chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inject given in L deltoid. Laughing and talking  walked back to class. Sat down. Became very pale, sweaty, disoriented. Teacher walked pt back to office. Pupils equal, very slow to respond. Parents called - talked w/mother later - no
0.05/25MG IM Benadryl/Diphenhydramine in left deltoid 14:20. To prevent nausea/vomiting. Then gave .03 Pfizer vax Right arm. Patient has history reaction with shingles vax. At 14:40 Patient reports no itching/nausea.
This spontaneous report as received from a registered nurse refers to an 11 month old patient of unknown gender. On 12-NOV-2014 the 11 month old patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (dose, route were not reported, lot # reported as K007451, expiration date reported as 21-NOV-2015). No adverse effects were noted. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Drastic Hair Loss; Loss of 10-15% Volume of Hair; felt lethargic; arm pain; throbbing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 68 year-old male patient received bnt162b2 (COMIRNATY), administration date 12Oct2021 (Lot number: 30125BA) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: 06Aug2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious) with onset 14Oct2021, outcome "unknown", described as "Drastic Hair Loss; Loss of 10-15% Volume of Hair"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "recovered", described as "arm pain"; PAIN (non-serious) with onset Oct2021, outcome "recovered", described as "throbbing"; LETHARGY (non-serious) with onset 12Oct2021, outcome "unknown", described as "felt lethargic". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated to me he received the Pfizer Covid Vaccine on 12Oct2021 and no more than two days later he began to experience drastic hair loss that had never happened before. Caller wanted to know if this was a reported side effect of the vaccine. Caller is a 68 year old male who reports hair loss, 10%-15%, that began no more than two days after receiving his first Pfizer Covid vaccine injection. Caller stated that he had a head full of hair prior to Covid injection and this has never happened before. Caller goes on to explain that around 06Aug2021 he contracted Covid. He began to feel progressively more sick and on 15Aug2021 he had a really bad day, so on 16Aug2021 he was tested for COVID and the test was positive. Caller states he felt bad for approximately 10 more days. Caller says he waited 5 weeks after contracting COVID to receive the Pfizer Covid vaccine and he is not sure if his previously having Covid contributed to his hair loss. Caller states he went to see his doctor yesterday and they decided together to wait on getting the second dose due to his hair loss. Second dose was due on 02Nov2021. Caller also reports experiencing arm pain for two weeks after vaccine injection, that turned into throbbing which lasted for about a week but is gone today. Caller also says he felt lethargic right after vaccine injection with no ambition but that wore off pretty quickly. Caller did not have the expiration date. Caller declined any further demographic information. Response: After review of the prescribing information informed caller that I did not see hair loss as a reported side effect, however these may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials. LAB-1451-12.0 Revised: 29Oct2021  No follow-up attempts are possible. No further information is expected.
No other AEs; a temperature excursion on ROTATEQ that was administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, drug reactions, allergies and concomitant medications.   On 22-APR-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 time dose, route defaulted to oral, lot # T033812, has been confirmed to be a valid lot #, expiration date 29-DEC-2021) (exact dose, route of administration and anatomical location were not provided), for prophylaxis. Administered dose of vaccine experienced temperature excursion of 48.2 degrees Fahrenheit (above 47 degrees Fahrenheit) for 2 hours. There was no adverse event reported. Data logger was not involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA007516: US-009507513-2104USA007568: US-009507513-2105USA003675:
Fingers turn light yellow and become very cold.  Happened about once a week initially but progressed to multiple time every day.  Only some fingers are affected. Which fingers, how many and how far up my each fingers alternates each time this occurs.
initial hours I was okay.  I took 500mg total of OTC Tylenol 10 minutes after the injection as a precaution.  I did that with the 1st dose too and had no issues that first time.  By 2pm I got very sleepy for no apparent reason. I took a 1 hr nap.  By 6 pm I had INTENSE stomach cramps. By 7pm I had non-stop cramps and diarrhea until 3am the next day at which point it abruptly stopped.  During that time I felt chills but I did not have a fever.  It was nothing I ate. We all practice great handwashing, hand sanitizing etc.
Headache; I wake with what feels like a hangover and typically it gets worse from there.; I wake with what feels like a hangover and typically it gets worse from there; Progressing to what may be a tension level headache; Maybe finishing with what l can only imagine is what a migraine may feel like.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A patient of unknown age and gender received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on 10Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history included covid-19 from Jan2021 to Jan2021 and was hospitalized from 18Jan to 23Jan. Received the remdesivir injections for 5 days and was discharged. The patient concomitant medications were not reported. The patient previously received first dose of vaccine BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number- not reported) via an unspecified route of administration on 15Feb2021 as dose 1, single for COVID-19 immunization and experienced flu like symptoms, headache and feeling abnormal. On an unknown date in 2021, the patient experienced headache (It's now 6 months later and he still have daily headaches), Many days the headache was almost debilitating, he wake with what feels like a hangover and typically it gets worse from there, At best many of the hours in a day it felt like a bad hangover, progressing to what may be a tension level headache and maybe finishing with what patient could only imagine is what a migraine may feel like. The patient underwent lab tests and procedures which included angiogram (MRA) showed unknown result, computerised tomogram (TMJ CT scan) with unknown result, magnetic resonance imaging (MRI of neck and spine) with unknown result, magnetic resonance imaging head (MRV of Brain) showed unknown result on an unknown date. The treatment medications included Nortriptyline at bedtime, Nurtec, Zipsor, Ubrelvy and Ajovy injections. Zipsor when Nurtec or Ubrelvy did not help. Seeing a neurologist but to date still had issues and did not see any light at the end of a very dark tunnel. Reporter wanted to know anyone that is actively studying covid related headaches. The clinical outcome of the events headache, it gets worse from there was not recovered while that of other events was unknown.  The Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Red right arm; itchy right arm; swollen right arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red right arm), PRURITUS (itchy right arm) and PERIPHERAL SWELLING (swollen right arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced ERYTHEMA (Red right arm), PRURITUS (itchy right arm) and PERIPHERAL SWELLING (swollen right arm). At the time of the report, ERYTHEMA (Red right arm), PRURITUS (itchy right arm) and PERIPHERAL SWELLING (swollen right arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Around 05/01/2021- I was having a pain on my right side. I was having severe  gastro issues. There was nothing to predict it, or nothing that caused it. It just happened.  By July my symptom s became very severe, my  liver enlarged to 18.7 cm  and that was discovered through an ultrasound  in August. I was referred by my doctor in order to get the ultra sound. I had a HIDA scan on the 09/07/2021- my gall bladder had a low ejection fraction of less than 31 %.  And I am currently waiting for the general surgeon to give me a call for surgery.  I have never had these symptoms before the vaccine.
Brain zaps A  startling  ,painless, wave of  sensation throughout my brain .  The sensation stops me in my tracks and I?m briefly confused  but quickly reorient .
tingling all over; muscles set on fire; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling all over) and MYALGIA (muscles set on fire) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PREDNISONE (PREDNISON) for Arthritis, DICLOFENAC DIETHYLAMINE (ANTI INFLAMMATORY) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling all over) and MYALGIA (muscles set on fire). At the time of the report, PARAESTHESIA (tingling all over) and MYALGIA (muscles set on fire) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
The day after the vaccine(5-31-19) she complained of a fever of about 99 degrees and just general malaise and arm soreness. She said the fever went away the day after that(6-1-19) but the soreness stayed. Also on 6-1-19 her left arm where we gave the shot was inflammed, red and hot to the touch. The redness and a little bit swollen went down her arm about 8 inches. She said it was sore and hot to the touch. She is supposed to let me know if it gets any better or any worse today 6-2-19.
This spontaneous report has been received from a pharmacist and referring to a currently 48-year-old female patient with no pertinent medical history, concurrent conditions, concomitant medications, and drug reaction or allergies. On 16-MAY-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly (IM) in the left deltoid muscle, lot number R002085, expiration date 26-OCT-2019 (strength, dose, and frequency were not reported) for prophylaxis also reported as "pneumococcal". On an unspecified date, the patient experienced redness, swelling and rash at the injection site and consequently she was advised to go to an emergency room (ER) and being there, the patient was placed on treatment with BENADRYL. No laboratory tests or diagnostic procedures were performed. At the reporting time, it was unknown whether the patient recovered or not from the adverse events. The causal relationship between the adverse events and the therapy with PNEUMOVAX 23 was not provided.
Information has been received from a physician concerning a female in her 70's who on approximately 26-FEB-2008 was vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). It was noted that the patient was told by the administering local clinic "that they always give VARIVAX (Merck) as the shingles vaccine". It is unknown if medical attention was sought. There was no product quality complaint. Additional information has been requested.
This case was reported by a pharmacist via sales rep and described the occurrence of shingles in a 58-year-old female patient who received Shingrix for prophylaxis. On 22nd September 2018, the patient received the 1st dose of Shingrix. On 15th October 2018, 23 days after receiving Shingrix, the patient experienced shingles and erythema. On an unknown date, the patient experienced fever. The patient was treated with Valacyclovir. On an unknown date, the outcome of the shingles, fever and erythema were recovered/resolved. It was unknown if the reporter considered the shingles, fever and erythema to be related to Shingrix. Additional details were provided as follows: This case was reported by pharmacist for herself. The age at vaccination was not reported but it could be 57 or 58 years. After receiving Shingrix, the patient experienced low grade fever of about 100 degree F for 24 hours. On 15 October 2018, the patient got first red spot which began to spread next day. The patient went to doctor and diagnosed with shingles and received Valacyclovir as treatment. Shingles took 6 days to dry up. The pharmacist agreed to receive follow up and would call medical directly to ask about how long to wait after outbreak of Shingles and Valacyclovir to get her 2nd shot.
Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. During 2012, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2017, the patient was treated at a Medical Center for vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct an proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles. The patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Large red area(about 2.5 inches across) at injection site.  hot, itchy, slightly raised  Appeared on the third day and is still present on day 10.
Vaccine given 3 days after expiration.  Expired 09/29/2023, administered 10/02/2023. Provider advised that patient be re-immunized.  No adverse reaction to expired vaccine.
On thursday Sept 18, 2008 around noon, recieved flu shot to L deltoid continued to work.   Approx 9:00pm rash appeared first on hands then chest migrating to the neck and face.Took Allegra D at approx 10:00 pm at 10:30 relief was noted
Patient was admitted to HCF on 11/22/2021 as observation due to weakness and inability to care for herself at home.  Patient was tested for COVID19 prior to hospitalization which returned positive.
Patient presented to ED for evaluation of palpitations.  These been going on for 2 weeks.  Nothing makes it better, nothing makes them worse.  She has had them in the past. She got her Covid vaccine booster last week, started having issues with increase in her heart palpitations, more racing heart, a general sense of discomfort in her heart area.  She went to see her cardiologist, she brought her own EKG monitoring through the phone, frequent PVCs were noted.  Her metoprolol dose was increased and an echocardiogram was ordered, but she cannot get in until the end of November through the system and would like to have that redirected.  Her cardiologist thought that she had some myocarditis related to the Covid booster, is expecting it to settle down with time.
experienced stomach pain; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lyme disease" (ongoing). The patient's concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "experienced stomach pain"; NAUSEA (non-serious), outcome "unknown", described as "nausea". Additional information: After both COVID-19 vaccine doses, patient (female, 29) experienced stomach pain, nausea. Patient suffers from underlying condition Lyme disease (unrelated to vaccine). Reporter did not wish to be contacted for follow-up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
36 Hours after dose, March of 2018 I had a stable stress fracture on the outside of my left ankle. Full use regained (with exercise after 6-9months.  After standing up, the same pain returned at moderate high intensity. Location and type of pain is similar/identical to 1 month after fracture.  It?s as if previously damaged tissue is being triggered.
Information has been received from a Licensed Practical Nurse referring to unspecified amount of patients of unknown age and gender. There was no concurrent condition or medical history reported. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (lot # L004014, expiration date March 2017 and lot # L016428, expiration date July 2017) (dosage, strength and route unknown) (temperature fridge 0.1 degree centigrade, time frame 2 hours and 59 minutes). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
85 years old with past medical history of diabetes, hypertension, hyperlipidemia, dementia presented to local Medical Center with a complaint of generalized weakness and hyperglycemia.  From the ER chart it appears the home health nurse went to check on the patient and she found that he was not acting like himself.  She is unsure when his symptoms have started.  When she checked his blood glucose it was 500.  On presentation to the ER his blood glucose was 202.  Patient is currently confused and is only alert and oriented x1.  The patient's son was at bedside at Medical Center.  He indicated to ER that patient has been getting weaker and more confused over the last couple days.  He was tested for COVID and was found to be positive.  He had a chest x-ray which was negative.  On presentation blood work was done which showed a creatinine level of 1.58.  I reviewed blood work in care everywhere and patient appears to have a creatinine baseline around 1.6.  In July 2021 he had a creatinine of 1.66. In December 2021 he had a creatinine of 1.59.  He had a urinalysis done which was significant for scary protein otherwise unremarkable.  He had a CT of the brain which was negative. Patient is on insulin at home.  Patient is poor historian.  Most of the history was collected from the ER chart and care everywhere. When seen, patient was resting in bed comfortably.  No acute distress.  Patient follows commands appropriately.  Conversing normally but would not answer questions correctly.   Clinical Summary PT/OT evaluation and therapy provided.  Patient qualified for Express Care but family expressed that they would prefer to take him home for care at home.  Home health was provided.  Supportive care provided for viral illness.  Keppra was adjusted due to renal function.  Tolerating room air on day of discharge.  Dietary support provided throughout the admission.   Discharge diagnosis COVID infection Acute hypoxic respiratory failure Toxic metabolic encephalopathy Acute on chronic encephalopathy  Chronic severe protein calorie malnutrition with cachexia, present on admission Dementia Failure to thrive Generalized weakness Chronic kidney disease stage IIIa Hypertension Hyperlipidemia History of seizure
Racing heartbeat (120bmp), increased blood pressure (165/85), dizziness, lightheaded. Happened within 5 mins of injection. Symptoms passed and returned to normal within 15 mins.
After experiencing the expected sore arm, fever, chills and headache which incapacitated me for about 18 hours, I then experienced the most severe heartburn I have ever had for about two hours, starting 34 hours post vaccination. The pain was so severe that I almost ended up going to the ER.
Acute appendicitis - patient that was admitted to the hospital and taken to the operating room and underwent a(n) Laparoscopic Appendectomy.  The patient tolerated the procedure(s) well and was transferred to the ward post operatively.  Post operative course was unremarkable.  ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
On January 14th, I began to have hives on my upper neck, back and face followed by an itchy bruning/hot sensation. Scalp was very itchy. The next day, I woke up and my eyes were swollen and had hives all around my eyes, ears and neck. I was prescribed prednisone. Monday, January 18th, I started to have hives throughout my entire body as well as debilitating chest pain with a lump on my throat type of feeling. Chest pain still occurs and is still debilitating. Itchiness is severe and hives cone and go throughout entire body.
Woke up with feeling of nausea tried to make it to bathroom but blacked out. Suffered significant facial trauma including lose of half of front tooth. I then had significant chest pin and trouble breathing. Remainder of day felt dizzy and nauseous with fever (99.3) and chills. Severe muscle aches and pain at injection site.
Pediarix given into Rt. Thigh - pt held breath, stiffened, arched back, seemed unable to respond to voice or focus.  Experienced decreased muscle toned -color pale.  Recovered in 60-90 seconds.  Doctor examined and decision made to give Hib and Prevnar.  After these 2 vaccines given pt again immediately started crying, became apneic, dusky, bradycardic.  She had an opisthotonic - like rection, arched her back This episode lasted 1-2 minutes  The baby's exam then returned to normal with normal vital signs.