chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ENTIRE body hurts. Joints, muscles; ENTIRE body hurts. Joints, muscles; ENTIRE body hurts. Joints, muscles; headache; Minimal pain at injection site; This is a spontaneous report from a contactable nurse (patient herself). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248; expiry date: unknown) intramuscular (left arm) on 07Jan2021 at 15:30, at a single dose, for COVID-19 immunization. Relevant medical history included hypertension (HTN), hypothyroid, and early pulmonary HTN. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899) intramuscular (left arm) on 17Dec2020 at 15:15 for COVID-19 immunization. The patient previously received bactroban ointment and experienced allergies. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 08Jan2021, at 5:00 a.m. the patient's entire body hurts, including joints and muscles and also had severe headache and minimal pain injection site (less sore than first shot). Patient confirmed that she did not have any of these symptoms with the first dose. Patient took ibuprofen but did not seem to help. Patient is a registered nurse working in a small, rural hospital. Outcome of the events headache and minimal pain at injection site was unknown, while for the remaining events was not recovered. The patient has not been tested for COVID-19 since vaccination.
It was like I had a COVID; It was like I had a COVID; It made me sick; Headache; I ran a fever; This is a spontaneous report from a contactable consumer or other non health professional (patient) via Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: AWO198) via an unspecified route of administration on 02Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She has not done her second one because she said, she had a reaction and she did not tell me what that reaction was and her question was can she still get the second vaccine, she does have the medical information phone number. She stated they got that in the system, it was all there, she called in and reported it. On an unspecified date in Jul2021, it made her sick, it made her have a headache, she ran a fever. It was like she had a COVID. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
the vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022 after 30 day Use By Date; No adverse event; beyond used date was on 24Sep2022 and they used it and made an error, Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (beyond used date was on 24Sep2022 and they used it and made an error, Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022 after 30 day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 9-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (beyond used date was on 24Sep2022 and they used it and made an error, Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022 after 30 day Use By Date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (beyond used date was on 24Sep2022 and they used it and made an error, Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022 after 30 day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (beyond used date was on 24Sep2022 and they used it and made an error, Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022 after 30 day Use By Date).    No concomitant medication were reported. It was reported that one of the vials beyond used date was on 24-Sep-2022 and they used it and made an error. Four patients were given doses from that vial (Monovalent). Individual vial of size 2.5 ml. The vial was initially stored in the refrigerator on 25-Aug-2022. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-651820 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-651820:same reporter
190 patients (9 different lot numbers) received a vaccine past the beyond; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender 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 an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond).    Concomitant medications details were not reported by the reporter.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   Treatment details were not reported by the reporter.  This case was considered for the 149 adult patient out of 190 reported who was received the vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Appearance of rash noted 9-13-06, located on left knee. Described as "lots of tiny dots clumped together to make large red area:. On 9-14-06, she noticed the rash had spread to bilateral tops of hands and forearms. Also located on stomach and back. Describes as very itchy. Complain of "electric sensation" occasionally along back- "similar to shingles pain". Denies fluid or blisters with rash. Afebrile.
Pt. reports drooping of his left eye and left lip, which lasted a few hours, one day after receiving his first dose of the COVID-19 vaccine.
Reporter states unclear whether this constitutes reporting but pt was seen w/in 24hr of vax for presumptive bacteremia & mild dehydration;
After the second Moderna Covid-19 immunization on 3/4/21 she developed swelling and significant soreness in the left arm which she felt was improving but then around 1 week later developed a very deep ache/tired feeling in the left arm from shoulder to elbow with stabbing needle sensation. Pain is constant and is worse at night which causes sleep disturbances.
3/2/2022 Mammogram revealed a complicated Cyst. Cyst on the left side, same as the vaccine injection. This is being monitored every 6 months. It has not grown or gotten bigger.
Dizzy, vomiting, upset stomach, fever, chills, weak- can't walk, some dissociation- difficult articulating what he's feeling, hands felt large, vision got tunneled.
Her upper arm was swollen, red and hot from the shoulder to the elbow in the arm she received the vaccines in. It is getting better but still slightly red and swollen. She has had the high dose flu shot before with no problems.
Woke in middle of night with bad headache and body/joint aches. All next day was extremely fatigued.
Sever Dizziness/vertigo  in mornings, then mild as day goes on.
Post-licensure Safety Surveillance Study of Routine Use of MENACTRA, trial code MTA30. Initial report received on 04/Oct/2005 from a investigator participating in the above-mentioned trial under the reference number MTA30. A 13- year-old male subject developed febrile illness with nausea, vomiting and fever one day after he received an injection of MENACTRA, lot number U1589AA. The subject received in concomitant an injection of DECAVAC, lot number U1565CA and Hepatitis A vaccine lot number 0202R. The subject took 2 Advil at 0430. He had vomited three times since 0300. The subject was seen in the emergency department on 06/Aug/2005. He has had a moderate fever and headache as well as complaints of nausea, vomiting and fever since receiving immunization the day prior. Right now he feels much better. His mother brought him to ER because his heart was beating (illegible). At 0820 an IV was started, with Ziofran. At 0915 - Mom was at her son's bedside and he was resting comfortably although was complaining of stomach pain. The subject still thinks he is hungry and it is causing abdominal discomfort. No PHM. Review of systems notable for fever, nausea/vomiting/diarrhea. Heart rate was regular rhythm and rate. A urinalysis on 06/Aug/2006 showed appearance-cloudy, blood-small, ketones - 40mg%, protein 100mg%, Bacteria - occasional, mucus - 2+, Blood tests showed creatinine low - 0.6 (normal 0.8 - 1.5), neutrophils high - 85% (normal 50 -70), Lymphocytes low - 5% 9 normal 20 - 70). The subject was discharged at 0950 with a diagnosis of fever, vomiting and diarrhea with instructions to follow-up with the pediatrician. The patient recovered. Documents held by sender: Laboratory Results (urinalysis, chemistry, CBC), 12-18 year old Adolescent visit Report. Pediatric and adult injection/treatment slip, Consent form x2, Emergency Department Physician Record, Medical Screening Exam, Medication Administration Record, Emergency Department nurse's notes, Emergency Department Triage form.
Vaccine administered on 12/17/12. Rash developed on leg noticed on 12/18/12. 12/19 leg hurt, neck, stomach, knees hurting 100 fever, mildly tender throughout leg. 17 x 8 cm erythema left lateral leg.
Fainting, nausea, vomiting, fever (102.7), headache, dizziness, hyperventilation, diarrhea, lethargy, pale skin, blurred vision. Patient had vasovagal fainting episode right after GARDASIL & MENACTRA. That evening developed fever, nausea & vomiting, hyperventilation went to the ER - next morning diarrhea started. Treatment: TYLENOL, rest, BRAT diet.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 20-Dec-2021; Covid-19 vaccine that were given beyond the 30 day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 20-Dec-2021) in a 46-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2022 at 8:06 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 15-Feb-2022 at 8:06 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 20-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 20-Dec-2021) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions. It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event. It was unknown if other vaccines were given on the same day as Moderna COVID-19 Vaccine to the patient. It was unknown if patient received other vaccines within one month prior to any dose of Moderna COVID-19 Vaccine. The 30 days Expiry date vaccine went into 2 to 8 °C thaw state on or about to 20-Dec-2021, this vaccine administered until its Mfg date of 04-Apr-2022  No treatment drug information was received.
Sudden rise in body temp and onset of uncontrollable shaking (could not hold thermometer in my mouth; had to put thumb and corner of pillow in between my teeth to keep from cracking a tooth). Managed to take 400 mg ibuprofen and about 75 min later shaking/chills mostly subsided; temp at that time was 100 degrees. Normal temp 97.3 - about 12 days before temp on waking was back to normal. Weakness in legs and dizziness first 5 days after vaccine. Sinus congestion, runny nose.
Sx: Perfuse sweating, loss of consciousness, vomiting, inability to answer questions, decrease in HR, loss of color to face.  Txt: HR, observation, patient remained seated as they were seated when they lost consciousness and were vomiting concurrently, 911 called, BP, HR taken Outcome: Post emesis patient regained consciousness within 2 minutes regained normal color and  was alert and oriented
Pt developed hard, erythematous abscess or right thigh 10 days after receiving Hep B immunization in right vastus lateralis. Slight temp, very painful area. Treated with KEFLEX q6h x 10 days & hot soaks to area.
SUSPECTED COVID-19 INFECTION; ARM HURTING FOR ABOUT 2 WEEKS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced suspected covid-19 infection, and arm hurting for about 2 weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm hurting for about 2 weeks and suspected covid-19 infection was not reported. This report was non-serious.
Pt received Influenza Virus Vaccine Inactivated Sanofi-Aventis lot number UI871AB the next day she noted a large bruise about 6-7 cm on site. The bruise was tender, swollen and itchy. She has not had any other symptoms and she notes that today she feels that the swelling is down and the tenderness and bruising is resolving.
I had shingles approximately 5 years ago on right head/face nerve stem. Received prescription med at the time for the outbreak (intended for early onset of shingles. Cant remember what. A couple of years afterward I was vaccinated for shingles with (ZOSTAVAX?). Last June received first shot of Shingrix since advertised as a more effective shingles vaccine.  On subject date (11/07/18) was vaccinated for flu (FLUARIX QUAD) and then received second SHINGRIX shot. Approximately 10-12 hours later developed a strong headache in area where i had shingles (along right top side of head). Went to bed.  Later woke up with Flu like symptoms. Series of severe chills and sweats cycles lasting all night. Very tired the next day like I had the flu. Fully recovered after a few days of rest. I am other wise in very good health.
Initial unsolicited report received from a consumer (patient's mother) on 9 June 2015. This case is linked with mother case (2015SA082748). A patient (age 0 day) received a dose of FLUZONE (batch number and site of administration not reported) during foetal life via transplacental route on an unspecified date in the year 2012. It was reported that mother had received FLUZONE intramuscularly in the year 2012 during pregnancy and her last menstrual period was not reported. Information related to medical history and concomitant medications in mother was not provided. On an unspecified date, patient was born with kidney failure. Laboratory investigations and corrective treatments were not reported. The gestation period at exposure, gestation period at onset of event and pregnancy exposure timing was not reported. At the time of this report the outcome of the event was unknown. Upon medical review, the case was considered as serious due to important medical event: Kidney failure. Documents held by sender: none.
right 2nd toe numbness that spread to great toe and then midfoot.  The next day the left foot was numb.  Some paresthesias in hands but that quickly resolved.  Right foot still feels "asleep" most of the time, regardless of positioning.  No weakness.
Fever range 103 F - 105 F for 48 hours. Crying (uncontrollable). Vomiting (48 hours). Poor appetite. Lethargy. Nodule and rash at injection site showing up after 10 days (painful).
In the next day or two after getting second shot, he developed itchy rash all over arms, trunk, he did not worry about it but it has persisted over 2 weeks now, presented to office - had printed an article about Morbilliform  Rash  (Dermatology On Line Journal  27:1:20)
suspected vaccination failure; received the full schedule of Shingrix on 2020, has experienced 2 episodes of shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's date of birth and vaccine data was not provided. The patient received full schedule of Shingrix in 2020. After receiving Shinrix, the patient experienced 2 episodes of shingles. This case was considered as suspected vaccination failure, since the details regarding, time to onset for event and laboratory confirmation were not provided.    The reporter consented to follow up.
2 in. raised area with redness reported by a nurse faint reddened area approximately 5 in. in dia. Skin is hot to the touch. Reddened area extends several in. down to the elbow. Pt reports fever, malaise and all over "not feeling well", itching. Pt has tried BENADRYL and hydrocortisone cream w/o result. Redness has spread further today but has been present since Sunday. Will f/u w/MD on 9/5/13.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. On 2nd August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site blisters and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site blisters and injection site pain were unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site blisters and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on an unknown deltoid and called back pharmacy on 8th August 2018 to report that the injection site was sore, red, and warm to touch. There was also reportedly a fluid-filled sack at the injection site which, according to the patient, moved around and changed sites on her arm each day. The reporter was uncertain of time of onset and progression of symptoms, but reported that the patient said her symptoms were still there.The pharmacist provided lot number M77B4 and expiration date of 8th August 2021, but he stated that he did not believe that was the lot number administered. He did not have access to the lot number which was administered. He had not seen the patient's arm.
Case number PHEH2014US021048 is an initial spontaneous report received from a nurse on 17 OCT 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413601) intramuscularly on an unknown date. It was reported that she did not receive any vaccine because it ran down her arm when it was administered. The nurse stated that on 09 OCT 2014, the patient had a knot at the vaccination site and it was warm to touch. The outcome of the events was unknown. The seriousness and causality of the events was not reported.