chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 24 year old female with sulfonamide allergy and a history or rosacea who on 28-JUL-2008 was vaccinated intramuscularly with the first dose of GARDASIL  vaccine (yeast) into the left deltoid. There was no concomitant medication. On approximately 29-JUL-2008, "one to two days after the first vaccination"' the patient developed rashes and blotches on her face and neck. The rashes and blotches were still present at the time of this report, but were improving. The patient sought unspecified medical attention. No further information is available.
Pt vax; exp local reactoin redness & swelling, low grade fever, fatigue & muscle aches.
Post vax, on 12/18/2000, the patient was negative for varicella virus serum antibodies. Unspecified medical attention was sought for the patient. No additional information is expected.
Redness, heat, itching, mild swelling  in area of approx 7x7 cm surrounding injection site.  It is ongoing since first identified on 2/16 at 08:00.  Physician consulted this date with diagnosis of cellulitis and/or allergic reaction. Doxycycline prescribed.
had swelling of her whole body from her head down to her toes; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (had swelling of her whole body from her head down to her toes) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced SWELLING (had swelling of her whole body from her head down to her toes). At the time of the report, SWELLING (had swelling of her whole body from her head down to her toes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not reported.
Day 1 I had pain in the arm consistent with other vaccines I have received. It only hurt when I moved my arm.  It lasted a couple of days and then went away. After that pain stopped a aching pain started on Day 4 or  5 and continued to get worse. I was in significant pain constantly for several days (NOT just when moving my arm) and ice and pain meds didn't help. It finally started to subside on Day 8 and Day 9 I was pain free.
Breakthrough COVID-19 case with symptom onset 8/10/2021: Cough (new onset or worsening of chronic cough). Death 8/18/2021. From vital record cause of death: CARDIOPULMONARY ARREST, SENILE DEGENERATION OF THE BRAIN. Per vital records, Codes include: Not yet coded ; Other Significant Conditions include: None listed. Place of death: NURSING HOME-LONG TERM CARE FACILITY, ASSISTED LIVING; PRONOUNCING AND CERTIFYING PHYSICIAN
3 hours after Hepatitis A given on 3/21/14, child had fever, vomiting, and rapid heart beat. Mom took her to ER. Released and tx with antibiotics IV and to continue at home antibiotics. ER diagnosis - Adverse drug reaction, leukocytosis.
Body aches, chills, fatigue, hands and feet swelling and numbness/pain began approximately 12 hours after receiving the Pfizer booster and flu shots together. Body aches, chills, and fatigue subsided after approximately 3 days. Hands and feet swelling, pain, and numbness is still going on currently. Have been taking OTC NSAIDs, taking baths, receiving massages, and elevating limbs with no improvement in symptoms. Went to the doctor on 11/26/21 and was told nothing could be done for me.
Patient was given her vaccine at 3:09 pm and the vaccine expired at  2: 02 pm.
now COVID positive with symptoms; now COVID positive with symptoms; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Dec2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient received the vaccine on 16Dec2020 and now COVID positive with symptoms as of 19Dec2020. The patient asked that should he (she) still get the second vaccine. The outcome of event was unknown.  Information on lot/batch number has been requested.
This retrospective pregnancy case was reported in a literature article and described the occurrence of spontaneous abortion in a female subject of unspecified age who was vaccinated with H1N1 (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of H1N1 (unknown route, site of injection and batch number). Her last menstrual period was on unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine at an unspecified trimester. At an unspecified time after vaccination with H1N1 vaccine unspecified and prior to 20 week's gestation, the subject experienced spontaneous abortion. This case was assessed as medically serious by GSK. This case is linked to 27 other cases (related by publication). Summary of the article: The potential serious consequences of maternal influenza infection in pregnancy have long been recognized; pregnant women are at increased risk for influenza-associated morbidity and mortality. As reviewed recently, there are limited data on the safety of influenza vaccine in pregnancy; however, to date, there has been no indication that seasonal influenza vaccines containing inactivated virus pose a risk to the mother or the foetus. This has led to the current recommendation that all pregnant women be vaccinated with the seasonal influenza vaccine regardless of trimester. Despite these recommendations, vaccination rates remain less than optimal. Surveys have demonstrated that mothers' concerns about safety contribute to poor compliance with vaccine recommendations. This situation was escalated during the 2009-10 H1N1 pandemic season, when lack of safety data about the pandemic H1N1 vaccine was coupled with intensive public health messaging that emphasized the need for all pregnant women to be vaccinated. Additional safety information pH1N1-containing vaccines when used in pregnancy was therefore needed. The purpose of this study was to evaluate the foetal risk and relative safety of the pH1N1 influenza vaccine. To assess risks and relative safety of the pH1N1-containing vaccines, the author conducted a prospective cohort study of pH1N1-vaccine-exposed and unexposed comparison women who were recruited during pregnancy and followed to outcome between October 2009 and August 2012. There were 1032 subjects available for analysis; 841 women were exposed to a pH1N1-containing vaccine in pregnancy, and 191 women were unexposed to any influenza vaccine in pregnancy. Nine of 328 (2.7%) first-trimester-exposed pregnancies resulted in an infant with a major birth defect compared to 6/188 (3.2%) in the unexposed. The hazard ratio (HR) for spontaneous abortion was not elevated. Adjusted HRs for preterm delivery were elevated for exposure anytime in pregnancy, specifically with exposure in the 1st or 2nd trimester. However, the mean decrease in gestational age in the exposed pregnancies was approximately three days. In conclusions, no meaningful evidence of increased relative risk or HR for major birth defects, spontaneous abortion, or small for gestational age infants was demonstrated.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and genger who on 22-AUG-2014 was vaccinated with a dose of ZOSTAVAX that had expired on 14_JUL-2014 (lot number and route were not reported). No adverse events were reported. Additional information has been requested.
Hives all over body. Treatments include Zyrtec and Benadryl. Symptoms improve and then come back the next day. Symptoms are ongoing.
Received vaccine early afternoon Thursday, Jan 18, began to develop sore throat, coughing, running nose Friday afternoon, Jan 19, fever and severe headache Friday night, and continued to experience all the symptoms through Sunday evening, bed bound. I went to an Urgent Care Clinic that sent me to ER, where I was diagnosed with flu. I began to take TAMIFLU since Monday afternoon, improved, but as of now (Wed, Jan 24), hives appear on my upper lip.
2-3 hours after vaccination, pain in left arm injection site, swelling, pain radiating  to shoulder. Patient seen in ED at Medical Center. Patient said that he had blood work done and EKG, also had hypotension probably due to allergic reaction.
On 4Feb08 patient walks in clinic and seen by RN. Pt. C/O of a painful rash on right side of neck. Patient states that he began to experience right side headache during the night of 29 Jan 08.  Plan: Refer to family physician for immediate DX & TX. Patient was seen same day by MD.
Redness; Hypersensitivity reaction; Itching; Rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching), HYPERSENSITIVITY (Hypersensitivity reaction), ERYTHEMA (Redness) and RASH (Rash) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hypercholesterolaemia and Hypothyroidism. Concomitant products included PRAVASTATIN for High cholesterol, METOPROLOL for Hypertension, LEVOTHYROXINE for Hypothyroidism, CYANOCOBALAMIN (B12 1000 SR) and CALCIUM for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PRURITUS (Itching) and RASH (Rash). On 13-Feb-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On an unknown date, the patient experienced ERYTHEMA (Redness). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) ongoing from 01-Mar-2021 for Rash and Itching, at a dose of 10 mg once a day. At the time of the report, PRURITUS (Itching), HYPERSENSITIVITY (Hypersensitivity reaction), ERYTHEMA (Redness) and RASH (Rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient saw a new doctor who gave the Medrol Dose Pak but told not to take it until 3 weeks after the second shot.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Follow up received on 08-may-2021 contains no new information. On 08-Jun-2021: Follow up received on 8-JUN-2021.Patient's demographics, medical history, concomitants  and second dose details were updated. On 12-Jul-2021: Follow-up received and contains no new information On 22-Jul-2021: Follow up received on 22-JUL-2021. No new information was received.
Information has been received from a registered nurse concerning a 9 year old female with no pertinent medical history who on 16-MAY-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (Lot #656050/0245U).  It was unknown if the dose was tolerated.  On 18-JUL-2007 the patient was vaccinated intramuscularly with a 0.5 ml second dose of Gardasil.  There was no concomitant therapy.  On 18-JUL-2007 the
Menopause; Inflammation drained from right thumb; Pain in right thumb; This spontaneous case was reported by a consumer and describes the occurrence of MENOPAUSE (Menopause), INFLAMMATION (Inflammation drained from right thumb) and PAIN IN EXTREMITY (Pain in right thumb) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In January 2022, the patient experienced MENOPAUSE (Menopause), INFLAMMATION (Inflammation drained from right thumb) and PAIN IN EXTREMITY (Pain in right thumb). At the time of the report, MENOPAUSE (Menopause) and PAIN IN EXTREMITY (Pain in right thumb) outcome was unknown and INFLAMMATION (Inflammation drained from right thumb) had resolved.            Concomitant Medication use information was not provided by reporter.  It was unknown if patient was enrolled in a covid-19 vaccine trial.   The reporter's causality for the event(s) of menopaus and inflammation drained from right thumb   with humira(adalimumab) was no reasonable possibility. Also, for the event of pain in right thumb was not provided.  Treatment Medication use information was not provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-620479 (Patient Link).
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 19-JUN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had multiple excursion varying from 28.9 degrees Fahrenheit (-1.7222 degrees Celsius) (lowest recorded temperature) for 48 hours to 64.8 degrees Fahrenheit (18.22 degrees Celsius)(highest recorded temperature) for 24 hours. The vaccine status was reported and "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Approximately 3 weeks post vaccination, the patient developed what she thinks to be shingles. Defined borders of back and shoulder with painful rash and blistering along with nerve pain post rash. Nerve pain continues to date 3.5 months post vaccination with still some blistering present on shoulder. This has not been diagnosed by a physician. No treatment has been used to date.
Severe swelling around injection site extending from shoulder to elbow x apprx. 3 days. No treatment- pt self monitored site
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. Initial solicited report received from an investigator (Health Agency) in a trial on 21 September 2017. A 44 year-old female subject with palpitations/pounding heart without exercise, Abnormal ECG (electrocardiogram in the past), and no other significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 02 August 2017. On 25 August 2017, 23 days after vaccination the subject was diagnosed with G61.0 Guillain-Barré syndrome. For subject, Troponin I, ECG, Echocardiogram not performed. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the event, G61.0 Guillain-Barré syndrome was not reported. Relationship to investigational product according to company: not associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a 44-year-old female subject who developed Guillain-Barre syndrome 23 days after receiving a dose of ACAM2000 vaccine. GB syndrome is very rarely observed after ACAM2000 (three cases in 590400 vaccinees). Alternative etiologies need to be ruled out. Based on data available, the sponsor assesses this event as not related to study vaccine.
strong burning sensation where I have had the Shingles; This case was reported by a consumer and described the occurrence of burning sensation in face in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (on the face, around left nostril and upper lip left side for 8 years).   On 10th December 2020, the patient received the 1st dose of Shingrix. On 17th December 2020, 7 days after receiving Shingrix, the patient experienced burning sensation in face. On an unknown date, the outcome of the burning sensation in face was not recovered/not resolved.   It was unknown if the reporter considered the burning sensation in face to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The had shingles on my face for 8 years now around the left nostril and upper lip left side. The patient recently got the Shingrix vaccination a week ago from the time of reporting as approved by the physician and on the day of reporting the patient was having strong burning sensation where he/she had the shingles.
Tingly and numbing lower left side of my lip; numbing lower left side of my lip; Eye feel tired; Eye feel tired, low level pain behind them; slight sore throat on the left side; the standard arm feels heavy and a bit achy; This is an initial spontaneous report received from a contactable consumer. A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Batch/Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 30Mar2021 16:00  as single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus, seasonal allergy and allergy to animal from an unknown date and unknown if ongoing. Concomitant medications included metformin and dulaglutide taken for an unspecified indication, start and stop date were not reported. The patient experienced tingly and numbing lower left side of my lip, eye feeling tired, low level pain behind them, slight sore throat on the left side and the standard arm feels heavy and a bit achy on 30Mar2021 16:30. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
I had a known exposure to COVID-19 on June 24, 2022 I had a sore throat. I tested negative until June 26, 2022. Once I tested positive I continued using my Albuterol Inhaler and contacted my Primary Care Physician on June 29, 2022. I had congestion, cough, sore throat, headache, wheezing. I am feeling better with mild shortness of breath.
she was tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (she was tired) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced FATIGUE (she was tired). At the time of the report, FATIGUE (she was tired) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Patient wanted to know the side effects because she was tired. She had vaccine two days ago.   Reporter did not allow further contact
Ten minutes after administration pt c/o nausea, feeling hot and faint. Assisted to bed to lie down. BP 100/60, P 60. Diaphoretic. Thirty minutes after administration of vaccine c/o abdominal cramping and had BM. BP 110/70, P 68. Fifty minutes after administration of FluMist feeling normal.
Fever, sweating, runny nose, pain in injection area, diarrhea, vomiting & still sick but not as bad as yesterday.  Also for question # 20 "Has the patient recovered from the adverse event(s)? I answered no Because I still have these symptoms but not as bad as yesterday.
Patient is fully vaccinated.  Boosted on 12/22/2021.  COVID + at ED visit on 1/3/2022.  53-year-old female with a history of liver transplant. Patient presents to the emergency department with concern of covid infection. Patient states that her symptoms started 2 days ago. She is having body aches, fatigue, feeling feverish, nausea. She is on chronic immunosuppressants for her transplant. She does have bilateral chest pain worse with deep inhalation and cough. Denies any shortness of breath, hemoptysis, lower extremity swelling, history of PE or DVT. CXR: Chest appears as stated without evidence of a suspicious pleural or parenchymal abnormality. Normal EKG. Discharged home stable
First dose was July 2, 2019.   Had slight reaction....swollen red arm, some achiness, but able to work (though not to usual standard).   Anticipated perhaps same issue for second dose so I took one Ibuprofen within hour of receiving vaccination.     12 hours post vaccination: began low grade fever @100 degrees, severe body aches, headache, racing heart, nausea and extreme fatigue.  Took another ibuprofen. 21 hours post vaccination: above symptoms, plus balance issues, weakness and beginning vomiting.   Took another ibuprofen.  Cancelled all work and events for day.  Went back to bed and slept.   28 hours post vacc, was able to eat a little soup without vomiting.  Went back to bed and slept until 35 hours post vacc.  Got up and ate a very small plate.  Went back to bed with another ibuprofen at 36 hours post vacc.  Still slight fever.   45 hours post vacc. woke up without fever, but still achey.  Strong enough to eat more and do light work.   I usually do not have reaction to vaccinations, so was very surprised to encounter such a severe reaction.
Pt reports dizziness, slurred speech, shakiness, and red/inflamed upper extremities (finger-tips) 3 hours after vaccination. These symptoms resolved with the use of Naproxen after 2 hours (by 5 hours post-vaccination).   Pt also reports that she experienced full body aches and fatigue that started 3 hours post vaccination and lasted for 1 full day. Pt also reports that she experienced headache that started 3 hours post vaccination and lasted 3 full days (but she does suffer from chronic headaches).
Administrative error. Patient was 16 and did not meet criteria for the Moderna vaccine. No adverse effects or symptoms have occurred.
Next AM awoken in Pain, Redness, golf ball swollen area. Watched it for the next day talking only Tylenol. Swelling & Redness Spreading from one side to the other of my arm.  Next day worse, called Teledoc and Pharmacist who directed me to see Primary physician right away in AM. Or go to ER. Teledoc ordered Doxycycline  and Triamcinolone Acetonide Cream for next AM was seen by Primary started talking and using both on November 23rd.  Arm throbbing constantly, swelling is still there and redness continues. Throbbing goes does my arm to my ring and middle finger. Having night sweats since this started.