chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vertigo; A spontaneous report was received from a consumer concerning himself, a 70-year-old, male patient who developed vertigo.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 12 Feb 2021, approximately 2 days prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (lot#: 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient presented to the emergency room with an extreme case of dizziness, nausea, and the inability to turn head his head left or right. The patient was diagnosed with vertigo and was hospitalized for 2 days. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, vertigo was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Full body flushing  & tingles, numbness in face, feeling faint, dizzy, weak legs and arms, cold feet, head felt heavy, felt spacy, headaches, slight nausea. Normal heart rate, normal breathing. Lasted 1 day post first vaccination on August 9, 2021 and  lasted 3 days post second vaccination on September 7th, 2021. Then ALL the same symptoms returned exactly 2 weeks post 2nd vaccination and lasted for 8 days  ( September 20th - 27th, 2021). Patient is still dealing with headaches, some flushing and dizziness today Oct 1st, 2021
I started feeling extremely weak, to the point I called my husband and told him it wasn't safe for me to drive the rest of the 10 minutes home.  Upon getting home, my husband had to help me to my bed where I passed out immediately and slept for several hours.  It took a few days to feel good again.  I felt like I was hanging onto life by a thread.  I am now too afraid to ever get a flu shot again nor do I want my kids getting a flu shot again.
Information has been received from a physician concerning a 60 year old female who in March 2008, was vaccinated with a dose of ZOSTAVAX subcutaneously.  Subsequently the patient experienced tingling in her right arm for about 2 weeks.  Unspecified medical attention was sought.  The patient was recovering.  No product quality complaint.  Additional information has been requested.
Severe Headache, Extreme inflammation in already injured neck and upper body bringing current pain level to 10.  Fever, chills, naseau, dizziness, tiredness.
PT received 1st  dose of the Pfizer at 5:00PM (10/28/2021) from our facility. PT. called the Health Dept. at around 9:30 AM (10/29/2021). PT. stated that they experienced Nausea, Fever (103 F), Body aches, chills, and chest pain at 1 am this morning (approximately 8 hrs after receiving the first COVID-19 Pfizer vaccine.) PT stated that they took Tylenol and Zofran, but symptoms still persist. As of 10:45 AM we have referred the PT to seek their primary care physician for further assistance.
No adverse event; Maternal exposure during breast feeding; This spontaneous case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and NO ADVERSE EVENT (No adverse event) in a 38-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Jun-2023, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 20-Jun-2023, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding).    No concomitant and treatment medications were reported. Index number was reported as UN-09730.   Reporter did not allow further contact
Patient admitted 4/9/2021 to hospital and required mechanical ventilation the next day for Covid-19 pneumonia
Severe abdominal cramping; I never had a stomach ache like this before; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (Pfizer COVID 19 Vaccine, solution for injection), via an unspecified route of administration on 13Jul2021 (Batch/Lot Number: EW0198) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 Batch/Lot Number: EW0217) on 22Jun2021 for covid-19 immunization; Not side effect. It was reported that, I am having, I had diarrhea yesterday (14Jul2021) and today (15Jul2021) and I am having severe abdominal cramping and I need to know if this is the side effect of this injection. Consumer was also informed about the role of Pfizer Drug Safety and requested to file a safety report, consumer stated, "It's going to take 10 minutes? I can't sit here for 10 minutes on the phone, I mean I have to go 'down' (voice not clear) this is bad. But if you can't transfer me, I will just call my doctor." LOT#: Consumer stated, "I never had a stomach ache like this before (15Jul2021), so the second dose was EW0198. The first one I had not side effect, the date here is (13Jul2021). The outcome of the events was unknown.
Patient to be immunized for both influenza and tetanus. Upon administration of Boostrix, patient began to feel lightheaded and dizzy. After a moments time, Flucelvax was administered in opposite arm and patient stated again was feeling nauseous and overwhelmed. Pharmacist monitored the patient for support. Patient became nauseated with minimal vomiting. Pharmacist guided for more support and aided to technicians for more support. Continuous monitoring occurred for about 5 minute and patient reported feeling less nausesous and alert. Emergent healthcare authorities not contacted to scene. Followed up with patient primary care provider of incident. Followed up with patient well-being.
This spontaneous report as received from a consumer refers to a 4 year old female patient. It was reported that there was no pertinent medical history or drug allergies. On 19-JUN-2014 the patient was vaccinated with PROQUAD (Merck) (route, strength not reported). The reporter stated that she believes that this was patient's second dose of "MMR and varicella" and that was unsure if the patient received the PROQUAD (Merck) for the first dose, or whether they were received separately. The reporter stated that the patient's leg got swollen, and became hard and red on 19-JUN-2014 (reported as the first two days after injection). The reporter also mentioned that the patient got little bit of fever on an unknown date in 2014 and on 27-JUN-2014 the patient had small red bumps on her back, torso and face. The reporter also mentioned that bumps were not itchy, although there was one bump on her face which seemed to bother the patient. The reporter also mentioned that bumps were not itchy, although there was one bump on her face which seemed to bother the patient. The reporter reported that the patient wakes up at night around 11pm as bathed in sweat like her fever just broke. The reporter also stated that the patient was giving her baths and over the counter TYLENOL. The outcome of leg did swell and get hard and red was reported as recovered/resolved. The outcome of bathed in sweat and small red bumps on her back, torso and face, one bump on her face which seemed to bother her was reported as not recovered/not resolved. No product quality complaint was involved. Additional information is not expected.
Pt vaccinated on 9/19/17. Woke with generalized macular rash on 9/20/17. Pt seen 9/20/17 4:47 pm. Dad stated rash no worse, no better. Advised BENADRYL. Pt is with limit vaccine record. Has had Tdap and flu, but this was first Hep A.
acute vertigo/most likely benign paroxysmal positional vertigo; This is a spontaneous report from a contactable physician (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly, on 22Dec2020 at a single dose (reported as 0.3) for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient experienced acute vertigo/most likely benign paroxysmal positional vertigo on 02Jan2021, which was reported as medically significant. The patient could barely get out of bed on 02Jan2021. The clinical course was reported as follows: The patient did not have any systemic symptoms after receiving the first vaccine but 12 days (as reported) after, she did have some acute vertigo; reported as very serious for her. She could barely get out of bed the first couple of days after getting it. The patient went to ear-nose-and throat (ENT) because she wanted to determine the likelihood of the vertigo having anything to do with her getting the vaccine before she got her second vaccine. She was told it was most likely benign paroxysmal positional vertigo, most likely positional, had nothing to do with the vaccine, and that she was okay to go ahead and get her second vaccine. The vertigo went away within a couple of days. The patient clarified that by 06Jan2021, she was feeling much better and recovered completely. The clinical outcome of acute vertigo/most likely benign paroxysmal positional vertigo and barely get out of bed was recovered on 06Jan2021.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Sender's Comments: The reported acute vertigo/most likely benign paroxysmal positional vertigo occurred 12 days after the first dose of COVID 19 vaccine, BNT162B2, is considered an intercurrent disease, unlikely related to BNT162B2 administration.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site discomfort in a 89-year-old female patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020). On 11th January 2018, the patient received the 1st dose of SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced injection site discomfort, incorrect storage of drug and vaccination error. On an unknown date, the outcome of the injection site discomfort, incorrect storage of drug and vaccination error were unknown. The reporter considered the injection site discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient received the dose of SHINGRIX (on left deltoid) after it was stored in the freezer, which led to incorrect storage of drug and vaccination error. The patient experienced no side effects except discomfort at the injection site. The case has been linked with case US2018009454, reported by the same reporter.
Small raised red patch on left forearm. .5?x.75?. Treated only with lavender oil.
fever of 105 degrees; my arm was instantly sore and swollen; my arm was instantly sore and swollen; My right hand was completely swollen and I couldn't move my fingers; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself) from a Pfizer. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 20Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history included pneumonia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 27Feb2021 for COVID-19 immunization and experienced sick, temperature went up to 105, severe headache, swollen lymph nodes, swollen glands in the head and neck, her joints were stiff, she couldn't move. On an unspecified date in Mar2021, the patient experienced fever of 105 degrees, my arm was instantly sore and swollen, my right hand was completely swollen and I couldn't move my fingers. Patient called to say 24 hours after she took the 1st dose she is very sick. Her temperature went up to 105 had a severe headache, swollen lymph nodes, swollen glands in the head and neck, her joints were stiff and she couldn't move. Patient mentioned she was tested positive way back Nov2020 and had pneumonia. Patient took the 1st dose on 27Feb2021 and wants to get an answer if she should get her 2nd dose of Covid-19 vaccine on 20Mar2021. I have already gotten my second dose and it wasn't quite as bad as the first one. For 2.5 days I had a fever of 105 degrees and my arm was instantly sore and swollen. My right hand was completely swollen and I couldn't move my fingers. Why does each person have different symptoms. No one at my job or even my 80-year-old mother did not have these severe of side effects. The patient underwent lab tests and procedures which included body temperature was 105 degrees, SARS-CoV-2 test was positive on an unspecified date in Nov2020. Outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Provider ordered MMR + Varicella to be administered. Staff gave patient MMR-V + Varicella. Manufature was called. Mom was made aware. Staff education was Provided.
Redness and swelling at injection site. Rash on other sites of body. Chest tightness.
This is a 86y.o. male with a past medical history of colitis, HLD, hearing loss, HFrEF, CAD, multiple myeloma with chronic anemia who presents to ED with complaint of fever since Friday. Pt states he had a fever with a cough productive of green sputum on Friday, and saw Dr. who started him on azithromycin 250 and Tessalon. Pt states his cough has since improved, but he has had a persistently high fever with a max temp of 104F. Pt states his fever was 102F this morning, and took 600mg Tylenol. Pt has a history of multiple myeloma for about 1.5 years treated with chemotherapy by Dr. Pt states he received both of his COVID vaccines. Pt denies loss of taste or smell, SOB, chest pain, diarrhea, nasal drainage. Patient denies previous GI bleed, melena, hematochezia or hematuria. Pt admits to a mild residual cough.
pt w/hx of asthma, recv vax 1130AM & began w/swelling, itching all over 24 hr p/vax;erythematous maculopapular rash inc in size over rt upper extremity 8x5cm;
Pt thought she was going to die and describes herself being so extremely sick with flu for 32 days beginning the day after the vaccine was administered.
Red itchy eyes, swollen lips, itchy and hives all over body. Patient did go see her dermatologist and they gave her some cream to use on her face. Patient did state that she dose have food allergies, but she watches what she eats.
Fatigue, skin hurts, joints hurt, headache, nausea, pain at injection site, lose of appetite
GENERAL BODY ACHES; FOGGY FEELING IN HEAD; HEADACHE; LOW FEVER; This spontaneous report received from a patient concerned a male of unspecified age. 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 was not reported, administered on 2021 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 2021, the subject experienced general body aches. On 2021, the subject experienced foggy feeling in head. On 2021, the subject experienced headache. On 2021, the subject experienced low fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the general body aches, foggy feeling in head, headache and low fever was not reported. This report was non-serious.
I just had a slightly sore arm and a low grade fever for one day right after the vaccine. It wasn't notable really.  Mammogram - May 3rd - a routine one - I had put it off to go until I was fully vaccinated plus two weeks and I called and got in after that. Found something with the Mammogram and had a biopsy on May 10th - positive result for breast cancer. No other testing. I had surgery on June 15th for a lumpectomy and a lymph node removal. June 15 -  Cancer was on the left side. It didn't spread to my lymph node. Radiation is on September 21 - no chemotherapy needed at this time. Recovery is ongoing. I have to have radiation for four weeks.
I had the sho, the second, one,  in the evening and I was fine. Next morning, about 14 hours later I woke up ( 5 AM ) and my hands were really swollen, with pain in my distal joints in particular, I could not even close my hands around a spoon to put sugar in my coffee. There was pain on palpation of my bones in my hands. There was pain in my knees and my ankles. Really weird, I have no arthritis at all. However, it was the very same reaction I had when I initially took Ceclor, an old antibiotic about 20 years ago.  4 /6 hours later it had all disappeared! 24 hours after the vaccine, when I had almost forgotten about the morning, I suddenly had fever (37.9) and moderate chills! It also started from nowhere as I was watching TV at the time. I took a Tylenol and went to bed. Next morning I was fine and felt wonderful. I am a physician myself and it was really surprising for me. The arm had no pain, nothing at all, but the chills were disturbing. I am fine and happy now. I have taken ALL the vaccines available and never had a reaction like this, including rabies, and each and every vaccine I had to take. I am absolutely fine and happy and thankful.
On March 10th, 2021. about 20 hours after the vaccine i started having a strange itchiness between my shoulder blades (upper back area). it comes and goes. sometimes its a tingling/numb feeling & sometimes its a crawling feeling.  on April 7th i had my second dose of Moderna. on April 28th I was seen at my doctors office for swollen supraclavicular lymph nodes in my left arm. My doctor informed me that she believed this could be from the Vaccine.
Hives within 2 hours after injection at site. Influenza - pain into axilla Left arm & back x 24 hours. Prescribed w/ tylenol & ibuprofen, gave in 48hrs.
SEVERE PAIN IN PELVIC JOINTS, UNABLE TO GET OUT OF BED. SEVERE PAIN ENTIRE LEFT ARM FROM NECK TO FINGERS, UNUSUALLY SEVERE CHILLS, LIGHTHEADEDNESS/DIZZINESS.
Vomiting x 2, vomiting continued next day and then developed fever. Hospitalized for three days.
9/4/19 patient began to complain of occipital headache, dizziness, and visual changes.  He was seen in the Medical Center Emergency Department the same day (symptoms had resolved at that point)and then the next day at this pediatric office because symptoms were continuing intermittently.
Fever 103R, in/out of consciousness, vomiting, lethargic.
1/18 - vaccine given. that night  mother noted pea sized lump under vaccine  with overlying redness.. 1/22 lump got bigger and by 1/24 was small sized avocado pit size with lavender coloration on skin. 1/23-diffuse red dots with itch. 1/25 - dots gone, nodule smaller to size of cherry . seen 1/26 by allergist - dx local hypersensitivity or foreign body arthus reaction likely to aluminum phosphate adjuvantin vaccine.  Recommended not revaccinating untilk at least 5 years old.  By 2/4 - lesions almost all gone without any treatment.
Persistent headache a few hours later. Later on, a body fatigue, hot/cold, puking, while the headache continued, trouble sleeping.
Early June 2021 severe cramps in hips,legs feet and begin shortness of breath. No change since started
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 18-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Became very dizzy, light-headed, and nauseous immediately after receiving the vaccine. Nurse was VERY sweet and helpful and had me lie down and slowly work up to standing up over a long period of time and sip some juice. The following day, I am experiencing achy joints, fatigue, a mild fever, and pain at the injection site. These symptoms are bothersome and are making normal activities difficult.
sore arm; tiredness; Felt warm; not feeling well; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING HOT (Felt warm), MALAISE (not feeling well), CHILLS (Chills) and FATIGUE (tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced FEELING HOT (Felt warm), MALAISE (not feeling well) and CHILLS (Chills). On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness). At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING HOT (Felt warm), MALAISE (not feeling well), CHILLS (Chills) and FATIGUE (tiredness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication reported.  Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: New events were added chills,feeling not well and felling warm
Pain during shot, chills from arm pain all night, increasing upper arm pain and inability to move arm without pain. Can barely get myself dressed and undressed due to pain. Cannot lift with left arm. Cannot sleep on left side. After a few of weeks of no relief and no decrease in pain, I went to my regular physician (11/15) and diagnosis was nerve impingement due to vaccination. Waiting to begin physical therapy on 12/4 and in the meantime take over the counter pain meds.
This case was reported by a healthcare professional and described the occurrence of inappropriate preparation of medication in a subject aged between 0 and 4 years old unspecified gender who was vaccinated with HIBERIX (GlaxoSmithKline). In August 2010 the subject received the diluent only of the 1st dose of HIBERIX (.5 unknown, unknown, unknown thigh) and experienced inappropriate preparation of medication. A pharmaceutical product complaint was associated with this report. It was reported that one of ten vials contained diluent only (the product contained ten units of diluent, but only nine vials of medicine). Ten doses were administered, but the facility was uncertain which child received the diluent only. According to product complaint investigation results reported by GSK quality assurance on 01 September 2010, the product complaint assessed to be unsubstantiated.