chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered past the 30 day refrigeration time; storage medication error; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (storage medication error) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (storage medication error). On 24-Aug-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (storage medication error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.
(L) deltoid swollen, swelling up into neck and cheek, throat felt like "closing up".
Customer give us the wrong birthdate of 1/30/2012 so was given a pediatric dose of the Pfizer vaccine. This was confirm again at the time of the vaccination, The aunt call us back after 6 days and said that his birthdate was wrong and should be 1/30/2010. So patient receive a pediatric dose of the Pfizer vaccine instead of the adult dose.
skin bump/rash/pimple/red spots; skin bump/rash/pimple; black spots on skin like sun spots; headache; pain during injection; injection site reaction (red, painful, swollen and hot); injection site reaction (red, painful, swollen and hot); she couldn't mover her arm; injection site reaction (red, painful, swollen and hot); This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fungal infection. Previously administered products included flu shot (received on an unknown date for flu shot). Concurrent medical conditions included sarcoidosis, pancreatic cancer, penicillin allergy and iodine allergy.   On 27th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th December 2019, immediately after receiving Shingrix, the patient experienced injection site pain and headache. On an unknown date, the patient experienced injection site erythema, injection site swelling, injected limb mobility decreased, injection site warmth, red spotty rash, pimples and skin discoloration. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, headache, injection site erythema, injection site swelling, injected limb mobility decreased and injection site warmth were recovered/resolved and the outcome of the red spotty rash, pimples and skin discoloration were not recovered/not resolved.   The reporter considered the injection site pain, headache, injection site erythema, injection site swelling and injection site warmth to be related to Shingrix. It was unknown if the reporter considered the injected limb mobility decreased, red spotty rash, pimples and skin discoloration to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. The patient received a dose of Shingrix in an unknown arm.  She stated that the needle was very long therefore the injection was given intramuscularly (not subcutaneously) in the arm.  The patient did not have the lot number or expiration date of Shingrix because she called from her car and all her paperwork was at home.  She stated that it was painful during the actual injection.  The patient had a headache before she left the pharmacy on 27th December 2019.  She also stated that the injection site was red, painful, swollen and hot.  She was unable to move her arm nor could anyone touch her arm and she had to be careful not to lay on it.  Less than a day, the patient noticed some little bumps on her skin like a rash.  She said she had a couple of bumps that looked like a pimple on her skin in different parts of her body such as breast and legs.  They were red and some were black spots on the skin like sun spots.  She stated she stayed out of the sun due to her history of sarcoidosis.  Injection site reactions resolved after 5 days.  The reporter consented to follow up.
Entire arm swelled up to be deep purple-red, hot, hard itchy and painful. Child crying and complaining. Lasted two weeks before beginning to subside. Self administer Motrin and Benadryl.
Patient received vaccine. About 5-10 minutes later patient started feeling light headed. He sat down and then laid down and briefly lost consciousness for a couples of seconds. Patient was evaluated and monitored. Other than fatigue, Pt had full return to base line and was released
Headache, Sedation, Myalgia, Arthralgia, Fever & NauseaVomiting  Narrative:
Had itching at site immediately rash above site developed later in the day. About 10 minutes after injection developed nausea then felt very hot became clammy and sweaty. Felt lightheaded became pale had to played down on the ground.
redness; swelling at the site of injection/swelling became present/swelling was getting; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 2ZN2D, expiry date 16th September 2022) for prophylaxis.   On 21st August 2020, the patient received the 1st dose of Shingrix. On 22nd August 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema was recovering/resolving and the outcome of the injection site swelling was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and complaining about the swelling at the site of injection. The patient mentioned that after the vaccine was administered, redness and swelling became present.  The redness was subsiding, but the swelling was getting bigger.  The Pharmacist provided vaccine and as much patient information as available. The reporter consented to follow up.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies, and concomitant therapies were unknown by the reporter. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB injection 10/1 microgram/ml (dose, route, lot number and expiration date were not reported) for prophylaxis. On an unspecified date, the patient needed a booster of RECOMBIVAX HB due to low titers (Hepatitis B surface antibody negative) or exposure. It was unknown if the patient sought medical attention, treatment was given or laboratories were performed for the event. The outcome of the event was unknown at the time of reporting. The patient had not received the booster of RECOMBIVAX HB at the reporting time. The reporter did not provide a causality assessment between the event and the suspect vaccine. Additional information has been requested.
pt. describes dizziness and weakness in arms shortly after recieving 2nd dose vaccine. BP 177/88, O2 98, HR 81. Pt was monitored for 30 minutes, pt. drank water and orange juice. Pt. felt better 30 minutes later, BP improved 157/83, o2 96, HR 80. Pt went home with sister.
Woke up a 2 am with lots of hearing loss and ringing. Ended up getting treated immediately with prednisone 60mg x 9 days and then taper down over 9 more days
Patient developed varicella 5 days after vaccination. Treated with Acyclovir.
PT WAS SITTING AT POST-VACCINATION AREA AND SUDDENLY FAINTED. PT FELLED OVER AND WAS SHAKING. HE REGAINED CONSCIOUSNESS RIGHT AWAY WHEN HE HEARD SOMBODY CALLING HIM. HE SAID HIS HANDS WERE COLD
Patient received vaccine on 02-apr-2022, post expiry date of 01-apr-2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 02-apr-2022, post expiry date of 01-apr-2022.) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 02-apr-2022, post expiry date of 01-apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 02-apr-2022, post expiry date of 01-apr-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The Pharmacist was calling to verify an expiration date for lot number 026L21 B. The pharmacist said that when his Pharmacy received this vaccine on 23FEB2022 that a Pharmacy staff member looked up the expiration date and came up with an expiration date of June 2022. However, another Pharmacy Staff member looked up the expiration date of the Moderna Covid-19 vaccine in question and the expiration date was 01APR2022.Number of doses/vials: 80 doses administered. The vial did not undergo any temperature excursions. Caller mentioned 155 patients were vaccinated with expired doses from 2Apr2022 to 19Apr2022. The Pharmacist did not have any other information on the patients currently.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that thought that the vaccine expired in Jun-2022, however it was expired in 01-Apr-2022. No treatment information was reported.
Pt recv vax on 11/2/98; on 11/8/98 pt exp vax site redness, tenderness & induration
1805 vasovagel, pale skin moist, put in reclining position, legs elevated. moist clothes applied to face & neck.  pulse 80 strong regular, R 16. 1810 sitting up  skin w/d. Patient made full recovery and left the clinic at 1830.
This spontaneous report was received from patient's great grandmother concerning his 1-year old male great grandson. Concomitant medication included Flu shot and DtAP. The patient had no pertinent medical history or drug reactions/allergies. The patient's current conditions were not reported. On 02-NOV-2018 (after his first birthday), the patient was vaccinated with M-M-R II injection, 0.5 ml once, indicated as routine vaccination (prophylaxis) (anatomical injection site was not provided). The reported lot number was N009799 and expiration date was 24-MAR-2019. Other suspect therapy included varicella virus vaccine live (Oka/Merck) (manufacturer unknown) administered on the same (dose, dose number, anatomical location, route of administration, lot number and expiration date were not provided). In November 2018 (reported as 09-NOV-2018 or 10-NOV-2018), the patient developed a measles rash starting on his buttocks and back which has since spread to the rest of his body. Also, the patient developed a fever of 100.4 degrees. The patient sought for medical attention and received treatment for the adverse events by seeing the doctor. There were no lab diagnostic studies performed. At the time of this report, the patient recovered from the fever, but the patient still had the measles rash. The causality assessment between the suspect therapies and the adverse events was not reported. Upon internal review, Measles was determined to be medically significant.
This is a spontaneous report received from a contactable pharmacist. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient was vaccinated incorrectly with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) as it did not go into the deltoid muscle. The patient has redness at the injection site and upon consulting with her physician, she was told that she had cellulitis as a result of the injection not being given in the muscle. The outcome of the events was unknown.  Information on the batch number has been requested.; Sender's Comments: Based on the information currently available, the wrong technique in PREVNAR 13 administration might have played a contributory role in triggering the development of redness and cellulitis at vaccination site considering the close time association.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient developed ascending lower extremity weakness ultimately requiring hospitalization with clinical diagnosis of Guillain-Barre syndrome.
PATIENT RECEIVED BOOSTER DOSE OF MODERNA COVID-19 VACCINE 2 MONTHS EARLY.  LAST DOSE OF MODERNA COVID-19 VACCINE WAS 070821 AND BOOSTER DOSE WAS GIVEN 102621.
About 2-3 hours later, and my body was just swollen, the back of knees were swollen, my arm and body is swollen. Like the first dose it was my lymphatic system that caused the swelling. I have been having treatment (PT) for my arm 3 times a week to try and get the swelling down. I have seen Doctor on 01/11/2021 and 02/09/2021. Doctor was the one who put in the referral for home health. The PT and RN have been been coming out to my home to see me.
This spontaneous report as received from a Certified Medical Assistant refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. Additional information is not expected, because the reporter refused additional contact.
This is a spontaneous report from contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine, Formulation: Solution for injection, Lot Number/Expiration Date: Unknown), via an unspecified route of administration on Mar 19, 2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not have an allergic reaction to the first dose. She reported that she got her first dose of the vaccine on Mar 19, 2021 and tested positive for COVID on Apr 2, 2021. She had a monoclonal antibody infusion on Apr 3, 2021 as treatment. She stated on Jul 3, 2021, it would be 90 days since she had the infusion. She was calling to ask if it was ok to take the second dose, or if she needs to start over again. At the time of report, outcome of events was unknown. Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
VIVOTIF oral vaccine given at home eve of 2/28/13 as directed. VIVOTIF not prescribed at facility - it was prescribed at an outside travel clinic. Mother called facility A.M. of 3/1/13 to report that patient had swollen lips, was c/o chest tightness and throat discomfort. Mom instructed to give child BENADRYL (total 50mg given). Child was seen at facility in A.M. of 3/1/13. Chest & throat discomfort resolved following po BENADRYL. Patient did present with swollen facial lips in clinic.
"Moderna COVID-19 vaccine EUA"  Dose one: Soreness at injection sight with a one inch lump, Headache, nausea and vomiting.  Side effects started that evening and continued the following day. Dose Two: Soreness at injection sight, Nausea, Headache, Dizzy, Brain Fog and Chills. Side effects starts that evening and I still have them.  Ibuprofen is not helping the headache but is helping the soreness.
7/10/12 @ 7:35 -> pain reported by patient in left upper arm/deltoid area as well as both shoulders and neck. Left upper arm swollen, 4" length area of redness, warm and tight to touch. Left arm diameter at longest width about 13 1/2" compared to right arm diameter at same position about 11.75".  Swelling is uniform.
Patient with severe swelling, erythema, and pain to right deltoid area. Palpable hematoma.
normal arm pain as expected, while driving home felt pain spreading weakness in left hand, fine after a day.  after a few days left testical soreness comes and goes still occurs today even after 3 months. also left hip sorenesses hard to describe like a pinching pain inside depending on how i am sitting or standing never had this before started the same weekend in july when got the shot
Pt recvd vax 4NOV93 & from 20-28NOV had flu-like sx; cont to feel tired, but worked as scheduled; 19JAN sent home, t100, sore throat, & achy; 24JAN devel weakness w/pain & numbness in lower extremities, not able to urinate dx pneumonia
Patient received a Janssen vaccine although he had previously gotten two Pfizer vaccines at another facility. Patient responded he had never gotten a previous COVID-19 vaccine in the past on the prevaccination questionnaire.
Shingles; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. No information was provided regarding the pt's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On an unspecified date in 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for the long-term prevention of shingles and/or zoster-related conditions.  On an unspecified date (reported as "subsequent to inoculation"), the pt was hospitalized and treated for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the pt suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment and quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. Outcome was not recovered and causality was reported as related.  Additional information has been requested.
Information has been received from a certified medical assistant concerning a 36 year old female, with no medical history reported, who on 12/30/2005 was vaccinated IM with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot unknown). Concomitant therapy included montelukast sodium and budesonide (Pulmicort). On 12/30/05 th pt developed large swollen arm with redness and tenderness at the injection site. She also experienced chills and hot flashed. The pt called the doctor on call. The physician recommended the use of ice packs. The injection site reaction spread to the whole upper arm and she could not move the arm. The reporter and the doctor felt that the pts experience was serious because of the symptoms. Subsequently, by 1/4/06 ht pt got better but the arm was still tender. The clinical outcome was reported as recovered. No product quality complaint was involved. The pts experience, injection site reaction, swollen arm, redness and tenderness at the injection site, chills, hot flashes, could not move the arm, and arm still tender were considered to be other important medical events by the reporter (OMIC). Additional information has been requested.
VOMITING; NO HUNGER; "NOT ALL THERE" FOGGY; NAUSEA; FATIGUE; HIGH FEVER/BURNING UP; SEVERE HEADACHE CALLED AS MIGRAINE; BODY ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight was 68 kilograms, and height was 164.59 centimeters. The patient's concurrent conditions included back pain, neck pain, and methadone allergy, and other pre-existing medical conditions included the patient had no illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: paracetamol. On 14-MAR-2021, the subject experienced severe headache called as migraine. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced no hunger. On 14-MAR-2021, the subject experienced "not all there" foggy. On 14-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced fatigue. On 14-MAR-2021, the subject experienced high fever/burning up. On 16-MAR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe headache called as migraine, and high fever/burning up on 17-MAR-2021, and vomiting on MAR-2021, and was recovering from body aches, nausea, no hunger, "not all there" foggy, and fatigue. This report was non-serious.  The additional information was received from consumer/non health care professional on 23-Mar-2021. The following information was updated and incorporated into case narrative- patient demographics (patient height, weight, age at the time of vaccination and age group), methadone allergy, and no illness at the time of vaccination were added.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23. No concomitant medication was reported. The patient told the pharmacist that on an unknown date after receiving the PNEUMOVAX 23 vaccine, he or she then contracted pneumonia. No treatment information was reported. The outcome of pneumonia is unknown. No further information was provided. Additional information has been requested.
about 1 1/2hr p/vax began high pitch screaming cry, up all noc; present for almost 12 hr; maybe stopped 12-15mins p/1130PM but would start crying again; Saturday afternoon finally stopped crying slept 2 hr then would cry; dx OM
pt recv ax & w/in 24hr p/vax exp migraine pain & vomiting;pt is recovering;
Vaccine given on 9/12/13 at approx 3pm. Redness and swelling of (Lt) deltoid where admin the next day. (+) joint pain ever since with increasing intensity - worse today.