chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021 at 3:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Oct-2021 at 3:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.  It was reported that the vaccine was at frozen storage condition at the time of the temperature excursion. Excursion duration was 1 month. On 19-Nov-2021, the Moderna COVID-19 vaccine vial went from the super cold freezer to the refrigerator. The vaccine was returned to the freezer/refrigerator/ultra cold freezer, or maintained at room temperature. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened. The patient was given doses from a vial that were stored in an ultracold freezer which is colder than they should have been.
Patient noticed red rash, warm to the touch on left upper arm / rash was slightly raised and itchy.
client waiting in post-vaccination area and started to have difficulty breathing. Post-vaccination nurse notified Vaccination Team Lead. After 1 minute, difficulty breathing did not decrease, client also reported a metallic taste in mouth. Reaction at 9:32, EAMS called 9:33, Epinephrine administered at 9:34 in right arm, IM. 0.5mL administered per protocol. EMS arrived 9:37. Client placed on stretcher and transfer of care to EMS at 9:43.
Since receiving the vaccine, I have no had my menstrual cycle. I took two pregnancy tests and both came back negative and my husband is sterile, due to his vasectomy he received 6 months ago. It has been two months since my last menstrual cycle which was right before I got vaccinated.
pt says she had a few episodes of feeling dizzy before having a stroke.  Pts right hand became numb, she had some confusion, she was nauseated and had a severe headache several days prior to going to the emergency room.  On 3/28/21 her face was dropping on the right side so was brought ER.  She was admitted and given CT and multiple test.  She was treated for a Stroke and stayed for about 3 days.  She was discharged to FU w/ Neurologist next week.
5 minutes post vaccination, patient became pale, cool, clammy, lethargic, lips blue with brief loss of consciousness (15 seconds). When regained consciousness pt. reports continued dizziness & ligh-headedness. Assisted to floor, legs elevated. V/S 110/70, 71-HR, 96%-O2, A&Ox4. EMS activated. Upon EMS arrival EKG, orthostatic VS, and FSBS taken, all reported to be WNL, with BS being low normal @ 66. EMS administered PO glucose tube, FSBS rechecked by EMS, 78. Patient reports to no longer feeling dizzy or lightheaded, declined to go to hospital, left site with mother.
Sore throat for several days and sinus congestion felt run down sx stayed thru mid Dec.
On April 25th, I woke up with a dry scaly rash on my face in several areas.  Over the course of the last several months, this rash along with bumps that resemble mosquito bites have appeared and healed over a couple of weeks, then appeared again and again.  Both scaly areas and welts are very itchy.    On July 13, I was seen at the doctor listed above where a biopsy of one of the scratched welts was taken; requiring 2 stitches.  Nothing of merit was found.  I have since broken out with the same rash again all over my body.  It is primarily the red welts and is very itchy.  Almost all welts appeared at once this last time while I was in my car driving home from work.  I have pictures of many of them taken that evening.   It was recommended that I return to the doctor for another biopsy.  I was told not to scratch the welts prior to that appt.  That proved to be next to impossible.  The appt was to be on July 29th; however, currently, all welts are scabbed over and healing so I cancelled the appt.  Additionally, the area where the welts have been leave what looks like a hole in my skin causing some scarring.   (I have picked at them as I would have any other blemish and have never had this result)
Information has been received on 04/29/2004 from a registered nurse concerning her 3 year old son who two weeks ago, was vaccinated with varicella virus vaccine live (Oka/Merck).  Subsequently, the patient developed a hot , swollen injection site lesion the size of a quarter.  Hospitalization was not required.  Unspecified medical attention was sought.  No product quality complaint involved.  It was also reported that about one year ago the patient was vaccinated with measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, and had an injection site reaction.
my arm hurt; This spontaneous case was reported by a non-health professional and describes the occurrence of MYALGIA (my arm hurt) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 006C21A) for COVID-19 vaccination.     Concurrent medical conditions included Epilepsy. Concomitant products included LORAZEPAM (ATIVAN) for Epilepsy, CARBAMAZEPINE (TEGRETOL) and CLOBAZAM for an unknown indication.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-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 MYALGIA (my arm hurt). At the time of the report, MYALGIA (my arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided.  Patient  provided he has a history of Epilepsy, but normally has  lot of energy. He stated he took his pre-workout mix and was still needing to take naps, usually gives him a lot of energy.   This case was linked to MOD-2021-230006 (Patient Link).
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 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 2:04 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021, 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 21.24.  Concomitant products were not provided.  On 12-FEB-2021, Excursion time was 09 AM, temperature was 29, 10 AM, temperature was 35, 11 AM, temperature was 35, total doses given for the day was 55, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-FEB-2021, vial was moved to clinic on 12-FEB-2021. 3 vials were sent to clinic. Vaccine BUD date was 10-MAR-2021.  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 Fisher brand 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.   This case was linked to MOD-2022-566976.
severe shooting leg pain; injection site soreness; condition aggravated; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included leg paralysis (partial) and nephropathy (peripheral).   On 25th June 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 26th June 2019, 1 days after receiving Shingrix, the patient experienced injection site pain, condition aggravated and leg pain. On 27th June 2019, the outcome of the injection site pain, condition aggravated and leg pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, condition aggravated and leg pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The patient experienced injection site soreness and severe shooting leg pain in her right leg.  The reporter consented to follow up.
Date place in refrigerator was 18Oct2021.; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Date place in refrigerator was 18Oct2021.) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date place in refrigerator was 18Oct2021.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Date place in refrigerator was 18Oct2021.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date place in refrigerator was 18Oct2021. Patient did not experience temp excursion and any adverse event
Received Varicella shot #2, 22 days later rash/fever began. Hospitalization for IV ZOVIRAX therapy due to hx of immunocompromised status and steroid therapy. Hospital notes sent with form also. Dx with post-vaccination varicella illness.  6/27/08 Reviewed hospital medical records of 5/3-5/4/2008. FINAL DX: varicella, chickenpox Records reveal patient experienced fever & rash approx 3 wks s/p vaccines.  Month prior had exacerbation of Crohn's disease & steroids increased.  Rash was mostly papular over trunk & head w/excoriation & scabbing & erythema over chest.  Admited to monitor due to immunosuppression.  Case reviewed w/GI & ID.  Tx w/IV antivirals, decreased of steroids & antibiotic ointment.  Improved & d/c to home on continued oral antivirals w/instruction to resume methotrexate & increase steroids as lesions crusted & cleared.
Everybody else I know that got the vaccine couldn't move their arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Everybody else I know that got the vaccine couldn't move their arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Everybody else I know that got the vaccine couldn't move their arm). At the time of the report, LIMB DISCOMFORT (Everybody else I know that got the vaccine couldn't move their arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received on 30-JUN-2021 contains no significant information.
Really bad hurting in chest pain, swollen lips and a headache. Had to go to ER.  Forgot to mention the vaccine shot. They finally decided it was an allergic reaction. Gave a steroid shot and Benadryl. Sent home on steroids for 5 days. The next day had rash and itching. The next day it was worse looked like lace pattern rash over most of his body and really bad itching. Like this through the 20th then he took Claritin and put on anti -itch cream. The next  day the rash had mostly cleared but still a little itchy. Today the 22 I have had a really bad headache.
SWEET SYNDROME; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age, race, ethnicity and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced atypical presentation of Sweet syndrome with nodular erythema and oral ulcerations. The patient was vaccinated 7 days prior to the first symptoms experienced by the patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sweet syndrome was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000280091.; Sender's Comments: V0: 20230449728-Sweet syndrome. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Arm redness, swelling. Developed 7d after vaccination and appearance consistent with cellulitis.
This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. On 14-AUG-2017, the patient was inadvertently administered a dose of GARDASIL, lot reported as: L012190, expiration date: 13-APR-2017, for prophylaxis.  No adverse effects were reported in the patient. Lot number: L012190  has been verified to be a valid lot number for GARDASIL.
Burning sensation inside entire body; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the right arm on 10Aug2021 at 08:45 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included hashimotos disease, melanoma and allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) from an unknown date for an unknown indication and unknown if ongoing. The patient previously took clindamycin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Aug2021 at 23:00, the patient experienced burning sensation inside entire body. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event burning sensation inside entire body was not recovered at the time of this report.
Had a fever; fever was terrible/ Had fever again; I had so many blankets on top of me still I was cold; Headache; Weakness; I had a terrible experience last night; Sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 21Nov2021 21:00 (Lot number: FH8027) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 21Nov2021 21:00, outcome "recovering", described as "Had a fever; fever was terrible/ Had fever again"; NASOPHARYNGITIS (non-serious) with onset 21Nov2021 21:00, outcome "recovering", described as "I had so many blankets on top of me still I was cold"; HEADACHE (non-serious) with onset 21Nov2021 21:00, outcome "recovering", described as "Headache"; ASTHENIA (non-serious) with onset 21Nov2021 21:00, outcome "recovering", described as "Weakness"; OROPHARYNGEAL PAIN (non-serious) with onset Nov2021, outcome "recovering", described as "Sore throat"; FEELING ABNORMAL (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "I had a terrible experience last night".  Additional information: Consumer stated, he had second dose of Pfizer (COVID 19 Vaccine) yesterday noon, he got the second done noon, by 9 pm  had a fever, headache, weakness, the fever was terrible though like  had so many blankets on top of me still I was cold. So, by 5 am the fever was out, was gone and then now had fever again since lets say 5 am like as of now he had a fever and a sore throat. The patient asked what he needs to do. Consumer further stated, he cannot have, he had a terrible experience last night, cannot have it again. He does not know what to take, should he take Nyqul, Tylenol, Ibuprofen. Consumer was suggested to visit Emergency room in case of emergency and informed the role of Pfizer Drug Safety and Pfizer Medical Information again. consumer who stayed he has not fully recovered.  No follow-up attempts are possible. No further information is expected.
This report describes autism in a male child of unspecified age who was vaccinated with Infanrix for prophylaxis. This report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject received an injection of Infanrix on 6/10/97. He also received injections of Tri-Immunol; 8/12/97 and 2/24/98, hep B vaccine 12/27/96 and 3/5/97, Hib-Titer 6/10/97, 8/12/97 and 1/14/98. The subject's attorney alleged that "As a result of the mercury in thimerosal-containing vaccinations received during those developmental years, the subject now suffers, and in the future will continue to suffer from the toxic neurological effects of his mercury poisoning, including but not limited to autism." The mercury poisoning and autism in this report are considered to be medically serious (OMIC).  Follow up on 12/08/03: "Following the administration of GSK vaccines, the subject experienced five upper respiratory infections, two episodes of left otitis media, pharyngitis, and one episode of bilateral otitis media.  Those were not reported as adverse events due to vaccine administration, but were found during the course of review of the subject's medical records.  Therefore, they are not listed as adverse events.  The most recent info received on 11/21/03 did not provide the outcome of the alleged events. The mercury poisoning and autism in this report are considered to be medically serious by GSK."
Patient received vaccinations at approx. 0930 and left facility without incident. At 10:00am phone call received from mother stating child had broken out in red rash on face and abdomen and was scratching at her skin. Advised parent to seek medical attention immediately for possible allergic reaction.
Pt has probable POTS which worsened immediately after receiving flu and HPV #3.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site warmth (injection site feels warm), rash macular (bright red spot at injection site and it's spreading), vaccination site pain (soreness in arm) and vaccination site swelling (swelling at injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 004M20A) for COVID-19 immunization. Concomitant products included temazepam and omeprazole for an unknown indication. On Jan 27, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 27, 2021, patient experienced vaccination site pain (soreness in arm). On Feb 3, 2021, patient experienced vaccination site warmth (injection site feels warm), rash macular (bright red spot at injection site and it's spreading) and vaccination site swelling (swelling at injection site). On Jan 28, 2021, vaccination site pain (soreness in arm) resolved. At the time of the report, vaccination site warmth (injection site feels warm), rash macular (bright red spot at injection site and it's spreading) and vaccination site swelling (swelling at injection site) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No treatment information provided.
Sore, red, swollen injection site (for 4 weeks after 2nd shot, but for only 1 week after 1st one); fever (short duration); fatigue; headache on day 2 only; joint pain; nausea
Swelling for several and a tight feeling around a large area where the vaccine was shortly after the shot was given (maybe a few hours to a day) I normally have some swelling so thought nothing of it. It then started itching itching is reduced that subsided and now I have a large red rash around my arm that looks a bit like a lymes disease ring rash.
High fever (102) 36 hours after injection, weakness, nauseous, body aches, head ache