chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable mother reporting on her daughter. This consumer reported similar events for two patients. This is the first of two reports. A female patient of unknown age (the older daughter) received PREVNAR 13 (lot E23419) 0.5ml single dose, intramuscular in right thigh at 12 months on 23May2011. The patient received the same vaccine also at 2 months, 4 months and 6 months of age and with each vaccine the patient had an allergic reaction. The patient also received on the same date the following vaccines DTAP, HIB, hepatitis a vaccine, MMR and varicella vaccines all at 1 DF. After receiving the vaccine she had multiple side effects, some starting early on and others starting later on unknown date in May2011. Reporter stated that the initial side effect reaction was almost instant. The vaccine side effects lasted weeks in durations. The patient experienced unable to walk, unable to stand, equilibrium was out of wack, high fever of 104, puffed like marshmallow, red rash, vomiting, diarrhea, fainting, dizzy, not able to breathe, hives, swollen lymph nodes, facial pain, head pain, screaming and crying out of control for hours, speech delay. Now she had developed several food allergies, including peanuts, eggs and soy. At the time of the events, she weighed less than 18 pounds. The outcome of the events was unknown.
Information has been received from a medical assistant concerning a 7-year-old male patient who on 29-SEP-1999 was vaccinated with a dose of varicella virus vaccine live. On approximately 28-DEC-2005, the patient developed chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Chills; dizziness; Headache; This is a spontaneous report from a non-contactable consumer (patient). A 23-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) intramuscular, administered in Arm Left on 04Feb2021 14:30 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for covid-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Feb2021 12:00AM the patient experienced chills, dizziness and headache. Patient had not received any treatment for adverse event. The outcome of events was not recovered.    No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.
I DEVELOPED A MASSIVE BLOOD CLOT (DVT) IN MY LEFT LEG. SYMPTOMS BEGAN WITH SWELLING AND B=NOTICBLE SHARP PAIN IN THE CALVE OF ME LEFT LEG. AN ULTRSOUND IMAGE FROM MY GROIN DOWN TO MY ANKLE OF MY LEG REVEALED A MASSIVE 18 INCH LONG BLOOD CLOT!!!! I WAS HOSPITALIZED FOR SEVERAL DAYS ON A HEPARIN IV DRIP, DISCHARGED AND NOW BEING TREATED AS OUTPATIENT FOR NEXT SEVERAL MONTHS ON EILIQUIS BLOOD THINNER MEDICATION.   THERE HAS NEVER BEEN BLOOD CLOT HISTORY IN MY FAMILY.  I'M AN ACTIVE HEALTHY MALE, NON SMOKER, VERY LIGHT ALCOHOL CONSUMPTION AND BIKE 10-40 MILEEVERY DAY. I'VE HAD NO ACCIDENTS OR INJURIES THAT COULD HAVE RESULTED IN POSSIBLE CLOTTING.  THIS CAME TOTALLY OUT OF THE BLUE .
This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate route of vaccination in a 26-year-old female patient who received FLULAVAL QUADRIVALENT (batch number AR57J, expiry date 31st May 2015). On an unknown date, the patient received FLULAVAL QUADRIVALENT (intravenous). On an unknown date, an unknown time after receiving FLULAVAL QUADRIVALENT, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination was unknown. Additional information: the vaccine was given IV instead of IM.
Information has been received from a nurse practitioner concerning a 60-year-old female with a history of herpes zoster and no known drug allergies who on 15-AUG-2007 was vaccinated subcutaneously with a dose of 0.65 mL of zoster vaccine live (Oka/Merck) (656395/0290U). On 22-AUG-2007, seven days post vaccination, the patient developed shingles. There were lesions under her left breast, and on her buttocks. Medical attention was sought at the office. No treatment was given. There were no laboratory tests or diagnostic procedures. The outcome was reported as improving, "the patient is better, but the lesions remain." No product quality complaint was involved. The nurse practitioner is interested in the VZV program. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/24/2008.  No additional information is available.
States t102.8 AX early AM & cranky, states sleepier than usual, appetite poor; t102 AX approx 1PM; "cold sx", sore throat;
Information has been received from a consumer concerning her 9 year old daughter who on 10Jun97 was vaccinated with a dose of varicella virus vaccine live. On 04May05 the pt experienced breakthrough varicella with lesions on the head, trunk of genital area. More lesions were appearing at the time of this report. It was noted that a mild fever was present, but no treatment was mentioned. Medical attention was sought. No product quality complaint was involved. Follow up information from the physician office indicated that, according to the doctor, there was no reaction to the varicella vaccination. Additional information is not expected.
This spontaneous report was received from a pharmacist refers to a multiple unspecified patients of unknown demographics. The patients' concurrent conditions and medical history were not provided. On multiple unspecified dates, the patients were "possibly" vaccinated with improperly stored doses of GARDASIL 9 lot # K026247 and expiration date 29-JAN-2017, (dose, route of administration and anatomical location were not reported). There were no concomitant medications provided. The GARDASIL 9 vaccines were exposure to 34F for 295.75 hours. There was no previous excursion and no data logger issue. No adverse effects reported. No product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.
Product storage error; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No concomitant medication was reported.  Date vaccine was placed in refrigerator was 29-oct-21. No adverse event and no temperature excursions was reported.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with 2 doses of GARDASIL (lot# unspecified) on an unknown date and later for the third dose. No other co-suspects were reported. No concomitant medications were reported. The patient was not experiencing any known symptoms. Additional information has been requested.
Severe head ache,fever of 103.6,nausea,throwing up,couldn't hold down water,heart beat to fast,trouble breathing,weak ,dizzy,the shakes.
Arm pain where the injection site is; Diarrhea; A little feverish; Felt really kind of sleepy /groggy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 30Sep2021 (Batch/Lot number: unknown) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Thyroid" (unspecified if ongoing), notes: she takes thyroid medication. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 immunization; Bnt162b2 (Dose:02), administration date: Apr2021, for COVID-19 immunization, reaction(s): "varicose veins". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 30Sep2021, outcome "not recovered", described as "Arm pain where the injection site is"; DIARRHOEA (non-serious) with onset 30Sep2021, outcome "not recovered", described as "Diarrhea"; PYREXIA (non-serious) with onset 30Sep2021, outcome "not recovered", described as "A little feverish"; SOMNOLENCE (non-serious) with onset 30Sep2021, outcome "not recovered", described as "Felt really kind of sleepy /groggy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, pyrexia, somnolence.  Additional information: Consumer stated that she had diarrhea / watery stools, sleepy/groggy after the vaccine that she got yesterday afternoon around 3pm, patient was still groggy, still had some diarrhea, her arm hurts. Patients brother (49 years old, male) who's a doctor, he's a MD had some side effects from his second Pfizer vaccine and he had it go on for almost 2 weeks. Patients brother said 10 days or 12 days, he had to take time off from work he's fine now." Caller also mentioned that she noticed after second vaccine, all of a sudden within that same week she  ended up with varicose veins. Patient also stated her mother (84 years old, female) had her Pfizer booster vaccine and had some arm pain, she did feel groggy, but not bad. patient felt it more than she did. Then patients mom's brother (83 years old, male) felt nothing and neither did his wife.   Follow-up (13Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Blood pressure keeps going up and down for couple hours; This is a spontaneous report from a contactable nurse (patient herself). A 49-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via an unspecified route of administration in the right arm, on 18Jan2021 at 13:15, at a single dose, for COVID-19 immunization. Relevant medical history included blood pressure abnormal. Concomitant medications included spironolactone. The patient previously received amoxicillin and experienced allergies. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the Nursing Home/Senior Living Facility. On 18Jan2021, at 13:15, the patient's blood pressure keeps going up and down for couple hours. The patient did not receive treatment for the event. Outcome of the event was recovered with sequel. The patient has not been tested for COVID-19 since vaccination.  Information on batch/lot number has been requested.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient entire arm from deltoid to above elbow red, hot and swollen-she put ice said felt better so i advised her to take benadryl and follow up with me on sunday july 17
Headache for first and second days Heart palpitations second and third days Insomnia for at least four nights
Information has been received from a physician concerning a 9-month-old male who on 26-SEP-2006 was vaccinated PO with a 2.0 mL dose of Rotateq (Lot # 654392/0578F). The physician reported that on 06-MAR-2007, the patient tested positive for rotavirus. It was noted that blood tests were also performed (results not provided). Unspecified medical attention was sought. In March 2007, the patient recovered. Additional information has been requested.
Extremely loud ringing noise in my left ear!! Burning sensation down both arms and both legs and burning sensation in my upper back, also. This lasted for about an hour.
Patient was accidentally administered the Influenza vaccine in the left thigh instead of the Hepatitis B vaccine. Parents were informed about the mistake, and extensively discussed low risk of any adverse effects from flu vaccine administration. Discussed small possibility of low grade fever within the first 48 hours of administration and possibility of mild erythema and mild swelling at the site of administration. The correct Hepatitis B vaccine was administered, with parental consent, in the right thigh during the same visit.  Followed up with the parents later that day and the patient had not developed any fever or adverse events.
Patient woke up with left sided facial numbness and palsy. Treated with Prednisone.
After approximately 5 min after receiving the shot i started to feel a strong feeling of dizziness along with nausea, i could not stand and fainted, they carried me to a private area where i was picked up by the ambulance, my vital signs were not ok.
This spontaneous report was received from a male patient of unknown age. The concurrent condition of the patient included neuropathy, allergy to LIPITOR and CELEBREX. On an unknown date in March 2015, also reported as about 2 months ago, the patient was vaccinated with ZOSTAVAX (dose and route of administration was not reported) for prevention of shingles. Concomitant therapies included NEURONTIN, adefovir dipivoxil and vitamin B complex. The patient reported that his neuropathy was getting better until he received ZOSTAVAX. Before vaccination it was only in his legs but after vaccination, the patient felt throbbing from his toes to his shoulders. On 26-MAY-2015, the patient was lounging in the sun. On 27-MAY-2015, the throbbing was really bothering him. On an unknown date in 2015, the patient experienced redness and a rash on his groin area. The patient sought medical attention and called physician. The physician recommended to see neurologist. The vaccine was not reintroduced. The outcome of the events was reported as not recovered. No product quality issue was involved. Additional information has been requested.
Sore, painful, red huge area around injection site armpit sore, swollen lymph node, warm to the touch, very painful, very irritating to patient.
pt recvd vax; 2 days after infection had ear ache & was dizzy; was n; seen by MD; dx as ear infect; later seen by MD & he dx as TMJ;
Had cavities in his teeth after covax vaccine; This is a spontaneous report from a non-contactable consumer or other non hcp via Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 03Feb2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced had cavities in his teeth after covax vaccine on an unspecified date. On 03Feb, received covid vaccine. Went to the dentist, has a cavity. Prescribed an antibiotic for cavities. Inquiring if that would have an effect on his vaccine. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of had cavities in his teeth after covax vaccine (dental caries). The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1/28/11-appt. erythema, induration, warmth (R) deltoid down to midarm, wraps around posterior arm and onto shoulder. No fevers. Start SEPTRA-antibiotics. 1/31/11 Mom reports - next day improved, following day almost gone - today - hardly noticeable.
This spontaneous report as received from a nurse, referring to a female patient of unknown age. The patient had was allergic to ciprofloxacin. The patient's medical history and concomitant therapies were not reported. On 21-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N019348, expiration date 08-FEB-2019, intramuscular, for prevention of pneumonia (strength, dose and frequency were not reported). Later on the same date, the patient experienced pain in arm that vaccine was administered in that was shooting into fingers (pain in extremity), fever, shaking, and hives, so the patient began taking cephalexin (KEFLEX) 500 mg twice daily for 7 days. The patient sought medical attention by calling physician medical practice and informed that her symptoms were much improved. No laboratory diagnostic studies and no intervention to prevent serious criteria were performed. The assessment causality between pain in extremity, hives, fever and shaking with PNEUMOVAX 23 was not reported.; Sender's Comments: US-009507513-1710USA000621: US-009507513-1710USA000626:
This spontaneous case, was initially received on 28-Sep-2017 from Other Health Professional, concerning a male patient of unspecified age. The patient was administered with FLUCELVAX QIV (between 06-Sep-2017 to 26-Sep-2017: as reported) (dose: 0.5 ml, batch number: 195214, expiry date: Apr-2018, dose: 0.5 ml, route of administration, anatomical location: not reported). Multiple temperature excursions were occurred on 08-Sep-2017, vaccine was stored at 33F (1st excursion), on 11-Sep-2017, vaccine was stored at 33 F (2nd excursion), on 12-Sep-2017, vaccine was stored at 33 F (3rd excursion), on 13-Sep-2017, vaccine was stored at 33 F (4th excursion) (explicitly coded as incorrect product storage). The patient was administered with vaccine which was stored at 33 F (explicitly coded as drug administration error). The outcome of the events was not reported. The reporter assessed the events as non-serious. Non-significant case correction received with 28-Sep-2017: Batch no. (195214) was captured in the case form and narrative amended accordingly.
I had a very normal, healthy pregnancy and delivery.This is my second pregnancy that went into a miscarriage. The fetus stopped growth at 6w5days right around the time of my second dose of vaccine. I was initially detected with subchorionic  hemorrhages, the fetal growth stopped around 6w5days. There was initial heart beat on the first ultrasound on 7th June but the later ultrasound on 18th June had a deceased fetus of 6w5days. It was a miscarriage and had to undergo D&C on June 22
Mild-mod muscle/tendon/joint aches at bilat anterior hips beginning 1 week after 1st injection and exploding  in intensity and breadth one week after the 2nd injection. Areas currently involved: pan-pelvic, bilat shoulders, lower neck, L knee and R Achilles. Symptoms worse with immobility/cooling (PMR-like). Partially respond to NSAID's  on which I've been dependent since 01APR2021 to accomplish ADL's. Symptoms have slowly decreased in intensity in recent 2 weeks but show no sign of completely abating. Can't  sleep in a bed due to pain; often need a narcotic Rx to quell pain to allow sleep at night.
pt recvd vax; titer 0.5 IU 90 days p/ pre exposure series;19apr94 f/u:returned form; listed vax is ID dose,but route is indicated as IM for all 3 doses;addtl booster dose administered;
We realized that lot #008C21A has an expiration date of 10/13/2021 there was no adverse effect at the time, just reporting the expired dose administration
Pt given vaccines on 5/1/17. Pt returned on 5/10/17 and Dx with acute supportive otitis media and started amoxicillin.  Pt returned on 5/17/17 with a rash that appeared to be viral-stopped Amoxicillin. Pt returned on 5/18/17 with large bluish, eryth spots Dx with Erythema-multiform and started TAMIFLU due to a POS Flu test. Pt has been rash free since 5/22/17 reported by mom.
Night after vaccine fever chills nausea and body aches Next day mild fever and body aches with fatigue Fatigue only two days after vaccine
Patient presented with chest pain and abnormal troponin. Cardiac catheterization was normal. Peak troponin was 3.73
tested positive today for covid 19; tested positive today for covid 19; This is a spontaneous report from a non-contactable other hcp (Hospital worker) reported for him/herself.  A patient of unspecified age and gender received series of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient completed Pfizer Covid vaccine series in January (as reported) and tested positive today (31Mar2021) for Covid 19, also reported that "This is my second report in two days of positive Covid post vaccination with Pfizer Covid vaccine." The outcome for the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: Based on the information available, the reported event is possibly related to the suspect drug in terms of drug ineffective.
pt recv vax; severe local rxn; cellulitis lt arm at site of injection; associated w/ fever, confusion, lethargy;
Onset a dinnertime, following with decrease use right leg. Continued until bedtime, No ambulating right leg, Sx resolved in AM. Walking fine. Remains asymptomatic with function. Has "rash" right leg injection sites
shingles; Information was received from a lawyer regarding a case in litigation and refers to male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 23-OCT-2012 the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(strength, route, dosage schedule, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation, patient was treated for shingles.The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).     As a direct and proximate result of patient use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Headache, Diarrhea, INJECTION SITE PAIN, BODY ACHES, CHILLS Narrative:
Day 1: Tired Day 2: Vomiting Day 3 - 5 Tired Day 6: Low blood Pressure Atrial Fibrillation