chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date) 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)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2023, 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 22-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date) 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 (Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date).    No patient details were provided.  Concomitant product use was not provided by the reporter.  It was reported that dose was administered after 30-day Use by Date or after manufacturer Date of Expiry. Individual vial size was reported as 2.5 ml. Dates vial was initially stored was 19-Jun-2023, 22-Jun-2023, and 23-Jun-2023. Vial did not undergo any temperature excursions. Vials were administered on 19-Jun-2023 (1Patient), 22-Jun-2023 (2 patients), and 23-Jun-2023 (2 Patients). Reporter stated that he wanted to wait on the assessment as it was just 1 day after expiration date. Suspect product dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 4th out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-730746 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730746:Mater case
States she had tingling in her hand RT the day of receiving a Hep B injection 03/30/2005 On 04/13/05 she presented to the ER for TX. Ultracet RX.
Patient came into clinic on 1/12/2021 for his 1 yr old  vaccine visit-instead of separated vaccines ordered ,  MA gave KINRIX and Proquad  intended for another patient in clinic. Mom was notified about the error and sent home after reviewing possible side effects of these vaccines and tylenol dosing . Manager contact mother following day on 1/13/2021 and mother reported patient was doing well since vaccines given. On 1/21/2021- telephone encounter - mother called clinic stating child with fevers since vaccine being given and rash appeared on his face on 1/21/21.  Also reports trouble sleeping but no other symptoms at that time.  Based on hx and symptoms reported by family , possibly reaction to vaccines. Reviewed tylenol and motrin alternating schedule with parents and dosing.
vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not provided.  This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
When I got up after mid night I had vertigo (real dizziness), I had nausea  and weakness. When I got up Saturday morning it was necessary for me to hold onto the furniture to get to one part of the house to the other. I didn't have good balance on Saturday morning. I did call my insurance company has a 24 hour nurse line.  Nurse asked me general questions, if my symptoms get worse. I should go to an urgent care. By Sunday morning I was feeling well.   please contact
My son experienced chest pain and was very tired - Sat 6/19 - I thought normal Sunday 6/20 - seemed normal Monday 6/21 at 11 am severe chest pain.  Taken to hospital - was hospitalized with heart inflammation and very high troponin numbers until Thursday 6/24 - numbers were still elevated but he was allowed to go home since the numbers where on the downward trajectory  Has a follow up apt 7/2 @ 3 pm.
Pt reports pain in her left upper arm and shoulder; she reports limited range of motion and says she can't reach her arm over her head.
Day 8 - delayed reaction at site of injection. Large red raised welt (between baseball and softball size), hot to touch and tender
This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age. It was reported that the RECOMBIVAX HB of unknown dose, have undergone a second temperature excursion dated 2-JUL-2014 and have been administered post initial excursion reported as 16-JAN-2014. Excursion supported. It was reported that no adverse events an no concerns are reported by any patients. RECOMBIVAX HB have been administered since date of last excursion of 27-JAN-2014 is with Lot number reported as H017013 and expiry date reported as 01-JUL-2015. This is one of the several reports from the same source: different patients same reporter. Additional information has been requested.
Red color, slight swelling, pain on the right arm where shot was given. Also, I had Herpes eruption on my lips, headache, and slight fever.
17JUL94 4PM pt awoke crying loudly, t102 APAP administered;pt slept -very cranky when woke;temp inc & dec w/APAP;18JUL97 4AM t104;APAP given;t102;slept;t99;
Had cellulitis of arm, swelling and hardness, heat at injection site given subQ above elbow, rxn was to shingles shot. Unknown if pt had chicken pox or not. ER gave course of cephalexin and SEPTRA I told pt to take antihistamine too (rxn has resolved).
Shot site very swollen and painfull. Size of a small egg. Surrounding skin (6 - 7 inches in diameter) very red and itchy. Swelling susideded after 48- 72 hours. Redness remained for 5 days.
morbilliform rash area of confluence on face, neck, arm & post trunk; spot on lt buttock;
Information has been received from a physician referring to a 15 year old patient of unknown gender. On 14-OCT-2015 the patient, who had already received two doses of M-M-R II, received a third dose of M-M-R II in error (extra dose administered). The patient was not experiencing any adverse effects. Additional information has been requested.
Nothing too serious but I felt I should report it.  At approximately 2am this morning  (Feb 28, 2021) I woke up and my left arm where I received the vaccine was tingling. I did not sleep on my arm and I feel this had no connection to my position in my bed. I went back to sleep and the feeling has not returned. At approximately 11 am this morning (Feb 28, 2021) the site where the vaccine was given is very pink and VERY itchy.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. Since 01-APR-2015 (dates od specific vaccinations not reported), the patients were vaccinated orally for prophylaxis with doses of ROTATEQ (lot # K005394, expiry date 23-FEB-2016; lot # K013861, expiry date 18-MAY-2016), which were exposed to temperature outside of the recommended range since that day. The reporting nurse was not aware of any adverse effects at the time of this report. This is one of the several reports received from the same source. Additional information has been requested.
Minor HA and soreness the night of shot, redness and swelling at injection site. No itching, trouble breathing or hives. On 9/22/16 the patient presented with bruising and red spots on the under side (armpit area) of the injection site.
Patient called in report arm pain for 2 days. Patient reported taking TYLENOL on 10/13 & 10/14 with still ongoing arm soreness. Patient also reported nodule appearing over neck region. Patient counseled to take anti-histamine and seek medical attention on Monday 10/17.
I have a lot of drainage of the sinus but I don't have a fever so the doctor said it's viral. The drainage is very thick and gets down into my bronchial tube and makes my chest feel heavy and I have to use my inhaler and nebulizer. It goes away for a week and gets better then comes back. I was just at the doctor's again last week and sent me for a chest x-ray last week and it came back clear. She put me on a 5 day antibiotic and steroid, those are not finished and now it's coming back. She doesn't know what it is.
When patient presented for booster dose on 10/20, pt reported he got a rash on his ankles after previous Pfizer dose.  Time course and severity unknown.
Diarrhea; tingling/painful skin; tingling/painful skin; This is a spontaneous report from a non-contactable consumer, the patient. A 34-years-old-non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EW0172) via unspecified route of administration on 03May2021 at 12:00 (at the age of 34-years-old) as a single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0153), via an unspecified route of administration on 12Apr2021 at 12:00 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021, the patient experienced diarrhoea and tingling/painful skin. The clinical outcome of diarrhoea, tingling and painful skin was not recovered.  No follow-up attempts are needed. No further information is expected.
Fever 105 9hr p/DTP #3; Treated w/Tylenol/Advil
dry cough, headache, body aches, scratchy, shortness of breath,. starting 11/20/21
This spontaneous report was received from a physician via company representative who refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unspecified date in August 2017 (reported as last month), the patient was vaccinated with GARDASIL (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. In August 2017 (reported as since the vaccination), the patient has been feeling aches and pains over her body. The patient's mother scheduled a doctor's appointment for the patient. The physician said it was most likely flu. The outcome of the event was not reported. The relationship between the event and GARDASIL was not reported.
Throat is bothering me; low grade fever; warmness at the right arm injection site; redness at the right arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warmness at the right arm injection site), OROPHARYNGEAL DISCOMFORT (Throat is bothering me), VACCINATION SITE ERYTHEMA (redness at the right arm injection site) and PYREXIA (low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced VACCINATION SITE WARMTH (warmness at the right arm injection site) and VACCINATION SITE ERYTHEMA (redness at the right arm injection site). On 11-Aug-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Throat is bothering me) and PYREXIA (low grade fever). At the time of the report, VACCINATION SITE WARMTH (warmness at the right arm injection site), OROPHARYNGEAL DISCOMFORT (Throat is bothering me), VACCINATION SITE ERYTHEMA (redness at the right arm injection site) and PYREXIA (low grade fever) outcome was unknown.            No concomitant medication use was reported.  No treatment information was reported.  Action taken with the drug in response to events was not applicable.
Information has been received from a medical assistant concerning an 11 yr old black male with no pre-existing allergies, birth defects or medical conditions, who on 30Mar05 at 2:30PM was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (lot 649482/0765P). There was no illness at the time of vaccination. There was no concomitant medication. On 09Apr05 in the AM the pt broke out with full blown chicken pox. There were no relevant diagnostic tests or lab data. Additional information has been requested.
She got home after having the vaccination about 11:00, went to the bathroom, tried to get up but couldn't get up, felt paralyzed. Sat about an hour before she got some help to get up. She crawled into the bedroom, rolled onto a mat and slept there because she could not move.  It's getting better but is more in her hips.
Information has been received from a health professional who was informed by a physician's office concerning a 5 year old patient who on an unknown date was vaccinated with a dose of PEDVAXHIB (OMPC) instead of a dose of hepatitis A injection (unknown manufacturer). No adverse reactions were reported. This is one of several reports received from the same source. No further information is available.
This case was reported by a physician and described the occurrence of swelling injection site in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent medical conditions included allergic rhinitis. Concurrent vaccination included MMR (non-gsk);manufacturer unspecified;unknown;right arm given on 19 October 2012; varicella virus vaccine (non-gsk);manufacturer unspecified;unknown;right arm given on 19 October 2012. On 19 October 2012 at 11:00 the subject received a dose of KINRIX (unknown route, left arm). On 20 October 2012, during the day (1 day after vaccination), the subject experienced injection site pain reported as "left arm hurting". On 20 October 2012, 34 hours after vaccination with KINRIX, the subject experienced swelling injection site, injection site redness, and injection site hot to touch. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events were worse. On 22 October 2012, the subject was at the physician's office for management of the adverse event. The physician considered the events were probably related to vaccination with KINRIX.
C/o localized papular rash on legs that presented 1 day after immunizations given.
Persistent sinus infection, headache, extreme sinus pressure, clogged ears, loss of taste/smell .  Unresponsive to Augmentin treatment, unresponsive to methylprednisolone treatment, pending azithromycin response.
Not feeling well and in bed; Arm has extreme sore; A good size place where the shot was given; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well and in bed), PAIN IN EXTREMITY (Arm has extreme sore) and VACCINATION SITE MASS (A good size place where the shot was given) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling well and in bed), PAIN IN EXTREMITY (Arm has extreme sore) and VACCINATION SITE MASS (A good size place where the shot was given). At the time of the report, MALAISE (Not feeling well and in bed), PAIN IN EXTREMITY (Arm has extreme sore) and VACCINATION SITE MASS (A good size place where the shot was given) outcome was unknown.            No concomitant medications were reported.  No treatment details were reported.
Pityriasis rosea-herald patch 24 hours after receiving ZOSTOVAX-duration 6 weeks. No treatment.
Patient reported that she had received the COVID vaccine on Wednesday March 10th, then broke out in rash and hives Sunday night approx midnight, going into Monday AM.
Patient is 68 yo male s/p full Pfizer COVID vaccination: dose 1 on 2/16 and dose 2 on 3/23. Patient called in on 7/28 with symptoms of fever of 103, chills, and cough. PCR test results positive on 7/28. Pt received Casirivimab/Imdevimab infusion on 7/29.
Dizziness; Weakness; I experienced eight of the twelve affect you could have; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and Lot number was not reported), via an unspecified route of administration on 07Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced eight of the twelve affect you could have plus lot of the severe one it is dizziness and weakness. The outcome of the events was unknown.  Information on lot/ batch has been requested. Follow-up attempts are completed. No further information is expected.
I have idiopathic intracranial hypertension that has been stable since July 2021. I woke up the morning of October 28, 2021 with a massive headache that had been building for a week and half, since around 10/18, and my vision was dark and blurry in my right eye. I also had a moment of aphasia for about 2-3 minutes where I could not speak. I don't know if this was related to the vaccine or just the normal course of this illness, as I have only been diagnosed with this since May 2021. I had testing done that showed the beginnings of papilledema in my right eye, but normal CSF pressure and nothing new in my CT scans.
Throat swelling; Heart palpitations; Itching, redness and hive over injection site; Injection Site Hives; Injection site redness; Nausea; fatigue; Armpit pain and local site reaction; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Sep-2021 and was forwarded to Moderna on 05-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Throat swelling), PALPITATIONS (Heart palpitations), VACCINATION SITE PRURITUS (Itching, redness and hive over injection site), INJECTION SITE URTICARIA (Injection Site Hives) and INJECTION SITE ERYTHEMA (Injection site redness) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced AXILLARY PAIN (Armpit pain and local site reaction). On an unknown date, the patient experienced PHARYNGEAL SWELLING (Throat swelling), PALPITATIONS (Heart palpitations), VACCINATION SITE PRURITUS (Itching, redness and hive over injection site), INJECTION SITE URTICARIA (Injection Site Hives), INJECTION SITE ERYTHEMA (Injection site redness), NAUSEA (Nausea) and FATIGUE (fatigue). At the time of the report, PHARYNGEAL SWELLING (Throat swelling), PALPITATIONS (Heart palpitations) and NAUSEA (Nausea) outcome was unknown, VACCINATION SITE PRURITUS (Itching, redness and hive over injection site), INJECTION SITE URTICARIA (Injection Site Hives) and INJECTION SITE ERYTHEMA (Injection site redness) had resolved and AXILLARY PAIN (Armpit pain and local site reaction) and FATIGUE (fatigue) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication was reported. No treatment information was provided.
Ear pain; This is a spontaneous report from a contactable consumer (the patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first Pfizer COVID vaccine dose. She was due for her second dose today, 10May2021. She stated she was having ear pain and was anticipating taking antibiotics to treat it. She wanted to know if she were to start taking antibiotics, should she wait to take the second dose of the vaccine? The outcome of ear pain was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Began with 7 hours of deep chills, fevers beginning 10 hrs after shot. Strange metallic smell in nose for one hour.  Some tender mild swelling of lymph nodes for next 10 hrs, headache persisted 6hrs, , then mild congestion for 24 hrs. Malaise persisted throughout 24 hours even with bed rest.