chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter informed that in the facility where she worked there had been temperature excursions with her freezer. It happened for weeks since April 2022. She stated that in total there were 49 patients affected, but this number was including the Pfizer vaccines that they had, so she was not sure how many patients were affected and received the Moderna Covid 19 vaccine. The patients received Moderna vaccine in the facility between 21-Apr-2022 to 18-Jun-2022. Storage condition at the time of the excursion was frozen. Expiration dates were unknown and lot numbers included 065K21A and 045L21A. Maximum temperatures reached: 30 Fahrenheit Degrees Minimum temperatures reached -18.9 Fahrenheit Degrees. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute. The vials were now stored in frozen. Visual inspection did not note any vaccine state change. Number of vials/doses impacted was not sure.  No treatment information was reported.
uncontrollable shaking for 30 minutes on the day of the vaccine, has happened 1-2 times since
received a third Bexsero; This case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (received 2nd dose at pharmacy this past summer and there was no record of it in database).   On 2nd December 2021, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd December 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The age at vaccination was not reported. The patient did not told that she had received her 2nd dose at pharmacy this past summer (in 2021) and there was no record of it in the database. The patient received 3rd dose of Bexsero, which led to extra dose administered. The reporter consented to follow-up.
after receiving shoT we wenT home and I kepT an eye on him because of family hisTory he sTarTed geTTing raspy at first I said maybe he caughT someThing buT he jusT kepT geTTing worse To fasT for a cold his sTomach sTarTed to hurT I gave him some sysrazine he sounded worse as Time wenT on I Took him back to Drs and Dr. (PA had done shoT) who gave me his # and sTronger for His sTomach
1-2 hours after receiving second vaccine injection, noted severe weakness and heavy feeling in legs. Had to leave work to go home. 2 days later noted onset of tongue numbness and unable to sip coffee. Noted progressive drooping left side of face, difficulty speaking clearly,  and tearing of left eye; also numbness and burning of tops of feet. Evaluated in the ED on 4/27/2021. Noted to have dysarthria and left facial nerve palsy.  CT head and MRI head demonstrated no hemorrhage, mass effect. On CT scan, intracranial vessel calcification noted c/w cranial atherosclerosis.  On MRI few nonspecific high T2-weighted foci within the subcortical white matter of the frontal lobes of uncertain clinical significance. Pt given scripts for Valtrex and 7 day course of steroids.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.).    This case contains information for the 32nd patient out of 77 patients as described by the reporter.  Concomitant medications were not reported.  It was reported that the vaccine was administered to 77 patients before it was known if the vaccine was ok to use after the excursion.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
9 x 6 cm red, raised, sore, warm to (R) arm.
client signaled to EMT  for assistance. Client was a 15 year-old male found sitting upright, alert and tracking and stating he was dizzy. Client had a chief complaint of dizziness. Client stated that he began to feel dizzy approximately "2-3 minutes" after his vaccination. Client denied falling and denied any injury. Client denied any allergies or past medical history. Assessment revealed no swelling, discoloration, hives, shortness of breath or other signs of anaphylaxis. Client stated that he felt dizzy but denied any pain throughout his body. Client appeared mildly pale but was alert and oriented to person, place, date and event. Client's airway, breathing and circulation were intact. Vital signs: pulse 78, O2 99%, Respirations 12, Blood pressure 118/82, Eyes equal and reactive to light, lung sounds clear bilaterally. Temperature 97.8. Client and his mother consented to an additional 30 minute observation. Client had a granola bar and juice while waiting and his color pallor subsided. After lying down for five minutes, client stated that he felt better. Remaining vitals were: 0945 - 99% O2, pulse 76, respirations 18, blood pressure 118/78, 1000 - 116/78, Pulse 70, respirations 16 99% O2, 1010 - 118/78, Pulse 76, Respirations 16, 99% O2. Client's mother was provided with all relevant information and instructed to seek medical care or the emergency room if signs of a severe allergic reaction occur later. No medications were administered.
Feeling of pins and needles in toes and fingers; This is a spontaneous report from a contactable consumer, the patient.  A 65-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 16:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not take any concomitant medications within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Apr2021 about a week after the first dose, the patient experienced feeling of pins and needles in toes and fingers for 2 weeks which started about a week after the first dose. The patient was unsure if to take the second dose of vaccination which was scheduled the next day otherwise felt fine. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the event. The clinical outcome of the event feeling of pins and needles in toes and fingers was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Unknown date of vaccination, physician asked for this to be reported, possibly related to Covid vaccine. Patient admitted to hospital with syncope and bilateral pulmonary embolism.  Patient treated and discharged home after after 2 days
Tachycardia Narrative:  PREVIOUS REPORT ID# on 1/7/2021: Originally reported as Moderate now this incident has been upgraded to severe as the employee states her symptoms have persisted and worsened continuing palpitations and significant tachycardia. She is now seeing a cardiologist (no prior cardiac hx but she is asthmatic). She states she has never tested + for COVID. Cardiologist's current diagnosis is paroxysmal tachycardia but is ruling out other possible etiologies. She has been on a heart monitor and her HR has been up to 210. She has been off work this entire time.
Patient was mistakenly administered a Fluzone quad influenza vaccine instead of Fluad for 65+.  Patient was informed of the error and advised that no further action needs to be taken at this time.
Tinnitus in right ear, sometimes shifts to left. Tinnitus has been constant since receiving the first vaccine. It seems to be getting louder. Received 2nd vaccine dose on March 13th.
Right arm vaccination with influenza was provided by the said providers.  Patient did not look at arm when vaccinated, did not need a band-aid after injection.  Seemed to have some pain at the time of injection. Regular soreness associated with injection occurred the next couple of days so tried to move arm to losen up.  Pain in right shoulder has been increasing since Tuesday September 28 2010.  Range of motion is decreasing.  Pain is getting to the point where it is noticable with any movement.  Pain is worst when lifting arms to change clothes, put up hair or sratch.  Now beginning to hurt when lifting anything heavier than 10 pounds with my right arm.  There is pain when she pushes down directly on the crease of right shoulder. Continued pain.  Worse in the morning.  No redness or inflammation where vaccination was given.  Tried IBU 600mg to help, but not.  - Patient was offered on 10/4 as soon as information was recieved about ADE to see provider, she declined at this time.
Within 2 hours of vaccine I started experiencing shortness of breath and my throat tightened up.  I tried to drive to the ER but stopped at urgent care since they were closest.  They found that along wit my breathing issues my BP was also running higher than normal.  I was given a steroid to get my breathing and BP under control.  I was released to go home, but told that if symptoms returned that I was to go to the ER immediately.  Given a 5-day prescription for Prednisone to keep future symptoms at bay.  The next few days my face and neck were very swelled, but I was able to breathe.  I was given the vaccination in my left arm, and my fingers have been swollen on my left hand.  The fingernails on my middle, ring, and pinky fingers are also very sore to the touch.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Information on pertinent medical history, drug reaction/allergies and concomitant medications were not reported. On 05-JAN-2018, the patient received improperly stored M-M-R II lot# N010496 with expiry date of 31-MAR-2019 for prophylaxis. No adverse effect was reported. Temperature/time frame: 9 C to 25 C (13.2 C) for 14 hours. There was no previous temperature excursion. The call was because of data logger.
Patient said she developed a pimple/ward looking mass on the arm of the injection. she reported to us it occurred about a month after the vaccinations. She said its hurts when she touches it.
21FEB97 mom noted small bumps in fold of lt arm-raised & spread also lt leg groin fold-hive like;24FEB97 rash same areas-pt scratching used DPH & Calamine lotion;
patient is 5 years old and received the 6month - 4year vaccine; patient is 5 years old and received the 6month - 4year vaccine; allergies; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 5-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2023 as dose 2 (maroon cap), single (Lot number: FX5095, Expiration Date: 30Jun2023) at the age of 5 years intramuscular, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Lot number: GD1857, Expiry Date: 30Sep2023, Dose: 01), administration date: 16Dec2022, when the patient was 5-year-old, for COVID-19 Immunization. The following information was reported: HYPERSENSITIVITY (non-serious) with onset Jan2023, outcome "unknown", described as "allergies"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), UNDERDOSE (non-serious) all with onset 18Jan2023, outcome "unknown" and all described as "patient is 5 years old and received the 6month - 4year vaccine".  Additional information: Reporter stated that the patient is 5 years old and received the 6month to 4year vaccine on 18Jan2023. Reporter stated that this was the patients only dose of the 6month to 4years vaccine. Prior to this vaccine the patient had received one dose of the Pfizer COVID Vaccine for ages 5-11. Reporter stated denies any other medications, medical conditions, labs, testing, or treatments for the patient relevant to report. States that all she sees are some allergies, does not provide any further information. Prior Vaccinations (within 4 weeks), list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was unknown; stated is uncertain about the time frame, if the vaccines the patient received on 16Dec2022 are within 4 weeks, Reporter states that the patient received that mentioned dose of the Pfizer COVID Vaccine for ages 5-11 on that day and also received a few other unspecified vaccines.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300015929 same patient/drug, different dose/event;
Initial unsolicited report received from a Nurse on 25-May-2018. This case involves a patient (age and gender not reported) who have not received all of the dose of MENACTRA (Batch number, expiry date, dose, dose in series, route and side of administration were not reported) as the needle came off the syringe on an unknown date. Patient's medical history and concomitant medication were not reported. It was a case of actual medication error due to vaccine underdose, occupational exposure to product and needle issue. It was unknown whether adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Swelling, redness L thigh-mildly warm to touch. Probable immunization reaction, but tx'd with Omnicef 250 BID x 10D to cover for possible cellulitis. The follow up received on 7/23/03 states Omnicef change to Duricef.
Rapid heartbeat and dizziness bordering on fainting.  Subsided somewhat when I reclined but re-occurred upon standing.  Lasted 3 hours until I went to bed for the night.  Symptoms did not keep me awake.
Arm swelled up greatly.  Red rash from wrist to the top of arm, spreading a bit to chest/ back.  Lasted about 2 weeks total.  Frist treatment was not working.  It was a cream and a pill.  I do not remember the name of either anymore.  Second treatment was a stronger cream and the same pill.  Took about 2 weeks to get the swelling to go down and the rash to go away.  There is still a rash and swelling that comes back from time to time.  It is random as ive noticed.  A knot where the shot was given will show up, raising about a quarter inch.
small rash on my upper right / few small red dots; pimple; This case was reported by a consumer via call center representative and described the occurrence of red rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced red rash and pimples. On an unknown date, the outcome of the red rash and pimples were recovered/resolved.   It was unknown if the reporter considered the red rash and pimples to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced small rash on my upper right chest area with a few small red dots and one of these patches got like a big pimple. The patient stated that the events disappeared several days later. The patient was wondering if can get the second dose or not.
She got her vaccine, it woke her up out of her sleep and woke up with loss of feeling in her thumb, middle finger, index finger and ring finger.  It's been a few months and now her feeling has not come back.  She first felt it was related to her sleeping on her arm or something, but then when she had this shot it happened again and feels it's related to the vaccine.  She cannot use her right hand well as she cannot tell if she is holding the leaf in her left fingertips or not, not able to open a bottle of water, etc.   She has not gone to a doctor for this, but does have an appointment with her PCP on 6/6/23.    She talked to somebody at church who had a similar reaction after he received his Shingrix vaccine.  She has not taken anything for her symptoms.  She rubs her fingers to try and get some feeling back.  Has tried other remedies and nothing has changed.
Pt recv vax & devel "severe, non-infectious inflammatory rxn @inj site.
No additional AE; Nurse reported 35-year-old patient received PROQUAD, instead of MMR II in her MMR/varicella series. Patient received both VARIVAX and PROQUAD yesterday. No additional AE/no PQC.; Patient received both VARIVAX and PROQUAD yesterday; This spontaneous report was received from a nurse and refers to a 35 year old female patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 20-JUN-2023 (also reported as yesterday), the patient was vaccinated with on dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # W024547, expiration date: 31-JAN 2024) upon internal review stablished as therapy type rHA (dose, route of administration, anatomical location not provided) as prophylaxis, instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) in her vaccination series (wrong product administered). On the same date, she received varicella virus vaccine live (oka/merck)(VARIVAX) (overdose) (lot #, expiration date, dose, route of administration, anatomical location not provided) as prophylaxis.  No additional adverse events were reported.
Pt received Tdap (Adacel) 2/11/15. Grand Mal seizure, witnessed. Sustained compression fx T7 during seizure. Since then has had 2 more. Negative CT, 2 MRIs.
Information has been received from an R.N. concerning a 19 year old female patient who on 09-JAN-2007 was vaccinated IM with a dose of GARDASIL (lot #653978/0955F) and felt dizzy and lightheaded. Medical attention was sought. At the time of the report the patient was recovering. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007.  Follow up information has been received concerning the 20 year old female student who on 09-JAN-2007 at 9:30 a.m. was vaccinated IM in left deltoid with her first dose of GARDASIL, lot #653978/0955P.  After the first injection, the patient felt faint.  On 06-MAR-2007 at 10:00 a.m. The patient was vaccinated IM in left deltoid with her second dose of GARDASIL, lot #655619/1427P.  After the second injection, the patient did faint.  She went out approximately 5 minutes, came to and then felt fine.  The patient stated she "does this for all injections, even eye drops".  She was reported as recovered on 08-MAR-2007.  Additional information is not expected.
pt recvd vax 15DEC92 & several hrs following the vax pt exp intermittent weakness, numbness & tingling in lt arm radiating to the hand, tightness in throat, weakness & generalized fatigue; presented to ER & had a nl neuro exam; anxious;
He had a history of presyncope and syncope since 2017. At that time, he had normal cardiac testing including serial ECG, Echo, and event monitoring.  Three days after his second COVID vaccine he started having progressive symptoms. He began having several episodes of dizziness. He started having palpitations, chest pain, and flushing that occurs at rest and with activity. These symptoms are newer and not the same as the symptoms he was experiencing in 2017.
Patient was given a Moderna booster vaccine, 0.25ml, from a vial that was opened more than 12 hours.  The vial was opened on 5/6/22 at 0900.  Patient was notified and returned to the office for another booster shot from a newly opened vial.  Pt did not have any adverse reaction.