chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received TD booster 12-8-06 post 2nd degree burn. Left arm developed cellulitis (18 of upper arm affected) hot, red, painful, swollen. Seen by ER physician and given antibiotics. (on 12-9-06 states she had flu like symptoms with temp 100 deg x 2 days).
This spontaneous report has been received from a Medical Assistant via a company representative, concerning a female patient of unknown age. The patient's concurrent conditions and pertinent medical history were not reported. On 14-JUL-2015, the patient received late second dose of GARDASIL (lot #, exp. date, strength and dose were not provided). It was unspecified when the patient received her first dose of GARDASIL, however, it was confirmed that interval between first and second dose administered had definitely been longer than 2 months. No adverse effects were reported. Additional information has been requested.
The patient was given Hepatitis B and Prevnar immunizations on 12/19/2000. The next day the patient had swelling to the face, fussiness, and a low grade temperature.  The patient had swelling, tenderness, a local reaction at the Prevnar immunization site.
6. March 4 Descending stairs from bedroom to living room, pain and burning now throughout legs and feet; left leg pain behind knee, walking with limp; suspect some swelling in both legs  7. March 7 Consult with on-call doctor at clinic on Sunday who recommends emergency room visit; decide to wait until Monday  8. March 9 Call my vascular physician?s office; Dr. recommends emergency room visit; it is late, decide to wait until next day  9. March 10 Emergency room visit. Doppler exam shows no vascular change; attending physician suggest neuropathy as possible cause for leg pain  10. March 11 Dr. exam confirms no vascular change; also concludes possible neuropathy explanation for pain  11. March 15 Barely ambulatory, son helps me walk to emergency room visit; also having low back and left pelvic pain; no etiology  12. March 18 Dr. video teleconference; prescribes MRI of lumbar region and x-ray of left knee  13. March 27  Second Covid19 shot  14. March 30 MRI and X-ray at hospital; can barely walk to appointment, must use wall to support me when I walk between procedures; numbness and burning over whole body, especially extremities; numbness and tingling in face and throat  15. March 31 Speech therapy appointment; still unable to walk without holding on to objects and walls; other symptoms the same  16. April 6 Dr. in-person appointment; still difficulty walking; other symptoms the same; Dr. prescribes Duloxitene, 30mg initially, 60mg therapeutic dose; recommends neurology appointment with Dr.  17. Present: Tingling/burning in all limbs; tingling in left side of face; difficulty with balance
After injection was given, student/patient reported feeling "low".  An ice pack was applied to the back of the neck.  He was given 2 4 oz containers of apple juice.  He slowly drank the first container while sitting and talking with the nurse.  Afterwards student returned to class less anxious and more relaxed.
Very sore arm from site to hand over 6 weeks Doc can?t figure how to treat
c/o facial tightness and left arm pain after taking the vaccine.  pt. stated that she always feel that way when her BP is elevated.  BP was 150/101, and patient had just taken her BP medications.  Monitored pt. for 20 mins. and proposed rechecking BP, but she refused.  Pt. verbalized feeling better prior to leaving the parking lot.  Advice pt. to recheck BP at home and f/u with PCP if need be.
First dose of Moderna in February 2022 and waited to get the second dose; looking at the batch number and says they got the shot but it expired in May; This spontaneous case was reported by a patient and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (First dose of Moderna in February 2022 and waited to get the second dose) and EXPIRED PRODUCT ADMINISTERED (looking at the batch number and says they got the shot but it expired in May) in a 35-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   In February 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Jun-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 30-Jun-2022, the patient experienced INTENTIONAL PRODUCT USE ISSUE (First dose of Moderna in February 2022 and waited to get the second dose) and EXPIRED PRODUCT ADMINISTERED (looking at the batch number and says they got the shot but it expired in May). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (First dose of Moderna in February 2022 and waited to get the second dose) and EXPIRED PRODUCT ADMINISTERED (looking at the batch number and says they got the shot but it expired in May) outcome was unknown.            Concomitant medication of the patient was not reported.   The patient reported that the lot number was put on some website and it was found that the lot number expired 20-May-2022.  The patient had first dose of Moderna in February 2022, but she got seriously sick and ended up in ICU due to her esophagus. For this reason the patient waited to get the second dose.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-602828 (Patient Link).
Pregnancy Info:  -Healthy pregnancy, velamentous cord insertion only complication -Due date: 3/3/21 -Induction set for 2/24/21  Adverse Event: -Rash around injection site. Began one day after injection and went away, then returned 7 days post-injection. Red and itchy, non-painful round rash of around 4 cm diameter around injection site. Upon return, the rash lasted about 4 days. Rash was warm to touch.
I received my second dose of the Janssen/J&J vaccine on 12/10/2021. On 12/18/2021 at about 5 PM, I experienced sudden diarrhea with incontinence. Prior to the injection, I had experienced  sudden diarrhea with incontinence over approximately a 9-day period; there had been a recent recall on lettuce on account of Listeria, and I wondered if I had possibly been affected by this. On 12/27/2021, I gave a stool sample to my PA, which she tested on a 21-sample panel; no definite cause was found, and I was subsequently prescribed dicyclomine on 1/12/2022. On 1/1/2022 and on 1/8/2022, I had more incidents of sudden spontaneous diarrhea with incontinence.
This spontaneous report was received from a healthcare worker (medical assistant) and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 07-JUN-2016, the patient was inadvertently vaccinated with a third dose of PROQUAD (lot #, expiration date, exact dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
my blood pressure has gone up relative to the past reading that I take everyday; 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. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "my blood pressure has gone up relative to the past reading that I take everyday". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received his first Pfizer vivid shot on Tuesday and after a couple of days that past his blood pressure has gone up relative to the past reading that I take everyday. Is normal for it to happen and is temporary.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
face was puffy/she went to bed with the face still puffy/woke up and it was fine; face was covered in hives/spots started to disappear/woke up and it was fine; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face was puffy/she went to bed with the face still puffy/woke up and it was fine) and URTICARIA (face was covered in hives/spots started to disappear/woke up and it was fine) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. FT9142) for COVID-19 prophylaxis.     Concurrent medical conditions included Milk allergy (not anaphylaxis but when she drank cows milk, she breaks out in hives). Concomitant products included CYPROHEPTADINE HYDROCHLORIDE (PERIACTIN) and FAMOTIDINE for an unknown indication.    On 22-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2022, the patient experienced SWELLING FACE (face was puffy/she went to bed with the face still puffy/woke up and it was fine) and URTICARIA (face was covered in hives/spots started to disappear/woke up and it was fine). The patient was treated with CETIRIZINE HYDROCHLORIDE (EQUATE ALLERGY RELIEF [CETIRIZINE HYDROCHLORIDE]) for Allergy, at a dose of 2.5 milliliter. At the time of the report, SWELLING FACE (face was puffy/she went to bed with the face still puffy/woke up and it was fine) and URTICARIA (face was covered in hives/spots started to disappear/woke up and it was fine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Past medical history included J2 dependent.  It was reported that paitent received  the vaccine yesterday last night and did not see anything, but 40 minutes later after they drive home, her face was covered in hives and face was puffy. Caller reported the primary care doctor told her to gave an allergy medicine and all she had was Equate brand cetirizine hydrochloride 2.5 ml. Caller told it helped, the spots started to disappear an hour after and then she went to bed with the face still puffy and then woke up and it was fine.
pt recv vax 21APR98 & 23APR98 pt had gen rash to body mainly on face;seen by MD;advised mom to cont immun;
On day of shot, I was fine, more tired than usual by bed time.  Next morning I was extremely weak and fatigued not able to get out of bed for two hours. I went downstairs to get water, blacked out and completely fainted. I got out of bed around 10:25 or so, went downstairs very slowly, saw clock when I was able to get up around 10:47. I don't believe I was passed out for long.   Woke up on kitchen floor, arm bruised. Thankfully head was not injured, apparently fell with arm supporting head (assumption since no head injury).   Advised by nurse to come to dr. office, they tested blood pressure, top number was 82 (did the tilt test for orthostatic hypotension). EKG was normal and other blood tests were normal.  Was diagnosed with dehydration and low BP.  I habitually drink water and even if I did potentially skip a day, I should not faint.
21MAY96 pt came into clinic & recv Td vax d/t stepped on nail & had never had Td a/;pt returned to clinic 29MAY96 rt arm turned red, swollen w/enlarged nodes in rt axillary area;c/o pain in rt side of neck, sent to ER;
Redness at injection site; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness at injection site) and INJECTION SITE PAIN (Pain at injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at injection site) and INJECTION SITE PAIN (Pain at injection site). At the time of the report, INJECTION SITE ERYTHEMA (Redness at injection site) and INJECTION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product reported by reporter. No treatment medication reported by reporter.
Developed fever 102.6 with H/A and dizziness 45 hours after injection.  No other symptoms.  Fever down to 99.6 within 48 hours of onset of symptoms.  Not see at PCP...though they were notified.  Merck was the manufacturer.
pt reports swelling rash in area of injection became painful and required visit to PCP office and treatment with antibiotic
dead arm; Feels achy; feels like he has a rash; he has Covid; This is a spontaneous report from a contactable reporter via Pfizer-sponsored program.  Amale patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient got his 1st dose on 18Mar2021 and he had no side effects until recently. In Mar2021, the patient was experiencing no fever, but felt achy and a dead arm. In Mar2021, the patient felt he has a rash but no visible rash was on the outside of the skin. The patient did get tested for Covid and it was negative in Mar2021, but it was reported that then the patient had Covid (in Mar2021, sars-cov-2 test unknown results; patient had Covid). The outcome of the events was unknown. Follow-up attempts are completed. The batch/lot number is not available despite the follow-up attempts made. No further information is expected.
Meningitis; This serious case was reported by a consumer via interactive digital media and described the occurrence of meningitis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced meningitis (Verbatim: Meningitis) (serious criteria GSK medically significant).The outcome of the meningitis was not reported.   The reporter considered the meningitis to be related to Shingles vaccine.     The company considered the meningitis to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient stated that he/she got meningitis from this Shingles vaccine. The follow-up could not be possible as no contact details were available.
Hep B #3 outdated 1/11/04 given on 2/3/04.
I was experience what I though was COPD exacerbation. I had no symptoms, no cough, no chills. I went to the doctor twice and to the ER. They did blood work, showed my WBC was high. They did a chest x-ray, showed double pneumonia. They did an EKG, normal results. I am on medicine for it.
Missed second COVID Vaccine dose, has an appointment to today to get the second dose; headache; fatigue; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "Missed second COVID Vaccine dose, has an appointment to today to get the second dose"; HEADACHE (non-serious) with onset 26Mar2021, outcome "recovered" (Apr2021), described as "headache"; FATIGUE (non-serious) with onset 26Mar2021, outcome "recovered" (Apr2021), described as "fatigue"; NAUSEA (non-serious) with onset 26Mar2021, outcome "recovered" (Apr2021), described as "nausea".  Additional information: The caller stated after her first dose of the vaccine on 26Mar2021 she had a headache for 3 weeks, fatigue, and nausea. She asked if these symptoms are pretty consistent after the second dose for people that experienced them with the first? She stated she had a family emergency trip to take care of her mom and never go the second dose. Today is day 39 and she is on her was to an ap-pointment at 5:00 to get the second dose. The caller enquired if the vaccine wass still effective if it is given after 3 weeks. She asked, ifo nedon't get the second dose by 6 weeks do one had tostart over in the future?. Caller reports she took her first covid vaccine on 26Mar2021 about 29 days ago and she did not get the second dose because she had to come to # to take care of her mother. Caller reports she read at an online site she can have the shot up to 42 days after the first but, the Pfizer site reports it has to be 3 weeks. She has appointment to get the shot in 45 minutes at a pharmacy. Caller wants to know would it be valid to get the second shot and would it create an immunity.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Little soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in left arm. The patient experienced a little soreness which went away. For the tolerability of 2nd dose, refer case US2020230711 reported for same patient. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020230711:2nd dose
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received on an unknown date). On 13th December 2018, the patient received the 1st dose of SHINGRIX. On 13th December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, upset stomach and tiredness. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the upset stomach and tiredness were unknown. It was unknown if the reporter considered the injection site pain, upset stomach and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age of patient was reported as 70 plus. A day before reporting, the patient received SHINGRIX on an unknown arm and experienced sore arm at injection site, some stomach upset and general tiredness which does not required medical attention. The patient asked question for his daughter that if SHINGRIX could be administered to a person on Humira who was 50 plus years old had rheumatoid arthritis and no spleen. If SHINGRIX was live or dead vaccine. The call center representative replied that SHINGRIX was non-live vaccine and Your daughter's healthcare provider would determine the right treatment plan for her. There are no warnings, precautions, contraindications for her using it but patients who were immunocompromised were excluded from large clinical trials. Immunosuppressive therapies might reduce the effectiveness of SHINGRIX. The patient also asked if any coupons are available to help offset the cost of the 2nd dose. This case has been linked with case US2018GSK227323 (patient's wife), reported by same reporter.
Patient received correct pediatric Pfizer vaccine, however 11 days later the pharmacy received a recall notice stating that this lot number actually expired 9/30/22 even though it was not listed this way. Further information has now been provided that the stability data for this vaccine lot was currently active through 10/19/22. Reporting due to first recall information. Patient did not report any adverse effects or noted side effects.
Several hours post vax, pt experienced headaches (migraine), feeling of weakness and sluggishness. Pt has a nodule with discoloration-2 inches in left arm and 1 inch in right arm. Area above nodule starts to peel after approximately 3 days.
Local rash, redness, and swelling that developed the following day. Apply ice to area as well as hydrocortisone cream to area.
This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 05-JAN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA) (lot # L012479, expiry date 10-APR-2017, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a patient who was vaccinated with a first dose of Rotateq. It was reported that it had been 16.5 weeks (also reported as 6.5 weeks) since the first dose and the patient was to received a second dose on 13-JAN-2007. It was noted that the patient was doing fine. So product quality complaint was involved. Additional information has been requested.
Inappropriate age at vaccine administration; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) 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 concomitant medications were provided. No treatment details were provided.
A non-serious spontaneous report of FLUMIST got into child's eye was received from a nurse concerning a female child.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Follow up: A non-serious report of FLUMIST got into child's eye was received from a nurse in the USA concerning a three year old female. There was no adverse event associated with this medication error at the time of the report, not on 07 JAN 2009 when the the reporter was contacted: therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Additional information received on 07-Jan-2009 and incorporated into narrative: no adverse events occurred.