chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was given the YF-VAX vaccine and it caused her MS to flare up; Initial information received on 12-Jan-2023 regarding an unsolicited valid serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was given the YELLOW FEVER VACCINE -  [YF-VAX] and it caused her ms to flare up.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing MS.   On an unknown date, the patient received suspect YELLOW FEVER VACCINE - (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) in unknown administration site for Immunization.  On an unknown date, the patient developed a serious event of patient was given the vf-vax vaccine and it caused her ms to flare up (multiple sclerosis relapse) (unknown latency) following the administration of YELLOW FEVER VACCINE - . This event was assessed as medically significant.  Pharmacist is calling to find out if the YF-VAX has any contraindication for patients that are autoimmune compromised. The caller also stated that she is wanting to know if it is safe for a patient to get the vaccine if they have Hashimoto Thyroiditis and if it would cause an abnormal immune reaction. The pharmacist is requesting information on abnormal immune reaction with Hashimoto Thyroiditis and for any autoimmune reactions.   Action taken with YELLOW FEVER VACCINE (YF-VAX) was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient was given the VF-VAX vaccine and it caused her MS to flare up).  At time of reporting, the outcome was Unknown for the event patient was given the vf-vax vaccine and it caused her ms to flare up.; Sender's Comments: Sanofi company comment dated 16-Jan-2023: This case involves an unknown age and unknown gender patient who was given the YELLOW FEVER VACCINE - [YF-VAX] and it caused her ms to flare up. Based on reported information underlying medical history remains as confounding factors for reported event. Additional information regarding additional risk factor, concomitant medications, medical treatment and family history excluding other predisposing etiologies would be needed for complete assessment of the case.
Fever 102, crying, began 1 day later, 3 days after shots had 1 hour screaming episode.
died as a result of the COVID-19 vaccine shot; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for twenty patients. This is one of twenty reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The reporter personally knows of 20 people who have died as a result of the COVID-19 vaccine shot. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s): PFIZER INC-202101393431 same reporter, product/event; different patient; Reported Cause(s) of Death: died as a result of the COVID-19 vaccine shot
Local erythema 7 cm x 8 cm with induration & mild tenderness. Fevers, no constitutional symptoms.
Sore lump at site of injection in right deltoid, no other symptoms or signs at all
On 3/24 at 7pm I received my first Moderna vaccine. That evening and the following 2 days my arm was very sore. On 3/25 I had a headache but that was the extent of the side effects until 3/31. On 3/30, I gave myself my monthly Aimovig injection in my stomach (left side). On 3/31 at approximately 1pm, I noticed a few what looked like bites on my right arm. As the day progressed a few more appeared as well as about 4 inches around the injection side of my Moderna vaccine it turned red, sore and hot. When I woke up the morning of 4/1, the "bites" I thought I had were clearly hives as there were many on both arms and they were swollen, hot and itchy. I contacted my primary care physician and was advised to take Benadryl. I took Benadryl and also got Benadryl cream which I put on both arms. The hives worsened and by day 3 my arms and hands were covered in huge hives. I went to a CSV Minute Clinic and was prescribed Prednisone 10mg tablets (54 of them). I started immediately and after a couple days they started to gradually get batter. I finished my last pill today (4/16). I still have a faint rash on both arms but it's no longer itchy or swollen.
Initial report received from a nurse on 02/Nov/2005.  A 37-year-old female complained of a metallic, bitter taste in her mouth 10-14 days after receiving the injection of DECAVAC, lot number U1576BA.  Route and site of administration was not reported.  Vaccine was received "approximately 02/Sep/2005.  The patient received in concomitant HAVRIX, lot number not reported.  The patient had no other complaints.  The patient also received the flu shot after the symptoms started.  She was seen by an ENT specialist on 02/Nov/2005.  A mirror exam was within normal limits.  A scope was not performed.  The patient denies any medications or injections in the month prior to receiving the immunization, nor has she experienced these symptoms previously.  As per the reporter the patient has not recovered.
patient received dose 2 on 1/27/2022, then admitted for pneumothorax. pt has stage IV NSCLC adenocarcinoma and reported  arm/shoulder pain starting 3 days prior to admit (1/28/2022)
20 min post injection, patient returned to administration site with with general itching and 1 inch red area on her (L) arm and 3-4 inch red area on back of neck. BP was 138/88. Patient decided to take a BENADRYL which she had at her desk. Within 10 min of original symptoms itching & redness gone. Telephone call 3 hrs later patient had no symptoms & had reported to her MD.
No additional AE reported; Caller is a physician reporting that an expired dose of M-M-R II was administered to a patient on 6SEP2022. Caller reports that the M-M-R II dose expired on 30JUL2022 and did not experience a temperature excursion prior to administration.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-SEP-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live rHA (M-M-R II) 0.5 milliliter administered for prophylaxis (valid lot #T025929, expiration date: 30-JUL-2022) (strength, anatomical location and route of administration were not provided). No temperature excursion occurred prior the administration of the vaccine. No additional information or adverse event was reported.
About 12 hours after the second dose I felt extremely sick. I had a fever, chills, body aches, sore throat and extreme exhaustion. Around 30 hours later I started to have severe chest pain. It was hard to breathe and for a few hours I was worried I was going to have a heart attack. I put on my Apple Watch to record my heart rate and it was jumping from the 70?s to the 115?s just laying in bed. Now after reading that I am not the only one who had severe chest pain I am worried about any long lasting effects since I decided not to go to the doctor for these chest pains.
Per father approx 25 - 30 min after leaving our office. Pt developed bronchospasms requiring epinephrine per Pts father. Pts father notified us at 1pm twin sister also received vaccine with no reactions reported.
Received Influenza Vaccination 11/03/09 follow two day later with rash entire left arm to mid back. Employee reported on 4/27/10.
R arm pain, decreased mobility, neuralgia to (R) forearm within 8-12 hours of PNEUMOVAX.
This infant had redness, and swelling approximately the size of a nickle. The doctor ordered Benadryl and the patient responded well to it. The swelling started to go down after 15 minutes.
B/P 110/40. Temperature 98.8 (O)- One week after receiving vaccination, started chills, fever, headache, insomnia, generalized body aches.
allergic reaction; eyes were running so bad; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (eyes were running so bad) and HYPERSENSITIVITY (allergic reaction) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History Information was reported.     On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced LACRIMATION INCREASED (eyes were running so bad). On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, LACRIMATION INCREASED (eyes were running so bad) and HYPERSENSITIVITY (allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Said that she has a terrible head cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Said that she has a terrible head cold) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Said that she has a terrible head cold). At the time of the report, NASOPHARYNGITIS (Said that she has a terrible head cold) had not resolved.            No concomitant medications were reported. It was reported that the patient looked miserable and had terrible head cold that had not gone away despite any treatment.   This case was linked to US-MODERNATX, INC.-MOD-2022-669102, US-MODERNATX, INC.-MOD-2022-668777 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669102:same reporter US-MODERNATX, INC.-MOD-2022-668777:same reporter
Mild nausea, muscle/body aches, and hot flashes for 12 hours
Lost sense of smell; Lost sense of taste; chills; Fever; Body ache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ANOSMIA (Lost sense of smell), AGEUSIA (Lost sense of taste), CHILLS (chills), PYREXIA (Fever) and MYALGIA (Body ache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (Fever) and MYALGIA (Body ache). On 18-Jan-2021, the patient experienced ANOSMIA (Lost sense of smell) and AGEUSIA (Lost sense of taste). On 18-Jan-2021, CHILLS (chills), PYREXIA (Fever) and MYALGIA (Body ache) had resolved. At the time of the report, ANOSMIA (Lost sense of smell) and AGEUSIA (Lost sense of taste) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 test: (Negative) Negative.     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 concomitant medications and treatment details were not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow-up received on 15-Apr-2021 contains information regarding outcome of the events.
ITCHING OF EYES AND LIPS. 97.6, 130/76, 81.  25MG BENADRYL GIVEN PO. 0909 STATES NO MORE S/S PER PT.
Suspected Vaccination failure; Just got shingles; Still was painful; 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: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Just got shingles) and pain (Verbatim: Still was painful). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-Jul-2023 This case was reported the patient via interactive digital media. The patient got the vaccine and just got shingles. Very mild but still (the recent time), it was painful This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
Information has been received from a registered nurse (R.N.) concerning a male child in elementary school (who is between grades 3-5) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was reported that an outbreak of chickenpox began in an elementary school in November 2005. "recently", "since November 2005", the male child developed chickenpox and sought unspecified medical attention. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
On March 25, 8 days after the vaccine shot in my left arm, I began experiencing intense pain on the left side of my neck and head. By March 28 the pain had become so excruciating I went to an Urgent Care facility and they sent me to the Emergency Room. While in the ER I had blood tests and a CT scan which all came back negative. I was given Oxycodone-Acetaminophen for the pain and prescribed Cephalexin in case there was some type of infection. They also ruled out Shingles. I continued to have pain and contacted my Primary Care Physicians Office and spoke with one of the Physician Assistants two times the next week. She prescribed Baclofen 10 mg and took me off the Cephalexin and put me on Amoxycillin because we thought the problem might have been an ear infection. The next week I spoke with my Primary Care Physician, and he believed I was suffering from Trigeminal Neuralgia, so he put me on Carbamazepine 200 mg twice a day. That same week, on April 9, I was finally able to meet with the Physician Assistant at the Neurologists office and she also believed I was suffering from Trigeminal Neuralgia. I continued to take the Carbamazepine daily and the Baclofen and Oxycodone-Acetaminophen as needed. On Monday April 12 I informed the nurses at the Neurologist office that I was experiencing several symptoms/side effects that included dizziness, weakness, difficulty swallowing and a pounding heartbeat. The nurses talked with the PA and the PA took me off the Carbamazepine and put me on Oxcarbazepine 150 mg twice a day and she prescribed Methylprednisolone 4 mg. On Thursday April 15 I began to have intense prolonged pain behind my left ear down to the neck and in the Trigeminal nerves in the forehead and top of the head on the left side. I was in so much pain I slept for less than 2 hours. The next morning, I vomited and went to the Emergency Room again. At the ER they treated my pain with a headache IV cocktail that included Ibuprofen, Benadryl, an anti-nausea medication, Fentanyl, and a steroid. Within an hour my pain level dropped from a 9 to a 3 and I was released. The ER prescribed Gabapentin 300 mg (3 times a day) which I started the evening of April 16. I have had less constant pain since leaving the ER and starting the Gabapentin, but I continue to have pain in the Trigeminal nerve areas and neck with some flare ups that reach a 7 out of 10 in pain. I am scheduled for an MRI on April 23 and a visit with the Neurologist on May 10.
Information has been received from a physician concerning a 25 year old female patient with no pertinent medical history or no drug reactions or allergies who on 20-APR-2010 was vaccinated IM with the first dose of GARDASIL (663551/1495Y). Concomitant therapy included YAZ. Subsequently the patient was testing for "high risk" for HPV. The patient sought unspecified medical attention. The patient had not received further doses yet. At the time of the report, the patient had not recovered. Additional information has been requested.
On day of vaccination, patient experienced acute onset of vomiting, diarrhea and headache with resolution of vomiting and headache within 24 hours.  The initial illness was attributed to norovirus (known to be circulating in the community at the time with multiple nursing home outbreaks)  Relief occurred but diarrhea and nausea resurfaced about day 5-6; however, and worsened by day 7 when a robust take was documented in clinic. On days 8 and 9 a large area (> 3 inches) of erythema was documented in photographs.  This robust take was resolved by day 12 without specific therapy.  Patient was seen by private MD for continued diarrhea, anorexia, fatigue and malaise and weight loss of 7-8 lbs on 3/26/03 (day12).  Blood work including electrolytes, LFTs and WBC was normal.  Stool O&P and shigella, salmonella and campylobacter were negative.  The patient spent most of her time in bed days 12 - 16.  Pt is stoic.  Returned to work on day 17, thinking she was improved.  She was seen by her son-in-law, an anesthesiologist, who gave her IV fluids.  By history, she was so dehydrated her skin was tenting. At this time (day 20-21), she had experienced a total of 10 lbs weight loss because she was unable to eat.  Ultimately seen by private physician again (3/10).  Repeat bloodwork included a second set of electrolytes and LFTs, all normal.  An ultrasound of the common bile duct, pancreas and gall bladder was performed - normal.  Patient was started on protonix, and reglan on day 31 with symptomatic relief by day 32.  Symptoms have continued to improve and weight has stabilized at this writing.  Scab fell off on day 37.
(L) arm site of injection 3 cm erythema upper, arm induration, painful movement.
Janssen COVID-19 Vaccine EUA. My left arm swelled and a red rash covered my arm. The next day I had hives on my head and itching. Hives appeared on my trunk and legs. Benadryl kept is under control, but I am still experiencing itching and hives but it is decreasing.
This initial spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The reporter stated that on multiple unspecified dates ranging from 30-Sep-2015 through 13-OCT-2015, the patients received improperly stored doses of VAQTA injection (lot # L002717 with expiration date 02-JUN-2017, lot # L009445 with expiration date 01-JUN-2017 and lot# L018499 with expiration date 25-FEB-2017; dose, frequency and route were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reported within 30 minutes of vaccine that she had nerve pain in her wrist that has still not subsided.
Thigh swollen, red, & warm.  Fussiness, uncontrolled crying.
On 5/1/01, child comes to office complaining of itchy rash with fever. On exam, by doctor, found multiple small separate erythematous macules, some early vesicles and some small eschar. Treatment: no school until all lesions scab over; Caladryl lotion for topical application.
(L) arm redness an pain to touch (L) armpit and inner aspect (L) arm. Deltoid no redness or swelling. Went to urgent care facility, no treatment, told to report reaction by MD.
Information has been received from a clinical research associate referring to an unspecified number of patients of unknown age and gender. On or about 23-JUN-2015 the patients were vaccinated with doses of PNEUMOVAX 23 (dose and route were unspecified, lot # K018528, expiration 14-APR-2016) that was improperly stored. No adverse effects were reported. Additional information has been requested.
Child awoke the next morning after immunization given with confluent hives about 22 hours after MMR. Child treated with IM Benadryl followed by every 6 hours oral Benadryl and will follow-up tomorrow. No steroids given secondary to no respiratory compromise and recent live virus vaccine.
Lower lip swelling that began 2 days after the vaccination.  patient is currently being seen in the ER for the same and there is a question as to whether this is allergic in nature vs. infection (but there is no obvious infectious starting source)
pt recvd vax; exp elev liver enzymes w/in 1 mon of vax;
feel really ill after the vaccine; 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 MALAISE 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE. At the time of the report, MALAISE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
This initial spontaneous case was received form other health care professional (pharmacist) on 24-Oct-2017, concerning a 73-year-old elderly male patient. The patient's past drug included PNEUMOVAX. The patient felt ill for couple of weeks prior to vaccination. The patient's concomitant medications were not reported. On 12-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number 178602, expiry date: 20-Apr-2018) for the first time. On the same day, the patient was also administered with PNEUMOVAX (dose, route of administration, batch number, expiry date, anatomical location, manufacturer and trade name: not reported). On 13-Oct-2017, after 2 days of vaccination, the patient experienced dizziness and violent nausea. On 17-Oct-2017, the patient was recovered from the events. The reporter assessed the events as non-serious. Non-significant follow-up report received on 13-Nov-2017: Vaccination date of pneumonia vaccine was confirmed as 12-Oct-2017.
Increased heart rate while resting (SVT), extreme fatigue after increased heart rate, shortness of breath with daily normal activities,
A physician reported that a patient, who has HIV infection, received Prevnar. A blood culture was performed and was positive for serotype 6B. As of the date of this report, no further information was available.