chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: COVID infection following COVID vaccine series 01/07, MODERNA, dose #1 02/04, MODERNA dose #2 08/29 SARS-COV-2 Variant Sequencing RESULT: pending 08/29 COVID swab, result: detected 08/30 pt cc:body aches and burning lungs exposure: unknown 08/30 ESR 7 08/30 LDH 256.8 08/30 CTA PE Impression: 1. No pulmonary embolism, pneumothorax, aortic aneurysm or dissection. No focal airspace consolidation. 2. Bilateral axillary lymph nodes which are fatty replaced in the hilum and may be related to prior treatment for lymphoma. Prominent left axillary lymph node which is present on comparison study dated 6/18/2021 and was likely the lymph node biopsied on 7/26/2021. Otherwise, no mediastinal adenopathy 08/30 CXR impression: Bibasilar atelectasis. 08/30 FERRITI 509.7 08/30 CRP 0.349 08/30 pt admit to medicine cc: body aches and "burning lungs" dx: Covid pneumonia LOS: 2 days 08/30 PT/INR 11.6/1.4 08/30 ABG: result: i-pH 7.39, i-PC02 39.6, i-P02 72, i-HCO3 24.0 09/01 FIBRINOGEN: 212 09/01 DDIMER: 0.27 09/01 ESR 2 09/02 FIBRINOGEN: 177 09/02 DDIMER: 0.30 09/02 ESR <1 09/26 COVID swab, result: not detected
No adverse event.  Given dosage of bivalent age 5-11 years old at dose of .3ml when he is 12 years old
Right arm red and swollen with probable cellulitis. Keflex antibiotic prescribed.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient had a twin. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 18-FEB-2016, the patient was vaccinated with an expired dose of MMR II injection, lot # reported as K00738, expiration date 16-JAN-2016 (strength, dose and route of administration were not provided. No adverse effects were reported. Lot number K00738 is an invalid lot number for MMR II. This is one of several reports received from the same reporter. Additional information has been requested.
Large swollen area with redness. Treated with Benadryl and Motrin.
The patient fainted and unconscious for a few minutes. She woke-up after tapping and calling her name. Contacted emergency services.
pt recv vax 23SEP95 & IN late NOV or earl DEC97 pt was exposed to sibling who had wild type, poss contracted from daycare;2wk later 12DEC97 pt to MD w/approx 60 fluid filled vesicles some of which had scabbed over;
chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (Fever) 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 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (Fever). At the time of the report, CHILLS (chills) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
At 0750 pt had 1st dose of covid vaccine moderna on Right Deltoid, at 0757 pt started to have seizure and witnesses by staff and mother lasted less than 30 seconds. Pt  Woke up and alert oriented x4. (11 activated. Pt BP 138/45, HR 69, RR 17, 97.  0805 Pt BP 108/59, HR 64, RR 16, O2 at 100 % at 2lpm via nasal canula . 0810 fire deparment arrived.  Pt and pt parents refused to go to ED 0820. Pt Bp 115/60, HR 66, RR 16, O2 at 100 % RA and NSR  On ekg done by fire department . Pt is alert oriented x4  Fully awake. .  Moderna lot # 001C21A Exp. 10/12/21. At 0830 pt went home assess by PA. Pt is asymptomatic.
10 YEAR OLD PATIENT WAS INADVERTANTLY GIVEN ADULT PFIZER BIVALENT 12+     WHEN CONTACTED , THE FATHER SAID HIS DAUGHTER WAS NOT FEELING WELL AT ALL AND DIDN'T GO TO SCHOOL THE FOLLOWING DAY.  HER SYMPTOMS INCLUDED AN EXTREMELY SORE ARM THAT SHE SAID FELT LIKE SHE COULD NOT MOVE IT, A SORE THROAT,  LOW-GRADE FEVER, SHE WOKE UP CRYING AND  AND HAD TROUBLE SLEEPING DURING THE NIGHT DUE TO PAIN. HE STATED THAT SHE TOOK  IBUPROFEN FOR PAIN, DOSE UNKNOWN.
1 hour after vaccine started having severe headache took Ibuprofen and ALTRAM 2 hours later headache went away. Approx 14 hours after immunization skin rash over site of injection and a few inches around. Warm to touch swelling at site of injection. Today she noticed small area of rash on both forearms. No itching.
I had immediate, but manageable pain, at the site of the injection. It gave me a sore upper arm and stiff neck. I ignored all symptoms and went about my day. Showed houses, wrote an offer, and went to bed about 10:30pm. I was awakened from a deep sleep at 4:30 am (about 14 hrs after the vaccination) with an all-over body sensation that continued to get worse. I tried to come up with a word to describe what my body was feeling. It was like all my insides were being, "scrambled" and then continued to almost burn. I was not right at all. I got out of bed, woke my husband, went to the bathroom and began to faint. I made sure to get to the floor and crawled back to beside the bed with a complete strangling feeling to my heart. It was as if I might have been having a heart attack. My husband got me a chewable baby aspirin (kind of a joke between us). I took it (could not have swallowed a drink at this point). Within a few minutes, my heart felt like it released. It was scary and painful and over almost as quickly as it started. My heart almost felt bruised after. I went to the Dr again the next day to make sure I was ok. Doctor did an EKG and found my heart to be ok. I will need you to verify what lot number and Dose number in the series. I do not have this information.
within 48 hours of receiving the 2nd dose of the Moderna vaccine, patient developed body aches, anorexia, nausea, chills and transaminitis.  She required  hospitalization.  No obvious cause was delineated for these issues during her hospital stay
Seizures seeing a neurologist now for it; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Na), for COVID-19 immunization. The following information was reported: SEIZURE (medically significant), outcome "not recovered", described as "Seizures seeing a neurologist now for it". The event "seizures seeing a neurologist now for it" required physician office visit.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Ongoing hospitalization.  Admitted with headache, vomiting, shortness of breath, chills, body aches. Treatment empirically for sepsis; ceftriaxone and IV fluids
Information has been received from a registered nurse concerning a female patient with amoxicillin allergy and no pertinent medical history who on 05-OCT-2009 and 14-DEC-2009 was vaccinated IM with the first and second dose of GARDASIL. Concomitant therapy included TRI-SPRINTEC. Two to three weeks following the second dose vaccination, the patient developed a lump at the injection. No complaint of redness, warmth, or discomfort noted. The same reaction occurred following both the first and second doses. The second dose was given in the left arm and the first dose was given in the right arm. The "lump" had resolved following the first dose. The patient had sought medical attention by phone call. There were no lab diagnostic tests performed. At the time of report the patient's status was recovering. Follow-up information has been received from a licensed practical nurse concerning this 22 year old female patient with no illness at time of vaccination and with amoxicillin allergy who on 14-DEC-2009 at 09:24 was vaccinated IM with the second dose of GARDASIL (Lot # 662304/1013Y) at left deltoid. On 06-JAN-2010 at 18:07 the patient had a slightly painful bump on her arm. Patient stated it happened after the first dose of GARDASIL but went away on it's own. Patient denied redness, warmth or drainage. At the time of report the patient's status was recovered. Additional information is not expected.
Huge knot, redness,  sore arm, finger tingle x 2 days. Thought pretty normal. Day 3-6. I iced my arm which helped take out the heat and the redness. Day 7-present Knot harder and maybe bigger. And the tingle in the arm and fingers  is back. I've done some  research and this is not mentioned anywhere. Especially at 12 days. Nor anyone i know with this symptom. I thought it was worth mentioning. Will call doctor if arm tingle doesn't go away by early next week.
i got deep blood clots in my leg 10 days after getting the booster shot.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Completed, Unknown Manufacturer), for COVID-19 IMMUNIZATION. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "i got deep blood clots in my leg 10 days after getting the booster shot.". Therapeutic measures were taken as a result of thrombosis.  Clinical course: The patient got deep blood clots in her leg 10 days after getting the booster shot. It was reported that If she had any of these ailments she was at a higher risk of being sicker with covid. She was very much for the vaccines until a friend had a heart attack after one of her vaccine shots, Dr said she had long thick big blood clots that caused her to have the heart attack, she too had big block clots in her leg. Patient also stated that "Had to pay a lot of money for ELIQUIS Med, on it for 3 months. I was blessed to not have had an a bad heart or lung complication that could have been fatal".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
flushing, headache, itchy skin, tongue feels swollen, sore throat-onset about 24-48 hours after
Within a week or two of receiving the first vaccine, patient developed low grade fever of 100.0 to 101.0 that was unceasing for months afterwards. She developed fatigue and was very sleepy, along with a feeling of light-headedness.  After the second injection, the dizziness became worse, the fatigue increased, and new symptoms began. She began having sweats and chills, a racing heart, increased anxiety, exercise intolerance, dizziness, and nausea.
10-15 minutes after seasonal flu shot was administered I felt an icey feeling in my chest and neck and almost lost conscienceness over and over again during the course of 1 hour.  I just kept fighting it off trying to stay conscience.  I was at work, paramedics were called.  They said my blood pressure was 113 over 78 and my blood oxygen level was 100%.  I am a healthy, 130lb, 5' 4" female.  The feeling subsided after 1 hour.  Later in the day I felt a low grade fever come on (99.6 deg f), I began having aching joints and tender skin on my legs which became worse into the evening.  11/17 my temperature was normal by morning (98.6) but my joints continued to ache throughout the next day, along with an occasional (4 times)sharp pain in my head.  11/18 joints less achey, sharp pains in my head twice.  11/19 joints less achey, one sharp pain in my head this evening.
pt recv vax in 1991 & 1996 devel pneumococcal pneumonia strain 14 w/sepsis & was hosp;@ time of report pt had been released from hosp;
Received pfizer vaccine on 5/30/21 and 7/9/21. Presented to ER on 1/30/22 and found to be COVID19 positive. Patient presented to ER due to a fracture and incidentally found to be COVID10 positive. Admitted for fracture. Not treated  for COVID19 as he was asymptomatic. Discharged on 2/9/22.
Pain and swelling at the injection site, redness, hardness. Body aches all over. Light-headedness.
Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016220448) on 21 April 2016. This case involves a female patient (age was not reported) who was vaccinated with a booster dose of (DPT Shot) (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient had experienced seizure. Laboratory investigations and corrective treatment was not reported. On an unspecified date, patient was recovered from the event. Upon internal review, the company decided to consider the event serious because of important medical event: seizure. List of documents held by sender: none. Sender's Comments: This is poorly documented case received from consumer where seizure is reported after receiving DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED). Manufacturer of the vaccine not provided. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Significant flare in my RA, with joint pain in hand and wrists that continue. This required to be put on Methotrexate with some improvement in symptoms, but not 100%.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. Patient was not pregnant. Patient medical history, drug allergy and reactions were unspecified. On an unknown date, the patient was vaccinated with ZOSTAVAX single dose vaccine (therapy route: vaccine, lot # unspecified, expiry date unspecified) for shingles. Concomitant medication was unspecified. On an unknown date, patient developed significant swelling and pain, which extended from the injection-site, to the neck area. The symptoms lasted for several weeks and patient sought medical attention prompted a visit to the Emergency Room. No product quality complaint. Patient was recovering from the reported event significant swelling and pain, which extended from the injection-site, to the neck area. Action taken with ZOSTAVAX was assessed as not applicable. Causality of the reported event was unknown (not provided). Additional information has been requested.
No adverse symptoms.  Patient is over 7 years old and was given the DTaP vaccine instead of Tdap.
she is very hot and sweaty; She is having hot sweats; she is very hot and sweaty; She is having hot sweats; her blood pressure is dropping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (COMIRNATY), administration date 14Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "factor VIII blood disorder" (unspecified if ongoing), notes: she had factor VIII blood disorder. The patient's concomitant medications were not reported. The following information was reported: HYPERHIDROSIS (non-serious), FEELING HOT (non-serious) all with onset 14Oct2021, outcome "unknown" and all described as "she is very hot and sweaty; She is having hot sweats"; BLOOD PRESSURE DECREASED (non-serious) with onset 14Oct2021, outcome "unknown", described as "her blood pressure is dropping". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that his wife had her first shot today and she spoke to her doctors before getting it because she had factor VIII blood disorder and she was very hot and sweaty and her blood pressure at the moment was 98/54. The blood pressure was normally 126/76 and when they took few moments later it was 104/64 and 10 minutes after previous measurement, was now 98/54. The reporter was concerned about his wife whose blood pressure was dropping and was having hot sweats  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a female patient of unknown age who on 12-JUL-2015 was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date were not provided). On 13-JUL-2015, the patient developed a red, round, warm, itchy area with a ring around it at the injection site. At the time of the report, the outcome of injection site erythema, infusion site warmth and injection site pruritus was reported as not recovered. Additional information is not expected as the reporter did not provided contact details.
Itchy Hives/rash on front middle torso, eventually scabbed, but hasn't gone away in almost 3 weeks.
Had between cycle menstrual bleeding for the first time in my life, has lasted 7 days so far and is still on going.
This spontaneous report was received from a pharmacist and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On multiple unspecified dates, the patients were administered improperly stored doses of RECOMBIVAX HB lot # M039201 with expiration date 04-NOV-2018 and lot # M032653 with expiration date 31-MAY-2018 (dose and route of administration were not reported). The doses were exposed to 59 degrees Fahrenheit for 12 hours. The temperatures were not recorded with a data logger and there were no previous excursions. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
EXTENDED SORENESS AT SITE OF  INJECTION; This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: sleep apnea, cpap, and alcohol user, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, the patient experienced extended soreness at site of injection. Laboratory data included: Pain scale (NR: not provided) 2-3/10. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 1/10. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from extended soreness at site of injection. This report was non-serious.
trouble sleeping 2 day; achy; fever; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (trouble sleeping 2 day), PAIN (achy), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Urinary incontinence. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced INSOMNIA (trouble sleeping 2 day), PAIN (achy), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea). At the time of the report, INSOMNIA (trouble sleeping 2 day), PAIN (achy), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products include unspecified medicine for urinary incontinence.  Treatment medications was not provided by the reporter
Annular urticarial reaction with coalescent plaques. Onset rash about 6/10/10 -> seen 6/11/10 and given BENADRYL-> seen 6/14/10 with pale scattered small barely palpable lesions.
Dizziness Narrative: Patient still continues to have dizziness from the Moderna booster 10 days post vaccination
chills; severe body aches; fever; fatigue; This is a spontaneous report from a contactable consumer. A 23-Year-old female patient received Pfizer Covid 19 (BNT162B2) (Batch/Lot number: EL3247, Expiration date: Unknown, Solution for injection), on 22Feb2021 around 09:30 AM on left Arm as Dose 2 single for covid 19 immunization (age at vaccination: 23-Year-old). Medical history included unspecified known Allergies. Concomitant medications were reported as unknown. Patient previously received first dose of BNT162B2 (Batch/Lot number: EL3247,Expiration date: unknown, solution for injection) on 01Feb2021 on left Arm as Dose 1 single for covid 19 immunization. The patient had not received any other vaccine and other medication in four weeks. The patient had not affected with covid19 before or after vaccination. On 22Feb2021 patient experienced chills, severe body aches, fever and fatigue. No therapeutic treatments were received. The outcome of the events was reported as unknown.  Follow-up attempts completed. No further information expected.
PT RECEIVED FLU VACCINE 10/26/2021 ON LEFT ARM, AND PT DEVELOPED LUMP WITH A RASH AFTER THE VACCINE, RASH CAN BE DESCRIBED AS RED AND BURNING.
VACCINE HAD A TEMP EXCURSION WHERE IT WAS NOT MOVED FROM THE FREEZER TO THE FRIDGE IN A TIMELY MANNER. PER THE PFIZER REP AND CDC IT IS RECOMMENDED THAT THE CLIENT BE REVACCINATED AND RESTART THE SERIES.
Day 1 Short of Breath, Day 2 Flu like symptoms and SOB, Day 3 Joint pain and SOB
vaccine was administered outside of Facility- reported by patient ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------ I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 7/4/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA J96.00 ACUTE RESPIRATORY FAILURE 4/10/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 7/4/2021 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY J96.00 ACUTE RESPIRATORY FAILURE 4/10/2021 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 7/4/2021 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY J96.00 ACUTE RESPIRATORY FAILURE 4/10/2021 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 7/4/2021 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY J96.00 ACUTE RESPIRATORY FAILURE 4/10/2021 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
I developed a rash, fever, headaches, and chills and was diagnosed with Shingles
Adverse: Chills, Mid Grade Fever, Body Aches. Treatment: Bed Rest over the counter pain meds Outcome: 04/30/21 Still experiencing fever and aches
Patient the immunocompromised dose of Moderna COVID vaccine at 0.5 mL, instead of the 0.25 mL which he should have received; pt is not severely immunocompromised as currently defined by the CDC. Pt reports no adverse reactions.