chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients).    Case contains the information regarding patient 2 of 100 reported.  Concomitant products were not reported.  Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, lot numbers unknown to the HCP.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
chest tightness, short of breath, uncontrollable shaking, headache, felt cold. Seen in ER same day: normal head CT, normal labs (CBC, CMP, TSH Sx resolved and discharged home.
The night of the vaccine I had muscle aches and I started gagging. The muscle aches were better in a few days. I went to the Emergency room the night of the shot.  I was diagnosed with a bladder infection. The urge to gag was constant. I was given some nausea medicine in the ER and it helped a little I became dehydrated after a week. I had no appetite and had the gag reflex problems for three weeks.  I was diagnosed with a kidney stone about three weeks after vaccination. My anxiety was also bad during that time. I have been feeling better, less anxious and eating more for the last two weeks.
This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 2-month-old female patient received PREVNAR 13, (solution for injection in pre-filled syringe, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at a single dose for immunization and PEDIARIX, via an unspecified route of administration on an unspecified date at an unspecified dose and frequency for immunization. The patient's medical history and concomitant medications were not reported. The patient developed a rash on an unspecified date. The outcome of the event was unknown.
Information has been received from a pharmacist referring to a patient of unknown age and gender. In approximately January 2012 (reported as "4 1/2 years ago"), the patient was vaccinated with the first dose of ZOSTAVAX (strength, dose, frequency, route, lot# and expiration date were not reported). In May 2016 (reported as "one month ago") the patient received a second dose ZOSTAVAX (inappropriate dose of vaccine administered). Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. Since 07-OCT-2015 (until the reporting time of 03-DEC-2015), the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L030592 with expiration date 12-FEB-2017, lot # L027634 with expiration date 21-JAN-2017, dose and route not reported). Information regarding concomitant medications was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
red at the site; itchy 2 spots that emerged on the other arm; swelling on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling on the injection site), VACCINATION SITE ERYTHEMA (red at the site) and VACCINATION SITE PRURITUS (itchy 2 spots that emerged on the other arm) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041LZQA) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (she got COVID 5months ago). Concurrent medical conditions included Asthma.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling on the injection site). On 01-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red at the site) and VACCINATION SITE PRURITUS (itchy 2 spots that emerged on the other arm). At the time of the report, VACCINATION SITE SWELLING (swelling on the injection site), VACCINATION SITE ERYTHEMA (red at the site) and VACCINATION SITE PRURITUS (itchy 2 spots that emerged on the other arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   treatment and medication history was not provided
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 9:21 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 11:32 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 73.21 for dose administered on 28-Feb-2021 and 73.29 for dose administered on 30-Mar-2021. No concomitant medications were reported. Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature 27 degrees Fahrenheit at 09:00 AM and 26 degrees Fahrenheit at 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  Batch number 019B21A underwent temperature excursion on 30-Mar-2021 with temperature 33 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 30-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Information has been received form a nurse referring to an unknown number of patients of unknown age and gender. Information about concurrent conditions and medical history was not provided. Since December 2014 the patients were vaccinated with PROQUAD (Merck) (lot # reported as K010796, expiration date 04-FEB-2016, dose, dose#, frequency and route not reported) which had been improperly stored (incorrect product stage). No information regarding concomitant therapy was provided. No adverse effects reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information is not expected as there was no consent for follow up contact.
Hot to touch at injection site; Itchiness at injection site; Redness at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     No medical history was provided. .  Concomitant products included ISOSORBIDE MONONITRATE, PANTOPRAZOLE, LOSARTAN, ACETYLSALICYLIC ACID (BAYER ASPIRIN), METOPROLOL and ATORVASTATIN for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE WARMTH (Hot to touch at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Student pharmacist mistakenly gave a third Shingrix vaccination. No treatments given or outcomes reported.
Lethargic, pale, dilated pupils, cold clammy skin; Rushed to Hosp;
Rotator cuff tear with no trauma, left supraspinatus full thickness tear, with no prior trauma, with worsening pain about one month after vaccine injection into that shoulder.
1025AM pt fainted p/vax followed by sz (less than 1min);BP 104/60, P98;1035AM nauseated-vomited;11AM BP 100/60, P52 & weak;1110AM vomited, P72;1120AM BP 100/60;1130AM BP 110/68, p60;1135AM pt to sisters home to rest & felt better
Myalgia, Arthralgia, Fever, UrticariaPruritus, Warm injection site, hives, body aches, chills, fever Narrative:
Mom called approx 1530 on 6/3/09 stating "my son got shots there yesterday now he is having an allergic reaction." Mom questioned as to what kind of allergic reaction child was having she stated "his leg where he got the shot is swollen and has a lump.  This never happened before. The lady that was there before told me this would be his last shot in the series."  I explained to mom that this is normal.  The child received a tetanus shot in the left leg, which was the one that was swollen.  I recalled the conversation I had with mom and dad about tetanus forming a lump in the muscle and the need to gently massage, cool compress today (6/2/09) and warm compress tomorrow (6/3/09).  Mom stated " I tried that it didn't work." I assured mom it may take more than one try to work the lump down. Mom said, " he cried last night, he never cries."  I asked if she gave Tylenol for comfort, she said "no he didn't have a fever".  I assured mom that Tylenol is also a pain reliever, and that his leg was probably sore from the shots.  Mom states, "no fever, no vomiting, no diarrhea. Child continues to eat and drink.  Mom told if continues to be concerned about childs condition by all means please seek medical attention at a doctor's office or nearest ER.  Mom encouraged to reread her VIS form.
A sister reported that her 46 year old brother received an injection of Tetanus Toxoid absorbed in 04/99 for a head wound. He subsequently experienced numbness of his elbows and legs, shortness of breath, falling, loss of balance an incoordination. As of 01/05/00, no further info was available.
Patient received vaccination at primary care appt. 7/14/09, was called with lab f/u on 7/15/09 when the patient reported her arm was swollen from about the shoulder to an inch above the elbow and hard and red.  AT ER visit 7/16/09 reported  experienced warm, red, and raised area on L shoulder, L upper arm, and L side of neck; pt. c/o burining pain in all of these areas. No c/o itching.
ENDED UP IN THE HOSPITAL; DEATH; This spontaneous report received from a consumer via a company representative from social media concerned 'multiple patients'. The patient's height, and weight were not reported.  No past medical histories or concurrent conditions were reported. The patients received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose were not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported and have been requested. No concomitant medications were reported.   On an unspecified date, the many patients got vaccinated and ended up in the hospital, and were hospitalized (date unspecified). The number of days of hospitalization were not reported. On an unspecified date, the patients died from an unknown cause of death. It was unspecified if an autopsy was performed. The cause of death was not reported. The action taken with covid-19 vaccine was not applicable. The patients died of death and ended up in the hospital on an unspecified date. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210844140, 20210844317 and 20210844359.; Sender's Comments: V0-20210846858-COVID-19 VACCINE AD26.COV2.S-Death and Ended up in the Hospital(Fatal); These events are considered un-assessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
A few days after my vaccine I got an ingrown hair on my left thigh. Within a day it developed into cellulities in a large area that required draining at a hospital and a five day course of antibiotics.
Cellulitis reported by patient who is also a nurse; Redness and swelling that spread under arm from injection site; This is a spontaneous report received from contactable reporter (Nurse) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM 197 protein) (PREVNAR 20) as DOSE NUMBER UNKNOWN, SINGLE (batch/lot number: unknown) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE CELLULITIS (medically significant), outcome "unknown," described as "Cellulitis reported by patient who is also a nurse; Redness and swelling that spread under arm from injection site." The event took place after use of the product.  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM 197 protein) has been requested and will be submitted if and when received.; Sender's Comments: A possibly contributory role of PCV 20 in triggering the onset of VACCINATION SITE CELLULITIS cannot be fully excluded, considering the temporal relationship. 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
RECEIVED 2.5 ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 27 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: 07-MAR-2022) 2.5 ml, administered on 21-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-NOV-2021, the patient experienced received 2.5 ml of the janssen covid-19 vaccine. On 21-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5 ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211220916, 20211220216, 20211220460, 20211220206, 20211220178, 20211220527, 20211220262, 20211220552, 20211220619, 20211220697, 20211220754, 20211220764, 20211219871, 20211219714, 20211219701, 20211219926, 20211219926, 20211220129, 20211220177, 20211220262, 20211220233, 20211220177, 20211220152 and 20211220146.
At 10 mins after injection pt c/o of nausea, dizziness and blurred vision. Given water and ice pack to back of neck. Pt. sat until able to walk. Moved to exam room. Pt. laid on exam table for at 20 min. Seen by MD at 1 hr after vaccine. Still had dizziness and blurred vision. BP was WNL at each check. Pt left at 2 hrs. Advised to see PMD if still feels bad. When pt left had slight blurry vision, no nausea, slight dizziness.
Symptom started about 12 hours after injection. Fast heart rate and fever, eventually going up to 103. Fever subsided about 1.5 days after the injection. Joints in my body started swelling. Pain in the joints, especially spine. The pain was enough that I almost went to the ER. The pain subsided 1.5 to 2 days after the injection.  Headache throughout until about 2 days after injection. I took multiple doses of acetomenifen, ibuprofen, and an ice bath to reduce the inflammation. It's been a few months and I still have painful, swollen lymph nodes on my right side. Injection site right shoulder. These symptoms were enough that I will probably avoid Maderna in the future.
Patient entered to observation after receiving the covid vaccine. started to report feeling dizzy and fainted. patient began to keel over, and was escorted by two nurses on the floor. Patient did not hit his head, and no sustain injury on the way down. Patient was placed on supine position with legs elevated. Peep breathing exercises encouraged. Vitals were initiated and recorder. Patient had a syncopal episode, responded to sternal rub. Patient lost consciousness again and once again responded to sternal rub. Vitals were initiated and EMS was activated. Patient vitals were stable with one orthostatic hypotension. Patient reported feeling better and refused to go to the hospital with EMS. Patient was escorted out of building visibly looking better, no pale noted, left site at 1:30 PM.
some excursions were discovered with ROTATEQ; No other adverse events reported; This spontaneous report as received from a physician and his clinical research coordinator and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies, historical drugs or medical history.      On an unspecified date, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) single dose, orally, lot # 1661000, expiration date on 13-MAY-2021 as prophylaxis (strength, dose, and frequency were not reported).        On unspecified dates, the administered dose of vaccine experienced the following temperatures of excursion: 1.6 degrees Celsius above the recommended storage for a maximum of 19 hours and 31 minutes and on a separate occasion it was exposed to 1.3 degrees Celsius above for a maximum of 16 hours and 49 minutes (Incorrect product storage). There was previous temperature excursion however it was not reported.
MOMENTARY ARM PAIN; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the patient experienced momentary arm pain. On 10-MAY-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from momentary arm pain, and fatigue on 10-MAY-2021. This report was non-serious.
Pt devel sensory sx in the feet & perineum about 1 wk p/receiving flu vax; pt noted numbness of the toes, which spread to feet & ascended to level of ankles; achiness in lower extremities; loss of sensation in perineal area;
Got sore arm same day, not bad.  Towards bedtime I got chills, went to bed. Got up during night to use bathroom, no problem. At 6:30 am the next day, I went to bathroom, got extremely dizzy. Had to crawl on floor to get to bed. Otherwise I would have passed out.