chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:15 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:15 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) 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 21.36.  Concomitant products were not provided.  On 03-APR-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-APR-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-APR-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 PM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.   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.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Location area of arm that received the administered vaccine sore, swelled, hard to move. Nausea, severe stomach trouble, headache.
Myalgia Acetaminophen 650 mg QID take two tablets by mouth every 6 hours as needed for mild pain, fever, or headache, diphenhydramine 100 mg qid take two capsules by mouth every 6 hours hold cetirizine while on diphenhydramine
The pt experienced a rash on the legs, face, and tummy right after the hepatitis B vaccine. 15-30 minutes post vax. The erythematous rash was located at the thigh, papular and red on the face.
Throat felt like it was closing up.  Tightness in chest similar to the feel during an asthma attach.  Neither resulted in wheezing or extreme difficulty to breath that required immediate attention.  Watering of the mouth similar to when you are about to vomit (gum helped with this).  Swelling of the hands, feet and legs.  For my hand I could push in on the skin which would leave an indent and slowly began to fill back out.  I also noticed blurry vision when trying to read while waiting my 15-20 minutes at the location.  None of these required immediate medical attention  and occurred fairly quickly after the injection and appeared to resolve in 3-4 hours.  I reached out to my primary care provider a few days later to determine if I should get the 2nd vaccine.  He indicated that it sounded like an allergic reaction and asked if I reported to VAERS.
Received the pfizer covid-19 vaccine (lot:FC3182) had an allergic reaction/anaphylaxis that started with itching and continued to hives and throat hoarseness. Received treatment via the vaccine administrator in the form of oral benadryl and treatment in the emergency room including IV fluids, IV pepcid, IV solumedrol, and oral atarax. Also received a prescription for an epi-pen in case of worsening reaction at home. Unrelenting headache that started the day after receiving the vaccine and enlarged lymph nodes have been noted and are being evaluated by primary care physician on 9/15/2021.
lt arm deltoid area + raised, taut erythema, + warmth, sl temp elevation 37.9 remaining 3 days p/vax
No adverse event; administration of an expired Moderna Monovalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of an expired Moderna Monovalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 19-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 042C22A) for COVID-19 prophylaxis.     The medical conditions and allergy information was not known.     On 05-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 05-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of an expired Moderna Monovalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of an expired Moderna Monovalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administration of an expired Moderna Monovalent vaccine).    No concomitant medications were reported.    It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that 5.5 mL vial was initially stored in the refrigerator on 03-Apr-2023. The vial did no underwent any temperature excursions.  No treatment medications were reported.
supposed to have his second dose on 06May2021 but he missed it; This is a spontaneous report from a contactable consumer or other non hcp Pfizer-sponsored program COVAX US Support. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown, expiration date not reported) via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced supposed to have his second dose, but he missed it on 06May2021. Outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever, myalgias, redness at vaccine site, itching, nausea, chills.
Supraclavicular lymph swelling after 3 days, posterior cervical chain swelling noticed after two weeks
Left arm upper arm and shoulder area redness, swelling, warmth, tenderness.  Possible associated low grade fever at home prior to clinic appointment.
She got the vaccine and started out with nausea below the vomiting point, and she could not eat much and had stomach upset.  She did not feel well.  She went to bed for a whole day and then slept the following day.  It is still going on but not quite as bad, very tired.  The arm was a little sore the night of the vaccine, but when she started using the arm the feeling left.  Did have some soreness for a couple of nights.  She can still hardly eat, but her stomach feels better.  She has the bad feeling where she cannot eat but a few bites as she gets nauseated then.  She has not taken anything for her symptoms.  She is just not feeling well at all as if you don't want to be out of bed.  It's a big struggle for her to get up and get her something to eat.  Something that she doesn't have to cook.
Sore arm; Dizzy; Face is flushed; Nauseous; Face is tingling; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizzy), FLUSHING (Face is flushed), PARAESTHESIA (Face is tingling) and NAUSEA (Nauseous) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-1900, the patient experienced PARAESTHESIA (Face is tingling). On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizzy), FLUSHING (Face is flushed) and NAUSEA (Nauseous). At the time of the report, PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizzy), FLUSHING (Face is flushed), PARAESTHESIA (Face is tingling) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD21-045076 (E2B Linked Report).; Sender's Comments:  MOD21-045076:Crosslinked case
received a dose of the Moderna COVID-19 Vaccine that expired on July 25th; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medications were reported. No treatment information was provided.
pt calls about 1 yr ago receiving MMR & 3 days later red patch that itched appeared on lateral thigh & gluteal area turned into blistey, very white & hard & then to a black scab; discolored for months; not aware of elevated temp; blisterin;
Large local inflammatory reaction in left upper arm. BENADRYL PRN. MOTRIN PRN. Ice to area.
Cerebellar thrombotic stroke 1/28 manifested by sudden onset dizziness and vomiting. Symptoms not improved with fluids and rest.  Misdiagnosed 1/29 in ER as vertigo.  Not diagnosed until 1/30/2021 upon readmission to ER.  Treatment: sub-occipital craniotomy, steroids, and 3 days ICU with ICP monitoring.  Outcomes: chronic left cerebellar atrophy with minimal clinical symptoms
COVID-19 Vaccine EUA  6 hours after receiving the vaccine I developed terrible chills (no fever), headache, fatigue and body aches.  This lasted for 48 hours. I slept most of this time.  I had COVID back in November for 3 weeks and these symptoms were just like when I was sick although only at ~50% of the degree.
Vaccine at 10:30am. 3pm left shoulder sore, stiffness in left side of neck, feeling chilled so put on warm clothes. 6:30pm my shoulder area feels HOT, inflammed and sore. Feeling heat on the left side  of my body, neck and head. Vey intense feeling of heat and inflammation in my body radiating from my shoulder, up the side of my neck and most of my head and down my left side,.  6:45pm  back of my neck very hot. temp 96.4.  8:20pm feeling better; not too hot. Shoulder is sore but not too hot. temp 97.7.   Today shoulder area is very sore but otherwise feeling better.      My concern: Will the second  vaccine cause a more pronounced reaction?  On Monday I will report my symptoms to my PCP...no one is there on the weekend.
1min post vaccination pt had a syncopal event and landed on the floor.  The patient hit her face on the floor, accompanied by  loss of consciousness.  Mother estimates there was LOC for ~30seconds.  Upon gaining consciousness, pt was assisted to private observation area by nurse and put into lying position.  VS Taken Vitals: @15:05 BP 104/68, HR 64, RR 20, 100% O2 Sat -- > @15:12 95/50, 70, 18, 100% Orientation assessed.  Pt was assisted to sitting position and ate/drank.  Tolerated well.  Pt/parent advised to monitor for worsening condition and s/s of adverse effects.  Advised to notify healthcare provider.  Verbalizes understanding of teaching and will have pt to MD within 24hrs.
Less than 24 hours past vaccines, patient's right upper arm got very hot, red, swollen and sore. Next day, 4/1/04, decreased swelling, redness and soreness. Exam 11:30am- deltoid firm red induration 6 cm in diameter with redness fading out to 12cm (width)x 9cm (lengt.). Non tender.
Forty-eight hours post vax the patient experienced a generalized rash. Five days later the patient experienced joint swelling, pain and fever. The patient is being treated with Prednisone.
Date of vaccination I was 6 weeks and 1 day pregnant. On 12/28/21 9 weeks and 5 days my babies heart stopped beating. My baby died.  3 weeks and 4 days after receiving the covid 19 vaccine.
doses given after temperature excursion; Product storage error; 0.5 ml of booster dose dministered intramuscularly; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion), PRODUCT STORAGE ERROR (Product storage error) and ACCIDENTAL OVERDOSE (0.5 ml of booster dose dministered intramuscularly) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion), PRODUCT STORAGE ERROR (Product storage error) and ACCIDENTAL OVERDOSE (0.5 ml of booster dose dministered intramuscularly). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion), PRODUCT STORAGE ERROR (Product storage error) and ACCIDENTAL OVERDOSE (0.5 ml of booster dose dministered intramuscularly) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored RECOMBIVAX HB (dose, lot # and route of administration were not reported). Patients were also vaccinated with improperly stored TD. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Drug ineffective; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and in Oct2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in May2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Eryhtromelalgia" (unspecified if ongoing); "Fibromuscular dysplagia" (unspecified if ongoing); "Gluten allergy" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN, start date: Apr2022; AMITRIPTYLINE, start date: Jan2020; MULTIVITAMINS [VITAMINS NOS], start date: 01May2019. Past drug history included: Clindamyasin, reaction(s): "Allergy"; Vicodin, reaction(s): "Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Nov2022, outcome "unknown"; COVID-19 (medically significant) with onset Jan2023, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset Jan2023, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300051016 Same patient/product and different dose/events;
This spontaneous report was received from a pharmacist referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX lot # M040623 and expiration date on 31-DEC-2017 or with lot # N012492 and expiration date on 17-MAR-2018 (dose and route of administration were not provided) for prophylaxis. Concomitant therapies included sterile diluent (MRK), used for reconstitution of the vaccine and which was properly stored. The doses of ZOSTAVAX were exposed to a temperature excursion of 15 degrees Fahrenheit (°F) to 46°F, during a time frame of 17.5 hours which was detected by the data logger. There was not prior temperature excursion and neither adverse events nor product quality complaints were reported.
Erythema in left arm in maculo-papular design in lower arm >6" from injection site.
Client complained of  tightness in throat, swelling of tongue and face 15 minutes after vaccination. 50 mg of PO Benadryl was administered to client at 1400, she was able to swallow and finished taking the medication at 1405. Vital signs were taken at 1404 (Blood Pressure 110/80 Heart rate 70 Oxygen 96%). EMS services were called and arrived at 1409. Client stated that the swelling was no longer progressing. Client left with EMS at 1412.
Patient said she didn't notice anything until yesterday (6/7/18) but that it might have started earlier. Location surrounding  injection by about 2 inches was light/white, but the distal part of the upper arm was bright red and warm to the touch. It didn't look swollen but the patient said it was 'puffy'. Patient also mentioned she had gotten cellulitis in the past from a IV needle in her hand. I advised patient to call her doctor when she gets home and get checked to be safe.
After immunization was given, mother and pt walked out to front counter of HD. Pt informed mother he wasn't feeling very good. Mother told pt to sit down and put head down between his legs. Secretary then called for nurse. Pt skin color pale, warm and dry. Pulse at 96. Pt given some water, soda crackers. Stated he felt better. Pt remained at HD for 1/2 hour-45 minutes following incident. Nurse walked out to car with pt and mother. Contact with mother on 7/29/03 and mother stated pt was fine.
2 days after vaccination, diarrhea started; red, firm spot at injection site DTaP. Rubbing his eyes. Rash all over trunk, mild cough and congestion. Given Zyrtec and Keflex.
Got the Flu Shot had reaction- (egg allergy ); Documented allergy to administered drug; This case was reported by a consumer via interactive digital media and described the occurrence of contraindicated product administered in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included pneumonia shot for prophylaxis.   Concurrent medical conditions included egg allergy.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season and pneumonia shot at an unknown dose and frequency. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced contraindicated product administered and documented allergy to administered drug. On an unknown date, the outcome of the contraindicated product administered and documented allergy to administered drug were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was allergic to egg and vaccinated with Flu shot led to contraindicated product administered and documented allergy to administered drug. The patient was also got the Pneumonia shot and had a reaction too. Now patient was questioning about  the Covid vaccine. No further information was available
I woke up on 2/27/2021 with a red rash on my neck, chest, stomach, back, arms, legs, bottom and pelvic area.  I called the on call physician. Took over the counter Benadryl. The rash cleared up on Monday, 3/1/2021.  Still feel itchy on 3/1/21, 3/2/21, 3/3/21, 3/4/21. Used over the counter hydrocortisone cream.
Administered expired vaccine; 12 hour punctured vial expiration time 8:00 PM, 19/Aug/2021) to the immunocompromised patient at 11:00 AM on 20/Aug/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) and PRODUCT STORAGE ERROR (12 hour punctured vial expiration time 8:00 PM, 19/Aug/2021) to the immunocompromised patient at 11:00 AM on 20/Aug/2021) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, 026L20A and 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021 at 11:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) and PRODUCT STORAGE ERROR (12 hour punctured vial expiration time 8:00 PM, 19/Aug/2021) to the immunocompromised patient at 11:00 AM on 20/Aug/2021). On 20-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) and PRODUCT STORAGE ERROR (12 hour punctured vial expiration time 8:00 PM, 19/Aug/2021) to the immunocompromised patient at 11:00 AM on 20/Aug/2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.
Numbness and nerve tingling  pain in injection arm.  Loss of feeling in thumb, index and fore fingers on right arm the iight of the second injection.
pt recv vax 7MAY96&10MAY96 t102.5,lethargic&fatigue;pt seen on 14MAY for the 1st time -exam neg;20MAY96 morbilliform rash post wk&entire back&chest&abd;