chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna shot and inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage; They used two vials from the freezer after 30 days to administer them to 4 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They used two vials from the freezer after 30 days to administer them to 4 patients) and PRODUCT STORAGE ERROR (Moderna shot and inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They used two vials from the freezer after 30 days to administer them to 4 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna shot and inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They used two vials from the freezer after 30 days to administer them to 4 patients) and PRODUCT STORAGE ERROR (Moderna shot and inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Reporter stated that it was notified to them that their upright freezer (two separate doors for freezer and fridge) was not good to use after 30 days. They normally pull the vials out before the 30 days to thaw. Reporter further stated that they wanted to have a stand alone freezer because of an automatic defrost cycle on some two door freezer/fridge combinations.  The vial was initially stored in the refrigerator on 17-May-2022 (1 vial) and 19-May-2022 (1 vial). The temperature had not gone out of range at all, and the vial did not undergo any temperature excursions  Reporter further stated that the patients had not contacted them about any problems.  No treatment medication were provided.
On the same day that I received vaccine I had a 102.9 fever for 5 days, I couldn't sleep felt like I got hit by a bus with aches and pains and all that stuff and that went on for longer than 5 days.
Information has been received from a physician concerning a 63-year -old female patient who on 19-JAN-2007 was vaccinated with a dose of Zostavax (lot# 652947/1411F). Subsequently, on an unspecified date following vaccination, the patient developed a "hive like reaction, no vesicles" on one side of her face. Unspecified medical attention was sought and she was treated with BENADRYL. It was reported that the patient recovered. No product quality complaint was involved. Additional information has been requested. 06/22/2007 This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a physician concerning a 64-year-old female patient with allergies to sulfa, penicillin, DEMEROL  and clindamycin, who on 19-JAN-2007 in the pm was vaccinated subcutaneously in the left arm with a dose of ZOSTAVAX (Oka/Merck) (lot# 652497/1411F). Subsequently, when the patient awoke the day following the vaccination, the patient had developed a "hive like reaction, no vesicles" on one side of her face and swelling over the left side of her face was reported. She also reported localized swelling on her left arm. Unspecified medical attention was sought and she was treated with BENADRYL. It was reported that the patient's face swelling resolved after 3 days and the arm swelling resolved after 7 days. The "hive-like" reaction recovered on an unspecified date. No product quality complaint was involved. Additional information is not expected.
It was determined there was a preparation error on 1/19/23. Between 4-5 individuals received Moderna 6 month to 5 years monovalent formulation. Preppers unintentionally prepared 1 vial of the 6 months to 5-year monovalent formulation (with volume of 0.5 ml per dose) and labeled it as a Moderna 12+ years bivalent formulation. There was a total of 14 patients scheduled to receive the Moderna 12+ years bivalent on 1/19/23. The clinic is unable to determine if patient received the correct bivalent dose versus the Moderna 6 month-5 years monovalent formulation.   Information about other Moderna formulation: Moderna 6 months to 5 years monovalent dose, Lot AS1414B, manuf. exp 2/13/23.  Patient has been notified of vaccine error that may have potentially impacted her. No reported signs/symptoms of adverse reaction.
Temperature Excursion: Pfizer adult dose (purple top) remained in the freezer 21 days past the 2 week limit (-13 F to 5 F) and was administered to patient; no known symptoms, signs, or concerns were reported.
Information has been received from a physician concerning a 20 year old female with no medical history reported, who on 01-APR-2008 was vaccinated with a dose of Gardasil.  On 05-APR-2008, the patient died four days after receiving Gardasil.  The patient sought unspecified medical attention.  An autopsy was performed which ruled out suicide and anything suspicious.  The cause of death is currently unknown and they are performing toxicology tests to try to determine the cause.  No product quality complaint was involved.  The reportable physician considered death to be immediately life-threatening and disabling. Additional information has been requested.7/14/08-autopsy report received-COD:Undetermined. Died unexpectedly while working as a health aid. Postmortem examination reveals focal nodular hyperplasia in liver; this finding though significant, cannot accoutn for sudden death. There is no evidence of pregnancy. Toxicology analysis negative. Based on history, autopys, and toxicological examination, cause of death is undetermined.
Within 2 or 3 days I developed tinnitus. It was a white noise kind of buzzing. It seems to be there all the time at a nuisance level and has not gone away or receded as of this date 5-29-22. It did not seem to get any worse when I received the second Moderna Covid shot, or the booster shot.
A 15-year-old received a Pfizer booster shot. We followed-up the day after patient received the injection. Patient's guardian claims she is only experiencing a sore arm and no other symptoms.
Patient received the 1st dose of Shingrix on 30 Jun 2019 and a late 2nd dose on 25 May 2023.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 2HC4L, expiry date 09-JUL-2024) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30-JUN-2019).   On 25-MAY-2023, the patient received the 2nd dose of Shingrix. On 25-MAY-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Patient received the 1st dose of Shingrix on 30 Jun 2019 and a late 2nd dose on 25 May 2023.). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 26-MAY-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email or postal. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
Client received a second booster dose of Janssen.  There were no adverse reactions, no treatment required.  Outcome of client is stable with no adverse reaction.
warm to the touch; injection site pain re-emerged; injection site redness; pain at the injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (pain at the injection site), FATIGUE (fatigue), VACCINATION SITE PAIN (injection site pain re-emerged) and INJECTION SITE ERYTHEMA (injection site redness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (fatigue). On 26-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (injection site pain re-emerged) and INJECTION SITE ERYTHEMA (injection site redness). On 18-Jan-2021, VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (fatigue) had resolved. At the time of the report, VACCINATION SITE WARMTH (warm to the touch) outcome was unknown and VACCINATION SITE PAIN (injection site pain re-emerged) and INJECTION SITE ERYTHEMA (injection site redness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication is not reported No treatment drug has been reported.   This case was linked to MOD-2021-029943 (Patient Link).
Feet and legs have been swollen; After the 1st dose she had issues with her right foot; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (After the 1st dose she had issues with her right foot) and PERIPHERAL SWELLING (Feet and legs have been swollen) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced LIMB DISCOMFORT (After the 1st dose she had issues with her right foot). On an unknown date, the patient experienced PERIPHERAL SWELLING (Feet and legs have been swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (After the 1st dose she had issues with her right foot) and PERIPHERAL SWELLING (Feet and legs have been swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information include 2 different antibiotics.   This case was linked to MOD-2021-218760 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up received by safety 02-Jul-2021 included a TCR: HCP details provided.
Information has been received from a healthcare worker concerning a male who in 2003 was vaccinated with PNEUMOVAX and developed what was thought to be cellulitis. The patient was suing the facility claiming he developed REITERS syndrome from the cellulitis that required back surgery and a long, painful recovery. His lawyers are making claims against the clinic including "dirty needles". The patient went to office and specialist for medical attention. At the time of the report, the patient's status was unknown. Upon internal review, REITER'S syndrome and cellulitis were determined to be other important medical events. This is one of several reports received from the same source. Additional information has been requested.
A few weeks after booster had rapid heart beating and high BP also pressure in L ear and head. Numb feeling in head.
First noticed redness, hot to the touch, swelling, rash around injection site and down left arm to above the elbow on Tue. 5/18.  Thought it was a bug / spider bite so treated it accordingly.  By Fri. 5/21, it had not gotten better so reported it to V-Safe after identifying the symptoms online as "COVID Arm".  Started approximately 6 days after the vaccine was administered.  Information online states that  symptoms should be gone after a couple days but it has now been a week since they first appeared.  Left arm is getting  better but rash is still visible above the elbow with some tenderness and a little warm to the touch.  I wanted to report this due to the length of time I have had it and how long it is taking to clear up.
got a rash on his legs; This is a spontaneous report received from a contactable consumer. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient got eh first dose as well a week before and he's got a rash on his legs on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
became very pale and weak and could not stand and had agonal yawning approximately 15 minutes after administration of immuniztions.
20 MINUTES AFTER VACCINATION PATIENT COMPLAINED OF FACE SWELLING AND FEELING FUNNY.  I SAT WITH HER FOR AWHILE AND I DID NOT WITNESS ANY SWELLING, HIVES, RASH, OR TROUBLE BREATHING. SHE DID NOT COMPLAIN OF ANY ITCHING. SHE DECIDED TO GO TO URGENT CARE BEHIND THE PHARMACY.
Vaccine administered on 07/17/2002. Mom returned to clinic on 07/19/2002, Right thigh showed 6X 5 in induration w/ noticiable itching. Prescribe Westcort
"Serious Pruritus" - All Over Body/Itchy Sensation - All Over Body; Rash-All Over Body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS ("Serious Pruritus" - All Over Body/Itchy Sensation - All Over Body) and RASH (Rash-All Over Body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PRURITUS ("Serious Pruritus" - All Over Body/Itchy Sensation - All Over Body) and RASH (Rash-All Over Body). At the time of the report, PRURITUS ("Serious Pruritus" - All Over Body/Itchy Sensation - All Over Body) and RASH (Rash-All Over Body) outcome was unknown.        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.   The patient's medical history  and relevant concomitant medications weren't reported Treatment information was not provided
I felt a heaviness/weakness in both of my legs almost immediately.  This lasted for about 48 hours then I felt better.  Then 10 days later I started feeling shocks and weird pains in my legs off and on for 6 days. I then started feeling weakness in my legs. It has gotten worse now at 21 days out plus I feel a weakness in my arms as well. I also am having trouble sleeping and feel some shaking in my legs at night.
Information has been received from a nurse practitioner concerning a 71 year old female patient with no known drug allergies, hypertension, hyperlipidemia, hypothyroidism, sleep apnea, osteoarthritis, diverticulitis, and anemia and a history of breast cancer, left total knee replacement and childhood chickenpox who on 20-FEB-2008, was vaccinated SQ in the left arm with a 0.65 ml dose of ZOSTAVAX (Merck) (lot number 658838/1412U).  Concomitant therapy included lisinorpril (manufacturer unknown), hydrochlorothiazide, lovastatin, LEVOXYL, INDERAL and aspirin.  There was no rash at the site of injection or elsewhere within 42 days of the vaccination.  Subsequently, on 04-MAY-2009, the patient developed shingles.  The patient had a vesicular rash with multiple lesions on her left breast to her mid back.  Her maximum temperature was 98.6 F.  The patient's pain was rated 8-9 on a scale from 0 to 10.  There was no recent exposure to chicken pox or shingles.  Medical attention was sought at an Urgent Care Clinic, as the patient was out of town when this occurred.  A specimen was not collected for PCR analysis because the lesions had dried up at the time of follow-up.  At the time of the report, the patient was recovering.  Additional information is not expected.
Severe headache and dizziness after Gardasil Shot! 9/29/09 Medical records received from dates of service 2/2/09 to 8/24/09 PCP, Allergist, ENT, Neurologist. Patient seen by PCP 2/2/09 DX:sinusitis. Presenting with HA.  3/9/09 and 3/18/09 visits no change and C/O HA. 3/24/09 Allergist consult, normal findings. 4/05/09 Neurologist consult DX: tension HA or mixed migraine HA cannot be ruled out suggest to see a specialist for TMJ for clicking in jaw. 4/20/09  and 4/30/09 PCP visit DX:allergic Rhinitis. 5/6/09 ENT consult DX: reccurent sinusitis.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 18th February 2019, the patient received the 1st dose of SHINGRIX. On 19th February 2019, 1 days after receiving SHINGRIX, the patient experienced pain in arm, erythema, swelling, myalgia, fatigue, headache, shivering, fever and gastrointestinal symptom nos. On an unknown date, the outcome of the pain in arm, erythema, swelling, myalgia, fatigue, headache, shivering, fever and gastrointestinal symptom nos were unknown. It was unknown if the reporter considered the pain in arm, erythema, swelling, myalgia, fatigue, headache, shivering, fever and gastrointestinal symptom nos to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 67 or 68 years old. The patient went to bed at 8 pm.  Did not consent to follow up.
"day p/DTP/OPV/HIB recvd ran t102, vomiting "quite abit", continues today 30OCT91, nasal & chest congestion;
Information has been received from a licensed practical nurse concerning a 20 week old male who was vaccinated with his first dose of ROTATEQ vaccine live (human-bovine). Medical attention was sought in the physician's office. There was no product quality complaint. Additional information has been requested.
Local reaction to pneumovax.  Erythema/induration of skin left deltoid region, moving down to just above elbow.  Started 6 hours after injection.  Prescribed medrol pack, keflex, and lortab.
Information has been received from a physician concerning a 16 year old male patient, with no pertinent medical history and no known drug allergies, who on 17-MAY-2011 was vaccinated with his first dose of GARDASIL (Lot #, dose and route not reported). Secondary suspect administered on the same day included: the second dose of VARIVAX (Lot #, dose and route not reported). Concomitant therapy included the first dose of MENACTRA. Physician stated he always had the patient lying down on the table when vaccinations were administered. He waited at least 20 minutes after the vaccinations were administered and then had client sit up, stand up, and assisted walking him to the waiting room. In a few minutes doctor looked out at the waiting room and noticed client was pale, clammy and when checked his pulse was thready. Physician stated he had patient lying down and raised his legs, and monitored him until patient's pulse was normal and he had recovered. Physician stated he did not believe the event was a vasovagal episode. Physician reported that patient was in his office for approximately 50 minutes. He reported he even assisted patient into the elevator and downstairs into the car. Physician confirmed that on 17-MAY-2011 patient fully recovered from the events. Additional information has been requested.
Shot was give immediately became warm to touch, inflammation more than the size of a quarter. Pt was given BENADRYL & MOTRIN per Dr.
3 degree fever for approximately  6 hours, gout type symptoms of pain in both left and right ankles and feet which resulted in being forced to crawl on floor to move around house for approximately 15 hours before being able to use walker to be ambulatory
Received booster dose they gave me 0.5ml, they didn't give me 0.25ml; Lymphedema; Swollen arm; Bad sleep at night; Whole face is red / chest is red; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (Lymphedema), PERIPHERAL SWELLING (Swollen arm), INSOMNIA (Bad sleep at night), ERYTHEMA (Whole face is red / chest is red) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer (NOS) (Had cancer twice), Autoimmune thyroid disorder and Asthma. Concomitant products included TAMOXIFEN for Cancer (NOS).   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OVERDOSE (Received booster dose they gave me 0.5ml, they didn't give me 0.25ml). In December 2021, the patient experienced LYMPHOEDEMA (Lymphedema), PERIPHERAL SWELLING (Swollen arm), INSOMNIA (Bad sleep at night), ERYTHEMA (Whole face is red / chest is red) and PYREXIA (Fever). On 10-Dec-2021, OVERDOSE (Received booster dose they gave me 0.5ml, they didn't give me 0.25ml) had resolved. In December 2021, PYREXIA (Fever) had resolved. At the time of the report, LYMPHOEDEMA (Lymphedema), PERIPHERAL SWELLING (Swollen arm), INSOMNIA (Bad sleep at night) and ERYTHEMA (Whole face is red / chest is red) outcome was unknown.            Concomitant products used included Tamoxifen to prevent estrogen from cancer, thyroid medicines and immunomodulator.  No treatment medication was provided.
The patient presents with URI symptoms for since 10/31.        Symptoms include nonproductive cough, sneezing, stuffy nose, "different voice".
? Saturday/ Sunday  4/17/21 - 4/18/21 Arm pain Dull headache  Light nausea  Tiredness  Lip twitching  ? Tuesday  4/20  Worse Headache  Worse Nausea  Loss of appetite  Brain fog Pressure in head Sholder/neck pain Skin sensitive   Skin sensitivity to touch lasted a month   Went to urgent care but can't rember what day