chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 66 year old female patient with tetracycline hypersensitivity and no pertinent medical history. On 08-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # L011533, expiration date reported as July 2016, 0.65 ml, subcutaneously. Concomitant therapies included hydrochlorothiazide (manufacturer unknown). In July 2015 (reported as after receiving ZOSTAVAX), the patient experienced redness and soreness at the injection site. The patient called pharmacist. No treatment was given for the adverse event. No lab diagnostics studies were performed. The outcome of injection site erythema and injection site pain was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Patient said she had tingling in her hands and was cold and shaky. She was very concerned so she went to ER but was not seen and then scheduled an appt at urgent care for approx 430pm.
pt recv vax 6DEC97 & reports no GI sx, but devel hives-worse on 7DEC97;tiny pinprick hives;called immed care& stopped the vaccine series;still some itching 8DEC;
Pt presents with shakiness and chest pressure. States these episodes come and go. Pt becomes SOB and feels like its hard to breathe.  The patient is here with some vague complaints of pressure that starts above his eyes and moves down into his neck, down to his arms and and occasionally down to his toes.  According to the patient he has been experiencing this for quite a while but it varies in degree of severity.  He stated since Tuesday he is just felt more off.  He has been having more shaking when the episodes come on and more pressure in his chest.  He stated just comes out of nowhere.  He did go to his PCP earlier this week and he had a CT of the head with and without contrast yesterday.  The results are normal.  He denies any changes in his medications.  Said he did just get the Covid vaccine yesterday.  He said he does have some shortness of breath but that is also been going on for a few years.  He occasionally gets nauseated with the pressure.  He denies any vomiting or fevers though.  I do not suspect an adverse reaction to the vaccine at this time.  He did have a head CT that was performed yesterday.  There were no acute findings.  We did do a cardiac work-up today which came back unremarkable.  His electrolytes are normal.  His urine sample was also normal.  His D-dimer did come back slightly elevated so we did do a CT of the chest.  For the most part it was unremarkable no acute findings.  Some scarring from back when he had Covid last year.  We also discussed the nodule in his lungs.  I do not suspect a stroke at this time.  I do not suspect ACS.  His EKG is unremarkable.  We did schedule him for outpatient ultrasound Doppler of his bilateral carotids.  Unfortunately we are unable to do those today.  He was given strict return precautions.  Patient is stable.  He verbalizes understanding and is agreeable.  I did discuss the patient with his PCP.  They are possibly leaning a little bit more towards anxiety related.
Red marks on skin following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red marks on skin following vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red marks on skin following vaccination). At the time of the report, ERYTHEMA (Red marks on skin following vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication was provided.   No treatment information was provided.
bilateral sensorineural hearing loss; dizziness,; tinnitus; viral conjunctivitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 15-AUG-2019, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date in August 2019 (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered bilateral sensorineural hearing loss, dizziness, tinnitus, and viral conjunctivitis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events were considered not recovered/not resolved. The events were considered related to zoster vaccine live (ZOSTAVAX).  The reporter considered all events to be disabling. Upon internal review, the event of bilateral sensorineural hearing loss was considered to be medically significant.
24hr p/vax devel fine rash on lower arms & face w/itching;itching relieved by PO DPH:
Generalized aching; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized aching) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced PAIN (Generalized aching) and HEADACHE (Headache). At the time of the report, PAIN (Generalized aching) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient experienced Achy body AND Headache after vaccination which was resolved on   On an unknown date. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   This case was identified as part of a retrospective clean-up activity  received in the Moderna were missed to be booked-in  No treatment information was reported.
arm soreness; muscle pains; tiredness; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), MYALGIA (muscle pains), FATIGUE (tiredness) and CHILLS (chills) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), MYALGIA (muscle pains), FATIGUE (tiredness) and CHILLS (chills). On 30-Mar-2021, CHILLS (chills) had resolved. On 31-Mar-2021, MYALGIA (muscle pains) and FATIGUE (tiredness) had resolved. On 01-Apr-2021, PAIN IN EXTREMITY (arm soreness) had resolved.            Treatment medications were not provided. No concomitant medications were reported. The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable   This case was linked to MOD-2021-066124 (Patient Link).
Patient received an additional dose of the Pfizer Bivalent Booster on 12/22/2022. His first booster dose of Pfizer Bivalent was administered on 09/22/2022.  Patient does not have any adverse effects so far.
no additional AE; expired dose administered; This spontaneous report was received from a other health professional and refers to a 4 years-old patient. The patient's concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were not provided  On 05-JAN-2020, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S017250, expiration date 01-DEC-2020) 0.5 ml, once (route of administration was not provided) for prophylaxis. The vaccine was reconstituted with a sterile diluent . No adverse event occurred. The outcome of adverse events was not provided.
I started recognizing an onset of shingles, I started a rash and nerve inflammation so I immediately wen t to the Doctor and received a Valacyclovir prescription.
Sore arm at injection site-starting in afternoon after injection, day after injection  Flu-like symptoms including muscle aches and chills - starting 8pm-12am day of injection
approx 12 hrs p/vax pt devel hives; pt was said to exp some sl SOB; DPH was administered & the sx dec;
first vaccine did not hurt therefore she is not sure if it was administered properly; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (first vaccine did not hurt therefore she is not sure if it was administered properly) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007021A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Patient had a  bad reaction to penicillin.). Concomitant products included AMLODIPINE for an unknown indication.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (first vaccine did not hurt therefore she is not sure if it was administered properly). On 07-Jul-2021, PRODUCT ADMINISTRATION ERROR (first vaccine did not hurt therefore she is not sure if it was administered properly) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
At the time of injection, the nurse said she had bled a little; a "quarter size of bruise on her arm a couple of days later"; lump under the arm; This is a spontaneous report received from a contactable consumer (patient herself) of an unspecified age received second dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration on 01-APR-2021 as single dose for COVID-19 immunization and first dose on an unspecified date via unspecified route of administration. At the time of injection, the nurse said she had bled a little and caller stated that she developed a "quarter size of bruise on her arm a couple of days later" and a "lump under the arm" and said the bruise was going away now. Caller had a concern was the vaccine still effective asked was the vaccine was given possibly in a vein or capillary. No info found regarding bruising after the injection or inadvertent administration in a capillary/vein. Referred to her HCP. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Mother stated child had temp of 106 first day after vaccination (11/15/10) 105 degrees F second day and 104 F third day, combined with prolonged crying.
She had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She had a sore arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE for Thyroid disorder.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (She had a sore arm). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. In 2021, PAIN IN EXTREMITY (She had a sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       After a day or two, the soreness went away. It was not too bad.  The patient states she never had a history of COVID positive. The patient had no known allergies and no other health conditions.   This case was linked to MOD-2022-475042, MOD-2022-475046 (Patient Link).
Pt developed a red splotchy circle around the vaccination site 10 days after vaccination. Pt is applying warm compress to the site.
Extremely severe joint inflammation and pain in the elbow and arm.  Left wrist became severe and diagnosed with DeQuervains Tenosynovitis.
I had my vaccine (left arm) at around 10:30 am on sept 16 , 2022. After two hours of  my vaccine I had a headache that start with the left side of my head. Then around 4 pm I started to feel feverish, terrible headache, body aches and soreness on my left arm.
Frightened her; Half side of breast beet red,Armpit became beet red; Horrible rash near injection site for 3 days and 4 nights; Itching near injection site for 1 sold day; This spontaneous case was reported by a patient and describes the occurrence of FEAR (Frightened her), ERYTHEMA (Half side of breast beet red,Armpit became beet red), VACCINATION SITE PRURITUS (Itching near injection site for 1 sold day) and VACCINATION SITE RASH (Horrible rash near injection site for 3 days and 4 nights) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEAR (Frightened her), VACCINATION SITE PRURITUS (Itching near injection site for 1 sold day) and VACCINATION SITE RASH (Horrible rash near injection site for 3 days and 4 nights). an unknown date, the patient experienced ERYTHEMA (Half side of breast beet red,Armpit became beet red). At the time of the report, FEAR (Frightened her) and ERYTHEMA (Half side of breast beet red,Armpit became beet red) outcome was unknown and VACCINATION SITE PRURITUS (Itching near injection site for 1 sold day) and VACCINATION SITE RASH (Horrible rash near injection site for 3 days and 4 nights) had resolved.            No concomitant medication was reported. Dates of vaccine administration, lot numbers and expiration dates were not reported. It was reported that horrible rash near injection site for 3 days and 4 nights and Itching near injection site for 1 sold day. No treatment medication was reported.   This case was linked to MOD-2022-592473 (Patient Link).   Reporter did not allow further contact
Type A flu; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Type A flu) in an adult male patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Type A flu). At the time of the report, INFLUENZA (Type A flu) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  It was reported that vaccine was On Feb 14th, patient took the vaccine shot After 2 weeks patient had a type A flu, last about 4 days. Treatment information was not provided.
A rash developed on right arm where MENVEO vaccine was administered. Patient describes it as itchy. Prescribed diphenhydramine.
Neurological / Cognitive side effects: trouble forming sentences, word loss, short term memory loss, typing issues, slowed hand / eye coordination, numbness and tingling in left hand, wrist and foot (injection side) - could not feel the bottom of my foot for the first 2 days, gait affected. Side effects began to lessen on day 5, but still dealing with some slight speech issues and short term memory loss.
Paient was vaccinated on 3/29/2021 with dose 1 of Moderna. Patient developed COVID symptoms on 4/4/2021 and passed away on 4/16/2021.
This spontaneous report was received from a nurse via a company representative and refers to a female patient of unknown age. The patient had no pertinent medical history. No information regarding the patient's concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with GARDASIL 0.5 ml (dose also reported as unknown) (route of administration, lot number and expiration date were not reported) for prevention of Human Papilloma Virus. After receiving the vaccine, the patient fainted. The nurse caught the patient and the patient was fine. The company representative did not know if this was the patient's first dose of GARDASIL and did not know if the patient received any subsequent doses. The patient did not seek medical attention and no treatment was given for the adverse event. There were no lab diagnostics studies performed. The patient recovered soon after the event occurred. There was no product quality complaint involved in this case. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
he did the same with the first two, was like somebody punched them  in the arm for 2,3,4 days/The first two doses were given on 13-FEB-2021 and 15-MAR-2021 both given in left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (he did the same with the first two, was like somebody punched them  in the arm for 2,3,4 days/The first two doses were given on 13-FEB-2021 and 15-MAR-2021 both given in left arm) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included Back injury, Kidney stones and Surgery (For ruptured disc, floating fragments, pinched nerve. Patient has been managing it with Gabapentin). Concurrent medical conditions included Gout and Charley horse (In his thigh.). Concomitant products included ALLOPURINOL for Gout and Kidney stones, LISINOPRIL, GABAPENTIN and SIMVASTATIN 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 an unknown date, the patient experienced VACCINATION SITE PAIN (he did the same with the first two, was like somebody punched them  in the arm for 2,3,4 days/The first two doses were given on 13-FEB-2021 and 15-MAR-2021 both given in left arm). At the time of the report, VACCINATION SITE PAIN (he did the same with the first two, was like somebody punched them  in the arm for 2,3,4 days/The first two doses were given on 13-FEB-2021 and 15-MAR-2021 both given in left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient was cleaning out his car and that pain started to re-occur and he started to have zaps in his leg. Patient does not know if that is associated with the shoulder because of the muscle part of it. Patient was taking gabapentin for zapping in leg, patient has never been tested, or have the symptoms of COVID. No treatment was provided by the reporter.   This case was linked to MOD-2022-522969, MOD-2022-522804, MOD-2022-523033 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2022: Lot number, route updated from the follow-up source document.
slipped in parking lot on cold day while transferring to car  Narrative:  pt, after this fall and ER trip that happened on the day of the vaccine,  -pt had a history of metastatic lung cancer and was admitted to outside hospital with altered mental status and found to have brain mets, is now in hospice. Low likelihood that covid vaccine was responsible.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I received my first three anthrax vaccinations from lots FAV030 in November and December of 1998 as mandated by the military vaccination program. FAV030 has tested positive for Squalene. I have also received several other anthrax shots from other lots. I was forced by the military to take some of these shots outside of the licensed schedule for them. I was in my mid-20's when I received the first shots an in extremely good physical condition. Within several months of receiving the injections, I developed seborrheic dermatitis. It has become progressively worse since then and now covers my entire face, head, groin, and underarms. My skin is red, inflamed, itchy, and covered with scales. I can only partially control it with a strong prescription steroid cream and shampoo. Seborrheic dermatitis is an immune disorder. My body's immune system has been triggered to attack it's own skin. The medication I use to control it has it's own set of side effects and risks. I also developed heart fibrillation's which have likewise become more frequent and severe in the years since 1998. Additionally, in the months following the anthrax injections, I suffered bouts of debilitating dizziness. Finally, I have developed chronic sleep problems. I have not been able to obtain a restful night of sleep in several years. I did not have any of these problems before receiving the Anthrax injection. There is very little doubt in my mind that the anthrax vaccine is the causal factor for my problems.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient received an improperly stored dose of M-M-R II (lot # N002337, expiry date: 20-JAN-2019) for prophylaxis which was reconstituted with a properly stored sterile diluent (STERILE DILUENT) (lot # N013282, expiry date: 23-AUG-2019). The temperature excursion ranged between 32 degrees Fahrenheit (°F) to 35°F (35.4F) on an unknown date for a time frame of 2 minutes. There was a previous temperature excursion which ranged 32°F to 35°F (35.2 F) for 11 minutes and 47°F to 77°F (51.9F) for 17 minutes. The call was because of a data logger. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1803USA004144: US-009507513-1803USA004145:
Patient had a fever starting 4/29/21, slight cough and congestion, thought he had a cold. On 5/4, he complained of chest discomfort and on 5/5 he was diagnosed with pneumonia. He was given antibiotics and an inhaler at Medical Center and sent home. On 5/6/21 he was taken to Hospital and Medical Center with oxygen sats in the 80's, a fever of 102 and diagnosed with COVID 19. On Friday the 7th he was upgraded to ICU due to his O2 sats not staying above 90%. On Sunday May 9, he suffered a stroke and the Neurologist stated he had most likely suffered a stroke a few weeks prior. Prior to the vaccine, he was acting completely normal and had no symptoms.