chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doses administered after 30-day Use By Date and expiry date; doses administered after 30-day Use By Date and expiry date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date and expiry date) and PRODUCT STORAGE ERROR (doses administered after 30-day Use By Date and expiry date) in a 42-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     The patient had no known drug allergies. The patient had no chronic/acute illness and it was unknown if the patient tested positive/negative for COVID-19 within last month.  Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for an unknown indication.    In April 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date and expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (doses administered after 30-day Use By Date and expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date and expiry date) and PRODUCT STORAGE ERROR (doses administered after 30-day Use By Date and expiry date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The number of doses/vials was 36.  The vial was initially stored in the refrigerator on 25-Feb-2022.  It was reported that date and time of administration of vaccine was 1-Apr-2022 and 8-Apr-2022.  The vials did not undergo any temperature excursion.  The patient had not received any daily medications.  HCP confirmed that the patient was not experiencing any side effects at the time of reporting.   No treatment medications were reported.
Exactly 1 1/2 hours after the shot was administered I suddenly developed chest pain shortness of breath and rapid breathing. I also got a migraine soon as the shot was administered and I never get headaches. It?s evening and I still have a migraine. My low back pain increased severely. I experienced numbness in my right hand.
About 30 minutes after 2nd shot on 9/21/2021, noticed I was having problems with vision and focusing. I wear contacts so I assumed I was having contact issues. After a couple days of the condition, I realized I had double vision with very high sensitivity to light (sunlight and artificial lighting) This was with contacts in, without contacts and wearing glasses, or no glasses or contacts. It was very difficult driving, especially at night. I had to wear a patch over one eye. I could not watch TV without a patch. I had to keep the lights in my office off so I could focus. I could not recognize people unless they were standing right in front of me. This went on for about 6 weeks. I feel I am back to normal with no double vision but still have some sensitivity to bright conditions.
pt recv vax & devel redness, swelling, & warmth from the inj site to the elbow;pt was seen by MD & hosp w/dx of cellulitis;pt remains in hosp @ the date of this report & is receiving IV ATB therapy;
On 6-12-08, pt developed back pain, fever, and acute onset of weakness. He was initially admitted to floor but developed resp. distress and was transferred to Ped ICU and intubated. He was subsequently diagnosed with transverse myelitis.9/18/08-records received for DOS 6/13-7/22/08-DC/Transfer Summary DX: Acute transverse myelitis. Respiratory failure. Presented to ED on 6/11/08 with acute onset of upper back pain and weakness in upper extremities and lower extremities with upper worse than lower. Developed problems with balance. Unable to squeeze parent's finger, and developed upper body twitching and shaking. Fever 103. In ED unable to raise arms. Developed respiratory distress and was intubated and placed on mechanical ventilation. Hyperglycemia due to high-dose Solu-Medrol. Aspiration pneumonia. Nasograstric tube feedings.  Continued with low grade fevers. Transferred to rehabilitation facility. 2/27/09-records received-rehabiliation facility with subsequent decannulation after venitaltor dependency. Neurogenic bladder. Postvoid residual. 1/25/2010 Follow-up: patient had an active transverse myelitis and continues to have physical limitation he continues to received physical therapy services.
Unable to move or speak within minutes of vaccination.  Completely drenched in perspiration to the point of dripping.  Brought back to room to be given immediate care until symptoms resolved within approx. 20 minutes.  Next day - internal ulcers in all mucosal membranes.  Within Days - Hands blue, swollen and painful on and off.  Arthritis symptoms.   Vaccine induced both diseases that were in remission and made symptoms more severe.
Lymph nodes swollen the size of an orange; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old male patient 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 01Apr2021 (at the age of 57-year-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0172) via an unspecified route of administration in the left arm on 22Apr2021 at 11:45 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and 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 vaccination. The patient did not receive any concomitant medications. On an unknown date in Apr2021, the patient's lymph nodes swollen the size of an orange. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lymph nodes swollen the size of an orange was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
unconsolable crying 12 hrs elevated t103; localized red @ site of inject lt leg;
Shortness of Breath During Observation; Fast Heart Beat; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath During Observation) and HEART RATE INCREASED (Fast Heart Beat) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DYSPNOEA (Shortness of Breath During Observation) and HEART RATE INCREASED (Fast Heart Beat). On 05-Mar-2021, DYSPNOEA (Shortness of Breath During Observation) and HEART RATE INCREASED (Fast Heart Beat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Started by feeling dizzy today around 11:45 am then a headache that I still have,  Around 2:00 pm I started with pain in both ears and feeling tired. No feeling well. Right now I laying in bed.
Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 32°F; doses 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 (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 32°F) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 64-year-old male 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 2:08 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:08 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 32°F). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 32°F) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.   On 03-Apr-2021, Excursion time was 9 AM, temp was 34 , total doses given for the day was 210, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021, 20 vial was moved to clinic. Vaccine BUD date was 29-Apr-2021.  Vial was stored on cooler 1 , on 03-Apr-2021, Excursion duration at 8 AM:38,  9 AM:34, 10 AM: 38, 11 AM:42, 12 AM:41, 1PM : 41, 2 PM : 41, 3 PM: 40, 4 PM: 40 and 5 PM : 41.  It was reported that unknown number of patients were 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. Vials only punctured right before administration  Treatment medications were not reported.
Dorsum of tongue: Painful papule surrounded by erythema with purple hue. Loss of taste.
PT COMPLAINS OF SIGNIFICANT WEAKNESS, FAITUGE,  AND SEVERE CONSTIPATION STARTING HOURS AFTER VACCINATION.
Pain radiating down arm where vaccine given, throbbing in elbow of same arm, severe headache, nausea, major swelling and erythema to the injection site for 5 days.
Shingles spot , has recurred on back; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingle in a spot on his/her back prior to first vaccination).   In OCT-2018, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles spot , has recurred on back). The outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 7-Mar-2023 The patient had received a dose of Shingrix and has had 3 cases of shingles. The first incidence of shingles was after her receiving Shingrix vaccination (no further details known), second incidence of shingles was a spot on her back (no further details known) and third case of Shingles also occurred after her vaccination and it was confirmed 7th March 2023.  The shingles appeared on the patient's back in the same area as the second incidence.  The current case of shingles was not resolved.  The patient will contact health care professional regarding getting the second of Shingrix vaccine. Insufficient schedule of vaccine as the patient could not confirm second of Shingrix dose was administered. The patient asked that it was possible for her to get revaccinated when this clears up or would it be ineffective. The patient gave permission to follow up with her. As per latest document it was not confirm whether the patient had received the second dose of Shingrix and as per narrative it seems that due to medical reason patient had not receive the dose therefore case was kept as non-serious for first dose only.
swelling  of upper arm but not at the injection site.  Just about an inch away.  Swelling of lymph node in armpit of arm where injection was given.  Nothing was done.   Swelling subsided gradually over the next 48 hours.
Vaccine that administered beyond use date after the thaw process; dose administered as 0.25ml instead of 0.5ml; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and UNDERDOSE (dose administered as 0.25ml instead of 0.5ml) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     It was unknown if patient had ever diagnosed positive with Covid-19.  It was unknown if patient had any acute illness at the time of vaccination or up to one month before. It was unknown if patient had any chronic or long-standing health conditions.     On 12-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and UNDERDOSE (dose administered as 0.25ml instead of 0.5ml). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and UNDERDOSE (dose administered as 0.25ml instead of 0.5ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 48 years 11 months. No concomitant drug was reported. It was reported vaccine administrated beyond use date after the thaw process. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  No treatment information was provided by the reporter.
no additional Ae; Nurse reported PEDVAX HIB was administered after multiple temperature excursions to a patient on Nov 15, 2022; This spontaneous report has been received from a nurse, referring to a 3-year-old male patient. The patient's medical history, concurrent conditions, concomitant medications were not provided.  On 15-NOV-2022, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, once, lot number U034518 has been verified to be a valid lot number, expiry date 18-MAR-2024 but updated to 28-MAR-2024 after internal review) (strength, anatomical location, and dose were not reported), the third dose of pneumococcal vaccine conj 13V (crm197) (PREVNAR 13) 0.5 milliliter intramuscularly on the left deltoid, batch number FM5699 (strength, frequency, and expiry date were not reported), and a dose of diphtheria vaccine toxoid (+) hepatitis B vaccine rhbsg  (yeast) (+) pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid  (PEDIARIX) (strengths, doses, frequencies, administration routes, anatomical locations, lot numbers, and expiry dates were not reported) all the vaccines indicated as prophylaxis (product storage error).  The vaccines were stored at a temperature of -0.3 °C (Celsius) for a time frame of 21 minutes,  -1.8 °C for 23 minutes, -2.7 °C for 24 minutes; 0.6 °C for 19 minutes, 0.7 °C for 6 minutes; and 1.2 °C for 14 minutes. There was no previous temperature excursion.  No additional adverse events were reported.
pt recvd vax & 5 mins later devel generalized hives & itching, c/o feeling faint; pt was treated successfully w/IV DPH;
In the evening following the injection the patient said she developed hives, Her arm puffed up and the top of the shoulder was red and hot. This reaction persisted for about 5 days then finally started to diminish with resolution after about 1.5 weeks.
fever & vomiting 45 mins p/dose, lasting 24 hrs; recvd 2nd dose 9DEC93;
feel under the weather; chills; tired; rash on right arm at the injection site that is round in circle; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feel under the weather), CHILLS (chills), FATIGUE (tired), VACCINATION SITE RASH (rash on right arm at the injection site that is round in circle) and VACCINATION SITE PAIN (sore arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and PAROXETINE for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 27-Apr-2021, the patient experienced MALAISE (feel under the weather), CHILLS (chills), FATIGUE (tired) and VACCINATION SITE RASH (rash on right arm at the injection site that is round in circle). At the time of the report, MALAISE (feel under the weather), CHILLS (chills), FATIGUE (tired), VACCINATION SITE RASH (rash on right arm at the injection site that is round in circle) and VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication also include apple cyder vinegar gummies and chlorthalicone.  Treatment details include anti-itch cream.
Large area of redness "3x3" soreness & warm to touch fever 101 degrees, 97.8 degrees at time of visit on 11/9/08
Information has been received from a registered nurse referring to a 20 year old patient of unknown gender. Concurrent condition and medical history were not reported. On 22-JUL-2015 the patient was inadvertently vaccinated with a dose of (Merck) PROQUAD (lot # K025760, expiration date 08-JUN-2016, 0.5 ml) subcutaneously (Drug administered to patient of inappropriate age). No adverse experiences were reported. Therapy with PROQUAD was continued. Additional information has been requested.
About 10 mins after receiving PROQUAD and KINRIX vaccines, pt told mom his throat felt tight and he felt sick. Mom took him to the clinic lobby bathroom where he began to vomit. Face was red, developed hives on face and facial swelling. Taken back to exam room by wheelchair. HR 125, RR 20, O2 96%. Dr called into room immediately and ordered dose of EPIPEN Jr, which was given about 9:50. O2 @ 2 l/min by cannula applied. Pt taken to hosp ER by wheelchair, accompanied by Dr and RN. Given IV fluids along with BENADRYL, SOLU-MEDROL and famotidine. Discharged home about noon.
Child recd #2 dose of VARICELLA on 6/23/09 in right thigh on 6/25/09 mom noticed bruise and red swelling -> saw MD 6/25 and MD circled induration with instructions to mom.  Monday 6/29/09 post swimming mom noticed the site to have tripled saw MD 6/29/09, site measured 6 cm X 6 cm, child placed on antibiotics po BID X 10 days.
severe pain in arm; Swollen posterior cervical lymph node/ Enlargement of lymph nodes; shaking chills; Fever 103F; Shaking; This spontaneous case was reported by a physician and describes the occurrence of TREMOR (Shaking), PAIN IN EXTREMITY (severe pain in arm), PYREXIA (Fever 103F), LYMPHADENOPATHY (Swollen posterior cervical lymph node/ Enlargement of lymph nodes) and CHILLS (shaking chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and Unknown) for COVID-19 vaccination.     No Medical history was provided by the reporter.    On 23-Apr-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 23-Apr-2021, the patient experienced TREMOR (Shaking), PYREXIA (Fever 103F) and CHILLS (shaking chills). On an unknown date, the patient experienced PAIN IN EXTREMITY (severe pain in arm) and LYMPHADENOPATHY (Swollen posterior cervical lymph node/ Enlargement of lymph nodes). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 26-Apr-2021, TREMOR (Shaking), PYREXIA (Fever 103F) and CHILLS (shaking chills) had resolved. On 14-Jun-2021, LYMPHADENOPATHY (Swollen posterior cervical lymph node/ Enlargement of lymph nodes) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (severe pain in arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Body temperature: 103 High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was unknown by the reporter.  Patient reported the blood work testing for Sjogren's disease and Lupus. Patient also reported that she had to put off a mammogram due to side effects as fever and shaking chills.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-100836 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: NNI On 06-Jun-2021: NNI On 07-Jun-2021: Patient initials was added On 10-Jun-2021: Event added On 14-Jun-2021: Event and Patient Initials updated.  E2b linked report added. On 27-Jul-2021: Significant FU :  AE Details provided
Debilitating tinnitus in both ears six days after second shot.  No easing of symptoms whatsoever.
After the pharmacist administered the Pfizer vaccine, the patient showed the card and administering pharmacist found that the first dose was Moderna. Talked to  the patient, apologized and informed the patient about the error and told to contact the pharmacy for any question or any side effects may experience.  Patient had no adverse effects, but advise to seek medical attention if needed. Patient has no primary physician.
24 yo male with (R) UE redness, warmth, swelling, and pain x 1 day. Received 5th anthrax vaccination 2 days ago. PE reveals large erythematous and edematous area measuring 31.75 x 18.5 cm with + effusion over elbow and + ITP to post elbow.
Herpes Simplex outbreak on lips multiple sores - was treated with Valacyclovr 1gram
This spontaneous report was received from a certified medical assistant and refers to 4 patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates in April 2016 (reported as "within the last month"), the patients were vaccinated with doses of ZOSTAVAX 1 dose (lot # M003486, expiration date: 27-MAR-2107; route was not provided). On unknown dates in 2016 (reported as "a couple of days after receiving the vaccine"), all patients developed cellulitis, warmth, a raised area and itchiness around the injection site and returned to the physician's office due to the events. The outcome of the events was unknown. The relatedness between the events and the ZOSTAVAX was not reported. This is on of two reports received from the same reporter. Additional information has been requested.