chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; achiness; Fever; tiredness; Sore throat; This is a follow up spontaneous report from a Pfizer-sponsored program. A contactable 91-Year-old female consumer reported.  A 91-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9264), dose 1 via an unspecified route of administration, administered in Arm Right on 31Jan2021 10:38 as dose 1, single for COVID-19 immunization. Medical history was not reported. Concomitant medication(s) included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. No additional vaccines administered on same date of the Pfizer suspect. No adverse event following prior vaccinations. It was reported that the patient reported some side effects after receiving the first dose of the vaccine. The side effects included Chills, achiness, Fever, tiredness and Sore throat on 01Feb2021. The patient reported that the fever was sporadic and low grade. The patient asked if the patient could take Benadryl or Tylenol before the second shot, because she had reaction to most medication and usually took Benadryl, mostly before antibiotics. The second shot is due on 22Feb2021 at 1:45pm. The events did not result in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date. Therapeutic measures included Tylenol after a week for the reported events. Outcome of the events Chills, achiness, Fever, tiredness and Sore throat was reported as recovered on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information is expected.
felt really bad; felt unwell; This is a spontaneous report from a contactable consumer (patient). An adult male patient of an unspecified age received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (tradename unspecified, solution for injection in pre-filled syringe, lot number and expiry date were not reported),  via an unspecified route of administration on an unspecified date as unknown, single dose for pneumonia shot (immunization). The patient's medical history was not reported. Concomitant medication included influenza vaccine (FLU) on an unknown date for flu shot (immunization) as unknown, single dose. A few years ago, patient got 2 at the same time, he got a flu shot and a pneumonia shot on the same day. He felt really bad for part of a day. He felt unwell that was years ago. he does not have any brand name, manufacturer name or lot number expiration information to provide for these vaccines from years ago. The outcome of the events felt really bad and felt unwell was unknown.   No follow-up attempts are needed; information about batch/lot number cannot be obtained.
Cellulitis, red, warm to touch, at injection site and knot under skin 2 days after admin of Hib and Prevnar. Assessed by NP in MD office and felt reaction may be r/t the child's movement during admin of vaccines.
Weakness, dizziness, muscle & joint  pain, fatigue, neck pain and stiffness
Events occurred about a week after the vaccine. Symptoms include  closing of throat, swelling of tongue, dry mouth, nervous system changes (eyes not focusing, shaky hands).
Loss of taste and smell.  Sore neck, shoulder, arm on side vaccination was given. Generalized body aches. Congestion, extreme fatigue and chills all lasting  for 3-4 days.
Rash all over his body; Headache; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a male patient who received Herpes zoster (Shingrix) (batch number 4F7B4, expiry date 15th November 2021) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUBLOK) for prophylaxis.   On 15th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and FLUBLOK. On 15th October 2019, less than a day after receiving Shingrix, the patient experienced headache. On 20th October 2019, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash and headache were not recovered/not resolved.   It was unknown if the reporter considered the generalized rash and headache to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The patient received Flublock in the left arm approximately 1 inch away from Shingrix injection site.  On the same day after vaccination, the patient had headache and 5 days after vaccination had rash all over the body. The reporter stated that, the rash was not itchy or bothersome. It was unknown if the reporter considered the generalized rash and headache to be related to Flublok
DIZZINESS; This spontaneous report received from a patient concerned a 76 year old male. The patient's weight was 120 pounds, and height was 65 inches. The patient's past medical history included heart attack, and concurrent conditions included pollen/seasonal allergy, alcohol use, and non smoker, and other pre-existing medical conditions included the patient did not have history of drug abuse or illicit drug usage. The patient was previously treated with fexofenadine hydrochloride for pollen, seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and  expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021 around 14:00, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness. This report was non-serious.
limited mobility of left arm; pain; Fever; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (limited mobility of left arm), PAIN IN EXTREMITY (pain), PYREXIA (Fever), CHILLS (chills) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus and Hypertension. Concomitant products included METFORMIN for Diabetes mellitus, LISINOPRIL for Hypertension.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced MOBILITY DECREASED (limited mobility of left arm), PAIN IN EXTREMITY (pain), PYREXIA (Fever), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Unknown. On 15-Apr-2021, PYREXIA (Fever) and CHILLS (chills) had resolved. At the time of the report, MOBILITY DECREASED (limited mobility of left arm), PAIN IN EXTREMITY (pain) and FATIGUE (fatigue) was resolving.            The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable      Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: follow up doc attached on 19 JUL 2021 in which outcome is updated to resolving.
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2022-449479 (Patient Link).
Initial report received from a non-healthcare professional on 6 December 2012. A 12-year-old male patient, had received a dose of FLUZONE (batch number UH745AC, number in series and route of administration were not reported) on the right deltoid, a dose of MENACTRA (batch number U4414AA, number in series and route of administration were not reported) on the right deltoid and a dose of ADACEL (batch number C4251AA, number in series and route of administration were not reported) on the left deltoid, all on 03 December 2012. The patient had no known allergies. The patient had no illness at the time of vaccination. On 04 December 2012, after vaccination, the patient developed red, warm to touch area, size of half dollar at injection site of right arm. On 04 December 2012, the patient took BENADRYL. On 06 December 2012, the patient's symptoms were worse. ON an unspecified date, the patient had developed slightly swollen, red, warm to touch rash on right arm size of 3 cm and the patient also experienced lightheaded ness and right arm felt weak and heavy. Laboratory details were not reported. At the time of this report, the patient had not recovered from the events. Documents Held by Sender: None.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 23-year-old male. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root case for medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic. Additional information was received on 12-May-2009; product investigation results.
Within 3 hours of vaccine given, vomited 3 times, developed headache.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications Oral Contraceptive. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: patient received anti viral COVID 19 Treatment Paxlovid from 05Jul2022 to 06Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202200934096 Same patient, different product and event;
Started w/a fever up to 104F 1 day after vaccine. Red hot area to immunization site of Pneumococcal vaccine on (L) deltoid.
Family calling EMS d/t change in mental status. Pt has been refusing to eat. Temp
Patient described a shooting pain down to her elbow immediately after administration. Patient called the pharmacy the next day to report pain continued intermittently up to 5 times per day since receiving vaccine. RPh advised patient to contact PCP with any concerns. RPh called patient 11/1/23, patient reported issue resolved.
Patient received Covid 19 vaccine. While in observation, patient had complaints of shooting pain down left arm (the arm she was vaccinated on). Patient also complained of upper chest pressure by collar bone. EMS responded to evaluate. EMS recommended transport for further evaluation of any cardiac issues, however patient signed refusal. Patient stated that her and her significant other would transport her to hospital for further observation after they leave clinic.
Immunizations given on 9/3/10. T increased 103 degrees night of 9/3/10. On evening of 9/4/10 staring episode lasting 10 secs.; 2nd episode 9/7/10; 3rd episode 9/8/10.
Patient was sitting with her mother and family member when she slumped down. They noticed when the patient slumped down and was immediately at the patients side. Paramedics were also called to patient side.  Mother states that patient with history of Seizures (3-4 times a week).  Mother describes that patient puts her head down and bends forward in a sitting position with her Seizure activity.  Patient was immediately placed on stretcher and frequent vitals taken. Patient vitals stable throughout visit. Patient Seizure like activity lasted for 5-6 mins then became post itcal and crying.  At that time it was determined that patient be transported to the nearest ER for further evaluation. Patients pediatrician called and notified of patient condition and plan for transport.  office agrees for patient to be transported to the nearest ER. Fire rescue on site at 1220 pm and patient transported to ER by 12:23pm.  Mother followed with her paramour in separate vehicle.
Patient scheduled an appointment for a shingles vaccine. He came in for a shingles vaccine. The MA administered the shingles vaccine and then noticed when documenting that the patient had already had the 2 dose series. He really needed a Hepatitis B vaccine. Doctor, Patient and Manager notified. No apparent issues when 3rd dose was received.
approx 17hr p/vax pt devel hives on abd, neck & lower arms;advised to contact child MD for treatment for hives;
rash on her arms shoulders, chest, and upper back; arm swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on her arms shoulders, chest, and upper back) and VACCINATION SITE SWELLING (arm swelling at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE SWELLING (arm swelling at the injection site). On an unknown date, the patient experienced RASH (rash on her arms shoulders, chest, and upper back). The patient was treated with TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE [TRIAMCINOLONE ACETONIDE]) for Rash, at an unspecified dose and frequency. On 18-Feb-2021, VACCINATION SITE SWELLING (arm swelling at the injection site) had resolved. At the time of the report, RASH (rash on her arms shoulders, chest, and upper back) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow up received contains no new information.
Immediately after vaccine, I had pain in my arm the first few hours. That night I had a little fever and  the next day I was fine.  8/11/2021 - In afternoon, I  noticed a very dark floater coming over my eye. I went to the hospital. No pain. They referred me to. Eye Center Eye emergency place to see opthamologist - I went immediately. They did pressure test and dilatated the pupil. They did every test they could find. Dr said it was normal for people my age.
hosp p/episode w/unk cause; aspiration (pneumonitis?), severe bronchospasm; EMS to ER nonresp @ scene ? aspirated @ scene; hx esophagus trouble, stridor; pupils pinpoint; P173, crying, P211;dx aspiration pneumonitis, severe bronchospasm
Rash on legs; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200), via an unspecified route of administration in the left arm on 31Mar2021 at 10:45 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 18:45 the patient experienced rash on legs. The patient did not receive any treatment for the event. The clinical outcome of the event rash on both legs was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Information has been received from a health professional concerning a patient who on an unspecified date was vaccinated with a 0.65 mL dose Zostavax. It was reported that 42 days after vaccination, the patient developed a rash. The physician "suspected that the rash might have been an outbreak of zoster." Unspecified medical attention was sought and the patient recovered. A product quality complaint was not involved. Additional information has been requested.
A few weeks after the shot my left thigh started hurting. A few months after that the pain travelled down my leg. Over a weekend my left calf increased in size to the point in which I couldn't pull up my pant leg. For a couple weeks leading up to this, I also started having a shortness of breath. My doctor told me to get to the ER. They found two DVTs in my left calf and both of my lungs were covered in blood clots. No doctor could explain what happened because I'm a very active, and not sick, person.
pt says he had an episode of SVT about 24 hours after taking the vax that lasted about an hour.  His heart rate was going from 110 to 230 during this hour.  EMT took him by ambulance to ER.  Blood pressure 145/95 upon arrival to ER.   He was given IV treatment and Tylenol.  He had Chest X-ray, blood labs and EKG.  Test were normal.  His DX was SVT.  He was monitored and released to FU w/ Cardiologist.   Later in the day he took Benadryl and Ibuprofen for the the fever and chill symptoms
I have been diagnosed with AFIB.  This was well under control while taking Metoprolol for the past several years.  Since taking the vaccine I have been experiencing several episodes of AFIB every day.   I  have a Kardia diagnostic  tool which confirms the AFIB episodes.
Since the administration of the vaccine, persistent headaches, non-erosive polyarthralgias, recurrent oral and genital ulcers, anterior uveitis of repetition have appeared, everything points to having developed behcet's disease after vaccination, currently under follow-up by rheumatology.
Information has been received from a Registered Nurse (R.N.) and the consumer for the Pregnancy Registry for Gardasil concerning a 28 year old female patient with bacterial infection, sulfonamide allergy and a history of miscarriage few days before Memorial day, and HPV positive who on 08-OCT-2007 was vaccinated IM into left arm whether first dose of Gardasil lot #0530U. Concomitant therapy included "vaginal cream" [therapy unspecified] and YASMIN. The nurse from the physician's office reported that on 09-OCT-2007 the patient notified that her urine pregnancy test was positive on 08-OCT-2007. The patient mentioned that she took a second urine pregnancy test at home on 12-OCT-2007 which was positive. The last menstrual period date was 01-SEP-2007. The patient indicated that she has a follow up visit scheduled with the physician. She confirmed that she was pregnant before but "miscarried at home few days before memorial day." No adverse symptoms and no other information available. The outcome was unknown. Follow up information was received from the registered nurse on 31-MAR-2008. On an unspecified date the patient had an elected termination of the pregnancy. No other information is expected. Upon internal review elective termination of pregnancy was considered to be an other important medical event.
Irregular and heavy periods lasting longer than normal up to 8 days (at this point) - After the first shot my period was 2 weeks early; Irregular and heavy periods lasting longer than normal up to 8 days (at this point) - After the first shot my period was 2 weeks early; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 13:00 (Lot number: EW0170) as dose 1, single for covid-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing). There were no concomitant medications. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), MENSTRUATION IRREGULAR (non-serious) all with onset Apr2021, outcome "not recovered" and all described as "Irregular and heavy periods lasting longer than normal up to 8 days (at this point) - After the first shot my period was 2 weeks early". The event "irregular and heavy periods lasting longer than normal up to 8 days (at this point) - after the first shot my period was 2 weeks early" and "irregular and heavy periods lasting longer than normal up to 8 days (at this point) - after the first shot my period was 2 weeks early" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of heavy menstrual bleeding, menstruation irregular.  Additional information: Patient's current age was reported as 40 (unit: unknown). Facility type vaccine was reported as Pharmacy or Drug Store. Patient did not receive other vaccine in four weeks. Patient did not receive other medications in two weeks. Now the patient was getting her period every two weeks since the second vaccine shot. Before that she was always regular. Patient had no covid prior vaccination. Patient was not tested Covid post vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.