chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at injection site; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of chills (received 1st dose on unknown date, refer case US2020AMR184222).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had pain at injection site maybe due to inexperience pharmacist who administered. The insurance would not reimburse for a doctor's visit. Event lasted for 20 hours.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR184222:same reporter
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO (batch number 157101, expiry date unknown). On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional information was reported as follows: The age at vaccination was not reported. The patient called back to the reporter's office about the pain with the vaccine. The reporter agreed to follow up. This case is 1 of the 8 cases, reported by the same reporter.
Hospitalized; Has been 49 days since the first dose; A spontaneous report was received from a consumer concerning a 81-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was hospitalized during the scheduled second dose and has been 49 days since the first dose/ product dose omission issue.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 05 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch no: 011M20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date, the patient was hospitalized during the scheduled second dose and has been 49 days since the first dose. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event was hospitalized during the scheduled second dose was not provided. The outcome of the event has been 49 days since the first dose was considered resolved.; Reporter's Comments: This report refers to a case of hospitalization and. product dose omission issue for mRNA-1273 (Batch no: 011M20A) with no other AEs reported
got the flu; Initial information received on 23-Nov-2020 regarding an unsolicited valid non-serious case a non-health care professional via social media in the   This case involves an adult patient with an unknown demography details who got the flu (influenza), while having received vaccine influenza vaccine.   The patient's medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown dates, the patient received two doses of suspect influenza vaccine (produced by unknown manufacturer) (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown dates, (latency: unknown) after starting the suspect vaccine therapy, the patient got the flu (influenza) both the times he/she took the flu shot. Stopped taking it and the patient did not have the flu since.   Details of laboratory data not reported.   It was not reported if the patient received any corrective treatment.  The patient had recovered from the event, at the time of this report.  There will be no information available regarding batch number in this case.
This spontaneous report as received from a Registered Nurse refers to a 18 year old female patient. No medical history or concurrent conditions reported. On 31-JUL-2013 the patient was vaccinated with the first dose of GARDASIL. (Route, lot# and expiration date were not provided). Concomitant therapy was not reported. On 21-OCT-2014 the patient was vaccinated with the second dose of GARDASIL (route, lot# and expiration date were not provided). No adverse effects reported. Additional information has been requested.
Breakthrough case admission after 2 vaccines  Pfizer 6/8/21 lot# ER8736;  Pfizer 6/29/21 lot# Ew0187
Pt called pharmacy to report swelling, tender to touch, redness and pain due to injection. Also reports hear and itchiness->advised pt to seek medical care at MD/hospital.
Symptoms:  Loss of voice, cough, Moderate Headache, and Mild Temp lasting approx 24 hours. Did not require emergency treatment, took 1000mg APAP with rest.   I just wanted to report for data purposes to assist in possible reactions.
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 19 year old male. 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, intramuscular, batch number: 201A21A, and expiry: 21-SEP-2021) .5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211038507, 20211038614, 20211002617, 20211034734, 20211038664, 20211038411, 20211039749, 20211038442, 20211040433 and 20211039732.
Starting the morning after the second dose, she developed encephalopathy--was speaking incoherently, unsteady on her feet, fatigued. Had fever of 101. Next day was making sense, but could not remember what was going on and repeatedly asked orientation questions. Slept nearly all day. Over the next couple of days improving but still somewhat confused. Thought she had gone to work when she was at home all day. At this point, is nearly back to normal, but has no memory of the events of the first two days after the vaccine. Interestingly, her sister had the vaccine a few days before, and developed weakness on one side (she is not my patient).
Vasovagal syncope, followed by nausea/vomiting, declined transport to ER
Right eye became heavy within 2 minutes of receiving vaccine and resolved 20 minutes following injection. No visible deficit.  Bilateral eye blurring R>L that has lasted for 2+ hours following injection.
Drowsy; swollen left breast; Dizzy; swollen left arm/ swollen left under arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), SOMNOLENCE (Drowsy), PERIPHERAL SWELLING (swollen left arm/ swollen left under arm) and BREAST SWELLING (swollen left breast) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced DIZZINESS (Dizzy) and PERIPHERAL SWELLING (swollen left arm/ swollen left under arm). On 06-Aug-2021, the patient experienced BREAST SWELLING (swollen left breast). On an unknown date, the patient experienced SOMNOLENCE (Drowsy). On 09-Aug-2021, PERIPHERAL SWELLING (swollen left arm/ swollen left under arm) and BREAST SWELLING (swollen left breast) had resolved. At the time of the report, DIZZINESS (Dizzy) and SOMNOLENCE (Drowsy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter
could not navigate her legs; She was not able to stand up on her own; could not move her legs; This is a spontaneous report from a Pfizer-sponsored program  from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, on 23Mar2021 as a single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162b2 on 23Mar2021 and at night she could not move her legs. She was not able to stand up on her own and could not navigate her legs. She rushed to the emergency. The patient was scheduled to take the second dose of the vaccine on 13Apr2021. She was worried that maybe she would experience the same effects of the vaccine. The clinical outcome of the events, could not move her legs, was not able to stand up on her own and could not navigate her legs, was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Feels weak; Awaken from sleep; Headache/headache on her left side of head; She couldn't breathe; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She couldn't breathe), ASTHENIA (Feels weak), INSOMNIA (Awaken from sleep) and HEADACHE (Headache/headache on her left side of head) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001BZ21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sleep apnea. Concomitant products included GABAPENTIN, PARACETAMOL (TYLENOL) and CORTISONE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced DYSPNOEA (She couldn't breathe), INSOMNIA (Awaken from sleep) and HEADACHE (Headache/headache on her left side of head). On 18-Mar-2021, the patient experienced ASTHENIA (Feels weak). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DYSPNOEA (She couldn't breathe), ASTHENIA (Feels weak), INSOMNIA (Awaken from sleep) and HEADACHE (Headache/headache on her left side of head) outcome was unknown.            Patient was advised to lay on her side with a proper pillow under her head when sleeping  and to take rest. Healthcare provider was aware of the Moderna vaccine administration at the time of cortisone injection. Patient is not sure about the lot number as writing was not legible on the card.(might be 20B21A).
Received vaccine 1/23/09.  Febrile seizure 1/30/09
Steady growth of cyst-like area on side of face, first noticed by patient (reporting) early/mid-November, 2022 (about a month after receiving vaccination) seen by dermatologist 1/12/23 (5-week delay due to difficulty in getting an appointment). Dermatologist diagnosed as Keratoacanthoma of cheek, from his notes on MyChart:  ?ordered DESTRUCTION MALIGNANT LESION 0.6-1 cm (Face)? by excision and electrodesiccation. Size of tumor was 0.9 cm in his notes. Currently the wound is healing without any adverse symptoms.
Patient's parent states that 2 weeks after receiving vaccine, the child experienced muscle weakness. Parent read an article online and presented today, 08/14/2020 to report reaction.
Itching  started within an hour all over, hives started about 3 PM across abdomen and spread from there, took Benadryl at 7 PM.  Bed at 7:30 PM woke up at 5:00 and felt funny and went back to sleep and woke up 7 AM and tongue really swollen, difficulty swallowing and drove self to ER and after arrival, difficulty breathing,  O2 sat down to 89%.  at 10  minutes later gave IV Benadryl, Solumedrol and IV EPI. Within 1 minute of EPI all symptoms gone except tongues swelling.  Stated in ER for 5 hours. Everything normal and discharged.  Hives returned 12 hours later and topical cream Mometasone used.  Still on Oral Steroids and Oral Benadryl for 10 days. Hives continued for 2 weeks.  Developed irritated and painful  skin eruptions that looked like blood blister and as disappeared left behind a pit and a scar.  Just now resolving in the last week.
R09.02 HYPOXEMIA 9/7/2021 FAILURE TO THRIVE SYNDROME, ADULT R09.02 HYPOXEMIA 9/7/2021 DEHYDRATION R09.02 HYPOXEMIA 9/7/2021 DYSPHAGIA R09.02 HYPOXEMIA 9/7/2021 DEHYDRATION R09.02 HYPOXEMIA 9/7/2021 SEPTIC SHOCK
Left arm pain at injection site. Diarrhea, terrible headache, body aches from head to toe, fatigue
patient came in today 07/24 and was asking about adverse effects of the vaccine. she listed some adverse effects she had experienced and most of them were listed in the package as normal or expected adverse effects such as sweating, fatigue, muscle aches, fever and shivering. she said she had no GI issues, but said the events did not start until the next day in the evening.  the one thing she did report which is not listed is bone aches, I asked the patient if she thought maybe this was just muscle aches which are normal but she said it was pretty bad "bone pain" and also reported some chest tightness. I asked patient if it was bad enough she needed medical attention or if she called her md and she said not that it was not that bad but it took about 3 days to get better, at this point she said she was much better but wanted to make sure this was ok and was not sure if she needed to let us know. patient still wants to get second dose.
Left ocular redness, inflammation, and irritation noticed one week post vaccination (10/1/21); initial treatment with antihistamine with limited resolve; recurring weekly inflammation;  severe ocular inflammation, photophobia, redness led to seeking medical treatment on 10/22/21; treatment included ophthalmic drops and systemic and ophthalmic steroids; follow up/ongoing care with Optometrist/PCP
Lack of effect/ Suspected Vaccination failure; Shingles; This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and unknown 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were received as follows: The patient completed the 2 dose series of Shingrix and then developed a case of Shingles. The reporter consented to follow up. The reporter did not vaccinate the patient and they did not have the data at the time of the call.
pt recv vax 5DEC97 910AM & 11AM pt noted some rash on neck;pt exp itching recommend seek med care;12:40 to ER given DPH & decadron IV;
bell Palsy symptoms/left facial nerve palsy; This is a spontaneous report from a contactable physician reported for a female patient.  A 30-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) solution for injection, intramuscular, administered in arm left on 15Jun2021 (Batch/Lot number was not reported) as dose 2, single (at the age of 30-year-old, not pregnant) for COVID-19 immunization.  The patient medical history was not reported. Concomitant medication included clindamycin.  The patient previously took amoxicillin and azithromycin and experienced allergy both.  The patient previously received BNT162B2 for Covid-19 Immunization as 1st dose.  There was no other vaccine in four weeks.  The patient did not have COVID-19 prior vaccination, no COVID tested post vaccination.  The most recent COVID-19 vaccine was administered in pharmacy or drug store.  Since the vaccination, the patient had not been tested for COVID-19.  Patient started developing left facial weakness 3 days after the vaccination on 18Jun2021 and had progressed to significant left facial nerve palsy on 18Jun2021. Seen today (22Jun2021) in ER by the physician, 4 days of progressing bell Palsy symptoms from 18Jun2021. These events resulted in emergency room/department or urgent care.  These events did not result in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating or congenital anomaly/birth defect.  The patient received treatment of steroids and antiviral medications.  Outcome of the events was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: There is a reasonable possibility that the event Bell's palsy was related to BNt162b2 based on known drug safety profile and temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
CDC reports: 2 mo infant developed local rxn @ inject site & screaming episode lasting 5 hrs following DTP/OPV immunization.
Allergic reaction approximately one week post vaccination. Severe Redness, swelling and soreness at site of application.
Erythema with pronounced boarder 13mm x 6mm, pruritus, and heat starting 12 days after vaccination
Pt had temperature 105F-106F, unable to walk "periodically" and crying with severe leg pain in both legs, falling in the floor and continues to complain of leg pain at times. Seen by MD at hospital and he ordered no further immunizations; other ordered to be given. Mild URI treated with Tylenol.
pt recvd vax & devel neurological sx including lt-sided paralysis which required hospitalization;pt was found to have Multiple sclerosis;probably has been discharged;outcome: some residual paralysis;
Patient at  mass vaccination site and being monitored in 30 minute area in her car after Moderna vaccine. History of allergies with anaphalaxis to Bee, sodium nitrate and sulfa.  At approximately 10 minutes the 15 minutes later had onset of rash and tightness of her throat. Over the next 15 minutes developed a rash on her chest. Given Benadryl 50 milligrams 25 minutes after her vaccine immediate when rash began. EpiPen about 30 minutes after her vaccine due to increasing symptoms of chest tightness without any improvement. Patient with stable vital signs. Blood pressure 157 sats 97 pulse is 104. Chest clear bilaterally. Able to talk and answer questions.  Paramedics called prior to Epipen and they arrived before next dose due. At their arrival they took over care and gave second Epi and transported to the hospital.
Patient was vaccinated in January 2021, has had factor V leiden treated with xarelto. Developed arterial blood clot 5 months post vaccination. Currently hospitalized with cough, sore throat, shortness of breath. Currently being treated with coumadin for closer monitoring. No IV therapies administered thus far.
Baby began crying and could not be consoled. This went on for approximately 2 1/2 hours. Then he started to have trouble breathing. Took to ER, the reaction was basicaly over by the time we saw the doctor.
about 330PM mom called clinic to report pt had been sleeping very soundly, sl lethargic-no APAP given as per instructions yet as child was asleep per mom T101.8 upon awakening w/projectile vomiting x 1;pt not crying or fussy; poss viral flu
pt recvd HIB/OPV/DTP & exp a swollen tongue which was protruding for approx 24 hrs & then resolved; no tx was initiated;
This spontaneous report as received from a nurse refers to a currently 15 year old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 04-NOV-2001, 29-JAN-2002 and 04-FEB-2003, the patient was vaccinated with three separate doses of RECOMBIVAX HB (dose, concentration, route of administration, lot# and expiration dates were not reported). The patient was also vaccinated with an adult dose of RECOMBIVAX HB on 10-OCT-2017 (intramuscular, lot# M041384, expiration date 07-JUN-2019). No adverse effects were reported. The outcome of inappropriate schedule of drug administration was unknown.
Injection site hot; Injection site itching; Injection site pain; Injection site swelling, raised; Injection site redness; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE SWELLING (Injection site swelling, raised) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Egg allergy, Allergic to cats, Allergic to dogs, Allergy to molds, Fish allergy (whitefish) and Penicillin allergy.    On 29-Mar-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE SWELLING (Injection site swelling, raised) and VACCINATION SITE ERYTHEMA (Injection site redness). At the time of the report, VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE SWELLING (Injection site swelling, raised) and VACCINATION SITE ERYTHEMA (Injection site redness) 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.   The patient was using an unspecified prescribed cream on the affected area as a treatment for the events. Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Updated reporter details, patient demographics,relevant history,added three additional events and treatment medication On 02-Jul-2021: Patient's date of birth was updated
I did not have an adverse reaction to the vaccine. In 11/2022, I developed a cold with a cough that has not gone away. I have had many tests and they don't see anything wrong. I have lost 16 pounds and I cannot sleep because of the cough. I feel so worn down and tired of being sick.
Allergic reaction on both arms. It itches and is red bumps, like mosquito bites. Reaction has lasted 2 weeks.
the following day 1/14/21  was extremely fatigued and had the big red mark and itch in the area of the injection.  It went away and 8 days later 1/21/21, 2" diameter big red area that was itchy came out.  No pain in the arm unless touched, hard to touch.   Still has red hard area, warm to touch.
Patient received flu shot on 9/21. She has a rash on the site of injection a few days after the shot and some muscle cramps along her right thigh. Patient came to the pharmacy to speak with the pharmacist in regard to the reaction on 9/26. Patient has been using Benadryl cream to help with the itching.  She said the rash has improved over the past few days. Pharmacy will follow up with the patient in next week.
After shot, in treatment area tightness in throat and vomiting. Gave IM 50mg diphenhydramine 0932