chrisvoncsefalvay/vaers-outcomes huggingface dataset:
not able to receive the second dose of the vaccine as the Moderna COVID19 vaccine; COVID19; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Dec-2021 and was forwarded to Moderna on 23-Dec-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID19) and PRODUCT DOSE OMISSION ISSUE (not able to receive the second dose of the vaccine as the Moderna COVID19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced COVID-19 (COVID19). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not able to receive the second dose of the vaccine as the Moderna COVID19 vaccine). At the time of the report, COVID-19 (COVID19) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (not able to receive the second dose of the vaccine as the Moderna COVID19 vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 antibody test: positive (Positive) had COVID-19 in March.         No concomitant medication was given.  No treatment medication was given. Patient had COVID19 in March and because of that she had to wait for her second dose.  Company comment This is a regulatory case concerning a female patient of an unknown age with no medical history reported, who experienced the non-serious AESI event of COVID-19. PRODUCT DOSE OMISSION ISSUE was considered as an additional event. The event occurred on an unknown date in March 2021, after the first dose of mRNA-1273 (administered in December 2020). The rechallenge was assessed as not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report. COVID-19 is diagnosed after receiving only first dose, the second dose has not been administered, so lack of efficacy situation cannot be properly assessed.   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2021: Follow up contains no new information.; Sender's Comments: This is a regulatory case concerning a female patient of an unknown age with no medical history reported, who experienced the non-serious AESI event of COVID-19. PRODUCT DOSE OMISSION ISSUE was considered as an additional event. The event occurred on an unknown date in March 2021, after the first dose of mRNA-1273 (administered in December 2020). The rechallenge was assessed as not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report. COVID-19 is diagnosed after receiving only first dose, the second dose has not been administered, so lack of efficacy situation cannot be properly assessed.
7x7cm swelling right thigh with fever on swollen area. Mom brought child today for us to see the injection site. 25.1in Needle was used.
Information has been received from a nurse practitioner concerning a 17 year old female with allergies to penicillin and amoxicillin who on 02-APR-2007 was vaccinated IM with a second dose of 0.5 ml of Gardasil (Lot # 654702/0011U). Concomitant therapy included EFFEXOR and ORTHO TRI-CYCLEN. On 21-APR-2007, the patient experienced an itchy throat without respiratory distress, but did not seek medical attention. On 01-MAY-2007, the patient was seen by the nurse practitioner who described the circular lesions. 04-MAY-2007, the patient developed lesions, which manifested as circular with white spots, on her hands and at the achilles tendon of the feet after she received the second dose of Gardasil No fever was noted. The "target" appearance resolved in three days. On an unspecified date, a rapid plasma reagin card test was performed, the result of which was negative. The patient outcome was unknown. Additional information has been requested.  Additional infromation is not expected.
101C Fever (2-3 days), Severe Body aches (concentrated around lower spine; 5 days), Headache (6 days), Fatigue (3-4 days), trouble talking (hazy mental state; 5 days), Lymphadenopathy (Right-side neck; 15+ days), soreness (right arm; 15+ days)
Approx 15 minutes after vaccine administered, pt. developed hoarseness, throat irritation. Was given 25 mg PO BENADRYL. Approx 50 minutes after administraiton, pt. developed mouth and tongue numbness and tingling. Took 50mg more of PO BENADRYL.
Pain in arm; Chills; Nausea; Vomiting; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and MYALGIA (Body ache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and MYALGIA (Body ache). At the time of the report, PAIN IN EXTREMITY (Pain in arm), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
19 year old male, ADSM, is referred by primary care physician to FBVHC for evaluation of smallpox vaccine inoculation site concerns and left axillary pain.  Symptoms: flu-like symptoms <96 hours, chest pain, pain, erythema, pruritus
Information has been received from a certified medical assistant concerning a 5 year old 8 month old male who on 22-MAY-2006 was vaccinated with second dose of hepatitis A virus  vaccine inactivated (lot number 653616/0201F) 0.5 ml IM into left deltoid. The first dose was given on 04-AUG-2005. The patient had no illness at the time of the vaccination. It was reported that, on 22-MAY-2006, the patient vomited within 1/2 hour of receiving hepatitis A virus vaccine inactivated. At the time of reporting, the patient was recovering. Additional information was received from the certified medical assistant who reported that the child was hospitalized and has since recovered. Additional information was received from the certified medical assistant. It was reported that on 22-MAY-2006 at 1130 hours, the patient started vomiting with 30 to 40 minutes of the vaccination and was taken to the emergency room by the mother. The patient was observed and was doing fine (previously reported as hospitalized). On 22-MAY-2006, the patient recovered. No additional information is expected.
Severe muscle aches, chills, pain, arthritis, weakness  Pfizer-BioNTech COVID-19 Vaccine EUA
Jerking of face - onset 8/25/05. No fever. Taken to Urgent Care then sent to ER. Mother states an MRI and blood sugar was done. Cause undetermined by physician who then advised follow-up with a neurologist. Child scheduled for EEG 8/29/05. Family history of diabetes and maternal grandmother has epilepsy. Intermittant jerking continues, but child is able to perform daily activities.
1/10/23 I got blocked nose, not completely, sore throat and beginning to have a cough. I had no fever. I had a little bit of a headache. I felt like it was from flying on an airplane, just dehydrated. 1/11/23 I felt a little worse, so I scheduled a flu test. 1/12/23 I tested positive for COVID, negative for Flu. I contacted my doctor and had a telehealth visit that afternoon. Since my symptoms were mild and I had no fever, I did not need PAXLOVID. I told her I was taking ROBITUSSIN, RICOLA throat lozenges and VICKS nasal spray. She told me to continue those medications and if I had worsened symptoms, she would prescribe me antibiotics. My voice is still a little bit croaky and not coughing all the time like I have been. My nose is less blocked. I feel like I am recovering.
Herpes on lips.  I have NEVER had a cold sore in my life and I have had several on my lips since I had the shot.  I am due to get the second shot this week and the cold sores are still visible and hurt
Initial unsolicited report received from a health care professional via Pfizer under reference number 2016538292 on 07 February 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (Tetanus vaccine) (batch number, expiry date, dose, route and site of administration were not reported) on unspecified date. Patient's medical history and concomitant medications were not reported. On unpecified date, following the vaccination the patient experienced vomiting. Lab data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
Po Typhoid: 7/10-pill #1- no problems 7/12-pill #2- no problems 7/14-pill #3 -extreme exhaustion, fever, chills, N/V  felt better 7/15 7/16: pill#4: fever, chills, N/V, fatigue: not as severe as 7/14 Today 7/17: feeling better
Dose of Moderna vaccine inadvertently administered from a partially thawed vial.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Dose of Moderna vaccine inadvertently administered from a partially thawed vial.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Dose of Moderna vaccine inadvertently administered from a partially thawed vial.). At the time of the report, PRODUCT ADMINISTRATION ERROR (Dose of Moderna vaccine inadvertently administered from a partially thawed vial.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  It was reported that a patient was inadvertently given a dose of Moderna vaccine from a partially thawed vial. There was a cylinder of frozen vaccine in the middle of the vial, and the dose was drawn from the small amount of liquid surrounding it. At the time of reporting the provider estimates that the vial was still 80-90% frozen.  No treatment medication was reported by the reporter.
At 12:30 pm  on Day 09 after receiving vaccine I developed a red, hot, hard swelling 1" by 1 3/8" at the vaccination site.  Took Tylenol 500 mg. x 2 and Advil 200 mg. x 1.
Urinary tract infection that was septic; Renal failure; Positive for covid; Confused; Losing her balance; Had no control of her bladder and urinated on the bed; Wasn't feeling well; Tired and didn't want to get up; A spontaneous report was received from a consumer concerning a 77-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination related malaise, urinary incontinence, fatigue, confusion, loss of balance, renal failure, severe urinary tract infection that was septic, and Covid 19.   The patient's medical history, as provided by the reporter, stated she was sneezing and coughing few days before receiving her first dose vaccine. Concomitant medications reported included iron, metolazone, nicardipine, simvastatin, torsemide, levothyroxine, glimepiride, apixaban, potassium chloride, acetyl salicylic acid, and donepezil 5mg.  On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 032L20A) for prophylaxis of COVID-19 infection. The route of administration was not provided.  On an unspecified date in Jan 2021 after receiving the first dose vaccine, the patient experienced not feeling well, urinary incontinence, tiredness, and didn't want to get up.  On 25 Jan 2021, the patient was losing her balance and confused. She was hospitalized and diagnosed with renal failure, as well as, severe urinary tract infection that was septic.  On an unknown date post hospitalization, the patient tested positive for Covid-19.  Treatment drug administered included Tylenol, Azithromycin, Promethazine, 325mg aspirin, and Vitamin D.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, like not feeling well, urinary incontinence, tiredness, confusion, loss of balance, renal failure, severe urinary tract infection that was septic, and Covid-19 positive test were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded except for the event of COVID-19.  The event of COVID-19 is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-033912:
Suspected vaccination failure; Got them for the second time, but very mild; This case was reported by a consumer via media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had got the new Shingrix shots for and still got shingles for the second time, but it was very mild. The reporter advised that one should get the shots. This case was considered as suspected vaccination failure since the details regarding time to onset and lab test confirmation was unknown at the time of reporting
Sudden onset severe pain seven days after my second Pfizer injection. No rash or swelling. Very severe pain for 12 hours. Still very painful when reaching or raising my arm nearly 24 hours later.
Patient experienced fatigue and injection site pain.  Patient developed a raised red bump (three by two inches in diameter) that was warm to the touch and painful. Patient continued to experience fatigue and was diaphoretic. Patient consulted Primary Care Provider due to symptoms.
Vaccine at 10 am 12/18/2020 That same day:  Feet numbness at 10:45 am - resolved at 4 pm L hand numbness around 11 am - quickly resolved lower face numbness around 11 am - intermittent throughout the day  all symptoms resolved by evening/overnight 12/19/2020 mild facial numbness about 4-5 hours during the day  fully resolved by 12/19/2020 evening, without any further symptom recurrence at any site
urinary incontance Narrative:  Patient contacted telephone triage today requesting to speak with PCP clinic. States he had reaction to his first covid vaccine, which was given on 2/23/ 2021. States after the vaccine, he developed "massive, extreme headache -  extreme sleepiness, weakness, no muscle strength, and I lost all control of my urine for about 3 days. I actually had to wear diapers for a few days." Patient states symptoms lasted approximately 3-4 days, prior to resolving. Feels better now, symptoms have resolved, but he is wondering if he should take the second vaccine, which is scheduled for 3/23/2021.
Body aches; I had sinus, sinus got infected by it; Fever like; Feeling ill; Sick; This is a spontaneous report received from a contactable consumer or other non hcp. A 60-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0181) via an unspecified route of administration in Arm Left on 28Jun2021 12:30 as single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing, sinusitis from an unknown date and unknown if ongoing I had sinus. The patient's concomitant medications were not reported. The patient experienced he was calling about the symptoms and side effects that occurred after receiving the first dose of the vaccine. It seems that it got him into full Covid reaction, he have had Covid before and he think he have had it twice but once confirmed and the second time it was confirmed, the first time, it was too early, he didn't have all of the symptoms to get checked. After the second day like 2 days after getting it, he started getting body aches, he had sinus, sinus got infected by it, fever like but no fever and that was the same symptoms as the first time when he believe he had it and since then feeling he was feeling ill. So, he feel like he was having Covid all over again and it had been about a week now and he was still sick. The clinical outcome of the event sick was not recovered and other was unknown.  No follow-up attempts possible. No further information expected.
Nausea, severe vomiting, sore joints/muscles, dull headache.  Lasted until 3am, then gradually OK.  1st dose no side effects at all.
Pt was bleeding as the needle was pulled out, when I wiped her arm down we noticed the hard lump on her arm. The area was very red. As serum was being injected pt stated that it felt really thick. Pt complained of pain in the area. No other symptoms. Dr. evaluated pt and advised to take BENADRYL, ice for a couple of hours & then heat.
A non-serious spontaneous report of burning eyes post administration of FLUMIST has been received from a company representative/non health professional concerning children of unknown gender, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither medical history nor concomitant medication was reported for this patient. On an unknown date in Aug-2010, patient received FLUMIST. It was reported that out of 600 doses of FLUMIST, 10% of the people complained that their eyes were burning post administration of FLUMIST. The outcome of the event burning eyes post administration of FLUMIST was unknown.
MA mixed two Shingrix adjuvant vials and administered to this patient; Then administered the full vaccination of the adjuvant and VZV; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The MA (medical assistant) mixed two Shingrix adjuvant vials and administered to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The office caught it and then administered the full vaccination of the adjuvant and VZV to the patient. The reporter consented to follow up.
After 8 days left arm vaccine injection site became sore, hot and mildly inflammed.
MMR vaccine administered 10/14/04 due to equivocal antibody level. Presented to ED on 10/29/04 with complaint of aches and stiffness to joints and swelling in hands. Treated with Toradol 60mg IM and referred to Rheumatologist. Also instructed to take Motrin 500mg TID and Zantac 150mg BID. Meds prior to ED visit: Flonase,Zyrtec, Estrogen and Progesterone.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 50-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 06May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Nov2021 as dose 3 (booster) , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Treatment of covid-19 was by paxlovid, taken orally with start and stop date on May 2022. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Cold, clammy extremeties, weak peripheral pulse's. Tx IV hydration - improved.
No additional AE reported; expiration date 26-OCT-2020, vaccines administered 22-APR-2021; A nurse reported a fourth dose of ROTATEQ was administered to a patient who is 12 months old. The patient has already received 3 doses of ROTATEQ; This spontaneous report was received from a nurse referring to a 12-month-old male patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 22-APR-2021, the patient was vaccinated with an expired fourth dose (extra dose administered) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, oral, lot number 1660939 dose 4, expiration date reported as 24-JUN-2021, but upon internal validation was determined as 26-OCT-2020, for prophylaxis. No adverse event was reported.
patient started with chest pain prior to ER visit, substernal, worse with breathing and leaning forward. Also with fever.
Case number PHEH2014US021298 is an initial spontaneous report received from a pharmacist on 20 OCT 2014, with the follow-up information received from Quality Assurance Department (reference number: 332248) on 19 NOV 2014. This report refers to a patient of an unknown age and gender. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145201) from a pre-filled syringe (PFS) on an unknown date. It was reported that while injecting the vaccine into the patient, the vaccine is not coming out of the needle instead it was running down the patient's arms. It was reported that this was the second PFS that was not functioning properly (initial report did not involve a patient). The investigation determined that, FLUVIRIN batch number: 145201 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified for the complaint. The most probable root cause is user handling. The complainant stated that vaccine leaked at the needle connection site and that the needle is self-contained in the syringe; however, Novartis do not supply syringes for this batch. It is probable that the needle was not adequately attached to the syringe.   Follow-up information received from the Quality Assurance Department reference number: 332248) on 19 NOV 2014: Updated batch review report.