chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/8/22  I woke up in the middle of the night, thought I was going to get up. My left leg and left arm were not working, I fell and hit your head.  I went to Emergency Room and was admitted to the hospital for a TIA.  I had an MRI, CT of head, Echocardiogram, Carotid test and blood work. I was on a heart monitor. I was given a blood thinner while in the hospital and was continued on my regular medications.  I was discharged on 12/9/22 . Later I was put on a mobile heart monitor.  I have recovered.
Tested NAAT positive for COVID 9/19/21 after being fully vaccinated.
This spontaneous case was received from healthcare professionals on an unpublished manuscript regarding a 64-year-old male patient. Concurrent conditions included metabolic syndrome and impaired gluocose tolerance. Information on patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, unit, dose number, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date (16 months post vaccination), the patient was presented with six days of floaters and cloudy vision in his left eye that persisted despite topical prednisolone treatment. The patient was not otherwise immunocompromised. The patient's vision acuity was 20/200 and intraocular pressure was 10 mmHg. On an unknown date, the patient underwent unspecified examination which revealed significant anterior chamber and vitreous inflammation and superotemporal retinitis with a "headlight in the fog" appearance. Empiric treatment with trimethoprim/sulfamethoxazole was started for presumed toxoplasmosis for the patient. A course of oral prednisone was also initiated and topical prednisone was increased. On an unknown date, at one week follow-up, another region of retinitis was noted and unspecified blood tests were performed which was negative for infectious and inflammatory etiologies, including toxoplasma. On an unknown date, polymerase chain reaction (PCR) test of his aqueous fluid was performed which was positive for Varicella Zoster Virus (VZV). Antibiotics were discontinued and the patient was treated with oral valacyclovir 2 grams 3 times per day for three weeks, followed by 1 gram 3 times per day for three weeks with a steroid taper. On an unknown date, upon completion of therapy, retinitis (necrotizing retinitis) had resolved (recovered) and visual acuity was 20/30 and at six months follow-up, visual acuity was 20/25 with a stable region of chorioretinal atrophy on examination. The outcome of the event varicella zoster virus infection was unknown. Causality assessment of the events was unknown. The reporters also mentioned that the patient experienced milder disease and longer latency periods. It was also reported that longer latency periods may be associated with wild-type virus in ARN due to VZV as well as systemic disease and the patient may have been relatively immunocompromised from metabolic syndrome. Upon internal review, the event necrotizing retinitis was determined to be medically significant. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1812USA005657.
Patient reported dizziness after first dose, was asked to stay for 30 minuted of observation following second dose. Patient progressed from dizziness (BP taken at this time, was normal) to nausea/dry heaving, with coughing and shortness of breath/chest tightness, which was not alleviated by her Albuterol inhaler.  The contents of one Epipen was administered to the patient and she was transported to the hospital via ambulance.
Initial information received on 11-Dec-2018 regarding an unsolicited valid serious case received from a health professional (Pharmacy Director). This case was linked to 2018SA388808 (same reporter). This case involves a 54 years old female patient who experienced neuropathy on her arm, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1817 via unknown route. On an unknown date, the patient developed a serious neuropathy on her arm (neuropathy peripheral) approximately 2 weeks following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant as per Important medical event. No lab test was reported. Final diagnosis was neuropathy on her arm. It was not reported if the patient received a corrective treatment. Outcome of the event was not reported. List of documents held by sender: none. Sender's Comments: Patient presented with peripheral neuropathy of her arm after vaccination with FLUBLOK QIV. Time to onset is compatible with the role of vaccine. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information, the role of vaccine cannot be assessed.
STOMACH HURT; SHORTNESS OF BREATH; CHEST PAIN; FLU LIKE SYMPTOMS(COLD, CHILLS, HEADACHE, HEAD CONGESTION AND SICK); LOT OF MUCUS; This spontaneous report received from a consumer concerned a 56 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and low platelet count. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUL-2021, the subject experienced flu like symptoms (cold, chills, headache, head congestion and sick). On 21-JUL-2021, the subject experienced lot of mucus. On 25-JUL-2021, the subject experienced chest pain. On 25-JUL-2021, the subject experienced shortness of breath. On an unspecified date, the subject experienced stomach hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu like symptoms(cold, chills, headache, head congestion and sick), lot of mucus, stomach hurt, chest pain, and shortness of breath. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
The vaccine was administered 6 days too early by the vaccinator. The first dose was given on 1.6.22 and the second dose was given on 1.21.22. No adverse symPtoms were observed. Patient was observed for 45 minutes. Vital signs at 1648 BP 118/78, HR 90bPm, 100 % 16resPirations. Parents were instructed to seek emergency medical services for any signs or symPtoms and to call their Pediatrician immediately for monitoring.
Information has been received from a registered nurse concerning her 1 year old son with milk allergy and no other medical history who was vaccinated with a dose of MMR II. There was no concomitant medication. After received the vaccine the patient developed fever and also was diagnosed with Pervasive Developmental Disorder (PPD). The reporter stated that the patient had nurses who come 5 days a week to help him with his speech. No laboratories studies performed. The patient sought unspecified medical attention. The patient recovered from the fever, but he had not recovered from Pervasive Developmental Disorder. Pervasive Developmental Disorder and fever were considered to be disabling. Additional information has been requested.
I had my vaccination on 10/14/2022. On 04/02/2023 I started to have a sore throat. On the evening of 04/03/2023 I had the worst sore throat of my life. I had congestion headache and my hips hurt. I tested COVID-19 Positive on 04/03/2023 at 11PM. I contacted my physical on 04/04/2023 and had prescribed me Paxlovid. I presently feel better but I still have congestion runny nose and sore throat. I am still weak with slight shortness of breath. I still have no taste nor smell.
Pt presented 4 days after immunization with a 5cm area of redness, warmth, and swelling.  A slightly erythematous macular rash extended from the injection site down the arm to the L hand.  Pt also had low grade temp. of 99.2 degrees F and fatigue.
stress; She has a cold sore; a little puffy around her lip; This is a spontaneous report from a contactable consumer reporting for self via Pfizer sponsored program. A female patient of an unspecified age (age: 92 or 79, unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Feb2021 at single dose for covid-19 immunisation. Patient received the first dose on unknown date. The patient medical history was not reported. The patient's concomitant medications were not reported.  Patient has a cold sore that started coming on a few days ago. It didn't come out yet but it has been a little puffy around her lip starting 3-4 days ago. She stated, with all the stress from the whole year her resistance is probably low but it has nothing to do with the vaccine. She definitely knows it is from all the stress going on. She stated she had relatively no effects from either dose. She asked if it is okay to take Valacyclovir for the cold sore. After verbal response provided, she stated she probably will err on being conservative and not take it. She wanted to take Valaciclovir (for herpes) but she don't want to do anything since she waited so long for the vaccine and she would like to ask if it is okay to take another medication after her 2nd shot. Outcome of events was unknown.   Information about lot/batch number has been requested.
Headache; aching joints; sore arm; This is a spontaneous report from a contactable 62-year-old female consumer reported for herself.  A 62-year-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 04Feb2021 (patient was 62-year-old at the time of vaccination) at single dose for covid-19 immunization. The patient's medical history was not reported. The patient's medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medication included desvenlafaxine succinate (PRISTIQ). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot: EL3247) via an unspecified route of administration in left arm (at the age of 62 years) on 14Jan2021 at single for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. On 05Feb2021, the patient experienced headache, aching joints, sore arm. The patient not received any treatment for the events. The patient was not hospitalized. The events were non-serious. The outcome of events was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Patient fully vaccinated and died of Covid related causes. The patient had shortness of breath, cough, and pneumonia. She was admitted to hospital where she passed away.
low grade fever, chills, headache, muscle pain,  whole body tired all in the first 24hrs. after that didn't feel right for the next couple of days then he started having sore throat and coughing. within the last 5 or 6 days he lost his voice for about 4 days kept a fever and a lingering cough which he cant get a full breathe.
Red rash warm to touch from bottom of deltoid to mid tricep covering most of bicep. advised patient to take benadryl and use benadryl cream as well as an ice pack, patient said nothing else was wrong and if anything else occurred she would report back.
3-4 hours after receiving injection, left arm became swollen/painful/tender. No erythema or warmth.
Information has been received concerning an 8 year old female who on 12-DEC-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) 0.5 mL subcutaneous in the right arm (lot#659355/1518U). There was no illness at the time of vaccination and no concomitant medication. On 13-DEC-2007, the patient developed a 3-inch in diameter injection site reddened area. The patient had no fever. The patient's mother sought medical attention by phone and was instructed to apply a compress to the patient's right arm and give the patient Advil. Follow up information from the nurse indicated that their "Immunization Reaction Protocol" was used. There were no other symptoms and no other treatment was given. Follow up information from the nurse provided no additional information. Current patient status was not reported. Additional information is not expected.
Strong rash in different parts of my body. Arms, chest, lower back, buttocks, thighs/very painful; This is a spontaneous report from a contactable consumer (patient). This 74-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via an unspecified route of administration in the right arm on 26Jan2021 at 16:45 (at the age of 74-years-old) as a single dose for COVID-19 immunization. Medical history included heart valve disease, with a new aortic valve and two bypasses from Jun2018 and unknown if ongoing; and allergy to sugar, dairy and wheat from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) from an unknown date for an unknown indication, and warfarin sodium 7.5 mg from an unknown date for an unknown indication. The patient had not received any other vaccines in the 4 weeks prior to the COVID vaccine. The patient reported that two days after receiving the first dose he had broken out in a strong rash in different parts of his body; arms, chest, lower back, buttocks, and thighs. He reported they were starting to settle down a bit now (as of 01Feb2021) but were very painful. The event was reported as non-serious, and did not require hospitalization. No treatment was provided for the event. The clinical outcome of strong rash in different parts of my body; arms, chest, lower back, buttocks, thighs, very painful was recovering. It was also reported the patient had not been tested for COVID-19 since vaccination.
This is a non serious spontaneous case from a nurse of a medication error. The reporter causality was not provided to Flumist. A nurse reported a series of medication errors. The nurse misunderstood the dosing instructions for FluMist and administered a double dose of vaccine to seven pt's . Prior to the administration of the vaccine she removed the dose divider clip thereby giving 0.50ml per nostril versus the prescribed dose of 0.25 ml per nostril. On 26Oct04, at 9:00 in the morning, the reporter gave a double dose of FluMist to a 38 year old female pt whose medical history was not reported. The reporter stated the pt had chills with the onset time and outcome are unk. No further information is available.
6/23/08 Administered in R deltoid, Tdap, IM. along with Yellow Fever, SQ. Patient called Thursday, 6/26/08 with nickle size red spot in back of R arm from Yellow Fever.  Instructed to take one Benadryl and call MD if continues or syptoms worsen.  Per conversation with patient on Monday, 6/30/08, she relayed the following weekend occurances.: Patient states she called MD on Friday, 6/27/08 and took another Benadryl per his suggestion.  Saturday, 6/28/09, patient states the red spot continued so she took a Claritin because the Benadryl made her sleepy. Also on Saturday, her R shoulder began to swell with fluid. Sunday the R shoulder swelling increased to the size of a baseball. Denies heat emission, denies redness.  The swelling appeared fluid filled.  Monday, 6/30/08, the swelling remained the same.  Denies respiratory difficulties, nor any other symptoms. Advised to see her primary care Physician today.
Patient's arm was swollen, red and warm to touch from the top of the deltoid muscle to the elbow. Pt was unable to lift her arm. Patient reported having difficulty with dressing herself the day after getting the vaccine and that lasted for about 7 days. Patient stated she had a fever and body chills and feeling unwell.
07/26/2022 we began to notice bumps forming around her face. I did contact her doctor and they said to monitor it. Over the weekend we rubbed Benadryl on it and it started to improve. However, when she went into day care it came back as well. We took her to the ER and they stated that she is most likely having an allergic reaction to something however they don't believe that it was due to the vaccination. Since going to the ER her symptoms are improving dramatically and the rash on her face is getting a lot better. She also has a twin that received the exact same vaccines at the same time and she is doing completely fine.
Client received pediatric formulation of pfizer for 2nd doses and should have received adult formulation of pfizer as is 15 years of age.  Client did receive adult formulation of pfizer for initial dose.  Reported to Pfizer.  Guidance given from pfizer.  Notified mother, that dose does not need to be repeated per CDC guidance.  First dose was adult formulation.  No adverse events /symptoms/side effects noted other than pediatric formulation used for 2nd dose instead of adult formulation.
Approximately 24 hrs post vax pt developed a fever and an injection site reaction characterized by redness and swelling. No further info was available at the date of this report. Manufacturer's Comment: The reporter indicated that 3 pts experienced this event; however, they are not presently identifiable. Addtl reports will be generated when identifying info is provided.
She can't bear the pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (She can't bear the pain) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine headache.   On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN (She can't bear the pain) and HEADACHE (Headache). At the time of the report, PAIN (She can't bear the pain) and HEADACHE (Headache) outcome was unknown.            Other concomitant product use included medications for migraine headache. Treatment information included medication for headache.  Action taken with mRNA-1273 in response to the events was  not applicable.
A non-serious, spontaneous report of administered expired product was received from a nurse concerning a six-year-old male, subsequent to FLUMIST. The patient received FLUMIST on 26-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information received on 31-Mar-2009: include Product Complaint Investigative results.
After 1st vaccine: local reaction at vaccine site. Itching, swelling, redness spreading down upper arm. Persistent for about 4 days. Fatigue. Menstrual cycle 2 weeks early beginning day after vaccine. After 2nd vaccine: same local reaction that spread and presented similarly to cellulitis. Temperature 103F. Nausea, vomiting, fatigue, body aches, chills lasting about 72 hours. Menstrual cycle started day after vaccine 1 week early. Since vaccine fatigue has lingered but all other s/s have resolved.
This spontaneous report as received from a physician regarding a male patient of unknown age. Medical history and concurrent conditions were not reported. On 02-JUN-2015, the patient received improperly stored PROQUAD (Merck) (lot# K025766, expiry date: 08-JUN-2016, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was no concomitant medication reported. No adverse effects was reported and no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Had an unexpected and unusual localized reaction to the PPD test. Symptoms included increased erythema, tenderness, and a nodule (6 mm). It is suspected that a 0.1 ml of anthrax vaccine was erroneously administered to the sm instead of the standard PPD solution.
Hives (on right arm); Redness (on left arm); This spontaneous case was reported by a patient family member or friend and describes the occurrence of URTICARIA (Hives (on right arm)) and ERYTHEMA (Redness (on left arm)) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced URTICARIA (Hives (on right arm)) and ERYTHEMA (Redness (on left arm)). At the time of the report, URTICARIA (Hives (on right arm)) and ERYTHEMA (Redness (on left arm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Left sided numbness/tingling in face; shortly after the numbness and tingling moved down into her left arm and left leg.  Still experiencing numbness/tingling and weakness/fatigue in left arm and leg.  Still complains of tingling in face- left side.
101 fever for 24 hours, red rash on hands, face, tummy, and back was given Benadryl.
5DEC96 sz;motor activity & was post-ictal 20-40min;taken to ER;t38C;irritable, seemed to have a lot of pain, diff walking, seemed to have a lot of pain, diff walking, t102;BOM,conjunctivitis & neutropenia;dx feb sz from OM;
Large area of swelling, warmth, redness around vaccine site. Skin breakdown centrally with clear exudate.
The night of the injection I had a headache and chills no fever.  In the morning my headache was a migraine no energy and a rash on forehead. My evening my head was on fire and blister formed on rash.  My ear was ringing and hurt   It was painful to swallow.  Went to ER and was Dx with shingles  was prescribed valtrex 1gram q8 hours and lotramin lotion