chrisvoncsefalvay/vaers-outcomes huggingface dataset:
herpes viral encephalitis; Rhabdomyolysis; Community Acquired Pneumonia; Streptococcus Pneumonia; myopathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or around 12-JUN-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). One day after receiving zoster vaccine live (ZOSTAVAX) (on approximately 13-JUN-2017), patient developed weakness in his arm and nerve pain in both legs. He was treated for herpes viral encephalitis and was ultimately diagnosed with rhabdomyolysis and community acquired pneumonia due to Streptococcus pneumonia and myopathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries, 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 zoster vaccine live (ZOSTAVAX), patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Meningoencephalitis herpetic, myopathy, pneumonia streptococcal, pneumonia and rhabdomyolysis were considered to be disabling.      Upon internal review, meningoencephalitis herpetic, pneumonia streptococcal, pneumonia and rhabdomyolysis were considered to be medically significant.  Additional information has been requested.
Client complained of "seeing black" numbness in right arm, feeling anxious, and was diaphoretic at 1711. Vital signs were taken at 1715 (Heart rate 70, Oxygen 98, blood pressure was unable to attain).  Client stated that he had not eaten anything all day and only drank "a little bit of water many hours ago." Blood pressure taken at 1717 (110/70). Client escorted to zero gravity chair at 1718.  Client given water and two cookies. At 1724 client stated that he is feeling better. Blood pressure taken again at 1730 (118/75).  Client left unassisted with a steady gate at 1731, and was driven home by his father.
Pt came out from receiving vaccine and once she left the room started falling to the floor. She was incoherent for a few seconds. She quickly came through. Pt says she felt tingling in her hands, arms, and legs. Throat felt a little scratchy. Gave her some water and got some frozen water bottle because her skin was clammy. It took her about 20 minutes to come back to normal.  Paramedics were called but by the time they arrived she felt better. Patient refused the paramedic ride. She stayed and extra 30 minutes to call down. She says the tingling in legs was gone but the arm and hand she receivied the vaccine in were still a little tingly. Informed pt that if she felt and worse or anything out of the ordinary to go to ER.
I had facial numbness only on my left side of my face. I also had some facial swelling on my left side of my face and my left eye has blurry vision.
I am having some numbness and weakness on my left side. I am still able to move my hands and arms and face but I do have some numbness in my left arm and on the left side of my face. It comes and goes with severity. It just feels as though my left half is not really connected to my body.
This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), OROPHARYNGEAL PAIN (throat pain), NECK PAIN (has neck pain), FEELING ABNORMAL (didn't feel good) and PYREXIA (she had a low grade fever) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LAMOTRIGINE and DESVENLAFAXINE SUCCINATE (PRISTIQ) for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced DYSPNOEA (shortness of breath), OROPHARYNGEAL PAIN (throat pain), NECK PAIN (has neck pain), FEELING ABNORMAL (didn't feel good), PYREXIA (she had a low grade fever), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (throughout the day she feels exhausted / very very tired). At the time of the report, DYSPNOEA (shortness of breath), OROPHARYNGEAL PAIN (throat pain), NECK PAIN (has neck pain), FEELING ABNORMAL (didn't feel good), PYREXIA (she had a low grade fever), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (throughout the day she feels exhausted / very very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: No new information was provided in the source document.
(From interview with Charge Nurse): Patient became very confused on 11/03/2021. On 11.04.2021 She developed wheezing and had diminished lung sounds, and became agitated and more confused.  POA agreed to put her on hospice care. No treatment apart from hospice.
Laid in bed; Nausea immediately after injection, nausea continues; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Laid in bed) and NAUSEA (Nausea immediately after injection, nausea continues) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (oesophageal). Concomitant products included VITAMINS NOS for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced NAUSEA (Nausea immediately after injection, nausea continues). On 15-Feb-2021, the patient experienced MALAISE (Laid in bed). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) ongoing since an unknown date for Nausea, at an unspecified dose and frequency. At the time of the report, MALAISE (Laid in bed) outcome was unknown and NAUSEA (Nausea immediately after injection, nausea continues) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included unspecified acid reflux medication.
Information has been received from a registered nurse concerning a 20 year old female with an allergy to amoxicillin (AUGMENTIN) who on 29-NOV-2006 was vaccinated IM, into the deltoid, with a first dose of HPV VLP vaccine (yeast) (lot # 654540/0800F). Concomitant therapy included ORTHO EVRA. Approximately 1 minute after the vaccination, the patient reported that her "throat felt constricted."  Subsequently, the patient recovered after 5 minutes.  On 25-JAN-2007 the patient was vaccinated with a second dose of dose of HPV VLP vaccine (yeast). Five seconds after the vaccination, the patient experienced "numbness in the throat" that lasted a short duration. The patient reported that she developed an intense headache 30 minutes after the vaccination that lasted until she went to bed. On 26-JAN-2007, the patient recovered from the headache.  Unspecified medical attention was sought.  There were no laboratory or diagnostic tests performed.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007.  Initial and follow-up information has been received from a registered nurse concerning a 20 year old female with an allergy to AUGMENTIN who on 29-NOV-2006 was vaccinated intramucularly, into the deltoid, with a first dose of GARDASIL (lot # 654540/0800F).  Concomitant therapy included ORTHO EVRA.  Within 1 minute after the vaccination, the patient felt "tightness in throat" and lightheadedness.  Subsequently, the patient recovered after 5 minutes.  On 25-JAN-2007 the patient was vaccinated, intramuscularly with a second dose of GARDASIL (lot #654540/0800F).  As the vaccine was administered the patient experienced "momentary numbness at the throat area of neck" that lasted a few seconds.  Twenty minutes after the vaccination, while the patient was on the road, she called the physician's office to report she had developed an intense frontal headache.  There were no visual problems and it was not interrupting her ability to function.  The headache that lasted until she went to bed.  On 26-JAN-2007, the patient recovered from the headache.  There were no laboratory or diagnostic tests performed.  Additional information is not expected.
Woke up shaking, SOB, very fussy, eyes rolled back in his head. Dx: seizure, adverse immunization reaction. Occurred on  06/11/02, T 99 deg F. Family called CHN, CHN referred family to clinic for evaluation by physician. Tylenol given. RTC on 06/12/02 for follow-up.
Information was received from a medical assistant regarding a male patient, who vaccinated with ROTATEQ on 01-OCT-2012. The medical assistant reported that the patient was administered an expired dose ROTATEQ (reported lot # 0185AA, expiration 21-SEP-2012). No adverse effects reported. Additional information has been requested.
Body aches, chills, feverish, fatigue, sneezing started on evening of 12/23. 12/24 - loss of taste, body aches but improved, sneezing. 12/25-cough, severe nasal and sinus congestion, no smell or taste, sneezing. 12/26-congestion, no smell and improved taste, achy, scratchy throat. Sought medical advise on 12/26 primarily due to congestion and scratchy throat.
Myoclonic seizure, admitted to hospital for these jerks, EEG positive for myoclonic epilepsy, likely benign myoclonic epilepsy, MR and further workup pending, started on KEPPRA.  Follow- up information received via e-mail on March 17, 2010. The vaccine in question was not administered at this hospital, so for further records of vaccine administration please contact the office of patient's PMD. His office phone number was provided.
BREAKTHROUGH COVID: FULLY VACCINATED WITH BOOSTER by Pfizer, COVID POSITIVE. She is Admitted to the Hospital for COVID19, Headache, Malaise,  Hypokalemia, Hyponatremia, Hypocalcemia, Hypertension, Hypertension, and Hyperlipidemia. Pt treated with dexamethasone and Zithromax for covid pneumonia and hyponatremia.
Varices in his throat ruptured; A spontaneous report was received from a consumer concerning a 55-years-ol male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced varices in his throat ruptured (oesophageal varices haemorrhage).  The patient's medical history included Diabetes 2 and throat varices diagnosed in 2019.  Concomitant medications reported included metformin, glipizide, sitagliptin phosphate, empagliflozin and propranolol.   On 13 Feb 2021, prior to the onset of the symptoms, the patient received his first of two planned doses of mRNA-1273 (Batch number: unclear) intramuscularly for prophylaxis of COVID-19 infection.    On an unspecified day in Feb 2021, the varices in his throat ruptured. He went to the hospital and was in ICU for 5 days. His physician told him that it has nothing to do with vaccine.Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, varices in his throat ruptured, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Vaccine Administration error HIB vaccine mixed with Merck DILUENT for MMR DILUENT Lot # 4060X Exp Dec 2010
Tingling; site of injection was swollen and red; site of injection was swollen and red; Ache; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) solution for injection, via an unspecified route of administration on left arm on 17Jan2021 07:00 at a single dose for Covid-19 immunization. Medical history included diabetes, cholesterol, and blood pressure. There were no concomitant medications. Patient received the first dose of the Pfizer COVID 19 vaccine on 17Jan2021 at 07:00AM in the left arm. She noticed she had aches and chills midday on Monday 18Jan2021 and also a headache all of which went away as of this morning 19Jan2021. Today (19Jan2021), this morning she woke up and her arm at the site of the injection was swollen and red. Later, she noticed she had tingling (19Jan2021) throughout the lower part of her arm and hand. The tingling was on and off and wasn't there right away. She was scheduled to receive the second dose of the vaccine 06Feb2021. Patient was looking for recommendation on second dose. Outcome of the event ache, chills, headache was recovered on 19Jan2021; tingling was not recovered; while injection was swollen and red was unknown.  No follow-up activities are needed. No further information is expected.
Woke up from sound sleep at approximately 3:30AM  on 3/ 27 /221 due to severe scalp burning and itching.  Symptoms continued throughout the day.  At 7pm  n same day seen by Urgent Care practioner previously noted.
nausea/ nausea is killing me; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea/ nausea is killing me) and PYREXIA (Fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced NAUSEA (nausea/ nausea is killing me) and PYREXIA (Fever). At the time of the report, NAUSEA (nausea/ nausea is killing me) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information was provided by the reporter.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE NON ST ELEVATION MI ACUTE DVT, UNSPECIFIED VEIN
started with a small rash on top of R hand and then progressively moved up right arm and back of neck and then to the left wrist and arm. Red, raised bumps, very itchy .
6 days of abdominal pain, nausea, found to have acute pancreatitis with elevated amylase/lipase without any other identifiable etiology
This spontaneous report was received from a healthcare worker and refers to a 4 year old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 03-DEC-2015, the patient was vaccinated with an improperly stored M-M-R II (lot # K021151, expiry date 02-NOV-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A. was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A. will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt. states the next morning after her shot the left side of her face was numb and droopy. She went to the Emergency Dept thinking she had had a stroke. ED team did complete stroke workup, but nothing. They then told her it was an adverse reaction to her Covid vaccine. She was sent home and the numbness and drooping resolved by Monday morning. Now she just has oral ulcerations that look to be herpetic and the ED staff told her that was in response to the "stress, etc." of her reaction and treatment.
chills; fatigue; heat from head; sweating; Passed out; A spontaneous report was received from a  51- year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced heat from head, sweating, passing out, chills and fatigue.  The patient's medical history was not provided. No concomitant product use was reported.  On 03-Mar-2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 001211a) intramuscularly for prophylaxis of COVID-19 infection.   On 03-Mar-2021, 4.5 hours after the administration of the vaccine the felt heat from head and was sweating following which the patient passed out. On 04-Mar-2021, it was reported the patient was feeling better despite of experiencing chills and fatigue. Treatment information was not provided.  Action taken with mRNA-1273 was unknown.  The outcome of the events was unknown; Reporter'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.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician).  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown), on 31Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 09Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: seafood" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (unspecified date) Negative, notes: tested negative after Paxlovid course; (19Jul2022) positive, notes: had return of cough/headache - repeat test Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
ARM FROM SHOULDER TO PINKY FINGER HURTS IF SOMETHING  TOUCHES IT; FEELS IRRITATED; FEELS LIKE NERVE DAMAGE; FEELS LIKE THE HAIR ON ARMS HURT; PASSED OUT TWICE; SUNBURN LIKE FEELING IN VACCINE INJECTION ARM WITH NO REDNESS OR RASH; SEVERE STOMACH ISSUES FOR A  WEEK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient donated blood and passed out twice.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  4 days later, the patient donated blood and for the first time ever, passed out twice. The patient had severe stomach issues for about a week but that have resolved. The patient's arm that she received the vaccine in, felt like a sunburn- no redness, rash or swelling. The patient's arm didn't hurt unless something is touching it.  It was not hot to the touch but felt very strange and very sensitive from her shoulder all the way to the tip of her pinky finger on the outer portion of arm. It was very sensitive even when washing the hands. The patient mentioned that it felt like nerves have been damaged. It felt like hair on arm hurt. It fell irritated. The caller mentioned that her daughter got the vaccine the same day and experienced the same thing but didn't last as long-maybe a couple of days and it was gone. On an unspecified date, the patient felt like passed out twice, sunburn but no redness, no rash and it started from the shoulder to pinky finger (coded as sunburn like feeling in vaccine injection arm with no redness or rash), arm from shoulder to pinky finger hurts if something touches it, feels irritated, feels like nerve damage and feels like the hair on arms hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe stomach issues for a week on MAY-2021, and the outcome of passed out twice, sunburn like feeling in vaccine injection arm with no redness or rash, arm from shoulder to pinky finger hurts if something touches it, feels irritated, feels like nerve damage and feels like the hair on arms hurt was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210531194.; Sender's Comments: V0:20210525585-covid-19 vaccine ad26.cov2.s-Passed out twice. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Extreme pain at site of injection. Raised red area 3" in diameter around site of injection; raising arm above shoulder level is excruciating. All of this is still ongoing as of two days later. I've gotten flu shots every year and never had local site pain this bad. I don't know if it's just something specific to the pneumoccocal vaccine but this a really, really lousy side effect. I also had a severe headache the evening after the vaccination and general malaise the next day, but I don't know whether those had anything to do with the vaccination. The arm pain, though, seems pretty obviously connected.
12yr PH male referred to ED by MD for tachycardia up to 160s found on routine physical 2 days after receiving first dose Pfizer vaccination. Fount to have ectopic atrial tachycardia that has not responded by beta blocker therapy. Transferred to CTICU for amiodarone initiation.
mild to moderate localized swelling of inj site, no induration, no increased temp;instructed mom to apply warm soaks, use APAP/motrin & report any inc pain or swelling;
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 05-AUG-2016, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX 19400 PFU (lot # L012478, expiration date 10-JUL-2016, dose and route not reported). No adverse effect was reported. Additional information has been requested.