chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received the first dose of Moderna vaccine on March 19 followed by which I had pain in my arm and redness and swelling at injection site. That subsided within 3 days.   I have once again developed redness and swelling at the same injection site 8 days after the vaccination and this is accompanied by itching.
Information has been received from a registered nurse concerning a 13 month old male with no relevant medical history and no drug allergy who on 16-JUL-2008 was vaccinated subcutaneously into right arm with 0.5 ml the first dose of VARIVAX (Oka/Merck). Suspect therapy given subcutaneously into the left arm included a first dose of MMR II (Wistar RA 27/3) (MSD). Concomitant therapy subcutaneously into the right arm included the third dose of POLIOVAX (Lot number A0996). Concomitant therapy included tuberculin purified protein derivative. There was no illness at the time of vaccination. 1 to 2 days after the vaccination (on approximately 17-JUL-2008) the patient developed fever. The patient sought medical attention by phone and was seen in the office on 19-JUL-2008. The diagnosis was: mosquito bites, viral exanthema. Therapy was given. No further information is available.
patient received Moderna Covid 19 3/11 on/around 3/18 or 3/19 she started having swelling and severe redness in her arm that started to get worse over the course of few days. It became itchy as well. She presented to PCP on  3/23 and was prescribed cephalexin 500mg qid x 5 days. Even after 2 days of treatment was still red, swollen and itchy
Seen 7/30/10 left arm swollen 8cm by 9cm warm compress to arm.
Info has been received from an RN concerning a 12 year old white female with no medical history or known allergies who on 6/19/95 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. There was no concomitant medication and no illness at the time of vaccination. The reporter indicated that "a week ago," on approximately 5/13/05, the pt's titer was negative. Unspecified medical attention was sought. A product quality complaint was not involved. Follow-up info was received from the RN who reported that on 5/14/05 at 09:54 AM, the pt had titers drawn and was found to be non-immune. A varicella zoster AB test was negative at 0.29 TSR. There were no adverse events following prior vaccination. See laboratory section for all other laboratory results. No further info is expected. The RN also reported that the pt's sister had a negative titer after vaccination with varicella virus vaccine live.
9 hours after the vaccination, I woke with seizure like sub-0 chills where I where I felt like I was lying in the snow without clothes on.  Very hard shaking. Put on flannel pj's and wool socks, but could not get warm.  The violent shaking lasted about 3 hours. Along with what felt like 12 migraines at the same time.  My forehead was very hot, but that could have been from my hand being so cold.  My thermometer battery was dead.  The next morning, and for almost a week, I felt very lethargic as if I were watching myself from outside my body, hard to drive and focus, head felt like a giant bruise and I was incredibly tired. The tiredness has never gone away and I feel weaker every day here two (2) months later.
This spontaneous report as received from a physician refers to a unspecified patients of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of (Oka/Merck) VARIVAX (dose and route were not reported) lot # K003408, expiration date 06-MAR-2016 that were improperly stored. The temperature excursion for the (Oka/Merck) VARIVAX was found to be supported with in-house stability data. Secondary suspects and concomitant therapies were not reported. No adverse symptoms reported. Additional information has been requested. This is one of several reports received from the same reporter.
hearing loss; Bilateral tinnitus; This is a spontaneous report from a contactable nurse (patient). A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on unknown date 18:30 (Lot Number: EK9231) as single dose, dose 2 via an unspecified route of administration, administered in right arm on unknown date (Lot Number: EL3249) as single dose for covid-19 immunisation. Medical history included pituitary micro adenoma; known allergies: sulfa. No history of hearing loss, no family history, no occupational/environmental history for hearing loss. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications within 2 weeks of vaccination included bupropion, Hormone Replacement Therapy. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient received BNT162B2 on 28Dec2020 (unknown it was the date of the first dose or the second dose). The patient experienced bilateral tinnitus, had an audiogram which revealed moderate to severe sensorineural hearing loss (with left ear moderate and right ear severe) on 30Dec2020. The patient was not pregnant, not pregnant at time of vaccination. The events resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The patient received treatment as audiogram for the events. Covid-19 PCR (blood test) on 24Dec2020: Negative. Since the vaccination, the patient had been tested for COVID-19. Outcome of the events was not recovered. This report assessed a serious, disability.; Sender's Comments: Based on current information available and considering drug-event temporal association a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported events of Hearing loss and Tinnitus. The case will be reassessed further upon receipt of additional information.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Immediately post vax, the pt developed redness, stiffness, and tenderness at the injection site which spread to her elbow. The injection site area was hard and the range of motion in her arm was diminished. She sought medical attention and was advised to ice the arm.
Facial swelling began shortly after administration of H1N1 flumist and worsened on the second day.
Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 06-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K016425, expiration date 26-MAR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reported. Additional information is not expected because the physician did not wish to be contacted.
This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number and expiry date were unknown), via an unspecified route of administration on 09Feb2021 (at the age of 79-years) as a single dose for COVID-19 immunization; and liraglutide (VICTOZA), via an unspecified route of administration from 10Feb2021 to an unspecified date at unknown dose, weekly for an unspecified indication. The patient's medical history and concomitant medications were not reported. It was reported that everything was going fine until she had her COVID-19 vaccine on 09Feb2021, and then on 10Feb2021 she had the liraglutide injection. That's when everything went wrong and had to be hospitalized. She is losing her magnesium and her potassium. She had diarrhea, hadn't eaten in 5 weeks, was throwing up, and lost weight. She just can't eat, everything tasted so bland. She is getting better now though. The action taken for liraglutide was unknown. The outcome of the events was recovering. No follow-up attempts are possible; information about the lot number cannot be obtained.
Received vaccine on 3/19/03 and the next day, right thigh was 27.5cm (left 20cm) and red, warm but not tender. Pt was afebrile. It resolved almost entirely by 3/21/03 with Benadryl.
Patient started experiencing shortness of breath and fever about 3 days PTA (admitted on 7/17/21) and was treated with a Zpak and doxycycline as an outpatient. Her symptoms did not improve, so she presented to the ED on 7/17. Patient was tested for COVID  per protocol and the test came back positive. CT PE came back negative, but a large left pleural effusion was discovered and patient was admitted for treatment. Since pt remained on room air during her hospitalization, Infectious Diseases decided not to treat pt for COVID since pt is fully vaccinated (received Pfizer on 2/8 and 3/11) and they didn't believe her presentation was caused by COVID. Pt had a similar presentation of LLL PNA with pleural effusion in 12/2019.
Rhabdomyolisis turning into Polynephritis that was antibiotic resistant for 2 months now and severe whole body edema and HTN
A report has been received from a Physician concerning a 17 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started during Oct-2013. It was reported that the patient had tested positive for H1N1 which started on 15-Dec-2013. The outcome of the event of tested positive for H1N1 is unknown. The report was considered to be non-serious.
Information has been received from a medical assistant referring to a 4 month old female patient. No relevant medical history or concurrent conditions were reported. On 03-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322.  Additional information has been requested.
Seizure - collapsed while in the bathroom, roommates described a seizure, hit head in fall, was unconscious for a brief period and then disoriented when she regained consciousness. A second seizure occurred on November 29 also in the morning. This one lasted approximately 4 - 6 minutes. She was disoriented upon regaining consciousness, taken to the hospital where EEG confirmed a seizure and she was diagnosed with epilepsy.
Patient received Pfizer D2 04/26/21 and received Pfizer booster early on 07/31/21 as indicated in this report.
Information has been received from a physician via a field representative referring to a 2 year old male patient. On 26-OCT-2012, the patient was vaccinated with the first dose of ROTATEQ (lot# H015649, expiration date unknown), 2 ml, orally. On 07-JAN-2013 and 05-MAR-2013, the patient was respectively vaccinated with the second (lot#:H016904, expiration date unknown) and third (lot#: H019649, expiration date unknown) dose of ROTATEQ 2 ml, orally. On approximately 15-JAN-2015, the patient experienced vomiting and diarrhea. After 1 week of vomiting and diarrhea, on 22-JAN-2015, the patient's mother called the office to seek medical attention. The patient visited the office and performed a lab test on an unknown date in 2015 which showed positive for rotavirus on an unspecified date in 2015. Fluids and other unspecified treatments had been given for the events. The outcome of the events was reported as recovered/resolved. Additional information has been requested.
Roughly one month after receiving  dose #1 of Moderna COVID-19 vaccine, patient noticed left eye swelling and irritation. The following day, the patient was unable to purse her lips and lost taste on the left side of her tongue. She also was unable to close her left eyelid and now reports throbbing in her left eye.
Patient became lightheaded while leaving clinic. Rested on bench but feel on ground. Was able to get up and proceeded to go to car with an unsteady gait. Opened door to car but collapsed outside car. Mom RN. Heart rate low and irregular. Skin cold and clammy. Patient responded to questions inappropriately. Help from clinic sought. Patient taken back into clinic for medical care. Was able to proceed home 30 minutes later. Home and rested for rest of day.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Shingrix for prophylaxis. Co-suspect products included Shingrix for prophylaxis. In March 2018, the patient received the 1st dose of Shingrix (intramuscular). In June 2018, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix and less than 3 months after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased, weakness of arms, nocturnal awakening, numbness of upper extremities and condition aggravated. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injected limb mobility decreased, weakness of arms, nocturnal awakening, numbness of upper extremities and condition aggravated were unknown. The reporter considered the injection site pain, injected limb mobility decreased, weakness of arms, nocturnal awakening and numbness of upper extremities to be possibly related to Shingrix and Shingrix. It was unknown if the reporter considered the condition aggravated to be related to Shingrix. Additional details were provided as follows: The patient received 1st and 2nd dose of Shingrix in left upper arm. After both doses, the patient had severe pain at the injection site that was really, really bad for about 3 days and gradually subsided over a period of 2 to 3 weeks. After about 4 weeks, when the very sore and severe pain subsided from the shot, she began to had a constant numbing, weakening pain in her left upper arm in the area above her elbow. It had become so bad that she could not fully control the action of her arm in moving it and she certainly could not lift her arm up without pain or even turn it around to scratch her back. She wake up during the night and her arm was hurting her and she could not sleep due to the pain and sometimes wakes her up at night because of the aching. This effect was causing me to have weakness in this arm so she could not depend on lifting things with it and it limits her ability to move her arm. This pain continues to at the time of reporting, more than 2 months after the second shot. The pain was a spot on her arm a little lower down than the actual injection site, but still above her elbow. She had no problems with her right arm. The reporter stated that events must be listed as a possible side effect. No information was available regarding event onset data of injected limb mobility decreased, difficulty sleeping and numbness of upper extremities and which event started after which dose (1st or 2nd dose). Clarification raised.
Initial report was received from a consumer, who is also the patient's grandmother, on 08 March 2013. A four-year-old male patient had received an fifth dose of DTaP (manufacturer, lot number, route and site unknown) in January 2013 (seven weeks ago on a Thursday). Forty eight hours post-vaccination, the patient experienced "neuro problems" of shaking but not seizures. Uncontrollable intermittent shaking started two days post-vaccination after he complained of loss of appetite and being very tired. The patient was taken to an urgent care clinic since symptoms were off and on. One minute the patient is fine and the next he is shaking his head and upper and lower extremities. An MRI could not be performed due to the shaking. The reporter denied any illness at the time of vaccination and history. Outcome was not reported. Documents held by sender: None.
INCOHERENT- HAD TO BE HELPED TO WALK AROUND AND COUGHED ALL NIGHT. STARTED THAT EVENING AFTER VACCINATION. PT DID NOT TAKE ANY BENADRYL OR ANY OTHER. PT STATES IT LASTED  FOR 2 DAYS. PT IS BETTER ON THURSDAY BETTER. PT IS REPORTING IT TODAY 5/13/22.
flu-like symptoms; fever; chills; body aches; This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 7M2KB, expiry date 30th March 2020) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms, fever, chills and general body pain. On an unknown date, the outcome of the influenza-like symptoms, fever, chills and general body pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever, chills and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu like symptoms, fever, chills, body aches. The reporter did not give consent to follow up.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, current condition and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 09-AUG-2016 the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU (dosing details were not reported). On an unknown date in August 2016 after the patient was vaccinated the patient was prescribed methylprednisolone and an unspecified inhaled corticosteroid for an unknown reason on 10-AUG-2016 (adverse event). The outcome of the event was unknown. The reporter did not provided the causality assessment between the event and the suspect therapy. There was no product quality complaint involved. Additional information is not expected as the reporter did not wish further contact.
Four months after 4th Pfizer dose, broke out in a rash on my arms and legs in a rash of red dots. There were no physical bumps and it wasn't itchy. Lasted for 1 day then it was gone.
patient states that her shoulder is frozen on the right side, she has limited mobility. Patient also states that her shoulder throbs at night with a stabbing pain and has to take pain medication to alleviate the pain to sleep. Patient states that she has a gripping pain when she moves her right shoulder a certain way. Patient stated she did ice the area where the flu shot was given and has also taken an NSAID to relieve the pain, but she still has limited mobility with using her right shoulder.
follow up from ED  she states that Friday she got flu shot  Monday her upper arms were painful from mid upper arm up and felt like she had numbness and tingling finger ans like her and hands were sandbags  it went away and the next day her leg s were involved  and the next day she felt really tired she felt she had sand bags on her legs  her symptoms lasted a week but she has persistent fatigue  she has also had pain in her hips  one of her sons who got the  flu also had less severe symptoms   she stopped iron briefly thinking that it was causing her symptoms
Day of vaccination around 6 , real bad headaches with shooting pains in my head. My throat got real sore. Then my neck started hurting on both side, mostly on left side where I got shot. Then I had headaches and pains all over. My chest also hurts. Then this morning, I woke up and my fingers are numb on the left hand side.  Slight coughing. Stayed in ER for 3 hours.
3/29 Afternoon, malaise, slight anterior left chest discomfort.  3/30 3:30p.m.-malaise continues, intermittent sharp, stabbing pain, posterior left chest with mild, anterior chest discomfort.  Pain in posterior chest under shoulder blade.   4/2  Chest discomfort continuing.  Tenderness now present in both groins. 4/3  Evaluated by personal MD-tenderness in area of lymph nodes in both left anterior chest and left bi-lateral groins.  Vioxx prescribed.
fever of 101.8, aches from tips of right fingers to tips of left fingers and down my back to my buttocks, headache, blurry vision,extreme fatigue. all lasted about 28hours. now just pain at the injection site.
Swelling at site, went to Dr. and started on blood thinner in case of clot. Everything fine and reappeared. I suggested she see specialist concerning clotting.
Temp of 101 on 1/27, may be related to flu vax, also grape fruit sized welts at site. 1/29 Benadryl given, Benadryl cream and ice packs to welt.
Much fussier than normal, crying more, lethargic, difficulty staying asleep, skin more reactive (breaking out in rashes/dry patches).
ringing in ear; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) in the right arm on 13Mar2021 at 17:45 (at the age of 61-year-old) as a dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) in the left arm on 03Apr2021 at 17:45 (at the age of 61-year-old) as a dose for COVID-19 immunisation. Medical history included diabetes. Concomitant medications included metformin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), esomeprazole sodium (NEXIUM) and ezetimibe (MANUFACTURER UNKNOWN). 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 13Mar2021 at 17:45 the patient experienced ringing in ear since the first dose and more so on the 2nd dose. Came and went then in varying degrees. Always present. On 15Mar2021, the patient underwent nasal swab test and the result was negative. No therapeutic measures were taken as a result of the adverse event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event tinnitus was not recovered.    No follow-up attempts are needed. No further information is expected.
redness, swelling, warmth, felt bad enough to leave work, saw pcp diagnosed with cellulitis, prescribed cephalexin
Information has been received from a nurse practitioner concerning a female who on 13-DEC-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot number and expiration date not provided). After receiving a dose of PNEUMOVAX 23, prior to 21-DEC-2010, the patient developed a rash along her chest, right arm and back. The patient sought unspecified medical attention. Treatment was given for the rash but the medication was unspecified. At time of the report, the patient's outcome was unknown. Additional information has been requested.
MMR administered left lower forearm at approximately 3:00pm on 7-23-08 - at 4:30pm RN looked at left arm where MMR given.  Red and raised area approximately 60mm x 37 m in deviation and redness extended approximately 1" from there - rechecked on 7-24-08 at 8:10am, induration gone.  Now just some redness only - no fever - client did notice a rash inside of lower forearm in right and left arm and had rash around neck on 7-23-08 that night - received MMR due to titer showed not immuned to Rubella - advised to use ice pack prn - she used nothing - resolving on its own.
Vaccinated pt admitted in labor with covid infection. No info available on vaccine type, manufacturer, location, date, etc.
patient had a rash form on her abdomen that was raised and red and becoming painful that she stated started approximately Friday or Saturday (10/4 or 10/5). Morning of 10/6 she came to pharmacy to report and ask for advice. She was advised to talk to her doctor or if he wasn't available to go to urgent care to have rash checked out. Urgent care doctor diagnosed her with shingles and prescribed Valtrex and lidocaine for treatment.