chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. In 2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and for the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-FEB-2016, the patient was treated by a Nurse Practitioner at an Urgent Care facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. She has been prescribed MEDROL and valacyclovir for management of her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer signification medical expenses, pain and suffering, and other damages. Additional information has been requested.
No adverse event.  Patient was administered Covid-19 vaccine on 6/29/2022 and the vaccine expired on 6/3/2022.  Scheduled for revaccination.
Severe nausea, heart palpitations, syncope, shortness of breath and triggered an organ rejection event (I am a kidney transplant patient).
15 mins post vaccination c/o nausea, headache, stomach ache.  Not resolved after 35 mins. Child seen by school nurse parent called to take child home.
Experianced bad headache; Migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03May2021 (Lot number: EW0176) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 04May2021, outcome "unknown", described as "Experianced bad headache"; MIGRAINE (non-serious) with onset 04May2021, outcome "unknown", described as "Migraine". Therapeutic measures were taken as a result of headache, migraine.  Additional information: Patient stated she did take ibuprofen and then Tylenol a few hours later because it wasn't getting better. Patient stated she saw somewhere online that she doesn't need to take those things and that's why she was asking to see if she can keep taking it or if she needs to stop. Ibuprofen: Patient states they were 200mg per capsule, she took two. LOT: R85574, Expiry Date: Feb2023. Patient states they were the Advil Liquid Gels. Quantity: 160. Tylenol: Patient stated it says Tylenol Extra Strength, 500 mg each, took two tablets. LOT: PEA001, Expiry Date: Feb2023. Patient states Quantity: 100 capsules.  No follow-up attempts are possible. No further information is expected.
Suspected vaccination failure; I had shot 2 times & still got them.; This case was reported by a consumer via interactive digital 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. 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 case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient received the two doses of Shingles vaccine and still got them. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Fever 102.5, face rash, generalized tonic clonic seizure approximately 3 minutes -> TYLENOL -> EMS called -> took to ER.
Patient in and out of fainting status.  I steadied head a couple times.  She said she felt like she was going to "Pass out".  She was seated and I cradled her head when needed.  She was given cold water and orange juice to drink and eventually a cookie.  She stated she had not eaten much today.  She felt better after a couple minutes.  I called a family member (with her daughters help) to contact a family member to pick her up.
Moderna vaccine was administered - reported by patient  I21.4 ACUTE NON ST ELEVATION MI 4/14/2021 ACUTE NON ST ELEVATION MI J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/13/2021 ACUTE NON ST ELEVATION MI J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/11/2021 ACUTE NON ST ELEVATION MI R09.02 HYPOXIA 4/14/2021 ACUTE NON ST ELEVATION MI I21.4 ACUTE NON ST ELEVATION MI 4/14/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/13/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/11/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION R09.02 HYPOXIA 4/14/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION I21.4 ACUTE NON ST ELEVATION MI 4/14/2021 PNEUMONIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/13/2021 PNEUMONIA J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/11/2021 PNEUMONIA R09.02 HYPOXIA 4/14/2021 PNEUMONIA
Achy, tired-sleepy, minimal pruritus-forearms/lower legs, rash-sides of neck, shoulders, upper back, left arm pain from 7-5-18 to 7-8-18. Prednisone 20mg 1 tablet by mouth daily for 5 days.
headache; This is a spontaneous report from a Pfizer-sponsored program . A contactable female consumer (patient) of an unspecified age received first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced headache. The patient was scheduled for second dose and wanted to know whether she can take Tylenol prior to her second dose. The outcome of event was unknown.  Information about Lot/Batch number is not provided. No further information is expected.
No adverse effects reported.; One patient received improperly stored VARIVAX; This spontaneous report was received from a Nurse referring to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 13-MAY-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, route, dose, frequency, and anatomical location were unknown) with  lot # N034556 and expiration date 05-DEC-2019 for prophylaxis and was reconstituted with an sterile diluent.  The administered dose of vaccine experienced the temperature excursion of  6°F to 14°F (-14°C to -10°C) (6.08F) degrees Fahrenheit for 1 hour 50 minutes. No previous temperature excursion and no adverse events were reported. There was a digital data logger involved.
The next day after receiving the vaccine I had red itchy spots come up on my body.  I was given a prescription for a cream to help with the itching. I had this happen to me for each vaccine.  Since receiving my vaccines, my liver enzymes have increased, and my cholesterol has increased.  I tested positive for COVID-19 on 06/17/2022.  I had a cough, very tired and congested. I contacted my doctor and received a prescription for a benzonatate.
Non stop periods/DUB DUB DUB kind of  non stop drip./Non severe periods; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Non stop periods/DUB DUB DUB kind of  non stop drip./Non severe periods) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 042B21A) for COVID-19 vaccination.     Concurrent medical conditions included Behcet's syndrome. Concomitant products included AZATHIOPRINE SODIUM (IMURAN [AZATHIOPRINE SODIUM]) and COLCHICINE for Behcet's syndrome.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Non stop periods/DUB DUB DUB kind of  non stop drip./Non severe periods). At the time of the report, HEAVY MENSTRUAL BLEEDING (Non stop periods/DUB DUB DUB kind of  non stop drip./Non severe periods) outcome was unknown.            No treatment medication details was reported.
I did want to share my reaction. I do have filler. This was my main side effect although I got all of them; This spontaneous case was reported by a health care professional and describes the occurrence of SKIN REACTION (I did want to share my reaction. I do have filler. This was my main side effect although I got all of them) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced SKIN REACTION (I did want to share my reaction. I do have filler. This was my main side effect although I got all of them). At the time of the report, SKIN REACTION (I did want to share my reaction. I do have filler. This was my main side effect although I got all of them) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.
Client reports noticing itching and soreness @ right arm injection site and a "quarter-sized" area that felt hard and was yellowish in color @ 5PM on 1/8/09.  The area increased to the diameter of a "coke can".  Client phoned the 1-800-CDC-Info # on the VIS--was instructed to circle the area with a permanent marker.  1/9/09 AM the area was the same size with 6 pencil eraser-sized papular like "blisters" @ injection site and three to four tiny bumps.  There was some erythema below the circled area.  1/9/09 PM--client went to Hospital and was seen by Dr. and told that she had developed "chickenpox" @ injection site.  1/12/09--the blisters had dried and were sloughing.  Itching and soreness were gone.
Pt started having a lump in her throat and stated it was hard to swallow. Pt states that she also a tickle/scratch that would make her cough. VSS. Zyrtec given to help symptoms. Pt stated that this happened with her first vaccine of Moderna as well.
NEUROLOGICAL PAIN; SHINGLES; INJECTION SITE ITCHING; LEFT SIDE INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy, oak allergy, and sumac allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A121A, expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced left side injection site pain. On 01-JUN-2021, the subject experienced injection site itching. On 02-JUN-2021, the subject experienced shingles. On an unspecified date, the subject experienced neurological pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left side injection site pain on 22-MAY-2021, had not recovered from shingles, and injection site itching, and the outcome of neurological pain was not reported. This report was non-serious.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: syncope-Mild, Additional Details: Patient reported throat tightness and difficulty breathing. immediately after patient lost consciousness. patient was repositioned and one injection of epinephrine was given. paramedics came within 10 minutes and carted her off to hospital.
Sore arm, chills, body aches, nausea, slight fever, tiredness
day 1 - nausea without vomiting, malaise, pain in lower stomach area, fever 98.5F to 100.7F. - not able to eat any food, drank plenty of water.  day 2 - watery stool, light malaise, fever 97.9F to 100.2F then during night time fever 98.2F to 99.1F  day 3 - fever 97.0F at 7:10 AM
Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 47-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-065536 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-065536:First dose case
not being able to lift my left arm higher than my shoulder.; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, via an unspecified route of administration, administered in Arm Left on 16May2021 12:00 (Batch/Lot Number: EW0185) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included fibromyalgia from an unknown date and unknown if ongoing. The patient stated, "I do have fibromyalgia so I don't know if this is causing part of the reaction." Concomitant medication included levonorgestrel (MIRENA) taken for an unspecified indication, start and stop date were not reported. The patient previously took tetracycline and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation and experienced vaccination site movement impairment and blood pressure decreased and morphine and experienced drug hypersensitivity. The patient stated, "About 4 weeks after the second dosage, I started having the same symptom of not being able to lift my left arm higher than my shoulder. This has continued for the last month and is still happening now" on Jun2021. The patient underwent lab tests and procedures which included blood pressure measurement: dropped on Apr2021. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Insomnia, night sweats, pulled muscle or bad cramp in quadricep, restless leg.
Patient complained of headache unrelieved by APAP, all day. Patient says she developed a series of red blotches on chin and up left cheek. Blotches not itching, not warm to touch, no itching/burning.
abdominal pain; enema relieved pain; This case was reported by a other health professional via sales rep and described the occurrence of abdominal pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced abdominal pain and pain. On an unknown date, the outcome of the abdominal pain and pain were unknown.   It was unknown if the reporter considered the abdominal pain and pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's child. The age at vaccination was not reported. The patient had symptoms of left lower quadrant abdominal pain and pain after Shingrix. The reporter agreed to follow up. This case was linked with case US2021AMR206096, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR206096:same reporter
Pt was administered the 6 months-4 y.o. MONOVALENT vaccine for her 3rd dose instead of the 6 months- 4  y.o. BIVALENT vaccine. No adverse reactions occurred. Pharmacist was contacted and informed pt is not indicated for redosing at this time. Pt should wait until a booster is recommended for age range to receive bivalent dose, or get 5-11 y.o.  bivalent dose when she turns 5. Pt waited 20 min after dose and was feeling well when she left.
I received the vaccination on the 11th in the PM. By the evening my arm started to swell, get hot and painful. I could hardly move my arm by Saturday morning. It was sore into my shoulder and was 1 and 1/2 inches larger than my other one. I called insurance company and was instructed to put heat on it and take Ibuprofen. I was running a fever of 101 by Sat. eve. On Sunday, it moved down my arm to include 1/2 of my forearm. I saw my nurse practioner at my place of work today and she insisted I go see the Dr. which I did, paid my copay and he looked at it and said, yes, it is pretty red, but it would go away over time and to put cold on it. I have consulted with several people since and was reassured that moist heat was the best. At the moment, my arm is aching, still red and flabby from the cellulitis.I am still sore into my shoulder. Your comments are welcome.
This spontaneous report was received from a nurse referring to a patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 08-JAN-2019, the patient was vaccinated with an expired dose of VAQTA (lot # N028743 and expiration date 23-NOV-2018) (strength, dose and frequency were not reported), intramuscularly for prophylaxis. No known adverse effects.
Pfizer COVID vaccine dose #2 given 6 days early. Dose #1 given previously on 12/5/2021 so dose #2 was due on 12/26/21.  Pt reported no ADR. Per CDC dose #2 needs to be repeated 21 days after invalid 2nd dose
disseminated welts, erythematous, puritic.  Started on lower back then spread to arms,  legs and traveling to face .  Started 1 hour after injection and still spreading 24 hours later.Advised Benadryl po at onset of rash.  Pt states very little relief and advised to report to local ER for management and eval.
chest pain; Received her first dose of Comirnaty on 22Apr2021. The patient found out she is 20 weeks and 5 days pregnant as of today; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 22Apr2021 (Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient's last period was 10Apr2021. The patient received her first dose of vaccine at first week of pregnancy. The mother was due to deliver on 10Feb2022. On 10May2021 patient went to the emergency department (ED) complaining of chest pain. While in the ER they worked her up and consulted with cardiology but there were no significant findings and it was inconclusive whether the chest pain was caused by vaccine. At the time of reporting the patient's chest pain persisted. The reporter stated that the patient told the her that she was not pregnant when she received vaccine and the she found out she was 20 weeks and 5 days pregnant on the day of reporting, so she must have been pregnant but just did not know it. The patient consulted primary care physician (PCP) who advised patient to wait on getting her second dose of the vaccine. The patient was now seeking advice from the clinic since she was pregnant and was asking if she should receive the 2nd dose. The outcome of chest pain was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Severe fatigue, headache, ear fullness, nasal drainage, nausea, weakness, itching hands and feet, pain at injection site.
Information has been received from a registered nurse concerning a patient who on an unspecified date received a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient experienced an injection site reaction. At the time of this report the patient's outcome was unknown. This is one of three reports from the same source . Additional information has been requested.
Information has been received from a 76 year old female patient referring to herself. In September 2015 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously for shingles prevention (dose, dose #, lot # and application site were not reported), and "almost immediately developed a zoster-like rash". The patient stated she went to her primary physician who confirmed she had developed shingles. The patient also stated that she not only still had the zoster-like rash on her arms and wrists, but she also had pain in her "little finger and ring finger" (unspecified left or right hand). The patient stated she did not have strength enough in her hand to grip things, and had also had to see a neurosurgeon as a result (onset date unknown). The patient was given unspecified pain medications to treat the events. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Patient received second dose of Moderna vaccine in right arm at around 2:28pm. Approximately ten minutes after vaccine administration, patient began to feel "itchy and burning in throat." RN notified NP (site lead) and assessed patient. Patient denied SOB, denied dizziness, patient stated itching and burning was increasing. RN administered 50mg/ml 1ml diphenhydramine via IM injection to patient's left deltoid. Within minutes patient instantly stated she was feeling relief from symptoms. Patient advised to sit and wait for additional 30 minutes observation. Patient continues to deny SOB.
PTS MOTHER CALLED ON 9/8/2020 STATING THAT PT WAS COMPLAINING OF A STIFF NECK AND THAT HE WOULD NOT TURN HIS HEAD TO THE LEFT.  TREATMENT RECOMMENDED WAS OTC TYLENOL OR MOTRIN AS NEEDED, GENTLE STRETCHING EXERCISE, AND OTC BENGAY TYPE OF CREAMS
No additional AEs or PQC reported.; Caller reported MMR II was administered IM instead of SQ.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from a registered nurse and refers to a patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 21-JUL-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, 0.5 milliliter (also reported as mg), lot #U013035, expiration date: 23-APR-2023 (vaccination schedule was not provided) intramuscularly instead of subcutaneously, for prophylaxis (Incorrect route of product administration). No other information was provided, no additional adverse events were reported.
Approx 4 wks after imm. developed severe weakness lasting 3-4 wks; rash on chest and buttocks & fingers; inject site red with white eruptions. Did not see a MD.