chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After injection I removed the syringe from patient's arm/the neck of the syringe broke; the neck of the syringe broke; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Apr2023 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 12Apr2023, described as "After injection I removed the syringe from patient's arm/the neck of the syringe broke"; SYRINGE ISSUE (non-serious) with onset 12Apr2023, described as "the neck of the syringe broke".  Additional information: The patient was given Prevnar 20. After injection and removed the syringe from patient's arm, the reporter went to close the safety lock on the needle and the neck of the syringe broke.   The reporter considered "after injection i removed the syringe from patient's arm/the neck of the syringe broke" and "the neck of the syringe broke" associated to pneumococcal 20-val conj vac (dipht CRM197 protein).  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (loss of smell) and AGEUSIA (loss of taste) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 019B21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. In June 2021, the patient experienced ANOSMIA (loss of smell) and AGEUSIA (loss of taste). At the time of the report, ANOSMIA (loss of smell) and AGEUSIA (loss of taste) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication use was unknown. Treatment information was unknown.
had a positive PCR; This is a spontaneous report from a contactable healthcare professional reporting for herself. This female patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced COVID-19 virus test false positive on 22Jan2021. The patient had a positive PCR on 22Jan2021 and she was advised to go ahead and get her dose of the vaccine.  Information on the lot/batch number has been requested.
Headache, Myalgia, Diarrhea, NauseaVomiting,  injection site soreness initially, then on the 30th arm was very sore, runny nose, shoulder/neck aches, severe N/V/D, severe fatigue Narrative:  Did not need to seek medical care. Stayed at home.
This spontaneous report was received from a pharmacist via a company representative and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concurrent conditions and concomitant medications was reported. On an unknown dates, the patients were vaccinated with ZOSTAVAX (dose, lot #, expiry date, route of administration and anatomical location were not specified). The pharmacist reported that when he administered ZOSTAVAX to multiple unspecified patients of unspecified dates, some of the patients, who received the ZOSTAVAX, complained that it hurt when ZOSTAVAX was administered. The outcome of the event was unknown. The reporter did not provide the causality assessment. Additional information has been requested.
shivering at approximately 11PM that same day; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (shivering at approximately 11PM that same day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced CHILLS (shivering at approximately 11PM that same day). At the time of the report, CHILLS (shivering at approximately 11PM that same day) outcome was unknown. Not Provided          No concomitant medications were provided.  No treatment medications were provided.  Reporter reported that they received the shot at the same time of day during the middle of day, and reports that her patient began to experience the side effect of shivering at approximately 11 pm that same day. Reporter described her husband's reaction as being light and not so severe.
I had an uncomplicated, healthy pregnancy prior to being vaccinated at 36 weeks along. My due date was 4/1/2015 but I was induced on 3/18/2015 due to gestational hypertension and pre-eclampia. My son was born on 3/19/2015 weighing only 5lbs 8oz. I was given terbutaline prior to delivery and my son had hypoglycemia. Initial glucose was 55 but repeat glucose around 4 hours of life was 26. He was symptomatic with jitteriness, thus he was given formula and transferred to the Intermediate Special Care Nursery for further management. In the ISCN he did require a tube feeding. He also had jaundice past the mid chest. I was never able to breastfeed again after him being in the ISCN. He has been sick since the day he was born (allergies, ear infections, cough, respiratory issues) and also delayed
Right arm:  red, hot, swollen circle around injection site 2" in diameter-lasted 2 days.  Fever up to 101 for 30 hrs, nausea, fatigue, muscle aches.  Took tylenol and motrin (off/on).  Arm still sore at 40 hour point, redness going down, fever gone, aches minimal,
Narrative:  COVID infection following COVID vaccine series 12/21/2020, Pfizer, dose #1 01/11/2021, Pfizer, dose #2 08/22 CXR impression: Mild, hazy left basilar pulmonary opacity. Pneumonia could be considered. Cardiomegaly. No evidence of left-sided heart failure. 08/22 pt admit to medicine cc: Generalized weakness, shortness of breath, cough dx: COVID-19 Pneumonia, Acute on Chronic Hypoxic Respiratory Failure LOS: 4 days 08/22 pt cc: exposure: unknown 08/22 COVID swab, result: detected 08/22 SARS-COV-2 Variant Sequencing result: pending 08/22 TROPONIN I result: 0.048 08/22 bnp result: 16.0 08/22 DDIMER result: 0.49 08/23 PROCALCITONIN result: <0.05 08/23 ESR result: 46 08/23 FIBRINOGEN result: 371 08/23 DDIMER result: 0.46 08/23 SARS-CoV-2 AB result: >2500.0 08/24 SARS-COV-2 IGG Eval result: 0.23 08/24 FIBRINOGEN result: 312 08/24 DDIMER result: 0.31 08/24 ESR result: 53 08/25 ESR result: 42 08/25 FIBRINOGEN result: 300 08/25 DDIMER result: <0.22 08/26 ESR result: 33 08/26 FIBRINOGEN result: 245 08/26 DDIMER result: 0.23
Chills, fever 103.0 , muscle and joint ache, headache, nausea, vomiting, sore left arm at injection site and lump in under left armpit
Malignant carcinoma; Scab appeared in the arm in the same injection site; This spontaneous case was received on 07-Oct-2020 from a pharmacist via Agency (reference number: SEQW20-03046), processed together with additional information received on the same day and concerned elderly male patient of an unknown age. The patient was 91 years old at the time of initial reporting.  The patient's past medical history included skin cancer in his leg. The patient's concomitant medications were not reported.  On 18-Oct-2019, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 263073 and expiry date: 03-May-2020.  On an unknown date, after receiving Fluad Quadrivalent, the scab appeared in the arm in the same injection site. The scab never went away.  On an unknown date in 2020, after a year, the patient went to the doctor, who diagnosed him with a malignant carcinoma. The doctor removed the cells. The pharmacist was not certain but believed that the patient was ok and to her knowledge, the carcinoma had not spread.  The outcome of the events was not reported.  The event of malignant carcinoma was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  The reporter did not provide a causality assessment.  Company comment: Neoplasm malignant and vaccination site scab are associated with the use of the suspect product - Fluad Quadrivalent. Chronology is unclarified for vaccination site scab and unsuggestive for neoplasm malignant. The patient's past medical history included skin cancer in his leg while concomitant medications were not reported. Causality is assessed as possibly related for vaccination site scab and unrelated for neoplasm malignant due to reported confounder.; Sender's Comments: Neoplasm malignant and vaccination site scab are associated with the use of the suspect product - Fluad Quadrivalent. Chronology is unclarified for vaccination site scab and unsuggestive for neoplasm malignant. The patient's past medical history included skin cancer in his leg while concomitant medications were not reported. Causality is assessed as possibly related for vaccination site scab and unrelated for neoplasm malignant due to reported confounder.
feverish all day p/vax; had general sz 17 hrs p/vax -taken to ER via ambulance; observed & released (jerking all 4 extremities per hosp report);
pt recv vax 25JAN96 & 7MAR97 pt devel chickenpox lesions;required visit to MD office on 8MAR97;pt recovered;
Swollen raised tender area around vaccination spot. (Larger than presumed normal). Quite big (3 inches long 1 inch wide).
Post vaccine pt stated she started coughing, got scared. pt admin Epi-pen to right thigh per self then notified medical staff of s/s. VS 1051- 120-80,  78hr. No studder, wheezing noted. BS clear BLT. HR  regular. Pt requested to go to ER via ambulance 911 called by fire dept . loss- BP 120/80 hr 118Resp 24, pt transported via ambulance at in stable condition. Pt mom is aware
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 17Apr2021 as dose 2, single (Lot number: EW0151), in left arm and on 19Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12May2022 as dose 4 (booster), single (Lot number: 004M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "latex allergy" (unspecified if ongoing); "opiod pain meds" (unspecified if ongoing). Concomitant medication(s) included: FLOVENT, start date: 01Jan2011; ALBUTEROL SULFATE, start date: 01Jan2011; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Jan2011. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknon results, notes: Indication: Covid-19 treatment; (11Jul2022) Positive, notes: Tested positive again 11Jul; (13Jul2022) Positive, notes: still positive on 13Jul with mild symptoms; (Jul2022) Negative, notes: Tested negative on day 3 of paxlovid dosing- and continued to test negative for 6 days. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
The Covid vaccine was given April 20 of 21 within eight days of having the vaccine I started to develop shortness of breath fatigue chest pain, I ended up at our local emergency room and was admitted with pulmonary embolism, blood clots in both lungs I stayed a total of three days hospitalized.
At 6pm on March 7th severe pain occurred in upper thigh like a tourniquet was around right thigh at groin level. After two days numbness started going down the leg. First the thigh then over the knee then up the inner side of the thigh. Leg weakness also occurred and could barely lift leg. After a 3-4 weeks shooting pains started happening in the numb parts of the leg. Started Physical Therapy in April 5th for leg weakness and numbness. Continued therapy until May 18th
1st dose with Pfizer and 2nd dose with Moderna; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Jan-2022 and was forwarded to Moderna on 19-Jan-2022. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose with Pfizer and 2nd dose with Moderna) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (1st dose) on 19-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose with Pfizer and 2nd dose with Moderna). On 09-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose with Pfizer and 2nd dose with Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were reported.  The patient had no symptoms after the 2nd dose. The patient have no medical conditions and no medications.   This case was linked to MOD-2022-455309 (Patient Link).
Vomiting and diarrhea at 1230am the night after vaccination. Hot flashes and cold chills, feeling of unease, vomiting the next evening at 10 pm.
Day later onset itchy and hard hot painful bumps at injection site. 7 days later bump is larger, continue itching, redness , warm and painful to touch.
Reports of high fever and chills as well as mental status changes within 24 hours of vaccine. Patient was administered ibuprofen at home and seemed to reduce symptoms. Today patient states she is still chilling but has improved
This spontaneous report as received from a healthcare worker (certified medical assistant) refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with a doses of ROTATEQ injection, route of administration not reported, defaulted to oral (strength, dose, indication, lot# and expiry date unspecified), that were improperly stored on unknown dates. No concomitant medications were reported. No adverse effect were reported. Additional information has been requested.
Presents to urgent care day after 1st moderna vaccine with chills, SOB, body aches, headache - normal immune response, d/c'd home in stable condition
pt recv vax 26JUN96 & 7JUL97 devel approx 20 chickenpox all over the body;pt recovered from sx;
Slept a lot; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept a lot) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     The patient's past medical history included Vertigo. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (Slept a lot) and HEADACHE (Headache). At the time of the report, HYPERSOMNIA (Slept a lot) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications were provided.
About a week after the vaccine, at the site of the shot my arm is swollen, hot and itchy. The lump is vertical and about 3 in long, red, and warm to the touch.
Difficulty Breathing; Fatigue; Headache; Injection Site Pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty Breathing), FATIGUE (Fatigue), HEADACHE (Headache) and INJECTION SITE PAIN (Injection Site Pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included OMEPRAZOLE for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced DYSPNOEA (Difficulty Breathing), FATIGUE (Fatigue), HEADACHE (Headache) and INJECTION SITE PAIN (Injection Site Pain). At the time of the report, DYSPNOEA (Difficulty Breathing), FATIGUE (Fatigue), HEADACHE (Headache) and INJECTION SITE PAIN (Injection Site Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not reported by the reporter.
Bleeding nose; sore arm  ,tenderness on the left arm , bleeding on the nose; tenderness on the left arm; A spontaneous report was received from a consumer, concerning a female patient of 55 years of age, who received Moderna's COVID-19 vaccine and experienced Pain in extremity, Tenderness, Epistaxis.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 07-Jan-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 037K20A) via unknown route for COVID-19 infection prophylaxis.  On an unspecified date, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.  On an unspecified date, after First dose of vaccine, the patient experienced Pain in extremity, Tenderness, Epistaxis. No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the events were considered to be unknown at the time of this report.
Patient woke up with a fever of 101 and a rash covering his back. Rash is small pink raised bumps.
On say 8 after my shot I have redness and swelling at the injection site. It was painful for a couple of days after the shot, got better and then on day 8, redness, swelling, and heat at the injection site.
This case was reported by a other health professional and described the occurrence of inability to walk in a unk patient who received FLUARIX TRIVALENT (batch number CA775, expiry date 30th June 2015). In 2014, the patient received FLUARIX TRIVALENT (unknown). In 2014, less than a year after receiving FLUARIX TRIVALENT, the patient experienced inability to walk (serious criteria hospitalization and GSK medically significant) and swelling. On an unknown date, the outcome of the inability to walk and swelling were unknown. It was unknown if the reporter considered the inability to walk and swelling to be related to FLUARIX TRIVALENT. Additional information received: The suspect vaccine initially reported was FLUARIX QUADRIVALENT but the batch number reported corresponded to FLUARIX TRIVALENT. Therefore the suspect vaccine was replaced by FLUARIX TRIVALENT.
This spontaneous report was received from a consumer concerning his grandson of unknown age. On an unknown date, the patient was vaccinated with a dose of MMR II (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, the patient experienced ear infections and hearing loss. It was unspecified if the patient sought any medical attention. The outcome of hearing loss and ear infections was unknown. The consumer did not provide the name and demographics of the healthcare professional. Legal issue was involved. Adverse event was sent to legal department. The relatedness for ear infections and hearing loss was unknown for MMR II. Upon internal review, the event, hearing loss was considered as medically significant. This is one of the two reports from the same source. Additional information has been requested.
Developed mild fever, marked swelling and erythema of left upper extremity. Hospitalized 10/16 through 10/18/04. IV Oxacillin, PO Benadryl, and Ibuprofen. Discharged on 7 day course of Augmentin, Benadryl PRN. I believe patient had a combination of a large local inflammatory reaction and possible cellulitis. Full recovery by 10/19/04.  Nurse follow up on 11/01/04 states: "Pain."
11/20/21 My joints were really weak. My elbows, shoulders, hips and ankles had no energy for days. It was like my arms just wanted to hang because the joints were so weak. Driving around town, it was all I could do to push on the pedal, my ankle was just so weak. This lasted a week or so. My joints did not hurt or ache, just really weak. I still experience this off and on.
pt recv vax 14MAY97 & there was some blood aspirated into the syringe; pt revaccinated w/proper dose in other arm & w/in 5min pt exp dizziness;became hypotensive (BP 70/40) & immed recovered p/being placed supine;vasovagal not r/t vax;
Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium
Started 1/15/21 at 12:30am. Headache, fever (101), Dehydrated, muscle and joint pain (Very Severe) throughout entire body.  Could not go to work. Took Tylenol (1000mg) at 10am. Could not rest or sleep. Fever and headache end at 3pm 1/15/21? Took another 1000mg Tylenol at 3pm 1/15/21. Muscle and body pains end at 11pm 1/15/21.
This spontaneous case initially received on 11-Nov-2016, was reported by a health professional and concerns a 53-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA from 09-NOV-2016 to 09-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT57108. No additional suspect drugs. Adverse reactions/events and outcomes: On 11-Nov-2016, the patient experienced an egg size lump on side of neck by collar bone (outcome: unknown).
Patient states that he had a mildly sore arm within 24 hours of receiving the vaccine. The pain only worsened as days went by. He went to see his doctor who prescribed a round of steroids orally, which did not help. Has an MRI scheduled to see if they can find out more.