chrisvoncsefalvay/vaers-outcomes huggingface dataset:
postherpetic neuralgia; herpes zoster; Information has been received from a lawyer regarding a case in litigation which referred to a patient (pt) of unknown gender and age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster) and for routine health maintenance (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). Afterwards, on an unknown date (reported as after receiving zoster vaccine live (ZOSTAVAX) vaccine), the patient suffered herpes zoster and postherpetic neuralgia. As a result of those symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. In addition, the pt sustained severe and permanent personal injuries. Further, the pt had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster and postherpetic neuralgia were considered as disabling events by the reporter.
On 11/8/2016 administer after couple days throbbing pain in arm/aching arm with warmth over week pain increase and patient took Ibuprofen. Two weeks later she said she was not able to raise arm and went to ER-room. They referred her to orthopedic MD which is had appt on 12/5/2016 and due to inflammation told to come back on 12/19/2016.
Slight sore throat; instead of getting .25ml he got .5ml; inappropriate schedule of vaccine administered; feeling fatigued; physical and mental state not fine; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Slight sore throat), FEELING ABNORMAL (physical and mental state not fine), INCORRECT DOSE ADMINISTERED (instead of getting .25ml he got .5ml), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) and FATIGUE (feeling fatigued) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041Z1A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine and Pfizer vaccine. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. In December 2021, the patient experienced FEELING ABNORMAL (physical and mental state not fine) and FATIGUE (feeling fatigued). On 22-Dec-2021, the patient experienced INCORRECT DOSE ADMINISTERED (instead of getting .25ml he got .5ml) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 27-Dec-2021, the patient experienced OROPHARYNGEAL PAIN (Slight sore throat). On 22-Dec-2021, INCORRECT DOSE ADMINISTERED (instead of getting .25ml he got .5ml) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Slight sore throat), FEELING ABNORMAL (physical and mental state not fine) and FATIGUE (feeling fatigued) outcome was unknown.            No concomitant medications was provided. The patient does not take any medications and also has not contacted his HCP.
p/vax pt devel cellulitis & was adm to hosp;tx w/unspecified ATB & recovered;
1.5 x 3 cm area of faint erythema and induration and min tenderness (R) deltoid at site of DTAP injection.
Three hours after injection patient became shaky and unsteady. He then became weak and fatigue and had slight headache. He then began to have a sore throat and had swollen lymph nodes in throat. Reports he felt feverish, but never ran a temp. He now has rash over side of face, groin and penis. Reports burning behind his eyes and on his scalp. Has seen his Doctor and an ophthalmologist and a dermatologist.
On 3AUG91 small amount of fever, 4AUG91 c/o itching @ site of inject, 5AUG91 site turned red, felt hot to touch, itching; 6AUG91 area as large as orange, hot, itching, has whelps looks like hives on red area; t98.4 oral this AM;
Information has been received from a licensed practical nurse concerning a 48 year old male with diabetes and asthma and no allergies who on 11-APR-2007 was vaccinated SC with a dose of MMR II. Concomitant therapy included unspecified anti-inflammatory drugs. On 19-APR-2007 the patient received second dose of MMR II (Lot# 654985/1181F) about 1 week after first vaccination. The first vaccination was not documented resulting in the second vaccination. The patient experienced dizziness and was diaphoretic immediately after vaccination. The patient's blood pressure was slightly elevated. The patient was sent to the Emergency room for evaluation. No diagnostic laboratory tests were performed. At the time of report, the patient has not recovered. A product quality complaint was not involved. Additional information has been requested.
102 fever, chills, nausea, headache, severe body aches and weakness.  Fever continued to 5/9/2021.
10-12 hours in I felt arm and neck pain near the injection sight. Pain continued for next 24-36 hours.  36 hours later  I had indigestion,  acid reflux and difficulty sleeping.  48 hours later I  started having dizziness, nausea, mild headaches, eye tenderness, tired.
Minor headache; Minor pain in the shoulder near the injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162B2 (BNT162B2), administered in arm left, administration date 22Mar2021 (Lot number: ER8727) at the age of 38 years as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 22Mar2021, outcome "recovering", described as "Minor headache"; ARTHRALGIA (non-serious) with onset 22Mar2021, outcome "recovering", described as "Minor pain in the shoulder near the injection site". Therapeutic measures were not taken as a result of headache, arthralgia.  Additional information: The patient did not receive any other vaccine within four weeks of the COVID-19 vaccine. Prior to vaccination, the patient had no history of COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Gum Periodontitis; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 19Feb2021 as a single dose for covid-19 immunization. Medical history included ache in upper left gum (molar area) from 20Jan2021, patient had Teeth Periodontitis on 20Jan2021 (Admission to the hospital due to the event: No, Any treatment received: Yes, Still experiencing: Fine Now). The patient's concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on 29Jan2021for COVID-19 immunization and fistula was developed on her gum on 06Feb2021. The patient received the second dose of vaccine on 19Feb2021 and on the same day she experienced gum periodontitis. She waited until 05Mar2021 for procedure to clean around and under her tooth. Her next appointment was on 29Mar2021 and it appeared better. Treatment medication included antibiotic for 5 days. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient fell and was unable to get up due to leg weakness. Uncertain whether syncope also occurred. Pt. also had transient altered mental status. He was taken to hospital, where he was found to have mildly elevated CK and mild hyponatremia. No additional diagnoses were made. Pt gradually improved and was back to baseline within a week.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 66-year-old female patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 4th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th June 2018, less than a day after receiving SHINGRIX, the patient experienced fever, chills and rash. On 5th June 2018, the outcome of the rash was recovered/resolved. On an unknown date, the outcome of the fever and chills were recovering/resolving. The reporter considered the fever, chills and rash to be possibly related to SHINGRIX. Additional information was reported as follows: The healthcare professional reported that, the patient received first dose of SHINGRIX on Monday around 5:55 pm.  On the same day of vaccination, the patient experienced a little fever and chills as well as a rash on her feet. The rash resolved the next day, after the vaccination while the fever and chills were still present, but were mild. Since then the healthcare professional was unsure if the events had resolved. The healthcare professional was unsure whether an emergency room or doctor visit was required, the patient was hospitalized or not, it was disabling or life-threatening or whether it jeopardized the patient or intervention was required, (other than the discontinuation of the drug) to prevent one of the listed outcomes. The reporter stated that the patient was exposed to someone with a cold so she was unsure if the symptoms could be related to that instead. Other pharmacist at pharmacy, administered the SHINGIRX vaccine.
(L) deltoid 6 X ^6 in swelling and redness. No breathing difficulty.
Sore left arm; Inappropriate age at vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore left arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore left arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-193597 (Patient Link).
Patient reports skin tingling to left arm very soon after injection. She was kept on site and no further symptoms developed. Throughout the rest of that day and subsequent days, skin tingling expanded to include most parts of her body. Three days after injection she developed right upper and lower eyelid swelling and pain. All of these symptoms were present when she was evaluated today 11/27/2021.
Diarrhea after First Vaccine; Stools have changed color after First Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea after First Vaccine) and FAECES DISCOLOURED (Stools have changed color after First Vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea after First Vaccine) and FAECES DISCOLOURED (Stools have changed color after First Vaccine). At the time of the report, DIARRHOEA (Diarrhea after First Vaccine) and FAECES DISCOLOURED (Stools have changed color after First Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No treatment medications were reported.
After receiving COVID-19 vaccine, patient experienced lightheadedness, dizziness, extreme fatigue, blood pressure was labile, throat swelling and shortness of breath. RRT called, patient was monitored, vitals taken, glucose monitored, O2 administered at 2 L/min. Pt reported feeling dizzy and fatigued, but other symptoms improved. No medication interventions noted. patient discharged and scheduled for 2nd COVID vaccine 9/20.
Patient reported a headache to me in the temple and body aches.  I advised her to get with her Dr. She saw a provider at the urgent care and was evaluated and provided medication.
1005 Pt report dizzy. B/P 122/86, HR-74, R-18, 02 sat99% ra. Pt also reports some anxiety prior to vaccine. 1010 reports  dizziness getting better. 02 sat 99% ra, HR-72, 1021 Reports dizziness resolved. B/P 124/80, HR-79, 02 sat 100%, R-20. Pt discharged with husband and daughter. Instructed to f/u with MD as needed.
Sometime in the middle of the night/early am Jan 6 I rolled over in bed and had vertigo, it felt like I was doing flips. The whole day I had to be careful I would get vertigo so bad it I moved to quick. I went to my Chiropractor, he thought it was the benign and had me do a specific maneuver. It made me nausea for an hour then went away.  As long as I didn't bend over funny I though I was ok. On the 9th and 10th I felt general dizzy, I would turn and just kind of felt like I was spinning.  I took Sudafed because my ears felt full. Then the vertigo was just gone.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Started during the night of the vaccine, extremely cold during the night, unable to warm up, headache, light headed, woozy, nauseated, fever...took Tylenol for fever.  Symptoms last all day 9/19/2021, better this morning 9/20/2021...still very sore, feverish, warm arm.
Pfizer-BioNTech COVID-19 Vaccine EUA:  Patient received second COVID-19 vaccination in the morning and overnight developed fever (maximum temperature 103 degrees fahrenheit), body aches, and urinary urgency, frequent urination, and dysuiria. Patient reports fever and body aches after receiving the first vaccination for COVID-19 but did not last as long as they did with the second vaccination. The next day patient presented to urgent care, diagnosed with urinary tract infection, and prescribed antibiotics.  At visit with primary care provider six days later all symptoms resolved and no new symptoms reported.
Pt reported to stop walking right after 12 month vaccines, now with tremor and right sided weakness.
They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case contains information for the 16th patient out of 24 patients as described by the reporter.  Concomitant medications were not reported.  The vaccination clinic received incorrect guidance from the DOH in regards to the vaccination, who instructed to order and administer the vials with pink top to patients.  It was reported that 24 pediatric patients were administered underdose bivalent vaccine doses for either their first or second doses. They received 0.2 ml dose from the pink vial instead of the 0.25 ml dose from the blue cap vial. The patients were aged between 6 months to 5 years. The patients were being contacted and revaccinated with the correct dose.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 04-DEC-2015, patient received improperly stored VARIVAX dose 1, from lot # L015045 (dose and expiry date unknown). On 08-JAN-2016, patient received second dose of VARVIAX from lot # L015045 (dose and expiry date unknown) which was improperly stored. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
headache,cold. PT got 2nd covid vaccine yesterday around 1100. Sx started since last night. C/O headache and chills. Denies n/v/d. No chest pain or SOB.  P/w mild generalized constitutional symptoms 2/2 COVID vaccine. Well-appearing, no increased WOB, normal vitals. Will discharge to quarters with symptomatic treatment.
Hypotension, tachycardia, dizziness, nausea, vomiting (intermittent x 4 days), left arm pain, joint pain, chills, low grade temperature, diaphoresis, lethargy confusion (day 1 only) headache- symptoms last 4 days with height at 24-48 hours
Everything just started to get flowy, my right ear was stuffed up for a long time and it stayed like that until now, but I do not have the hearing loss I had before.  The dizziness came so bad I had to call an ambulance on 05/17/2021. I was admitted for 2 days in the ER and then in a room. The second time I called an ambulance was on 06/11/2021. They gave me shots and stuff through my IV for nausea and dizziness and I told them if they were not able to do anything else I will go home and I did. I had been to my PCP, neurologist, and ENT doctor. My ears might have been stuffed up in April or May. After my first shot the only symptoms I had was my heart started pounding really fast like half hour later and I got fleshed. I did not have any symptoms with the second one, the only thing is that my arm was sore. My ENT doctor today said that I should be good. They diagnosed me with vertigo. They did blood work, EKG, and brain scan.  From all the doctors that I have seen they said that I have a virus in my inner ear. They put me on 7 days of 60 mg steroid and antiviral. That did the trick, I am doing better now and nausea medicine.
Information regarding PREVNAR 13 was received from a consumer regarding an 18 month old male patient who experienced diarrhea. At 18 months of age, the patient received a dose on 19 Aug 2010. Negative for reactions to vaccines or any illness at the time. Indication for PREVNAR 13 was immunisation. Product was administered on 19 Aug 2010. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced diarrhea on 21 Aug 2010. The patient was recovering. No additional information was available at the time of this report.
Noticed fine red rash on neck and trunk early today. No fever, not fussy. Mother states baby's clothing may have been laundered in new detergent-not sure what caused rash.
Site: Redness at Injection Site-Mild, Additional Details: Patient experienced raised rash at injection site 24 hours after vaccination.