chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized for a neuromyelitis optica flareup; This case was reported by a consumer via call center representative and described the occurrence of neuromyelitis optica in a 32-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included myelitis transverse. Concurrent medical conditions included neuromyelitis optica spectrum disorder and anti-aquaporin-4 antibody.   On 11th September 2020, the patient received the 1st dose of Bexsero. In September 2020, less than a week after receiving Bexsero, the patient experienced neuromyelitis optica (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the neuromyelitis optica was unknown.   It was unknown if the reporter considered the neuromyelitis optica to be related to Bexsero.  Additional case details were reported as follows: The patient reported case for herself. She stated that on Sunday, 13th September 2020, she was hospitalized for a neuromyelitis optica flareup. All information was not available. The reporter did not consent to follow up.
SEIZURE LIKE REACTION 4 MINUTES FOLLOWING THE ADMINISTRATION OF VACCINES WITH HYPERTONIC UPPER EXTREMITIES (NO CLONIC MOVEMENTS) AND EYES FIXED WITH NO MOVEMENT LASTING FOR 2 MINUTES.  HE RECOVERED COMPLETELY BUT HE COULD NOT REMEMBER WHAT HAPPENED.
temperature excursion due to a malfunction with the refrigerator,excursion lasted for 69 days 1041 hours and 56.0-63.0 degrees Fahrenheit,with no reported adverse event; vaccine was given post excursion to two patients, with no reported adverse event; Initial information received on 21-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA060514(CLUSTER).  This case involves a 11 years old male patient whose reported stated vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] exposed to temperature excursion due to a malfunction with the refrigerator, excursion lasted for 69 days 1041 hours and 56.0-63.0 degrees Fahrenheit and vaccine was given post excursion to two patients, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ALTHAEA OFFICINALIS ROOT, CINNAMOMUM CAMPHORA ESSENTIAL OIL, CITRUS AURANTIUM OIL, EUCALYPTUS GLOBULUS LEAF ESSENTIAL OIL, MENTHA X PIPERITA ESSENTIAL OIL (GARDISIL); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for Immunisation.  On 20-Feb-2023, the patient received a 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test-0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE, solution for injection (lot: U7048AA, expiry date: 28-Feb-2024) via intramuscular route in right arm site ( strength: standard) as Immunization or TB skin test.  On an unknown date the vaccine was exposed to temperature excursion due to a malfunction with the refrigerator,excursion lasted for 69 days 1041 hours and 56.0-63.0 degrees Fahrenheit (product storage error) and On 20-Feb-2023, the vaccine was given post excursion to two patients, with no reported adverse event (poor quality product administered)  (latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  First time product used : Yes Still using product : No  Action taken with MENINGOCOCCAL VACCINE was not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recvd Hep B vax in approx 1990; 3 to 4 wks p/vax devel fatigue, malaise, lymphadenopathy, & lt knee arthritis, characterized as serum sickness; also stated had fascitis of the plantar surface of feet, painful to walk;
On 1/16/2004 he received anthrax vaccine (AVA) dose #4 (#5 according to agency). He developed pain, redness and swelling at the site that day which subsided over the next 3 days. On day 5-7 post vaccination the constant shooting pain in arm and chest began along with arthralgias. 6/10/04 he had an ED visit for abdominal and back pain with the diagnosis of GERD. In December, 2004 was seen for pain, numbness and tingling of his right arm that migrates to the side of his chest, and down arm to fingers. Since the 1994 AVA he also c/o migratory arthralgias---knuckles, wrists, elbows, knees; fatigue and memory lapses as in unable to remember something that before 1994 was easy. Symptoms have been constant since 1994 for a couple of years changing to intermittent with the frequency becoming less as time goes on. The most bothersome symptom is the arm pain that radiates to lower arm and to lateral chest which has decreased so that last episode was 1 1/2 years ago.
Patient called  and complained of chest pain after the covid booster vaccine ( Pfizer) that she got few days ago. patient advised to see a Dr and seek medical attention as soon as possible.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 13-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N016089, expiration date: 22-NOV-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Patient received a COVID vaccine that was not diluted appropriately. It was not diluted enough, so they were given a higher concentration of vaccine than recommended for their age.  Patient waited 15-20 minutes after vaccine and did not show any signs or symptoms.  1.5 week check up on patient and they continued with no symptoms.
On 05/2022 COVID-19 I had no symptoms or fever. No issues whatsoever. I was traveling and was positive. I was coming home from a trip and had to stay 10 days before being allowed to come back to my home state. We did not have to quarantine and there was no issue with me having symptoms. 11/2022 I had acute bronchitis; I was treated at urgent care. I had a bad cough, bad sinuses and aches all over. It felt like the Flu. I was not tested for Covid -19, but no one touched me, and I had no tests at home to take. I had the cough for 6 weeks.
Fatigue, Chills, Headache, Loss of Appetite and Balance problems. Feeling Wiped Out for about 12 hours!
Within 5 min of getting the shot my face became flush. That lasted for about 30 seconds. A few minutes later my neck became very itchy. This lasted for maybe a minute or two.. about an hour later my legs became very itchy. This lasted maybe a minute and was immediately followed by my face getting flush again. This also lasted about a minute. Maybe 15 minutes later the same two events repeated in the same order. Both again lasted maybe a minute.   During this time there was a little bit of tingling around my lips. This came and went for a few hours.   15 or so minutes after the 2nd round of itchy legs/face flush, my throat became itchy for a couple of minutes.   I did go to the urgent care and while was told by that doctor that as all of these had come and gone within a minute or so and that my breathing had not become an issue that I didn't need an epi shot and that I could just go home.   I didn't experience any further allergic reactions, just the expected ones.
VACCINE ADMINISTERED WAS STORED AT FREEZER TEMPERATURE FOR TOO LONG.  PATIENT HAS BEEN ADVISED AND MAY GET REVACCINATED.
Swelling and redness and heat on the site location.   Went to urgent care and they said cystitis , however, Pharmacy said Covid arm.  Took few days to calm it down
This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a 74-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. In September 2018, less than a month after receiving SHINGRIX, the patient experienced vesicular rash and pain. On an unknown date, the outcome of the vesicular rash and pain were recovered/resolved. It was unknown if the reporter considered the vesicular rash and pain to be related to SHINGRIX. Additional details were reported as follows: This case was reported via click to chat. The age at vaccination was not reported however, it could be 73 or 74 years. The patient came in after receiving SHINGRIX in the previous week from the date of reporting with unusual rash which was painful and almost reminiscent of shingles but came and gone which was bilateral. The physician did not have lot number, and stated the vaccine was given at a pharmacy.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 14:45 as dose 4 (booster), single (Lot number: GJ2524) at the age of 50 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective and covid-19 with Paxlovid treatment from 27Dec2022 to 31Dec2022.
Client presented to ED on 7/11/2021 with concerns for fever, malaise, cough, sore throat and diffuse body aches. Client placed in Observation status and not admitted as an inpatient. Client left the hospital on 7/12/2021. Follow up call by Public Health on 7/13/2021 - client reported symptoms continued, but milder.
Information has been received from a Licensed Practical Nurse concerning an unspecified patient of unknown age and gender.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 04-MAY-2017, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB for prophylaxis, lot # M027884 and expiration date of 19-APR-2019 (dose, frequency and route of administration were not reported). The vaccine was exposed to a temperature of 1 Celsius degree for 44 minutes. There was reported a prior temperature excursion, the vaccine also was exposed to a temperature of 1 Celsius degree for 35 minutes. The call was placed because of a Digital Data logger report. No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a  Doctor of pharmacy refers to a patient of unknown age. On 30-APR-2014, the patient was vaccinated with improperly stored 0.65 ml dose of ZOSTAVAX (Lot # not reported) subcutaneously. The pharmacist stated that the ZOSTAVAX reached a high temperature of 12 F and was out of range from 02-APR-2014 to 08-APR-2014 for a total of about 96 hours. No adverse effect was reported. Additional information has been requested.
I developed a severe migraine that lasted approximately six days. This was accompanied by nausea and vomiting.
Hive-like lesions developed after the patient's 3rd Gardasil injection. She states that the lesions began around her injection site on her (R) arm and spread out throughout her body
37 y/o male received LAIV4 around 0930. Patient awoke around 0200, with generalized flushing, palpitations, hives, and throat swelling. He self treated with oral BENADRYL 100 mg and symptoms started resolving in 30 minutes, and were completely resolved within 90 minutes. Symptoms have not recurred again. Felt well on day of vaccine receipt. No other possible exposures. No hx of previous vaccine adverse reactions.
I was working with older people who were positive of COVID-19; a couple of days later, I had a heavy congested cough and couldn't breathe so I went to the emergency room where they checked my blood pressure and blood oxygen concentration level. They ran chest x-ray tests, blood cultures, oxygen concentration and a COVID-19 PCR test that came back positive. They put me on oxygen, gave me steroids (Decadron), and breathing treatments. I was hospitalized for 4 days until slight recovery and was discharged. I was told to follow-up with my asthma doctor for additional steroid medication to take for at-home treatment to continue recovery.
6 days after vaccine patient developed area pruritis/erythema with induration on left area in roughly deltoid area - quite large, axilla spared.  Resolved over several days with Benadryl.
Below injection site patient developed pain, erythema, swelling, itching, area confluent.
fainted; started seeing everything blurry; arm tingling; pain on her arm; Fever; feeling like very high, like from a very strong medicine; chills; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced PYREXIA (Fever), FEELING ABNORMAL (feeling like very high, like from a very strong medicine) and CHILLS (chills). On 13-Jul-2021, the patient experienced PAIN IN EXTREMITY (pain on her arm). On 14-Jul-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), VISION BLURRED (started seeing everything blurry) and PARAESTHESIA (arm tingling). At the time of the report, SYNCOPE (fainted), PYREXIA (Fever), FEELING ABNORMAL (feeling like very high, like from a very strong medicine), CHILLS (chills), PAIN IN EXTREMITY (pain on her arm), VISION BLURRED (started seeing everything blurry) and PARAESTHESIA (arm tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  It was not reported if the patient was received any corrective treatment for the event.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
First symptoms were sensitivity to light, eye pain, headache, fatigue, and woke up with chills during the night.  Day after vaccine: nausea, headache, pain in arm, stuffy/running nose, fatigue, light headed/dizzy, not hungry.  Longer term effects felt 1 week after vaccine: abdominal and back pain (not associated with menstruation), dizziness, sensitivity to light, eye pain, fatigue
it feels like a rock in there; muscle where the shot went in it is not hard but its painful; cannot lift it up; it feels like a rock in there; muscle where the shot went in it is not hard but its painful; cannot lift it up; Sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) at the age of 73 years as 1st dose, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown" and all described as "it feels like a rock in there; muscle where the shot went in it is not hard but its painful; cannot lift it up"; PAIN (non-serious), outcome "unknown", described as "Sore". Therapeutic measures were not taken as a result of pain in extremity, loss of personal independence in daily activities, pain.  Additional Information : The patient reported that patient got the vaccine yesterday and the only thing is patient's arm with shot in the arm, patient had a rock in it and could not lift it up. So, how long would that last. Would they get better. When patient got the shot it was really no problem patient did not even feel it going in and yesterday afternoon patient was fine it was only like during the night when patient slept patient woke up and patient's arm was, it feels like a rock in there you know the muscle where the shot went in it was not hard but it was painful that was what patient meant. Patient could not explain so good. patient reported Well, patient did not think it would not last, patient was fine it was just today it was sore. Patient's second dose would be in 02Apr that is why patient took it, the second one. The patient did not receive any treatment for the events.   No follow-up attempts are possible. No further information is expected.
father called & brought pt in d/t erythema in rash appearance over site area;was quarter size;today is baseball size, et tender w/redness, induration noted but no obvious swelling detected;itching denied;encouraged to use APAP & DPH
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-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 EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.
Patient admitted she was very nervous for vaccine. Took a moment to calm down. After receiving vaccine started feeling dizzy, trouble keeping eyes open. Moved patient to a private area. Provided water and apple juice. Took BP. 94/63 mmHg. Patient requested ice packs because feeling sweaty and diaphoretic. Provided ice packs. Repeat BP 101/75 mmHg. Patient is a young healthy female, likely low baseline BP. Patient reported feeling better and departed. Likely vasovagal response due to being nervous and "insult" of needle in arm.
Severe chest pain and shortness of breath. Pregnant. Due date 02/16/2022. Birth weight 7lbs 7 oz.
Patient Contracted COVID-19 even though he had received both shots in his vaccination. Patient ended up in-patient at hospital with respiratory distress
2 days after injection total red rash over head, chest, neck, arms, back, stomach, and legs.
Initial and follow up information has been received from a nurse practitioner (NP)/ certified nurse midwife, and a nurse, concerning a 17 year old caucasionr female patient, who on 17-APR-2007, at 3:30pm was vaccinated IM in the left deltoid with the first dose of Gardasil (Lot #657617/0384U). Concomitant therapy included Yasmin. There was no known illness at the time of vaccination. The nurse practitioner reported that 18-APR-2007, (previously reported by the nurse as on the same day, 17-APR-2007), the patient developed a rash on the left arm (the arm of injection), which later spread to both arms; the rash was described as "redness with urticarial raised patches." The nurse added that the patient also developed a fever. At the time of this report, the NP confirmed that the patient had recovered from the rash and fever (date unspecified). The patient sought unspecified medical attention. No further information is expected. Additional information has been requested.
She has immediate hoarseness; trouble swallowing after a couple hours; allergic reaction to the covid vaccine; This is a spontaneous report from a contactable consumer. A 85-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunization.The patient 's medical history andc oncomitant medications were not reported. The patient stated her mom had an allergic reaction to the covid vaccine. she believed she may be allergic to peg. She enquired if vaccine without peg would be made in future for people who cannot take it. she stated that her Mom is 85 years old and really needs this vaccine and stated if she just take a chance with it again. She has immediate hoarseness of voice and trouble swallowing after a couple hours which resolved by next day.The outcome of the events was unknown.  Information about lot/batch number has been requested.
Initial unsolicited report received from a nurse on 04 November 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE INTRADERMAL QUADRIVALENT (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 unspecified date in 2014, following the vaccination, the patient had developed cellulitis of upper arm. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. Upon medical review, the case was considered as serious due to important medical event: cellulitis of upper arm. List of documents held by sender: none.
pt exp a seizure w/LOC 2 hrs p/receiving flu vax; previously had surgery for removal of a brain tumor;
severe vertigo, headache, X 72 hours unrelieved with OTC medications.  increased chest pain and shortness of breath at rest intermittently unrelieved.  Rash at site of injection X 1 week, itching
Redness, discomfort, rash at injection site. Started 8 days after injection.