chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of elevated liver enzymes in a 61-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included crohn's. On 6th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th May 2019, 64 days after receiving SHINGRIX, the patient experienced elevated liver enzymes (serious criteria clinically significant/intervention required). On an unknown date, the patient experienced headache (serious criteria clinically significant/intervention required), intermittent fever (serious criteria clinically significant/intervention required), fatigue (serious criteria clinically significant/intervention required) and malaise (serious criteria clinically significant/intervention required). The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the elevated liver enzymes was unknown and the outcome of the headache, intermittent fever, fatigue and malaise were not recovered/not resolved. It was unknown if the reporter considered the elevated liver enzymes, headache, intermittent fever, fatigue and malaise to be related to SHINGRIX. Additional details were provided as follows: The reporter wife received her 1st dose of SHINGRIX. She started having intermittent fever, malaise, fatigue, and headache one week ago, treated with tylenol. On 9th May 2019, the reporter stated that she was told that her liver enzymes were exceptionally high. The reporter was consented to follow up.
"generalize redness" in injection site area; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA ("generalize redness" in injection site area) and VACCINATION SITE PRURITUS (itchiness) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA ("generalize redness" in injection site area) and VACCINATION SITE PRURITUS (itchiness). At the time of the report, VACCINATION SITE ERYTHEMA ("generalize redness" in injection site area) and VACCINATION SITE PRURITUS (itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient used Hydrocortisone cream as treatment for the events.
I?m glad someone made this video because i noticed when you get the derma jab dose #1 one of #2 you will experience a late period. During the time of your regular period there will be muscle aches, bloating to the point that you?ll look pregnant, severe cramps, and possible severe headaches but no regularly scheduled period. My period usually comes on the 10th of the month but it didn?t come until the 20th of the next month. I think scientist need to look further into this people some women died after getting the jab due to blood clots and this could be a reason if your hormones are off balance and your flow is off.
(3/10-3/11) Fatigue, headache & body aches on day of vaccine and overnight  (3/11) 12:00pm lightheadedness and fatigue (took nap)  (3/11) 3:10pm overall weakness (took 99mg Potassium tablet) and sudden onset of paralysis that lasted for 1 1/2 hrs  (3/11) 6:05pm still feeling fatigued and a little weak, but strong enough to get out of bed on own
?Moderna arm?; large red rash the size of my fist at injection site; slightly itchy; feels warm to the touch
sore when she first got it, but not real sore, but kinda sore/ some soreness over the weekend; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset Sep2022, outcome "recovering", described as "sore when she first got it, but not real sore, but kinda sore/ some soreness over the weekend".  Additional information: The reporting patient, her husband, and daughter got the shot on Friday; it was a booster dose, the one that just came out, Pfizer's. She said that she's not very sore, she was sore when she first got it, but not real sore, but kinda sore. Then when she went to sit down and wait for them (husband and daughter), it wasn't sore. As the days went on, the reporting patient and her husband weren't real sore; she could still feel it. The patient was asking if it was supposed to be real sore. The patient didn't have a lot of pain; she (the person who administered it) pulled it together, and the patient didn't have the pain over the weekend, just had some soreness over the weekend. The patient's husband didn't have a lot of pain either. It's not like when you get a flu shot its really sore. The patient couldn't remember if it was sore the last time. She was wondering with these new shots if they were really sore and if not real sore, if they were doing their job. The patient further stated that she wasn't sore, her daughter wasn't sore, and was wondering if it was working on them. For the patient, it was tested wrong and it was very important to know if it was working. The patient was asking what Pfizer would be going to do about the individuals who got the vaccine and it didn't work. The patient further asked if it was working or not. She had some soreness, but not a lot of soreness, like when she got a flu shot that was a lot of soreness. She never had a lot of soreness. Most of her soreness was gone. The patient asked if that was how this booster was working.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201174174 same reporter, product, and event; different patient;US-PFIZER INC-202201177556 same reporter, product, and event; different patient;
The arm where I received the shot hurts on occasion.  The pharmacist said it would be sore for a few days but it's been almost 3 months.  Sometimes if I stretch it, it hurts. If I lay on it, it can hurt.
Cough; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization. On an unspecified date, 5 days after the vaccination, the patient had cough. The outcome of the event, cough, was unknown.  Information about lot/batch number has been requested.
Sore arm, muscle aches, weakness, chills approximately 20 hours after injection (the next day). Interfered with daily activities. No medical treatment. Resolved by following day (45 hours after injection)
Nausea, general malaise, h/a, edema, fever to site, flu like sx's;
Red Rash on the entire upper left arm; COVID arm; Hot to the touch (Left upper arm); Itching Left Upper Arm; Hard to the touch (Left upper arm); This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red Rash on the entire upper left arm), VACCINATION SITE REACTION (COVID arm), FEELING HOT (Hot to the touch (Left upper arm)), PRURITUS (Itching Left Upper Arm) and INDURATION (Hard to the touch (Left upper arm)) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red Rash on the entire upper left arm), VACCINATION SITE REACTION (COVID arm), FEELING HOT (Hot to the touch (Left upper arm)), PRURITUS (Itching Left Upper Arm) and INDURATION (Hard to the touch (Left upper arm)). On 23-Feb-2021, RASH ERYTHEMATOUS (Red Rash on the entire upper left arm), VACCINATION SITE REACTION (COVID arm), FEELING HOT (Hot to the touch (Left upper arm)), PRURITUS (Itching Left Upper Arm) and INDURATION (Hard to the touch (Left upper arm)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
PT C/O NAUSEA, HEADACHE,ANXIOUS, V/S CHECKED O2 SAT 100%,PULSE 99,BP127/77.GATORADE GIVEN,EDUCATE PT TO EAT SALTINE CRACKER SLOWLY,AVOID FRIED GREASY SWEET FOOD. OBSERVED PT FOR 15MINS,PT STATES THAT SHE IS MUCH BETTER,PT WAS SENT HOME PULSE 79.
Patient reported bilateral numbness in fingers and feet with dry mouth.  Symptoms lasted greater than 15 minutes.
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Janseen product on 03/12/2021.   They first became symptomatic for COVID-19 on 07/25/2021 and tested positive for COVID-19 on 07/31/2021.  They were seen in emergency department on 08/03/2021 but were not admitted to hospital at that time.  The individual reported complete recovery from their illness on 08/05/2021. However, they were seen in emergency department again on 08/15/2021. A COVID-19 test collected on 08/15/2021 was negative, but an additional test on 08/16/2021 was positive. The individual was admitted to hospital at that time, and was admitted 08/16/2021-08/31/2021. They were then hospitalized again 09/15/2021-09/18/2021. An additional COVID-19 test on 09/15/2021 was negative. They individual was found to have pneumonia and have had bilateral pulmonary embolisms. The individual died after refusing further treatments and refusing to be transferred to a different hospital for more intensive care, on 09/18/2021. "Post-COVDI-19 Syndrome" is listed on the death certificate, which is why I am reporting this one, even though the most recent COVID-19 test was negative.
64 yo female with hx bipolar disorder on multiple psych meds, Htn, here for same day visit. Pt reports got her second covid vaccine on 3/92021 in the left arm, Pfizer. Yesterday (3/10/21) woke up with severe right knee pain, felt like she could not bear weight/ws going to fall. She went to son's apartment who is in same building and then went to lie down in bedroom. Because she drinks a lot of water, she had to get up to go to bathroom to urinate. She was about to sit down on toilet, when she felt both her legs go numb as well as her arms and her vision was blurred. She tried to grab the tub but fell forward on the floor. She states she urinated on the floor. She was on the floor for about 30 mins until her son got her up and back to bed. Later in the day she needed to urinate again and when she got up, she felt unsteady and fell on the bureau bruising the left arm.  Since she feels a bit unsteady with gait and used a walker to come hre today. She denies feeling dizzy before her falls. She denies striking her head. She denies convulsions or hx of seizure disorder. She reports no new meds, only recent change an increase in her alprazolam dose. She does report a headache day after her vaccine.'She denies vomiting or diarrhea or antecedent illness. No longer has headache. She denies positional changes Of note she is on propranolol (prescribed by psych) as well as lisinopril-hydrochlorothiazide for HTN  64 yo female with bipolar disorder on multiple psych meds, htn on propranolol 20 mg bid and lisinopril-hydrochlorothiazide, s/p recent Pfizer covid vaccine, s/p presyncope episode after experiencing severe right knee pain and attempted micturition. Pt felt like her sight was affected and experienced numbness/weakness in legs and arms causing a fall. Did not hit head.  The history is most suggestive of a vagovagal episode.
Patient developed an immediate swelling at site of injection.  She did not report discomfort, just some stiffness.  Observed for 30 minutes, then patient felt jittery.  Observed for another 20 minutes and took a BP reading, which was 196/113.  Patient reported uncontrolled BP for the past week. Administered 25 mg diphenhydramine PO.  Swelling began to subside.
After 3rd dose felt fevers and chest pain, has had fevers continuining in the 99-100 range, also fatigue, noted some hallucinations after 2nd dose but only head fogginess after 3rd dose.  Pt state she was in bed for 2 weeks and has been very fatigued since then. Now at the 6 week point her fevers are coming down and she feels better
This spontaneous report as received from a healthcare worker also reported as a corporate executive via a company representative refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient was vaccinated with ZOSTAVAX, for prophylaxis (dose, route of administration, lot number and expiration date were not reported).        The reporter stated that according to some pharmacist, the patient "died from getting ZOSTAVAX" on an unknown date. The cause of patient's death was not reported. It was also unknown whether an autopsy has been performed. No further details were noted on the after-hours adverse event voicemail. Additional information has been requested.
Lymph node enlargement in the left side of my neck above the clavicle bone. Initially, it was tender. But now not tender and still palpable
administration of a Third dose; This case was reported by a physician and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th June 2018) and Shingrix (2nd dose received on 3rd September 2018). Concomitant products included PNEUMOCOCCAL VACCINE (PREVENAR).   On 1st June 2022, the patient received the 3rd dose of Shingrix (intramuscular) .5 ml. On 1st June 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 01-JUN-2022 Reporter's Comments: The patient self-reported the case. The patient was administered with varicella zoster 50 yrs plus (shingrix - shingles) 0.5 ml intramuscular and pnucn20 (Prevenar 20) (pneumococcal conjugate, 20 valent). The patient's intention was to receive Prevnar 20, however, the patient was informed by his/her provider that he/she only had a single prior dose of Shingrix and required a second dose to complete his/her immunization for shingles. After receiving both Shingrix, and Prevenar vaccines, the patient later discovered that he/she previously had two prior Shingrix vaccines. The reporter asked what were the complications or risks of receiving a 3rd dose of Shingrix vaccination after completed series of 2 doses. The reporter also asked if there were any issues associated with concomitant administration of Prevnar 20 on same day. Additional Supportive Information: The patient inadvertently administered with third dose of Shingrix, which led to extra dose administered.
flushing; Reaction; Soreness; Nausea; "Rush" Throughout body; Dizziness; Heart Racing; Hard to Swallow; hoarseness which continued for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT ("Rush" Throughout body), DIZZINESS (Dizziness), PALPITATIONS (Heart Racing), DYSPHAGIA (Hard to Swallow) and FLUSHING (flushing) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concurrent medical conditions included Osteoporosis. Concomitant products included ALENDRONATE SODIUM (FOSAMAX) for an unknown indication.    On 02-Feb-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DISCOMFORT ("Rush" Throughout body), DIZZINESS (Dizziness), PALPITATIONS (Heart Racing), DYSPHAGIA (Hard to Swallow), VACCINATION SITE PAIN (Soreness) and NAUSEA (Nausea). On 02-Feb-2021 at 2:32 PM, the patient experienced VACCINATION SITE REACTION (Reaction). On an unknown date, the patient experienced FLUSHING (flushing) and DYSPHONIA (hoarseness which continued for 24 hours). At the time of the report, DISCOMFORT ("Rush" Throughout body), DIZZINESS (Dizziness), PALPITATIONS (Heart Racing), DYSPHAGIA (Hard to Swallow), FLUSHING (flushing), DYSPHONIA (hoarseness which continued for 24 hours), VACCINATION SITE REACTION (Reaction) and NAUSEA (Nausea) had resolved and VACCINATION SITE PAIN (Soreness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant follow-up information received.
Initial and follow up information has been received via the Merck pregnancy registry, from a licensed practical nurse (LPN), regarding a 25 year old Caucasian female (previously reported with LPN as the patient), (gravida 2, para 1) with no pertinent medical history and no allergies, who on 28-MAR-2007 was vaccinated IM, with the first dose, 0.5 ml, of Gardasil (lot #653937/0637F). There was no concomitant medication. The patient had her LMP on 11-MAR-2007, and was unknowingly pregnant. The pregnancy was confirmed by a positive pregnancy test. The estimated date of delivery was 16-DEC-2007. No other symptoms were noted. Follow up information from the LPN, indicated that in April, prenatal vitamins (unspecified) were initiated. In May 2007 through July 2007, ZOFRAN was initiated for nausea. In 25-JUL-2007, an ultrasound was normal. The LPN indicated that the patient had 3-4 ultrasounds due to polyhydramnios (dates not reported), but indicated the ultrasounds showed "normal testing." In September 2007 and continued through the end of pregnancy, ZANTAC was initiated for heartburn. On 06-DEC-2007, a C-section was performed, with reference to the polyhydramnios and a large for gestation baby. The patient delivered a normal, male infant (no congenital anomalies), birth weight 8 lb 10 oz, length 22 in, head circumference 14.5. The patient experienced a late postpartum hemorrhage, and required a dilatation and curettage (D & C) (date not specified). The outcome of the symptoms were not specified. Upon internal review, polyhydramnios and "large GEST baby" were considered to be serious as other important medical events (results in C-section). Additional information has been requested.
Pain, redness, and swelling at the injection site, Muscle pain, Tiredness, Headache, Upset stomach, Chill
Individual in recovery monitoring, approx after 5 minutes, individual had a syncopal episode and fell from a sitting position in a chair to the floor. Individual hit side of head/face on floor, recovered but dazed. Evaluated by paramedics, refused transport.
Janssen COVID-19 Vaccine EUA Nausea, headache, fever, muscle soreness
Grand Mal Seizure; Ventricular arrythmia; Cardiac Arrest; Sore arm; Sore joints; Headache; This case was reported by a physician via call center representative and described the occurrence of grand mal seizure in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2019, the patient received the 2nd dose of Shingrix. On 9th December 2019, 3 days after receiving Shingrix, the patient experienced grand mal seizure (serious criteria hospitalization and GSK medically significant), ventricular arrhythmia (serious criteria hospitalization and GSK medically significant) and cardiac arrest (serious criteria hospitalization and GSK medically significant). In December 2019, the patient experienced pain in arm (serious criteria hospitalization), soreness of joint (serious criteria hospitalization) and headache (serious criteria hospitalization). On an unknown date, the outcome of the grand mal seizure, ventricular arrhythmia, cardiac arrest, pain in arm, soreness of joint and headache were unknown.   It was unknown if the reporter considered the grand mal seizure, ventricular arrhythmia, cardiac arrest, pain in arm, soreness of joint and headache to be related to Shingrix.  Additional case details were reported as follows: Less than a week after vaccination the patient complained of sore arm, sore joints, headache. On Monday 9th December 2019, 3 days after vaccination patient had a grand mal seizure, ventricular arrhythmia, and cardiac arrest. The patient was currently hospitalized. The reporter did not have lot or expiration date of Shingrix as it was given elsewhere. The reporter consented to follow up.
Dizziness that lasted 30 minutes; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness that lasted 30 minutes) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event (No adverse event reported.).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced DIZZINESS (Dizziness that lasted 30 minutes). On 25-Mar-2021, DIZZINESS (Dizziness that lasted 30 minutes) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant nor treatment medications were reported.   This case was linked to MOD21-080998, US-MODERNATX, INC.-MOD-2021-089690 (E2B Linked Report).; Sender's Comments:  MOD21-080998:wife case US-MODERNATX, INC.-MOD-2021-089690:Husband Case
Orthostatic hypotension leading to unconsciousness, Shortness of breath, dizziness, headache, fatigue
On 6/16/00, the pt reports that her left arm was red and swollen from shoulder to elbow, was very warm to the touch.
This spontaneous report as received from a certified medical assistant refers to a 4 months old male patient with no pertinent medical history, drug reactions or allergies. The patient was vaccinated orally with (lot # 1673AA) dose 1 of ROTATEQ on 01-MAY-2012 (dose not reported) and was vaccinated orally with dose 2 of ROTATEQ on 17-JUL-2012 (lot number and dose not reported). No other co-suspects were reported. There was no concomitant medications. The medical assistant reported that on 19-JUL-2012 the patient began to gag and then vomited. The patient only received a partial dose. The patient did not seek medical attention and no lab diagnostic tests were performed. No treatment was given for the reported events. The patient recovered from the urge to gag and vomit on 19-JUL-2012. The relatedness for began to gag and vomited was not provided for ROTATEQ. Additional information has been requested.
Mother reports inconsolable crying for 3-4 hr w/in 24 hr post vax. red, hard & warm @ site of shot.  Mother contacted child's MD by phone to report above.
Shortness of breath, Diffuse Pulmonary Embolism with Ground glass opacities, happened over course of 1 week