chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of ice pick headache in a 56-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included migraine headache. On 16th February 2019, the patient received the 2nd dose of SHINGRIX .5 ml. On 17th February 2019, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms and injection site erythema. On 18th February 2019, the patient experienced ice pick headache and shooting pain. On an unknown date, the outcome of the ice pick headache, influenza-like symptoms and injection site erythema were not recovered/not resolved and the outcome of the shooting pain was unknown. It was unknown if the reporter considered the ice pick headache and shooting pain to be related to SHINGRIX. The reporter considered the influenza-like symptoms and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated she had ice pick headaches where the pain was shooting through the same spot in her head and she described it as shooting pain. She wanted to know if the SHINGRIX could had triggered this headache. She said she had the normal flu like symptoms on Sunday and her arm is still was red at the site of the injection, till the reporting time. Due to the obvious pain the patient was having, additional questions were not asked.
PAIN IN BOTH KNEES; PAIN IN ARMS; This spontaneous report received from a consumer concerned a 78 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: Alzheimer's, non alcohol user, non smoker, and arthritis, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug usage. The patient had no known drug allergies. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number:1808980, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-APR-2021 on right arm for prophylactic vaccination. No adverse events reported post primary vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number:1855194, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 22-NOV-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the reporter noticed that her husband was in pain after receiving the booster dose with his expressions of ooos and ahhs. The patient was specifically experiencing pain in both his knees and arms (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in both knees and pain in arms was not reported. This report was non-serious. This case, from the same reporter is linked to 20211240355, 20211240436, 20211240486 and 20211240211.
More than 36 days after the first dose without receiving the second dose; Had an allergic reaction; All her body was filled with like weal, her face, her ears, all her body; Couldn't stop scratching herself; Her arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (All her body was filled with like weal, her face, her ears, all her body), PRURITUS (Couldn't stop scratching herself), PAIN IN EXTREMITY (Her arm hurt), PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose) and ALLERGY TO VACCINE (Had an allergic reaction) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus and Allergy. Concomitant products included METFORMIN for Diabetes.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (Her arm hurt). On 29-Mar-2021, the patient experienced URTICARIA (All her body was filled with like weal, her face, her ears, all her body), PRURITUS (Couldn't stop scratching herself) and ALLERGY TO VACCINE (Had an allergic reaction). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 28-Mar-2021, PAIN IN EXTREMITY (Her arm hurt) had resolved. On 30-Mar-2021, URTICARIA (All her body was filled with like weal, her face, her ears, all her body), PRURITUS (Couldn't stop scratching herself) and ALLERGY TO VACCINE (Had an allergic reaction) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was diabetic she couldn't get the vaccine, and also, that she could not  be given the second dose because it would be a stronger reaction.  Additional treatment information were steroids and another medication for allergies.
Patient administered two dosed of Influenza quadrivalent within a 5 day period. Protocol for adults is to administer one influenza vaccine. Patient to return in one week to ensure if adverse reactions are to occur that patient will be assessed.
Child waited in office 15 minutes post vaccine and just after leaving the office, did not feel well. Mom had him sit on the floor then child fainted. Brought back into exam room for evaluation by MD.
Information has been received from a medical assistant concerning a male patient who on 15-SEP-2008 was vaccinated with the first dose of ROTATEQ and vomited immediately. The patient sought medical attention in office. No product quality complaint involved. Additional information has been requested.
My ear, my back and my neck heated up and I got the prickling sensation on my skin; My ear, my back and my neck heated up and I got the prickling sensation on my skin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: ER2613) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM taken for hypertension. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 immunization. The following information was reported: FEELING HOT (non-serious), PARAESTHESIA (non-serious) all with onset 30Mar2021, outcome "recovered" and all described as "My ear, my back and my neck heated up and I got the prickling sensation on my skin". Therapeutic measures were not taken as a result of feeling hot, paraesthesia.  No follow-up attempts are possible. No further information is expected.
Doctor's nurse practitioner called in on 10/18 as vaccine failure. Mom called back on 10/14: < 20 lesions right arm pit 5 lesions there and another few in left arm pit. Itching.
Pt had covid; This is a spontaneous report from a contactable Nurse.   A 58-year-old-female consumer patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 14Aug2021 at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history included Rheumatoid arthritis. Concomitant medications included HYDROXYCHLOROQUINE SULFATE and tofacitinib citrate (XELJANZ XR) orally from Sep2017 at 5 mg twice daily for rheumatoid arthritis. It was informed that patient had Covid- 19 on 16Aug2021. It was also reported that he was aching and hurting and cough from Covid. At the time of the reporting the patient had not yet recovered from 'I'm aching and hurting' and cough, while outcome of other events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
About 1 week after receiving Pfizer #1, she developed migratory hives at night. Resolved by morning each day. Received vaccine #2 on 2/10- nocturnal hives continued. Has been taking Zyrtec 10mg and famotidine 20mg twice daily for over a month and now hives remain in daytime and have extended to neck and face. No lip or tongue swelling and no shortness of breath.
Pt received TD, Hep A dose 1 and Hep B dose 3 on 11/21/2001. A few minutes after, pt fell on the floor and had jerky movements of lower extremities for a few seconds only, afterwards he felt a little bit weak but is awake, alert and coherent. Pt is referred to ER for further evaluation.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. In March 2017, reported as on 15-MAR-2017 and 16-MAR-2017, the patients were vaccinated with improperly stored VAQTA, lot # M039202, expiry date 11-MAR-2018 (dose, route and site of administration were not reported) for prophylaxis. No adverse effects noted. Administered doses of vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 10 hours. Data logger was involved. Previous temperature excursion reported was between 32 to 35 degrees Fahrenheit for 18 hours. This is one of several cases received from the same reporter. Additional information is not expected, as there was no consent given for further contact. Sender's Comments: US-009507513-1704USA000918: US-009507513-1704USA000916: US-009507513-1704USA000917.
FELT CRUMMY; SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (FELT CRUMMY) and PAIN IN EXTREMITY (SORE ARM) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In August 2021, the patient experienced MALAISE (FELT CRUMMY) and PAIN IN EXTREMITY (SORE ARM). At the time of the report, MALAISE (FELT CRUMMY) and PAIN IN EXTREMITY (SORE ARM) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
08/01/2022:2nd dose of vaccine received to left deltoid. 3pm - arm twitching, 8pm - right arm/hand weak, 11pm - very tired. 08/02/2022 Patient reported at 2:00am - fever, head chills, extreme weakness, extreme dizziness, unable to get out of bed. 11am - symptoms clearing but has other lingering symptoms. 08/03/2022 , left arm remains sore and some swelling, two itchy welts near injection site.
This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced eyesight went downhill / in less than 48 hours after taking the shot had trouble with her sight. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of eyesight went downhill / in less than 48 hours after taking the shot had trouble with her sight was not reported. This report was non-serious. This case, from the same reporter is linked to 20220615899.
Narrative: Patient received 2nd dose of COVID Vaccine, Moderna on 4/1/21. He had no history of covid infection. There were no reported side effects from vaccination. Patient accepted hospice care on 4/9/21 and passed away at home on 4/12/21. Placed on hospice due to myelodysplastic syndrome and prostate cancer. Patient had no history of adverse reaction to any vaccines. At the time of death there was concern that he may have gangrenous Rt toe/foot (has PVD) and did not want any aggressive care or work up. Death was likely multifactorial, but not related to COVID vaccination.
Urticaria rash - face, chest, injection site RT, no resp abnormalities.
This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (SHINGRIX) for prophylaxis. Co-suspect products included Herpes zoster (SHINGRIX) for prophylaxis. Previously administered products included Shingles vaccine (received the original shingles shot years ago from the date of reporting). On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and incomplete course of vaccination. On an unknown date, the outcome of the ophthalmic herpes zoster and incomplete course of vaccination were unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to SHINGRIX. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The physician wanted the patient to get the new SHINGRIX vaccine. It was two separate injections. The patient broke out with shingles. The patient refused to get the 2nd injection, that was 3 years ago. The patient still had breakouts on eyes, lips, face and foot. No contact details were reported. The case had been linked with US2021AMR259450 (deleted) reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR259450:same reporter.
Patient called and reported feeling drowsy, fever, chills, upset stomach, and rapid heartbeat when no adverse effects experienced with first dose.
ADMINISTRATION OF EXPIRED VACCINE TO 9 MALES; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced administration of expired vaccine to 9 males. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine to 9 males was not reported. This report was non-serious. This case, from the same reporter is linked to 20210955494.
Pfizer-BioNTech COVID-19 Vaccine EUA: three days after vaccination and two days after colonoscopy patient presents with persistent black emesis, fatgue, chills, and body aches starting soon after colonoscopy. Patient transported to emergency department (ED) at another facility for management.
Sore throat; Gets winded while talking; headache; feeling like she has a cold; joint pain; This is a spontaneous report from a contactable consumer or other non hcp (Patent).  A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EW0150 ), dose 2 intramuscular, administered in Arm Right on 26Apr2021 10:30 as single dose  for covid-19 immunisation.  First dose was given 05Apr2021, 10:00 Pfizer COVID vaccine, Lot ER8733, Expiration was unknown. Injected intramuscularly in left arm. The patients concomitant medications were not reported. The patient did not had any prior vaccination before to this vaccine. On 26Apr2021 21:00 patient had  joint pain and achiness , On 28Apr2021 19:00 the patient experienced headache, on 28Apr2021 12:00 she was  feeling like she has a cold, On 29April2021 12:00, she has  sore throat, on 29Apr2021 12:00  she reported she gets winded while talking. The events were worsened. The patient was recovering from joint pain. The patient had a queried that she had first and second doses of Pfizer COVID Vaccines but is having some symptoms and is not sure if she has gotten COVID or not, she was not sure whether should get tested or not.  The outcome of the rest of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
After about 2-3 minutes from vaccination, the patient's hands bilaterally became swollen with erythema.  It was clearly visible.  The patient also noted "tingling" in her right arm where she received the vaccine.  In addition, there was localized erythema at the injection site with about 5 cm in diameter.  I gave the patient 37 mg of Benadryl and the edema immediately was reduced in addition to the erythema resolved.  She had no more tingling.  I observed her for 30 minutes and all was fine with the patient.  I then checked on her 1 hour later and all was good.
approximately 2? in diameter.  Lower belly, and arms.  Some have healed, others are still present (growing?)
Erythema multiform & target lesion devel rash & facial swelling p/MMR/OPV/DTP (7-8 days p/)
Left thigh injection site pain starting 12/13, vomiting starting morning of 12/14
Information has been received from a health professional concerning a her 19 to 21 year old daughter who on approximately 21 Sep 2006 "about 6 weeks ago" was vaccinated IM with a first dose of Gardasil (yeast). Within 5 to 6 hours of vaccination, the patient developed hives and swelling of her hands and feet. The patient was given (Benadryl) and the symptoms began to heal. Subsequently, the patient recovering. No product quality complaint was involved. Additional information has been requested.
Pt recvd 1st dose of w/no noted problem; pt recvd 2nd dose of vax 18AUg92 w/in an hr following vax, pt exp sore arm w/pain @ the inject site; dx resolved w/in 24 hrs;
Sx onset 7/19/21 with runny nose, nasal congestion, fatigue, headache & loss of smell. Tested on 7/23/21 which resulted as positive.
(the affected) experienced headaches following the vaccination and on July 19th had an aneurysm that burst in her brain. Patient is still at the hospital as of September 4th.
On April 6th, the vaccine site was a little red and began to itch.  By April 9th, the are of redness had grown larger and still itched. By April 11th, the area of redness had grown yet larger and was still itching. The area today is larger, somewhat swollen, red, itching and feverish.
COVID-19; COVID-19; Vaccine brand = Pfizer / BioNTech; Vaccine administration date = 28Feb2022; Vaccine brand other = Moderna; Vaccine administration date = 07Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: er2613), on 08Apr2021 as dose 2, single (Lot number: er8737), on 27Aug2021 as dose 3 (booster), single (Lot number: fc3183) and on 28Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Sep2022 as dose 5 (booster), single (Lot number: as7140c) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing), notes: Other medical history: Cancer; "PE" (unspecified if ongoing), notes: Other medical history: PE; "PVC's" (unspecified if ongoing), notes: Other medical history: PVC's. Concomitant medication(s) included: WARFARIN; TOPROL. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Sep2022, outcome "not recovered", described as "Vaccine brand = Pfizer / BioNTech; Vaccine administration date = 28Feb2022; Vaccine brand other = Moderna; Vaccine administration date = 07Sep2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: It was reported, the patient had no known allergies. Patient received other medication in 2 weeks. Anti-viral PAXLOVID was given from 02Nov2022 to 07Nov2022 for COVID 19 Treatment.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Patient developed rash within 2 hours after receiving vaccination, self treated with diphenhydramine 50 mg Q6 hours for 24 hours. Not responsive - doctors visit resulted in prescription for prednisone.
Information has been received from a registered nurse referring to a 54 year old male patient with no drug allergy/reaction. The patient's medical history included hepatitis C. In April 2014 (reported as "2 years ago") the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# were unknown). No concomitant therapy was taken. On 27-APR-2016 the patient was seen at the facility for medical attention stating he developed "a tingling feeling on his left rib area" an unspecified time after receiving ZOSTAVAX. The patient also requested another dose of ZOSTAVAX since he did not think he built up enough antibodies from the first one (vaccination failure). No treatment was given to the patient for tingling and no lab was performed. The outcome of tingling feeling was reported as recovered (date unspecified). The outcome of "did not build up enough antibodies" was unknown. Causality was not provided. Additional information has been requested.
Pt had GI cramping, metallic taste in mouth, palpitations, Nausea, lightheaded, increased respiration, itching of the site.
The patient came in for their COVID vaccine. The adult and pediatric dose boxes were in the same drawer in the refrigerator and the pediatric box was opened. The pediatric dose was administered and the error was discovered when processing another vaccine. Pfizer was contacted and the recommendation was to re-administer the age appropriate vaccine as soon as possible. The patient was contacted and a voicemail was left. Once he is reached we will recommend we re-vaccinate with the appropriate vaccine.
1-3 d after injection, had 3 cm lump at site with "pimple", redness, tenderness, pain into shoulder.  7d after injection, has 3 cm hard lump, mildly tender, complained of itching. No redness or other surface symptoms.
STRANGE FEELING IN THROAT AND CHEST THAT PROGRESSED TO CRUSHING CHEST PAIN. CHILLS, BODY ACHES, SOB, NAUSEA, RASH. I STILL HAVE SOB AND I DONT KNOW IF IT WILL BE TEMP OR PERMANENT.