chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hemiparesis; legion on my left frontal temporal lobe; spinal fluid leak.; weakness in my right arm and leg; telangiectasia on my pons; Central nervous system lesion; Vitreous floaters; Epidural blood patch; shingle blisters; tingling; twitching in my arm and face; burning sensation; This is a spontaneous report from a non-contactable consumer. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249 and expiration date was not reported), intramuscular, administered in Arm Left on 20Jan2021 at dose 2, single for covid-19 immunization. The patient had no medical history. Concomitant medications included fluoxetine hydrochloride (PROZAC); buspirone; cyanocobalamin (VITAMIN B-12); fish oil (OMEGA 3 FISH OILS). The patient experienced hemiparesis on an unspecified date. On 02Feb2021, patient started experiencing tingling and twitching in her arm and face. On the 3feb2021, she developed shingle blisters on the left side of abdomen. A week later (Feb2021), she had the burning sensation of shingles all over her body. She continued to have weakness in right arm and leg, tingling in right hand and sparkling floaters in her vision. She also had Central nervous system lesion on an unspecified date. She had a MRI of brain and was identified telangiectasia on her pons and also found a legion on left frontal temporal lobe. Patient's neurologist ordered a MRI of her neck which came back clear. On 06Jul2021, she had a lumbar cap analysis of spinal fluid and on 12Jul2021, she had to have a blood patch because she had a spinal fluid leak. The patient underwent lab tests and procedures which included Lab Work, lumbar puncture, magnetic resonance imaging neck: unknown results, magnetic resonance imaging head: abnormal. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Chills; Body aches; A lot of pain in the injection site; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (Body aches), INJECTION SITE PAIN (A lot of pain in the injection site) and FATIGUE (Very tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.   On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced CHILLS (Chills), MYALGIA (Body aches), INJECTION SITE PAIN (A lot of pain in the injection site) and FATIGUE (Very tired). The patient was treated with PARACETAMOL (TYLENOL) for Chills, Myalgia, Injection site pain and Fatigue, at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), MYALGIA (Body aches), INJECTION SITE PAIN (A lot of pain in the injection site) and FATIGUE (Very tired) outcome was unknown.      No relevant concomitant medications were reported.
On the day following immunization he felt tired and achy with swollen neck lymph nodes. Two days after immunization he also experienced sinus pressure, runny nose, cough and sneeze. Treatment was rest. All symptoms have resolved.
13-year-old patient received the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE. On 29-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
CHIEF COMPLAINT:   pt's 29 year old boyfirend sent pt. in for eval due him testing positive for covid. pt. has hx. of COPD and wears 4 L's oxygen chroniclly. pt. denies any symptoms.
This spontaneous report was received from a registered nurse refers to a 5 year old female patient. No medical history was reported. On 28-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J000445, expiry:11-APR-2014) 0.65 ml, subcutaneously instead of VARIVAX. No concomitant medications were reported. No adverse effect were reported. Additional information has been requested.
Headache, Myalgia, Fever, NauseaVomiting, Site/arm discomfort - severe, Fatigue, chills Narrative:
Fever of 103.4, severe headache, dizzy/lightheaded, body aches, nauseous
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a elderly male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was received as follows: The GlaxoSmithKline (GSK) medical information scientist reported to GSK response center. The GSK medical information scientist reported that a day before the date of reporting, in afternoon around 2 pm central time, he was attending annual conference in 2018. The reporter told him that the patient who was older than fifty years of age had arm tenderness which was lasted for a couple of months. The reporter did not know if the tenderness interfered with the patient's daily activities. The patient did not receive a second dose of SHINGRIX. It was unknown whether the tenderness involved the site of injection. The patient received SHINGRIX at the reporter's pharmacy. No further related details were provided.
Patient received the Adult dose COVID vaccine on 12/3/2021. The patients mothers states that the patient did not had any adverse reactions or side effects after getting the vaccine.
Heart arrhythmia, rapid heart beats( lasting 6 weeks) nose bleeds, (lasting longer in duration and more frequently)
1st dose pfizer vaccine was given to patient on 07/05/2021. We found out on 07/09/2021 that vaccine expiration was  out side the recommended 31 day expiration date window. We reached out to pt on 07/10/2021. Pt did not communicate if there was any side effect. She will return to the pharmacy on 07/12/21 to receive the 1st dose again.
body ache; Very Tired; Upset Stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 16Feb2021 18:00 (Lot number: EN9581) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "IBS", start date: 2002 (ongoing), notes: ongoing; "Hysterectomy", start date: Jan1995, stop date: Jan1995; "Vertigo", start date: Feb2010 (ongoing), notes: Ongoing; "Seasonal Hay Fever", start date: 1968 (ongoing), notes: Ongoing; "Lumpectomy", start date: Sep1977, stop date: Dec1978. Concomitant medication(s) included: LACTAID taken for lactose intolerance; GAS X taken for irritable bowel syndrome, start date: 2005. Vaccination history included: Bnt162b2, administration date: 28Jan1202, for Covid-19 immunisation, reaction(s): "my upper arm began itching and was red and swollen/my arm where I had the shot swelled up and was red and was warm to the touch", "my upper arm began itching and was red and swollen/my arm where I had the shot swelled up and was red and was warm to the touch", "my upper arm began itching and was red and swollen/my arm where I had the shot swelled up and was red and was warm to the touch", "my upper arm began itching and was red and swollen/my arm where I had the shot swelled up and was red and was warm to the touch". The following information was reported: PAIN (non-serious) with onset 17Feb2021, outcome "recovered" (17Feb2021), described as "body ache"; FATIGUE (non-serious) with onset 17Feb2021, outcome "recovered" (17Feb2021), described as "Very Tired"; ABDOMINAL DISCOMFORT (non-serious) with onset 17Feb2021, outcome "recovered" (17Feb2021), described as "Upset Stomach". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Patient was staying in a homeless shelter during an outbreak of COVID-19. He developed mild symptoms on 4/25/2021 and was tested on 4/28/2021 by PCR, which was positive.
8 1/2 x 3 1/2 cm pink area to left upper outer aspect of thigh. No treatment.
This spontaneous report was received from a medical assistant concerning a 8 month old male patient. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 01-DEC-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ dose 2, lot # L029617, orally, as prophylaxis (Strength, dose and expiration date were not reported), which experienced a temperature excursion (temperature and timeframe were no reported). It was not reported if there were previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA006956: US-009507513-1704USA006957: US-009507513-1704USA006958: US-009507513-1701USA005974: US-009507513-1704USA007664: US-009507513-1704USA007665: US-009507513-1704USA007666: US-009507513-1704USA007667: US-009507513-1704USA007668: US-009507513-1704USA007669: US-009507513-1704USA007670: US-009507513-1704USA007671: US-009507513-1704USA007672: US-009507513-1704USA007673.
Pediarix HIB vaccine administered on 1/18/06. About 4pm Baby started to cry unconsolable during every hour.
Hives located at the torso, back, buttocks, shoulder and bilaterally; This spontaneous case was received on 12-Oct-2020 from other non-health professional (consumer) via Health Authority (reference number: SEQW20-03369) and concerned a 50-year-old, male patient.  The patient had no relevant medical history. The patient's concomitant medications included Truvada (emtricitabine, tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP).  On 03-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid-right arm) for influenza immunisation. The batch number was not reported.  On the same day, eight hours after receiving Flucelvax QIV, the patient developed hives located at the torso, back, buttocks, shoulder and bilaterally. The patient was treated with Benadryl for the event.  On 04-Oct-2020, the symptoms were resolved overnight, and the patient recovered from the event of hives.   The reporter did not provide a causality assessment.  The reporter assessed the event as non-serious.  Company comment: The event of hives is assessed as related to Flucelvax QIV.; Sender's Comments: The event of hives is assessed as related to Flucelvax QIV.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 09-JUL-2012, the patient was inoculated with ZOSTAVAX, (lot # and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated by a physician located in for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, 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, and pain and suffering, and other damages. Additional information has been requested.
Rash contained on right side (buttock, hip and top of leg (R) side), varicella-like rash, lots of itching and redness, treating with BENADRYL PO and topical.
Initial report received on 18 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 16-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3801AA received on 01 April 2011, lot number C3911AA received on 02 June 2011 and lot number C3926AC received on 09 August 2011 (routes and sites of administration not reported). On 18 May 2012, the subject developed a cough, approximately nine months after the last dose. A paroxysmal cough (without whoop) began on 22 May 2012. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR and negative culture on 25 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 25 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 04 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 17 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
The pt woke up on 3/18/01 with a rash starting at head and working down. The pt describes as  "diffuse morbilliform rash" worse on head". The pt was scratching at the head and refused to eat or sleep. The pt had a fever of 101.0 since onset of rash.
body aches starting 15 hours post-injection, fatigue starting 17 hours post-injection, fever starting 18 hours post-injection. Fever lasted 6 hours, fatigue and body aches continued into next day lasting 24 hours
PAIN RADIATING UP THROUGH MY NECK AND DOWN PART OF MY BACK. PAIN HAS CONTINUED TO STAY IN MY THE UPPER PORTION OF MY BACK RIGHT BESIDE MY RIGHT SHOULDER BLADE. PAIN SEEMS TO BE WORSE IN MORNING WHEN I WAKE UP OR IF I AM NOT MOVING AROUND. ALL OF THIS WAS THE REGULAR FLU SHOT GIVEN BY OCCUPATIONAL HEALTH.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reported. On 08-JUL-2015, the nurse reported that the patient received a dose of improperly stored (Oka/Merck) VARIVAX (dose, frequency and route were unknown, lot # K009757, expiration date 09-JUL-2016; lot # L008272, expiration date 11-MAR-2017). No concomitant medication was reported. No adverse effects were reported. There were no product quality complaints PQC involved. Additional information has been requested.
swelling in neck & throat area-hives neck, chest & upper arm;DPH, steroid, adrenaline;
Pt c/o of shoulder pain,  thinks she has SIRVA from flu injection.  No adverse reactions known.
Breakthrough case admission after 3 vaccines MOderna 2/23/21 LOt# 007M20A;  Moderna 3/23/21 LOt# 015M20A;  Moderna 9/30/21 Lot# 005C21A
brief episode of vasovagal syncope - onset approximately 5 minutes after vaccine administration, lasted approximately 1 minute, resolved without intervention
Fever, nausea, body aches, enlarged and painful lymph nodes (axila region/right arm), tiredness
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot#J016188, expiration date:02-OCT-2016 and lot# J015437, expiration date: 09-OCT-2016.  The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 17 months old child patient of unknown gender. On 26-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route not reported, lot # J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
This case was reported by a healthcare professional and described the occurrence of pregnancy in a 26-year-old female subject who was vaccinated with Boostrix for prophylaxis. Previous vaccination included Boostrix given in 1997. Concurrent medications included Prenatal vitamins. ON 15 May 2007 at 16:00, the subject received 2nd dose of Boostrix (unknown, left deltoid). The nurse practitioner reported the subject received Boostrix dose while pregnant. The subject, who was 26-years-old at the time of the vaccination, experienced drug maladministration. The last menstrual period and estimated delivery date were unspecified. The immunization series with Boostrix was delayed. Follow-up information received via the nurse indicated that the subject's physician did not realize that Boostrix was a category C for pregnancy. It was reported that the subject developed a upper respiratory infection on 14 June 2007. No outcomes were provided regarding the pregnancy or the upper respiratory infection. Further follow-up pending. Follow-up information was received on 03 April 2008 from a nurse. The pregnancy was a normal conception. Estimated date of delivery was 23 September 2007. On 23 September 2007, approximately four months after receiving BOOSTRIX, the subject gave birth to a full-term female at 37 weeks of gestation. The baby weighed 3142 grams, was 18 inches in length, and hada head circumference of 23 inches. Apgar score at one minute was 8. Apgar score at five minutes was 9. It was not reported if ther were any birth defects noted or not. Follow-up details received on 08 April 2008 indicated that the infant was healthy and that the delivery was spontaneous vaginal. No further details provided.
Large whelp at injection site 2 weeks after injection.   Heat/soreness at site. No other effects.
Patient was given MMR vaccine sub Q in right leg. While at the checkout window mom noticed red welts and hives around the injection site. Placed patient in an exam room, examined by Dr. Patient was given 1 tsp of BENADRYL, waited for 30 mins. Patient reassessed by Dr. Discharged home.
Four weeks after receiving my second COVID-19 vaccine, I had a mammogram. Two suspicious areas were found on my left breast.  One is a 2cm oval mass within the lower left breast, posterior depth, with circumscribed margins. The other suspicious area consisted of a group of amorphous calcifications spanning approximately 2cm.
This spontaneous report as received from a health professional refers to a 5 year old patient. On 25-JUL-2014 the patient was vaccinated (oka/merck) VARIVAX (lot # J014229, EXP 08-NOV-2015 dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
there was no signs & sx reported from mom-vax were given 22SEP92; pt died of presumed SIDS 1OCT92; the ME report stated asphyxiation;
Information has been received from a health professional concerning a 65 year old female patient who on 25-AUG-2006 was vaccinated with a dose of Pneumovax 23 (lot # 651399/0486F). On 25-AUG-2006 the patient developed cellulitis at the injection site. She was treated with an antibiotic. Subsequently, the patient recovered from cellulitis at the injection site. It was reported that the patient's cellulitis was considered an other important medical event. Additional information is not available.
Shoulder/arm  Injury related to vaccine administration Allergic reaction, redness, itching on the site, pain on the site, large hematoma
1day p/vax pt possibly had fever & chills; felt weak, nausea; in ER c/o tingling/numbness of hands, feet & mouth area; given IV fluids & adm to hosp; improved in less than 24 hrs;
Feet swelled a lot (not huge) if not elevated. Lasted a couple of months.  Normally I don't have that problem.
Information has been received from the MedWatch program from a 62 year old female consumer who is an attorney, regarding herself. Her history included chicken pox and prednisone (1996). She currently takes COUMADIN (unknown indication). She had her COUMADIN level checked 03JAN2014, prior to receiving ZOSTAVAX, and was told it was okay and she could go ahead with the vaccine. Other reported medications included diphenhydramine 25mg occasionally to help her sleep, albuterol "occasionally" and FLOVENT "sometimes when her colleagues have colds to keep her airways open" (unclear if taken concomitantly). On 03JAN2014 the patient received ZOSTAVAX via a subcutaneous injection into her deltoid muscle. The pharmacist applied a band aid following the injection, but was unable to pinpoint the injection site. On 04JAN2014, the patient removed the band aid from her arm and she noticed "two oozing blisters" with a pink color around the site. She believes that one of the blisters is at the site of ZOSTAVAX administration and the second blister is on the opposite side of the injection site. She thinks that it is possible that the needle went through one side to the other. She contacted her physician by phone and he suggested she start VALTREX. As of the phone call, the consumer did not start VALTREX and the two blisters were continuing to ooze. In a follow-up phone call the patient provided the lot number and expiration date of the ZOSTAVAX. Additional information has been requested.
Information has been received from a registered nurse concerning a 14 year old Hispanic male with acne who on 03 OCT 2001 at !0:00 was vaccinated with the first dose of varicella virus vaccine live (lot #635605/1151K) (diluent lot #0422L) in the right upper arm. Concomitant therapy on the same day included the third dose of hepatitis B vaccine, recomb (ENGERIX-B) (lot #ENGS100A2) in the left deltoid and tuberculin purified protein derivative (PPD TINE TEST) (lot #C0835AA) on the left forearm. On 03 OCT 2001, five minutes after the injections, the patient experienced dizziness. The child was laid on a bed and monitored by the nurse and physician. Subsequently fifteen minutes later, the patient recovered from dizziness. Follow up information received from the nurse reported that the patient's vital signs were monitored for 2 hours and remained stable. It was also reported that he was ambulatory, experienced no loss of consciousness, was alert and oriented and complained of no difficulty breathing. No further information is expected.