chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date, Dose administered after 30 day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (inadvertently administer the vaccine 11 days after expiration date, vial was initially stored in the refrigerator on 27May2022 and administered on 31May2022) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis. No allergies (medications, food and other products), Unknown if patient ever had COVID positive test or diagnosis. Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (Vaccines given within 1 month prior to Moderna COVID-19 vaccine: Flu Lot No : UJ745AA.) on 18-Oct-2021. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date, Dose administered after 30 day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (inadvertently administer the vaccine 11 days after expiration date, vial was initially stored in the refrigerator on 27May2022 and administered on 31May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date, Dose administered after 30 day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (inadvertently administer the vaccine 11 days after expiration date, vial was initially stored in the refrigerator on 27May2022 and administered on 31May2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. On 01-Nov-2021, patient received first booster dose of Moderna vaccine. On 31-May-2022, patient received second booster dose of Moderna vaccine (batch no. 033K21-2A) after expiration date. It was reported that the vial was initially stored in the refrigerator on 27May2022 and vial  did not undergo any temperature excursions. It was unknown if AE cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). Unknown if patient experienced a similar event in the past. No treatment medications were reported.
103.5F fever, severe chills/sweats, joint pain, myalgia, eye pain, neck pain, headache, injection site pain, weakness, light headedness,  axillary lymph node swelling and pain.  still experiencing eye pain and lymph node pain
Patient loss her sense of taste and tested positive for COVID; Patient loss her sense of taste and tested positive for COVID; This is a spontaneous report from a contactable other hcp. A 30-Years-old female patient (pregnant: unknown) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: EN5318), via intramuscular route of administration, administered in Arm Left on 04Mar2021 as (at the age of 29-Years-old) unknown dose number, single for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was reported as workplace clinic. The patient medical history and concomitant medications were not reported. It was unknown that the patient received any other vaccines within 4 weeks prior to the COVID vaccine and other medications received within 2 weeks of vaccination. Prior to vaccination, the patient diagnosed with COVID-19 was reported as unknown. Since the vaccination, the patient been tested for COVID-19. The patient loss her sense of taste and tested positive for COVID on 05Aug2021. No hospitalization was prolonged. The adverse event was resulted in doctor or other healthcare professional office/clinic visit. Prior The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05Aug2021. No treatment was received for the reported events. The outcome of the event was reported as not recovered.  Product Quality Complaint: Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN5318 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN5318, fill lot EN5317, and the formulated drug product lot EN5316. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events covid-19 and drug ineffective and the suspect drug BNT162B2.
Pt came in and had redness, swelling at injection site also said she felt "a little lethargic". Instructed pt to call MD but she felt it wasn't serious enough for MD visit but wanting to report injection site reaction.
Patient developed shortness of breath and tachycardia/palpitations in the evening after receiving the vaccine, as well as "pins and needles" sensation over her torso.
Lightheadedness, nausea, decreased response to questioning, and profuse sweating during entire event! EMS contacted as precaution.
Red, raised, itching patches to R post. and anterior arm down to the flank area. Symptoms started on 12/15/09. Hives remain on anterior arm area. BENADRYL 25 mg x 1 dose.
Patient taking part in Hepatitis A clinic. 955am HepA shot given right deltoid IM. 10am Patient fell/passed out in hallway, Unknown if he hit head. 1015am BP 68/44, HR 39, BS 107, O2 97% RA, Very diaphoretic, blurry vision. Encouraged to drink water. 1020am vomited. 1034am ambulance called. 1051am 56/342 HR, O2 99%. 11am Ambulance arrived and transported patient to ER.
tingling on her left arm.; This is a spontaneous report from a contactable consumer (patient) via a Regulatory Authority. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received both doses and had tingling on her left arm. She was going to see her doctor on 16Jul2021 however, she wanted to know if tingling was temporary or she should be concerned. Medical questions were addressed by the program forwarded/referred to medical information. The outcome of the event was unknown.  Information on the Batch/lot number has been requested.
Patient had NSTEMI secondary to spontaneous coronary artery dissection. She was managed medically.
This case was reported by a healthcare professional and described the occurrence of a hard lump at the injection site in a 4 month old male subject who was vaccinated with Pediarix for prophylaxis. The subject had no significant medical history or concurrent conditions. Concurrent vaccination included pneumococcal vaccine and an unspecified vaccine given in the left leg on the same date, 06 September 2006, as Pediarix. On 06 September 2006 the subject received 2nd dose of Pediarix at 0.5 ml, intramuscularly, in the right thigh. An unknown amount of time later, on the same day of vaccine administration, the subject developed "a knot at the sight of administration of the Pediarix." This was considered to be a medication error. It was thought that the vaccine went into the fat instead of the muscle. At the time of reporting the outcome of the events was unspecified.
rash on her legs. She had (1) rash on each leg, on her thighs, on the outer parts of her thighs; rash on her legs. She had (1) rash on each leg, on her thighs, on the outer parts of her thighs/One had a tiny bump; This is a spontaneous report from a contactable consumer (patient reported for herself). A 42-year-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 16Apr2021 11:30 (Batch/Lot number was not reported) at the age of 42 years old as single dose for covid-19 immunisation. Medical history included Horrible allergies to mold, crab meat, chicken hot dogs. The patient had never taken the flu shot because she couldn't digest eggs properly. Concomitant medication received within 2 weeks of vaccination included valaciclovir hydrochloride (VALAREX) sporadically. Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Apr2021 10: 00, the patient had what appeared to be a rash on her legs. She had (1) rash on each leg, on her thighs, on the outer parts of her thighs. One had a tiny bump. It basically looked like one put blue dye on a golf ball and then stamped her thigh. Treatment was not received for the adverse events. This report was non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
History and exam as noted below, differential of acute, tender lymphadenopathy reviewed, although no obvious source of infection, this could be a reaction to the second COVID 19 shot even 2.5 weeks later, reviewed with patient the results of her blood tests including inflammatory markers that were normal, US results discussed as well as the radiologist's impression, in the absence of an other associated systemic changes or red flags we will monitor for now and follow up ion 8 weeks or so, sooner if sx are not improving or she develops any of the new changes we talked about
pt recvd vax; 12 hrs later, pt exp extreme fever; ached all other; bad chills; teeth chattering; shakes; v; very n & h/a; lasted 1 day; ran low grade t 100.8 for several days;
on 10/23/2021 I started getting chills.  I could not get warm.   when I went to bed I ended up with a fever and was very tired, kind of lethargic.  we called nurse and she suggested i go to ER. I was tested negative and treated with tylenol. and fever went down
Patient went to the ER due to several fainting and arm hurting.  ER Doctor examined her and did not find anything.
Patient is extremely upset that this happened; She did not receive a full dose; A large amount of vaccine had come out of the injection site and ran down her arm; Patient was given Fluad Quadrivalent instead of high dose influenza vaccine; This spontaneous case was received on 23-Sep-2020 from other non-health professional via agency (reference number: SEQW20-02256) and concerned a 74-year-old, female patient.   The patient's past medical history included flu, after which the patient started receiving vaccines and did not have any trouble. The patient's current medical history and concomitant medications were not reported.  On 07-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: less than 0.5 ml, route of administration, anatomical location, expiry date: not reported) instead of the high dose influenza vaccine (explicitly coded as: 'Wrong vaccine administered') for protection against seasonal influenza. The patient stated that the clerk administering the vaccine seemed very unsure of herself and ''not confident in what she was doing" when she was administering the vaccine and did not know how to hold the syringe compared to the many other times she received an influenza vaccine from other people The patient noticed that, after administration of the vaccine, a large amount of vaccine came out of the injection site and ran down her arm, and patient was pretty sure that she did not receive a full dose (explicitly coded as 'Accidental exposure to product' and 'Incomplete dose administered'). The patient was extremely upset that happened. The batch number was not reported. The patient did not get any corrective treatment.  At the time of initial reporting on 23-Sep-2020, the patient had not recovered from the event of  'emotional distress'.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: A 74-year-old, female patient was administered incomplete dose of Fluad Quadrivalent. Patient was given Fluad Quadrivalent instead of high dose influenza vaccine. A large amount of vaccine had come out of the injection site and ran down her arm. Reportedly, the patient was extremely upset that this happened. Incorrect dose administered, accidental exposure to product and wrong product administered are assessed as not related, per company's conventions. The event of emotional distress is considered not related to the suspect vaccine substance, due to accidental nature of events.; Sender's Comments: A 74-year-old, female patient was administered incomplete dose of Fluad Quadrivalent. Patient was given Fluad Quadrivalent instead of high dose influenza vaccine. A large amount of vaccine had come out of the injection site and ran down her arm. Reportedly, the patient was extremely upset that this happened. Incorrect dose administered, accidental exposure to product and wrong product administered are assessed as not related, per company's conventions. The event of emotional distress is considered not related to the suspect vaccine substance, due to accidental nature of events.
ADMITTED TO HOSP AFTER BYSTANDER CPR. COVID TEST AT ADMIT POSITIVE
7/3/07 Approx 3 hr after pneumo. vac. given (L) arm swelling, chills fever and HA. Husband gave Tylenol which was helpful (decreased H/a and chills fever) 7/4 (07 when client woke (L) arm swelling from (L) elbow to collar bone area. Client stated she didn't go to MD due to holiday. nonone there. 7/5/07 MD visit to Dr -advised Benadry/Tylenol and see surgeon if symptoms didn't get better will admin antibiotics. Client in today to report 7/6/07. Stated swelling has gotten better with Benadryl. Client going to Dr at 10:45 am. Antibiotics and Dr
Information has been received from a health professional concerning an approximately 9 year old male who on 20-AUG-1998 was vaccinated with Varivax (Oka/Merck) (lot 626688/0650H). Subsequently, the patient experienced a generalized rash with <50 lesions. This case was documented or evaluated by a physician. The child was not hospitalized. No additional information was provided. Additional information has been requested.
Migranes started 8/7/2022 daily headaches continued until January 2023; slowly better January 2023
ACHING; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-APR-2021, the subject experienced aching. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aching on 05-APR-2021. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Mom described to Dr that patient was pale looking and appeared very dry, small amount of shaking, temperature of 100.3, the mother took him to the emergency room.  He was followed up with our office on 2/3/06 where Dr. diaganosed the child with an apnea spell, shot reaction. Dr. wanted to wait until his 4mo set of vaccines before she made a decision to give or not to give the dtap again, she decided to hold it for the 4/7/06 visit for several weeks, he was seen again yesterday at which time Dr. decided that the child should not have another dtap, she is going to start him on the pediatric dt as of his 6 mo. well child visit.
pt recvd vax & had inc t 103; fussy; unconsolable x 24 hrs;
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis. 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: This case was reported for reporter's friends. The age at vaccination was not reported. The reporter stated the patient's got shingles from the Shingles shot. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Swelling of entire upper arm, redness all the way around arm to the elbow, intense itching gradually diminishing over 1 week period.  Also developed tinnitus in both ears.
Information has been received from a physician concerning a patient who was vaccinated on an unspecified date with a dose of Zostavax (Oka/Merck).  Subsequently, on an unspecified date the patient experienced a "rash-like reaction with redness and hardness." It is unspecified if medical attention was sought.  The outcome is not reported.  This is one of several reports from the same reporter.  Additional information has been requested.
trying to find an appointment for my 2nd vaccine that is past due; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (trying to find an appointment for my 2nd vaccine that is past due) and PRODUCT AVAILABILITY ISSUE (trying to find an appointment for my 2nd vaccine that is past due) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (trying to find an appointment for my 2nd vaccine that is past due) and PRODUCT AVAILABILITY ISSUE (trying to find an appointment for my 2nd vaccine that is past due). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (trying to find an appointment for my 2nd vaccine that is past due) and PRODUCT AVAILABILITY ISSUE (trying to find an appointment for my 2nd vaccine that is past due) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information, if any, was not provided by the reporter.  Treatment information, if any, was not provided.
Client received his J&J vaccine and immediately afterwards he had a seizure-tonic clonic. Seizure lasted about 40 seconds, he was immediately evaluated by the paramedics on site. BP laying down was 117/74  p62 and later 116/82 p66. Client indicates that has a history of passing out when he gets his blood drawn. 911 was called and Medic arrived, client was transported to the hospital for further evaluation.
Achy after second shot; Tired/fatigue after second shot; A little nausea after second shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy after second shot), FATIGUE (Tired/fatigue after second shot) and NAUSEA (A little nausea after second shot) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 040A21A) for COVID-19 vaccination.     The patient's past medical history included Adverse food reaction (Food reactions).   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN (Achy after second shot), FATIGUE (Tired/fatigue after second shot) and NAUSEA (A little nausea after second shot). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. In April 2021, PAIN (Achy after second shot), FATIGUE (Tired/fatigue after second shot) and NAUSEA (A little nausea after second shot) had resolved.            No concomitant medication reported. No treatment information was provided.  The patient experienced no adverse effect after receiving first dose and had experienced the adverse events for 1.5 days after receiving second dose. The patient had a medical history of food reactions but nothing similar to that extent.   This case was linked to MOD-2022-437621 (Patient Link).
tightness in the throat; Headache; chest pain; sore throat; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 17Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 27Jan2021 for COVID-19 immunisation. It was reported on 21Feb2021, 4 days after receiving the second dose of the vaccine, consumer started experiencing headache, chest pain, sore throat and tightness in the throat. Consumer still experiencing these symptoms 11 days after receiving the second dose. Consumer stated  that consumer went to the ER several days ago and got an EKG and all done. They told her everything looked okay and that they didn't think it was a reaction to the vaccine. Consumer also added that consumer read on the internet from people receiving the vaccine that they were experiencing lingering chest pain. The outcome of events was not recovered.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.