chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) and his wife experienced shingles.  On 17-OCT-2007 at 14:41 the patient's wife received a response about transmission of the vaccine to another.  The caller does not think an adverse event was filed at that time.  The caller did not want to be identified or get further involved.  It was unknown whether medical attention was sought.  The outcome was unknown at the time of this report.  There was no product quality complaint.  No further information is available.
On the right arm where pt. received immunization there is a large rash under location of shot.
I experienced the following symptoms beginning 2:30  am 1/14/2021 through 1/15/2021 Uncontrollable shivering Fever of 100.3 Muscle/joint pain throughout my body  Swelling/ pain at injection site Fatigue Headache Vomiting
Had yearly physical at provider's office. Approx 25-30 minutes after Varicella vaccination began to have midsternal chest pain and fullness in throat. Ate ice all day to decrease throat sx - then came to ER.  6/02/2008 ER record received for DOS 5/08/2008 with DX: Allergic reaction to vaccination. Pt presented to ER with c/o substernal chest pain which radiated to the jaw and began ~30" after receiving Zostavax. Increased pain on deep breathing but no SOB. Throat feels swollen. PE WNL. Cardiac w/u (-). Tx with solumedrol and Medrol dosepack.
PULMONARY EMBOLISM; This spontaneous report received from a consumer and concerned a female patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced pulmonary embolism. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pulmonary embolism was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210450133.; Sender's Comments: V0: 20210446568-COVID-19 VACCINE AD26.COV2.S-PULMONARY EMBOLISM . This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient came in to the pharmacy on Monday, 3 days after vaccination, presenting with a red skin rash around the injection site. She stated that the area began itching Sunday and felt warm to touch. As of Monday, the itching had subsided some, but was still warm to the touch. She was instructed to use some Hydrocortisone cream for the itching. Upon speaking to the patient on Tuesday afternoon, she stated the rash has begun to lighten and the itching has almost gone away.
Narrative: COVID infection following COVID vaccine series 03/31 MODERNA, dose # 104/28, MODERNA, dose #2 08/16 pt cc: fatigue, headache, loss of taste or smell, myalgias, rhinorrhea exposure: unknown 08/16 COVID swab, result: detected
Breakthrough case admission after 2 vaccines  Moderna 4/16/21 Lot# 040B21A;  Moderna 5/14/21 Lot# 031B21A
Began to notice a rash on 30 Jan. He went to his local clinic and was given BENADRYL. During the weekend he noticed the onset of new lesions appearing on both of his hands, fingers and elbows. There was slight itching but he reported that the lesions were very painful and it hurt for him to bend his fingers. Multiple red papules noted on both elbows, bilateral hands with concentration of lesions noted over PIP joints. Few lesions noted on dorsal surface of fingers. No drainage, no swelling of surrounding tissue. No central clearing.
shingles on D 22 post vaccine.  Confirmed diagnosis of shingles on D 23 post vaccine.  Second dose of vaccine postponed pending recovery from shingles
chills; malaise; This is a spontaneous report from a contactable physician (patient). A 39-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), intramuscularly on 23Dec2020 at single dose on right arm for COVID-19 immunization. Medical history was reported as none. Concomitant medication included escitalopram. The patient received the vaccine on Wednesday and has been experiencing chills and general malaise since Thursday (24Dec2020), Friday and then 26Dec2020. The patient took ibuprofen 25Dec2020 as the treatment. The events outcome was not recovered. The paitent would like to know how long the symptoms would last and at what point should he be tested for COVID.
C/O five weeks of intractable cough.  COVID pneumonia.  He is positive for COVID. Start dexamethasone, empiric azithromycin, vitamin-C, zinc, Lovenox. Trend inflammatory markers.  developed a right-sided pneumothorax requiring chest tube placement. He was placed on Airvo however his saturations continued to worsen. Palliative Care was consulted and ultimately the family elected for comfort care.
Injection site very sore and painful, arm restricted movement lasting several days. Recurring discomfort and tenderness in muscle site.
Description per patient's message: "I just wanted to let you know that I had a rather severe reaction to the shot. It was the High dose. I don't know if I've ever had high dose before. I have had mild reactions in past. This time, my reaction was not allergic and resolved w/in 36 hours. I had the shot on Thurs at 4pm. My arm was expectedly sore that evening. I woke up around 04:00 to pee and could barely get out of bed. I was achy, chilled, clammy, exhausted walking down the stairs with shortness of breath. Felt like the proverbial freight train had hit me. Went back to sleep and at 07:00 I experienced dizziness so I took my BP. Sitting was 90/60 (normal), standing  dropped to 78/36. My heart rate (normally a bit high) was 143. These acute sx resolved quickly. I felt better as day progressed, had some additional flu like sx that evening. Was fine by Sat. a.m.  Won't be doing the high dose again."
Erythema size of baseball. Moderate to severe (L) arm pain extending up to neck. Fever 101 aboot 24 hours later, currently 102.5 being treated today.
Left arm received immun. 1/9/14; on 1/10/14 pt experienced soreness, redness, swelling, and fever in the arm left arm by 1/11/14 pt could barely move arm and had a fever; symptoms improved by 1/13/14; received MEDROL DOSEPAK 1/14/14.
Chief complaint:  redness on skin; redness right eye first, then left Patient informed immunizer on the second dose date; per nurse. MD checked out with no problem/concern in the eyes.
Information has been received from a consumer concerning her 16 year old daughter with no known pertinent medical history or drug reactions/allergies who on 06-AUG-2007 was vaccinated with a first dose of GARDASIL vaccine (yeast) 0.5 ml IM. On unspecified dates the patient received the second and the third doses of GARDASIL vaccine (yeast) 0.5 ml IM. Concomitant therapy included an unspecified vaccine. In March 2008, the patient experienced 50% loss of her hair. The patient also experienced bruising and swelling at the injection site on an unspecified date. The patient's 50% loss of hair persisted. The patient's physician had suggested that she should be tested for "heavy metals". The patient sought unspecified medical attention. No further information is available.
Redness, swelling, itching around injection site. Red whelps on both arms and chest approx. 6-7 minutes post injection of hep b vaccine. Ice pack applied to injection site and monitored. Benadryl was administered. Later that day, the pt's symptoms resolved.
Lost her vision; Leder Hereditary Optic Neuropathy (LHON); This spontaneous case was reported by a patient family member or friend and describes the occurrence of BLINDNESS (Lost her vision) and HEREDITARY OPTIC ATROPHY (Leder Hereditary Optic Neuropathy (LHON)) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced HEREDITARY OPTIC ATROPHY (Leder Hereditary Optic Neuropathy (LHON)) (seriousness criterion medically significant). On an unknown date, the patient experienced BLINDNESS (Lost her vision) (seriousness criterion medically significant). At the time of the report, BLINDNESS (Lost her vision) and HEREDITARY OPTIC ATROPHY (Leder Hereditary Optic Neuropathy (LHON)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by the reporter The doctor does not believe that it had something to do with the vaccine, but the reporter's sister states otherwise. The patient thinks that the vaccine has ignited her visual problem.  Treatment information was not reported  Company comment: This case concerns a 62-year-old, female patient, with no reported medical history, who experienced the serious, unexpected events of hereditay optic atrophy and blindness. The patient had blindness on unknown date after unspecified dose of mRNA 1273 vaccine, then 8 months after the vaccine, she was diagnosed with Leder Hereditary Optic Neuropathy (LHON) which is a genetic condition. The doctor does not believe that the vision loss was due to the vaccine, however patient thinks otherwise as she feels the vaccine ignited her condition. The rechallenge is not applicable as dose number is unknown. The genetic condition Leder Hereditary Optic Neuropathy remains a confounder to the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 62-year-old, female patient, with no reported medical history, who experienced the serious, unexpected  events of hereditay optic atrophy and blindness. The patient had blindness on unknown date after unspecified dose of mRNA 1273 vaccine, then 8 months after the vaccine, she was diagnosed with Leder Hereditary Optic Neuropathy (LHON) which is a genetic condition. The doctor does not believe that the vision loss was due to the vaccine, however patient thinks otherwise as she feels the vaccine ignited her condition. The rechallenge is not applicable as dose number is unknown. The genetic condition Leder Hereditary Optic Neuropathy remains a confounder to the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
The pharmacist gave me the shot and less than 24 hours later I had severe pain in my left shoulder. It is now 5 weeks later and I cannot raise my arm above my head or use my left arm. Pain is still severe and not getting better. I have an appointment with my primary care physician Wednesday November 21st, 2012.
Moderna COVID-19 Vaccine EUA Slight dizziness and fatigue one hour after shot, lasting 30 minutes Very mild soreness around site of vaccine, starting several hours after shot and still noticeable two days later
Severe swelling at injection site, circumferenced the arm; severe exhaustion; brain fog; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6Z06), via an unspecified route of administration in the left arm on 14Mar2021 at 09:45 (at the age of 55-years-old,) as a single dose for COVID-19 immunisation. Medical history included diabetes, type II. The patient had allergies to penicillin. Concomitant medications included Lantus (MANUFACTURER UNKNOWN), 60 Units, Metformin (MANUFACTURER UNKNOWN), Lisinopril (MANUFACTURER UNKNOWN), Multivitamins; all for unknown indication from unknown date and unknown if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021, the patient experienced severe swelling at injection site, circumferenced the arm, severe exhaustion and brain fog from day 2-4 post injection. The clinical outcome of the events, severe swelling at injection site, circumferenced the arm, severe exhaustion and brain fog was not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
severe thrombocytopenia.; 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 THROMBOCYTOPENIA (severe thrombocytopenia.) 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 THROMBOCYTOPENIA (severe thrombocytopenia.) (seriousness criterion medically significant). At the time of the report, THROMBOCYTOPENIA (severe thrombocytopenia.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.  Company Comment: This case concerns a patient of unknown age and gender,  with no relevant medical history reported, who experienced serious unexpected event of severe thrombocytopenia. The event occurred unspecified time after the unspecified dose of the Moderna COVID-19 vaccine . Rechallenge was not applicable since due to unknown outcome and lack of information on number of doses administered, no rechallenge was done and recurrence was thus, not applicable.  The benefit-risk relationship of product is not affected by this report; Sender's Comments: This case concerns a patient of unknown age and gender,  with no relevant medical history reported, who experienced serious unexpected event of severe thrombocytopenia. The event occurred unspecified time after the unspecified dose of the Moderna COVID-19 vaccine . Rechallenge was not applicable since due to unknown outcome and lack of information on number of doses administered, no rechallenge was done and recurrence was thus, not applicable.  The benefit-risk relationship of product is not affected by this report
I had vaccination on 10/14/2022. On 04/07/2023 I woke up with I felt crummy. On 04/08/2023 I started to experience cough extreme body and muscle aches extreme sore throat and shortness of breath with a low grade fever. I tested COVID-19 positive the evening of 04/08/2023. I haven't contacted a physical as of yet on 04/10/2023.
gradually increasing pain in upper chest, which became severe; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received BNT162B2 (BNT162B2; Batch/Lot number and expiry date was not reported) via an unspecified route of administration, administered in Arm Right on 25Feb2021 as SINGLE DOSE for covid-19 immunization. Medical history included diabetes mellitus. Concomitant medications included acarbose (ACARBOSE), sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]), metformin (METFORMIN) and losartan (LOSARTAN) all taken for unspecified indications, start and stop dates were not reported. The patient previously took denoral [risperidone] and darvon [betahistine mesilate] and experienced allergies. The patient experienced gradually increasing pain in upper chest, which became severe on 26Feb2021 at 20:00. It was reported that beginning in evening of day following vaccination: gradually increasing pain in upper chest, which became severe. Went to ER; tests there ruled out heart Involvement; referred to regular physician for follow-up (appointment booked for 03Mar2021). Pain slightly better when patient left ER, gradually subsided overnight and following day; pain gone on second following day. The patient underwent lab tests and procedures which included investigation: Test for heart involvement on an unspecified date (Tests there ruled out heart involvement). The outcome of the event was recovered.   Information about lot/batch number has been requested.
Febrile seizure x2, onset 16Sep; Transported/admitted to hospital.
Report from private physician's office regarding patient presenting with swelling of entire left arm. Was treated for allergic reaction.
Developed a full body rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Developed a full body rash) 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 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced RASH (Developed a full body rash). At the time of the report, RASH (Developed a full body rash) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that 8-9 days after vaccination patient develop full body rash.   Reporter did not allow further contact
have had a severe migraine headache; The pain was so bad that I was not able to open my eyes; The pain was so bad that I was not able to open my eyes, walk or talk; The pain was so bad that I was not able to open my eyes, walk or talk; The pain was so bad that I was not able to open my eyes, walk or talk; I still have a full headache; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Feb2022 10:00 (Formulation: solution for injection, Lot number: FJ1614) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto" (unspecified if ongoing), notes: Other medical history: Hashimoto; "Insulin resistant" (unspecified if ongoing), notes: Other medical history: Insulin resistant. Concomitant medication(s) included: DROSPIRENONE/ETHINYLESTRADIOL; METFORMIN; SYNTHROID. Vaccination history included: Bnt162b2 (Dose Number: 1, Prev dose Batch/Lot No: FJ1614, Prev dose Vaccine Administration Time: 02:00 PM, Prev dose Location of injection: Arm Right), administration date: 15Jan2022, when the patient was 42 years old, for Covid-19 Immunization, reaction(s): "I experienced pain at the injection site", "redness at the injection site", "had chills and night sweats", "had chills and night sweats", "fever", "headache", "Body aches", "swelling at the injection site". The following information was reported: MIGRAINE (non-serious) with onset Feb2022, outcome "recovering", described as "have had a severe migraine headache"; APRAXIA (non-serious) with onset Feb2022, outcome "recovered" (Feb2022), described as "The pain was so bad that I was not able to open my eyes"; GAIT INABILITY (non-serious), MUTISM (non-serious) all with onset Feb2022, outcome "recovered" (Feb2022) and all described as "The pain was so bad that I was not able to open my eyes, walk or talk"; PAIN (non-serious) with onset Feb2022, outcome "recovering", described as "The pain was so bad that I was not able to open my eyes, walk or talk"; HEADACHE (non-serious) with onset Feb2022, outcome "not recovered", described as "I still have a full headache". Therapeutic measures were taken as a result of migraine, apraxia, gait inability, mutism, pain, headache.  Additional information: The patient had a severe migraine headache. It started 12 hours after receiving second dose. The pain was so bad that she was not able to open my eyes, walk or talk. The pain was debilitating for 24 hours. The pain was still there- not completely gone- but tolerable. She was now able to talk, open eyes, and walk. But still have a full headache. The patient have been taking aspirin, Excedrin migraine, ibuprofen, Tylenol, caffeine, and advil for the headache. No complete relief yet. Prior to vaccination, patient has not been diagnosed with COVID-19. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Burning around my heart; Burning inside and around his kidneys/burning; It totally wiped him out; he napped for two hours; Pain; Felt like he had a fever at some point; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Burning around my heart), BURNING SENSATION (Burning inside and around his kidneys/burning), SOMNOLENCE (It totally wiped him out; he napped for two hours), PAIN (Pain) and PYREXIA (Felt like he had a fever at some point) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced SOMNOLENCE (It totally wiped him out; he napped for two hours), PAIN (Pain), PYREXIA (Felt like he had a fever at some point) and CHILLS (Chills). On 18-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPEPSIA (Burning around my heart) and BURNING SENSATION (Burning inside and around his kidneys/burning). On 21-Nov-2021, DYSPEPSIA (Burning around my heart), BURNING SENSATION (Burning inside and around his kidneys/burning), SOMNOLENCE (It totally wiped him out; he napped for two hours), PAIN (Pain), PYREXIA (Felt like he had a fever at some point) and CHILLS (Chills) had resolved.            Concomitant medications was not reported.  Treatment medications was not reported. The symptoms went away 3 days after the injection and patient was back to normal at the time of report.   Most recent FOLLOW-UP information incorporated above includes: On 25-Nov-2021: Follow-up information updates outcome of the events and narrative information
Injection site tenderness, flu-like symptoms including headache, low grade fever, muscle and joint aches, chills, making work impossible for two days.  Intensely painful and heavy menstrual period a week later, including passing palm-sized blood clots and intense pain that did not subside with otc pain killers, TENS therapy or heat. Patient does not have a history of painful menstrual periods.
Covid arm.  Rash on injection site about the size of two quarters.  Rash is more significant right after shower.   Not itchy.  No swelling.
Reported 10/29/10 07:03AM per mother. Varicella shot site red, hot, tender to touch, pain to shoulder. 08:30AM exam in office per doctor. Noted 6 cm diameter erythema. Tx with CLINDAMYCIN 150mg QID x 7 days.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients (no patient information known). On an unknown date, the unspecified number of patients were vaccinated with ZOSTAVAX, 19400 PFU (plaque forming units) (dose, route of administration and indication were not provided), that was improperly stored outside the prescribing information. No concomitants were reported. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. No further adverse event was information available. Additional information has been requested.