chrisvoncsefalvay/vaers-outcomes huggingface dataset:
herpes zoster; Information has been received from a lawyer concerning a case in litigation and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On or about 03-OCT-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered from herpes zoster. As a result of these symptoms, the patient was seen and treated by medical providers. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the Company's product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient 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. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The causality was related.   The event of shingles was considered to be disabling.    This spontaneous report as received from a lawyer refers to a patient of unknown age with routine health maintenance.    On 03-OCT-2017 the patient was vaccinated with zoster vaccine live(ZOSTAVAX), unknown for routine health maintenance and prophylaxis.       On an unknown date the patient experienced herpes zoster (disability).    The outcome of herpes zoster was reported as not recovered/not resolved.   The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).     {Additional information has been requested. / Additional information is not expected.}
This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A 21-year-old female patient received TRUMENBA (Lot Number: T52805, Expiry Date: Aug2019), via an unspecified route of administration on 06Sep2018 12:00 at a single dose for immunization at the university health clinic. The patient's medical history and concomitant medications were not reported. On 06Sep2018, 45 minutes after meningococcal group b rlp2086 was administered, the patient experienced temperature of 101.6 degrees and was shaking uncontrollably. The patient's vitals signs were taken; was given ibuprofen and was currently resting. Outcome of the events temperature of 101.6 degrees and shaking uncontrollably was unknown. The events did not require a visit to emergency room.
HA ,throat tightness, tiny red spot last night 1/5/2021. 1/6/2021 -4.5X3.5 hard, red, swollen, tender spot at injection site R upper arm. Narrative:  Pt experienced after vaccine was given on 1/5/20 HA ,throat tightness, tiny red spot last night 1/5/2021. 1/6/2021 -4.5X2.5 hard, red, swollen, tender spot at injection site R upper arm.
Per pt, she had felt really ill and had an outbreak of shingles. per pt, MD contributed it to an interaction with simponi IV and shingrix. Pt has rheumatoid arthritis and being treated with simponi IV and prednisone. Pt has recovered.
These are the symptoms of an 18 year old female pt received a Menomune vaccination on 01/19/2001.  Nausea, asthenia, dizziness, myalgia, headache, abdominal pain, arthralgia, chest pain and fever (99.5 deg. F)was noted on 01/25/2001.
mom states pt slept p/vax until arrived home;when awoke began crying & screaming cont;no temp elevation;referred to PMD;mom spoke to MD pt is doing fine today;cried cont x7 hr;
I have had a nightly fever (ranging from 100-102f) every night since 12 hours after vaccine. My normal body temp is 98.1.
This spontaneous report as received from a nurse refers to a unspecified patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On an unknown date in 2014 (reported as some time last year), the patient was vaccinated with dose one of GARDASIL (dose and frequency were not reported) intramuscularly. On 21-JAN-2015 the patient was in the reporting nurse's office and will receive the dose two of GARDASIL. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
Episodes of shaking, muscle spasms possible seizure, no fevers, ongoing, several (5-6 per day) lasting 1 to 2 minutes.
I cached COVID-19 and was sick for a week. It's like a flu, I took medication to treated it, Vomiting, diarrhea, loss of taste, loss of appetite, weigh loss.
My arm got very red with a knot on it.  I started taking benadryl and it is doing better but the redness is going down my arm.  I think in a day or two it will be better.
Received flu shot without incident.  Then received pneumovax and throat "closed a bit". She  went home, suffering chills, fatique. Slept > 2 hours.  Left arm very painful but not swollen or hard.
Medication Administration Error. Patient received 0.25 mL of Moderna bivalent vaccine instead of 0.5 mL.  The patient received an additional 0.25 mL to make the full dose later in the day when the error was discovered.
pt recv vax 15NOV95 & 19MAY97 pt devel a fever of 101, lesions all over body & joint pain;
The patient was mistakenly given the moderna primary dose for pediatric patients, as the bottle is still labeled "for booster dose only", but was supposed to get the moderna bivalent booster. The patient was informed of the mistake and did not have any adverse reactions. She decided to delay getting the bivalent booster in January after the holidays.
After recieving the shot a few hours later, I had fever and was so sick I slept for two days after woke up the third day with memory loss. Taken too Medical Center for treatment.  During the next months to cvome changed my quality of life forever. Everything was foggy all the time and I was passing out frequently. Then I started passing out more frequent all the way to a couple time a day. I decdided to go to the Hospital. I was almost died. I could not walk without passing out, I had Core  Pulimary Embolism, and was in shock, with a high heart rate. I was admitted int he ICU unit and Was going to be flown to another hospital for emergency surgery but to many covid patients at the hospital.
2nd dose received 54 days after the 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received 54 days after the 1st dose) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088d21a and 3002332) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received 54 days after the 1st dose). On 08-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received 54 days after the 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
SEVERE CHEST PAIN SWELLING OF CERTAIN AREAS IN CHEST DIFFICULTY BREATHING COSTOCHONTRITIS HEADACHES
Client received HPV and H1N1 about 1:30p.m. He was sitting up in a chair as per protocol after shots and was observed with his head down, not responding to verbal commands. He was assisted to the floor. VS WNL. He responded to command to squeeze hand, but could not open eyes or raise hand. O2 2L/NC applied. ? and arrived at 1:42p.m. Client then opened his eyes and became responsive. He left with his mother - no hospitalization.
Patient fainted after receiving the vaccine. Cut lip on tooth. Had previous syncope w/tetanus vaccine, but not with others, like flu.
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Weakness-Medium, Additional Details: COMPLAINS OF PAIN AND ISSUES STARTING IN THE LAST FEW MONTHS. THEY THINK ITS THE VACCINE BUT WE ONLY HAVE RECORDS OF VACCINE BEING GIVEN IN DECEMBER.
1) Patient awoke at 0400 with severe chills, and body aches. Patient wasn't able to get warm until using around 4 blankets, sweat clothes, and wife holding him. He was likely running a high fever at the time, but was not confirmed. Patient was shivering uncontrollably.  Recovered by the next morning. Had a slight temp elevation the next day. <100.   2) Patient had severe body aches. Moving around and walking around was uncomfortable. Injection sight was especially sore and painful. Lasted about 4 days before fully recovered.   3) Headaches. Patient reported headaches for approximately 7 days.  Typically the headache came on around 1700 every night and lasted until they went to bed.  After about 7 days the headaches stopped.   4) Fatigue. Patient reported General fatigue for about 5 days after the vaccination.   5) Joint pain. Patient complained of joint pain for approximately 3 days, and then it subsided.   Patient recovered from all this on his own. He self medicated with Ibuprofen for all symptoms for the first 2 days until most symptoms started to reduce. He did not seek any medical attention. Complained that his symptoms were worse than the symptoms he experienced when he contracted COVID 19 in July 2020.
(L) upper thigh with erythematous, warm tender lesion, 5 cm x 4 cm in length. Puncture wound noted. No streaking noted. Ibuprofen, cold compress, BENADRYL as needed.
Intermittent rapid heart rate episodes lasting approximately 1 hour and generally occurring multiple times per day lasted from May to December, 2021.
Information has been received from a medical assistant concerning a female patient age 70 years or older who "about two weeks ago" was vaccinated with a dose of Pneumovax 23 (lot # 651319/1007P).  Subsequently the patient experienced injection site rash and fever.  Unspecified medical attention was sought.  Additional information has been requested.
was given an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABxb35aa, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2022, the patient received Bexsero (intramuscular) .5 ml and Bexsero Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-Aug-2022 Reporter's comment: The medical assistant stated that a patient was given an expired dose of Bexsero in left arm on the day of reporting. No side effects were reported. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Finally diagnosed as Miller-Fisher Guillain-Barre Syndrome -Facial paralysis affecting: Vision, unable to make tears and eye muscle rigidness (unable to blink). Nasal passage obstruction due to cartilage not having tone and flat. Hearing affected due to receptor paralysis. Dietary affected by being unable to bite, swallow, or chew appropriately.  Communication limited, unable to annunciate.  Disfigurement and low self concept. Aug. 2 is month 10.  Improvement is occurring, albeit very slowly.
Pt presented with swelling and irritation around injection site and also developed a slight rash on his leg. His mother also noted a small hard spot on the injection site. Pt had a slight fever which is now under control. Pt is otherwise fine.
ANAPHYLACTIC REACTION; This spontaneous report received from a consumer concerned (1400) multiple patients of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient's experienced anaphylactic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylactic reaction was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210745140.; Sender's Comments: V0: 20210757746-Covid-19 vaccine ad26.cov2.s-Anaphylactic reaction. This event(s) is labeled per RSI and is therefore considered potentially related.
mild rash on the abdominal area and back.; This is a spontaneous report from a non-contactable consumer, the patient. A  patient of an unknown gender and age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182), via an unspecified route of administration in the right arm on 15May2021 at 10:30 as a single dose for COVID-19 immunisation. Medical was reported as not available and the patient did not have a history of allergies to any food or medications or other products. Concomitant medications included loratadine (CLARITIN), acetylsalicylic acid (BAYER ASPIRIN) and vitamin d nos (VITAMIN D) all from an unknown date for an unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172), via an unspecified route of administration in the right arm on 24Apr2021 at 14:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021 at 00:00, the patient experienced mild rash on the abdominal area and back. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken for the events. The clinical outcome of the event mild rash on the abdominal area and back was recovered on 17May2021.   No follow-up attempts are possible. No further information is expected.
first 24 hrs --only sore arm one day, post injection:  chills, fever (100.5), headache, weakness, nausea  (symptoms were like what I experienced the first days of Covid (Dec 4) except with Covid I ran little low and infrequent fever.
Described tongue tingling/numbness approximately 30 minutes after receiving the vaccine. Evaluated in ED - said it felt like tongue and throat were swelling.  No immediate intervention required. Discharged with diphenhydramine oral PRN, famotidine 20mg BID, prednisone 60mg Daily x 3 days and EPiPen
CLIENT RECEIVED PFIZER AS FIRST DOSE AND MODERNA AS SECOND DOSE COVID VACCINE ACCORDING TO database.
Hospitalization: 1/15/2023 - 1/23/2023 (8 days) Presentation to the ED: AMS COVID + date: 1/27/2023 Treatment: remdesivir and decadron Discharge to: hospice. patient expired 1/27/2023.   022M20A 3/12/2021 038B21A 4/15/2021
Day 1: fever (100.4), body aches, chills, sweats occurred throughout day. Swelling and soreness where injection was administered. Took Tylenol to help with side effect throughout day. Also drank green tea to help. Day 2: fever (100.4), chills during day, heavy night sweats. Swelling and intense pain where injected was administered. Arm could not go higher that 45 degrees. Painful to apply any pressure. Arm now is hot to touch. Took Tylenol to help with side effects throughout day. Alternate between Tylenol and Motrin to assist with pain and swelling in arm. Alternate between heat and ice to assist with pain and soreness. Day 3: fever (100.4), night sweats. Woke to a rash on bicep directly below where shot was administered. Arm continues to be hot where shot was administered and swelling has moved into bicep location as well. Arm cannot be lifted higher than 45 degrees. Alternate between Tylenol and Motrin to assist with pain and swelling in arm. Applied ice to arm to assist with swelling and pain.  Day 4: No fever. Mild night sweats. Swelling is in bicep of arm. Arm is hot to touch. Applied benedryl cream to outside of arm to assist with the mild rash. Applied cold compress to arm to assist with swelling. Motrin has been used to assist with swelling and pain. Arm can move to a 90 degree angle without assistance today.
Patient claims past two months after injection has increase weakness and unable to use his right shoulder, generalized weakness that started after vaccine.
Pt came back on 11/6/11 complaining of pain & swelling in left arm. Slight fever & numbness in left arm. Is unable to lift objects in the same hand & overall discomfort.
Shignles, V1 distribution diagnosed one month after second dose of SHINGRIX given.
I had vaccination on 04/07/2021. On 04/17/2021 I woke up in the middle of the night with a horrible headache. I went to the bathroom the left side of my face was drooping. I made an appointment for a zoom call and referred to neurologist. I was diagnosed with Bell's Palsy. The doctor said the vaccination triggered my immune system. It cleared up within a couple of days.
Patient was getting booster dose of moderna after initially getting J+J as first dose. Patient said he gets nervous around needles, but has not had a seizure before. Dose was given at around 10:05 am. About 1 minute after vaccination patient fell unconscious and started moving head back and forth with eyes opening and closing, his arms were tight i believed it looked like a seizure. It lasted about 10-15 seconds, the patient threw up 3 times after regaining consciousness.
I95.9 HYPOTENSION 5/4/2023 RECTAL BLEEDING ADENOCARCINOMA METASTATIC TO BONE I95.9 HYPOTENSION 5/4/2023 ADENOCARCINOMA, RIGHT LUNG MIDDLE LOBE
within 1 hour I was slightly disoriented (foggy), my balance was compromised. at 24 hours I was sweating and shivering, at 32 hours the fever broke, at 48 hours I was +80% of usual, at 7 days out I still have minor pain at the injection sight that feels like a deep bruise
Information has been received from a RN concerning an elderly pt who last week, on an unspecified date in approximately July 2003, was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (Lot # 645246/0029N). The pt developed local swelling, redness and warmth. The RN reported the pt was not hospitalized although treatment was required. It was noted the pt was treated with diphenhydramine HC1 (Benadryl). It was noted that the pt was previously immunized with a dose of pneumococcal vaccine 23 polyvalent "about 5 years ago". The RN expressed concern about the lot of pneumococcal vaccine 23 polyvalent, and she required a lot check. No additional information was provided. Unspecified medical attention was sought. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. The reporter also mentioned another pt who had similar experiences following vaccination with pneumococcal vaccine 23 polyvalent (WAES # 0307USA01204).
Patients mother states at 3 pm she noticed patients lip begin to swell and his left eye. Doctor ordered BENADRYL and Prednisone in office. Patient is being sent to ER for further assessment.
Pt was to receive combination vaccine of Dtap/hepB/IPV. Pt was given Dtap (infanrix) only.
Pt experienced a low grade fever 8-10 days post vax. The pt broke out in a rash 12 days post vax, was irritable, wanted to be held more than usual. The rash was on the neck, hair line, stomach and back and lasted for three days.
Painful abdominal pain and cramping developing several hours after injection.  Difficult to walk.
6 days after flu injection, woke up with blurred vision, projective vomiting,. TO ED, CT scan, lab work, MRI with and without contrast. Acute disseminated encephalomyelitis noted. Steroid infusion x 3 days.
Pain on the injection arm; Swelling; Redness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on the injection arm), SWELLING (Swelling) and ERYTHEMA (Redness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PREDNISONE for Arthritis, ALFUZOSIN and CARVEDILOL for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced PAIN IN EXTREMITY (Pain on the injection arm), SWELLING (Swelling) and ERYTHEMA (Redness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain on the injection arm), SWELLING (Swelling) and ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was not sure about receiving the scheduled second dose on 15-Jun-2021 due to his reaction.
Received immunization Wednesday 07/23, on Thur. lump on right deltoid Fri, redness and swollen-hot to touch.  Measured 5cm x 51/2cm.  Area of redness 1 1/2cm then white ring and then redness again.  Patient mom given dipidone AF cream to put on twice daily.
Booster; Feeling under the weather; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 30Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose no:1), for COVID-19 immunization; Bnt162b2 (Dose no:2), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "Booster"; FEELING ABNORMAL (non-serious) with onset 30Nov2021, outcome "unknown", described as "Feeling under the weather".  The lot number for bnt162b2 was not provided and will be requested during follow up.