chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient given vaccine after the 30-day refrigeration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient given vaccine after the 30-day refrigeration date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient given vaccine after the 30-day refrigeration date). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient given vaccine after the 30-day refrigeration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), 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 13-Oct-2021: Significant follow up received on 13 Oct 2021,Lot number added
CHEST TIGHTNESS ON LEFT SIDE (5 TIMES WITHIN THE LAST 72 HOURS); PAIN ON THE LEFT SIDE OF CHEST (5 TIMES WITHIN THE LAST 72 HOURS); PAINFUL TO BREATHE; HEART WAS TIGHT; SORE ARM A LITTLE; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for high blood pressure. On 07-APR-2021, the subject experienced sore arm a little. On 19-APR-2021, the subject experienced chest tightness on left side (5 times within the last 72 hours). On 19-APR-2021, the subject experienced pain on the left side of chest (5 times within the last 72 hours). On 19-APR-2021, the subject experienced painful to breathe. On 19-APR-2021, the subject experienced heart was tight. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm a little on 09-APR-2021, had not recovered from chest tightness on left side (5 times within the last 72 hours), and pain on the left side of chest (5 times within the last 72 hours), and the outcome of painful to breathe and heart was tight was not reported. This report was non-serious.
Altered smell /smell of regular perfume smell as a strong petroleum like smell; Patient's tongue has been tingly the whole time/When patient bites his tongue it is definitely not the same/normal; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Altered smell /smell of regular perfume smell as a strong petroleum like smell) and PARAESTHESIA ORAL (Patient's tongue has been tingly the whole time/When patient bites his tongue it is definitely not the same/normal) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CHOLESTEROL for an unknown indication.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced PAROSMIA (Altered smell /smell of regular perfume smell as a strong petroleum like smell) and PARAESTHESIA ORAL (Patient's tongue has been tingly the whole time/When patient bites his tongue it is definitely not the same/normal). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAROSMIA (Altered smell /smell of regular perfume smell as a strong petroleum like smell) and PARAESTHESIA ORAL (Patient's tongue has been tingly the whole time/When patient bites his tongue it is definitely not the same/normal) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Inconclusive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
One week after the J&J shot, patient began having trouble speaking, which over the next year progressed into having trouble walking. As of last week, he has been officially diagnosed with amyotrophic lateral sclerosis.
New and approved vaccine, then got a real bad case/Suspected vaccination failure; got a real bad case that caused her to lose some vision in one eye; Lose some vision in one eye; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received first vaccine on an unknown date and then experienced a mild case of 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), ophthalmic herpes zoster (serious criteria GSK medically significant) and vision decreased. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and vision decreased were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and vision decreased to be related to Shingles vaccine.  Additional details were reported as follows: The patient was the reporter's mother. The age at vaccination was not reported. The physician told the patient hat she needed the new and approved shignles vaccine. The patient then got a real bad case that caused her to lose some vision in one eye. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
15min post vax lt hand swelled & became red & hot;36hr later face swelled including eyes & mouth;48-50hr breathing became more difficult;
metallic taste almost immediately after the second dose, also explained that it happened with the first dose too but a little later (30 minutes) and lasted for 3 days
Right after I got the vaccine I had my mouth tingly and the next day I had a fever of 100.00 on Monday the 20th My arm was hard to move my lymph nodes on my right underarm  were swollen and painful  the injection site was hot it burned and itch. On Tuesday 21st I called the Urgent Care to have a virtual visit and they said it was cellulitis and the put me on steroids other treatment. I kept track of the right arm cellulitis  by outlining it and it kept growing they changed the medication. I also noticed my asthma was more aggravated I felt wheezing tightness and cough.
This case was considered medically important for event of hives. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 12-month-old male patient who experienced slight rash around the injection site and hives all over. At 12 months of age, the patient received a dose on 16-Jun-2010. The patient also received a dose of HIB (GlaxoSmithKline) on 16-Jun-2010. The patient experienced slight rash around the injection site on 16-Jun-2010 and hives all over on 17-Jun-2010. It was advised to give the child diphenhydramine (dose unknown) and to bring the patient back to the office if no improvement. The outcome was unknown. No additional information was available at the time of this report.
Within 1 hour of vaccine, pt c/o extreme fatigue, fever and chills. Short waves of nausea 3 1/2 hours after vaccine-onset of diarrhea
Pfizer 7/20/21, 8/11/21. Positive on 6/8/22
Pt has a past medical history of type II IDDM, history of uterine malignancy, and obesity.  She was transferred from facility for severe COVID pneumonia and acute hypoxic respiratory failure.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "myasthenia gravis" (unspecified if ongoing); "cancer" (unspecified if ongoing), notes: twice; "anaphylactic reaction / anaphylaxis" (unspecified if ongoing), notes: to Sulfa / sulfonamides; "sulfa" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation, reaction(s): "didn't have any reaction at all". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm". Additional information:  Eleven hours after getting the second shot, the patient had a little bit of a sore arm that lasted for a few hours. The patient reported that she was currently taking 26 other drugs.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021318289 Same reporter, drug and event; different patient.
pt recv vax 24SEP97 & on 13OCT97 pt exp a chickenpox outbreak consisting of approx 30 lesions;
03/11/22 presents to ED for "diarrhea, nausea, and vomiting". PMHx of "COPD, CKD, HFpEF, NASH cirrhosis, and type 2 DM on insulin"
pt became dizzy, sweaty and developed rapid heartbeat. ems called and responded. pt checked and cleared by ems.
LMP 09/05/20 Due date 6/12/21  From 9pm 10/7-10/9: Fever tmax 102, Chills, Muscle and body aches, headache, fatigue
Client stated her R arm became very swollen and throbbing with pain a short time after receiving her shot. She came back here later to find us closed. She went to ER to have it checked. They advised applying an ice pack. Today she said it is much better. I looked at it. It's approx the size of a quarter. Slightly red. I advised she alternate ice/warm packs. Also to watch for sign of more redness or throbbing. If so to see a M.D.
pt recv vax 27AUG98 & pt stated that in 8-9hr later started w/pain, little swelling & numbness to lower arm;no temp or swelling around inj site;pt took APAP & sx went away;
This spontaneous report was received from a certified medical assistant regarding an unspecified number of patients of unknown age and gender. Information on their concurrent conditions, medical history and drug allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stores doses of VARIVAX lot # K018964, expiry date 15-OCT-2016, lot# L013824, expiry date 21-APR-2017 and lot # L031066, expiry date 18-AUG-2017 (dose number, dose units, route and anatomical location were not specified). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Complain (PQC) involved. Temperature at which the vaccine was stored was 8.2 degree Fahrenheit for a time frame of 2 hours and 15 minutes. There were no previous temperature excursions. This is one of the two reports from the same reporter. Additional information has been requested.
Patient states that about 24 hours after receiving vaccine, she started getting swelling in lymph nodes near her collarbone and shoulder area.  She said they are extremely sore to the touch.  She also had fever (102.1) , body aches and fatigue.  Advised patient to monitor and seek treatment if needed.  She was going to use some blue emu to help with pain.
Upon receiving the vaccine my son became pale, his lips turned white, he couldn't walk, he was sweating and he was moaning. The medical assistant gave me an ice pack to put on the back of my son's neck and said he should raise his legs. The doctor and medical assistant said they never saw a child have this type of reaction. My son laid across two chairs in the doctor's hallway for an hour and a half before he could stand up to go home. My son said that he felt like he was going to die. A few hours later he regained color in his face. He had no energy and laid down the rest of the day. The next day 5/10/14 he wasn't himself, he was quiet all day and didn't have energy. To me it seemed as though he was trying to catch his breath at times, he has Asthma. The next night he had a fever of 102.9, he had deep shallow breathing. I woke him up to take Motrin, I told him to use his inhaler. We followed up with the doctor the next day, and it wasn't until a day or two after that, that my son felt better. My son has always had bad reactions to vaccines, but this was the worse. Since he's always had vomiting, fevers, night sweats, and swelling at injection sites, and this was the worse reaction, I'm concerned for what could happen in the future.
Sick as a dog 14 Hours after the 2nd primary shot; Body aches 14 Hours after the 2nd primary shot; Fatigue 14 Hours after the 2nd primary shot; Fever 101.4F 14 Hours after the 2nd primary shot; Chills 14 Hours after the 2nd primary shot; Nausea 14 Hours after the 2nd primary shot; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sick as a dog 14 Hours after the 2nd primary shot), MYALGIA (Body aches 14 Hours after the 2nd primary shot), FATIGUE (Fatigue 14 Hours after the 2nd primary shot), PYREXIA (Fever 101.4F 14 Hours after the 2nd primary shot) and CHILLS (Chills 14 Hours after the 2nd primary shot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced ILLNESS (Sick as a dog 14 Hours after the 2nd primary shot), MYALGIA (Body aches 14 Hours after the 2nd primary shot), FATIGUE (Fatigue 14 Hours after the 2nd primary shot), PYREXIA (Fever 101.4F 14 Hours after the 2nd primary shot), CHILLS (Chills 14 Hours after the 2nd primary shot) and NAUSEA (Nausea 14 Hours after the 2nd primary shot). On 20-Mar-2021, ILLNESS (Sick as a dog 14 Hours after the 2nd primary shot), MYALGIA (Body aches 14 Hours after the 2nd primary shot), FATIGUE (Fatigue 14 Hours after the 2nd primary shot), PYREXIA (Fever 101.4F 14 Hours after the 2nd primary shot), CHILLS (Chills 14 Hours after the 2nd primary shot) and NAUSEA (Nausea 14 Hours after the 2nd primary shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.4 F.         No concomitant medication was reported.  No treatment information was reported.  On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, lot number 023M20A.   This case was linked to MOD-2022-669124, MOD-2022-669098 (Patient Link).
pt Grandpa reports pt had a sore arm the next day and chills although no fever.  Pt went to doctors office that day and they cleared her.  She reports filling better although still a little sore arm
Extreme fatigue, diarrhea, vomiting, fever, chills, body aches
Pt recv vax on 10/22/98; a few hours post vax pt exp acute onset left sided sensorineural hearing loss, Annual follow-up received on 10/2/00 provided no additional data.
Patient reported severe pain and redness at and around the site of injection for 4 days after vaccination. The area of redness included the top of the shoulder down to the elbow.
1) EXTENDED MENSTRUATION 2) MIGRAINES 3) SWELLING OF EXTREMITIES 4) DIFFICULTY BREATHING
Breakthrough  COVID-19 case with symptom onset 8/22/2021: Shortness of breath/difficulty breathing. Hospitalized 8/25/2021-9/7/2021. Death 9/7/2021. Acute respiratory failure due to Covid-19
Systemic: Occassional muscle spasms/twitching-Mild, Additional Details: Patient reported the day after receiving first dose she noticed muscle spasms in the area of the vaccine. These happen occassionally even one month after the dose.
Two days after receiving vaccine, left side neck, left arm, and back began to hurt as if a nerve was pinched. It is still happening.
Mild pneumonia right middle lobe < 7 days post 2nd set vax's. Resp Sx, esp coughing, occurred for 3 wks prior, starting < 7 days post initial set of vax's. (2/6/03). Gradually recovered over the weeks following the CXR 3/14/03. No antibiotics given. Practitioner Dx'd as viral, not bacterial.
fever; Skin hurt; injection site burned; 5 canker sores in her mouth; This is a spontaneous report received from a contactable consumer (Patient). This 43-year-old female consumer(patient) reported for herself that she received bnt162b2 (bnt162b2,  solution for injection, Lot number: unknown) dose 2, via an unspecified route as a single dose on an unspecified date for covid-19 immunization. The patient's medical and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (bnt162b2, solution for injection, Lot number: unknown) through an unspecified route as a single dose on unspecified date for covid-19 immunization. On an unspecified date, approximately 24hrs after the vaccine she developed a fever of 102 and reported her skin hurt. She also noted that the injection site burned on an unspecified date. The fever lasted approximately 24 hours and 36 hours after the vaccine she noted around 5 canker sores in her mouth on an unspecified date. Not aware of other underlying conditions. Event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Large patches on face lost color and do not tan in sun. These are separate from the dry flakey patches
Initial unsolicited misuse report received from a nurse on 05-Jan-2017. This case involves a 42-year-old female patient, who was inadvertently vaccinated with 1 ml of FLUZONE QIV MDV via intradermal route (batch number: UI673AB, expiry date: 30-Jun-2017,) in right forearm instead of first dose of APPLISOL (manufacturer: PAR) (batch number: 772984; expiry date, route not reported) in left forearm on 12-Dec-2016. Patient had no illness at the time of vaccination. Pre-existing physician diagnosed allergies were reported as no known allergy and birth defects, medical conditions were reported as depression anxiety disorder. Patient's concomitant medication was not reported, any other vaccination within four weeks of suspect vaccination was reported as none. On 12-Dec-2016, same day following the vaccination, the patient developed redness at the site of the injection. On 19 December 2016 one week after the vaccination, patient had pain in right elbow that was difficult to move at all and patient was referred to ortho where she was diagnosed with a possible bursitis. On an unknown date, after the vaccination, patient reported that she was disabled due to the medication error and cannot drive or work. It was a case of wrong vaccine administration and inappropriate route of vaccination. Patient required emergency room/doctor visit on 19-Dec-2016. Patient had a right elbow X-ray negative. The patient received corrective treatment with Claritin and Medrol for vaccination site erythema. The outcome of the events was reported as not recovered. List of the documents held by sender none. Sender's Comments: Patient was wrongly vaccinated with influenza instead of PPD due to which patient had erythema at vaccinated site which was treated. A week later she had pain over right elbow which was diagnosed as bursitis due to which she was unable to work which lead to disability. Time to onset is compatible, additional information regarding patient medical history, disability whether temporary or permanent, and history of trauma over elbow or any positional problem like working with pressure on the elbow are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Apx. 1 hr. after receiving MedImmune H1N1 vaccine child c/o chest hurting and was wheesing.  Taken to ER. Chest X-ray and EKG were clear.  Given HHN x2(med unknown) wheezing resolved. MD told mother not to have child get second dose. Child had received Seasonal influenza nasal spray without any adverse reaction.
No additional AE reported.; HBP reported a dose of VARIVAX was administered after a temperature excursion.; This spontaneous report has been received from an office manager, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 18-JAN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliter (ml), lot #W020540, expiration date reported as 29-JUN-2024, but upon internal validation, established as 28-JUN-2024 (route of administration and anatomical location were not provided), administered for prophylaxis after a temperature excursion of 41.4 degrees Fahrenheits (F) with a time frame of 1 hour (h) and 58 minutes (min) (product storage error).   No additional adverse events (AE) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA008103:02321653 US-009507513-2301USA007926:02321654
One hour post vax, the pt experienced chills, rigors, uncontrollable shaking, nausea, and myalgia. All symptoms, except for myalgia, lasted two hours. Myalgia resolved on 12/10/99.
46 YO prescribed Shingrix by physician; This case was reported by a pharmacist via call center representative and described the occurrence of drug prescribing error in a 46-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster (Family History) (had family history of herpes zoster (several family members had suffered from zoster)).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug prescribing error. On an unknown date, the outcome of the drug prescribing error was unknown.   Additional Information: GSK receipt date: 26-Aug-2022 Reporter's comment: The pharmacist reported that the patient with a family history of herpes zoster (several family members had suffered from zoster) was prescribed Shingrix by the primary physician.  As far as the reporting pharmacist was aware that the patient did not suffer from any immunocompromising condition. The reporter consented to follow-up. Additional supportive information: The patient was prescribed Shingrix by the primary physician when she had the family history of herpes zoster, which led to drug prescribing error. As it was not clear that the patient had received the vaccine or not so in worst approach case was kept valid for prescribing error and follow-up request was raised for further clarification.