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 73-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 31-Mar-2021 at 9:49 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:49 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 73.37.  Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 31-Mar-2021. 14 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 32, 9 AM: 32, 10 AM: 40, 11 AM: 42, 12 AM: 43, 1PM: 44, 2 PM: 46, 3 PM: 46, 4 PM: 44 and 5 PM: 44.  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 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.
Day after getting his 3rd GARDASIL shot broke out in rash to upper back, quickly spread to trunk the extremities. Very itchy.
This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown age and gender. The patients' concomitant medications included MERCK STERILE DILUENT, lot # and expiration date were not provided. The patient's medical history and drug reactions/allergies were not provided. On an unspecified date in April 2018, reported as since 04-APR-2018, multiple patients were vaccinated with  improperly stored doses of Oka-Merck PROQUAD injection, lot # N025927, expiration date 18-MAR-2019 and lot # N034561 with expiration date 03-JUN-2019 or Oka/Merck VARIVAX injection, lot # N030407 with expiration date 03-OCT-2019 (also reported as 30-OCT-2019), lot # N026070 with expiration date 20-SEP-2019 and lot # N022996 with expiration date 23-AUG-2019, all for prophylaxis (route and anatomical location were not provided). The administered doses of the vaccines experienced a temperature excursion in the range between -14°C to -10°C during 138 hours as recorded by a data logger. Additionally, the vaccines experienced a temperature excursion in the range -14°C to -10°C during 66 hours and 30 minutes and also between -9°C to -10°F during 6 hours.There was no side effects reported. No product quality complaint was involved.
Missed subsequent period (period missed after both first and second COVID shot, but not after booster. Cycle was previously consistent, and there was no possibility of pregnancy.)
On March 4 the patient noticed the L side of her face sagging and thought it might be a stroke. She went to Urgent Care  and was diagnosed with Bell's Palsy.  She is currently being treated with Prednisone 60mg/day and Valcyclovir 1gr tid. She returned to the Vaccine POD with parents to inquire about the next vaccine. She has a neurologist whom she will see and discuss the issue
Starting around 11pm patient experienced mild fever, aches, chills. Overnight, fever increased, and pt had moderate/severe chills, aches, discomfort. Pt took Tylenol and ibuprofen overnight and fever after medication was approx. 101F. The next morning, pt experienced syncope and vomiting. Nausea, dizziness, fatigue, aches, low grade fever (99.4F) and mild chills continued for approx 36-48 hours.
Headache, Myalgia, Arthralgia, c/o chills,fatigue,itching around the injection site,slight sob. Told to follow up with primary care physician if promblems persist. Narrative:
Janssen COVID-19 Vaccine EUA At 7:00am on 3/11/2021 felt light headed as  waking up along obvious soreness on the arm where I received the vaccine- left arm.  Then later around 10:00am a feeling of tiredness came over my whole body.  Around 12:00pm I felt even more tired, lightheaded  and my eyeballs felt as if with high pressure in them and are feel sensitive to the sunlight.  Also, at 12pm, I had lunch, which was my first meal of this day and felt the necessity to lay in bed and take a nap for 20 minutes before returning to work.  While taking the nap I felt tingling on my feet, arms, hands and neck along with certain sudden muscle contractions on the same parts.
approx 12days p/vax pt broke out w/hives described as papular, raised centers, amorphous, blanched urticaria all over body.
Covid Arm...Delayed Cutaneous Hypersensitivity...Swelling, itching, Heat at site, redness which has spread over my upper arm, pain
Patient with itching, treat with BENADRYL 50mg every 6 hours. The patient only take one dose.
January 14, 2021: Rash to R brachial/arm area. Last about 12 hours. did not itch. Excessive Fatigue January 15, 2021: Hives to L abdominal/flank that was itchy, lasted about 1 day January 18, 2021: Cluster of hives to L flank/back that was severely itchy, red, and swollen.  ALSO hives to neck, tender, but did not itch. January 21, 2021: Swollen L deltoid, tender to touch, difficulty raising arm. no redness and headache  no new hygiene products, laundry detergent, lotions were used.
44 days between doses; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (44 days between doses) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (44 days between doses). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (44 days between doses) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24-MAY-2021 and does not contain any new information
Extreme muscle pain in arm and then became generalized to entire body requiring office visit to Dr.  These symptoms continue with little to no relief from anti-inflammatory medication taken as prescribed by PCP.
Pt received vaccine at 9:30am on 1/5/2021 At 7pm she reports generalized body aches At 5:30am on 1/6/21 she reported "slight headache", sudden dizziness, "seeing black spots", then fainting for unknown period of time. Upon regaining consciousness, she c/o head and back pain, globus sensation in throat, runny nose, "vomiting phlegm", cough, trouble breathing and wheezing. Family called 911, she was transferred to ED via ambulance (told +tachycardia on EKG in ambulance). Once in ED tx w/ IV fluids, promethazine and Toradol and discharged w/ dx of syncope, dehydration.  Pt reports intermittent HA and dizziness since event, worse during the first 48hr hrs (1/6 - 1/8) and progressively improving.  *Pt was positive for  Covid-19 in July 2020 and had headache, loss of taste, smell, sinus congestion and post-nasal drip x 2 weeks.
Injection site pain starting about half an hour after administration, worsening thereafter. Fever to 101 and myalgia starting about 21 hours post-vaccination.
Rash on abdomen, back and upper legs. Developed rash 4-5 days after vaccinations. Rash described as red raised welts.
Patient wrote on immunization consent form that he received Pfizer for Dose 1.  Grandmother was with patient and confirmed.  Patient did not have COVID card at time of vaccination.  Proceeded to administer Pfizer as Dose #2 and gave patient a Pfizer sticker (with lot # and date) to take home to adhere to his card.  The next day, patient's mom came in to show his card to us that Moderna was actually Dose #1.
Flu shot administered caused frozen shoulder requiring 6 months physical therapy. Arm is almost back to normal but not quite.
No additional AE; patient received VAQTA in error and was supposed to receive VAXELIS AND VAXNEUVANCE.; This spontaneous report has been received from a nurse referring to a patient of unspecified age or gender. Information of concurrent conditions, pertinent medical history, concomitant medications and drug reactions/allergies was not reported.  On 07-APR-2023, the patient received hepatitis a vaccine, inactivated (VAQTA) 25 U/0.5 mL intramuscular injection in error (0.5 mg x1 only (conflict information), lot # W023937, expiration date reported as June 2023, but upon internal validation established as 06-DEC-2023, route of administration and anatomical location were not reported) for prophylaxis (wrong product administered). The patient was supposed to receive diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (strength, dose, lot #, expiration date, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse event (AE) was reported (no adverse event).
This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored PROQUAD (Merck), Lot # K021151 and exp. 02-NOV-2016; Lot #L010141 and exp. 24-SEP-2016; Lot # L019995 and exp. 02-DEC-2016; Lot # L024124 and exp. 30-DEC-3026, (dose and frequency not reported). No adverse effects reported. No product quality (PQC) was involved. No further information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
Her smell is off; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Her smell is off) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (Her smell is off). At the time of the report, ANOSMIA (Her smell is off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by reporter.  No treatment information provided by reporter   Reporter did not allow further contact
Had my 2nd dose last Saturday, Feb. 20, at Hospital, Toledo, Ohio.  Had both injections in my left arm.  Noticed my left arm was sore at the injection site and now my arm is red and a bit swollen from my shoulder to my elbow, plus a little itchy but no rash.  Was taking Tylenol and icing it until my friend told me not to ice it.
Swollen airway, head, and neck, intense itching and burning that lasted for 2-3 days
Within 30 minutes of vaccination, pt developed itching, generalized erythema, and hives.  Provided pt with 2 DIPHENHYDRAMTINE 25 mg capsules and referred her to urgent care ctr.  Denied any difficulty breathing.  Pt was treated at emergency room and discharged the same day.
Shingrix vaccine was inadvertently administered subcutaneously; area grew to softball size and had a 2-3cm induration; was burning hot and massive; area grew to softball size/massive; was burning hot and massive; This case was reported by a physician and described the occurrence of injection site induration in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included shingles (had a prior episode many years earlier). Previously administered products included Zostavax (dose received on an unknown date).   In October 2020, the patient received the 1st dose of Shingrix (subcutaneous) and Influenza vaccine Quadrivalent 2020-2021 season (intramuscular). In October 2020, unknown after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site induration, injection site burning, injection site swelling and feeling hot. On an unknown date, the outcome of the injection site induration, injection site burning, injection site swelling and feeling hot were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site induration, injection site burning, injection site swelling and feeling hot to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: The age at vaccination was not reported. The patient had no history of allergies. The patient was inadvertently administered Shingrix vaccine via subcutaneous route, which led to intramuscular formulation administered by other route. The patient simultaneously received Influenza vaccine (Flu vaccine administered via intramuscular route in other arm). Less than 4 months after the vaccine, the patient experienced no pain when the vaccines was administered but area grew to softball size and had the 2 to 3 centimeter induration, was burning hot and massive, which lasted 2 weeks. The patient had local symptoms only, no systemic adverse effects. The patient willing decide to receive the 2nd dose. The reporter did not consent to follow up.
Four inch circular raise, itchy, warm to touch red rash that was present for eight days.
This spontaneous report was received from a pharmacist and refers to a 42-year-old male patient. No information regarding the patient's concurrent condition, medical history or concomitant medications was provided. On an unknown date in June 2020, the patient was administered the first dose (initial dose) and on an unknown date in July 2020, the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date in October 2021, the patient was vaccinated with the third and final dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 0.5 ml (route of administration, lot# and expiration date were not reported) for prophylaxis, outside of the recommended interval. The reporter stated that no additional adverse event (AE) was reported by patient.
Information has been received from a physician concerning a 14 year old female who was vaccinated with the first dose of Gardasil. Subsequently the patient experienced swollen lymph nodes on the same side as the injection two days after receiving the injection. The patient recovered from the swollen lymph nodes after the first injection with Gardasil. Two days after the second dose of Gardasil, the patient again experienced swollen lymph nodes on the same side as the injection. Clinical outcome related to the second occurrence of swollen lymph nodes in unknown. Additional information has been requested.
Swollen lymph node above left collar bone; This is a spontaneous report from a non-contactable consumer. A 27-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 31Mar2021 16:45 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation.  Medical history were none. No pregnant. No any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No Allergies to medications, food, or other products. Historical vaccination included BNT162B2 on 10Mar2021 08:45, in left arm, dose 1, lot number:EN6206 for covid-19 immunisation. The patient's concomitant medications were not reported. The patient experienced swollen lymph node above left collar bone on 01apr202110:00 with outcome of unknown. Appeared approximately 17 hours after the second Pfizer shot. I had not had any reactions after the first Pfizer shot. No treatment.  Follow-up attempts have been completed and no further information is expected.
Raised, warm to touch, red, somewhat itchy oblong rash approximately 2 inch x 2 inch oblong, occurring in left arm a few inches below injection site.
Developed rash on face/body. Seen in ER. Physical examination - urticarial rash. Rx: Benadryl 6.25mg PO, Prednisone 18mg PO. Decreased erythema.
Breakthrough Case of COVID, So I started feeling a scratch in my throat, and then the next day my nose was running, my eyes were running, I was congested, my sinuses were hurting and my ears were hurting and I was very fatigued. Symptoms are starting to wear off, my chest is not as congested and the other symptoms are starting to wear down, also my joint hurt all over.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-JUL-2022; No adverse event; Administered the vaccine to patient after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-JUL-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-JUL-2022).    No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Jun-2022. The date of vaccine administration was from 4-Jun-2022 until 26-Jul-2022. The vial did not undergo any temperature excursions. Patient received half dose. No treatment medications were reported.
20JAN c/o stomachache, jaundice, n/v, became very ill;condition rapidly deteoriated & adm to hosp;dx hepatitis;liver severly damaged & placed on transplant list;
TOOK ONE UNREFRIGERATED DOSE; This case (PVX2019-2201) was received from a consumer on 28-Aug-2019. It described a 30-year-old male consumer who "took one unrefrigerated dose" (PT: Product storage error), while being on Vivotif for an unknown indication.  Case report: The consumer took an unrefrigerated dose of Vivotif on 28-Aug-2019. He will be travelling on 11-Sep-2019.   Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of reported event was unknown.  Company's Comment: The causality of the event "took one unrefrigerated dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one unrefrigerated dose" was considered as not applicable.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The nurse reported that the patient was vaccinated with a dose of MMR II and (Oka/Merck) VARIVAX (lot#, expiry and dosage unspecified) subcutaneously approximately in June 2010, in July 2013, and in April 2014. No known adverse effects reported. Additional information has been requested. Follow up information was received from nurse. Patient demographics were updated. Medical history included developmental delay and allergic rhinitis. On 07-APR-2014 at 5:51 PM, the patient was vaccinated with a dose of MMR II (lot number H018950, subcutaneous in left arm) (number of previous doses reported as 2) and (Oka/Merck) VARIVAX (lot number J006962, subcutaneous in right arm) (number of previous doses reported as 2). On 07-APR-2014 at 5:51 PM, the patient received other vaccines DAPTACEL (manufactured by Sanofi) (lot number C4457AA) in left arm intramuscularly. Number of previous doses were reported as 5. The patient also received IPOL (manufactured by Sanofi Pasteur) (lot number J1727) intramuscularly in right arm on 07-APR-2014 at 5:51 PM. Number of previous doses were reported as 4. The patient was vaccinated at private doctors office or hospital and vaccine was purchased with public funds. Concomitant medications were reported as none.
Developed temp of 104 (mom removed theomometer when it reached 104) baby was listless but would not sleep or eat; Temp remained 104 x 24 hrs; (This was w/Tylenol & tepid baths)