chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6198; Expiration Date: 30Jun2021), dose 1 via an unspecified route of administration, administered in Arm Right on 24 Feb 2021 (at the time of 75-years-old), as first dose, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included unspecified product. The patient stated that he received the first dose of the Pfizer COVID vaccine on 24Feb2021. Caller states he initially had no side effects the first fifteen minutes after receiving the vaccine. Caller states a few days later on that Saturday he experienced dizziness, nausea, major aches, weakness all over the body and pains and headache (27Feb2021). He did not feel safe driving and he just felt down for the day. Caller states on Sunday he felt a little better but still had some nausea, headache and aches. Caller states he read the paperwork and thinks his symptoms were in the realm of normal. Caller would like to know if he was correct. He read that after the second shot the side effects were more severe and he would like to know if this was correct. He was actually in bed all night, was afraid to drive and was afraid to do anything. He was actually in bed all night, was afraid to drive and was afraid to do anything so, just took a day off and stayed at bed mostly, following day the Sunday felt much better and the following week, which was basically this week feel better, feel fine. Also asking should expect that his second question was could possibly be contagious being around someone else. The patient stated that stopped having these problems. The outcome of the events was resolved on 2021. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
No adverse event; On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.  It was unknown if the patient had any acute illnesses at the time of vaccination and up to one month before. It was also unknown if the patient had any chronic or long-standing health conditions.  On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 10-May-2023, the patient experienced UNDERDOSE (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.  For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine).  This case corresponds to 24th patient out of 27 patients as described by the reporter.  The age of the patient was reported as over 65 years.  Concomitant medication of the patient was not reported as it was unknown if the patient was taking any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination or at the time of the adverse event.  It was reported that on 10-May-2023, 27 patients had received 0.25 ml of bivalent booster instead of 0.5 ml. On 11-May-2023, the patients were contacted and on 12-May-2023, 18 patients received additional 0.25 ml. Vaccine body site was reported as deltoid.  The reporter did not report any other adverse reactions.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:case
Pt developed redness and swelling in L arm, 4 hrs after receiving a Pneumovax. She has not had any fever. Pt was given an injection of Benadryl and of Kenalog. She was sent home with a RX for Benadryl and Keflex.
PT'S MOTHER STATED THAT ABOUT 24HRS AFTER ADMINISTRATION OF VACCINE, SHE NOTICED REDNESS AND SWELLING AT VACCINATION SITE.  VACCINE (VARIVAX) ADMINISTERED 7/30/09 AT ABOUT 1030HRS.  PT C/O SORENESS AND ITCHING AT SITE.  NURSE ASSESSED ABOUT 35MM INDURATION, REDNESS AND MINIMAL WARMTH AT VACCINE INJECTION SITE. PT DENIES ANY OTHER SX'S AND NO OTHER SX'S ASSESSED BY NURSE AT TIME PT REPORTED ADVERSE EVENT TO ADMINISTRATION FACILITY (FAMILY MEDICINE DEPT).
Redness around the shot about 2x2 area. Redness still persisting at the periphary center totally cleared
Hives on arms, chest, underarms, and back up neck and onto scalp. Fever of 101-102 degrees and severe headache.
Narrative: Patient received booster COVID 19 Moderna vaccine on 30 November 2021. The patient experienced redness to chest, injection site, and itching. The patient was treated with methylprednisolone dose pack for six days. The patient's rash was improving after receiving the dose pack.
the day after woke up with a headache and muscle pain that continued to last. for the last two weeks I have also had tachycardia and extreme fatigue, on top of the muscle pain and headaches.
I got the shot on 1/13/2021 around 4:45pm. I woke up around 1am on 1/14/2021 warm and gasping for air. I was barely able to speak, calling out for my brothers to get my mom. I was continuing gasping for air while they called an ambulance. The paramedics arrived and checked my lungs and oxygen. By the time they arrived I was back to normal. I didn?t go to the hospital as they didn?t seem it was necessary and I was feeling okay. Later on in the day I just had some slight chest pain and some shortness of breath but it was gone by the end of the night. I?m completely fine now. I had no other symptoms or side effects.
340AM-620 10NOV 745AM & 815 loose stools; t99.6-malaise; 11NOV aching, t97.6; 12NOV weakness-stomach queasy; 13NOV improved-stomach better-no fever; 15NOV c/o stiffness in neck-warm packs w/relief-talked w/MD;
Shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's, concurrent condition, medical history, concomitant medications, drug reactions or allergies were not reported. In 2015, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided) at the pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unspecified date, subsequent to vaccination with Zoster Vaccine Live (ZOSTAVAX), the patient was treated by a health care provider at a medical office for shingles. As a direct an proximate result of patient's use of Zoster Vaccine Live (ZOSTAVAX) vaccine, she had and would continue suffer ongoing injuries, including but not limited to mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the reporting time, the outcome of shingles was considered as not recovered. The reporters considered the event of shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Mother reported to doctor (reported on 12/10/2018, not immediately after the event) that 7-10 days after the varicella he had low grade fever. Then later had 2 episodes of staring/not responding to voice but eyes open, breathing and normal appearing. Lasted 10-15 seconds. No other symptoms noted and then acted normally. Did not have any movement abnormality. She was concerned it could have be absence seizure though she did not call or report at the time.
Severe Vertigo; This is a spontaneous report from a contactable healthcare professional, the patient. A 47-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 21Mar2021 at 18:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 07:00, the patient experienced severe vertigo when woke up from the bed in the morning and had to hold himself, otherwise he could have fallen. No therapeutic measures were taken for the events. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event vertigo was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
No adverse event; That Monovalent administered to a patient after date of Expiry on 13Feb2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (That Monovalent administered to a patient after date of Expiry on 13Feb2023) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (That Monovalent administered to a patient after date of Expiry on 13Feb2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (That Monovalent administered to a patient after date of Expiry on 13Feb2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (That Monovalent administered to a patient after date of Expiry on 13Feb2023).    Nurse supervisor reported that a Monovalent vaccine was administered to a patient after date of expiry on 13-Feb-2023.  Dose was administered after 30-day use by date or after manufacturer date of expiry. Patient was administered with an individual vial. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 01-Jan-2023. The vial did not undergo any temperature excursions.  No concomitant medication reported. No treatment medication reported.
consumer reports that signs of a resurgence of asthma, absent since childhood, became manifest w/in 2-3 wks of immun; event occurred NOV91; 6SEP93 asthma is chronic requiring treatment;
an expired dose of IPOL was administered to patient, no AE; Initial information received on 14-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 5 years old male patient who was vaccinated with an expired 0.5 ml dose of IPV (VERO) [IPOL](lot P1F541M  and expiration date :07-Dec-2020) via intramuscular route in the left leg for prophylactic vaccination on 14-Dec-2020 (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) ; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) ; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (same day latency).   No adverse event reported at the time of reporting.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Febrile seizure occurred approx 5 hrs p/administration of 3rd dose of DTP; Had been given 60mg APAP suppository prior to receiving DTP & another dose 4 hrs later; Taken to ER p/sz & admitted for tx & observation;
No adverse event. The vaccine administered on 3/30/22 expired on 3/17/22. Moderna tested  the stability of the same lot number and determined that the dose given was still protective against the COVID-19 Virus.
A consumer (and health care professional) reported the following information via Novartis on 5 NOV 2009: An 11-year-old female patient was vaccinated with a pandemic H1N1-influenza vaccine (batch no. unknown) on 31 OCT 2009. She experienced flu like disease (elevated temperature up to 37.9 C, sore throat and cough) on 1 NOV 2009 persisting for four days. She had recovered at reporting date. Her father was also vaccinated. Please see case MA2009-3704 and MA2009-3705. This case previously recorded as MA2009-3705. Follow up received from a consumer on 03 Feb 2010: The outcome of events were reported fully resolved after approximate 3 days. This case previously also recorded as MA2009-3704. Follow up received from the consumer on 04 Mar 2010: A Co-suspect vaccine was coded as Influenza virus vaccine pandemic which the patient received on 23 Oct 2009.
The pt experienced a fever of 106 with a seizure 2 times, and respiratory distress.
Extreme Rapid Heartbeat; dizziness; Felt sick to my stomach; chill; Had fever the second day 101; headache; tired; have pins and needle feeling all over; Slight confusion; Ice cold feet and hands but was burning; This is a spontaneous report from a contactable consumer. A 55-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 12Feb2021 17:00 (at the age of 55-year-old) (Batch/Lot Number: EN6201) as dose 1, single for covid-19 immunization. The patient other medical history was reported none. Concomitant medications included valaciclovir hydrochloride (VALTREX); ascorbic acid (VITAMIN C ACID); zinc; nitric oxide (NITRIC OXIDE) taken for an unspecified indication, start and stop date were not reported. The patient previously took dexamethasone and experienced drug hypersensitivity. On 12Feb2021 17:00, the patient experienced extreme Rapid Heartbeat and dizziness immediately after injection. Had to empty my bowel right away. Hands and feet were freezing but my body was hot. Slight confusion. Felt sick to my stomach. Almost went to emergency room but decided to go home. Increase heart rate and chill lasted for a day. Ice cold feet and hands but was burning up. Heart rate slowed after a full 24 hours or so. Increased HR came back off and on for a day or two. Had fever the second day 101 and headache. Tired. Broke on the third day. Now on the third day, have pins and needle feeling all over mild. Cold hands and feet and extremely tired. The patient did not received treatment for AEs. The patient had other vaccine in four weeks. Other medications in two weeks are Valtrex, Vitamin C, Zinc, Nitric Oxide. The patient does not have covid prior vaccination. Covid tested post vaccination was reported as no. The outcome of event was reported as recovering.  Follow-up attempts completed. No further information expected.
Approximately 4 hours after receiving vaccine pt had sudden onset diaphoresis, nausea, very sore injection site, shortness of breath and hoarseness. He became achy and broke out in a cold sweat and felt chilled. He woke up in the am 10/9/15 and felt fine - all symptoms gone.
pain in my right hand subsides through out the day; clenched up into a fist/joint pain in my fingers and knuckles where I can't apply pressure with a fork, turn on the light switch or brushing my teeth; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in my right hand subsides through out the day) and ARTHRALGIA (clenched up into a fist/joint pain in my fingers and knuckles where I can't apply pressure with a fork, turn on the light switch or brushing my teeth) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for Thyroid disorder, VITAMIN D NOS for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in my right hand subsides through out the day) and ARTHRALGIA (clenched up into a fist/joint pain in my fingers and knuckles where I can't apply pressure with a fork, turn on the light switch or brushing my teeth). The patient was treated with GABAPENTIN at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (pain in my right hand subsides through out the day) had not resolved and ARTHRALGIA (clenched up into a fist/joint pain in my fingers and knuckles where I can't apply pressure with a fork, turn on the light switch or brushing my teeth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was prescribed medication for pain but it did not help.
Headaches 09/14/203. Nausea, diarrhea, aches, chills 09/15/2013 - 09/18/203.
This spontaneous report was received from a licensed practical nurse and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date in November 2018, the patient was inadvertently vaccinated with RECOMBIVAX HB lot# M037771, expiration date: 21-FEB-2019, intramuscularly (exact dose and site of administration were not reported) for prophylaxis instead of PEDVAXHIB, concomitantly with PEDIARIX. No adverse events were reported.
Mom reports t104 R w/APAP; mom reports calling MD who instructed to treat w/APAP which dec temp;
Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case is linked with 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851 (Same reporter source, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with a dose of Flu shot (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on unspecified date (reported as early one year). The patient's previous medications included vaccination with Prevnar 13, five year pneumonia shot and shingles vaccine. Other medical history and concomitant medications were not reported. On an unspecified date (reported as Jan), following the vaccination, patient experienced flu. The patient's laboratory data and corrective treatment was not reported. The outcome of events was not reported. List of documents held by sender: none.
Covid Arm - Itchy, very warm to hot spot, tightness, slightly achie. Over all I would discribe it as having a sunburn the size of a fist on my upper arm at the site of the injection.
approx 5Pm pt began c/o nausea & stomach hurt;c/o didn't sleep all noc;vomited in the morning when got up;cont to vomit the next day w/each attempt to eat;no fever parent was encouraged to call child MD;
Arm pain redness and swelling; Arm pain redness and swelling; Arm pain redness and swelling; fatigue; feeling unwell (fluish),; headache,; lymph nodes feeling swollen; no energy; air hunger; Nausea; muscle pain; joint pain; This is a spontaneous report from a contactable consumer. This non-pregnant 52 years old female consumer reported that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200), dose 2 via an unspecified route of administration on 25Feb2021 at 11:00 am in left arm (at the age of 52-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Facility type was reported as other. Patient's medical history included Fibromyalgia, Ehlers Danlos, Headaches and Trigeminal Neuralgia static Tachycardia Syndrome, Osteoarthritis, Chronic Fatigue from an unspecified date to unknown if ongoing. There were known allergies to penicillin and aspirin. Historical vaccine included first dose of bnt162b2, lot number; EL9264, via an unspecified route of administration on 29Jan2021 at 07:00 pm in right arm for covid-19 immunisation. No other vaccines were given in four weeks. Concomitant medications (in two weeks) included clonazepam (CLONOPIN), valaciclovir hydrochloride (VALTREX), midodrine, paracetamol (TYLENOL) and omeprazole (PRILOSEC), all from an unspecified date to an unspecified date at unknown dosage for unknown indication. On 26Feb2021, patient experienced Arm pain redness and swelling, fatigue, feeling unwell (fluish), headache, lymph nodes feeling swollen, no energy, air hunger, nausea, muscle and joint pain. AE did not result in emergency room and physician's office visit. No treatment was given for the AE. Patient did not have covid prior vaccination and was not tested for covid post vaccination. The outcome of events was not recovered.  No follow up attempts are possible. No further information is expected.