chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician's assistant concerning a 34 year old male nurse with no pertinent medical history, drug reactions or allergies who was vaccinated with a series of RECOMBIVAX HB and VAQTA inactivated and failed to seroconvert.  The nurse reported that he received the vaccinations while in the military, and was not certain who the manufacturer was.  The nurse is not experiencing any known symptoms.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Bruising at the injection site; Pain; Swelling; Tenderness in the left arm; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), SWELLING (Swelling), TENDERNESS (Tenderness in the left arm), HEADACHE (Headache) and FATIGUE (Fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN (Pain), SWELLING (Swelling), TENDERNESS (Tenderness in the left arm), HEADACHE (Headache) and FATIGUE (Fatigue). On 01-Feb-2021, the patient experienced CONTUSION (Bruising at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Pain), SWELLING (Swelling), TENDERNESS (Tenderness in the left arm), HEADACHE (Headache), FATIGUE (Fatigue) and CONTUSION (Bruising at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Reporter did not allow further contact
Pt died p/recvd Hep B vax; @ time of report, cause of death was unk; No further details were provided;
RN administered dose of H1N1 prefilled injectable syringe of vaccine intranasally to child in error.  Dr. notified, determined no danger or adverse effects expected, and advised child be given IM injection of vaccine to give H1N1 protection.  Parent was in agreement to this.
Patient developed 102 fever the same night vaccine was administered and three weeks later her arms began to twitch outward uncontrollably every few minutes especially in the AM. Video was recorded of this. We took her to the ER two times within week 07/31-08/05 where she was observed for a few hours and then released because the twitching stopped at that time. But it continued once home again. Incidents were recorded on video once again. She saw the doctor again for a follow up where doctor for follow-up where videos were shown again yet, doctors insisted it was a newborn reflex and nothing more. The twitching continued for a few more days yet, subsided gradually. Thankfully.
soreness of lt deltoid muscle which began 2 days p/receiving vax; awoke to find arm hot, red & swollen in the same area, measuring 18mm oval area of redness; t99.2;
This spontaneous report was received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent condition and concomitant therapy was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L015460, expiry date: 20-JUL-2017). No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
We had a store give Moderna shots past the BUD; Product moved from freezer to fridge on 9/20; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had a store give Moderna shots past the BUD) and PRODUCT STORAGE ERROR (Product moved from freezer to fridge on 9/20) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (Product moved from freezer to fridge on 9/20). On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We had a store give Moderna shots past the BUD). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We had a store give Moderna shots past the BUD) and PRODUCT STORAGE ERROR (Product moved from freezer to fridge on 9/20) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter. This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the non serious events of product storage error and expired product administered for mRNA-1273 vaccine (lot number 037F21A). The event product storage error occurred 56 days before the unknown dose number of mRNA-1273 vaccine administration while the event expired product administered occurred right after the unknown dose number of mRNA-1273 vaccine administration, the administered mRNA-1273 vaccine was 26 days past its 30-day use by date (initially placed in the refrigerator on 20 September 2021 and administered on 15 November 2021). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the non serious events of product storage error and expired product administered for mRNA-1273 vaccine (lot number 037F21A). The event product storage error occurred 56 days before the unknown dose number of mRNA-1273 vaccine administration while the event expired product administered occurred right after the unknown dose number of mRNA-1273 vaccine administration, the administered mRNA-1273 vaccine was 26 days past its 30-day use by date (initially placed in the refrigerator on 20 September 2021 and administered on 15 November 2021). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient's brother came into office stating patient had passed out in car - when staff personnel arrived, patient more alert and oriented - pale - brought back to office.  Lying down blood pressure 105/74 x 2 - observed - color good
On 4/16/21, the day after receipt of the second SARS-CoV-2 vaccine the patient developed new headache, fever, malaise, and myalagias.  on 4/17/21 the patient then developed chest pain which worsened over time and lead to diagnosis of myocarditis with decreased left ventricle function of 44-47% and with troponin I of 1.58 ng/mL.
Pt experienced weakness in body and blurry vision 5 minutes after 2nd dose of COVID-19 Pfizer. Pt woke up the next day to sharp lower back pain, body aches, HA and stomach discomfort.
I had my 2nd dose of Moderna Vaccine on 3/4/2021 @ 8:40 AM. By 2 PM I experienced extreme fatigue for the remainder of the day. Unable to perform simple tasks like preparing dinner. On 3/5/21, I woke with a fever of 100.4 F, and general flu like symptoms: Killer headache, body aches, cold chills. My fever didn't rise above 100.6 F and the headache was untouchable with Tylenol or Advil. On 3/6/2021, My fever was gone but my left arm at the injection site was very red swollen and very warm to the touch. Just when I thought everything was OK, Yesterday 3/7/2021, I had a bout of diarrhea from about 10 AM until 3 PM only to be followed by swollen glands of my neck on the left side, it was so painful to turn my head, swallow and speak. There was no fever. Today, 3/8/2021, I can speak, and turn my head without discomfort, swelling is down, but when I swallow I still have some mild pain. My reason for telling you all if this is that I believe the symptoms of diarrhea and swollen neck glands ( only on the left side, injection side) are not listed anywhere that I could find. Has any one else reported similar symptoms? Thank you for your time and all you do!
Dose 1 on 4/21/21- woke up next day and my eyes were hard to open/keep open. Vision okay, just could not keep open, not dry-very hard to describe. Also sent me into a Cluster Headache Episode that is increased severity/frequency/unlike other episodes (this is my assumption-that it was trigger by vax as not at all normal for me and all other things remained the same.  Dose 2 increased the episode again and continues on as of today
mom states pt cried for 2-3 hrs p/DTP w/some redness & swelling @ site; t102.4; pt given APAP, rubbed area w/rubbing alcohol & used cool compresses to shot sites; MD felt rxn to DTP; 29JUL92 t99-100;
One week following 2nd dose of Pfizer vaccine, Patient noticed swollen lymph nodes in left neck and left axilla. Vaccine was given in left deltoid. She had mild tenderness for 1 week that resolved. Left axillary node resolved completely. She has a single shotty node in left lateral neck that has reduced from original size.
A small sore appeared on baby's left eye. When he was in for circumcision 11-21-05 doctor mentioned it looked like herpes but did nothing. On 11-25 he began to get upset tummy and on 11-26 Mom took him to emergency for test. On Tuesday 11-29-05 doctor called parents and told them to take him to hospital for treatment with IV Acyclovir. Contracted strep in hospital and died.  5/29 Autopsy states COD as ischemic hemorrhagic colitis of small bowel; peritoneal surfaces demonstrate focal adhesions; neonatal herpes (c/s +). 12/14/07 Reviewed hospital medical records which reveal patient seen in ER on 11/26/2005 after experienced small spot on lateral edge of left eye x 3 days.  Area had opened up & then crusted over, eyes reddened & became slightly swollen.  Viral c/s obtained & tx w/Bactroban & was to be seen by pcp next day.  Both hospital records for admission of 11/29/2005 included.  Eye lesion had cleared but then developed blistering lesions on outside of left eye & base of penis.  PCP wanted patient transferred to higher level of care but family declined.  After culture (+) for herpes, returned to hospital & agreed to transfer to higher level of care.  Admitted 11/29-12/4/2007.  Tx w/IV antivirals & peds optho consult done.  Optho dx: herpetic keratitis & herpetic dermatitis of eyelid.  Condition deteriorated, intubated & admitted to PICU.  Taken to OR 12/4/05 secondary to abdominal distention due to sepsis.  Penrose drain inserted & drained approx 200 cc of clear straw colored fluid.  Cultures sent.  Continued to deteriorate & developed bloody drainage from abdominal drain.  Taken back to OR for exp lap & found total intestinal ischemia from ligament of Treitz to descending left colon.  Suspected a vascular insult due to underlying disease process.
Patient received H1N1 vaccine at school.  Experienced redness at injection site, then felt dizzy and weak.  Redness spread throughout body.  Epinephrine 0.3 mg was given, followed by epinephrine 0.2 mg a few minutes later.  Patient was brought to the emergency department experiencing shaking and tachycardic.  Unable to determine if ED presentation is due to vaccine or epinephrine. 11/9/09 & 11/13/09:  Emergency Department record received for date of service 11/4/09.  Dx:  Headache, tremor, redness after vaccine injection. Assessment:  Presented with shaking all over, some flushing of face and arms, occasional crossing of the eyes, possibly some nausea, no vomiting.  Given epi. on scene of H1N1 vaccine which precipitated more spasms and a headache.  CT Scan of head with no evidence of acute intercranial pathology. Steroids administered.  Discharged on prednisone, Benadryl, return to ED if trouble breathing or swallowing, to take one day off of work.
Left arm, sore arm, chills, numbness. She says the shot was given higher than usual and maybe hit the bone.
still have fever of 101; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (still have fever of 101) 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 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PYREXIA (still have fever of 101). At the time of the report, PYREXIA (still have fever of 101) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) fever of 101.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant treatment was provided.  No treatment medication was provided.  Patient had received booster dose on 15-DEC-2021 at 3 O Clock. Patient was still experiencing Fever of 101.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known allergy. No other medication in 2weeks. Patient took treatment (Paxlovid) from 28Mar2023 to 01Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
9cm x 7cm red, raised area note distal to injection site. Warm to the touch. Tender to the touch-otherwise not painful. No open areas noted. No drainage noted.
Breakthrough COVID-19 case with symptom onset 8/4/2021: New loss of taste or smell, Runny nose/Congestion.  Hospitalization of unknown duration.
Pt received PENTACEL, PCV13, ROTATEQ and flu vaccine on 3-6-17. Pt had a febrile seizure later that afternoon and went to ER.
PARTIAL DOSE; This spontaneous report received from a vaccine facility concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: 08-APR-2022) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced partial dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose was not reported. This report was non-serious.
Extreme fatigue, weakness, slept 14 hours in a 20 hour period, aching...especially lower back above waistline both sides. Upset stomach, no appetite. Headache. Fever. All over serious illness, felt like I'd been hit by a train.
This spontaneous report as received from a consumer referred to her 19 years old daughter. the patient was vaccinated with the three shots of GARDASIL back in 2007. No other co-suspects were reported. No concomitant medications were reported. About a year and a half ago, in JAN-2011 the patient got human papillomavirus (HPV). The patient sought medical attention by an office visit. No treatment information was reported. The outcome of the patient was unknown. The relatedness for the patient's HPV was unknown for GARDASIL. Additional information is not expected.
psoriatic arthritis; soreness in hands; may have exacerbated psoriasis, possibly causing it to advance into psoriatic arthritis; itchy / sensation in both forearms / began at the same time in both forearms; arm soreness at the injection site; tingling sensation in both forearms / began at the same time in both forearms; This case was reported by a consumer via call center representative and described the occurrence of psoriatic arthritis in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th June 2021, the patient received the 1st dose of Shingrix. On 11th June 2021, immediately after receiving Shingrix, the patient experienced injection site pain. In June 2021, the patient experienced tingling of extremity and pruritus. On an unknown date, the patient experienced psoriatic arthritis (serious criteria GSK medically significant), pain in hand and psoriasis aggravated. On an unknown date, the outcome of the psoriatic arthritis, pruritus and psoriasis aggravated were unknown and the outcome of the injection site pain and tingling of extremity were recovered/resolved and the outcome of the pain in hand was not recovered/not resolved.   The reporter considered the psoriatic arthritis and psoriasis aggravated to be possibly related to Shingrix. It was unknown if the reporter considered the injection site pain, tingling of extremity, pain in hand and pruritus to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix and arm soreness at the injection site began immediately after that and subsided after 3 days.  Approximately 5 to 7 days after receiving Shingrix, the patient experienced itching and tingling sensation. The itchy and tingling sensation in both forearms subsided approximately 1 week after it began. The patient also experienced soreness in hands (between 1 and 2 months) approximately 2 months later and was ongoing. Less than 2 months after receiving Shingrix, the patient was concerned that the that Shingrix might had exacerbated psoriasis and could possibly cause it to advance into psoriatic arthritis. The patient did not receive 2nd dose of Shingrix. The reporter did not consent to follow up.
on 3/19/21 had severe episode of dizziness and double vision, EMS transported to Emergency room. Given TPA and reported symptoms improving. Admitted.
Muscle pain; Area swollen in her left face; Body Pain; Coughing; My stomach is sore; I feel weak; Tired; Headache; Nauseous; Pain in arm; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program. An 81-year-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EW0172; Expiration Date: 31Aug2021,) via an unspecified route of administration, administered in the left arm on 27May2021 as dose 1, single for COVID-19 immunisation. Medical history included Blood pressure high and diabetes. Concomitant medication included metformin taken for diabetes mellitus. On an unspecified date the patient experienced headache, nauseous, muscle pain, area swollen in her left face, body pain, coughing, my stomach is sore, I feel weak, tired. On 28May2021 the patient experienced pain in arm. Therapeutic measures were taken as a result of headache, nauseous, muscle pain, pain in arm, area swollen in her left face, body pain, coughing, my stomach is sore, I feel weak, tired, and included treatment with Tylenol which doctor told patient. She stated that she got the first vaccine last 27May and she mentioned that she had a lot of reactions. It is like she had headache, she is nauseous, there is pain in arm, muscle pain and area swollen in her left face and there is body pain and she is still coughing until now, her stomach was sore and she just did not feel good. She felt weak like tired. She could not find the vaccination card and she was not able to inform me about the second dose appointment. Friday, reporter started pain come on in her arm. Thursday, patient had all day, after got it Thursday, got it 30 evening had it all the time coughing. The clinical outcome of all the events was not resolved. Follow-up attempts are completed. No further information is expected.
This case was reported by a other health professional via call center representative and described the occurrence of facial pain in a 61-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th June 2020) for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 27th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 27th April 2018, less than a day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced facial pain. On an unknown date, the patient experienced incomplete course of vaccination. On 28th April 2018, the outcome of the facial pain was recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the facial pain to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional stated the patient experienced facial pain the day of when patient received SHINGRIX, which subsided after 1 day. The healthcare professional did not report but patient was also delayed for second dose. As patient still had not received the second dose, which led to incomplete course of vaccination.
PVP administered 10/17/2005 Monday, approx 4 hours post injection noticed soreness and warmth entire upper arm. by evening noticed stiffness and large reddened site upper arm. Took 800mg Ibuprofen at that time. States c/o worse 10/18/2005 am, using ice to site and taking ibuprofen. Reported to me at 4:30 10/18/2005. Instructed to continue ice and ibuprofen. To come back 10/19/2005 am to recheck site. Area outlined also instructed if c/o increase to go to ER. To call Dr 10/19 am to advise him of reaction and need of further Tx. 10/19/2005 9:00am staff member returned to me to check site. Area very light pink no redness, warmth or swelling at site movement greatly improved of arm. Soreness almost completely subsided, re instructed to make PCP aware of reaction
Headache, Sedation, Myalgia, Arthralgia, Fever, restlessness, soreness, chills, and fatigue. pain at the injection site. Narrative:
Swelling in my lymph nodes on the same side as my vaccine; I have it only on one side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 28Feb2021 (Batch/Lot number: unknown) as dose 1, single and administration date 21Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swelling in my lymph nodes on the same side as my vaccine; I have it only on one side".  Additional information: Reporter seriousness for event was unspecified. After taking the first dose patient experienced above event, so patient wanted to know if she should wait and how long can she wait for the second injection. Later it was confirmed that patient experienced swelling in neck in lymph nodes and had it only on one side. Patient wanted to know if she should wait like delay second vaccine and if so then how long she can delay. Later it was confirmed that after taking second dose she had a lymph node swelling on her neck part that's why she called us.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.