chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of erythema in a 5-year-old male patient who received FLUARIX QUADRIVALENT (batch number 29PD2, expiry date unknown). Concomitant products included MMR. On 2nd November 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, 1 day after receiving FLUARIX QUADRIVALENT, the patient experienced erythema, pruritus and swelling. The patient was treated with BENADRYL and Steroids. On an unknown date, the outcome of the erythema, pruritus and swelling were recovered/resolved. The reporter considered the erythema and swelling to be related to FLUARIX QUADRIVALENT. The reporter considered the pruritus to be unlikely related to FLUARIX QUADRIVALENT. Additional information received as follows: The patient's mother reported that the patient received FLUARIX vaccine on left arm. The patient's mother stated that due to the red streaking, and the swelling of his upper bicep that spread to collar bone area and up to neck, she was encouraged to take him to the emergency department. He was given steroids there and within 24 to 36 hours later the issues were resolved. The patient's mother believed he had received an MMR and possibly another vaccine within 4 weeks of the flu shot. She stated that in 2017, he received FLUZONE and was having the same issues but not as severe. She noted that, the dermatologist had done skin testing but he still had a reaction. She also noted that the FLUZONE vaccine was given as split doses, one in each bicep area. She was treating him with BENADRYL. This case has been linked to the case US2017189700, reported by same reporter.
initial symptoms of Bell's Palsy noted---eye twitching, start of mouth paralysis. 12/28/2009 OB records state on 10/21/2009 patient with c/o's lt sided facial numbness and decreased eyelid movement. Dx'd with Lt Bells Palsy.
Event: REFRACTORY Pre-Eclampsia (Refractory Hellp Syndrome) Pregnancy History: Second pregnancy, first was a very early miscarriage on 9/11/2020 Due Date: 6/18/2021 Delivery Date: 4/22/2021 (emergency c section) Birth Weight: 3 lb 3.5  ounces
fever; headache; nausea; Feeling hot; This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2019, the patient received Shingrix (intramuscular). On 6th August 2019, 1 days after receiving Shingrix, the patient experienced fever, headache, nausea and feeling hot. On an unknown date, the outcome of the fever, headache and nausea were recovered/resolved and the outcome of the feeling hot was recovering/resolving.   It was unknown if the reporter considered the fever, headache, nausea and feeling hot to be related to Shingrix.  Additional details were provided as follows: The patient feeling hot like and he had fever, headache and a tiny amount of nausea.  On 7th August 2019, the patient was feeling better.  The reporter consented to follow up.
Patient was given immunization on Monday 8/24/20 and started to develop redness, edema, warm to touch on Wednesday evening. Patient says that injection site is painful as well. Patient was seen in the office on  8/28/20 at 10:15am. Patient is being treated with Bactrim.
had trouble moving about/ had a hard time getting out of a chair; he got chills and could not stop shaking; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (had trouble moving about/ had a hard time getting out of a chair) and CHILLS (he got chills and could not stop shaking) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 010A21A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced HYPOKINESIA (had trouble moving about/ had a hard time getting out of a chair) and CHILLS (he got chills and could not stop shaking). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 13-Nov-2021, HYPOKINESIA (had trouble moving about/ had a hard time getting out of a chair) and CHILLS (he got chills and could not stop shaking) had resolved.            Patient does not take any medications on a daily basis.
He has had tinnitus for years, had the second dose of vaccine and 10 days later has the worst tinnitus in his right ear. The tinnitus in his left ear is normal.(for him). He says there's lots of pressure. He spent the day outside doing yard work and has hay fever symptoms (runny nose, sinus pressure. He says he feels pressure in the right ear as well as ramped up tinnitus.
Patient was to receive her second dose of Pfizer Monovalent for ages 6m-4yrs. She inadvertently received a Pfizer Bivalent for ages 6m-4yrs instead. This was not identified until 1 week after the incident occurred. Patient's mother was contacted and told about the error. She was advised that per the CDC, that if a Pfizer bivalent is given early, it is still acceptable to count this for the primary series. Patient's mother is aware that this dose will not need to be repeated.    Correction made and new CDC card created for patient.
The day after 2nd Injection, high fever, fainting and blood in urine.  After many tests including a kidney biopsy, it was determined he has IGA Nephropathy.  Nephrologist has indicated that IGA was brought on by the COVID-19 vaccine.  Since this time, he has also been diagnosed with Supra Ventricular Tachycardia, also thought to be related to the vaccine.
pt recvd vax;devel redness,heat & swelling at inject site;had n,fever 103.7;gen body aches;dx of cellulitis made & tx w/ amoxicillin;pt has improved as of this date;
Patient reported waking up at 2am (~8 hours after vaccine) feeling a tingling sensation in her left toes, as if they had fallen asleep. This feeling spread to the right toes and has persisted throughout the day. Only other side effect noted was soreness at the injection site.
Received a call from patient on 11/12/21 regarding her reaction. Patient reported of experiencing rash/redness/itchy, chill, headache, painful to touch at the injection site. Called and confirmed regarding her adverse reaction with her primary care provider. Patient got an prescription of Keflex from her primary care provider office on 11/10/2021. Her provider instructed her to use Benadryl and ice the injection site area. Recommended her PCP to follow up with her regarding if Keflex is the correct on for her. Patient said she's doing better now and currently on prescribed antibiotic.
BODY ACHES; STOMACH ISSUES; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced body aches, stomach issues, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, fever and stomach issues was not reported. This report was non-serious.
Information has been received from a nurse practitioner concerning a 21 year old female who on 18-JUL-2007 was vaccinated with Gardasil. At around 2300 on the night of the vaccination, the patient developed a fever. Two days later, the patient recovered from fever. Additional information has been requested.
had a restless night; had pain at the site of injection; headache; low grade fever; does not feel well; arm pain, when she lifts her arm up; This is a spontaneous report from a contactable consumer or other non-hcp (Patient's mother). A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 15-year) on 03Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 administered on an unspecified date for COVID-19 immunization; after the first shot the patient experienced, knot under arm, could not lift arm up a week after the vaccine. On an unspecified date in 2021 the patient experienced headache, had a restless night, had pain at the site of injection, low grade fever, does not feel well, arm pain, when she lifts her arm up. Caller stated her daughter got her second shot yesterday. The clinical outcome of the events was unknown.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
COVID Moderna vaccine given to unapproved FDA age group.    This is a vaccination error.  A COVID19 Moderna vaccine was given to a 16 y/o.  Patient was not on the schedule.  It was at the end of the shift and extra dose was left due to no show.  Vaccine coordinator contacted the patient from the waitlist.  Patient received a total of 2 doses.  The patient received the first dose of Moderna on 1/19/21, and second dose on 2/6/21.   No adverse reaction was reported.   1st Dose lot #: 029L20A  given on LD 2nd Dose lot #: 011J20A given on LD
day after arm was red below deltoid in between bicept and tricep; itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (day after arm was red below deltoid in between bicept and tricep) and VACCINATION SITE PRURITUS (itching) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (day after arm was red below deltoid in between bicept and tricep) and VACCINATION SITE PRURITUS (itching). At the time of the report, VACCINATION SITE ERYTHEMA (day after arm was red below deltoid in between bicept and tricep) and VACCINATION SITE PRURITUS (itching) had not resolved.            Treatment included coconut oil application to injection site for itching. No concomitant medications reported.   Action taken with mRNA 1273 in response to event was not applicable.
Very sore, swollen and red arm at and around injection site for one week; 102.3 fever on day 1 following vaccination that was preceded with chills and migraine, and followed by sweats, full body aches and fatigue; day 2 fever of 102.6 with same pre- and  post-symptoms; much sleepiness and fatigue for a week following vaccine, along with near daily migraines for nearly two weeks. Had to take off two days from work. Took Excedrin, drank Emergen C powder with water twice daily for four days.
This spontaneous report as received from a Doctor of pharmacy refers to a patient of unknown age. On an unknown date, "a long time ago", the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). The pharmacist reported that on an unknown date, the patient experienced shingles following vaccination. The outcome of shingles was unknown. Additional information is not expected.
Shortly after receiving the post laceration TdaP booster, the patient notice itching at the site of injection. I noted  wheals localized to the deltoid area of the left UE. We applied ice and ordered antihistamines.  The following day, he returned for a recheck. This morning (05/19/2023) he had fading wheals, but new  swelling without redness, warmth, tenderness and painful UE ROM above expected post vaccine.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: emergency services was dispatched, but not taken to hospital
The nurse reported the patient received improperly stored vaccines; No additional AEs; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with an improperly stored of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (lot # U026664 and 1741817 has been verified to be a valid lot number rotavirus vaccine, live, oral, pentavalent, expiration date reported and establish as 24-FEB-2023, and 30-JUL-2022 respectively) (strength, dose, route of administration and anatomical location were not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (lot # U026217 has been verified to be a valid lot number haemophilus b conjugate vaccine (meningococcal protein conjugate), expiration date reported and establish as 02-NOV-2023).  The temperature of storage and time frame of the excursion were 34.3° Fahrenheit (C) for 55 minutes respectively.  If a digital data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA001821: US-009507513-2204USA001816: US-009507513-2204USA001791:
Difficulty moving my left hand, putting clothes on, reaching back. Chronic pain especially at night time while sleeping.
First I was lightheaded. Then very dizzy. Next I thought I was going to faint. Became very nauseous. Needed assistance to walk because of the dizziness. Laid down and took 2 Advil. Then slept for 3 hours. Woke up and symptoms were gone.
7/15/21: Patient arrived to ER due to shortness of breath and dry cough with generalized fatigue. Patient did test positive for COVID-19 on 7/15/21. Diagnosed with viral pneumonia with bilateral infiltrates, severe sepsis, acute hypoxic respiratory failure secondary to COVID-19, acute on chronic CHF. Completed a course of remdesivir, ceftriaxone and azithromycin.  7/25/21: patient discharged from hospital. Note: patient completed 2 COVID-19 vaccines series in May 2021. Patient received first dose of Pfizer COVID vaccine on 4/25/2021, followed by the second dose 21 days later, on 5/16/2021.
Information has been received from a nurse practitioner concerning a 5 yr old male who was vaccinated SC with a 0.5mL dose of varicella virus vaccine live. The nurse reported that the pt was previously vaccinated at another office and broke out with varicella lesions from head to toe. Unspecified medical attention was sought and no treatment was given. Subsequently, the pt recovered. A product quality complaint was not involved. Additional information has been requested.
Had chills; Elbowswelled up like a baseball, noticed more swelling; Elbowwarm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Elbowswelled up like a baseball, noticed more swelling), FEELING HOT (Elbowwarm to the touch) and CHILLS (Had chills) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced JOINT SWELLING (Elbowswelled up like a baseball, noticed more swelling) and FEELING HOT (Elbowwarm to the touch). On 26-Feb-2021, the patient experienced CHILLS (Had chills). At the time of the report, JOINT SWELLING (Elbowswelled up like a baseball, noticed more swelling) had resolved and FEELING HOT (Elbowwarm to the touch) and CHILLS (Had chills) had not resolved.            The patient visited their primary doctor for this a few weeks ago and was advised to wait it out at that time.  The patient reported it has been almost 6 weeks since they received their vaccination.  No Concomitant product use was reported. Patient has stated that that his elbow swelled up the next morning after getting the shot, and it occurred in his non-dominant arm (the left arm where he received the vaccination). The doctor said it was bursitis and drained it and it did not reoccur.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received on 07-JUL-2021 and Updated anatomical location of vaccination in product tab. updated Event outcome as Recovered and updated medically confirm of the event.Updated consent declined for further follow up.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Menstrual cycle was absent from Jan 2021 until July 2021.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the left arm on 30Jan2021 (at the age of 34-year-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 27Feb2021 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine and did not receive concomitant medication within two weeks of vaccination. The patient's menstrual cycle was absent from Jan2021 until July2021, since the patient received the vaccine and also missed a last month, always had a regular period. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event and included treatment with hormonal therapy progesterone (MANUFACTURER UNKNOWN). The clinical outcome of the event menstrual cycle was absent from Jan 2021 until July 2021, was resolved with sequelae on an unknown date in 2021.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FK9895), in left arm, on 05Oct2021 as dose 3 (booster), single (Lot number: 301358A), in left arm, as dose 2, single (Lot number: EN6205), in left arm and as dose 1, single (Lot number: EL9264), in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 12Oct2022 as dose 5 (booster), single (Lot number: 055F22B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing), notes: mild asthma; "meningioma" (unspecified if ongoing), notes: small meningioma; "anxiety" (unspecified if ongoing), notes: mild anxiety; "acid reflux" (unspecified if ongoing), notes: acid reflux; "chronic cough" (unspecified if ongoing), notes: Long term chronic cough. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Patient presented 2/14/2022 for evaluation of painful red spots to his toes. On physical examination he demonstrated non-blanching petechial lesions to Rt great, second, third and fifth toes and Lt third and fifth toes. Screening Labwork was negative other than a positive Rheumatoid Factor. He was reevaluated on 3/01/2022 and there were no new lesions or symptoms, and petechiae persisted but improving over time. No other significant symptoms.
Itchy red rash developing on back. Neighbor took pt to Urgent Care. Steroid injection and advised against 2nd vaccine 3/2/21.
pt recv vax 14FEB98 & pt devel T105 Saturday noc was seen in clinic 16FEB97 w/inc temp;
SEVERE, INTRACTABLE MIGRAINE 19 + HOURS.  I HAVE A HISTORY OF MIGRAINES SINCE THE AGE OF 12.  I HAVE NEVER HAD A MIGRAINE WITH ANY OTHER VACCINE AND IT HAS NEVER BEEN TO THIS SEVERITY OR LAST THIS AMOUNT OF TIME WITH NO BREAK OR RELIEF.  I ATTEMPTED TO ALEVIATE THE PAIN WITH MAXALT, TYLENOL, AND ICE PACKS WITH NO RELIEF.  THE HOSPITAL GAVE ME 2 LITERS OF FLUID, BENADRYL, REGLAN, AND TORADOL WHICH  LESSENED THE PAIN.  AT THIS TIME I STILL HAVE A MINOR MIGRAINE.
during the afternoon of the day vax was administered 19FEB93, pt started to have t38C; during the following day pt had inc pain & inflammation in the area; on the 3rd day pt was eval by MD & referred to hosp;
Lost voice/wraspy voice; Lost voice/wraspy voice; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 21Apr2021 at 11:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included SLE (lupus), high blood pressure, anxiety and known allergies to latex, pineapple, banana and berries. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included azathioprine (IMURAN), hydroxychloroquine phosphate (PLAQUENIL), valsartan (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT) and trazodone (MANUFACTURER UNKNOWN); all for unspecified indication, from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 13:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient previously received codeine (MANUFACTURER UNKNOWN) on  an unknown date for an unknown indication and experienced drug allergy. On 21Apr2021 at 15:00, after second dose (in afternoon), the patient experienced lost voice/wraspy voice. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events lost voice/wraspy voice were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
According to the documentation system, the patient received Moderna on 01/12/2021. The patient was administered Pfizer on 07/07/2021. The patient denies ever receiving the initial dose of Moderna.