chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash/persistent rash; scars; This case was reported by a consumer via call center representative and described the occurrence of rash in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax and Shingrix (on an unknown date the patient received 1st dose).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, immediately after receiving Shingrix, the patient experienced rash and scar. The patient was treated with neosporin (nos) (Neosporin). On an unknown date, the outcome of the rash and scar were not recovered/not resolved.   It was unknown if the reporter considered the rash and scar to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. Not long after getting Zostavax, the patient was advised to get the new shingles vaccine, Shingrix.  The patient received both doses of Shingrix, with the 2nd dose administered about 1 year ago.  Shortly after the 2nd dose of Shingrix he developed a rash on his right buttock and it had persisted since then. He had tried putting creams on it, neosporin and just keeping it dry, but the rash never goes away and it had started leaving scars. The emergency room visit required.
pt recv vax & devel a rash p/vax;pt recv vax 10OCT97 & 20OCT97 exp several hundred pin point fine papular rash & low grade fever of 100.7 R;
Rash just below vaccine site; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 12Apr2021 at 16:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included peanut allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patent did not receive any medication within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unspecified date in Apr2021, the patient experienced rash just below vaccine site. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event rash just below vaccine site was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Second dose not given within 42 days from the initial dose, scheduled for 19 Apr 2021; Diagnosed withcovid-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed withcovid-19 infection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not given within 42 days from the initial dose, scheduled for 19 Apr 2021) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included INSULIN for Diabetes.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced COVID-19 (Diagnosed withcovid-19 infection). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not given within 42 days from the initial dose, scheduled for 19 Apr 2021). At the time of the report, COVID-19 (Diagnosed withcovid-19 infection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not given within 42 days from the initial dose, scheduled for 19 Apr 2021) had resolved. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products include medication for high blood pressure. No treatment information was provided.
headache after the second shot; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable healthcare professional (HCP) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular on an unknown date (at an unknown age) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on an unknown date with no adverse effect reported. The patient completed the vaccination series, and she took some pain reliever for her headache after the second shot. The outcome of the event headache was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
pain, swelling and redness of injection site, swelling of  underarm lymph nodes.
Contracted COVID 19 after exposure to known infected persons.  Started experiencing symptoms on July 16 - sore throat, headache.  Tested positive w rapid antigen home test  on July 17 2022.  Symptoms worsened to include fever, coughing, headache, congestion.  Missed three days of work.  Contacted primary care physician via phone to ask whether anti-retro viral therapy was appropriate. Dr did not recommend that option.
Left arm was sore from shot and could not lift it, had to keep ice pack on arm.  Fatigue, body ache, headache, Oxygen level drop  Started on December 25, 2020, took Advil, noticed oxygen level drop on Saturday, December 26, 2020.  Have been sleeping since Friday and had a hard time waking up on Saturday, so I started checking my oxygen level and it was 89.  I got up and started walking and it helped to bring it up but every time I sit for any length of time it goes back down to 92 - 95.  I have called Dr. my Pulmonary Doctor and waiting on him to call me back.
This spontaneous report was initially received from a pharmacist and additional information from an office manager, concerning an unspecified  patient. Patient's medical history, concurrent condition, concomitant medication and previous drug reactions/ allergies were not reported. On 18-SEP-2017, the patient was vaccinated with one dose of an improperly stored ZOSTAVAX lot # M037015, expiry date 22-NOV-2017, for prophylaxis (strength, dosing details and anatomical location were unknown). No adverse symptoms were reported. The vaccine was exposed to the temperature of 29.8 F. The vaccine had previous temperature excursions. No data logger was involved. This is one of two reports received from the same reporters.; Sender's Comments: US-009507513-1708USA004943:
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no adverse evevnt; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.   This case is linked to cases 2023SA054981 and 2023SA057733.   This case involves Adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c (clesius) and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine, suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It is unknown if the patient experienced any additional symptoms/events   It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   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 guidelines. 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.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Patient received the second dose of his Moderna vaccine following his allogeneic stem cell transplant on 11/15/21 (prior doses were 2/2/21, 10/8/21, and 11/15/21 with the initial being prior to her transplant). He then presented to the emergency department on 11/18/21 with abdominal pain and diarrhea and was admitted to the hospital. At admission he was found to have a Enteropathogenic E.coli colitis (positive on GI multiplex panel) which was likely a cause of the diarrhea. He was also found to have a new onset cirrhosis of unknown etiology. He is still admitted for management of her ascites and newly developed AKI.
Got precancerous cells/ pap smear was abnormal; This case was reported by a consumer via interactive digital media and described the occurrence of precancerous cells present in a female patient who received HPV 16-18 (HPV vaccine) for prophylaxis.   On an unknown date, the patient received HPV vaccine at an unknown dose. On an unknown date, unknown after receiving HPV vaccine, the patient experienced precancerous cells present. On an unknown date, the outcome of the precancerous cells present was unknown.   It was unknown if the reporter considered the precancerous cells present to be related to HPV vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported the adverse event happened to someone they knew.  The patient got the HPV shots. The patient's pap came back abnormal months later and got precancerous cells. The reporter also stated nobody believed when they talked about this to peoples.      Lab Comments: On an unknown date, months later, the patient's pap came abnormal and showed Precancerous cells
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a elderly patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm (serious criteria disability) and mobility decreased (serious criteria disability). On an unknown date, the outcome of the pain in arm and mobility decreased were recovered/resolved. The reporter considered the pain in arm and mobility decreased to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. This was one of the 4 patients involving both male and female over the age of 65 years old. After receiving SHINGRIX vaccine, the patient experienced intense pain after the shot. The reporter stated that patient complained of whole arm pain with the shoulder and had decreased mobility of the arm. The reporter stated that after a couple of days the pain was better, but it was very intense for 24 hours and then it started to decline. The reporter reviewed her technique and stated that she was using a new 25g needle to give the injection after removing the needle that was used to puncture the vial stoppers. The reporter noted it was disabling to them because he/she was limited in mobility of that arm. The reporter didn't have specifics of the patient at the time of this report, but would be able to get that information.
Expired vaccine used with no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via the agency (Reference number-00363512) and transmitted to Sanofi on 18-Nov-2020.  This case involves a 12 year-old male patient who received 0.5 mL expired dose of POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) (lot P1E70, expiry date- 09-Nov-2020) via an unknown route in an unknown administration site for prophylactic vaccination, on 17-Nov-2020 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), and family history were not provided.  concomitant medications included varicella vaccine, hepatitis A vaccine and hepatitis B vaccine.  This was an actual medication error case due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
8 days after receiving 1st set of immunizations (including Rotateq) Pt developed bilious vomiting and blood in stool. Sent to ED and found to have ileocecal intussusception. Pt had an ileocecetomy.  5/9/08 Reviewed hospital medical records of 1/11-1/15/2008. FINAL DX: Ileocecal intussusception, surgically reduced & appendectomy Records reveal patient experienced abdominal distention, hypoactive BS & bilious vomiting.  Air contrast enema reduction initially thought to be successful but did not improve & developed significant abdominal distention.  Repeat abdominal x-ray c/w IS.  Repeat air contrast enema unsuccessful.  Taken to OR for ileocecectomy w/primary anastamosis.  Progressed well postoperatively & d/c to home.
Missed to receive the 2nd dose of vaccine , passed 35 days after the 1st dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed to receive the 2nd dose of vaccine , passed 35 days after the 1st dose.) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concomitant products included ACETAMINOPHEN, SALBUTAMOL (ALBUTEROL HFA), ALBUTEROL SULFATE, ATORVASTATIN, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), FLUTICASONE, FUROSEMIDE, GUAIFENESIN, METOPROLOL SUCCINATE, NICOTINE, OXYCODONE, SERTRALINE, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), TRAMADOL and POLYCARBOPHIL CALCIUM (FIBER) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed to receive the 2nd dose of vaccine , passed 35 days after the 1st dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed to receive the 2nd dose of vaccine , passed 35 days after the 1st dose.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were reported.  Patient lost the follow up and now came back to receive the 2nd dose of vaccine. Its passed 42 days after receiving the 1st dose.
Approximately 48 hours after receiving the Zostavax vaccine, the patient developed a red, itchy, hard lump the size of a fist at the site of injection.  While the entire lump was red and itchy, symptoms were most severe at the actual size of needle penetration.  Patient has been treating with Benadryl and hot compresses.
Breakthrough case of COVID May 2022 I developed on 05/11/2022 in the evening I developed a deep raspy voice.   On 05/12/2022 I developed, sore throat, cough, nasal congestion, fatigue. tested negative on a home test that day. 05/13/2022, another negative test and all the sx persisted. I called my doctor's office, they said they were no longer testing in the office, I needed to go to urgent care. 05/14/2022 I woke up with a low grade fever of 99.3 and other sx persisted, I went to Urgent care. I had a positive Covid test , lung x-ray showed  possible bilateral infarcts in my lungs and they sent me to rule out a pulmonary embolism. Saturday 05/14/2022 the hospital  drew blood work and D-dimer was elevated at 0.75. They did a CAT scan with contrast of my chest, that showed a plural effusion, but no clots. I came home and started on a Paxlovid and stopped the atorvastatin  The fatigue and cough is better, I have been getting a little better each day.
Fever; Chills; Achy; A spontaneous report was received from a 50-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, chills and being achy.    The patient's medical history was not provided. Relevant concomitant medication included atorvastatin.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 04 Jan 2021, the evening of administration, the patient experienced fever, chills, and being achy. No treatment provided.    Action taken with mRNA-1273 in response to the event was not reported.   The seriousness criteria of all the events was reported as non-serious.  The outcome of the events, fever, chills and being achy, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Information has been received from an office manager referring to a patient of unknown age and gender. Information about concomitant medications, pertinent medical history and drug/allergies reactions was not provided. On 22-JAN-2019, the patient received an expired dose of ROTATEQ (lot # N011651, expiration date 02-DEC-2018; frequency was not provided) orally for prophylaxis (expired product administered). No adverse effects were reported.
Fever (temp 100-102 degrees); chills followed by sweats; headache; nausea; severe muscle pain; sharp pains in chest, neck and pelvis; dizziness; loss of taste (coffee/water tasted very tinny) Lasted through out the day Main treatment - Advil and rest
This spontaneous report as received from a pharmacist refers to a 61 year old patient of unknown gender. On 06-SEP-2016, the patient was vaccinated with VARIVAX lot # L017144 due to human error for whom ZOSTAVAX was indicated. The patient had not reported an adverse experience. This case has been linked to case 1609USA006504 (same reporter link). Additional information has been requested.
Got deathly sick; projectile vomiting; major diarrhea; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Got deathly sick), VOMITING PROJECTILE (projectile vomiting) and DIARRHOEA (major diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Cardiovascular disorder NOS (I'm open heart patient and have cardiovascular disease).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got deathly sick), VOMITING PROJECTILE (projectile vomiting) and DIARRHOEA (major diarrhea). At the time of the report, ILLNESS (Got deathly sick), VOMITING PROJECTILE (projectile vomiting) and DIARRHOEA (major diarrhea) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.
IM  given@ 9;00am and  at 9;08 am  pt. begin to c/o palpitaions. VS taken R 22 P70 BP 154/112  sats 99% pt. states has Hx . HTN and she says took her BP medication this morning. VS re-check at 9:15 am BP 153/102 HR 66 Sat 99% R20. Pt states feels better now , denies any more symptoms.
Starting about 2 days after receiving the vaccine, I started Valtrex again because I had a flare up of cold sores. I took (2) 1 gram tablets and then 12 hours later I took (2) tablets and the cold sores did not come out. I would only normally get flare ups 1-2x yearly but since receiving the vaccine as soon as they go away they come back (2x monthly). This happened after each consecutive vaccine and actually worsened with each one.
E-mailed clinician 5/27/16 at 6AM with c/o GI urgency, loose BM's, joint pain. No problem at inj. site. No hx of any prob. w/prior IZs in lifetime (rec'd meningococcal vaccine elsewhere, 7/9/10).
APPREHENSION AND CHOLING SENSATION  PATIENT HAD NOT HAD ANYTHING TO EAT SINCE 6:30AM
Painful and swollen lymph nodes under both armpits. Right side was significantly more painful.  Pain spread into the right breast. Lasted for 5 days with strong symptoms, mild pain (right side only) continued for additional 3 days. Patient is a nursing mother.
Pt had Adacel and Menactra vaccines on 1-16-06. Mother called 1-17-06 to report child was very weak, dizzy, nausea and achy. Had tactile fever, temp unknown. Missed 2 days of school then resolved.
Sore arm and some fatigue. Treated with Tylenol about every 4-6 hours. Resolved by evening of next day (36 hours after injection).
Dizziness Fatigue Headache Disorientation Pain and occasional weakness in lower legs
Severe stomach pain and nausea, intermittently - Shot was on Thursday afternoon 3/30, pain started during the early morning hours of 4/1 and today is Tuesday 4/4 and pain continues but not as frequent. Taking OTC Nausea medication (Emetrol)
First shot instant headache for a day. Then for the  next 30 days felt like I was in a complete fog can't focus felt completely out of it and exhausted. Second shot left arm shoulder an my neck were so sore I couldn't turn my head for two days. It's  been since May with the first shot . I'm still feel like I'm in a fog absolutely exhausted and still can't keep focused.  Unfortunately it's effecting my job performance.
04/26/21 @ 1324 Patient c/o itching at injection site right arm. Upon assessment, there was no redness, swelling, Skin Temp WNL, no skin discoloration at the injection site. VS 97% O2, 87HR, BP: 190/98.  1330 - Benadryl was administered 50 mg tab by mouth.  1345- Patient states, "I feel better, I no longer have itching on my arm".
Hives; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (Hives) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not reported.  Patient who received the Moderna vaccine 30 minute ago and now has hives, but not all over the body.