chrisvoncsefalvay/vaers-outcomes huggingface dataset:
postherpetic neuralgia; shingles; other zoster related injuries; Information has been received from a lawyer regarding a case in litigation regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On or about 01-APR-2014, the patient was administered zoster vaccine live (ZOSTAVAX) by a healthcare provider in a pharmacy for the long-term prevention of shingles and zoster-related conditions (dose, route of administration, lot number and expiration date were not reported)..  On an unknown date, the patient was treated by a healthcare provider the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles, postherpetic neuralgia, and other zoster related injuries. The outcome of the events was not provided.
I started having dizziness two days after I received the 1st shot, it was strong the first 5 days, then it was lightly, mostly lightheaded and some dizziness depending on how I move my head. Today I have been dizzy for a couple of hours in the morning. My concern is that is not going away and I am worry, not knowing what to do. I contacted my PCP and left a message, I haven't talked to her yet.
Fever; Headache; Sweating; Feeling nauseous; A bit of chills; Goosebumps; This is a spontaneous report from a contactable consumer (the patient) via medical information team. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) through an unspecified route of administration on an unspecified date for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported feeling "normal side effects" which included a bit of chills, goosebumps, fever, headache, sweating, and feeling nauseous after the first dose. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Mother was present in room with minor patient. Patient was informed that she will be receiving 2 vaccine in one arm and 1 in the other arm. After administering 2 vaccines. Patient was informed that the last vaccine MCV4 would be administered into the other arm. Patient requested that the vaccine be administrated into the same arm because she was afraid. Honoring the patient's requests, when administering the MCV4 the patient move arm and tighten muscle causing a small soft raised tissue to appear immediately after administration.
Heavy head; Tired; Sore throat during evening hours; Stiff arm; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (Heavy head), FATIGUE (Tired), OROPHARYNGEAL PAIN (Sore throat during evening hours) and MUSCULOSKELETAL STIFFNESS (Stiff arm) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 12-Jun-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff arm). On an unknown date, the patient experienced HEAD DISCOMFORT (Heavy head), FATIGUE (Tired) and OROPHARYNGEAL PAIN (Sore throat during evening hours). At the time of the report, HEAD DISCOMFORT (Heavy head), FATIGUE (Tired), OROPHARYNGEAL PAIN (Sore throat during evening hours) and MUSCULOSKELETAL STIFFNESS (Stiff arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown.
I developed itching at and around the injection in about 8 hours after the injection.   The itching has continued but is better after three days but it has not stopped.
Patient complained of heaviness in chest and lightheaded.  Patient remained in observation for and additional 30 minutes before leaving the site.
Mild fever (99.5), on day1 post injection, continued to reduce to normal (98.6) by late day 2; headache day 1 post injection, lasted until late day 2; mild muscle pain at injection site from 1hr after injection, no pain by day 3.
Patient received 1st Moderna vaccine @ 0836, after 3-4 minutes of receiving the vaccine patient reported feeling flushed, faint & shaking to fingers/hands. Patient reports never having vaccine reaction or vasovagal episode in past. No other anaphylactic symptoms present. Patient reports having Covid in December but cleared to received vaccine today. Vitals stable, 127/82, HR 82, & O2 Sat 100% Patient monitored for additional 15 minutes after she reports to continue feeling same symptoms off & on, Vitals stable, 140/77, 71 & 100% MD called for further guidance, per MD ok to monitor for additional 15 minutes if symptoms don't resolve, patient can be seen in ER for further evaluation. All patient's symptoms resolved, vitals remain stable, 125/75, 69 & 100%. Patient's husband will drive her home
Sore arm; fever (102.6 F); Chills; joint ache; bodyache; vomiting; dizzines; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (fever (102.6 F)), CHILLS (Chills), ARTHRALGIA (joint ache) and MYALGIA (bodyache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for Migraine.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (fever (102.6 F)), CHILLS (Chills), ARTHRALGIA (joint ache), MYALGIA (bodyache), VOMITING (vomiting) and DIZZINESS (dizzines). On 30-Jan-2021, PAIN IN EXTREMITY (Sore arm), PYREXIA (fever (102.6 F)), CHILLS (Chills), ARTHRALGIA (joint ache), MYALGIA (bodyache), VOMITING (vomiting) and DIZZINESS (dizzines) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included acetaminophen.
My son presented with a fever of around 103-104 approximately 2 weeks after receiving his 12 month vaccines which included the MMR, VARIVAX, and influenza vaccines.  Shortly after the onset of his fever he developed a large (quarter size) welt on his leg.  The welt was hot to the touch and painful.  He then developed approximately 24 pox like marks on his body.  I called his pediatrician who advised me to administer Benadryl and Tylenol until his reaction resolved.  It took him about 5 days to recover.  I was unable to visit the pediatrician since we moved cross country between the administration of the vaccine and the adverse reaction.
pt recv vax 17OCT96 & pt devel knot @ inj site & cellulitis;tx w/DPH & Biaxin;sx resolved & pt has recovered;
woke 15 hours after vaccine with temp 101.5 and body aches. symptom subsided in 8 hrs
patient was given expired lot 051b22a exp 11/21/22. no adverse reaction after administration. patient was instructed to start series over in a few weeks.
8 days of the first injection of Moderna in my Buttocks, a lump, redness and soreness has occurred
arm was sore; first dose of Shingrix around November 22, 2019 but has not received second dose yet; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Next day after receiving the 1st dose of Shingrix the patient experienced arm was sore and soreness was resolved approximately four to five days later. The patient not received second dose yet although it has been longer than 6 months. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. This case has been linked with case US2020178098 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020178098:Same reporter
The patient fainted about 10 minutes after the vaccination.  Her husband caught her preventing her from falling to the floor.  An ambulance was called and took the patient to the ER.  After tests were ran, there was no problems found with the patient.
got their booster they died; This is a spontaneous report from a non-contactable consumer. This consumer reported similar event for two patients. This is the second of two reports.   A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took dose 1 and dose 2 of Comirnaty; both on unspecified date for COVID-19 immunization. The reporter informed that she knew of two people who got their booster they died. The patient died on an unspecified date. It was unknown if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101396129 same reporter/product/events, different patients; Reported Cause(s) of Death: got their booster they died
About a month or so after the vaccine I started experiencing Asthma relating issues noticing my Blood O2 and forced respirator output levels  lowered so I reached out to my PCP  and a Chest X-ray was performed to rule out pneumonia but it was clear so he prescribed additional Albuterol to help.  The symptoms didn't improve after several uses so he tried to increase my Wixela but insurance wouldn't approve so Advair 250/50  was added to replace that.  I had an appointment with my Pulmonologist who  prescribed Trelegy and today is the first day I start taking it with a f/u scheduled appointment 2/2/22 to see if that helps.
Had normal mild flu like symptoms in the beginning.  The injection site had a large hard lump that was hard to the touch.  After about a week I broke out in hives randomly with no known trigger exposure.  Was told by PCP this was a normal reaction to the Moderna (although, usually after the 1st dose, not the second)  hives lasted for several weeks.  Treated with topical benedryl and childrens benedryl tablets.
Next day woke up with shiver; Couldn't get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Next day woke up with shiver) and FATIGUE (Couldn't get out of bed) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS, Prostate adenoma and Kidney disorder.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced CHILLS (Next day woke up with shiver) and FATIGUE (Couldn't get out of bed). At the time of the report, CHILLS (Next day woke up with shiver) and FATIGUE (Couldn't get out of bed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive Positive.
DEATH; This spontaneous report received from a consumer via social media (Twitter) via company representative concerned a patient of unspecified age and sex of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. Patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: Unknown) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Reporter stated that, on an unspecified date the patient who was perfectly healthy, died. Reportedly, reporter had guaranteed that patient would not had died from the treatment. The cause of death was unknown. It was unknown if autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event death was fatal. This report was serious (Death). This case, from the same reporter is linked to 20211141893.; Sender's Comments: V0: 20211141837-COVID-19 VACCINE AD26.COV2.S-Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Chicken pox vaccine (Varivax) given 7/30/07. Inflammation of injection site noted 7/31/07. 8/1/07- (R) upper arm (site of injection) is reddened, inflammed, warm to touch. (3" x 3" area) No fever-Possible cellulitis per Dr on 8/1/07
heart discomfort during walking; Near fainting at home; Shortness of breath; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received bnt162b2 (PFIZER COVID-19 VACCINE), administered in arm left, administration date 04May2021 11:30 (Lot number: Ew0172) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Apples, peaches allergy" (unspecified if ongoing); "birch tree pollen allergy" (unspecified if ongoing). The patient did not receive other vaccine in four weeks of vaccination. Concomitant medications included: metoprolol; atorvastatin. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EW0153, Administration time: 11:30, Location: Left arm), administration date: 13Apr2021, when the patient was 43 years old, for Covid-19 Immunization. The following information was reported: ANGINA PECTORIS (medically significant), described as "heart discomfort during walking"; PRESYNCOPE (non-serious), described as "Near fainting at home"; DYSPNOEA (non-serious), described as "Shortness of breath"; all with onset 01Jun2021 20:45, outcome "recovered". Therapeutic measures were not taken as a result of angina pectoris, presyncope, dyspnoea.  Follow-up (30Nov2021): Follow-up attempts are completed. No further information is expected.
This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient. A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2022 as dose 2, single (Lot number: EL9266), in left arm and on 18May2022 as dose 3 (booster), single (Lot number: FM0173) at the age of 42 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Autoimmune disorder" (unspecified if ongoing); "known allergies: Lime" (unspecified if ongoing), notes: known allergies: Lime. Concomitant medication(s) included: HUMIRA; CELEBREX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Patient received Paxlovid from 31May2022 to 05Jun2022 for the treatment of COVID-19. 2 days after completion patient started experiencing worsening symptoms like first few days following Covid diagnosis. Extreme nausea, headache and body aches during treatment. Sender's Comments: Considering the nature of the reported events and product profile, a causal role of the suspect BNT162B2 cannot be denied for the reported events.
Fri Jun 19, 2009 12:04 PM  After pt was given TDAP and MENACTRA vaccines he jumped off the bed and sat next to his mother, while his brother received his VARIVAX.  As I was leaving the room I heard Mom say to pt "what's wrong"?  When I turned to look at him his entire body was rigid and his fist were clinched together tightly.  His entire body was shaking and his face became very distorted with his eyes twitching very fast.  He was unresponsive to his name being called.  The entire seizure lasted for a total of about 30 seconds.  Once I realized he wasn't in harm of falling to ground.  Shortly after it stopped I went over to the next room to call Dr.  When we returned to the room he was responsive to his name, but was bent over vomiting on the floor.  We helped him over to the bed so that he would fall if he became weak.  Dr. stayed with the patient while I gathered oxygen, pulse ox machine, and towels.  When I returned to the room he was lying in bed, LVN and I were in the room.  We started him on O2 3L for comfort only because O2 sat was at 98%.  He was pale, cold, and drenched from sweating his vitals were 98/52-70-98.0-16 with an O2 sat of 100% on O2 3L.  I applied cold towels to forehead and neck and gave a glass of cold apple juice.  By this time he was awake, alert, and oriented X 3.  Once he was stable Dr. examined him.  We keep him in the room for the next hour checking on him to make sure he was ok.  Before they left Dr. went in his room to exam him before they left.  Final vital signs were 104/76-74-16-100% o2 on room air.  I assisted pt to front door per wheelchair with mother at his side.  No signs or symptoms of distress noted.
Client received Janssen vaccine approximately 11 am on 5/21/2021. Complained of heart racing, panic feeling, anxiety, facial flushing, nausea soon after receiving injection. Appeared pale in color. Reports she was very anxious about getting the injection. Heart rate 149, blood pressure 161/92. 911 called and client was transported to hospital approximately 11:20 am. Blood pressure at that time 154/91, heart rate 130.  Client was called at 3:53 pm 5/21/2021 and reports she was sent home from hospital earlier after receiving a shot of Ativan. She stated she did have an EKG while at the hospital and they took her vitals. She reports she was told it was anxiety and discharged. She had actually went back to work at 12:50 pm earlier in the day and was at work when I spoke with her. She said she "felt a little woozy but heart rate was good now and she was feeling pretty calm at work?. Had no other complaints at 3:53pm when I spoke with her.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Systemic: Weakness-Mild, Additional Details: Patient was anxious prior to getting vaccination and then fainted upon administration, she was fully recovered about 1 hour post event when she left the pharmacy.
Within an hour of the vaccine my ears felt incredibly stuffy and my mouth and tongue had a very strange taste. I went along with my day even though I did not feel too well and finally went to bed. I woke up around 12:30 AM, and during my sleep, I had lost control of my bowels. I was extremely faint my eyesight was almost blacked out and I had to crawl to the bathroom where I had the worst bout of diarrhea I have ever had in my entire life. I started to shake violently, my hands and feet were very numb, and My breathing was labored. I was fearful for my life.
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Dec2021 at 16:00 as dose 3 (booster), single (Lot number: FJ8762), in left arm and on 23May2022 at 14:00 as dose 4 (booster), single (Lot number: FN2908), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Apr2021 at 13:00 as dose 1, single (Lot number: 019B21A), in left arm and on 04May2021 at 13:00 as dose 2, single (Lot number: 021C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pre-diabetes" (unspecified if ongoing); "Lichen planus in mouth" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "known allergies: lg amts of shellfish" (unspecified if ongoing); "known allergies: lg amts of cheese" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Dec2021 at 16:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 05Jul2023 to 10Jul2023).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300253697 Same patient, different drug, different event;
Initial unsolicited report received from a consumer via other company (Pfizer) on 19 Dec 2016. Manufacturer report number: 2016563870. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had sickness. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none
felt itching in her tongue; cough; throat is scratchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "guillen barre syndrome" (unspecified if ongoing); "stroke" (unspecified if ongoing); "BellTs palsy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TONGUE PRURITUS (non-serious), outcome "recovering", described as "felt itching in her tongue"; COUGH (non-serious), outcome "recovering", described as "cough"; THROAT IRRITATION (non-serious), outcome "recovering", described as "throat is scratchy". Therapeutic measures were taken as a result of tongue pruritus, cough, throat irritation.  Additional information: Reporter mother has h/o guillen barre syndrome and stroke and BellTs palsy She had first dose of vaccine after which she felt itching in her tongue Started cough Felt like her throat is scratchy I gave her prednisone After which she got better.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.