chrisvoncsefalvay/vaers-outcomes huggingface dataset:
GARDASIL 9 was out of the refrigerator; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided.  On 11-MAY-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R030453, expiration, date 23-JUL-2020 for prophylaxis (exact dose, vaccine schedule, anatomical location and route of administration were not provided) that might have been improperly stored.  On 13-MAY-2020, the reporter stated that the reporter's facility was made aware that the box of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was out of the refrigerator. It was unknown what date it was taken out of the refrigerator. At the time of this report, product was still out of temperature range. It was unknown whether there were previous temperature excursions or if digital data logger was involved.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R030453; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA008545:
injection site pain; chills; muscle aches; fatigue; Rash on torso, arms; This is a spontaneous report from a non-contactable other hcp (patient).  A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Jan2021 14:30 at single dose in Left arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. Medical history was none. Concomitant drug received within 2 weeks of vaccination included Multivitamin. The patient previously received first dose of BNT162B2 on 29Dec2020 03:15 PM at single dose in Left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After 6 hrs on 19Jan2021 21:00 PM, the patient experienced injection site pain. After 12 hrs the patient experienced chills, muscle aches, fatigue in Jan2021. The patient experienced Rash on torso, arms 36 hours after in Jan2021. The outcome was Recovering. No treatment received for events. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible, information about batch number cannot be obtained.
After initial side effects resolved 3 days following vaccination, a large raised red rash appeared on upper left arm (same arm as vaccination) 8 days after vaccination. and was warm to the touch.  Fatigue, low fever and diarrhea were also experienced.   The foregoing lasted 4 days.  Today is day 14 after first vaccination dose, and rash, diarrhea and fever have resolved, but still experiencing fatigue.
Started with itchiness in hands and arms; the next day the itchiness spread to back and legs, and I discovered  a hard, raised area at the injection site.  Furthermore, the injection site was surrounded by a red patch, approximately 3.5" X 2" in size, and the entire area was itchy,.  These symptoms are on-going as I report this.
Hives, Redness, itchy, leg tremors, nervous 25 mg Benadryl PO administered
Fever, headache, dizziness. Taking 400mg. Motrin every four hours and drinking lots of fluids. Fever has broken twice, but escalates without the meds.
Low grade fever (~100F), pain at injection site, systemic joint pain, headache, weakness, and left sided chest discomfort, inflamed upper airway (especially left side), nasal discharges, ear aches bilaterally, chills & fever:  3 days duration. Left sided chest discomfort become more regular on 3rd week post-vaccination, and episodes of left sided chest discomfort and pressure, with minor aches - running from front of left chest to the back of chest:  has now become more noticeably chronic.
presumed autoimmune optic neuropathy - 3 patients/presumed autoimmune optic neuropathy after pfizer-biontech (bnt162b2) covid-19 vaccine; This is a literature report for the following literature source(s):   A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OPTIC NEUROPATHY (medically significant), outcome "unknown", described as "presumed autoimmune optic neuropathy - 3 patients/presumed autoimmune optic neuropathy after pfizer-biontech (bnt162b2) covid-19 vaccine".; Sender's Comments: This report fails to include the basic information that is required for an independent medical evaluation. Assessment is postponed after receipt of a more complete case report.,Linked Report(s) : US-PFIZER INC-PV202200076321 Same article /drug /event and different patient;US-PFIZER INC-202201206056 Same article /drug /event and different patient;US-PFIZER INC-PV202200076321 same article /drug /event and different patient;
Tinnitus and panic attacks.  Treating the symptoms (panic/anxiety, meclizine for ear ringing)
My son was awakened by severe ear pain and agitation, telling me his ear hurt.  I administered children's Dimetapp and children's Tylenol, then warm compresses to the right ear.  By the following day, his ear was discharging clear, yellow liquid and blood.  His physician prescribed antibiotic ear drops for 7 days/ 3 times per day. I think it was Ofloxacin.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 12:03 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 12:03 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 53.78.  Concomitant products were not provided.  On 11-Jan-2021, At excursion time 09:00 AM, temperature was 34, total doses given for the day was 98 and at 02:00 PM, temperature was 35, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 11-Jan-2021. 9 vials were sent to clinic. Vaccine BUD date was 07-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Had not received the adeno yet. 18 Y/O FEMALE WITH ALLERGIC REACTION after 20 mins. of receiving immunizations. She developed hives and throat itching. She had no difficultly breathing. Given 50 mg IM of BENADRYL was returned her living area for the remainder of the day. To follow up with an allergists.
Pt reported swelling, redness, and itching at injection site week after injection. Pt stated sxs was resolving without tx.
Breast milk supply decreased significantly less than 24 hours of first injection.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Aug2021 (Lot number: FA7484) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: COLACE. The following information was reported: SUPPRESSED LACTATION (non-serious) with onset 04Aug2021, outcome "recovering", described as "Breast milk supply decreased significantly less than 24 hours of first injection.". Therapeutic measures were not taken as a result of suppressed lactation.  Additional information: If covid prior vaccination was No If covid tested post vaccination was No   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101103243 Foetus case
excruciating back pain; hip pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (excruciating back pain) and ARTHRALGIA (hip pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    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 BACK PAIN (excruciating back pain) and ARTHRALGIA (hip pain). At the time of the report, BACK PAIN (excruciating back pain) and ARTHRALGIA (hip pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-094702 (Patient Link).
Narrative: COVID infection following COVID vaccine series 01/02, Moderna, dose #1 02/27, Moderna, dose #2 08/16 COVID swab, result: detected 08/17 pt cc: exposure: unknown 08/17 SARS-COV-2 Variant Sequencing result: pending
First symptoms started when my left side of my body went numb, I was stumbling, and could not speak.Went to the minor emergency and was told I was having a migraine. Symptoms lasted 30-40 minutes. First siezure was a week later, sister found me passed out on the floor. I was unconscious a day and half. I was in the hostipal for 4 days and I was given Phenytoin ER 300MG daily.  Second siezure was 2 days after I got released from the hosiptal. I was admitted for 3 days. My medication dosage was changed to Phenytoin 25MG/ML Oral suspension 200MG every 12 hours. I had no memory of what had happened to me after the siezures occurred.  Doctor diagnosis altered mental state, syncope, stroke-like episode, siezure disorder
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 13-AUG-2012 , the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequently on an unknown date, the patient was treated for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has sustained and would continue to sustain severe physical injuries, emotional distress, mental anguish, economic, losses and other damages. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Did not have a adverse reaction. I just got Covid on December 10,2022 and CDC visage told me to fill this form out.  Headache, fever,chills, sore throat , cough, nasal congestion, body aches for 4 days.
pt recv vax & began crying in clinic & cont to cry >3hr & was seen @ clinic;exam WNL x/for crying & referred to MD;t103.0 R;
Had fever of a hundred cold chills body ache bad headache bad sinus infection diarrhea. Started Saturday the 29th.
blistery rash that appeared on her left arm on 11 August after receiving the Typhoid and Meningitis vaccines on 05 August, diagnosed as shingles and treated with Valtrex
Light headache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Light headache) and FATIGUE (Tiredness) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033821A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2021. Concurrent medical conditions included Gout and Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, ALOPURINOL for Gout.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced HEADACHE (Light headache) and FATIGUE (Tiredness). On 16-May-2021, HEADACHE (Light headache) had resolved. On 29-May-2021, FATIGUE (Tiredness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information was reported.
I had no adverse effects.  I did notice in the months after the shots that my tinnitus had increased ten-fold.  I didn't associate this with the shot until I heard it mentioned on TV show.
flu like symptoms; Injection site reaction; fever of 99; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE REACTION (Injection site reaction) and PYREXIA (fever of 99) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included CLONAZEPAM (KLONOPIN) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE REACTION (Injection site reaction) and PYREXIA (fever of 99). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 28-Mar-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE REACTION (Injection site reaction) and PYREXIA (fever of 99) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
W/in 15 min of receiving vaccine I was sick, sore throat, URI symptoms, tummy, all flu symptoms. I missed 1 full day of work. Was sick for 6 days.
Pain in both legs and feet , pain in arms and hands and hips and neck.  Higher Creatinine level. sometimes feet swollen.  X-rays on legs and feet ruled out arthritis by foot specialist and orthopedic dr. Referred to Neurologist and Kidney dr. Test to be taken in October.
Fever - Lasted 8 hours Headache - Lasted 12 hours Body Aches - Lasted 20 hours
On 6/1 pt returned to pharmacy complaining of stiff, inflexible left third (ring) finger and knuckle.  Pt stated that the finger and joint have been hurting, hot and slightly swollen and immovable since the day after the vaccine on 5/27.  An inspection of the finger and joint found that there was slight swelling and pain with slight heat.  Pt stated intolerance to NSAIDs and said she had used ice and Tylenol to little effect.  Pt was advised to go the hospital, as she didn't have insurance, as soon as possible.  Pt stated that she would when she could and decided on using triple antibiotic for at home remedy, despite RPh suggesting there would be little relief from it.
arm numbness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (arm numbness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HYPOAESTHESIA (arm numbness). At the time of the report, HYPOAESTHESIA (arm numbness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
body aches and pains; slight fever; greatly enlarged lymph node under right arm, size of an orange; 6 days later; large red swollen area on right arm; very warm to the touch and serious shoulder pain, can hardly lift arm; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6208) via unspecified route of administration in the right arm on 14Mar2021 at 13:30 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic lymphocytic leukaemia (CLL) and fatty liver. The patient had a history of allergy to Percocet. The patient had previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EL9266) via unspecified route of administration in the right arm on 21Feb2021 at 15:00 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient received medications (unspecified) within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 14Mar2021 at 16:00, the patient experienced severe body aches and pains, slight fever, greatly enlarged lymph node under right arm, which was in a size of an orange. 06 days later he had large red swollen area in the right arm, also had very warm to the touch and serious shoulder pain where he could hardly lift arm. No therapeutic measures were taken for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe body aches and pains, slight fever, greatly enlarged lymph node under right arm, large red swollen area on right arm, and very warm to the touch and serious shoulder pain, can hardly lift arm were not resolved at the time of this report.   No follow-up attempts possible. No further information expected.
Severe feet swelling the night of the first and second vaccine. Resolved two days after.  After the second shot, starting a few days later, I have had urgent watery diarrhea five times a week.
Low grade fever, body aches, fatigue, sore arm. Treated with rest and tylenol pm. Feeling better.
Initial report was received on 09 August 2011 from another manufacturer national service center (service request number 1-4381506938), who received the report from a health care professional. A female patient (age and date of birth not reported) with a history of HLH syndrome and liver cancer had received on 08 October 2009 a dose of H1N1 vaccine (manufacturer, lot number, route and site of administration not reported) and eight days later on 16 October 2009, the patient experienced respiratory failure. The patient was hospitalized in the pediatric ICU (dates not reported). According to the reporter, the patient developed HLH syndrome and liver cancer (also reported as history) from the vaccine. Treatments were not reported. According to the report, the liver cancer was in remission and the patient had not died. No further information was available at the time of the report. The patient's outcome was reported as recovering. Documents held by sender: none.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 30th July 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, influenza-like symptoms and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling, influenza-like symptoms and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, influenza-like symptoms and injection site erythema to be related to SHINGRIX. Additional information was reported as follows: The reporting nurse was the patient. The age at vaccination was not reported, it could be 50 or 51 years old.  The patient experienced pain, redness and swelling at the injection site (left arm). The patient also experienced flu-like symptoms which were not specified. It was not known how soon symptoms developed after the injection of SHINGRIX.
Period delayed. My period is regular (average cycle length is 28-30 days). However, my period was delayed 10 days after I had 1st dose of Pfizer (16Jun2021).; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 44-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0180) via an unspecified route of administration, administered in Arm Left on 16Jun2021 16:00 (at the age of 44-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. Patient received vaccine facility vaccine in pharmacy or drug store. Patient stated, Period delayed. My period is regular (average cycle length is 28-30 days). However, my period was delayed 10 days after I had 1st dose of Pfizer (16Jun2021) on unknown date. After 2nd dose of Pfizer (09Jul2021), my period was delayed 14 days. I had a little dark brown spotting right after the 2nd dose for 4 days. No treatment was received for the event. The outcome of the event was reported as unknown.  Information about lot/batch number has been requested.  Follow-up (25Aug2021): Follow-up attempts are completed. No further information is expected.