chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves six-year-old patient (gender not reported) who was vaccinated with a dose of ADACEL instead of DAPTACEL on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was unknown if patient had any adverse event. 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. Follow-up report was received from a consumer/non-healthcare professional (office staff) on 23-Oct-2018. No new information was updated. List of documents held by sender: none.
Pt presented for 2nd dose on 6/28. Pt noted that ~24hrs after receiving the first dose, he developed left sided hives and numbness that lasted a few days.  Unknown if any rescue medication was used during that time.  2nd dose held.
Extremely Sore Left arm for 22 days. No treatments. Constipation for 6 days. Enema given. Light Fever on days 3,4, and 6. No treatments. Severe coughing with lung pain from day 7- Present. Treatment is cough drops/Dextromethorphan HBr on Day 26. No male penis erections from Day 10-30. No treatments. Extreme Nausea from Day 14-Present. Feelings of vomiting but never did. 4-6 hours each day.
ACHES; STIFF NECK; SWELLING; GENERALIZED JOINT PAIN; MUSCLE PAIN9; INJECTION SITE PAIN; VERY FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 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 13-MAR-2021, the subject experienced aches. On 13-MAR-2021, the subject experienced stiff neck. On 13-MAR-2021, the subject experienced swelling. On 13-MAR-2021, the subject experienced generalized joint pain. On 13-MAR-2021, the subject experienced muscle pain9. On 13-MAR-2021, the subject experienced injection site pain. On 13-MAR-2021, the subject experienced very fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle pain9, generalized joint pain, aches, stiff neck, swelling, injection site pain and very fatigue was not reported. This report was non-serious.
Got my first shot, flared up / same thing with the second shot, but they cleared up quickly/Suspected vaccination failure; Got my first shot, flared up / same thing with the second shot, but they cleared up quickly; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with dermatologicals nos (Calamine Lotion). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination and age group were not reported. The case was reported by the patient. The patient got 1st shot of Shingles vaccine and had them for 9 months last year, the events also flared up. The patient went on the antibiotics immediately. Same thing with the 2nd shot of Shingles vaccine, but they cleared up quickly calamine lotion was your best friend. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratoy test confirming shingles were not provided. For tolerance in 1st dose refer case US2021AMR111243.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR111243:Same reporter
This spontaneous report as received from a pharmacist refers to a 67 year old male patient with no drug reactions or allergies. The patient had no pertinent medical history and took no concomitant medication. On 19-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX, 19400 PFU, 0.65 ml, subcutaneous in the left arm (lot # K018171, expiration date 23-OCT-2015). On 29-JUN-2015, the patient experienced painful rash, which started on the sole of one of his feet and had spread to the calf of the same unspecified lower extremity (the patient was diagnosed as having shingles). The patient was prescribed to take aciclovir 4 times a day for 7 days and gabapentin 300 mg three times a day as a treatment for the shingles. The patient started treatment on 09-JUL-2015. At the time of reporting the patient did not recover from the event. The patient sought medical attention. At the time of reporting the patient did not recover from the event. The patient sought medical attention. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Myalgia felt cold, shivering, chills, achy, sore arm and fatigue Narrative:
This case was reported by a nurse and described a 49 year old male patient who did not respond to Hep-B vaccine.   On 12 JAN 2004  and 10 FEB 2004, the patient received the first and second dose of Energix-B.  On 14 JUL 2004 the patient received the third dose of Energix-B.  On 16 SEP 2004, a Hep-B surface antibody titer was "negative".  The reporting nurse considered the event to probably be related to vaccination with Energix-B
Extremely delayed menstruation. Had one light period in July (9 weeks late) and nothing since (13 weeks). Not pregnant, no weight loss or other changes to explain symptom.
This spontaneous report was received from a healthcare professional concerning an unknown number of patients of unknown age and gender. In November 2015, the patients received improperly stored GARDASIL 9 lot # L014415, expiration date: 25-JUL-2016 (dose and route were not reported). No adverse effect reported. This is one of two reports received from the same source. Additional information has been requested.
Diarrheas; Headaches; Vision changes; Sore arm; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 07Feb2021 14:30 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies: Latex" (unspecified if ongoing), notes: allergies: Latex; "allergies: NSAIDS" (unspecified if ongoing), notes: allergies: NSAIDS; "allergies: Penicillin" (unspecified if ongoing), notes: allergies: Penicillin; "Slight depression" (ongoing), notes: Slight depression. Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR]. Past drug history included: Epinephrine, reaction(s): "allergies: Epinephrine", notes: allergies: Epinephrine. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Feb2021 17:00, outcome "not recovered", described as "Sore arm"; DIARRHOEA (non-serious), outcome "not recovered", described as "Diarrheas"; HEADACHE (non-serious), outcome "not recovered", described as "Headaches"; VISUAL IMPAIRMENT (non-serious), outcome "not recovered", described as "Vision changes". The events "sore arm", "diarrheas", "headaches" and "vision changes" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain in extremity, diarrhoea, headache, visual impairment. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received acyclovir within 2 weeks of vaccination. The first and second days were sore arm. After each shot and until the 16th day, the patient had ongoing diarrheas, headaches, vision changes and depression. The depression was still ongoing. The events resulted in healthcare professional office visit. The patient has not been diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101389517 Same patient, same product with different dose, different event
Around 4/8, I began to experience an intense fist-sized pain in my left-mid back. Later that day, the pain moved to where my appendix would be and lasted a couple of days. Afterward, the pain moved to my right mid-back. I already had a urology appt set for 4/14, we did a kidney ultrasound. The pain subsided for a few days.  The pain came back a lot worse all over my back on 4/16 and lasted several days. The pain made it difficult to get a full breath. I called my PCP but wasn't able to get an appt. The pain was gone by 4/19.
I received Flu shot in my left upper arm; I woke up in the morning with shoulder pain and limited range of motion. I called pharmacy several times with my complaint and they said someone would call me back but it took 2 weeks before someone responded to my concerns and advised me to see my doctor. I went to my general practitioner on 10/27/17 and he advised me to see an orthopedic doctor. I have had pain and limited range of motion for 8 weeks now and the pain in more intense when lying down preventing me from getting much sleep; I also have difficulty with upper body dressing and require assistance due to lack of range of motion and severe pain. I am scheduled to see orthopedic doctor for further treatment.
headache, flushing, redness , warmth and hardness at injection site, weakness and extreme fatigue
Information has been received from a registered nurse concerning an 8 year old female who was vaccinated on 07/31/1996 with a dose of varicella virus vaccine live (Oka/Merck).  The patient was seen on 03/31/2004 with a few pox on her trunk.  The child was noted to have chickenpox breakthrough.  Unspecified medical attention was sought.  There was no product quality complaint.
Temperature of 104.6F rectal at 22:20, 102.8F rectal at 23:25, 100.9F rectal at 00:15. Generalized seizure lasting approx 1-3 min observed by parents. Vaccines given 3/11/02 at approx 11:30. D/C from ER at 00:55 on 3/12/02.
Worsening SOB, cough and wheezing with history of COPD. Pt having fatigue, palpitations and leg swelling. Chest Xray suggestive of mild fluid overload/CHF, BNP 894.
This spontaneous report as received from a physician via a company representative refers to a 58 year old male patient. On 08-OCT-2013 the patient was vaccinated with ZOSTAVAX (lot#, dose and frequency not reported), subcutaneous. The treating physicians office manager explained that on 09-OCT-2013 the patient developed redness at the injection site after receiving ZOSTAVAX. The outcome of the event was reported as recovering/resolving. The patient had sought medical attention by office visit. Additional information has been requested.
pt recvd vax & PC from mom states T 100 ax; fussiness, pt lies on floor w/ arched back, eye w/ "spacy look";RN advised more apap;called RN again stated nl rxn when given apap this often;CHN advised to take to hosp stat; to hosp;
Imovax PEP administered on 1/17/22 for patient's day #3 and again on 1/21/2022 for client's day #7. On both days the right patient was identified, the right medication was given at the right dose and at the right time. The expiration date of 12/07/2021 was overlooked on both 1/17/2021 and 1/21/2021.
One day after I suffered from a bad headache, nausea (but no vomiting), muscle aches, shortness of breath, chest pain, and fatigue. Two days after the injection site is itchy.
This case was reported by a consumer and described the occurrence of respiratory virus in a 60-year-old female patient who received Flu Seasonal TIV Dresden (influenza vaccine unspecified 2011-12 season). Concurrent medical conditions included asthma. Concomitant products included FLOVENT, VENTOLIN HFA and lisinopril. In 2011, the patient received Influenza vaccine unspecified 2011-12 season. In 2011, 14 days after receiving Influenza vaccine unspecified 2011-12 season, the patient experienced respiratory virus and viral cold. On an unknown date, the outcome of the respiratory virus and viral cold were unknown. It was unknown if the reporter considered the respiratory virus and viral cold to be related to Influenza vaccine unspecified 2011-12 season Additional details: The patient received the flu shot from the unknown manufacturer in the fall 2011. 14 days after vaccination the patient experienced a viral cold affecting the respiratory tract.
Narrative: 69yo male pt with hx of liver cell carcinoma due to hepatitis C virus died on 8/19/2021. pt had received covid vaccines on 2/5/21 & 3/8/21. Likely vaccines are not related to pt's death given liver cancer diagnosis.
Started with cold symptoms, scratchy throat, runny nose, body aches, headache, cough. Went to work on 06.26.22 and rapid test was positive - treated with Paxlovid but only took 2.5 days before feeling lightheaded, foggy so stopped taking the antiviral
fever to 100; chills; myalgias; headache; axillary lymphadenopathy with swelling and pain; This is a spontaneous report from a contactable healthcare professional (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0140 expiration date unknown), via an unspecified route of administration in the left arm on 11Jan2021 at 10:45 at a single dose for COVID-19 immunisation.  Medical history included non-celiac gluten induced enteropathy, COVID from 27Sep2020 to an unknown date (had COVID with mild course x2 days), and allergies to NSAIDS and SSRIs. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), amlodipine besilate (NORVASC), colecalciferol (VITAMIN D [COLECALCIFEROL]), and omeprazole (PRILOSEC [OMEPRAZOLE]) on unspecified dates for unspecified indications.  The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899 expiration date unknown) on 22Dec2020 at 10:45AM in the left arm for COVID-19 immunization; also previously took amoxicillin and experienced allergies. The patient was not pregnant. On 12Jan2021, at 12:00 AM, 12 hours after vaccine, the patient experienced fever to 100, chills, myalgias, headache. The patient was better 12 hours later after one dose of Tylenol. The patient also had axillary lymphadenopathy with swelling and pain, present since day 1 post vaccine (12Jan2021) and still swollen but pain improving. There was no treatment received for the adverse events. The outcome of the events was recovering at the time of report.
Pt's left arm became swollen from deltoid to entire length of arm. She complained of discomfort and hives.
Received phone call, pt stated she began having symptoms 8 hrs after receiving shot, states she had high fever and severe swelling in her arm. Pt states went to PMD and was diagnosed with cellulitis and was treated with a steroid and an antibiotic shot and is currently on oral antibiotics and is improving.
UNABLE TO BREATHE; STOMACH ON FIRE; NAUSEOUS; UNABLE TO EAT; LOSS OF TASTE UNRELATED TO COVID-19; BLOATING; THROAT PAIN; LOSS OF SMELL UNRELATED TO COVID-19; MOUTH PAIN; THROAT SWELLING; BLOODY DIARRHEA; NOT FEELING GOOD; SEVERE HEADACHES; This spontaneous report received from a patient 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 not reported, batch number: 1805022, and expiry: UNKNOWN) 1 total, dose was not reported, administered on left arm on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-APR-2021, the patient had severe headaches that were not resolved with narcotic and migraine medication. On 05-MAY-2021 (8 days after vaccination), the patient had bloody diarrhea which lasted 3 days. On 16-JUN-2021, the patient was hospitalized for the stomach being on fire and would be getting an endoscopy to rule out an ulcer. The patient also had throat and mouth pain as well as bloating. It was reported that, the patient was unable to breathe because of throat swelling. The patient had visited emergency room on 17-JUN-2021 and 18-JUN-2021. The patient was discharged on 18-JUN-2021. It was reported that, the patient had not felt good since vaccination. On an unspecified date, the patient was being nauseous, unable to eat, loss of taste/smell unrelated to COVID-19.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bloody diarrhea on 08-MAY-2021, had not recovered from severe headaches, and not feeling good, and the outcome of nauseous, unable to eat, loss of taste unrelated to covid-19, bloating, throat pain, loss of smell unrelated to covid-19, mouth pain, throat swelling, stomach on fire and unable to breathe was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, from the same reporter is linked to 20210643383.; Sender's Comments: V0: 20210642487-covid-19 vaccine ad26.cov2.s-bloody diarrhea, stomach on fire, unable to breathe. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pt recvd vax & devel upper extremity pain & weakness, flu-like sx, general malaise & weakness throughout body, pain radiating down legs, paresthesia of fingers, fatigue; painful, myelitis, neuropathy, radiculitis, neurogenic bladder;
CKD symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 30-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1), for COVID-19 immunisation. The following information was reported: CHRONIC KIDNEY DISEASE (medically significant), outcome "unknown", described as "CKD symptoms". Clinical course: the patient suspected that CKD symptoms started after vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
nausea, fever (100.4), muscle pain, no appetite.   It felt as if I had the Shingles all over again.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender with no pertinent medical history, drug reaction or allergies reported. Since 03-JUN-2015, (specific dates unknown), the patients were administered doses of (Oka/Merck) VARIVAX subcutaneous (dose, lot number and expiration date were not provided) which underwent a temperature excursion. Concomitant therapy was not reported. No adverse effects were reported. This is one of several cases from the same source. Additional information has been requested.
Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR084564   Additional Information: GSK Receipt Date: 15-JUN-2023 This case was reported by a patient via interactive digital media. It was reported that a patient who got the Shingles vaccine shot immediately got shingles. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR084564 and US2023AMR084563, same reporter.; Sender's Comments:  US-GSK-US2023AMR084564:Same reporter US-GSK-US2023AMR084563:Same reporter
Injection site is red and hot; injection site is very red; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site is red and hot) and VACCINATION SITE ERYTHEMA (injection site is very red) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site is red and hot) and VACCINATION SITE ERYTHEMA (injection site is very red). At the time of the report, VACCINATION SITE WARMTH (Injection site is red and hot) and VACCINATION SITE ERYTHEMA (injection site is very red) outcome was unknown.            No concomitant and treatment medications were reported.
Welp saucer size right under injection site Flu like symptoms, fever at 102 deg
Fatigue, chest pains, inability to inhale completely, memory loss, continual joint aches, development of Hashimotos's disease, decrease in thyroid function, sever headaches
Swollen lymph nodes under right arm 29 to 30 hours after receiving vaccination. Still experiencing swollen lymph nodes 4 days later.
Pt had temp intermittently of 104.6 from 36 hrs p/immun to 4 days; no other sx; Seen by MD who did blood test which were neg;
Mild rash around groin and lower forearms. Very little itching, minor swelling and redness, especially in areas of tight fitting clothing, started early in the morning on April 21, 2021. Took an extra 5 mg Xyzal tablet in the morning and rash disappeared in an hour. Rash returned in the evening, so took my usual nighttime dose of 5 mg Xyzal  in the evening and it again disappeared in an hour. Rash retuned the morning of 4/22/2021, similar to the night before. Again, took Xyzal and it disappeared in an hour. Evening of 4/22/2021 the rash did not reappear. Still took evening dose of Xyzal, as usual. This morning, 4/23/2021, no rash present. Took a morning dose of 5 mg Xyzal to be sure.   A similar rash has occurred before...see below.