chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no patients experienced symptoms; improperly stored doses administered; This spontaneous report was received from a nurse and refers to a patient of unknown gender and age. No  information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.  On 05-JUN-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ ) orally, (lot # 1660666, expiration date 22-MAR-2021) (dose, frequency and strength were not provided) for prophylaxis. Administered dose of vaccine had temperature of 9,4 degrees Celsius) during a time frame of 35 minutes. There was no previous temperature excursion. Digital data logger was involved.   The patient did not experience any symptoms.  This is one of several reports from the same reporter.; Sender's Comments:  US- 009507513-2006USA005638: US- 009507513-2006USA005637: US- 009507513-2006USA005636: US- 009507513-2006USA005639: US- 009507513-2006USA005595:
Patient reported light headedness  and said he's not feeling good. After drinking water he stated he feels better after 15 minutes and requested to call emergency. He declined and left the pharmacy and stating he's feeling better and good.
Rapid weight gain; Fluid retention; This spontaneous case was reported by a pharmacist and describes the occurrence of WEIGHT INCREASED (Rapid weight gain) and FLUID RETENTION (Fluid retention) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Bedridden.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WEIGHT INCREASED (Rapid weight gain) and FLUID RETENTION (Fluid retention). At the time of the report, WEIGHT INCREASED (Rapid weight gain) and FLUID RETENTION (Fluid retention) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
July 24, 2021 felt off balance but just a little. July 29th almost collapsed at work but did not. Left work. Returned to work August 01st but could not work due to lightheadedness and Anxiety was worst than it has ever been. I woke up with  horrible sinus infection and extreme lightheadedness. The feeling was intense and occurred mainly when standing, Began antibiotics and sinuses got better. The woozy feeling in my head did not and I began to feel chronically fatigued. I couldn't drive. I felt burning sensation in the lower part of each leg(below the knee and downward.)  I began to feel better 08/21/2021 through 09/02/2021. On 09/03/21 had relapse with Lightheadness, fatigue and burning sensation in lower legs.
An expired Covid-19 pfizer vaccine was administered to the patient on 4/25/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke with patient on 5-9 and she will consider getting revaccinated.
Woke up the day after vaccine with right eye swollen, red, painful and draining Saw eye doctor who prescribed warm soaks to eye and Retaine eye drops 4 times a day Better in 5 days
This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP7534 and expiration date: not reported), via an unspecified route of administration in left arm, on 03Mar2021 at 14:30 (at the age of 63 years old) as dose 1, single for COVID-19 immunization in a facility reported as other. Medical history included chronic fatigue syndrome. The patient was allergic to amoxicillin, clavulanate (AUGMENTIN) and amoxicillin. Concomitant medications included diltiazem. The patient didn't receive any other vaccines in 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient didn't had COVID-19 and post vaccination, the patient was not tested for COVID-19. Two days after the vaccination, the patient experienced diarrhea on 05Mar2021. It was continued for the past 14 days, and still persists. The patient was treated with loperamide hydrochloride 2 mg for this event. The event led to doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
pt found dead in crib early AM had been sick w/cold & diarrhea; had seen MD x 2 for these; had viral meningitis w/sz 28DEC94-hospitalized;
Client c/o light headed feeling.  She gets the same feeling when she rides on the trains.  Vitals taken by paramedics and it was normal.
This case was reported by a nurse and described the occurrence of flu like feeling in a 43 year old male patient who received hepatitis B vaccine recombinant (Engerix B). The patient had no pre existing medical conditions and no allergies. The patient was not receiving any concurrent medications. On 01/31/2005, the patient received the first dose of Engerix B in the left deltoid (lot AHBVB034BB). Approximately two to three hours following the administration of Engerix B, on 01/31/2005, the patient experienced a flu like feeling, muscle and body aches and fatigue. The events resolved on 02/01/2005. In the nurse's opinion, the events were related to vaccination with Engerix B.
Slight sore felt achy; headache the next morning; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Slight sore felt achy) and HEADACHE (headache the next morning) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Slight sore felt achy) and HEADACHE (headache the next morning). At the time of the report, PAIN (Slight sore felt achy) and HEADACHE (headache the next morning) had resolved.            No concomitant medications were reported.  No treatment information was reported.
Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L031603 with expiration date 18-FEB-2017, therapy type rHA; lot # M007965 with expiration date 15-AUG-2017, therapy type rHA; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion. Data logger was involved. No adverse effect was reported. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient was vaccinated with an improperly stored dose of PROQUAD 0.5ml (unspecified dose), with lot number L031603 (expiration date 18-FEB-2017). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Later in the evening was in hot tub and noticed rash on abdomen. Got out and rash continue to spread to arms, chest and neck. Have used hot tub many times before - no problems. Called physician next day - recommended Benadryl- hydrocortisone  cream.
The patient received the Janssen vaccine lot # 1808980 in his left deltoid muscle at 1250pm on the side of the road from our mobile foot team. He was seated on the sidewalk during vaccination and remained seated for his observation period.  At 1301 the patient said he felt "fuzzy," and "light headed" but said "I do not feel like I'm going to pass out." The patient refused to lay down. He was offered a mat or the back of the car to lie down on. He was also given water by RNs and a snack by the police. He drank a few sips of water and refused the snack. His BP was 150/100, HR 76 and regular per palpation, RR 16 and unlabored. No signs of respiratory distress. The patients skin was dry and color was appropriate for ethnicity. At 1306 the patient said " I feel the same, a little light headed." RNs and asked him to describe what he meant by light headed as he still denied feeling like he was going to pass out. He said "I feel dizzy." RNs asked patient if he felt like he was spinning but he said no. BP 158/90, RR 18 and unlabored, HR 74 and regular per palpation. Pt still declined to lay down. At 1311 the patient still felt the same. RNs asked the patient to lie down again. The patient agreed to lay down in the back of the car. The patient stood up and said he felt short of breath upon standing. He has a Hx of COPD and said that he often feels SOB when he first stands. He took his own Ventolin Inhaler before laying down in the back of the car with the air conditioning on. It was 1316 when he laid down and vitals were taken again. BP 130/90, HR 70 and regular per palpation, RR 18 and unlabored. At 1321 the patient said "I feel a little better but still light headed and my head is throbbing but I get headaches every day." Vitals: 138/90, HR 70, Spo298%. At 1326 the patient tried to sit up but became flushed and said he felt "weird." Vitals were 144/90, HR 75, RR 18, Spo2 97%. RNs assisted the patient to lay back down. At 1328  RN asked the police to call 911 while RN placed a call to our lead RN. Vitals were taken again at 1331 BP 150/90, RR 18 and unlabored, HR 81, Spo2 98%. At 1337 the paramedics arrived with the ambulance and resumed care. The patient was transported to Hospital.
hives on back of neck, lower left shoulder blade, under left breast, and middle of sternum
Received the 1st dose of Shingrix last fall / Should she get the 2nd dose?; confirm that it is genital Herpes; This case was reported by a pharmacist via call center representative and described the occurrence of genital herpes simplex in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number NB9D3, expiry date 16th April 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and INFLUENZA VIRUS VACCINE INACTIVATED (FLUCELVAX QUAD) for prophylaxis.   The patient's past medical history included genital herpes.   On 7th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 7th October 2020, the patient received FLUCELVAX QUAD. In October 2020, less than 2 weeks after receiving Shingrix, not applicable after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced genital herpes simplex. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the genital herpes simplex and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the genital herpes simplex to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for second dose. The pharmacist reported that the patient had 1st dose of Shingrix and a dose of FLUCELVAX QUAD on same day and experienced 4 flares of genital herpes simplex. Till the time of reporting the patient did not received second dose, which led to incomplete course of vaccination.  The pharmacist inquired that if it is possible side effect of Shingrix and second dose can be administered. Health care professional states that she received a prescription for Valacyclovir on Oct 22, 2020. It was unknown if the reporter considered the herpes simplex to be related to FLUCELVAX QUAD.
Rash on face; This case was reported by a other health professional via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The pharmacy intern stated that the physician's office contacted the pharmacy and stated that the patient received Shingrix and then had a rash on their face. The reporter consented to follow up. The pharmacy intern stated no further details were provided by the physician's office, so she was unable to provide additional details at the time of this call.  The pharmacy intern consented to follow up from safety.
30-40 min felt flush skin on body face bright red.  Numbness tingling in hands and feet. Took some advil. Over next two days on and off hot flashes    tingling numbness on hands and feet.  Very cold feet couldn't get warmed up till wrapped up on heating pad. Ño fever but felt chills.  Sore arm site of injection.
I received the vaccine Oct 8, 2018 (right arm) and on the morning of Oct 19, 2019  when I woke up my arm hurt, the injection site was very firm, I could bend my arm, but was very weak with arm abduction, to the point that I almost had to assist my right arm with my left  with abduction. The right arm hurt down into the bicep and tricep region. This lasted until the evening of Oct 21 when it diminished.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient had no history of chronic illness.  The patient received his first vaccination (series 1) with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) on an unspecified date as prophylactic vaccination. The batch number was not reported and has been requested. The patient received his booster dose (series 2) with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) administered to his left arm on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-NOV-2021, the patient experienced chills and cough and on 12-NOV-2021 he lost his sense of smell. A COVID-19 home test kit was positive for COVID-19 antigen on 12-NOV-2021 and a PCR COVID-19 test performed on 13-NOV-2021 was positive for confirmed COVID-19 infection. Confirmed clinical vaccination failure criteria was met for the series 1 vaccination. The patient was recovering from chills and cough but had not recovered from loss of smell.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection and confirmed clinical vaccination failure was not recovered. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint, and reference number requested.; Sender's Comments: V0; 20211136590-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. 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: SPECIAL SITUATIONS
reports SOB and difficulty breathing  Pt observed for 45 mins no signs of acute distress 02; 97% on room air RR:18 Bilateral lungs clear upon auscultation with equal chest expansion Pt able to speak in full sentences without complication  denies itching. no swelling in throat no palpitation  Educated on vaccine and side effect ER precaution
Fatigue; body muscle aches; chills; low grade fever - 99.6F; arm pain at site of injection; swelling at site of injection; itching at site of injection; puffy face; Pfizer COVID booster shot received on 09Nov; This is a spontaneous report from a contactable consumer. This 43-year-old female consumer (patient) reported that:  A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FF2589, Expiration Date: 31Mar2022), via an unspecified route of administration on 09Nov2021 (at the age of 43 years old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history included, irritable bowel syndrome (IBS), dermatitis/eczema, sensitivity to dairy and Latex allergy (allergic contact dermatitis). The patient concomitant medications were not reported. Historical vaccine included patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) on an unspecified date as dose 1, single and the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) on an unspecified date as dose 2, single for COVID-19 (Primary Immunization series complete but unknown manufacturer). On 09Nov2021, the patient had pfizer covid booster shot received.  On an unspecified date, the patient experienced fatigue, body muscle aches, chills, low grade fever - 99.6f, arm pain/swelling/itching at site of injection - 2 inches in diameter and puffy face when waking up (transient) 5-8 AM. The patient underwent lab tests and procedures which included body temperature: 99.6 fahrenheit on an unspecified date low grade fever - 99.6F.  Patient received treatment for muscle aches Tylenol around 5:30 AM on unspecified date. The outcome of the events were unknown.  Follow-Up (15Nov2021): Follow-up attempts are completed. No further information is expected.
An attorney reported that an 18 month old male received his 5th dose of Acel-Imune, 4th dose of Hib-Titer and his 3rd dose of Orimune on 10/28/1996. In 1/97, at 20 months of age, the child allegedly "began to display symptoms of neurological damage consistent with mercury poisoning" which resulted in "permanent injuries". The reporter described those symptoms as "regression of his language skills, engaging in repetitive behavior, suffering from diminished cognitive ability and becoming socially withdrawn". The reporter attributed these events to the presence of thimerosal. CANCELLED: Upon further review it was determined that this patient received Tri-Immunol vaccine. See MCN HQB948028NOV2001 which will remains the case of record.
1:50 waiting in observation area,  became dizzy and lightheaded. Shaking, states very cold. Extremities cold. Color pale, nail beds cyanotic. Lips gray. Patient crying. States she experienced a pain in her right arm down the arm after the injection. BP 110/84 HR 63.  O2 sat 100% on room air . Hasn't eaten, had a protein drink for breakfast. States she had to stop taking the phentermine suddenly due to supply issue at pharmacy. Has been taking it for weight loss for over a year. States having blurred vision. EMT present. 2:00 Glucose 56 gave patient juice and teddy grahams. Patient drank juice, nibbled on crackers.  2:10 - Glucose recheck 62. Ate two teddy graham crackers. Encouraged to eat more and drink water, declined. Color remains pale, nailbeds still blueish. HR 60 slow and regular per auscultation. Patient still cold and shaking, has sweater on. Still having blurred vision. States she can't think clearly. Patient drove self. Instructed that she shouldn't drive home and recommended transport to hospital.  2:12 EMS activated 2:34 EMS arrived. EKG done.  2:37 BP 104/67 HR 59  2:47 BP manual per EMT was 110/70 2:50 Glucose 110 recheck per EMT 3:00 EMT states that they completed orthostatic BP checks and her BP remained stable. Patient's color improving. Patient declined transport per EMS. States that she will contact her co-worker to come pick her up at vaccine site.  3:10 patient ambulated (accompanied by nurse to door ) to her own car, states she will wait inside for friend and not drive herself. Signed refusal for transport.
1/13/21 Fever, aches, headache began and got progressively worse 1/14/21: 103 temp, toes hurt, skin hurts, ovaries hurt stomach hurts, left arm, neck, left armpit feels like a rod is going through it, restless legs, muscle spasms, frequent need to urinate. Cannot stay awake. Went to urgent care, tested negative for covid. Tested negative for UTI. Doc advises to go home and wait it out. 1/14-1/17 fever, severe body aches all over. Rod feels like it's driven across the entire body,  cannot get out of bed. Nerve and muscle pain. Headache. Muscle spasms.  1/18-1/20 fever resides, I finally get out of bed. pain subsides to left side. Vertigo begins, headache, nausea begins. Brain fog.  1/20-today: frequent episodes of vertigo. Pain in arms and legs like the muscle is being ripped away from the bone. Difficult time doing normal activities. Arms hurt just typing. Feeling inflammation all over. Aches and pains
stuffy nose, some sneezing on 20OCT; 21OCT inc congestion & sneezing, hoarse, felt warm, tired, headache, sl early AM cough; seen @ clinic;
Client moved her arm wile vaccine was being administered. Less than half a dose was administered.  Dose was repeated in opposite arm following ACIP guidance
After 2nd dose on Saturday, I began my period tonight, Tuesday, after being fully menopausal for over a year.
Chest pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided
Diffuse arthralgia and myalgia which started approximately 4 days after administration. Involvement of upper and lower extremities. At times severe. Difficulty with ambulation and simple daily tasks. This persisted for approximately 4 weeks.
Pt. with normal cycles prior to vaccine, had a very heavy cycle right after getting her shot, then did not have a period for 6 weeks, then had a cycle that lasted 22 days, followed by another cycle 6 weeks later. Now had had amenorrhea since August. No cycle in the last 2 months.
On 07/03/2006 patient was called regarding something totally different. She states she received today on 06/30/2006 am at 10:00 pm.  She had the chills and fever all day Saturday and into Sunday.  No swelling or redness at site of vaccine.  On 07/03/2006 patient reports she feels normal.  She just wanted doctor to be aware of this.  She has had  a regular td vaccine and she didn't have problems.