chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a health care worker refers to a currently 14 years old female patient with no pertinent medical history and no drug reactions or allergies. On 22-JAN-2001, the patient was vaccinated with the first dose, on 26-MAR-2003 with the second dose and on 06-AUG-2003 with the third dose of RECOMBIVAX HB, intramuscular, 5/0.5 microgram/ml (dose, lot # therapy type, expiration date were not reported). No concomitant therapy was reported. On an unknown date, the patient failed to produce antibodies following the administration of the RECOMBIVAX HB series. Unspecified "infectious disease serologic testing" was performed on an unspecified date in December 2014 and the results showed no immunity to hepatitis B (no specified lab values were provided). Due to the failure to produce antibodies after receiving the first RECOMBIVAX HB series, the patient received a fourth dose of RECOMBIVAX HB on unspecified dates. The outcome of the event was not reported. Relatedness between the vent and vaccination with RECOMBIVAX HB was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
States that a rash/hives started to appear 48 hours after receiving his vaccines. States it started  on his face and spread throughout body. No trouble breathing, no fever, no redness at injection site. States that she gave him Benadryl which helped for about 5 hours then rash/ hives returned. Rash/ hives still present.  States she does not currently have a pediatrician.  Gave information and phone number for evaluation.
Redness and swelling persistent at injection injection site Keflex 250mg/5ml BID x 10 days.
Has a hard time eating anything; Her whole body was shaking with chills; Chills; Headache; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of EATING DISORDER (Has a hard time eating anything), TREMOR (Her whole body was shaking with chills), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nauseated) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced EATING DISORDER (Has a hard time eating anything), TREMOR (Her whole body was shaking with chills), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nauseated). At the time of the report, EATING DISORDER (Has a hard time eating anything), TREMOR (Her whole body was shaking with chills), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nauseated) outcome was unknown.            Concomitant medications included unspecified arthritis medicine.  No treatment details were provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.
CHILLS; FEVER; PRETTY TIRED; This spontaneous report received from a patient via a company representative 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 not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. 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 subject experienced chills, fever, and pretty tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and pretty tired. This report was non-serious.
Dysgeusia. No treatment. Has not resolved since. Applies to specific foods - most notably, mustard.
1-2 days after shots, pt broke out in rash, fever, and slight trouble breathing. No Rx acc. to grandma.
I had one day of mild fatigue after the shot. I gave birth to my baby April 12. When I was at the hospital I tested positive for COVID. I wanted to report that. I had no symptoms. My second pregnancy - 2nd live birth with this birth. Estimated due date was April 16, 2021.
face is swollen; Rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face is swollen) and RASH (Rash all over body) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (face is swollen) and RASH (Rash all over body). At the time of the report, SWELLING FACE (face is swollen) and RASH (Rash all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was reported. No concomitant medication was reported
Right armpit area is swollen; Body is very sore and achy; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: FF2593) via an unspecified route of administration, administered in arm right on 13Oct2021 (age at vaccination 27 years) as dose 1, single for covid-19 immunisation. When probed for second dose vaccination due date, consumer stated, "It can be the "27th. The patient's medical history included none. Concomitant medication included influenza vaccine (FLU) taken for an unspecified indication from Oct2021 to Oct2021. When probed if any prior vaccinations within 4 weeks, patient stated, "he got the Flu shot about a week before first dose of Covid-19 vaccination. When probed for Flue shot LOT, consumer stated, "he had none of that information, he just understand it was a Flu shot. He got his (first dose vaccine) shot in his right arm and under his armpit area in his right arm was all swollen. It was like that about a day now. patient stated typically his body was very sore and achy, it's been swollen under armpit. When probed if any treatment for the event, consumer stated, "No, he had not. The outcome of events was unknown.  Follow-up attempts are completed. No further information was expected.
Pregnant patient received first dose of Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received first dose of Moderna vaccine) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 21-Jun-2020 and the estimated date of delivery was 28-Mar-2021. On 26-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received first dose of Moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy.  On 26-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received first dose of Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The date of positive pregnancy test was reported as Aug-2020.
Person who received vaccine attended a public H1N1 vaccine session. Person was given the LAIV (Nasal mist) because of age should have given the multi-dose injection.
Chief Complaint   weakness and fatigue. Covid positive approx 1 week ago  History of Present Illness     Patient is a 81 year old female with past medical history of breast cancer, nonmelanoma skin cancer, DM type 2, chronic V.fibb with RVR, PAD, s/p renal transplant lives at nursing home, is a poor historian. She had one week of increasing fatigue and SOB with dry cough, first covid pcr was negative but second one was positive and was transferred to the UH ED. Per her recollection she had 2 shots of COVID vaccine, but does not remember when the second dose was administered. Patient denies headache, vomiting, diarrhea, chills, sweating.
Temperature of 103.7 lasted for 24 hours, temperature of 100 lasted 3 plus days. Chills, body aches, headaches lasted 4 days. Exhaustion lasted 5 days.
MD ordered FLUZONE 0.25ml IM but FLUZONE 0.5ml IM instead. Parent called today 24H later (today) and child had no symptoms and no injury.
This spontaneous report received from a registered nurse referred to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Nurse reported patient received improperly stored VARIVAX (lot # M046005, expiry date: 18-NOV-2018) on 30-MAY-2017 (incorrect product storage). The vaccine was exposed to 15"F to 46"F (22.1F) for one hour. There was no previous temperature excursion. The call was because of data logger. Concomitant medication included a sterile water diluent. Nurse could not provide the lot and expiration for the properly stored sterile water diluent used to reconstitute the dose of VARIVAX. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004576:
STORAGE IN REFRIGERATOR (2 GRADE C - 8 GRADE) UP TO 30 DAYS.  (VACCINE USED AFTER 10/16/2021)
Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: Prior to vaccine, patient reported fainting after injections in the past.  Following administration of Pfizer covid vaccination (within first minute), patient said he was not feeling well.  Upon examination, he was found to be experiencing a clonic seizure.  The seizure lasted approximately 30 seconds, during which time patient was monitored for continued breathing. When patient regained consciousness, he was given water, had vitals checked, and examined by paramedics.  Declined hospitalizion.
Left arm swollen and hot, body aches, fatigue, nausea. Offered appointment to see MD. Mom preferred to monitor at home, will continue with Motrin prn and ice to arm. To call back if worsens or new s/s develop.
I started having  numbness and tingling in the left foot and left hand after taking the shot along with headaches.  I mention to my primary doctor during my physical and he has referred me to a neurologist that I have scheduled an appointment to further evaluate..  I continue to experience this and I'm awaiting my appointment with the neurologist.
Broke out in hives and itching all over my body. (wrist, back, under the breasts, low back, abdomen, back of legs) Benadryl at 10:30 on 4/20/2023  4/20/2023 it has eased up a little but is still very present.
Patient was given injection 17:50. Observed for 15 minutes and felt fine. Driving home she was on the phone with her daughter. She made it home and began to feel dizzy. Daughter asked if she was all right and she states her voice was sounding funny. Patient states she  felt like her throat was closing up. She immediately took 10 mL liquid benadryl she had at her house. She waited and felt better. She did not seek additional medical attention. Improved quickly and no further symptoms over the rest of the weekend.
Sore biceps; Achy neck; Warm to the touch at the site of injection; achy shoulders; redness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore biceps), NECK PAIN (Achy neck), INJECTION SITE WARMTH (Warm to the touch at the site of injection), ARTHRALGIA (achy shoulders) and INJECTION SITE ERYTHEMA (redness at the site of injection) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0111A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore biceps), NECK PAIN (Achy neck), INJECTION SITE WARMTH (Warm to the touch at the site of injection), ARTHRALGIA (achy shoulders) and INJECTION SITE ERYTHEMA (redness at the site of injection). The patient was treated with PARACETAMOL (TYNELOL) for Injection site erythema, Neck pain, Arthralgia, sore biceps and Pain in extremity, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore biceps), NECK PAIN (Achy neck), INJECTION SITE WARMTH (Warm to the touch at the site of injection), ARTHRALGIA (achy shoulders) and INJECTION SITE ERYTHEMA (redness at the site of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided.
Patient reported "tightness" in throat and itching in face seven minutes following vaccination. At 7:10pm, patient received diphenhydramine 32mL/80mg PO by clinic staff. Patient remained at clinic for observation until 7:25pm when she was discharged to husband who transported her to the ER for evaluation. ER noted symptoms completely resolved.
Drug erruption of shingrix was worst/8 months suffering flare ups; This case was reported by a consumer via interactive digital media and described the occurrence of drug eruption in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug eruption. On an unknown date, the outcome of the drug eruption was not recovered/not resolved.   It was unknown if the reporter considered the drug eruption to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-JUL-2022 Reporter's Comments: This case was received from patient via interactive digital media The reporter reported that, the drug eruption of shingrix was worst.  The patient was suffering flare ups from 8 months, every other month for 8 months now with no visible improvement.  The reporter suggested that to not get this vaccine.
24 hours post 1st vaccine, she started to get a pounding headache, muscle weakness, injection site soreness, malaise, felt warm .  She has been taking  Tylenol 4-6 hours.  Currently the head ache has improved,  but still felling weakness and  low energy but improving.
Since vaccination (6 months ago) I've had persistent soreness at the injection site. I cannot lean against the site, no put pressure on it. I get cold/tingling feelings down my arm that originate from my upper bicep (injection site)
Pt had a 2 inch swelled are at injection site. Area warm to touch. Ice applied and area getting better.
Case number PHEH2014US001688 is an initial spontaneous report received from a consumer on 21 Jan 2014 with a follow-up received from the physician on 10 Feb 2014. This report refers to a 66-years-old female patient. Her medical history was not reported. Her concomitant medication included Chlorthalidone at 25 mg orally QD for ankle edema. She was vaccinated with FLUVIRIN (batch number: 1308201 and expiry date: Mar 2014) intramuscularly at 0.5ml to left arm on 03 Oct 2013. On an unknown date. two weeks after vaccination, she experienced raised red knot at the injection site which was almost felt like rubber. Two weeks later it was redder and the size was about 1.4 inches circumference and itching. On an unknown date she also developed swelling at the vaccine site along with erythema. She visited physician and they prescribed a steroid cream triamcinolone and Triaminicin with some mixture of cream. At the time of follow-up report in 10 Feb 2014, she still had pain, swelling and erythema at the vaccination site. Other events recovered on an unknown date of Nov 2013 or Dec 2013. Seriousness and causality of the events was not reported. Follow-up received from the physician on 10 Feb 2014: Updated patient demographic, concomitant medication, dose and expiry date of FLUVIRIN, event and outcome.
Information has been received from a physician concerning a 36 year old female patient with asthma who on 09-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot#664476/1190Y) (Exp date: Unspecified), IM. Concomitant therapy included influenza virus vaccine (unspecified) and and ADACEL. It was reported that on 10-SEP-2010 the patient experienced fever, her arm was swelling from shoulder to wrist and she could not lift her left arm. The physician also reported that PNEUMOVAX 23 (lot#664476/1190Y), IM. was administered with influenza virus vaccine (unspecified) in the left arm patient and ADACEL was given in the patient's right arm. On 11-SEP-10 the patient recovered from all these symptoms. This is one of several reports received from the same source. Additional information has been requested.
Narrative:  Patient reported tingling sensation that started on left side and spread down torso shortly after administration of 1st dose of pfizer vaccine. Patient was able to depart without any intervention but stated symptoms did not resolve by time of departing.
Arm swelled from elbow to shoulder- red hive like reaction- itching & burning sensation continuously for approximately 3 days.
BLOOD CLOTS IN BOTH ARMS; NUMBNESS IN BILATERAL ARMS; REDNESS ON BOTH LEGS; SWELLING OF BOTH LEGS; PAIN IN BOTH LEGS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breast cancer. The patient experienced drug allergy when treated with hydrocodone, and oxycodone for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: unknown) dose was not reported, 1 total administered on 20-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in 2021, the patient felt numbness on both arms. Numbness got worse and patient went to emergency room. On an unspecified date in 2021, Laboratory data included: MRI brain results of which were pending. On an unspecified date in MAR-2021, a week after the vaccination patient went to emergency room due to redness, swelling, and pain on both legs. The doctor prescribed antibiotics which relieved those symptoms and was encouraged to get blood circulation assessed once patient returned to home. On 17-MAY-2021, patient got hospitalized, and on same day, ultrasound test showed a blood clot in each arm. Patient underwent chest X-ray and a test with and without contrast for the lungs. It was reported that patient was started on anticoagulants and physical therapy. On 18-MAY-2021, ultrasound of legs was negative for blood clots. On 19-MAY-2021, test in a machine with and without contrast to look at lungs (Lung scan) was within normal limits. On 19-MAY-2021, the patient got discharged from hospital. Patient stated that, consulted two doctors if it may have been the Janssen covid-19 vaccine that caused this and doctors said possibly and recommended that patient should report the information.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from redness on both legs, swelling of both legs, and numbness in bilateral arms, and had not recovered from pain in both legs, and blood clots in both arms. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210540231-COVID-19 VACCINE AD26.COV2.S-BLOOD CLOTS IN BOTH ARMS, NUMBNESS IN BILATERAL ARMS. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
In addition to just usual arm pain and tired on day on vaccine #1 12/23/2020; after 24 hrs had sudden onset extreme weakness, brain foggy, anorexia, extreme sleepiness, my weakness prevented me to continue typing my notes using my hand and walking out of room, made me immediately turn back to rest. Took 20mg prednisone and slept. Symptoms resolved after 2 hrs of sleep in chair in office. Next day took usual dose 2mg back. Doing ok but then after few days (Lee?s than a week) had paresthesia like (burning needle pin)  migratory on different parts of upper and lower extremity.  No motor weakness. This has gone on even after 2nd vaccine. 1/13/2021.  It got better in  February but then came back in April with increased frequency and intensity with small blisters on firearms both sides where burning sensations felt.  Now it also made me feel weak, sleepy, hands and feet Paine with mild spindle like puffiness of fingers with pain on pip more than mcp. Had to increase prednisone 10mg a day and felt tolerable but wheN go below 5mg, the pain of hand and feet and frequency of dysesthesis and blister was not well tolerated to do my routine work
Pt called to say he had a rash on his chest following Shingrix.  He did not specify exact time/date when it started.  Reported to pharmacy about 5 AM 5-29-19.  Denies SOB, difficulty breathing
her lips had a burning sensation and felt numb.; her lips had a burning sensation and felt numb.; This is a spontaneous report from a contactable pharmacist via medical information team.   A female patient of unspecified age received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a dose 1, single for COVID-19 immunization. On an unspecified date, 15 minutes post vaccination after 2nd dose of Pfizer's COVID vaccine, her lips had a burning sensation and felt numb. Reportedly it was lasted for 30 minutes and that was it. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
pt recv vax 17MAR97 & 28MAR97 pt devel approx 5-10 lesions/blisters on back that were like chickenpox;the lesions/blisters began to scab on 29MAR97;pt recovered from sx;
03/10/2016-bumps started around the injection site on the left upper arm, then spread to his neck, chest, and back, had headache and nausea.
Initial unsolicited case received from a nurse on 28 Sep 2017. This case involves 73-year-old female patient who was vaccinated with 0.5 ml one dose of FLUZONE HD (Batch number: UI835AB, expiry date: 27 Mar 2018, dose in series not reported) intramuscularly in deltoid on 26 Sep 2017. Patient medical history and concomitant medications were not reported. On 26 Sep 2017, same day after the vaccination, the patient went to her car and stated that she felt like jelly and after she began to hear voices in her car. She conversed with the voices until she realized she was alone in the car. This episode lasted 30 minutes, and did not recur. The patient did not report any visual hallucinations and did not receive any other vaccines that day. Relevant lab tests and corrective treatment were not reported. On an unknown date, the patient recovered from the event. (Reported as she has been fine since then). List of documents held by sender: none.
pt was given an extra set of vaccines today, HPV & TDaP. Pt EHR had no vaccine input and pt. chart had no HPV or TDaP. After vaccines were given pts mother pulled the shot record and handed it to me. When it was given to stamp today's vaccines I noticed pt had already been given the vaccines. Dr. spoke to patient mother.