chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 73-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.    On 28-Feb-2021 at 3:15 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 3:15 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (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 73.25.   Concomitant products were not provided.  On 28-FEB-2021 Excursion time was reported at 09:00 A.M and 1:00 PM with  temperature as 27 and 26 degrees Fahrenheit, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-FEB-2021 , vial was moved to clinic on 27-FEB-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-MAR-2021.  Vial was stored on cooler 1, on 28-FEB-2021 , Excursion duration At 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM : 37, 3 PM: 43, 4 PM: 45.  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 traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  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.
Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 09-FEB-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
No additional adverse effects reports; one male patient was administered improperly stored ROTATEQ; Information has been received from a vaccine coordinator, referring to a 6 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 26-FEB-2020, the patient was administered rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were unknown; lot # 1658255, expiration date 07-FEB-2021) orally for prophylaxis. The vaccine was exposed to temperature excursion below 2 degrees Celsius (0.8 degrees Celsius for 5 hours and 9 minutes on 02-MAR-2020, 0.9 degrees Celsius for 11 hours on 04-MAR-2020 and minus 1.3 degrees Celsius for 9 hours and 29 minutes on 05-MAR-2020) (incorrect product storage).   There was previous temperature excursion at above 9 degrees Celsius (9.3 degrees Celsius) for 3 hours 33 minutes on 25-FEB-2020 and at below 2 degrees Celsius (0.8 degrees Celsius) for 11 hours 39 minutes on 03-MAR-2020. The call was due to digital data logger. No additional adverse effects were reported.
Patient reports after receiving her vaccines, her right arm where her PPSV23 was administered became very stiff and had a raised, round area the size of a baseball at the injection site. She reports her skin felt itchy because her skin was so tight. She reports later that evening a raised line spread from her injection site on her right arm, down to her forearm, across her neck, and across her chest. She reports the raised area was not red. She reports the next day she ran a fever but is unable to recall the temperature. She reports she felt unwell and slept for several hours. She reports the following day her shoulder was also hot to the touch. Patient reports she applied Thieves essential oil to the area for several days, which relieved the swelling and pain.
Varicella rash on trunk/abdomen/torso; Pt has been diagnosed with chicken pox 3/2022 at the age 3.
Information has been received on 04-APR-2017 from a pharmacist regarding a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported.  On 03-APR-2017 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 lot # L017406 expiration 26-FEB-2017 unknown route for prophylaxis. No adverse effect reported. Additional information has been requested.
102 degree fever, onset 6 hours after vaccination, injection site swelling and redness and heat, aches and chills, nausea and emesis; insomnia as a result.
Patient awoke with a high fever, generalized myalgia and arthralgia on 12/04/2015. He felt a little better around 4:00pm when he was able to get up and take his temperature. It was 101.4F at that time. He gradually felt better over the next 3 days and was symptom-free on 12/08/2015 when he reported the incident to the Health Center. Patient received no medical care but was in consultation with his father who is a doctor.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age/gender. The patient's concurrent or historical conditions were not provided. Concomitant therapies were not reported. On an unknown date the patients were vaccinated with improperly stored of ROTATEQ orally (dose, lot number and expiration date were not provided). No symptoms were reported with regard to the medication error. This is one of several reports received from the same reporter. Additional information has been requested.
Both her legs hurt, it was very painful, and it got progressively worse; muscle aches and could not walk around; still has a red mark on her arm; arm was sore; red bump/lump; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Feb-2021. The most recent information was received on 11-Jul-2021 and was forwarded to Moderna on 11-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), VACCINATION SITE MASS (red bump/lump), PAIN IN EXTREMITY (Both her legs hurt, it was very painful, and it got progressively worse), VACCINATION SITE ERYTHEMA (still has a red mark on her arm) and MYALGIA (muscle aches and could not walk around) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), VACCINATION SITE MASS (red bump/lump) and VACCINATION SITE ERYTHEMA (still has a red mark on her arm). On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (Both her legs hurt, it was very painful, and it got progressively worse) and MYALGIA (muscle aches and could not walk around). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm was sore), VACCINATION SITE MASS (red bump/lump), PAIN IN EXTREMITY (Both her legs hurt, it was very painful, and it got progressively worse), VACCINATION SITE ERYTHEMA (still has a red mark on her arm) and MYALGIA (muscle aches and could not walk around) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For the second dose, the patient reported they did not have any reaction.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: follow up received on 11-jul-2021 is Significant Follow up  and  outcome of event updated
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.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Mar2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 23Oct2021 at 10:00 as dose 3 (booster), single (Lot number: 301458A) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23May2022 at 09:00 as dose 4 (booster), single (Lot number: 038A22A), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL, start date: 20Jul2022, stop date: 22Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jul2022, outcome "recovered" (04Aug2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jul2022) Positive; (30Jul2022) Positive; (04Aug2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course included: Other medical history was noted as none. Patient had no known allergies. Vaccine received was noted as yes. Other medication in 2 weeks was noted as Tylenol; start date was noted as 20Jul2022 and stop date was noted as 22Jul2022. Patient was tested positive on 20Jul2022, started Paxlovid for COVID 19 Treatment (indication also noted as treatment of COVID-19) (renal dose) on 21Jul2022, finished Paxlovid on 25Jul2022. COVID symptoms went away in 22Jul2022, but then had rebound Covid symptoms was noted on 30Jul2022 and tested positive. Patient tested daily, finally was negative on 04Aug2022.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Pain in her joints; Pain in ribs, back, and legs; nauseous; A spontaneous report was received from a consumer concerning a 77 year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) in the Emergency Use Program and felt sore, pain in joints and nauseous.  The patient's medical history, was not reported. Concomitant medications were not reported.  On 28-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (unknown Batch number), intramuscularly write if given) in the left deltoid for prophylaxis of COVID-19 infection.    On 28-JAN-2021, after to receiving mRNA-1273, the patient felt sore. And on the next day 29-JAN-2021, she felt pain in joints and nauseous. Additionally, pain continued to get worse in her ribs, back, and legs. Treatment for the event included Tylenol and aspercreme.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events, pain in joints, ribs, back, and legs and feeling nauseus were not resolved at the time of reporting of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
3 DAYS AFTER VACCINE, PATIENT BEGAN TO FEEL WEAKNESS IN ARMS AND LEGS.  FOR THE PAST TWO MONTHS WEAKNESS CONTINUED TO BECOME WORSE AND REQUIRING ASSISTANCE TO STAND FROM SITTING. EXTREME FATIGUE WAS EXPERIENCED BY PATIENT.  AFTER SEEING DOCTOR, SHE WAS DIAGNOSED WITH GUILLAIN-BARRE SYNDROME.  SAW NEUROLOGIST AND WAS TOLD IT WOULD TAKE UP TO ONE YEAR TO RECOVER. ON 02/11/2016 PATIENT CALLED HEALTH DEAPARTMENT TO INFORM NURSE. STATED THAT SYMPTOMS WERE SEVERE IN THE PAST TWO MONTHS AND ARE IMPROVING NOW.
Patient stood up and started to walk. Passed out. Found lying face-down on floor. He hit his face on a stand and seemed to blackout. He remembers feeling dizzy. He may have fainted or was knocked out by fall. Has a black eye; and swelling on eye and cheek.
Headache, nose bleed, body aches, swollen feet, anxiety, palpitations, very very tired, feeling of desperation , crying episodes, sob
On  June 3rd, 2021, I noticed my right side of my chest/breast swollen. I contacted my doctor and schedule an appointment for June 8th, 2021, looked at it and scheduled me for a mammogram was on June 21st . The mammogram came back normal and I was schedule a follow-up appointment with Dr. on June 28th, 2021 for blood work. Blood work results came back negative. I still have swollen in my right chest/breast and my doctor told me to come back if the swollen hasn't gone down in six months.
Shingles (herpes zoster reactivation) on right side of face.  Valacyclovir was started at approximately 72 hrs within initial symptom onset.
No additional adverse event.; A 5-year-old patient inadvertently received a dose of Gardasil 9.; This spontaneous report was received from an office manager on behalf of a healthcare professional and refers to a 5-year-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 03-AUG-2021, the patient was inadvertently vaccinated at age of 5 years with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot # T025370 was confirmed to be valid, expiration date 01-DEC-2022, (route and site of administration were not reported) for prophylaxis (inappropriate age at vaccine administration). No additional adverse event was reported. 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.; devicelotnumber: T025370; expirationdate: 01-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Severe skin and facial reactions immediately after the vaccine.  As a mom and advance practice nurse I started Bactoban and anti inflammatory meds and histamine blockers right away.  By day 4 it was severe and worsening.  Went to Physicians and he received 5 prescriptions (unknown dx- severe dermatitis vs Steven Johnson Syndrome).  Slight improvement but cont systemic  skin battle.   Worsening on Dec 4th.  Started oral steroids  and Benadryl and Bactroban ?. Went to Premiere Family Physicians that Monday.    They did tons on lab work and sent us to Vitalogy immediately for care.   Dx of erythroderma emergency ( covering 90% and said he should be hospitalized). With Covid outbreaks ww decided to treat with high dose steroids for 3 weeks and bleach baths with high dose steroid creams .  Can not work or go to college!  Md reports vaccine reaction continued and it is now common!  Now on Dupixa immunosuppressant, steroid creams and antihistamines regularly.   Still not gone after 5 months.   No end in site
patient has swollen shoulder at injection site, hard, very warm to touch.  has been expanding since first vaccination
severe headache/had a massive headache for a couple hours; This is a spontaneous report from a contactable reporter Physician. This Physician (patient) reported that-  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "severe headache/had a massive headache for a couple hours".  Additional information: Description of Event: Patient reported during a virtual meeting that he received the Pfizer BioNTech Covid 19. Vaccine recently and after the 2nd dose he had a severe headache which resolved. After the second dose of Covid vaccine he had a massive headache for a couple hours. Optional Information: Didn't have a headache after first dose but had one after second. Event took place after use of product. Reporter does not wish to be contacted for follow-up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
first shot around October 28 of 2020 / second until July 16 of 2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on 28th October 2020).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient self-reported the case. The patient did not get the second until 16th July 2021.  The patient asked was that too much time between the two shots which would mean patient would need another shingles shot now. It looked like patient was protected after the second dose even though it was delayed, which led to lengthening of vaccination schedule.
On November 29, 2022, I had a runny nose and started to cough.  On the 20th I tested positive for COVID-19 on my home test.  I spoke to the nurse practitioner.  Based on my health conditions I qualified for Paxlovid.  I began taking on the night of the 30th.  Symptoms remained the same for several days but ran a low-grade fever one night.  As of today, I am still coughing, and I don't feel like I have completely recovered.
16 year old received  both vaccine shots in the series, even  though Moderna EUA states >/= 18 years.
No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 10-SEP-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) 1 injection, lot # R025726, expiration date: 26-MAY-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple 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.  devicelotnumber: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; 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-009507513-2010USA001083:Same Reporter
Pt was given two shots and immediately after administered patient became pale, limp and clammy. Patient passed out and began to have seizure activity for a few seconds. Pt regained consciousness and her vital signs were taken and were within normal range.
vaccine #1 received 3/2/2021 and starting on 3/9/2021 symptoms of right fingers/hand/wrists swelling, pain, burning, tingling and pins/needles. Pain 8/10.  Consulted with Orthopaedics thinking trigger finger or carpal tunnel, Prednisone prescribed and EMG ordered. EMG conducted 3/23/2021 vaccine #2 received 3/22/2021 Same symptoms and pain level to left fingers/hand/wrist started on 4/15/2021 Visit with PCP 3/29/2021 and was made aware of reactions but knew she was under care of Ortho She has been in excruciating pain, debilitating and crippling at times. Difficulty to perform daily activities.
getting tired fast; Shortness of breath; Chills; achy joints; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious Courtesy case received from Pfizer via consumer/non-hcp.  This case involves an unknown age and unknown gender patient who was getting tired fast, shortness of breath, chills and achy joints after receiving vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and Covid-19 vaccine Bivalent.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included NAPROXEN (NAPROXEN) and unspecified vitamins.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE  (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received an unknown dose of non-company suspect Covid-19 vaccine Bivalent strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  It was reported that patient had a INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE   and after 48 hrs later had the Pfizer BioNTech Bivalent and now patient had shortness of breath (dyspnoea), chills, no fever 98 degrees, achy joints(arthralgia) and was getting tired fast(fatigue) (onset and latency: unknown) . Patient injection was like 30 hours ago and he/she was feeling like 4 hours. Patient do not have fever.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events   Outcome: Unknown for all events
2 days after receiving the first Moderna vaccine I developed seasonal - allergy - like symptoms.  My allergies are ONLY fall allergies.  No OTC or RX meds taken for this.  Then I received the 2nd dose of Moderna on 3-30-21. The next morning I could not smell or taste.  The same seasonal-like-symptoms continued until approximately 4-18-21.  On 4-16-21 I took 1 Sudafed PE hoping that relieving the allergy symptoms would allow my taste/smell to return.  It did not, therefore  I did not take anymore Sudafed. On 4-6 -21 I had negative COVID test.  On 4-23-21 I experienced a fleeting, slight sense of taste which occurs randomly but not every day. Living without a sense of taste or smell is horrible