chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 2/21/20 I received an email from company regarding a patient wanting to contact Pharmacy due to concerns about his flu shot administered on 10/18/19. I emailed my personal phone number and said to call whenever to discuss. The patient called and told me he has been experiencing pain in arm for 4 months. He finally went to his doctor office and states the vaccine was given in an incorrect location. I counseled patient on bursitis if vaccine is given too high in shoulder and showed empathy toward patient as well. He stated the vacine was given too low and now taking Gabapenting for nerve pain, he is unsure if damage will be temporary or permanent.
Patient is 8 years old and was due for a covid-19 booster vaccine. One of our staff members gave the patient a 0.3mL dose of the Pfizer adult formulation. The error was caught right away and the provider spoke with the patient/family. So far, patient/family has not reported any symptoms or concerns.
fatigued/ extremely tired; nauseated; severe headache behind my eyes; This is a spontaneous report received from a contactable consumer (patient). A 67-Year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EK9231), via an unspecified route of administration on right arm on 25Jan2021 13:15 at single dose for COVID-19 immunisation in hospital. The patient medical history included chronic migraine and brain aneurysm (surgery 2016). Concomitant medications included unspecified Multivitamins (Vitamins NOS) within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021, the patient experienced somewhat fatigued the first day after the vaccine, but the second day It was extremely nauseated, had a severe headache behind her eyes, and was so exhausted that she could barely get out of bed to use the bathroom. she felt better the following day but have since had some days when she is extremely tired. No treatment was received for the events. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient has not been tested for COVID-19 Since the vaccination. The outcome of the events was reported as unknown.
shingles appears 1 month later the second dose of Shingrix / suspected vaccination failure; shingles appears; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 7X743, expiry date 22nd May 2021) for prophylaxis.   On 20th December 2018, the patient received the 1st dose of Shingrix. On 25th February 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and 1 month after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was resolved with sequelae.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The shingles appeared 1 month later the second dose of Shingrix to a patient.  This case was considered as suspected vaccination failure as details regarding laboratory test confirmation and time to onset for the event was unknown at the time of reporting. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020200020:same reporter
Pt called the pharmacy on 11/20/17 to report that her right arm (where she got her flu shot) has a red rash and is sore. This started on Saturday, 11/18/17 (one day after her flu shot). She also states that the rash is also above each breast. The pt does not have a fever and states she is otherwise fine. She states if it is not gone by Friday she will go to her doctor.
Mom reports she noticed a change in pt's behavior starting the evening of 01/27/2005. Pt was withdrawn, quiet, clingy, and needy. Per mom, he stopped liking daycare and would have fit over going to daycare. Mom states he felt warm for about 1 week. No temp was taken. Tylenol was given with minimal relief. Behavioral changes lasted for 3 weeks and mom noticed on 02/19 Pt was back to normal self.
This spontaneous report ass received from a consumer reporting on himself a 61 year old male patient who on 23-MAR-2014, was vaccinated with ZOSTAVAX (dose, lot and route not provided). Concomitant therapies included LIPITOR. Consumer stated that his injection arm hurt the same day as administration on 23-MAR-2014, but on 24-MAR-2014, he felt sick and experiencing nausea, vomiting several times, headache and body aches. He stated his symptoms feel like a stomach bug. The patient sought medical attention called pharmacist. The patient said he has seen people had reactions from unspecified flu shots (MARRS # 1403USA012303). NO further AE information provided). The outcome of his injection arm hurt, his symptoms feel like a stomach bug, body aches, headache, vomiting several times, nausea and felt sick were unknown. Additional information has been requested.
Found out I have atrial fibrillation; Stroke after first dose; This case was reported by a consumer via call center representative and described the occurrence of stroke in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2022, the patient received the 1st dose of Shingrix. On 21st April 2022, 20 days after receiving Shingrix, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the patient experienced atrial fibrillation (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke and atrial fibrillation were unknown.   It was unknown if the reporter considered the stroke and atrial fibrillation to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR094009   Additional Information: GSK Receipt Date: 16-Jun-2022 Reporter's Comments: The patient self-reported this case. The patient had a stroke after his/her 1st dose of Shingrix vaccine and also found that he/she had atrial fibrillation. The patient had been going to doctor physical once a year and twice a year after he/she turned 65 year old. The patient stated he/she would have to go to assisted living soon. Additional Supportive Information: For tolerance to 2nd dose, refer case US2022AMR094009. GSK note: There was a discrepancy in product onset dates and event onset dates, AI was raised for the same and will be clarified in the next follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR094009:Same reporter
Patient started feeling jittery 24 hours later after receiving 1st dose; Patient had a sore arm; This spontaneous case was reported by a physician and describes the occurrence of FEELING JITTERY (Patient started feeling jittery 24 hours later after receiving 1st dose) and VACCINATION SITE PAIN (Patient had a sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included ESTRADIOL (ESTROGEL) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Patient had a sore arm). On 27-Feb-2021, the patient experienced FEELING JITTERY (Patient started feeling jittery 24 hours later after receiving 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING JITTERY (Patient started feeling jittery 24 hours later after receiving 1st dose) and VACCINATION SITE PAIN (Patient had a sore arm) 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.
Redness and swelling of R tricep area extending to elbow, non tender, no adenopathy.
body aches; chills; This case was reported by a nurse via call center representative and described the occurrence of general body pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2019, the patient received the 1st dose of Shingrix. On 19th August 2019, less than a day after receiving Shingrix, the patient experienced general body pain and chills. On an unknown date, the outcome of the general body pain and chills were unknown.   It was unknown if the reporter considered the general body pain and chills to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient reported that, received vaccine day before the reporting and was told about the possible side effects but, was sure that could not get them. On the day of reporting, the patient wondering about how she could expect the achiness and chills to last.
Patient was seen in the urgent care the day after she received the Shingrix vaccine. The patient experienced erythema and edema around the injection site. She did not require treatment for this issue to resolve.
still got the Shingles/ Suspected vaccination failure; Shingles; Tooth ache; Pain; Gum pain; Pain grom cheek to nose; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (Verbatim: still got the Shingles/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), toothache (Verbatim: Tooth ache), pain (Verbatim: Pain), gum pain (Verbatim: Gum pain) and facial pain (Verbatim: Pain grom cheek to nose). The patient was treated with gabapentin. The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the toothache, pain, gum pain and facial pain were resolved (duration 1 month).   It was unknown if the reporter considered the vaccination failure, shingles, toothache, pain, gum pain and facial pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, toothache, pain, gum pain and facial pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and still experienced shingles. The patient stated that he or she pray you never had a break out it was the worst pain he or she ever experienced. The patient reported that on last year his or her left gum area felt like a toothache it would start at the top of cheek and go to the nose. The patient went to the dentist and she told him or her had shingles.  The patient stated that he or she was in pain for a month. The diabetic physician gave him or her Gabapentin as a treatment and it was worked. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Red itchy rash at injection site; Red itchy rash at injection site; Red itchy rash at injection site; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 5730), intramuscular (left arm) on 22Dec2020 15:15 at single dose for Covid-19 immunization. The patient's medical history included Intracranial HTN (intracranial hypertension) and known allergies: PCN (Penicillin). Concomitant medication included acetazolamide sodium (DIAMOX), topiramate (TOPAMAX), and Multivitamin. The patient previously took Augmentin, tetracycline, and Ceclor and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced red itchy rash at injection site on 26Dec2020. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
Headache fatigue, shoulder pain Narrative:  states was "burning up" but did not take temp  headache worsened through next day injection site was red and  warm
Headache and sore arm at injection site with a few hours. Worsened overnight. Muscle aches within 12 hours after injection.
11-18-05 t 97.7- right arm tenderness, redness, swelling, cellulitis. Right arm 22 cm x 36 cm erythema. Right arm 2.54 cm > than left arm. Keflex 500 mg t T.I.D. times 7 days
Rash first appeared on left collar bone area, started to spread to other areas of chest.  Then to back and side of neck and under chin, finally a few rash spots appeared on face.  some rash on the back of my shoulder, and some on the back of both my hands. Doctor prescribed steroid cream, and said it has nothing to do with the COVID-19 vaccines because if it was related, rash would appear around injection site (no rash in that area).  With no improvement, finally referred to dermatologist; did a patch test and was told I have contact allergy!  Allergic to 5 out of the 36 tested.  Prescribed also steroid ointment, nothing else.  No improvement so far, rashes very itchy.
Redness (approximately 7in in diameter); Tenderness. Warm to the touch. On & off tingling sensation down the arm. Darker red in center w/ lighter red around surrounding injection site.
Pt. called overnight pharmacist stating she had a "round raised quarter sized welt." She had received vaccine 2 days prior. At the time she stated she had thought she had an egg allergy as a child-but she does eat eggs as an adult. She was observed for 15 minutes after vaccine administration.
Pt has been bleeding on and off since 6/14/2021. These are normal flows, with menstrual cramps during the first couple of days of bleeding. Pt says she has been taking iron supplements to prevent anemia.   Up until receiving her second Covid vaccine, her periods were regular and considerably less painful; she credits the bioidentical hormones for reducing her period pain.
sore arm; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (extremely tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 PAIN IN EXTREMITY (sore arm) and FATIGUE (extremely tired). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (extremely tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant medication information was reported.   This case was linked to MOD-2021-101721 (Patient Link).
Initial report received from a healthcare professional on 10 September 2013. A female patient whose medical history was not reported and had no concomitant medications, had received a dose of Flu vaccine (lot number, route, dose number and anatomical site of administration were not reported) on an unspecified date. On an unspecified date, after vaccination, the patient had had fever, dehydration. Laboratory investigations were not reported patient had received IV fluids and antibiotics as corrective medications. At the time of this report, the outcome was unknown. Documents held by sender: None.
2 in x 2 in- redness 1 cm x 1 cm knot.
developed rash 4 days after his immunizations: Diagnosed with juvenile Dermatomyositis (JDM) She has been referred to Pediatric Rheumatology. She has an appointment on 7/26/19. Anticipate she will be admitted & will start treatment at that time.
This case was reported by a nurse via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX (batch number MY2B2, expiry date unknown) for prophylaxis. On 8th November 2018, the patient received SHINGRIX (intramuscular). On 8th November 2018, several minutes after receiving SHINGRIX, the patient experienced shingles and rash. The patient was treated with antivirals for systemic use (Antiviral). On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. On the day of reporting, the patient received SHINGRIX on left deltoid. A few minutes after receiving SHINGRIX, the patient experienced a rash on the axilla area on the opposite side where the vaccine was administered. The cause of this rash was unknown, but shingles was being considered as a cause. A reaction to the vaccine and/or a yeast infection were considered as possible causes. The nurse declined to provide patient information. The nurse declined postal follow-up and agreed for phone call follow-up only.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 25-JUN-2013 the patient was vaccinated with an expired dose of GARDASIL (route not specified). Healthcare worker reported that this was the first dose of the GARDASIL series, with lot number and expiration date: 1511Z dose, exp. date 26-APR-2013 (reported as 29-APR-2013). Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
sore arm beginning about 2 hours after shot and still continuing 24 hours later. Pain when moving arm
After 10 hours of 2nd dose, I experienced anaphylaxis - rash all over my entire body, nausea, low blood pressure and my body was shaking from being so cold even though I felt like I was on fire from the inside.
Swelling of left leg.   Ultrasound left lower extremity (06/01/2021) showed extensive occlusive DVT. Started Xarelto on 06/01/2021.  15mg twice daily for 21 days.  Appointment to see vascular surgeon on 06/04/2021.
Tremors; headache; heart palpitations; shortness of breath; chest tightness; nausea; anxiety; high blood pressure; feeling unwell and doomed; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Feb2022 12:00 (Lot number: FE 3594) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Latex" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE [PREDNISONE ACETATE]. The following information was reported: TREMOR (non-serious) with onset 19Feb2022, outcome "not recovered", described as "Tremors"; HEADACHE (non-serious) with onset 19Feb2022, outcome "not recovered", described as "headache"; PALPITATIONS (non-serious) with onset 19Feb2022, outcome "not recovered", described as "heart palpitations"; DYSPNOEA (non-serious) with onset 19Feb2022, outcome "not recovered", described as "shortness of breath"; CHEST DISCOMFORT (non-serious) with onset 19Feb2022, outcome "not recovered", described as "chest tightness"; NAUSEA (non-serious) with onset 19Feb2022, outcome "not recovered", described as "nausea"; ANXIETY (non-serious) with onset 19Feb2022, outcome "not recovered", described as "anxiety"; HYPERTENSION (non-serious) with onset 19Feb2022, outcome "not recovered", described as "high blood pressure"; MALAISE (non-serious) with onset 19Feb2022, outcome "not recovered", described as "feeling unwell and doomed". The events "tremors", "headache", "heart palpitations", "shortness of breath", "chest tightness", "nausea", "anxiety", "high blood pressure" and "feeling unwell and doomed" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tremor, headache, palpitations, dyspnoea, chest discomfort, nausea, anxiety, hypertension, malaise.  Additional Information: No other vaccine in four weeks. Covid prior to vaccination and covid tested post vaccination. Pfizer have permission to contact the reporter about this event. Pfizer have permission to contact your/the patient's healthcare provider about this report. No follow-up attempts are possible. No further information is expected.
Large bump at site of vaccination formed after intramuscular injection of 0.5 mL.
Pt recvd 3rd dose of vax on 9JUN92 & 48 hrs p/vax devel tingling sensation in the fingers of the lt hand which lasted for approx 3 days;
Patient has a rash that is on her neck, that is on the side she had the vaccine and it is going towards the center. The area does not itch, but it is hot to touch. The area is raised and red.
flu like symptoms, itching started yesterday. red area at the injection 3-4-21 at 8pm. used aloe and reports it helped with the itching. recommended antihistamine and ice to area 10mins on/off, verbalized understanding.
Pain at the injection site began the day of vaccination, and remained until yesterday (1/6/2021). During this time there was no redness or swelling.  On 1/6/2021 arm became dark red swollen and hot with small blisters at the vaccination site (3inx2in) and, swelling and redness has extended down to the elbow on all sides of the arm. Also 1/6, experienced joint pain and chills in mid afternoon and fever of 100F. Treated with Advil 1/6. Some mild joint pain remains 1/7. Medrol dose pack started 1/7 for the arm pain and swelling.
On day one I had some dizziness a couple of hours after my injection.  That lasted for 2-3 hours. On the 2nd day just had some tiredness. Since then I have been fine.
Pts mother called and reported the pt was having difficulty swallowing. Pt was at home and was instructed to seek medical attention immediately.
Patient presented to the ED and was subsequently hospitalized for Compression fracture of lumbar vertebra within 6 weeks of receiving covid vaccination.