the morning of 4/21/21
04may90 pt vax heptaB. next day pt devel joint pain and fever, chills, abdo cramps.  fever remitted spontaneously in 3 hrs and joint pain in 12 hrs.  1 month later pt recv. 2nd vax w/ no adverse reaction.
Thrombocytopenia and neutropenia associated with fever, body ache, fatigue, chest tightness. Symptoms began about 1 day after vaccination and continued for about two weeks. About 8 days after vaccination, the patient sought medical attention and was diagnosed with the lab derangements noted above, PLT 120 and WBC 2.6. Covid test negative at that time. He was first seen by me about one week after that where his blood counts had improved but not normalized and he was still having some symptoms. He was last seen by me today, 3/30/21 and now asymptomatic and blood counts normalized.  No specific treatment was done.
Two minutes after the vaccination I became extremely hot and my heart began to race. My mouth became very dry and felt like I couldn?t swallow. It passed after a couple of minutes.   Red circular rash to the left of the injection site appeared 8 days after vaccination.
Allergic reaction, swollen lips, numb skin on face, itching all over body, scratching hives, blisters
Upper right arm pain 1 of 10 pain scale. Status post anthrax vaccination. Pt report tenderness of axilla, and erythema to effected arm from inferior aspect of deltoid to superior aspect right elbow. Pt denies any respiratory difficulties, numbness, palpitation, or any other symptoms. Pt has received 3 prervious anthrax IM injections without complaint.