chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; nausea; headache; This is a spontaneous report from a contactable consumer (patient).  A 60-year-old adult female patient received  second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246), via an unspecified route of administration on 08Jan2021 11:45 AM at single dose on the right arm for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), on 18Dec2020 12:00 PM on right arm. COVID-19 vaccine was administered in the hospital. The patient experienced chills, nausea and headache on 09Jan2021 01:30 AM. No treatment received for the events. The events were assessed as non-serious. Outcome of the events was recovered in Jan2021. The patient has not been tested for COVID-19 since the vaccination.
On January 1  this year I had a shoulder injury ism a Fri cook I was pulling chicken out of the frier and I felt this pain in between my shoulder blades it felt like a water balloon popped in my back I think it might be due to cross contamination the table leg at work is broken I think it was my lymph node that popped I've done a little bit of research about that so I think it was a slow process but now since that's happened I feel like I had a heavy metal poisoning I had blood urinalysis done Notting going to have a ultrasound and a mammogram done my doctor order wait for phone call with those for those appointments my oh my skin has turned this weird tan color like a vinegar color my pee smells bad my toenails have these weird  lines in themn the burning that happened after that popping in my back was so bad it made me cry I had red streaks in my skin down the middle of my back I used athlete's tape to hold the muscle up so I can continue to work I work for 3 weeks like that then I started noticing that and I touched different things it starts getting shocking feelings up my arms and whatnot so now I'm trying to not touch certain metals because it makes me hurt my lymph nodes on my body are swollen in certain places on my hands you can see where they're popping up like little pimples to where the lymph nodes are anyways if you have any questions please just call me
Patient developed a fever and a little vomiting. She also developed a rash on the back of her neck. The great grandmother stated "we put her in a warm shower and used cold compresses to bring the fever down." She also applied over the counter anti itch cream meds to bring fever of 105 down. When she asked pediatrician about it they were not concerned.
Head ache body aches tired ear ache skin sensitivity, skin feels sun burned, joint pain fever missed work, symptoms started 8 hours after receiving injection
ACHY MUSCLES, BONES HURT/ACHED,  FATIGUE FOR ABOUT 24 HOURS.
received 2 Flublock vaccinations in one flu season with no adverse event; Initial information received on 27-Oct-2020 regarding an unsolicited valid non-serious case received from the other healthcare professional from the agency via email at call center (reference number: US-SANOFI-00334210).  This case involved a 66-year old male patient who received 2 INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] vaccinations in one flu season with no adverse event (extra dose administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was an actual medication error due to extra dose administered.  On 21-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE with an unknown batch number via unknown route in unknown administration site for prophylactic vaccination.  On 16-Oct-2020, the patient again received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: UJ455AA) via unknown route in the left arm for prophylactic vaccination.   On 16-Oct-2020, it was reported that the patient received two Flublok vaccinations in one flu season with no adverse event (extra dose administered.).  At the time of reporting, the patient had no 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.
8/27/15 - arm stiffness. 8/28/15 - arm stiffness. 8/29/15 - stomach pain, legs achy, achy all over, tired. 8/30/15 - same more fatigue, stomach ache. 8/31/15 - same. 9/1/15 mild symptoms. 9/2/15 repeat as 8/29/15.
Information has been received from an office manager via company representative referring to a 67 year old female patient. The patient's concurrent condition, medical history and concomitant therapy were not provided. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot# and expiration date were unknown) for prophylaxis. After administration of PNEUMOVAX 23, "a couple weeks ago", the patient's arm became "hot and painful" and she also experienced myalgia, high fever, chills, weakness dizziness and could not bending her fingers or lifting her arm. No treatment was given for the adverse events. Additional information is not expected as there was no consent for follow up.
Next day, started with nausea in the M (8:00), then fever (12:00 PM), then chest pain (3:00 PM).  Went to the ER to be monitored. On Sunday, said pain moved from injection site to under arm (small lump).
About a week after the vaccine, I came down with pain in my lower back which progressed to the front lower abdomen and two red spots showed up on my right lower back side.
vaccine helped him to recover from cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization; Bnt162b2 (Dose: 2), for COVID-19 Immunization; Bnt162b2 (Dose: 3/ First booster), for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "vaccine helped him to recover from cancer".  Additional information: Caller's Concern: Caller is reporting a therapeutic effect regarding the COVID 19 vaccine. He mentioned that the vaccine helped him to recover from cancer. He also added that he got 2 vaccines and 2 booster shots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received H1N1 IM vaccine 3/11/2010. 3/13/2010 developed fever to 102; fever resolved in 24 hour. Also developed 3/13/2010 generalized pruritus with no other symptoms. No rash except erythema with scratching; no urticaria. No rash at site of shot. Still with pruritus 3/16/2010.
Intense pain in left shoulder radiating down into left elbow. Lymph nodes swollen from neck to armpit. Started in early morning of day following vaccine. Continued to worsen over a period of 6 days until i finally had to go to my primary care physician as my sypmtoms were worsening instead of subsiding. Also had alot of pain in area of vaccination as well along with feeling of tiredness and nausea.
08/23/22 presents to EC ED for "chest pain, abdominal pain, dyspnea". PMHx of "SVT, DVT on eliquis" "etastatic prostate cancer"
Missed her second shot; headache; her left shoulder started hurting whenever she would use it, she could not move her arm; diarrhea; felt really bad; arm hurt so bad that it woke her up every night.; low sodium; temperature of 99.8F which went up to 101F; left shoulder started hurting; felt cold; bad chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (felt cold), DIARRHOEA (diarrhea), FEELING ABNORMAL (felt really bad), PAIN IN EXTREMITY (arm hurt so bad that it woke her up every night.) and HYPONATRAEMIA (low sodium) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthritis (Patient had arthritis in her left arm/shoulder at baseline.) and Colonoscopy on 16-Mar-2021. Family history included Colon cancer. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), TOCOPHERYL ACETATE (VITAMIN E [TOCOPHERYL ACETATE]), ROSUVASTATIN CALCIUM (CRESTOR), MONTELUKAST SODIUM (SINGULAIR), OXYBUTYNIN and UBIDECARENONE (COQ-10) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced FEELING COLD (felt cold) and CHILLS (bad chills). On 22-Mar-2021, the patient experienced DIARRHOEA (diarrhea), FEELING ABNORMAL (felt really bad), PAIN IN EXTREMITY (arm hurt so bad that it woke her up every night.), HYPONATRAEMIA (low sodium), HEADACHE (headache), ARTHRALGIA (her left shoulder started hurting whenever she would use it, she could not move her arm), PYREXIA (temperature of 99.8F which went up to 101F) and ARTHRALGIA (left shoulder started hurting). On 03-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed her second shot). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, FEELING COLD (felt cold), DIARRHOEA (diarrhea), FEELING ABNORMAL (felt really bad), PAIN IN EXTREMITY (arm hurt so bad that it woke her up every night.), HYPONATRAEMIA (low sodium), PRODUCT DOSE OMISSION ISSUE (Missed her second shot), HEADACHE (headache), ARTHRALGIA (her left shoulder started hurting whenever she would use it, she could not move her arm), CHILLS (bad chills), PYREXIA (temperature of 99.8F which went up to 101F) and ARTHRALGIA (left shoulder started hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included Cortisone shot.
Vaccine leakage between syringe and needle. Patient given another dose, same lot numer, same arm, approximately one inch above original injection site
Patient was asked name, DOB and age and they responded with name, 8/15/XX and 65, was asked a second time about age and confirmed 65. NP administered the high dose flu vaccine, based on patient report of age and did not confirm age in chart. Miscommunication about age and birth year led to error.
Severe fatigue, moderate body aches, and mild headache started approximately 12 hours after vaccine administration and led to insomnia on night of 04/27/2021. Severe fatigue and moderate body aches persisted for 36 hours. Mild fatigue continues through 04/29/2021. Mild sore throat started midday on 04/29/2021 and continues.
Dizziness; Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 28Mar2021 at 14:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, allergy to nuts and fruit allergy (Berries). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient did not receive any medication within two weeks of the COVID vaccine. The patient previously took levofloxacin (LEVAQUIN) from an unknown date for an unspecified indication and experienced drug allergy. On 31Mar2021 at 09:00, the patient experienced dizziness; it began a few days after the 1st dose. It was intermittent but at week four, it was getting a bit worse and was occasionally accompanied by tinnitus which lasted 20-30 mins at a time, had only 3 or so bouts of tinnitus. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events dizziness, it was intermittent but at week four, it was getting a bit worse and was occasionally accompanied by tinnitus was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
tingling and tongue thickness, increase HR and BP Claritin given-symptoms subsides after few minutes Benadryl 25 mg x 2 po  given as a home meds per MD
Diaphoresis, vomiting, facial edema all within 10 minutes of administration. Patient given IV fluids and IV BENADRYL.
tested positive for covid virus; This is a spontaneous report from a contactable consumer, the patient via Pfizer Sponsored Program. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Solution for injection) via an unspecified route of administration on 11Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 19March, tested positive for COVID virus and on 22March had antibody infusion. Wondering when she would be able to get 2nd dose of vaccine. Event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Bad muscle pain left leg below hip for 36 hours.After that 48 hours of shoulder up neck bad muscle pain; Lose of feeling in that area when it does not hurt.; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 12:30 (Batch/Lot Number: ER2613) at the age of 66-year-old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Bad muscle pain left leg below hip for 36 hours. After that 48 hours of shoulder up neck bad muscle pain. This is still occurring but not real bad. Lose of feeling in that area when it did not hurt. Adverse event (AE) started on 25Mar2021 15:30. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), Disability or permanent damage, Congenital anomaly or birth defect. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.
Loss of taste. After taking a nap, I discovered I had lost my sense of taste across most of my tongue. I was able to detect some tastes along the very outer edges of my tongue, but nowhere in the middle. This continued for 3 days, after which my taste fully returned.
This spontaneous report as received from a physician regarding a male patient of unknown age. Medical history and concurrent conditions were not reported. On 07-JUL-2015, the patient received improperly stored PROQUAD (Merck) (lot number was reported as L009208, expiry date: 17-SEP-2016, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was not concomitant medication reported. No adverse effects was reported and no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had a reaction in the left arm where her FLUZONE HD flu shot was given. Patient had redness, swelling, warmth to the touch, and pain. She reported having trouble moving the arm. Patient reported that the reaction moved a bit down the arm and into the inner arm. The reaction started on 10/17/17, the day after the vaccine was given. The reaction lasted for approximately 4 days. Reaction was treated with an antihistamine and an ice pack and resolved without any further treatment. Patient reported post-immunization that she has a latex allergy. She did not indicate a latex allergy on her Vaccine Administration Consent Form. All items used to give immunization are labeled latex free.
pt recv vax 9NOV95 & that day devel pain & redness @ inj site;pt was evaluated by MD who noted an 8x15cm erythematous area w/purpuric borders;pt also c/o inj site itchy;
1 of 2 pts who recvd vax 14DEC94 & exp an adverse event;pt had a fever of 101 & inj site was red & swollen w/in 36hr p/vax;no other sxs; MD visit scheduled
A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin. No medical history was reported. No concomitant products were reported. The patient received FLUMIST (intranasal) (batch number NR) once/single administration, via nasal route, during 2015. On an unknown date, the patient experienced has a lot of different allergies. Treatment with FLUMIST (intranasal) was discontinued. The outcome of the event was unknown. The event was considered non-serious.
Information has been received from a physician's assistant concerning a female with no allergies or pertinent medical history who in August 2008, was vaccinated po with a 2 ml first dose of ROTATEQ. There was no concomitant medication. The physician's assistant reported the patient experienced vomiting and diarrhea approximately 5 weeks, September 2008, after receiving ROTATEQ. Unspecified medical care was given at the practice. A stool culture was obtained. There was no additional information provided because the patient's chart was not available. Subsequently, on an unspecified date the patient recovered from vomiting and diarrhea. A product quality complaint was not involved. Additional information has been requested.
Continuous screaming (shrieking cry) over 3 hours (only on that day) and resolved without intervention.
Dizziness, Headache, Myalgia, Arthralgia, Fever & NauseaVomiting Narrative:  Other Relevant History:
chills (couldn't get warm); fever (101-102F).; Body hurt really bad,; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills (couldn't get warm)), PYREXIA (fever (101-102F).), PAIN (Body hurt really bad,) and NAUSEA (nauseated) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21P or R or D) for COVID-19 vaccination.     Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 23-Mar-2021, the patient experienced CHILLS (chills (couldn't get warm)), PYREXIA (fever (101-102F).), PAIN (Body hurt really bad,) and NAUSEA (nauseated). At the time of the report, CHILLS (chills (couldn't get warm)), PYREXIA (fever (101-102F).), PAIN (Body hurt really bad,) and NAUSEA (nauseated) outcome was unknown. Not Provided    Treatment information was provided i.e., Tylenol   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
7 days after, i have my left shoulder is slightly painful, itchy, and swollen a little.
post-menopausal women that have had a period; This is a spontaneous report from a non-contactable consumer via Pfizer- sponsored program COVAX US Support. A female patient of an unspecified age received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Lot number and Expiry date was not reported) as 2nd dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Lot number and Expiry date was not reported) as 1st dose, single dose for COVID-19 immunisation. On an unspecified date, patient had post-menopausal women that have had a period. The reporter inquired whether there has been reports of post-menopausal women that have had a period after receiving the vaccine. Caller advised they have received both doses and experiencing a period after menopause. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Two days after the flu vaccine a rash started on patients hands bilaterally. And tongue broke out in red raised ulcerations. Later was confirmed by rheumatologist that Behcets disease was triggered by the influenza vaccination.
Patient came into our office to receive a flu vaccine with her mom and sister. Patient was afebrile and was given dose in right arm and tolerated well. Patient left office with mom and sister. We received a call from mom a short time later stating that patient had what mom thought was seizure at Pharmacy. Mom was informed to bring patient back into the office to be examined. Patient was brought in and seen by APRN-CNP who determined the event was a vasovagal syncope episode from receiving the flu vaccine. Patient was sent home with mom.
4/30/23  I was very tired. I have had problems with weakness in my legs.  I began getting more weak and had trouble walking. I saw a Neurologist. He suggested to be tested for Parkinson, Neck Issues and Brain issues.  I have an MRI scheduled and Physical Therapy evaluated.
Left arm began to swell was achy around 2PM states she went to the nurse and was given an ice pack. Notified ER and was instructed to contact them if no improvement on 11/13/2004. Seen at ER on 11/13/2004.
1st day inc diaphoresia, weakness 13OCT93 & chills & sore aching all over; 15OCT93 8AM tickling & burning in rt side of chest & tight (non-productive cough);
SWOLLEN LEFT LEG; LEG PAIN; This spontaneous report received from a patient concerned a 71 year old male. The patient's weight was 285 pounds, and height was 178 centimeters. The patient's concurrent conditions included high blood pressure, non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known allergies and no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-JUN-2021, the subject experienced swollen left leg. On 17-JUN-2021, the subject experienced leg pain. Laboratory data included: Pain scale (NR: not provided) 8/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen left leg, and leg pain. This report was non-serious.