chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he is having severe chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 60-year-old male patient received bnt162b2 (BNT162B2), administration date 29Apr2021 (Batch/Lot number: unknown) at the age of 60 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 2021, outcome "unknown", described as "he is having severe chills". Therapeutic measures were taken as a result of chills.  Additional information: It was stated that consumer called regarding her fiancé and the Pfizer COVID 19 vaccine that he had last night. When ask to report she ask how long it will take and says she just dropped by to check on him. Asks to be transferred directly to ask her question. Stated she just wanted to be sure his side effects are normal. Reports patient was having severe chills, he said it was so bad he felt like calling (withheld). He took some Tylenol and it helped.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
soreness of the arm, radiates to his elbow. the past 5 days patient reported that he developed muscle soreness in cheeks, knees, front leg, thigh, lump inside of the arm
1 day p/vax pt awoke w/angioedema & chest pain; tx w/claritin before being seen in hlth clinic;@ clinic pt treated w/epi, albuterol & pred;pt appeared to be recovering @ the date of this report;
Ecchymoses with raised erythematous eruptions at the Lower extermities and vental elbow  Also with microhematuria and edema of PIP joints bilaterally
PATIENT REPORTED SWOLLEN AND SORE ARMS STARTING ONE DAY AFTER THE VACCINATION. PATIENT WENT TO THE LOCAL EMERGENCY ROOM; AND SHE RECEIVED CEFDINIR 300MG CAPSULES. SHE WAS INFORMED BY MD THAT IT WAS AN INFECTION. PATIENT CAME TO THE PHARMACY ON 11/09/21 TO REPORT THIS ADVERSE REACTION. HER ARM IS NO LONGER SWOLLEN OR RED. PATIENT STATED THAT SHE STILL HAS ITCHINESS; AND SHE PICKED UP HYDROXYZINE HCL. PATIENT STATED THAT SHE DID NOT HAVE THE SAME REACTION FOR THE PREVIOUS DOSES.
A report was received from a health care professional on 25Nov03, concerning a 7 month old male vaccinee who inadvertently received Fluvirin on 20Nov03. On 20Nov03 the vaccinee inadvertently received 0.25ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporters causality assessment. Update 1, 11March04: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received. See Ref: PJP200301183, PJP200400053, PJP200400052, PJP200400051, PJP200400050, PJP200400049, PJP200400048, PJP200400047, PJP200400046, PJP200400045, PJP200400044, PJP200400043, PJP200400042, PJP200400041, PJP200400036, PJP200400039, PJP200400038, PJP200400037.
Pt received the first smallpox vaccine on 2/1/10 and had no reaction.  The second vaccine was administered on 2/12/10.  Pt stated that he noticed under his left arm he started see a rash on the 20th but came to the clinic on the 24th.  Pt has irritations under his arm.  It's sore to touch but no lymphadenopathy.  Pt treated with bacitracin and told to come back if it worsens.  No days missed from work.
Case number PHEH2014US019856 is an initial spontaneous report from the nurse received on 01 Oct 2014 and a follow up report from a health care professional received on 14 Nov 2014. This report refers to a 16-year-old male patient. On 16 Sep 2014, he inadvertently received only Men CYW-135 component of MENVEO (batch number: M14040) intramuscularly without reconstitution with Men A lyophilized component. No adverse event reported following this medication error. Upon follow up, it was confirmed that the patient did not experience any adverse event and was not traveling to any other place in future. Follow up report from a health care professional received on 14 Nov 2014: Updated confirmation from the health care professional that the patient did not receive any adverse event.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. 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 unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced sore arm. The reporter wanted to end the call, so was unable to obtain additional information. This case was one of the 5 cases reported by the same reporter.
Severe pain neck under occipital bone and left Trapezoid 8 hours after shot. 3 days in numbness to left side of mouth and tongue, 5 days in numbness radiating up to left eye. Diagnosis Bells' Palsy and prescribed Prednisone and acyclovir (Valtrex) (Vaccine shot given 01/08/08)
This initial spontaneous case, was received on 23-Oct-2017 by other health professional (nurse) and concerns a 53-year-old-adult female patient. The patient had no known allergy to any component of the vaccine (no egg allergy) and history of any drug allergies was not reported. On 18-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 01144611A, expiry date: not reported). On 18-Oct-2017, 2.5 hours after administration of vaccine, the patient had breathing problems, cough, felt like throat was closing and facial swelling. The patient had idiopathic anaphylaxis. The patient was treated with 2 doses of epinephrine and then 3rd dose was administered in hospital. On the same day, the patient recovered from the events. It was reported that, the patient had no inpatient hospitalization. The reporter assessed the events as serious (medically significant). Non-significant follow up received on 08-Nov-2017: The reporter confirmed the event stop date as 18-Oct-2017. It was reported that, the patient did not have an inpatient hospitalization. The narrative was amended accordingly. Follow-up received from nurse on 27-Nov-2017: Added patient's medical history, symptoms of the event idiopathic anaphylaxis, as breathing problems, cough, felt like throat was closing and facial swelling. Narrative was amended accordingly.
Middle finger of right hand turned white and numb.  I was cold and tried rubbing hands together to get warm.  Finger stayed numb for 20 minutes until I ran under warm water for several minutes.  No further episode until today, 2/3/2014.  At work when getting cold, middle finger of right hand and two middle fingers of left hand turned white and numb.  This had never happened to me prior to receiving the vaccine.  I disregarded it when it happened the first time, although, my first reaction was that it was a reaction from the flu shot.  Now that it's happening again, I am concerned.
We have an egg white allergy. Pediatrician assured us that the flu shot was okay. 20-30 min after (no food given in between) our daughter began reacting. Her face turned bright red, she had hives all over, her ears were red and swollen, and she was itching all over.
This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever 102.5 F), PAIN (top-to-bottom aches), INFLUENZA LIKE ILLNESS (feels just like coming down with the flu) and PAIN IN EXTREMITY (enhanced pain in the arms but not red) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included LORATADINE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), spirolactrone, GABAPENTIN (NEURONTIN), CARVEDILOL (COREG), INSULIN GLARGINE (LANTUS), INSULIN LISPRO (HUMALOG), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever 102.5 F), PAIN (top-to-bottom aches), INFLUENZA LIKE ILLNESS (feels just like coming down with the flu) and PAIN IN EXTREMITY (enhanced pain in the arms but not red). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
side effects (sore backs) one week after shots/ back muscle pain one week later; The initial case was missing the following minimum criteria: [Unspecified product]. Upon receipt of follow-up information on [15-NOV-2023], this case now contains all required information to be considered valid.   This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 88-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Oct2023 as dose 1, single (Lot number: HG4633) at the age of 88 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Manufacturer unknown), for COVID-19 immunisation. The following information was reported: BACK PAIN (non-serious) with onset 22Oct2023, outcome "unknown", described as "side effects (sore backs) one week after shots/ back muscle pain one week later". Therapeutic measures were not taken as a result of back pain.  Additional information: Patient's doctor said that he had patients with similar problems of pain after COVID Pfizer shot. Patient have had multiple Pfizer shots (COVID) with no aftereffects.
Drug dose administration interval too long; arm swollen; redness; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 87-year-old female patient who received Herpes zoster (Shingrix) (batch number M77B4, expiry date 8th February 2021) for prophylaxis.  Previously administered products included Shingrix (1st dose received in summer of 2018.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The age at vaccination was not applicable. The patient's daughter thought that patient received 1st dose of vaccine in June of 2018 and did not receive her second dose yet, which led to incomplete course of vaccination. The daughter provided patient's information for contact instead of her own.   Follow up information received from the consumer on 22nd April 2019: VAERS information was updated.   Follow up information received from the consumer on 24th July 2019: The patient demographic details was updated. On 4th August 2018, the patient received 1st dose of vaccine intramuscularly. On 4th August 2018, less than a day after vaccination the patient experienced swollen and redness around injection site. The patient used ice packs and ibuprofen. The redness and swollen were resolved within a week on 11th August 2018. On 28th March 2019, patient received 2nd dose of vaccine intramuscularly (batch number: E3Z7E; expiry date:27th April 2019), which led to lengthening of vaccination schedule. The VAERS information was updated. The reporter considered the swelling arm and erythema to be related to Shingrix.
Information has been received from a licensed practical nurse concerning a 20 year old female with sulfonamide, (Omnicef), (Bactrim), and (Levaquin) allergies, who on 11-JUL-2007 was vaccinated intramuscularly with a first dose of Gardasil (Lot# 657868/0523U). There was no concomitant medication. Subsequently, the patient had syncope after receiving the vaccination. She lot consciousness for 15 to 20 seconds while standing in the waiting room. A nurse was able to hold her just prior to "black out." The patient's blood pressure was normal. She was kept in the office for 30 minutes for observation and then released. No laboratory diagnostics were performed. The patient recovered on 11-JUL-2007. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a licensed vocational nurse refers to a 66 patients of unknown age and gender. Medical history and concurrent conditions were not provided. On unspecified dates between August 2014 and October 2014, 66 patients were vaccinated with improperly stored dose of GARDASIL (dose, route, lot number and expiry date were not reported). GARDASIL was found to be unsupported excursions with in-house stability data. No adverse symptoms reported. There was no concomitant medication. The outcome of the event was unknown. This is one of several reports received from the same reporter. Follow up information was received on 07-JAN-2015 from the nurse. Nurse reported that GARDASIL was administered during temperature excursion and was out of range from 01-AUG-2014 to 18-SEP-2014. There was no product quality complaint. Additional information has been requested.
Information has been received on 29-Apr-2004 from a registered nurse concerning her 3 year old son who was vaccinated with measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3). It was reported that "about one year ago" the patient had an injection site reaction. Unspecified medical attention was sought. No product quality complaint involved. It was also reported that the patient developed "a hot, swollen injection site lesion the size of a quarter" after being vaccinated with varicella virus vaccine live (Oka/Merck) (WAES # 0404USA02576).  Additional information has been requested.
Gross hematuria. Started 4 hours after injection. Cleared about 12 hours later.
Treatment of COVID-19; Treatment of COVID-19; Dose5 (Moderna Bivalent)/ Dose4, 3, 2 and 1 (Pfizer); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 14Mar2021 at 14:30 as dose 1, single (Lot number: EN6208), in right arm, on 04Apr2021 at 16:00 as dose 2, single (Lot number: ER8733), in right arm, on 22Oct2021 at 10:00 as dose 3 (booster), single (Lot number: 30125BA), in right arm and on 08Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FJ1620) at the age of 68 years, in right arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 07Sep2022 at 13:00 as dose 5 (booster), single (Lot number: AS7144B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing), notes: Hypothyroid; "High BP (controlled)" (unspecified if ongoing), notes: High BP (controlled); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: COLCHICINE, start date: 01Nov2022, stop date: 05Dec2022; ALLOPURINOL, start date: May2016; BUPROPION, start date: Jul1998; LEVOTHYROXINE [LEVOTHYROXINE SODIUM], start date: Aug2010; HCTZ, start date: Jan2011; METOPROLOL, start date: Jan2009; PAROXETINE, start date: Jan1997; SULPHAMETHOXAZOLE, start date: 14Nov2022, stop date: 25Nov2022. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Sep2022 at 13:00, outcome "unknown", described as "Dose5 (Moderna Bivalent)/ Dose4, 3, 2 and 1 (Pfizer)"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Within 10 minutes of vaccination patients chest began to fill heavy. No difficulty breathing just a pressure feeling. She also complained of a throbbing right arm (flu shot side). Her arm had noticeable swelling, but no redness or other symptoms. Her blood pressure was normal, 103/73, heart rate 58. There were no symptoms on the left arm (Moderna). Patient states she had received flu shots in another country before without issue. Patient remained in the pharmacy for observation. By 30 minutes the chest pressure was gone, but still had heavy filling of right arm she said it felt like a tight ball at site of injection. Patient refused injectable diphenhydramine, but did take 50mg oral diphenhydramine. After 45 minutes patient felt ready to leave the pharmacy with no further worsening of symptoms.
I had severe Gum pain , especially around my molars.; I had severe Gum pain , especially around my molars.; This is a spontaneous report from a contactable consumer (patient himself).  This 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown), via an unspecified route of administration, on unknown date (at the age of 43-year-old) at single dose and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number ER8737), via an unspecified route of administration administered in the left arm, on 31Mar2021 10:00 (at the age of 43-year-old) at single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Relevant medical history included chronic obstructive pulmonary disease (COPD) and asthma. Past drug history included allergy to celecoxib (CELEBREX). The patient reported she had severe gum pain, especially around her molars. The pain mostly went away by my 2nd shot, but lingered for a few months. Therapeutic measures taken as result of the event included 600 mg of ibuprofen a few times a day. Pre and Post vaccination COVID-19 tests were not performed. The patient had recovered with sequelae from the event.  The lot number for the vaccine (first dose), BNT162B2, was not provided and will be requested during follow up.
Patient developed ITP.  The diagnosis was made a few months later, but she had been bruising for a few weeks in advance. She is now treated by an oncologist and doing well.
severe chest pains  right after the injection      went to hospital 2 days after said ok  went back to hospital again complaining of chest pains and was having a heart attack
Information has been received from a nurse for the pregnancy registry for GARDASIL vaccine concerning a female who on 12-May-2008 was vaccinated IM with the first dose of GARDASIL (lot no. unknown). On 01-Oct-2008 she was vaccinated IM with the second dose of GARDASIL (lot no. 359182/1757U). The patient found out on 05-Oct-2008 that she was pregnant. the patient has also experienced soreness of her arm after the second dose of the vaccine. Additional information has been requested.
Pt developed itching, rash on her face and swelling, 1 day, post vax. Treated with Benadryl and helped.
ARM PAIN; MIGRAINE; TROUBLE SLEEPING; This spontaneous report received from a patient concerned a 37 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced migraine, trouble sleeping, and pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine, trouble sleeping and pain in arm was not reported. This report was non-serious.
Severe vomiting, fever, tremors, seizures, stopped eating, ended up with a G-tube placement.
Information has been received from a physician concerning an about 20 year old female who "at 5 years of age" in 1995 was vaccinated with a dose of VARIVAX (Merck) (LOT# not reported). "Recent" in 2010, antibody titer test showed that she failed to seroconvert. Unspecified medical attention was sought. No further information is available.
Intense arm and muscle pain; Intense arm and muscle pain; intense headaches for 3 days. Still have headache, on day 4; This is a spontaneous report from a non-contactable consumer (patient). An elderly female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 18Feb2021 at 13:00 hours (Batch/Lot Number: EL9267) as DOSE1, SINGLE for COVID-19 immunisation. The patient's medical history included allergies: sulfa from an unknown date and unknown if ongoing. Concomitant medications included preventative sodium, and hydrochlorothiazide. On 18Feb2021 at 08:00 PM, the patient experienced intense arm and muscle pain, and intense headaches for 3 days. The patient reported that she still has headache, on day 4, rest going away. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any treatment for the adverse event. The events were non serious and did not result in death/Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/Congenital anomaly/birth defect. The patient was recovering from the events.  No follow up attempts are possible. No further information is expected.
The day after the event about 24 hours there was increased pain and limiting range of motion in the arm of the vaccination. At about 30 hours after vaccination, patient had chills and felt unwell. Two days after vaccination patient had a fever of 102.4, chills, limited range of motion of the arm and erythema that was increasing around injection site. Erythema progressed down the arm distally and continued until 4 days after the injection and treatment of infection with clindamycin, vancomycin, and ceftriaxone at hospital.
Symptoms began with loss of grip in hands then loss of muscle strength in arms. Progressed to muscle weakness in legs such that if I could not stand up without assistance from a crouching position. Diagnosed with Guillain-Barre on 1/12/15 then treated with 5 days of IVIG. Symptoms improved then began regressing 2/16/15. Retreated with 5 days of IVIG with minimal improvement. Relapsed further and diagnosis was changed to Chronic Inflammatory Demyelinating Polyneuropathy on 3/12/15. Started on high dose steroids. Symptoms continued to relapse until I could no longer move my arms or walk. Last walked on 3/20/15. Admitted for hypertension urgency on 3/24/16 for 2 days. Had a syncopal episode on 3/29/15 requiring a visit to the ED. By 4/3/15, I had lost 20 pounds due to swallowing difficulty and was no longer moving anything but my head. Admitted for 5 days of plasmapheresis. Discharged on 4/10/15 able to move my arms and walk. Treatment to prevent relapses continue with IVIG every 3 weeks and methotrexate weekly.
c/o dizziness immed p/vax;sat down head lowest, did not feel better, so laid down;later stated had a h/a a/vax;pt was observed for 2hrs w/no other signs & sxs;pulse 80 & regular-later stated was hungry & ate