chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever, chills, nausea, body aches, head ache, loss of appetite, diareaha 8 hours after both injections lasting for 3 days
joint pain / elbow pain; was beat up and tired all through; he has back problems, but it made it worse; sore at the injection site; hard spot / at the injection site; blood pressure significantly went up / BP was 185/94 / had to double the dosage of his medications for blood pressure; first Shingrix Vaccine on January 2020 / 2nd Shingrix dose on October 31st, 2020; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included back pain (had back pain). Previously administered products included Shingrix (1st dose received on January 2020). Concurrent medical conditions included blood pressure high.   On 31st October 2020, the patient received Shingrix. On 31st October 2020, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the patient experienced joint pain, tiredness, back pain aggravated, injection site pain, injection site induration and increased blood pressure. The patient was treated with metoprolol, lisinopril and amlodipine. On an unknown date, the outcome of the joint pain, tiredness, back pain aggravated and increased blood pressure were recovered/resolved and the outcome of the injection site pain and injection site induration were not recovered/not resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the joint pain, tiredness, back pain aggravated, injection site pain, injection site induration and increased blood pressure to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, after vaccination with 2nd dose of Shingrix had joint pan, elbow pain, injection site pain and injection site hardness, back pain get worse, was beat up and tired all through and Blood pressure went up. The reporter stated that, the patient received dose 2 late due to COVID 19, which led to social problem. The patient was advised by his Cardiologist to monitor his BP for 36 hours. The patient received Metoprolol, Lisinopril and Amlodipine as a treatment medication for increased blood pressure. The patient  had to double the dosage of his medications for blood pressure. The patient reported that on 31st October 2020 his blood pressure was 185/94 and he increased his Metoprolol and on 1st November 2020 he had to increase his Lisinopril.  The patient stataed that all adverse events resolved except injection site pain and injection site induration. The reporter consented to follow up.
mom states pt had a sz the same noc hot shots, seen by MD in ER was given rx for Pedaprophen;
I had excessive vomiting for 5 hours couldn't keep anything down, had difficulty swallowing, lethargic, incoherent, felt dehydrated. Went to the ER around 2:00 pm.  Did several test.
Pt had seizure in pm - after having vaccines listed below - per ER - febrile seizure child treated and went home.
This case was reported by a pharmacist and described the occurrence of exacerbation of tinnitus in a 57-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject's medical history included allergy to gentamycin, allergy to neomycin and tinnitus. Concurrent medications included KLONOPIN. On 15 November 2008 at 10:11, the subject received unspecified dose of FLUARIX (.5 ml, unknown, left arm). On 16 November 2008, 1 day after vaccination with FLUARIX, the subject experienced exacerbation of tinnitus. The pharmacist reported that the subject experienced a worsening in her tinnitus after received FLUARIX. FLUARIX was administered at the pharmacy on Saturday, and then on Sunday she noticed the worsening of her tinnitus. The time of day for the onset is unknown. The worsened tinnitus was bothersome to the subject but has not required medical treatment at this time. Of note, the subject has a history of an allergy to neomycin and gentamycin but she has had flu vaccines in the past and never had a problem, thus the decision was made to use FLUARIX even though it contains a small amount of gentamycin. At the time of reporting the event was unresolved. The pharmacist considered the event was possibly related to vaccination with FLUARIX.
1st dose Vaccine 1/9/21; 2nd dose vaccine 2/14/21; developed hives/rash 2/15/21, resolved with Benadryl; developed chest pain, SOA, HA, jaw/teeth pain , and nausea 2/17/21; seen at Clinic 2/17/21 and sent to ED same day for eval; was d/c'd home from ED 2/17/21.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. The patient had been told that happened and in a few cases, people got them more than once. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.    This case had been linked with case US2021AMR183108, reported by the same reporter.
exposed to my sister/she did not know she had Covid/I tested positive with Covid test; exposed to my sister/she did not know she had Covid/I tested positive with Covid test; This is a spontaneous report from a contactable other HCP (patient).  This female patient of unspecified age reported for herself that she received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiration date were not reported) on 21Dec2020 00:00 (at unspecified age) as single dose, unspecified route, for COVID-19 immunisation. Medical history and concomitant medications were not reported.  The Patient received the vaccine on 21Dec2020 and was exposed to her sister on 22Dec2020 she did not know she had Covid. Patient tested positive with Covid test on 26Dec2020. Patient is scheduled to get second dose 11Jan2021. Lab data included a positive Covid test on 26Dec2020. The outcome of exposed to my sister/she did not know she had Covid/I tested positive with Covid test was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. Efficacy of suspect drug however, is documented 7 days after second dose. Patient has received only the 1st dose.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's current conditions or medical history were not reported. The patient received the first dose of GARDASIL series on: on 30-JAN-2014, second dose on -3-APR-2014 and third dose on 11-JUN-2014, (0.5 ml intramuscular injection, not numbers and expiration dates not reported). No adverse effects reported. Additional information has been requested.
This spontaneous report as received from a nurse via field representative on 19-NOV-2014 refers to a 16 year old female patient. On an unknown date the patient was vaccinated with her first dose of GARDASIL. Concomitant therapies included MENACTRA and hepatitis a virus vaccine (unspecified). On an unknown date the patient fainted for thirty minutes after receiving her first dose of GARDASIL. The event outcome was recovered. The patient sought medical attention via office visit on an unknown date. Additional information has been requested.
No additional AE; Inbound call from a medical assistant with a physician on the back line reporting AE for VARIVAX.  TE case filed under 02458467. AE details were provided by medical assistant. No symptoms reported. No additional AE/PQC.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.       On 08-AUG-2023 the patient was vaccinated with first dose of improperly stored  varicella virus vaccine live (oka/merck)(VARIVAX) lot # x006983 and expiration date 07-MAR-2025, for prophylaxis (exact dose, route and site of administration were not provided) (product storage error and no adverse event).     ; Sender's Comments:  US-009507513-2308USA009014:
Severe gas pain, vomiting, headache, temp 99.8, sleepy, weakness, loss of appetite.
an 83-year-old female with a history of advanced COPD with Pseudomonas colonization, hypertension, dyslipidemia, GERD and osteoporosis, who presented with increasing shortness of breath, cough and hypoxia on 08/24.  At the time of admission, chest x-ray was negative for infiltrate.  Patient is fully vaccinated against COVID, however COVID test was positive on 08/24.  Patient was placed in severe respiratory isolation.  Patient was continued on Spiriva, Symbicort and DuoNebs.  The patient also is on daily azithromycin and alternating colistin/TOBI treatments.  Patient was continued on colistin.  Patient had been started on Prednisone prior to admission, which was transitioned to IV Solumedrol.  Patient was also started on Remdesivir.  Pulmonary was consulted.  She was continued on IV Remdesivir (completed 5 days), breathing treatments as well as steroids with slow improvement in her respiratory status.  She was transitioned back to prednisone on 08/29.  As the patient had clinically improved, having completed treatment with remdesivir, and being transitioned to oral prednisone she was discharged to home on 8/30/22.  She was seen by pulmonary rehab on day of discharge, and will require 2 L oxygen with activity only.   She will be discharged home on 8/30/22.  She will be placed on a tapering dose of Prednisone at discharge, and should follow-up with her PCP in 1 week.
Pt inadvertently given Tetanus Toxoid Absorbed Purogenated vaccine that was not stored in refrigeration for 3 mos (storage requirements for this product are refrigeration at 2-8 degrees C). The pt experienced symptoms which included: chills, right arm warmth, pain, swelling and redness up to her neck, right arm lymph node swelling and severe muscle pain in leg, veins and body.
Multiple subsegmental pulmonary emboli with no history of DVT/PE. No other risk factors other than tobacco use and recent cataract surgery (<1 hour).  PE occurred 9 days after last vaccine. Pt presented with chest pain and SOB.
Left arm hot and red at injection site; Red blotches on chest and cheeks like sunburn; Flu like feeling; Left arm hot and red at injection site; Fever; chills; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Left arm hot and red at injection site), RASH MACULAR (Red blotches on chest and cheeks like sunburn), INFLUENZA LIKE ILLNESS (Flu like feeling), VACCINATION SITE ERYTHEMA (Left arm hot and red at injection site) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Left arm hot and red at injection site), RASH MACULAR (Red blotches on chest and cheeks like sunburn), INFLUENZA LIKE ILLNESS (Flu like feeling), VACCINATION SITE ERYTHEMA (Left arm hot and red at injection site), PYREXIA (Fever), CHILLS (chills) and FATIGUE (Very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Left arm hot and red at injection site), RASH MACULAR (Red blotches on chest and cheeks like sunburn), INFLUENZA LIKE ILLNESS (Flu like feeling), VACCINATION SITE ERYTHEMA (Left arm hot and red at injection site), PYREXIA (Fever), CHILLS (chills) and FATIGUE (Very tired) outcome was unknown.            Concomitant medications were not reported. Patient took Tylenol and Benadryl to relieve her symptoms.  Action taken with mRNA-123 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Shortly after getting this vaccine, I noticed I needed to stop to rest when doing things I previously had no trouble doing. I had no stamina. The stamina issue diminished but never went away. I initially attributed this to a more sedentary lifestyle during quarantine. I got the next dose of COVID-19 and the stamina issue became a breathing issue. I saw my PCP and asked for an EKG. This EKG revealed atrial fibrillation. On July 18 2022 I had my heart shocked back into rhythm and so far my heart has maintained the correct rhythm.
This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The patient had a past history of shingles. The episode of the shingles occurred and resolved prior to the administration of ZOSTAVAX. The patient has no drug reactions/allergies. On 16-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot # J004266, exp 12-JUN-2014), subcutaneous, dose not provided. There was no concomitant medication. On 17-SEP-2013, the patient had a little redness and warmth at the injection site. On 18-SEP-2013 redness had expanded to the size of a baseball and the warmth continued. No treatment was given. No lab was performed. The patient called the reporting pharmacist. At time of report the patient was not recovered. Additional information has been requested.
Gave Boostrix ( AC52B013AA exp 12/20/08)instead of Pediarix for third vaccination. Only noticed after another nurse entereding information into system brought it to my attention. Patient stayed 20 post vacinations without any adverse reaction. Note sent to parent to return to clinic but did not return as requested.
I received my booster shot on 23 rd December 2021. On 4th January, I started having itchiness around my arms first which spread across the entire body by evening. I was itchy all over my body. When I scratched my skin cause of unbearable urge to itch, the area turned red to dark red. At times, it will be elevated too. It has been over 2 weeks now I am still in the same condition. I do take Zyrtec every 2 or 3 rd day as I do not want my body to get used to the medication.
Pain and soreness within one hour after shot. On day 5 I developed rash and itching.
Resident visited ER on 1/4/2023 for nausea and vomiting at approximately 10 pm. Labs were drawn at the ER with no abnormal results reported by ER nurse. Resident returned to facility approximately 3 hours later. On 1/6/2023, resident stated he was "feeling fine" on two separate instances before vaccine administration, nausea and vomiting had subsided and vital signs were within normal limits. Vaccine was administered approximately 9:45 am. At approximately 2 pm, resident again stated he was feeling fine. At 3 pm, resident was seen by facility nurse practitioner, who noted resident was having bilateral audible wheezing. Resident refused transfer to ER at that time. Approximately, 3:20 pm, staff assisted resident from the bed to his wheel chair and resident suddenly become short of breath and pallor was noted by staff, resident was alert and oriented at this time. Pulse oximetry was 81%. Oxygen was applied at 4L /min. EMS was contacted for transport to ER. At 3:25 pm, resident became lethargic and unresponsive to stimuli, oxygen increased to 5L/min.  EMS arrived shortly after and patient was transported to stretcher and taken by ambulance to ER where he passed.
Approximately 12 hrs after receiving vaccine, pt developed fever of 101.9 shaking chills and stiffness in back and neck. Sx abated within 24 hrs.
Initial case received from a consumer on 27 October 2011. A female senior citizen (age not reported) received an injection (route and site not reported) of FLUZONE HIGH-DOSE (lot number not reported) on 24 August 2011. The patient had no problems with the regular flu vaccine. The patient's medical history and concomitant medications were not reported. On an unknown date the patient became ill and developed enormous amount of pain and anxiety. She was prescribed an antibiotic by her doctor. The patient's doctor and pharmacist agreed that the patient's suffering was caused by the vaccine. She got better but the illness returned again. She was prescribed another series of antibiotics which she just finished. The patient complained that the shot made her very ill and she has become depressed. The outcome was reported as not recovered. Documents held by sender: None.
Actually a booster dose rather than  full dose 3. About 1-1/2 day after vaccination site of injection became very red, sensitive, and blistered. Accompanied by a low grade fever. Followed up with reporter on day 6 and irritation at site of injection was slowly resolving and had scabbed over.
This initial spontaneous report was received from a registered medical assistant referring to an unspecified number of patients of unknown ages and genders. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On unspecified dates, the patient were vaccinated with improperly stored doses of MMR II injection (lot # K021950 with expiration date 10-NOV-2016, albumin status rHA and lot# L009545 with expiration date 19-MAR-2017, albumin status rHA; dose and route were not provided. No adverse effect was reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Severe pain in left jaw-the same side the shot was given. I felt like I had a toothache. This is no longer a problem although I still have a lump in my mouth. I have diarrhea off and on, that's still a problem. I still have abdominal pains, but not as much. the muscle weakness is no longer a problem
Swelling at and around injection site, hot to touch, severe itching and severe pain.  Swelling continued to worsen for 48 hours.
Reported facial and lip numbness x 3 days following covid vaccination (Bells Palsy) . By 5pm it had creep to the face, right cheek was not responding fully. Described the numbness like having a Novocain at the dentist.  Symptoms lasted 3 days
Loss of appetite; Weakness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), ASTHENIA (Weakness) and HEADACHE (Headache) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite), ASTHENIA (Weakness) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 21-May-2021 at 4:20 PM, DECREASED APPETITE (Loss of appetite), ASTHENIA (Weakness) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: abnormal (abnormal) going up and down (163/90).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include blood pressure medication.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: received with follow up information on 21-MAY-2021 shows that, the outcome of event(s) changed to recovered/resolved.
Patient received vaccine at 2:30 pm on 01/07/2021 and then 2 hours later started experiencing tingling in her lips and throat tightness. She then took a 25 mg tablet of Benadryl and experienced some relief before presenting to the emergency department. At the hospital she was given 60 mg of prednisone, in hospital note it was provided that she has started Rosuvastatin the night before but providers did not believe that was the cause of the reaction.
SORE ARM; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 5 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: factor v leiden. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm, nausea, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and the outcome of nausea and fatigue was not reported. This report was non-serious. This case, involving the same patient is linked to 20211218015.
had severe itching that started from her extremities (hands and legs), and finished with an allergic rash all over her body; had severe itching that started from her extremities (hands and legs), and finished with an allergic rash all over her body; Initial information received on 04-Jan-2022 regarding an unsolicited valid non-serious courtesy case received from a pharmacist.  This case involves a 54 years old female patient who had severe itching that started from her extremities (hands and legs), and finished with an allergic rash all over her body, while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included METHOTREXATE (OTREXUP) for Rheumatoid arthritis.  On 08-Dec-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported) via an unknown route in unknown administration site for vaccination.  On 24-DEC-2021 the patient developed a non-serious had severe itching that started from her extremities (hands and legs) and finished with an allergic rash all over her body (rash,pruritus) 16 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) was not applicable.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Pruritus and Rash.  At time of reporting, the outcome was Unknown for the events
6" x 3" rash on lower left side of back, several other smaller rashes similar in shape and color in proximity. Some itching but not severe.  Showed up about 8-9 days after first dose of Moderna.   Also, felt shortness of breath during exercise 8-9 days after first dose of Moderna. Woke next day with feelings of chest compression/tightness and coughing.