chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient also received first dose of VAXELIS and HAVRIX at same visit/ child received first dose at 6 months/use is outside; This non-serious spontaneous safety report, with reference number 02299227/ 02299222 was received by a partner on 08-DEC-2022 and forwarded to Agency on 08-DEC-2022 from a health care professional.   Due to the nature of the event, the causality between the event "Patient also received first dose of VAXELIS and HAVRIX at same visit/ child received first dose at 6 months/use is outside of PI" and Vaxelis was not applicable.  The case is considered as off label due to inappropriate schedule of vaccine administration.  Further information is expected.
Breakthrough case admission after 5 vaccines Pfizer 2/27/21 Lot# EN6202;  Pfizer 3/20/21 Lot# EN6207;  Pfizer 10/9/21 Lot# FF8841;  Pfizer 5/31/22 Lot# FN2908;  Pfizer 9/13/22 Lot# GJ2524
had both doses of the COVID-19 vaccination, a couple weeks after, the patient tested positive for COVID-19; had both doses of the COVID-19 vaccination, a couple weeks after, the patient tested positive for COVID-19; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A female patient of an unspecified age started received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE); both via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had both doses of the COVID-19 vaccination, a couple weeks after, the patient tested positive for COVID-19 on unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Bled Out 40% of blood from lower GI; Bloody diarrhea; Lightheaded; Sweating; Malaise; Fever; tachycardia; A spontaneous report was received from a pharmacist who is a 60-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bloody diarrhea, bled out 40 percent of blood from lower gastrointestinal tract, tachycardia, sweating, lightheaded, malaise and fever.  The patient's medical history was not provided. No concomitant product use was reported.  On 31 Dec2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   On 14 Jan 2021, the patient reported 14 days after receiving the vaccine, he developed tachycardia with a heart rate of 120 and did not feel right. The patient stated was sweating and thought he was having a heart attack.   On an unknown date, the patient saw his doctor who performed an electrocardiogram (EKG)  results not provided. The patient also stated he had blood pressure issues but did not provide any further information.  On an unknown date, the patient reported he was hospitalized with bloody diarrhea. He stated he bled out 40 percent of blood from his lower gastrointestinal track. He reported he had malaise and fever as well. The patient reported he had to have surgery to stop the bleeding.   Treatment for the event included surgery.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, bloody diarrhea, bled out 40 percent of blood from lower gastrointestinal track, tachycardia, sweating, lightheaded, malaise and fever, were considered unknown.; Reporter's Comments: This case concerns a 60 year old male patient, who experienced a serious event of gastrointestinal haemorrhage, associated with other non-serious events after receiving first dose of mRNA-1273. Very limited information regarding this event has been provided at this time.  Further information has been requested.
Next morning, post vax, had congested cough. Gave Robitussin. Went to doctor on 4/10/01 and was given Endol for sinus infection and 2 weeks later, no better and saw another doctor who gave him antibiotic and cough syrup for viral infection. Lungs remained clear. Continued to have cough.
See attch 1. Got shot Tues 'bout 1:30 pharmacy. Good stick, serum felt thick and hurt an bit, going in, gone about my merry bizzness, but all day the arm got more and more sore to lift up....like a hard "punch". 'bout 6:30 (dinnertime) I am not really hungry, but eat a little chicken n rice...'bout 8:30 I begin running temp of 99..99.5...100...100.4....my skin is beginning to sting. Stomach a little upset, eyes hurt in sockets, go to bed 'bout 9:00 feeling really crummy. Tremendous headache, backache, and throw up all the water, dinner bout 2 am. Laying on the bathroom floor in between...bout 6:30 this AM arm is a little stiff but can lift it up. Temp gone. Headache mild, back still feels like someone hit me with a tree trunk, and stomach still very queasy, little diarrhea.......Am I surprised? yes and no....I have had this reaction several years back, wouldn't get another shot for years because of it...with all the hoopla, and improvements in shots...I got one last year that was absolute breeze..."stick" and alone.....BUT last year I paid for it at "walk in: this year was on insurance at pharmacy.
Case number PHEH2015US023047, is an initial spontaneous report from a health care professional received on 04 Nov 2015. This report refers to a patient of an unknown age and gender. Medical history and concomitant medications were not reported. The patient vaccinated with FLUVIRIN (batch number: 1515201) inadvertently at a dose of 0.05 ml intramuscular on 30 Oct 2015. No adverse event was reported following this maladministration.
Adverse drug reaction; Weird sensation; Arm was very heavy like rubber bands were around it tight; Painful; Hands were icy cold; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Adverse drug reaction), FEELING ABNORMAL (Weird sensation), LIMB DISCOMFORT (Arm was very heavy like rubber bands were around it tight), PAIN IN EXTREMITY (Painful) and PERIPHERAL COLDNESS (Hands were icy cold) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010AZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 27-Feb-2021, the patient experienced ADVERSE DRUG REACTION (Adverse drug reaction), FEELING ABNORMAL (Weird sensation), LIMB DISCOMFORT (Arm was very heavy like rubber bands were around it tight), PAIN IN EXTREMITY (Painful) and PERIPHERAL COLDNESS (Hands were icy cold). At the time of the report, ADVERSE DRUG REACTION (Adverse drug reaction), FEELING ABNORMAL (Weird sensation), LIMB DISCOMFORT (Arm was very heavy like rubber bands were around it tight), PAIN IN EXTREMITY (Painful) and PERIPHERAL COLDNESS (Hands were icy cold) outcome was unknown.            Concomitant product use was not reported.  Treatment information was not provided.
Patient received 2nd dose of Bexsero and after she left the building and was at home she began to vomit.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 06Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 26Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 03Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "controlled blood pressure" (unspecified if ongoing); "chronic sinus & allergy issues" (unspecified if ongoing); "allergy issues" (unspecified if ongoing). Concomitant medication(s) included: CETRIZINE; VITAMIN C [ASCORBIC ACID], start date: 17Jun2022; VITAMIN D [VITAMIN D NOS], start date: 17Jun2022; MUCUS RELIEF DM; FLONASE [FLUTICASONE PROPIONATE], start date: 25May2022. Past drug history included: Lisinopril, start date: 12Dec2018, notes: Other medication details:, Other medication in 2weeks brand=Lisinopril,, Other medication in 2weeks start date=12Dec2018. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Positive, notes: Flu-like sxs & tested positive on 25May2022; (06Jun2022) Positive, notes: then felt sick again w/ head cold-like sxs & tested positive on 06Jun2022- rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid from 25May2022 to 29May2022 for treatment of COVID-19. Flu-like sxs & tested positive on 25May2022, took paxlovid as prescribed, then felt sick again w/ head cold-like sxs & tested positive on 06Jun2022- rebound. Infection never fully resolved w/ paxlovid tx. The treatment included Flonase & Zyrtec at Night.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
12 hrs after injection experienced chills, muscle and joint pain, fever, inability to sleep comfortably, tired but restless, headache, stomach upset
Pt had large red swollen area around injection site. Was given BACTRIM Bid x 7 days.
This infant had a fever since 03/10/01. Seen in the office on 03/13/01 presented with fever, according to the mother, fussy, fine rash all over the abdomen.
Pt inadvertently given Zoster vaccine in place of Varicella vac. no reaction found parents notified
Awoke around 10:00  next morning, March 31,  with a bad sore throat, and feeling of fullness in my throat. Observed that my uvula was swollen, but not so much as to interfere with breathing. Symptoms improved over course of the day. General malaise all day, and into following day. I called my primary care doctor, their office said the symptoms were not serious and didn?t require any professional attention.
Had a little bit of a back trouble prior to getting the 1st booster dose of the vaccine; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Had a little bit of a back trouble prior to getting the 1st booster dose of the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Had a little bit of a back trouble prior to getting the 1st booster dose of the vaccine). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Had a little bit of a back trouble prior to getting the 1st booster dose of the vaccine) had not resolved.            No concomitant product use was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-615240 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-615240:1st booster dose
Left upper arm radiating down to wrist. The pain  occurs mostly with arm extension and flexion.  This arm pain has persisted for 9 months since first injection.
Pt's arm is red and sore - in a 3 in radium from injection site - redness is still there 8 days after injection, soreness has gone away and redness has gotten better, pt's skin is very dry and almost peeling in a 1 in radium from injection site.
Left arm was sore at injection point; Pus and discharge at injection site; Pus and discharge at injection site; Could not raise arm without pain; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 03Mar2021 at 00:00 (at the age of 73-years-old) as a single dose for COVID-19 immunization. Medical history included cancer and diabetes. Concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. On 03Apr2021 at 00:00, the patient experienced left arm soreness at injection point, pus and discharge at injection site and the patient could not raise arm without pain for 4 weeks and he had pain while raising arm at the time of this report. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events left arm soreness, pus and discharge at injection site and included treatment with cephalexin 500mg for 5 days. The clinical outcome of the events left arm soreness, pus and discharge at injection site and could not raise arm due to pain were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
On 7/7/10 Pt. reported increased redness, swelling & pain to right arm. Antibiotics prescribed on 7/7/10.
The patient was treated for shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Fever, body aches, tired after 2nd dose of Covid vaccine on 2/10/21. EE received both Covid Vaccines Moderna, first dose 1/3/21, second dose 2/10/21. Patient tested Covid positive on 3/23/21  and 3/25/21.
Received COVID Vaccine on 1/8, general fatigue and headaches persistent for the first few days. Injection site pain prominent for the first few days. Symptoms still ongoing at the moment of writing this incident report excluding pain at the injection site
Fever, chills, weakness, rolling and staring eyes, irritable, fussy and loss of appetite. Gave childrens Tylenol, luke warm bath, and rest.
Side Effects hit him like a ton of bricks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side Effects hit him like a ton of bricks) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (Side Effects hit him like a ton of bricks). At the time of the report, VACCINATION COMPLICATION (Side Effects hit him like a ton of bricks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided    Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Attached Telephone Contact Report. Contains no new information. On 15-Jul-2021: updated reporter contact details.
Patient has history of allergies (confirmed no allergies to polysorbate or ethanol).  Patient began to experience nausea, dizziness at end of 30 minute wait post-vaccination, and stated he did eat and was drinking water. Patient did not state he was experiencing any shortness of breath or anaphylactic symptoms. Asked patient to remain seated so I could monitor him further and to immediately report if he started experiencing any shortness  of breath or anaphylactic symptoms. Patient started experiencing shortness of breath about 10 minutes later, and he self-administered an EpiPen prescribed to him that he brought with him. Pharmacy staff immediately called 911,  patient  was monitored and appeared in no acute distress and was talking normally. EMS arrived and examined patient. Patient was determined to have recovered and was cleared by EMS to return home without any further treatment, and patient was not taken to the hospital.
Pt started having pain in both arms after 5 mins after TDAP vaccine. I told pt to stay in the counseling area for 15 to 20 mins. Then shortly she started having some dizziness and she mention her both hands feel numb. I made sure it was not an allergic reaction. Pt was breathing fine, she said she is not having any breathing issues. Her husband was with her the whole time. I gave her some water and watched, then her husband said they want to go to their car. I objected but she seemed fine, so I let her go about 15 mins after the shot. I told them not to leave the parking lot until the pt feels well. Pt and husband walked out in front of me to their car. Then after about 10 min the pt came back saying she is having chest pain and her hand still feel numb. I asked her to sit down and had my tech call 911 while I watched the pt to make sure she is not having allergic reaction. First responders came and she went with them. She was able to talk and was breathing fine when they left. It seemed like she was having anxiety or mild syncope.
Patient recieved the moderna booster without omicron instead of the bivalent moderna booster with omicron. No adverse reaction reported.
Low Grade Fever, Severe aching, violent shivering for hours on end, Lethargic body and cloudy head.  Cranial pressure that felt around entire circumference of head.  Lasting over 36 hours each time that forced bed-ridden behavior, forced time off of work, and loss of appetite.  Spiked heart rate on numerous occasion throughout the following 36+ hours with heart rates spiking as great as 136 bpm.  I should of reported it and visited my physician, but there was nothing more they could do besides for me to hydrate, suppress with Tylenol, & ride it out.  Anyone with previous decent COVID cases should be advised against receiving the vaccine.  But entities are still forcing us to have it for our jobs.  I couldn?t endure a third round.  It was a violent illness following the vaccine, which was equivalent to one of my first ?bad? days of actual COVID.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant drug and drug reactions/allergies were not reported. On 19-JUN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route was not reported) lot # r024023, expiration date of 22-AUG-2019 for prophylaxis (product storage error). Other suspect therapies included sterile diluent (strength, dose, route of administration, lot/batch# and expiry date were not reported). No adverse effects were reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter.
(L) arm pain, erythema, swelling at injection site. Rec: cold compren and TYLENOL.
This spontaneous report was received from a pediatrician via company representative and refers to a 13-year-old male patient. The patient's medical history included exposure to unspecified pesticide at "very young age". On an unknown date, the patient was vaccinated with GARDASIL, intramuscular injection for prevention of Human Papillomavirus (lot# and expiration date were not reported). There was no information about concomitant therapies provided. On an unknown date, reported also as for one month, the patient experienced migraine headache and significant swelling of the arm. The patient sought medical attention (date was not provided). However it was unknown if he received any treatment for the events. Action taken with GARDASIL was not applicable (however it was also reported as therapy was not discontinued). The outcome of the events was unknown. The relatedness between the events and GARDASIL was not provided. Additional information has been requested.
Fever up to 102, body aches, redness, pain at site of injection, lasted 2-3 days.