chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Schizophrenia; Condition aggravated; This case was received via FDA VAERS on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    This regulatory authority case was reported by an other health professional and describes the occurrence of SCHIZOPHRENIA (Schizophrenia) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Schizophrenia. Concurrent medical conditions included Drug allergy (peniciilin , erthromycin). Concomitant products included ARIPIPRAZOLE, ATORVASTATIN, SULFASALAZINE, AMLODIPINE BESYLATE, METOPROLOL, METFORMIN HCL, LOSARTAN, LEVOTHYROXINE, ACETYLSALICYLIC ACID (ASPIRIN 81), CALCIUM and COLECALCIFEROL (VIT D3) for an unknown indication.    On 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced SCHIZOPHRENIA (Schizophrenia) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, SCHIZOPHRENIA (Schizophrenia) and CONDITION AGGRAVATED (Condition aggravated) had not resolved.        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.   Relapse of schizophrenia after 19 years of stable maintenance on antipsychotic drugs.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Vaccine given 8/7/07 - pt with fever, headache, vomiting, diarrhea, injection site edema, erythema and tenderness. Pt treated with antibiotic Keflex QID x 7 d, Atarax 25mg IM and Prednisone 20mg x 5d.
received vaccine at 7am on 10/3/08-  45 minutes later itching of lips- swelling.  given 50mg oral BENADRYL- did fine full recovery
This spontaneous report as received from a healthcare worker refers to a 2 years old female patient. The patient was vaccinated with a dose of VARIVAX (Merck) (lot number, dose, route and site not reported) "on an unspecified date within the last year" approximately in 2012. No other co-suspects were reported. No concomitant medications were reported. Subsequently the patient was diagnosed with a case of shingles on an unspecified date. No treatment information was reported. The outcome of shingles was unknown. The patient had sought unspecified medical attention. Additional information has been requested.
G1P0, 5 weeks 4 days gestation, symptom onset approx 12 hours after vaccination. Symptoms include severe myalgia, arthralgia, and constant chills but no fever. Moderate headache and tachycardia (100-130, most likely due to pain level). I had to leave work after about 2 hours d/t symptom severity. Symptoms were only slightly improved with 1gram of Tylenol every 4-6 hours. I have not history of adverse vaccine reactions. Symptoms resolved about 24 hours after onset.
Pt seen in ER twice for abdominal pain, fever, vomiting. Diagnosed with intussusception. Tried to reduce with barium enema several times but was not successful. Surgical reduction was done 9/26/08. Spent 6 days in hospital and went home with mom. Follow up showed no complications.  3/27/09-records received for DOS 9/29-10/1/08 DC DX: Ileocolic intussusception with exploratory laparotomy and appendectomy. Presented to ED with vomiting and stomach pain, vomiting bile and stools chalky green.  2/26/09-ED report for DOS 9/27/08 received C/O fever, vomiting. DX constipation.
lose smell and taste; lose smell and taste; Positive Rapid Covid Test; progressively fatigue; he had a headache; at night he had chills; fever with more fatigue; fever with more fatigue; This is a spontaneous report from a contactable other HCP (patient). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), (Lot number: EL3248, expiry date: 31Mar2021), via unspecified route of administration in left deltoid on 08Jan2021 as single dose for COVID-19 immunization. Patients medical history was not reported. Patient concomitant medications are Multivitamins, Zinc, colecalciferol (VITAMIN D), fexofenadine hydrochloride (ALLEGRA), Aspirin, and famotidine (PEPCID) from unspecified date and unknown still ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 20Jan2021, Patient underwent Rapid Covid Test (nasal swab test), tested positive for SARS-CoV-2 test positive. On 26Jan2021, Caller clarified that b he did not have any further symptoms at all, no fever, everything had resolved. Caller clarified that the reason he got tested was because he was having symptoms, on the 19Jan2021 Tuesday he became progressively fatigue at lunch he had a headache, and probably by 7-8pm at night he had chills and fever with more fatigue. He had No chest pain, No shortness of breath, and No wheezing. The symptoms improved, the headache improved Friday, he had mild lingering fatigue and low-grade temperature for next day or so, but it was Tuesday at which he had no symptoms at all. He did lose smell and taste for 24 hours, it was on Friday 22Jan2021, 100% percent couldn't even smell Vicks Menthol. His Second Dose is schedule for 29Jan2021. He enquired about contraindication to getting the second dose of the vaccine. The Outcome of events was recovering for pyrexia ,headache, fatigue The outcome of chills, loss of smell and taste was unknown. Follow-up (28Jan2021): This is a follow-up spontaneous report from a contactable other HCP (patient). New information includes clinical information.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 19-APR-2016, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (lot # L048467, expiration date on 19-APR-2016 (dose number, strength and anatomical location were not provided). Concomitant therapies were  not provided).  The vaccines were stored in a temperature of 47F during 2 hours. No previous temperature excursion was reported. No adverse events were reported. No product quality complaint was involved. Additional information has been requested.
Case previously recorded as MA2009-5491. We received the following information from a consumer via Medical Communications (MedCom) on 19 NOV 2009: A 16-month-old male vaccinated i.m. with 0.25 ml of S-OIV FLUVIRIN (batch number unknown) on 14 NOV 2009. Administration of S-OIV FLUVIRIN to a child younger than four is not recommended/licensed. No adverse event had been reported. MedCom ref. no.: NA09-008551.
I had received Moderna Booster 11/6/21 and woke up the following morning 11/7/21 feeling  chest pain & tightness where my heart is. It felt like my heart muscle was clenching very tightly with pain radiating up my left arm. I have recognized this feeling before as I previously had a heart condition some years back. The pain in my chest would tighten with achiness, then release, then tighten again. I began experiencing shortness of breath, dizziness. I admitted myself to Urgent Care at 10:00 AM, explained my symptoms to the medical provider, explained that I had received Moderna Booster, Flu vaccination in my left arm the day prior w/ Tetanus shot Friday 10/29/21.
Fever, chills, sweats, diarrhea, severe stomach pain, malaise, nausea, occipital neuralgia. All symptoms were ongoing and lasted until 9/27/2015.
Headache, bad body aches, ringing of ears, feeling very tired, have hard time focusing, eyes sensitive to light, very sore arm at injection spot.
temperature excursion/ABOVE 46F (46.73F) for 46 hours 5 minutes and 0 seconds; No additional AE/PQC reported at this time.; This spontaneous report was received from a nurse concerning a 2-month-old patient of unknown gender. The patient's historical drugs, historical conditions, and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with first dose of improperly stored temperature excursion of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) (lot number 1707585 and expiration date 21-FEB-2022 were verified as valid) taken orally for prophylaxis.   Moreover, the temperature was above 46 Fahrenheit degrees (F) (46.73F)  for 46 hours, 5 minutes 0 seconds , which was detected by digital data logger; with no previous temperature excursion. The recommended range temperature was 36°F to 46°F (2 degrees celsius (°C) to 8 °C).   This is one of the multiple case reported from the same source.   ; Sender's Comments:  US-009507513-2104USA002044: US-009507513-2104USA002043: US-009507513-2104USA002042: US-009507513-2104USA001947: US-009507513-2104USA002041:
SEVERE BODY ACHES, SEVER HEADACHE, NAUSEA, FEVER 102, CHILLS, ARM PAIN
Pt described nerve pain going in and down the right arm that went away within the hour of getting the vaccine. Four hours later, pt calls to report vision problems, seeing double ("up and down crown, double vision") that lasted for about 25 minutes and resolved. Pt then reports  lower back pain (level 2-3) around 6:45pm, neither sharp nor dull pain.
first dose of the vaccine on 10Mar2021, on 16Mar2021 he had a positive PCR and rapid test; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A male patient of an unspecified age (reported as 46 no units reported) received bnt162b2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as 1ST DOSE,SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient had his first dose of the vaccine on 10Mar2021, he started feeling symptoms on 15Mar2021 and had a covid test (both positive PCR and rapid test) on 16Mar2021 that came back positive. The patient stated that he is still having symptoms. He wants to know if he should proceed with his 2nd shot or should he delay it. The outcome of the event was not recovered.   Information about lot/batch number has been requested
Information has been received from a physician concerning a 12 month old male who on 07-JUL-2008 was vaccinated with the first dose of ROTATEQ and on 10-NOV-2009, was vaccinated orally with the third 2ml dose of ROTATEQ. After receiving all three doses of ROTATEQ, the patient experienced rotavirus. The patient was admitted into the hospital for 3 days. Test for rotavirus were performed. At the time of this report, the patient was recovered (date unspecified). Additional information has been requested.
Patient said that he experienced worsening memory, dizziness, balance and very lethargic started within 24 hours  of his booster dose. He is feeling okay now (on and off) and has made an appointment with his doctor.
Headache, slight fever, slight body aches, feeling "out of it" Injection site was really sore. Woke up @ 2am and could not fall asleep. Slightly hard to breathe, rash on injection site.
Suspected vaccination failure/Got the shot, four weeks later developed shingles; Developed shingles four weeks after shot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 weeks after receiving 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.     Additional Information: GSK receipt date: 1-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shot and about four weeks later he/she came down with the shingles. The patient advised that stay away from the shots. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
only received the adjuvant only for the 2nd dose of Shingrix; only received the adjuvant only for the 2nd dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: only received the adjuvant only for the 2nd dose of Shingrix) and inappropriate dose of vaccine administered (Verbatim: only received the adjuvant only for the 2nd dose of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-JUL-2023 The patient only received the adjuvant only for the 2nd dose of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No reactions were reported. The reporter did not consent to follow up.
I received on top of my right arm and having burning sensation going from my back of my knees and up into my neck/Burning sensation all over my body; Low grade temperature 99.0 a little bit fever; a little bit of sore throat; a little bit of pressure in my hand; muscle are really sore; This is a spontaneous report from a contactable consumer (patient). A 27-years-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EW0179, Expiry date: 30Aug2021) via an unspecified route of administration in right arm on 01Jul2021 (at the age of 27-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EW0169; Expiry date: 31Aug2021) via an unspecified route of administration in right arm on 10Jun2021 (at the age of 27-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included depression from an unknown date to unknown if ongoing. Concomitant medication included Prozac (Fluoxetine Hydrochloride) 20mg for depression from an unknown date to unknown date. The patient didn't receive other prior vaccination before four weeks. On an unspecified date, the patient reported that I received on top of my right arm and having burning sensation going from back of my knees and up into my neck/ Burning sensation all over my body; a little bit of pressure in my hand, Low grade temperature 99.0 a little bit fever, muscle are really sore and a little bit of sore throat and a little bit of pressure in my hand. The patient did not receive treatment for adverse events. The outcome of the adverse events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
migraine; slightly swollen gland bellowthe ear; Worst eye migraine she ever had; Severe ocular migraine; Neck was hurting but mostly on the left side; Woke up in the middle of the night with lots of pain; pain in their head move to the eye; really really bad headache,mainly on the left side; Nose started running; Headache; Aches; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Nose started running), MIGRAINE (migraine), HEADACHE (Headache), PAIN IN EXTREMITY (Aches) and HEADACHE (really really bad headache,mainly on the left side) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-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) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced RHINORRHOEA (Nose started running), HEADACHE (Headache) and PAIN IN EXTREMITY (Aches). On 18-Mar-2021, the patient experienced HEADACHE (really really bad headache,mainly on the left side). On 23-Mar-2021, the patient experienced EYE PAIN (pain in their head move to the eye) and PAIN (Woke up in the middle of the night with lots of pain). On 24-Mar-2021, the patient experienced NECK PAIN (Neck was hurting but mostly on the left side). On an unknown date, the patient experienced MIGRAINE (migraine), LYMPHADENOPATHY (slightly swollen gland bellowthe ear), MIGRAINE (Worst eye migraine she ever had) and RETINAL MIGRAINE (Severe ocular migraine). At the time of the report, RHINORRHOEA (Nose started running), MIGRAINE (migraine), HEADACHE (Headache), PAIN IN EXTREMITY (Aches), HEADACHE (really really bad headache,mainly on the left side), LYMPHADENOPATHY (slightly swollen gland bellowthe ear), EYE PAIN (pain in their head move to the eye), MIGRAINE (Worst eye migraine she ever had), PAIN (Woke up in the middle of the night with lots of pain), NECK PAIN (Neck was hurting but mostly on the left side) and RETINAL MIGRAINE (Severe ocular migraine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included were thyroid medication and high blood pressure medication.  Treatment medication were Tylenol and ibuprofen.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD21-062595 (Patient Link).
eyes didn't look right-crabby; t103 aux went to 104 during noc 48 hrs; rash on arm (upper arm) warm & red; diarrhea for 3 days;
Marked swelling of arm distal to injection site with circumferential red, warm skin. Pt was on Biaxin at time of injections.
Within moments of injection experienced metallic taste in mouth that lasted several days. Day after vaccine experienced fever up to 100.5 (even with 400 mg ibuprofen every 6 hours) that lasted 18 hours. Substantial pain that traveled from shoulder down the left arm. Very large swelling of the lymph node in left arm pit three days after injection.  (not recovered from this yet)
Approx. 15:38, mother notified nurse that gave vaccines that left (outer) upper thigh of baby was red and indurated after receiving MMR and Varicella vaccines. MD was notified at 15:40.
Temperature excursion occurred due to the placement of hand warmers in the insulated bag used to transport vaccine. All 81 persons receiving vaccine in lanes 5 and 6 between 14:00 and 16:45 were notified they received vaccine that was outside of the appropriate temperature range and were recommended to be revaccinated.
This spontaneous report as received from a pharmacist refers to an approximately 69 years old female patient. The patient was vaccinated SC. into back of right arm with a dose of 0.65 ml ZOSTAVAX (lot number reported as "H011431", expired date 12-SEP-2012) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that patient had rash on her unspecified arm and unspecified leg now. The patient had contacted pharmacy for medical attention. A the time of the report, the patient was not recovered. Additional information is not expected.
HOSPITALIZATION; OFF LABEL DOSING FREQUENCY; DEATH; This spontaneous report received from a parent through social media concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient was previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported, 1 total administered on OCT-2021 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following covid-19 vaccine ad26. cov2. s (Unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported, 1 total administered on NOV-2021 for covid-19 prophylaxis. The drug was associated with Off label use (Off label dosing frequency). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On unspecified dates in 2022, the patient was hospitalized in and out of the hospital (reason and duration unspecified) (Dose number in series 2). The number of days of hospitalization was not reported and it was unsure if the patient was discharged from the hospital. On 25-APR-2022, the patient experienced death and died from an unknown cause of death (Dose number in series 2). It was unknown if an autopsy was performed or not. It was reported as "...My son got 2 covid shots, 1 in October of last year, another in November of last year!!! He was in and out of the hospital about 5 times the first 4 months of this year!!! He passed April 25th of this year !!!!" (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hospitalization and off label dosing frequency was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0-20221139847-Death and Hospitalization. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Pt vaccinated with Meruvax II developed pain & swelling in the hand joints, knees & feet joints. Also facial swelling. Treated w/Ibuprofen.
12/28 Difficulty falling asleep, Awake in middle of night w/ achiness - couldn't get comfortable. This morning c/o headache, feeling exhausted and weak.
About 40 minutes after the immunizations DTaP, IPV, MMR, Varicella, the mom called stating the child had developed hives on torso and face. No breathing problems. Child was given 1/2 tsp BENADRYL. Hives were better - no other problems.
Received flu shot at approximately 10:00 am.  By 13:30 (1:30) had hoarseness and head itching and hot 'flashes', felt very warm.