chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna COVID-19 Vaccine EUA  1330 Hours - Increasing soreness 1630 Hours - Shortness of breath after moderate activity, Albuterol inhaler taken, relieved symptoms 1930 Hours - Increasing soreness and low grade fever with Tylenol 0130 - 0430 Hours - Excruciating full body pain with pain meds, fever, extremities freezing, body hot to touch, muscle spasms.  Pain radiated through body with slightest movement, felt in joints, muscles, bones.  Only alleviated by laying perfectly still.  Both injection sights became painful during this period, one in both arms.  Worst pain I have ever felt in my entire life, thought I might need to call ambulance and upon reflection, probably should have. Since then chills and sweating periods with minor exertion, getting less severe as time passes, but within norm.
The patient reported she was here for her second dose. The first was November 3, 2021, per patient, but no record could be found. The patient stated it was Pfizer. Because no record was found, the clinician was documenting it as "self-attestation". Upon completion of vaccination, the patient found a photo of the CDC card from the first dose which indicated her first dose was Moderna, not Pfizer. The patient was advised that the series would now be considered complete despite receiving a different manufacturer for each dose.
Patient has had a continual red dot where injection was given.  It looks like a pimple or mosquito bite. It is painful to the touch or otherwise.  The patient describes the pain as mild.
Patient in excellent health with no medical conditions or comorbidities was admitted to hospital with severe abdominal pain; diagnosed by CT w/contrast, with rare abdominal vasculitis; treated with Prednisone 60 mg.
Nausea; Vomiting multiple times; Severe headache; Fever; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the right arm on 20Apr2021 at 13:00 at the age of 30-year-old as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown via an unspecified route of administration in the left arm on 30Mar2021 at 13:00 at the age of 30-year-old as a single dose for COVID-19 immunisation. On 21Apr2021 at 03:00, the patient experienced nausea, vomiting multiple times, severe headache, and fever. The events did not result in doctor or other healthcare professional office or clinic, emergency room, or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, vomiting multiple times, severe headache, and fever were not recovered at the time of this report.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Patient recieved vaccine  FLUZONE QUADRIVALENT but she already received the "flu mist with no adverse event; Initial information was received on 17-Nov-2021 regarding an unsolicited valid non-serious case received from a other health professional and non-healthcare professional via Medical information (MI) under reference number - 00862943).  This case involves a 2-year-old female patient who received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] but she already received dose of flu mist (extra dose administered).  The patient's past medical treatments, concomitant medication and family history were not provided.  Concomitant medications included INFLUENZA VACCINE LIVE REASSORT 3V (FLUMIST) for prophylactic vaccination.  On 17-Nov-2021, the patient received a 0.5ml {total} dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number UJ776AA and expiry date 30-Jun-2022 was reported) via intramuscular route at an unknown administration site for prophylactic vaccination (it was also reported as left leg).   It was case of actual medication error due to extra dose administered (latency was on same day).   At the time of report, no adverse event was reported.  There were no laboratory data/results available.  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 the 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.
Information has been received from a physician concerning a pt with the SC form of sickle cell disease who was vaccinated with the first and second doses of pneumococcal vaccine 23 polyvalent. The child received the first dose at the age of 2 and the second dose at the age of 5 or 6. It was noted that the pt developed pneumococcal infection. In approximately October 2001, the child was admitted to the hospital due to pain. Within 30 minutes, the child collapsed and died. This case was reported while obtaining information from a lead author of a literature article titled "Streptococcus pneumoniae Sepsis and Meningitis During the Penicillin Era in Children with Sickle Cell Disease" (WAES0302USA02380, WAES0302USA02379, WAES0302USA02069). Additional info has been requested. The follow up received on 3/31/03 from a physician indicated that the child presented to the ER complaining of pain in her legs. She was afebrile. It was noted that she had slight desaturation and she was given oxygen by nasal prongs as well as pain medication. A chest x-ray was normal. Her symptoms did not resolve in the ER and so she was admitted to the 23 hour observation status. Approximately 2 hrs after arriving on the floor it was noted that she was becoming significantly desaturated and bradycardic. In very short order she arrested and was noted to be asystolic. CPR was instituted nearly immediately and the pt was intubated and given Narcan and cardiac drugs. Ventricular fibrillation was obtained but defibrillation was unsuccessful and after 25 minutes of resuscitation effort the resuscitation was called. According to the autopsy report, the date of death is reported at 11/1/01. The final anatomic diagnosis were Pneumococcal sepsis, adrenal hemorrhage, hepatic and splenic congestion, acute cerebral anoxic changes, thymic involution, and marrow with erythroid hyperplasia and myeloid left shift. Special studies indicated that toxicology studies showed opiates (morphine and codeine) at therapeutic levels and Streptococcus pneumonia was sensitive to penicillin. Additional info has been requested.  A 15-day follow up report received 04/11/2003 adds: This case was reported while obtaining info from a lead author of a literature article titled 'Streptococcus pneumoniae Sepsis and Meningitis During the Penicillin Era in Children with Sickle Cell Disease' (WAES #0302USA02380, WAES #0302USA02379, WAES #0302USA02069). Additional info has been requested. The follow up received on 5/21/03 received from a physician indicated that the source of the information regarding the penicillin-sensitive pneumococcus was a blood culture obtained in the emergency room at the time of admission approximately 2-3 hours before the pt's death.
RED MARK ON LEFT ARM; FELT SICK; NAUSEA; This spontaneous report received from a patient concerned a 75 year old white female of unknown ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with  covid-19 vaccine ad26.cov2.s for prophylactic vaccination on unspecified date (dose number in series 1) (unspecified manufacturer). No adverse events reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered at left arm on 08-NOV-2021 for prophylactic vaccination (dose number in series 2). No concomitant medications were reported.  On 08-NOV-2021, the patient received the booster shot of the Janssen Covid-19 vaccine and had a red mark on her arm (left arm), that would not be go away (not resolved). She also reported feeling nauseous (resolved) and sick 15 mins after receiving the vaccine (resolved) (all events dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt sick, and nausea (date unspecified) and had not recovered from red mark on left arm. This report was non-serious. This case, from the same reporter is linked to 20211133681.
Wife calls clinic to report husband has chickenpox after vaccine. Wife says husband had had hives and pimples all over his trunk, legs and arms for two weeks but no fever. She stated husband is mad at her for making him get shot and believes the skin problems is from the vaccine. They recently changed laundry soap and wife has a history of numerous episodes of shingles. Husband has been wearing new blue jeans. Rash has not been observed or diagnosed by a medical professional. Wife states husband refuses to see a doctor and there is no immune problem. He takes blood pressure medication only (Lisinopril and Norvasc). Wife is now medication husband with her RX of Valtrex, Benadryl and cortisone cream. Patient has been attending church having physical contact with others and possibly drinking from a communal cup.
I had sore throat, running nose, and cough that lasted for about 6 or 7 days. On Jan 3rd, I tested positive for COVID-19.  Then about a week later, I started having chest pain. I went to Urgent Care. They did blood work, normal result. They also did EKG and chest x-ray, all normal. I was referred to a cardiologist. I had to wear a heart monitor for about a week.  They did an heart ultrasound, show that I had infrequent PVC and PAC.
Headache, Myalgia, left arm hurting achey, chills Narrative:
Dizziness, Headache, Fever & NauseaVomiting Narrative:  Other Relevant History:
Patient developed fever (104 degrees), body ached, nausea and hives. Took MOTRIN and TYLENOL. Symptoms resolved in 24 hours. Rash/hives remain on upper chest and neck area. Referred to her PCP for evaluation and treatment.
15-20 minute episode of body stiffening, screaming and terrified look in eyes, onset approximately 1-2 hours, post vax, and was followed by another episode of approximately same duration and signs/symtoms at approximately 21:00 or 22:00. Has not reported to MD. Encouraged to call and advise us of MD's response. No continuous uncontrollable crying lasting 3 hours or more.
Had Janssen vaccine on 4/9 and within a day  developed subjective fevers and dyspnea which progressed until admitted to  Hospital on 4/11 and promptly intubated for respiratory distress.  Found to be in sepsis and ARDS with multiple negative COVID tests including an extensive respiratory viral panel, we have failed to culture any bacteria from multiple sputum cultures, Legionella antigen and HIV negative.  Have been treating as ARDS 2/2 atypical pneumonia, possible aspiration (although no aspiration event reported) with hospital course complicated by VAP.  Concern remains for possible reaction to Janssen vaccine.  Still admitted to ICU at Hospital.
Inject of TTOX given in lt upper arm on 11JUN91; Pt states inject site started itching that PM; Denies erythema or swelling; 2 days later site was red & swollen; Treated w/DPH;
Severe shingles; Severe shingles rash about 10 days out from vaccine; This is a spontaneous report from a contactable physician. A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6204; Expiration date: not provided) via an intramuscular route of administration on 11Sep2021 (age at vaccination 77-year-old) as dose 2, single for Covid-19 immunization at hospital. The patients medical history included antisynthetase syndrome and hypertension. The patients known allergies was statins. The patients concomitant medication included mycophenolate mofetil (CELLCEPT [MYCOPHENOLATE MOFETIL]); hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIZIDE); metoprolol; metformin; isosorbide mononitrate (IMDUR); aspirin [acetylsalicylic acid] and allopurinol. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL9269; Expiration date: not provided) via an unspecified route of administration on an unspecified date (age at vaccination 77-year-old) as dose 1, single for Covid-19 immunization. The patient had not received any other vaccine within 4 weeks. The patient was not diagnosed with Covid-19 prior to vaccination. The patient was not tested for Covid since the vaccination. On 21Sep2021, 10 days after vaccination the patient experienced severe shingles rash. An adverse events resulted into physicians office visit. Therapeutic measures were taken for the events was valtrex, prednisone and gabapentin. The reporter assessed the events as non-serious. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Patient received vaccine and a few minutes after complained of dizziness.  She was then given water and a little piece of chocolate which did not help and eventually she had fainted. Patient regained consciousness after a few minutes when paramedics came and checked her blood pressure which was found to be low (systolic was around 80). Patient did not go to the hospital and left the pharmacy.
pain in arm; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 70-year-old female patient started to receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EM9809), on the left arm, via an unspecified route of administration on 05Feb2021 17:45 (5:45 pm) at single dose for COVID-19 immunisation. Medical history included high blood pressure (HBP) and  allergies to medications, food, or other products, both from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received an unspecified medication within 2 weeks of vaccination. On 05Feb2021, it was reported that the patient experienced pain in arm. No treatment was received. The event was considered as non-serious and it did not result in death, life threatening condition, hospitalization, disability, or congenital anomaly. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination. The patient was vaccinated in a school. The outcome of the event was reported as not recovered. The patient is not pregnant.
arm so sore could not raise it above head all musces got sore, terrible h/a; next day OK;
Menstrual like bleeding, severe cramps, stomach pain occurring earlier than normal menstrual cycle. I am on a hormonal contraceptive and my period is very consistent every 30-31 days, but this bleeding occurred 2 weeks early and 12 days after my first COVID vaccine dose. Bleeding lasted approximately 8 days, and most of the time was much heavier than a normal period. I also do not usually experience cramping of any kind, but had severe discomfort associated with this bleeding.   In addition, I continue to have arm pain at the site of the injection, even 3 weeks after receiving the shot.
4 hrs. after receiving shot throat felt "tight", scratchy, eyes watery - scratchy "felt like something in them, discharge (clear) - went home from work - later that night felt feverish, chills, throat reddened. Felt ok next AM. ("Face looked slightly swollen".)
bad headache and glands in throat were swollen and painful. they last 2 days or so
Stomach pain after eating, points to the belly button. Awakes with stomach pain. Low grade fever 101 degrees.
needle leaked, resulting in underdose; administration error; This case was reported by a physician via call center representative and described the occurrence of accidental underdose in a 4-year-old patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th October 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 20th October 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced accidental underdose and drug administration error. On an unknown date, the outcome of the accidental underdose and drug administration error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The physician reported the patient  received a dose of Kinrix and the needle leaked during the administration, resulting in an underdose and accidental underdose and drug administration error.  The reporter did not consent to follow-up. No product quality complaint was reported for Kinrix by the reporter. The reported informed that due to an administration error the complete dose was not administered.
big red lump on side of right foot; Swelling over the bank of the ankle; Big red lump on side of right foot hurts to even touch. Left foot severe pain; Big red lump on side of right foot; Severe foot and leg pain; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient, received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 18Mar2021 at 16:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and high blood pressure. The patient was allergic to doxycycline and sulfa drugs. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN), trazadone (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN) and buspar (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administartion in the left leg on 26Feb2021 at 16:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. On 22Mar2021 at 07:00, 4 days after the vaccination, the patient had severe foot and leg pain. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure taken as a result of severe foot and leg pain included tylenol (MANUFACTURER UNKNOWN), anti-inflammatory drugs (MANUFACTURER UNKNOWN) and zpak (MANUFACTURER UNKNOWN). The pain eased for a couple of days but then was back again, worse than before. On an unknown date, the patient had a big red lump on side of right foot which hurt even to touch, left foot had severe pain and swelling over back of ankle. The clinical outcome of the events severe foot and leg pain, big red lump on side of right foot which hurts, left foot severe pain and swelling over back of ankle was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Parents c/o 6" red area on upper leg.  Denies any fever.  Patient saw physician on 5-07-04 in reference to this reaction and again on 05/08/04.
May 2021- started feeling unwell June 2021- extreme jaw pain dentist thought I needed a root canal but I didn?t, bizarre circumstances. Steroids made me feel better.  June 2021- lymph node in groin was enlarged and painful. Went to the doctor. Had blood work done. Rash on my face and arms had also started.  August 11, 2021- Groin ultrasound. They found 4 enlarged lymph nodes. I was still having pain.  August 19, 2021- ultrasound of my uterus and ovaries to check and see if there was anything abnormal there because of the pain I was having.  August 23, 2021- PET CT of my abdominal area to check for cancer September 2021- headaches start up severely to the point of making it difficult to function. I also have extreme fatigue making it almost impossible to complete daily tasks October 8, 2021- Go to a local Rheumatologist. Start the first round of tests November 30,  2021- brain MRI because my headaches are so severe  December 2, 2021- Nerve testing (EMG) for numbness in my hands and feet December 17, 2021- See a rheumatologist who does specialized testing and starts to try to figure out what is wrong.  January 10, 2022- Follow up with Rheumatologist to come up with a plan to try to fix me February 15-New  Symptoms. I wake up dizzy, having chest pain, increased heart rate and feeling even sicker February 17-See a cardiologist for my new symptoms. EKG and a plan to have a cardiac CT.   Prior to all of this I did NOT see doctors and did not have health issues.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 1st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, chills and pain. On an unknown date, the outcome of the injection site pain, chills and pain were unknown. It was unknown if the reporter considered the injection site pain, chills and pain to be related to SHINGRIX. Additional details were provided as follows: The patient reported that he had his dose of SHINGRIX in right arm and experienced pain at injection site, chills and achiness. The patient reported that he experienced the same adverse events on both injections (tolerance for 2nd dose refer case US2018GSK209725). The patient planned to follow-up with his physician on an unknown date.
Day 8 (3/27/2021) - 99 Fever, Chills, Inflamed Injection Site Day 9 (3/28/2021) - 99 Fever, Chills, Inflamed Injection Site Day 10 (3/29/2021) - Inflamed & itchy Injection Site (no fever) Day 11 (3/30/2021) - Inflamed & itchy Injection Site (no fever) Day 12 (3/31/2021) - Inflamed & Itchy injection site measures 6" in diameter Day 13 (4/1/2021) - Inflamed & Itchy injection site continues to measure as 6" in diameter Day 14 (4/2/2021) - Inflamed & Itchy injection site continues to measure as 6" in diameter Day 15 (4/3/2021) - Inflammation receding Day 16 (4/4/2021) - Inflammation receding Day 17 (4/5/2021) - Gone
Myalgia, Arthralgia, Fever & NauseaVomiting Pt self reported fever, myalgia, arthralgia, nausea. Pt self treated with ibuprofen 200mg.
Didn't feel good with a fever and was congested. Took a home COVID-19 test and was positive. Called doctor and was prescribed PAXLOVID and a ZPAK.
Had flu vaccine in right arm same time. Initially soreness at injection sites and woozy for about 1/2 hour.  Fine until around 9pm. Started noticing more than usual joint pain and all over body pain. 10pm took extra strength Tylenol which did not help. Continued to get worse and was very painful by 12:30 am.  Every part of my body was affected. Slept  somewhat ok.  When I got up was still a little overall soreness. Injection sites still hurt more. Felt sleepy.