chrisvoncsefalvay/vaers-outcomes huggingface dataset:
product COVID 19 Treatment, brand Paxlovid , indication Treatment of COVID-19; product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 21Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in right arm for covid-19 immunisation. The patient has no reported allergies. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included with in two weeks LOSARTAN; MONTELUKAST; DYMISTA. The following information was reported: VACCINATION FAILURE (medically significant) with onset Apr2022, outcome "unknown", described as "product COVID 19 Treatment, brand Paxlovid , indication Treatment of COVID-19"; COVID-19 (medically significant) with onset Apr2022, outcome "unknown", described as "product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: after a positive diagnosis via PCR. Therapeutic measures were taken as a result of covid-19. Clinical course: : I took Paxlovid after a positive diagnosis via PCR. By day 5 of the prescription I had a very faint line on the antigen test and was feeling fine. It has been a I took Paxlovid after a positive diagnosis via PCR. By day 5 of the prescription I had a very faint line on the antigen test and was feeling fine. It has been a week since I finished the Paxlovid and today is day 11 since I first tested positive. My congestion is back and other symptoms, and the line on the antigen test is dark again. (I recognize the antigen test wasn't intended to measure viral load but it's hard not to notice the difference).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Systemic: Body Aches Generalized-Mild, Systemic: Fever-Mild, Systemic: fatigue-Severe, Additional Details: MA from Dr. office called pharmacy to report that this shingrix vaccine received on 4/4/2023 was 3 rd shingle vaccines
A non-serious spontaneous report of received expired FLUMIST was received from a health professional concerning a 16-year-old male. Neither medical history nor concomitant medication was reported for this patient. The product expired on 08-Dec-2010. On 13-Dec-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. 04-Mar-2011: Follow up call was conducted on 04-Mar-2011, no adverse events were reported following administration of the expired FLUMIST.
Patient received dose, and was walking to sit down  in waiting area. Patient passed out and convulsed. Patient immediately regained consciousness and was A&O X 3. Patient became stabilized and within 5 minutes reported feeling normal again. Patient completed 30 minute wait in facility with no additional s/s of reaction. Patient reported not eating for at least 6-8 hours prior to vaccine.
Timeline was exactly the same as that of the first dose.  Day one, nothing, day 2 very sore arm, days 3,4,5 nothing.  Day 6 reaction.  After the first dose I developed high fever, body aches and lethargy on the sixth day and it lasted several days.  On the second dose, it followed the same timeline, but on day 6 my lips and cheeks swelled and kept swelling for 7 hours even though I was admitted to the hospital emergency room within the first hour and they gave me 4 drugs by IV to counteract the swelling.  The doctors told me I was having an allergic reaction, but I had not eaten anything out of the ordinary and I've never had an allergic reaction of any kind.  They were reluctant to admit that it was a Covid vaccine reaction, but they couldn't find any other answer and I knew it was... the timing was too coincidental.  Also, the drugs they gave did nothing and it took several days for my facial swelling to diminish.
Headache, Body aches, fever, fatigue, soreness at injection site.  Lasted 48 hours.  Recovered at home. Took Tylenol and Ibuprofen.
left arm soreness; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm soreness) and PYREXIA (slight fever) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced PAIN IN EXTREMITY (left arm soreness) and PYREXIA (slight fever). At the time of the report, PAIN IN EXTREMITY (left arm soreness) and PYREXIA (slight fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications also included blood pressure medications, Heart medications and Cholesterol medications. No treatment  had received by patient for the symptoms developed
pt recv vax 1MAY96 & devel an inj site rxn, characterized by redness, induration (8-10cm) & pruritus;pt to ER & was treated w/Keflex;
Information has been received from a licensed practical nurse concerning an adult female who in August 2005, was vaccinated IM with 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 647661/0055R). In Aug 2005, the pt developed injection site reactions to include pain, local warmth, redness and swelling. The pt's were reported as recovered. There was no product quality complaint involved. Additional information has been requested.
CHEST PAIN; NECK PAIN; EARS DIZZY IN MY LEFT ARM; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) 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 headache, chest pain, neck pain and ears dizzy in my left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chest pain, neck pain and ears dizzy in my left arm was not reported. This report was non-serious.
Patient started to develop a fever the day after the immunization, arm is red, warm and painful to touch. Redness is moving down the arm. Patient states she was hallucinating and had no appetite.
The day following vaccination, I felt oxygen deprived and nauseous. After going to bed at 12 am, I awoke at 1:30 with hammer like pains in the right thigh, right head, and bottom of right foot. Later I awoke again at 5:30 am with a seizure like jerk. The next day I had stinging pain in my right side and the bottom of the right foot.  My heart raced and skipped beats and felt like it was flopping.  The oxygen deprived feeling  continued for 5 days. The hammer like pains subsided. I continued to feel nauseous and exhausted for 2 weeks after vaccination. The third week I was just very tired. It was such an terrible experience, I didn?t think I would live through it.
his heart was racing, he was in atrial fibrillation; the injection site was swelled up; injection site was a little red; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (his heart was racing, he was in atrial fibrillation) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE SWELLING (the injection site was swelled up) and VACCINATION SITE ERYTHEMA (injection site was a little red). On 02-Apr-2021, the patient experienced ATRIAL FIBRILLATION (his heart was racing, he was in atrial fibrillation) (seriousness criterion medically significant). The patient was treated with DILTIAZEM ongoing since an unknown date at a dose of 1 dosage form; FUROSEMIDE ongoing since an unknown date at a dose of 1 dosage form and AMIODARONE HYDROCHLORIDE (PACERONE) ongoing since an unknown date for Heartbeats irregular and Hypertension, at a dose of 200 mg three times a day. On 02-Apr-2021, VACCINATION SITE SWELLING (the injection site was swelled up) and VACCINATION SITE ERYTHEMA (injection site was a little red) had resolved. At the time of the report, ATRIAL FIBRILLATION (his heart was racing, he was in atrial fibrillation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2021, Cardioversion: normal (normal) heart and vascular system looked fine. On 17-May-2021, Cardiac stress test: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-221013 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow up received 0-JUL-2021. No significant information. Contact information updated; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Dull ache at injection site x 3 weeks. Some tingling to digits on left hand.
Shot Friday ~1515, on Sunday started having sharp chest pain and not feeling well. Contacted Md and was told to take Ibuprofen and contact Pharmacy. Mom called and said On Tuesday, June 1st patient still experiencing some mild chest pain and achy. Contacted mom this morning but had to leave a message
Received my second shot of the vaccine and my armpit is swollen; It is just one armpit, the side that I got the shot on; Stiff neck; Pain in my neck and it ran down my arm; Pain in my neck and it ran down my arm; This is a spontaneous report from a contactable consumer or other non hcp. A 67-years-old female patient received BNT162B2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Formulation: Solution for injection Lot Number: EL9266, Expiration Date: 31May2021), via an unspecified route of administration, on an unspecified date as dose 2, single for covid-19 immunisation. The patient Medical history included none. There were no concomitant medications. On an unknown date, the patient had swelling in the armpit and it happened probably within like 10 to 15 minutes after she got the vaccine and it was only one not on both armpits it was just one armpit. On an unspecified date, the patient had pain in her neck and it ran down her arm and experienced stiff neck. The patient wanted to know if she could take Motrin that will make this swelling go away. The patient was asking how long it would last or what she can do about it. The clinical outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Fever of 103 F, sore throat, unable to eat, drink or swallow saliva, vomiting, cough, and nasal congestion, diagnosed in hospital with esophageal herpes simplex 1 infection- atypical infection, for a healthy child such as patient, he is not immune compromised and has no significant medical history, he was in the hospital for 8 days, was seen by neurologist and infectious disease Dr.
PATEINT RECEIVED INJECTION AND ABOUT 6 MIN LATER SHE FAINTED AND HAD A 5 SEC SEIZURE.  WOKE UP ON HER OWN
Itchy throat, hives/welt, redness, heat to the touch, sharp pulses of pain
Stabbing chest pain and heaviness.  Tachycardia and hypertensive upon ER admission with premature ventricular contractions on heart Monitor. I was given IV fluids.  Labs and chest ray came back normal.  I was discharged because they couldn?t find any thing wrong other than PVCs.  Chest pain continues after discharge. I have not had any prior heart condition or any other medical conditions..
Flu shot for child >36 months was given instead of flu shot for 6-36 month child as ordered.
Numbness; numbness; anxiety; Heart rate; she was out of it; feeling drunk; Fainted; Tightness in her Face; Weakness in the legs; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted), MUSCLE TIGHTNESS (Tightness in her Face), MUSCULAR WEAKNESS (Weakness in the legs), HYPOAESTHESIA ORAL (Numbness) and HYPOAESTHESIA ORAL (numbness) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 008B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), MUSCLE TIGHTNESS (Tightness in her Face) (seriousness criterion medically significant) and MUSCULAR WEAKNESS (Weakness in the legs) (seriousness criterion medically significant). On 08-Apr-2021, the patient experienced HYPOAESTHESIA ORAL (Numbness) (seriousness criterion medically significant), HYPOAESTHESIA ORAL (numbness) (seriousness criterion medically significant), ANXIETY (anxiety), HEART RATE INCREASED (Heart rate), MALAISE (she was out of it) and FEELING DRUNK (feeling drunk). On 23-Mar-2021, SYNCOPE (Fainted), MUSCLE TIGHTNESS (Tightness in her Face) and MUSCULAR WEAKNESS (Weakness in the legs) had resolved. At the time of the report, HYPOAESTHESIA ORAL (Numbness), HYPOAESTHESIA ORAL (numbness), ANXIETY (anxiety), HEART RATE INCREASED (Heart rate), MALAISE (she was out of it) and FEELING DRUNK (feeling drunk) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Body temperature: 99.5 (Inconclusive) Degrees Fahrenheit.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No medication as administrated ( No Epi Pen). Hospital doctor stated that the patient had anxiety attack. Patient stated she does not have history of anxiety. Patient was released from ER in the same day.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Vaccine was not administered as prescribed as Facility ran out. Resulting in a delay in care.
ERYTHEMA, MILD TO MODERATE SWELLING, WARMTH AND TENDERNESS.
Extreme GERD, lasting about a year. It is not resolved yet, but more mild and tolerable.
Severe vertigo, nausea and vomiting, and weakness presented to emergency department after 8 episodes of vomiting over 12 hours with no relief
I received my 2 booster shot on 05/02/2022 and my adverse event started on 05/03/2022 in the morning my arm hurt really bad. It was red, hot, swollen, and welted up. Within 45mins the redness spread all over my outer part of my upper arm. Then I went I drove myself to the emergency room they said it was cellulitis and I had allergic reaction from the booster shot. They prescribed me anti-biotics I took it for a week. I still have soreness and discoloration but it stop spreading. I am on the way to recovery from the adverse event.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on May 7, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced pain in extremity/sore arm, and tooth disorder/teeth problems, onset 2021, with outcome of unknown. Additional information: There is no concomitant list. The patient stated she did fine after her vaccine. Her arm was sore. She has been having teeth problems, but she didn't have any side effects. She believed she received the vaccinations in April and May 7, 2021. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 81 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Emycin [erythromycin, reaction(s): "Known allergies: Emycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever; Body aches; Incomplete course of vaccination; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number ML532, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 29th May 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, several days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, general body pain and incomplete course of vaccination. Shingrix was discontinued. On an unknown date, the outcome of the fever, general body pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the fever and general body pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by Medical Assistant. The reporter was inquiring that how much immunity a patient get after the 1st dose. The reporter stated, the patient did not want to receive the 2nd dose due to how the 1st dose reaction of fever and body aches several days after vaccination, which led to incomplete course of vaccination.  The reporter gathered patient information.
Slept 10 hours the night I had the vaccine then had flu-like symptoms for approximately 24 hours,- aches, fever, headache, chills.  Very sore arm as with the first shot as well.
RASH ON LIPS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 not reported, batch number: UNKNOWN) 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 subject experienced rash on lips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash on lips was not reported. This report was non-serious.
woke up with severe tiredness; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 18Mar2021 14:40 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN, Batch/lot number: Unknown), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "woke up with severe tiredness"; DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "dizziness".  Additional information: Got the second COVID vaccine yesterday at 240 pm (18Mar2021) and woke up with severe tiredness and dizziness. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client reported 24 hours after immunization left arm down to hand was itchy, purple, and splotchy for 24 hours. After 24 hours the symptoms went away.
Tight and itchy throat, thick tongue- started approximately 5 minutes after vaccine administration and lasted for approximately 4 hours.
About two days after I received the flu shot, I noticed that my back was itchy. A day later, a rash appeared and got bigger. I visited my PCP and he confirmed that it was shingles. Treatment included VALTREX and anti-itch OTC lotions. Signs: itching, red painful rash that was characteristic of shingles, shingles rash spread to inner right arm as well. Time course: less than 2 weeks.
Patient was admitted for respiratory distress, epigastric abdominal pain, +screen covid 19 positive, elevated troponin possible demand ischemia.  No need further for work up for the dilatated CBD. Cardiology recommend out pt follow up. covid 19 infections remains stable, no abdominal pain, nausea, vomiting, tolerating oral intake. Pt was discharged home stable condition.