chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tight in the chest; Cramping right at the top around my stomach; Runny nose; Dry cough; Hoarseness in her voice; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tight in the chest), ABDOMINAL PAIN UPPER (Cramping right at the top around my stomach), RHINORRHOEA (Runny nose), COUGH (Dry cough) and DYSPHONIA (Hoarseness in her voice) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atypical angina (Atypical angina with coronary vasospasm 20 years ago), Coronary vasospasm, Norovirus infection in June 2021, Thrombus and Intestinal ischemia. Concurrent medical conditions included Tachycardia. Concomitant products included METOPROLOL for Tachycardia.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced CHEST DISCOMFORT (Tight in the chest), ABDOMINAL PAIN UPPER (Cramping right at the top around my stomach), RHINORRHOEA (Runny nose), COUGH (Dry cough), DYSPHONIA (Hoarseness in her voice), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Chills, at a dose of 1 dosage form. In 2021, RHINORRHOEA (Runny nose), COUGH (Dry cough), DYSPHONIA (Hoarseness in her voice), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, CHEST DISCOMFORT (Tight in the chest) and ABDOMINAL PAIN UPPER (Cramping right at the top around my stomach) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) negative. On an unknown date, Heart rate: high (High) heart rate sometimes goes up to 165, but is currently around 75.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-321079 (Patient Link).
Information has been received from a female physician referring to herself. Patient's pertinent medical history included: asthma. On an unknown date the patient gave herself vaccinated with PNEUMOVAX 23, 0.5 ml injection for prevent pneumococcus (route and lot# unknown). No concomitant medication was reported. The patient reported that she had "flu symptoms and felt pain all over" from an unknown date. Patient had sought medical attention and self-treated. Therapy was reported as continued. The outcome of the events was unknown. Causality was not provided. No product quality issue (PQC) was involved. Additional information has been requested.
no new AE; A medical assistant reported ROT ATEQ was improperly stored and administered. The vaccine had multiple excursions that started on 09 MAR 2021; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The reporter did not provide information about the patient's pertinent medical history, drug reactions, allergies, and concomitant medications.  Since 09-MAR-2021, the vaccine Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot # 1742461, expiration date 17-NOV-2021) has been under multiple temperature excursions. On that day, at 34.5 Fahrenheit (F) for a timeframe of 3,5 hours; on 12-MAR-2021, 34.90 F for a timeframe of 0,75 hour; on 14-MAR-2021, 34.70 F for a timeframe of 0,5 hour; and on 16-MAR-2021, 19-MAR-2021, 21-MAR-2021, 22-MAR-2021, 23-MAR-2021, 10-APR-2021 and 12-APR-2021, at 35.2 F for a timeframe of 0.25 hours. On 03-MAY-2021, this vaccine was administered to the patient orally (dose, strength, scheme of vaccination were not reported), as prophylaxis. The data logger did detect the temperatures excursions.   No additional adverse event (AE) (no adverse event).; Sender's Comments:  US-009507513-2105USA002236: US-009507513-2105USA002232: US-009507513-2105USA007108:
Muscle pain at site of injection with generalized muscle and joint pain especially in lumbar, hips and feet
Muscle Pain; Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle Pain) and ARTHRALGIA (Joint Pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 032620A) for COVID-19 vaccination.     No Medical history was provided by Reporter.  Concomitant products included INSULIN GLARGINE (LANTUS), METFORMIN, ATORVASTATIN, LISINOPRIL, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), ACETYLSALICYLIC ACID (BABY ASPIRIN) and SEMAGLUTIDE (OZEMPIC) for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced MYALGIA (Muscle Pain) and ARTHRALGIA (Joint Pain). The patient was treated with PARACETAMOL (TYLENOL) for Arthritis, at an unspecified dose and frequency. At the time of the report, MYALGIA (Muscle Pain) and ARTHRALGIA (Joint Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-240171 (Patient Link).
This spontaneous report as received from a registered nurse refers to an unknown number of patients of an unknown age and gender. Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot number: M007764, expiration date: 30-JAN-2018, dose and route of administration were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Severe pain as vaccine was administered, persisting for about 10 minutes. This was followed by low grade fever, chills, and mild body aches at about 11pm. There was also intermittent nausea in the evening. Body aches continued into the following day.
breakthrough infection diagnosed via PCR (mild head congestion and cough); breakthrough infection diagnosed via PCR (mild head congestion and cough); breakthrough infection diagnosed via PCR (mild head congestion and cough); breakthrough infection diagnosed via PCR (mild head congestion and cough); breakthrough infection diagnosed via PCR (mild head congestion and cough); This is a spontaneous report from a contactable consumer. A 50-years-old male patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/lot number: unknown), via an unknown route of administration in Apr2021 (at the age of 50-years-old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history included asthma. Concomitant medications were not reported. No other vaccine in four weeks. On 11Aug2021, the patient had breakthrough infection diagnosed via PCR (mild head congestion and cough). Patient had not been diagnosed with COVID-19 prior to vaccination. He had tested post the vaccination. On 13Aug2021, the patient had Covid test PCR by nasal swab which resulted positive post vaccination. No treatment received. The outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After vaccine next day developed infection in elbow / Bursa. infection spread to hand and caused numbness in fingers
Headache, stuffy nose, nasal congestion, sore throat, general misery. Red circular (2in. in diameter) knot sore to the touch at injection site. Called clinic to follow up. Has had flu shots before with no reaction. Administered nasal wash, asthma maintenance inhalers, OTC cold medicine.
Flu shot 10/30/14 - instant pain wtih injection - got worse over time. Pain became severe and has lasted weeks.
Pain on left side getting worse over afternoon. Does not feel like muscular pain but rather hurts to breathe in on left side.
Patient with onset of significant pain in arm in the day following her immunization, mainly at night, worse with movement.  Discussed 2/15/07, pain still "exteme", but slowly improving.  Seen 4/12/2007 and diagnosed with tendonitis.  Patient currently undergoing physical therapy.
devel temp 7PM 1AUG91; t103 oral; APAP given; hallucinating during noc; not eating-hoarse today; parent did not contact MD;
Fever up to 102.7, myalgias, chills, body aches, dizziness, headache.  Patient used Tylenol and Ibuprofen PRN.
Approximately 5 hours after receiving the shot I became extremely dizzy when I tried to stand.  The was able to stand, but could not maintain my balance or walk in a straight line.  The dizziness subsided persisted throughout the night.  By morning (16 hours after the shot) the dizziness had resolved.  Over the next two days I had mild muscle pain, continuing to the present (48 hours after the shot).
polymyalgia rheumatica; RS3PE including elevated ESR and CRP; RS3PE including elevated ESR and CRP; RS3PE including elevated ESR and CRP; This is a spontaneous report from a contactable physician. An 83-year-old female no pregnant patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose for COVID-19 immunisation. No pregnant at time of vaccination. Medical history included Hypothyroidism, known allergies: Morphine. No covid prior vaccination. Concomitant medications included Levothyroxine. No other vaccine in four weeks. In Feb2021, since receiving vaccination, patient developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP. Responded to prednisone. Patient insists no symptoms until she received first dose. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 2 days. Lab data included Nasal Swab in Mar2021: Negative. Medrol/prednisone were received. Outcome of the event was recovering.  Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Itching to face and rash to legs. Did not take any medications. All side effects have resolved.
administered an expired dose; Knot in arm at the site of injection; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a female patient who received Men B NVS (Bexsero) (batch number ABXAB2AZ, expiry date 30th January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 7th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. In February 2022, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was not recovered/not resolved and the outcome of the expired vaccine used was unknown.   It was unknown if the reporter considered the injection site swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. Medical assistant reported that she inadvertently administered an expired dose of Bexsero to a patient on unknown arm, which led to expired vaccine used. The reporter also stated that the mother called in to the clinic on the date of reporting and stated that she had a knot in her arm at the site of injection and she did not knew the date of onset but claimed that it was unresolved. As per reporter information, the lot was ABXAB2AZ on the vial but was unable to verify lot in system. The reporter claimed that the expiration date was 30th January 2022, but she did disposed of the vial and original packaging. The patient's demographics were not able to be provided only that she was a female patient. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Information has been received from a RN concerning a 18 month old white, male, with an allergy to augmentin and penicillin, hypopituitarism, asthma, eczema, and immunoglobulin deficiencies, who on 09Jun04 (also reported as 25Oct04) was vaccinated with a first SC dose in the left thigh of varicella virus vaccine live (lot644032/1059M). Concomitant vaccines administered on the same day included: a first, SC dose in the left thigh of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot646579/0958N) and third SC dose in the right thigh of poliovirus vaccine inactivated (Ipol) (lot X0799). There was no illness at the time of vaccination. The RN reported that on 02May05 (also reported as 03May05) at 9:55AM, the pt developed 25 vesicular lesions on his trunk. Unspecified medical attention was sought and no treatment was needed as no other symptoms were noted. At the time of this report, the pt was recovering from the vesicular lesions. Follow up information from a RN indicated that on 16Nov04 the pt experienced about 12 pink papules scattered on his back and upper thighs. It was reported that the pt was treated with infant acetaminophen (Tylenol) and cool baths. Follow up information from a RN indicated that the pt did well and had no other problems. It was reported that the pt recovered. Additional information is not expected.
expired booster dose of Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired booster dose of Moderna vaccine) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired booster dose of Moderna vaccine). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired booster dose of Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up received , HCP details and  Patient's demographic updated and no ADR for the patient reported.
Moderate itchiness of the entire arm that received the injection.  Itchiness is very distracting and is preventing me from being able to concentrate on my work.  All I can do is scratch.  Minor itchiness of lower left leg and left side of face.  All the itchiness is on the left side of the body.  No visible rash.  Injection site is not swollen.  No other symptoms.  It's been four hours since the injection.
Initial report was received from a health care professional on 17 November 2010. A 23 year-old female patient, had received an intramuscular left deltoid injection of INFLUENZA vaccine (invalid lot number U3572BA) on 08 October 2010. On 17 November 2010 the patient's mother reported that the patient's left injection site continued to be sore and it hurt at time with movement of the left upper arm. The reporter states it is the first time he was aware of the "injection site soreness". The patient did not have a medical evaluation and treatments were not reported. No further information was available at the time of the report. Follow-up information was received from a health care professional on 04 March 2011. The patient's mother reported on 24 February 2011 that the patient went to her regular doctor who found some scar tissue deposit at the injection site. The physician stated that it was uncommon but may happen. The patient received some tissue massaging and the pain has been well relieved. The patient has resumed her normal activity on the affected arm now. The outcome was reported as recovered. Documents held by sender: none.
pt began crying 3 hrs p/vax; eyes heavy & groggy-irritable-immun sites sore, refused to eat, also cough, runny nose that did not have @ time of immun eve fever t102 R; rash noticed on face;
Itchy hands, 4 inch itchy raised rash on opposite arm vaccine was given; This is a spontaneous report from a contactable other hcp. A 47-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 13Feb2021 08:00 (age at vaccination 47 years) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Patient had allergic to anti-nausea medicine.Concomitant medication(s) included methylphenidate hydrochloride (RITALIN). The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EI8982, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 23Jan2021 09:00 as dose 1, single for covid-19 immunisation. Prior to 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. The patient experienced itchy hands, 4 inch itchy raised rash on opposite arm vaccine was given on 13Feb2021 08:30. Patient visited emergency room for reported events. Patient received treatment of Medication and cream. The patient was recovering from events.  Follow-up attempts completed. No further information expected.
She got up to go to the cash register about 5 minutes after receiving her vaccine.  As she stood at the register she felt flushed from the top of her head down to her body.  She felt hot and then felt pain down her body.  She also felt nauseous.  We gave her some water and had her sit down immediately.  We then called 911 upon her request.  Once the EMT's arrived she was feeling better. The EMT's stayed until her husband arrived.  She stated she did not need to go to the emergency room and she was okay to go home.  I followed up on 10/5 to see how she was and she stated she was doing well but felt maybe receiving the 65+ vaccine for the 1st time might have caused the reaction.
Employee received FLULAVAL vaccine on 9/19/16 and the morning broke out in a red itchy rash and hives on arms neck face, back and knees.
AFTER RECEIVING #4 ANTHRAX IN RIGHT ARM MEMBER HAS 10MM INDURATED AREA WITH ERYTHEMA AND PURITIS.
Patient was fully vaccinated with Pfizer with last dose given on 02/01/2021. Case developed covid symptoms on and tested positive for COVID 8/14/2021. He was admitted to Hospital on 8/16/2021. Case expired on 8/21/2021.
Raised and hard redness and itching on and around vaccination site. The rash was about two inches in diameter. The rash went away after a few days then returned. It was fully healed after about 1 week. No treatment.
Presented to ER -Died  6/26/09 Autopsy report states COD as SIDS & cause of death as undetermined.  Report also notes visceral congestion; petechiae of lungs; Simian creases of palms; undescended right testis; diaper dermatitis about anus; posterior neck capillary hemangioma; remote subdural hemorrhage.
Tiredness, muscle pain, headache, shivering, nausea. Pain at the injection site left arm only
This spontaneous report was received from a Registered nurse regarding an 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history was not reported. On 21-JUL-2016, the patient was inadvertently administered an expired dose of M-M-R II (lot #, dose, therapy type, route and site of administration were not reported) expiration date 16-JUN-2016. No adverse effect was reported. Additional information has been requested.
Occasional cough, occasional shortness of breath, and occasional wheeze. He believes this occurred after his COVID19 vaccination February 6, 2021.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: overweight. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose was not reported,1 total, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient tested positive for covid and have developed symptoms(suspected covid-19 infection, suspected clinical vaccination failure) and fortunately the patient was not hospitalized at that point but had been very ill.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210839400.; Sender's Comments: 20210839107 -covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure,. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Patient came to shot ex clinic for 2nd dosing of COVID vaccine.  Was screened and received 2nd dose of vaccine then proceeded to waiting area with his spouse for 15 min observation period.  After aprox 7 min patient and spouse called over nurse as patient was experiencing one of his "normal-see medical explanation above of patient condition" non-epileptic seizures.  Staff of nurse and 4 men performed immediate first aid measures lowering the patient to floor for safety, supporting airway and 911 was called as patient vital signs were elevated.  EMS services arrived within 5 min from call and proceeded to care for patient.  Patient was given po fluids and nasal versed with good rapid resolution of symptoms.  Patient and spouse both declined transfer to local hospital emergency services.