chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via another pharmaceutical company (Pfizer Inc.) concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy (with unspecified drug). The patient was not taking any other medications/products within 2 weeks of starting covid-19 treatment (with Paxlovid). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number and expiry date were not reported) dose was not reported, 1 total, administered at left arm on an unspecified date in APR-2021 09:00 am for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The patient additionally received Pfizer Biontech covid-19 vaccine (tozinameran) (Dose number in series 2) (form of admin and route of admin was not reported, batch number and expiry were not reported) dose was not reported, administered at left arm on 22-SEP-2022 17:15 pm for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (dose number in series 2). On an unspecified date in 2023, the patient experienced covid-19 infection (confirmed covid-19 infection) (Dose number in series 2) which resulted in confirmed clinical vaccination failure (dose number in series 1) for which the patient received Paxlovid drug (nirmatrelvir/ritonavir) (form of admin, route of admin, batch number and expiry date were not reported) dose and frequency were not reported received from 05-JUL-2023 to 10-JUL-2023 for covid-19 treatment. On an unspecified date in JUL-2023, Laboratory data included: COVID-19 virus test Negative. Patient reported as 14 days after testing negative for covid and at the end of Paxlovid treatment, on 16-JUL-2023 the patient tested positive and reexperienced the symptoms. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint and reference number requested.; Sender's Comments: V0: 20230751693- confirmed clinical vaccination failure. The event 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. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Pt presented to Primary Care 1/22/21  for evaluation left arm numbness and pain after reportedly receiving vaccine the previous day 1/21/21. Symptoms were improving, and appeared consistent with localized reaction. Concern is that Pt was underage for this vaccine at time of administration.  Home living agency was contacted, and reported Pt received vaccine at associated agency. This provider does not know lot # and dose administered. The agency PA has been contacted, and is aware of error- would be reporting to county health.
pt recv vax 19SEP96 & 20SEP96 cried for 2hr straight;eyes rolled back in head went stiff then shallow breathing;required 10min a/pt returned to nl;seen in ER p/t99 dx bronchitis, URI, ?sz;sz occurred in car;
Patient reported experiencing "chest tightness" approximately 3-4 hours following the first COVID vaccine dose.  The patient reported having chest tightness for the following 4 days.
w/in 2-3 mins of vax pt felt lightheaded w/visual disturbances, lips numb, very flushed;felt nauseated & like would faint;9AM BP 170/100, P80;910 DPH-255PM BP 124/72; pt observed until 330PM
Fever; body aches; exhaustion; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received second dose of BNT162B2 (Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on 02Feb2021 as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications was not reported. The patient had a historical vaccine of BNT162B2 for covid-19 immunisation at the age of 41 year. The patient experienced fever, body aches and exhaustion on 03Feb2021. The treatment was not received for the adverse events. Outcome of the events was recovering.  Information on the lot/batch number has been requested.
Secretions from eyes and nose; Numbness in mouth and lips; Secretions from eyes and nose; This spontaneous case was received on 02-Feb-2021 from other non-health professional via Med Communications (reference number: SEQW21-00380) and concerned a 57-year-old, female patient.  The patient's concurrent condition included unspecified problems with her thyroid. The patient's concomitant medication included levothyroxine for unreported indication.  On 06-Oct-2015, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, anatomical location, indication and route of administration: not reported). The batch number was not reported.  On an unspecified date, unknown amount of time after receiving Afluria Quadrivalent, the patient had secretions from eyes and nose for several hours and numbness in mouth and lips.  On an unspecified date, the patient recovered from the events 'nasal discharge' and 'discharge eye'.  The outcome of the event 'numbness oral' was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company Comment: A 57-year-old, female patient developed eye discharge, hypoaesthesia oral and rhinorrhoea after vaccination with the suspect product, Afluria Quadrivalent. There is lack of information regarding the vaccination date and events onset date. Therefore, chronology is unassessable. More information regarding the underlying medical history is needed. Information regarding the related diagnostic findings have not been provided. Due to lack of information, causality for the reported events is unassessable.; Sender's Comments: A 57-year-old, female patient developed eye discharge, hypoaesthesia oral and rhinorrhoea after vaccination with the suspect product, Afluria Quadrivalent. There is lack of information regarding the vaccination date and events onset date. Therefore, chronology is unassessable. More information regarding the underlying medical history is needed. Information regarding the related diagnostic findings have not been provided. Due to lack of information, causality for the reported events is unassessable.
Left arm became swollen and red. Armpit was painful all the way down to her elbow. Pt. went to PCP who told her to take CLARITIN and swelling went down.
Erratic behavior, facial paralysis - acute peripheral facial palsy.  Symptoms included a severe eye squint, crooked smile - both on same side of the face. Still present when smiling.
6 hours after vaccine my Tongue and gums became tingly (pins and needles) numbness, neck stiffness, swollen  left underarm with hard painful bulge, over all joint pain,  left arm numbness and swelling, fever .    1 week after vaccine still continue with the  painful hard bulge from left underarm arm and Neck numbness and stiffness.
After administering needed cotton ball for blood drop - after patient looked at blood said didn't feel well. Called in his wife. His head went back, eyes rolled back, started snoring loudly, didn't respond to yelling to him - sir, can you hear me. Patient came to, was very flushed, sweated slightly. We had called EMT - they arrived. He said felt better. He said believed just anxiety. Apparently had had similar episode to MMR as adult he did not report to us even after pharmacist questioned checking yes to fainting question he reported only as child not as adult, allergen and msc.
SOB, Chest pain- pt. was monitored BP was taken read 142/82, O2 was 100%  HR 91, RR24, was offered water and sat back in chair. Patient stated hx of complications in laparoscopic surgery with gallbladder that might have caused damage to heart. Pt also stated hx of mild anxiety to vaccines. Dr. checked on the patient and assessed pt heart, stated to monitor patient for 15 more minutes. pt vitals rechecked after 15 mins and read BP-138/80, HR72, O2100%, pt stated water and taking deep breaths helped her calm down. Pt has no PCP was referred to make an appointment with one to get checked up. pt stated she felt better and was good to leave.
Dizziness; Aches; Pain; Arm is still sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN (Aches), PAIN (Pain) and INJECTION SITE PAIN (Arm is still sore at injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included AMLODIPINE, LISINOPRIL, ATORVASTATIN CALCIUM and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced DIZZINESS (Dizziness), PAIN (Aches), PAIN (Pain) and INJECTION SITE PAIN (Arm is still sore at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), PAIN (Aches), PAIN (Pain) and INJECTION SITE PAIN (Arm is still sore at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Edema of injection (R) arm away from site of injection. Swelling near bicep area-mild edema, pt asked to take BENADRYL and ice.
FATIGUE AND SORENESS AT INJECTION SITE Narrative: SORE ARM STARTED 1-2 HR AFTER INJECTION AS DID FATIGUE.NAUSEA STARTED 2/3/2021
RASH AND ITCHINESS DEVELOPED THE NEXT DAY STARTING WITH SMALL RED AREA, AND GROWING TO INVOVLE FROM SHOULDER TO ELBOW.   PATIENT USED CORTISONE AND ZYRTEC TO TREAT ALONG WITH ICE.
given sub-q wrong route Called client @ 1455 spoke to her told her that dose valid but given wrong route. She had no questions.
Debilitating arm pain. Every joint  in my body aches. Dizzy. Fever. Chills.
pt recv vax & exp lymphadenopathy &  T104.6;pt had rt posterior cervical lymph node;dx systemic adenopathy;pt had persistent axillary adenopathy;had focal low density lesion rt kidney;spleen somewhat enlarged;ovarian cyst;bilat pneumonia;
Temperature excursion; No Adverse event; Patient received these vaccines post excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event) in an adult 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. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion).    No concomitant medications were reported.  The nurse reported that, there was temperature excursion on 01-Nov-2022 in the refrigerator. At the time of excursion, the vials were in refrigerated storage. It was individual vials and vial size was unknown. The maximum or minimum temperatures reached at time of excursion was minimum 34.8 F (Fahrenheit) and maximum at 42.49 F  for 14 Minutes duration. The vials were moved from freezer to refrigerator in less than 30 days. On visual inspection vials were in normal state.  The patient received the vaccine post excursion and remaining vials were discarded.   No treatment medications were reported.
This patient is over 65 years of age, so should have received the high dose flu vaccine. This patient received a standard dose instead. The provider was made aware that the wrong vaccine was given and had no clinical concerns for this particular patient. The patient was notified and did not have any concerns. The patient was not having any side effects from the vaccination and had no complaints.
PATIENT DID PASS OUT, SLUMPING FORWARD IN HER CHAIR, WE GAVE HER WATER UNTIL SHE FELT BETTER AND LEFT
24 hours after vaccination with redness, warmth shoulder on Dtap/Ipv side no fever, supportive care, mom to follow up if increase in symptoms.
This spontaneous report was received from a nurse refers to a patients of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies or concomitant therapies was not provided. On 10-OCT-2016, the patient was vaccinated with an improperly stored VARIVAX (lot# L050956 with expiry date 17-DEC-2017) first dose. The vaccine had a temperature excursion of 6.3 Fahrenheit (F) for 1 hour and 50 minutes, 6.6F for 1 hour and 40 minutes, 40.5F for 2 hours, 5.2F for 20 minutes and 6.3F for 1 hour and 50 minutes. Previous temperature excursions included 13.3F for 80 minutes, 9F for 420 minutes. The call was because of a data logger. No adverse effects reported. This sis one of the two cases received from the same reporter. Additional information has been requested.
I have a rash on my face that I have never had before. It has persisted over a month
severe headache x 4 days; 10 cm zone of dime sized indurated macules @ inject site; pt was spanked w/in minutes prior to inject;
Patient vaccinated for Covid and was admitted to ICU for acute respiratory failure and community acquired pneumonia due to Covid.
Patient received FLUZONE 0.5mL in the (L) arm. Has egg allergy but has received flu vaccine in the past with no reaction. Vaccine administered 11/11/15, presented on 11/13/15 small bruise at injection site, below injection site red and warm for 4", no pain, patient reports itching.
Flu like symptoms; Pains; Low energy/ Moderna Covid 19 vaccine and these doses took her down for 2 days.; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Pains) and ASTHENIA (Low energy/ Moderna Covid 19 vaccine and these doses took her down for 2 days.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A, 036B21A and 03421F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Food allergy, Allergy to grains, Vegetable allergy and Drug allergy. Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Pains) and ASTHENIA (Low energy/ Moderna Covid 19 vaccine and these doses took her down for 2 days.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Pains) and ASTHENIA (Low energy/ Moderna Covid 19 vaccine and these doses took her down for 2 days.) had not resolved.
Moderate tinnitus developed within two weeks of first vaccine dose.  Tinnitus persisting unchanged eleven weeks after first dose. Second dose received March 2, 2021.
Mild injection site soreness; A spontaneous report was received from a consumer concerning a male patient of unknown age, who was administered with Moderna's COVID-19 vaccine and experienced injection site soreness.  Patient's current condition included kidney stone. Concomitant mediations were mentioned was hydrocodone.  On 12-FEB-2021,prior to the onset of events, patient received the first of two planned doses of mRNA-1273 vaccine(Lot number: unknown) for prophylaxis of covid-19 infection.  Following the vaccination on 12-FEB-2021,the patient experienced injection site soreness.The patient wanted to know if he could take Hydrocodone because ha believes he has kidney stone and injection site soreness.No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the event, injection site soreness was unknown.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded. The reported event is consistent with the known safety profile of the vaccine.
12-8-10 Evening - Rash on (LT) around inj. site. Mom applied cream. Rash also noted on buttocks. 12-9-10 9AM phone call to Health Dept. rash lighter than last evening. Warm towel suggested. Mom will call if worsens.
This spontaneous report as received from a pharmacist refers to a 70 year old male patient. No information on patient's concurrent conditions, medical history or concomitant medications was provided. On 29-OCT-2015, the patient was vaccinated with the dose of ZOSTAVAX injection (dose, route of administration, lot# and expiration date were not reported). On 30-OCT-2015, the patient experienced severe swelling at the injection site after ZOSTAVAX therapy. No lab diagnostic studies were performed. The patient sought unspecified medical attention. The outcome of severe swelling at the injection site and the causality between the adverse event and ZOSTAVAX were not provided. Additional information has been requested.
like a slight paralysis; stiffness in the face; numbness in the face; A spontaneous report was received from a 64-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced like a slight paralysis, stiffness in the face and numbness in the face.   The patient's medical history, as reported, included high blood pressure. Concomitant medications reported included losartan.   On 13 Jan 2021, about 5 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 13 Jan 2021, about 5 minutes after getting the Moderna COVID-19 vaccine, the patient experienced a stiffness and numbness in the face, like a slight paralysis. It started in the nose and spread out to the eyes and forehead. After about half an hour, he still experienced it a little bit. No medications were taken for the events.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, like a slight paralysis, stiffness in the face and numbness in the face, was recovering/resolving.; Reporter's Comments: This spontaneous report refers to a case of a 64-year-old, male patient with medical history of high blood pressure who experienced a serious event slight paralysis and non-serious events of stiffness in the face and numbness in the face.  The events occurred 5 minutes after the administration of the mRNA-1273 vaccine (lot # unknown, expiration date-unknown). No treatment was administered, and patient is recovering. Based on the information provided which includes a temporal association, a causal association cannot be excluded.
Patient received H1N1 vaccine 11/7/09. Mom noticed behavioral change after vaccine. Child is acting out in school and is more angry and upset.
Woke up following morning with severe pain in neck - right side - neck stiff and movement limited  - lasted four days went to orthopedic surgeon - steroid shot and 10 hr heat pack and daily ALEVE for 7 days.
Inadvertently administered an expired dose of Acthib/No AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Agency (Reference number- 00381689) and transmitted to Sanofi on 04-Dec-2020.  This case involves a 15 months old male patient who inadvertently administered an expired dose of acthib/no adverse event, while he received vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot number# UJ175AA, expiry date: 26-Nov-2020) via Intramuscular route in right thigh for prophylactic vaccination, on 04-Dec-2020 (expired product administered).  The patient concomitant medications diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) and influenza vaccine (FLU).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  This was an actual medication error case due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
This spontaneous report as received from a registered nurse refers to a 59 year old female patient with arthritis, asthma and hypertension. The patient was allergic to Penicillin, Amoxicillin, Neomycin eye drops and Polytran eyedrops (Reactions were unspecified). On 19-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J000783, expiry date 30-APR-2014) 0.65 milliliter (ml), subcutaneously. Concomitant therapies included pantoprazole sodium, FLOVENT, potassium (unspecified), triamterene, calcium (unspecified), glucosamine, omega-3 marine triglycerides (fish oil) and ACTANENE. On 20-APR-2013 the next day, the patient experienced 6.5 inch by 4.5 inch welt that was red with white dots. The patient reported that the white spots went away quickly and the rash itches and burns. The patient sought medical attention (was seen in the office) and was given Hydrocortisone creme which had provided relief. On 20-APR-2013 (reported the day after vaccination), the patient had a small red spot, mid abdomen that resolved on an unknown date in April 2013 (reported as very quickly) without treatment. Diagnostic test performed was none. The outcome of 6.5 inch by 4.5 inch welt that was red with white dots and rash itches and burns was recovering/resolving. Additional information has been requested.
Patient presented with maculopapular rash over most of body and redness in mouth 14 days after receiving vaccinations - Diagnosed with uncomplicated measles.