chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cardiovascular event; vision issues; balance problems; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, lot expiration date, dosage, anatomical location and route of administration were not provided), for routine health maintenance and its intended purpose: the prevention of shingles (herpes zoster). Shortly after vaccination, the patient suffered a cardiovascular event (cardiovascular disorder), vision issues (visual impairment) and balance problems (balance disorder). As a result of those symptoms, the patient was seen and treated by medical providers was still under their care. As a direct and proximate result, the patient'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 the patient's 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, 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, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The cardiovascular disorder, visual impairment and balance disorder were considered disabling events.
Within 8 hours patient was weak, nauseous, head ache, complained of bad taste in mouth, muscle aches, and fatigue. Within 12 hours patient had fever of 99.9 and was fatigued with some vomiting and head ache. Within 24 hours patient was complaining of bad head ache, still fever at 99.2 no appetite,  muscle aches and some diarrhea  Day 2-3 patient had fever of 100.8, had chills, muscle aches, head ache, some disorientation,  nausea with vomiting (white, foamy, bad taste) and some diarrhea. Patient noted pain in mid back on rt and left side as well as some abdominal cramping. Day 3-4 patient had fever of 100.1, chills, less severe headache, muscle aches, fatigue, inability to concentrate,  no appetite, nausea, and minimal vomiting with complaint of bad taste in mouth (white foamy vomit, flecks of pink with a strong chemical taste and smell).
flushed face; weakness; extremely fatigued until she couldn't move hardly; fever temperature of 101.4; chills; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (flushed face), ASTHENIA (weakness), FATIGUE (extremely fatigued until she couldn't move hardly), PYREXIA (fever temperature of 101.4) and CHILLS (chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L2OA) for COVID-19 vaccination.   The patient's past medical history included No adverse event (No reported medical history.).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced FLUSHING (flushed face), ASTHENIA (weakness), FATIGUE (extremely fatigued until she couldn't move hardly), PYREXIA (fever temperature of 101.4) and CHILLS (chills). At the time of the report, FLUSHING (flushed face), FATIGUE (extremely fatigued until she couldn't move hardly), PYREXIA (fever temperature of 101.4) and CHILLS (chills) had resolved and ASTHENIA (weakness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Body temperature: 101.4 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment for the events included cold compress and drinking a lot of fluids.   Company comment:  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Patient received the vaccine on 31-Mar-2022 which had got expired on 24-Mar-2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 31-Mar-2022 which had got expired on 24-Mar-2022.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 31-Mar-2022 which had got expired on 24-Mar-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 31-Mar-2022 which had got expired on 24-Mar-2022.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received the second booster dose.  Patient received the vaccine on 31-Mar-2022which had got expired on 24-Mar-2022.  Concomitant drugs were not reported.  Treatment details were not given.
DTaP #3 yesterday. (r) thigh 6.5 x ERM. Red hot painful area. 99.3 temp. swelling at vaccine site. Itching, limping, running sideways - day 2 still not better.
Red spots; Itching; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2019, the patient received the 2nd dose of Shingrix. On 27th April 2019, 1 days after receiving Shingrix, the patient experienced localized erythema and pruritus. On an unknown date, the outcome of the localized erythema and pruritus were recovered/resolved.   It was unknown if the reporter considered the localized erythema and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The red spot went up and down the entire left arm within the next day. On 3rd day of vaccionation, the red spot covered the entire right arm. The red spots were associated with itching, and red spot continued to spread to the patient's chest and leg. The red spot had stared to disppear and there was no itching anymore. The patient consented to follow up. No further details were provided.
Arm is sore on her left; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever) and VACCINATION SITE PAIN (Arm is sore on her left) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 044A21A and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On 03-Dec-2021, the patient experienced VACCINATION SITE PAIN (Arm is sore on her left). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. On 02-Dec-2021, PYREXIA (Fever) had resolved. At the time of the report, VACCINATION SITE PAIN (Arm is sore on her left) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The patient was worried that ever since she had her 1st and 2nd shots, she keeps on having the pain on both arms where she had her shots.   This case was linked to MOD-2021-404746, MOD-2021-404747 (Patient Link).
Received vaccine at 9:30 am, stated feeling chilled approx 2.5 hours later. Then started to have dry cough and expiratory wheezes at night starting later that day and following day, which have been increasng along with dry cough and body aches.
AT INJECTION SITE: REDNESS, SWELLING, ITCHING, BLISTERS, AND SEVERE PAIN TRAVELING DOWN LEFT ARM FROM SITE OF INJECTION.
At 14:40 mom returns to clinic with child saying he is having a reaction to vaccines.  Patient is awake but drowsy and talking.  Mom states " he became unresponsive in drive thru line."  Child also urinated on himself.  Patient has 2-3 small red spots on chest and 2-3 small red spots on upper back.  Does not have labored breathing and child states does not feel short of breath.  Benadryl given per standing orders.  BP at 14:45 was 130/82.  rechecked BP at 15:00 it was 118/60.  Patient becoming more active.  Talking the whole time.  Mom states history of febrile seizures.  Last one 5 months ago.  No new red spots appearing on body.  Patient is alert and active.  Encouraged mom to watch child closely.  To ER if condition worsens.  Mom verbalized understanding.  Patient walked out with mom.
Moderna COVID-19 Vaccine , injection site on left arm experienced minor swelling over a hard lump, redness and itching nine days post injection.
No adverse event(s) experienced or reported by patient. Reporting to VAERS due to patient being 16 years of age and Moderna only currently approved for 18+ years old.
Rec'd Hepatitis A in error, should have received Hepatitis B.  Mom notified of error.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On 26-JAN-2017, the patient was vaccinated with expired dose of PNEUMOVAX 23 lot # L024129 with expiration date: 21-JAN-2017 (route, strength and dosage schedule were not reported) for prophylaxis. Nevertheless, no adverse effects were reported. There was no previous temperature excursions reported or product quality complaint (PQC) involved. Additional information has been requested.
Fever CHILLS, MYALGIA, FLU-LIKE SYNDROME Narrative:
Swollen lips; headache; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen lips) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     The patient's past medical history included Migraine.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (Swollen lips) and HEADACHE (headache). At the time of the report, LIP SWELLING (Swollen lips) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received: Added new event swollen lips
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. Concomitant medication(s) included: ROSUVASTATIN; EZETIMIBE. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was given as treatment for covid-19 from 25Jun2022 to 29Jun2022.
no adverse event; temperature excursion with PROQUAD and VARIVAX; a patient was inadvertently administered both PROQUAD and VARIVAX on the same day; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 26-APR-2021, the patient was inadvertently vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml injection, lot # T010288, expiration date: 20-SEP-2021 (route of administration and anatomical location were not reported) for prophylaxis and with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml injection, lot # T015999, expiration date: 08-MAY-2022 (route of administration and anatomical location were not reported) for prophylaxis (Incorrect product storage and Accidental overdose).  Administered doses of vaccines underwent the temperature excursion of 6 to 14  degrees Fahrenheit (F) (10 F) for 45 minutes. Digital data logger was not involved. The vaccines underwent previous temperature excursion of 6 to 14 F (13 F) for 15 minutes. No other adverse event was reported.
His wife called on 10/21 and reported that he had symptoms of arm swelling and a red streak that was about 2.5 inches long and went from the injection site down towards his elbow.
Calprotectin level was at 3,000 mcg; acute diarrhea (6-10 times a day); thought it was the stomach flu; fatigue; This is a spontaneous report from a contactable consumer or other non-HCP. A 40-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EP7534), via an unspecified route of administration, administered in left arm on 20Mar2021 as dose 2, single (at the age of 40-years-old) for COVID-19 immunization. Medical history included BRCA1+ (BRCA1 gene mutation) from an unknown date and unknown if ongoing, chronic migraine and known allergies to Sulpha. Concomitant medications/ other medications the patient received within 2 weeks of vaccination included fexofenadine hydrochloride (ALLEGRA); armodafinil; levothyroxine; omeprazole (PRILOSEC [OMEPRAZOLE]). Facility where the most recent COVID-19 vaccine was administered mentioned as Health Clinic/facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19mRNA VACCINE, Solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in left arm on 27Feb2021 at 07:00 (at the age of 40-years-old) as dose 1, single for COVID-19 immunization. On 03Apr2021 10:00 the patient experienced acute diarrhea (6-10 times a day). At first patient thought it was the stomach flu, fatigue. After 10 days patient did a stool sample and my Calprotectin level was at 3,000 mcg on 13Apr2021. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown whether the patient received treatment for the Adverse events. The patient underwent lab tests and procedures which included stool sample/Calprotectin level (faecal calprotectin): 3000 ug on 13Apr2021; SARS-CoV-2 RNA (COVID-19), Qualitative, NAAT (sars-cov-2 test): Negative Nasal Swab on 04Apr2021. The outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. No information on patient's medical history or concurrent conditions was provided. On an unspecified dates from 16-APR-2015 to 30-APR-2015, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # reported as K02338, expiration date 23-JUN-2016 (dose and route were not reported). The reporting nurse stated she had not researched the medical records, so it was unknown how many patients were involved. The nurse stated no adverse effects were experienced by any patient. This is the one of several reports from the same reporter's source. Additional information has been requested.
Increased Hand Shaking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Increased Hand Shaking) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, AMLODIPINE, ALPRAZOLAM and FINASTERIDE for an unknown indication.    On 23-Mar-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 TREMOR (Increased Hand Shaking). At the time of the report, TREMOR (Increased Hand Shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Severe hives covering entire body from head to toe.   Received shot on Wednesday around 1:00 . Woke up on Thursday with usual side effects ( body pain , fatigue )   Woke up on Friday with severe hives
PATIENT EXPERIENCED PRURITUS AND DEVELOPED A RASH THAT WAS 5-INCH BY 2-INCH WHERE THE VACCINE WAS ADMINISTERED. PATIENT REPORTED A.E. 3 DAYS AFTER ADMINISTRATION.
pt exp myalgias, muscle weakness & some type of neurological involvement;MD considering dx of GBS
MONOVALENT VACCINE GIVEN NOT RECOMMENDED ANYMORE. BIVALENT SHOULD HAVE BEEN GIVEN
Patient was administered a prefilled Covid-19 vaccine injection in L deltoid. Patient was monitored for 15 minutes following vaccine administration. Post injection the clinic soon realized the injection was empty without the vaccine present. The "prefilled' Johnson and Johnson vaccine was pulled back to 0.5 ml and individually packed and appeared to be a single use vaccine. The patient was called and notified via phone call of the situation and that the patient unintentionally did not receive COVID-19 immunization. Advised patient to FU for any questions or concerns. The Health Department was notified. Patient was understanding and denies acute concerns.
A non-serious, spontaneous report of "got H1N1 and now feeling like he has the flu" and nausea has been received from a consumer concerning an 14-year-old male, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received single dose of H1N1, Intranasal on 27-Oct-2009. On 27-Oct-2009, within an hour of receiving vaccine, began feeling like he had the flu and nausea. Neither outcome nor causality has been reported for these events.
He got his vaccine, and on Saturday around 11:00 PM he was sitting up and all of a sudden he started having a headache, he started feeling some pressure in his head, and then his stomach got feeling of throwing up.  The room then started spinning, he closed his eyes thinking it would go away, and he could feel like he was spinning.  That went on for about 2-3 minutes just spinning, and the headache persisted, his stomach sensation continued for about 10 minutes.  His headache was like a headache like that before, like somebody had hit him in the head really hard.  After 20 minute she took his BP and it was somewhat normal.  After 30 minutes or so the headache improved to about a 4/10, and he decided if it got worse he would take something.  He told his wife that she would have to monitor over the night, and he went to bed around 1:30-2:00 AM.  The next day he had a slight headache and noticed ringing in his ear, horn blowing constantly now.  He still has that today, 8/20/21.  He went to the doctor for this and initially he could not find anything wrong with him.  He told him that he usually doesn't have headaches, and if he did maybe once or twice a year, and that was unusual.  Between the time of the headaches and the time he saw the doctor he had headaches almost every day, which was about 5-8 days before he saw the doctor.  He did not prescribe him anything to take that he can recall.  He told him that it was part of the side effects that should go away.  He asked if he had any symptoms after the 1st vaccine, and he told him that it was mild but he did not inform the doctor as it was mild and felt that it was normal.  But, with these symptoms he decided to see him as it did not improve and he paid attention to the effects.   He was having some dental working and had a root canal during that time as well, he contacted the dentist as well, and told her what was going on.  She did not give him any advise on what to do for the headache.    He also saw his rheumatologist who does routine blood work, and they did not find anything abnormal either.    Within the last 10 days he is having extreme headaches all day long, and before it was just in the morning or afternoon and the sounds would come and go, but lately they are both loud 8/9 all day long and intense.  He has been taking Tylenol and Ibuprofen for these symptoms.   He has noticed that if he takes Tylenol for a week after 7 days he would have to increase the dose.  If he switch off from Tylenol to Ibuprofen he does not have to take a large dose but only for about a week, and then will have to go back to the other.   If he takes them 2-3 days a day and he feels like he's in a fog and not a good feeling.   He's hurting and just wants the pain to go away, very tearful at this time.
Multiple patients (25) were vaccinated with lot number FK9894, but the number was erroneously entered in database and on vaccine card as FK9729.
Headache, ErythemaMultiform, UrticariaPruritus, NauseaVomiting, chills, body aches, abdominal pain
48 hours after the first vaccine I developed a rash starting on my arms, moved to my back, then my chest and neck.  Went to the doctor and received a steroid shot for the itchy rash.  The rash got worse by 4/4, returned to the doctor for additional treatment.  I was given Triamcinolone Acetonide to apply to the rash.  I was told if I wanted the 2nd vaccine they could not provide further treatment.    I received the 2nd vaccine on 4/27/2021 and 48 hours later the rash got worse.  I have been to ER once because the sores were open and seeping and the doctor's office 4 times, receiving 3 steroid shots in total.   On  5/10 I returned to the doctor with sever bruising all over my body in addition to the rash.  The rash is painful and itchy all over my body at this time.
pt recv vax 23JAN97 & 27APR97 pt devel approx five lesions;3 of the lesions had crusted over and one was infected w/impetigo & one vesicle was in fluid-filled stage;
Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: tingling in index finger and thumb