chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose is considered invalid; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT SELECTION ERROR (Dose is considered invalid) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PRODUCT SELECTION ERROR (Dose is considered invalid). At the time of the report, PRODUCT SELECTION ERROR (Dose is considered invalid) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported No treatment medications were reported    This case was linked to US-MODERNATX, INC.-MOD-2021-100428 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-100428:
Left upper thigh with diffuse swelling and erythematous, polymorphous rash that blanches with palpatation, progressing from awakening this morning to evaluation down the leg to the knee. This is associated with warmth to touch.
Pentacel components were all given separately and an extra dose was given by accident with no reported adverse event; Initial information received on 11-Apr-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 years old male patient and reporter reported that pentacel components were all given separately and an extra dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was given by accident with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis B vaccine for Prophylactic vaccination; and measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination.  On 12-Jan-2022, the patient received 0.5 ml (milliliter) of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (lot C5765BA, expiry date: 28-Aug-2022) via intramuscular route (With unknown strength and at unknown administration site) for immunization.  On 12-Jan-2022, reporter reported that pentacel components were all given separately and an extra dose was given by accident with no reported adverse event (extra dose administered) (latency: same day).  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Chest heaviness; This is a spontaneous report from a contactable pharmacist. A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via an unspecified route of administration on 08Jan2021 at a single dose, for covid-19 immunization. Medical history included allergies from shellfish-derived products. The patient's concomitant medications were not reported.  The patient experienced chest heaviness on 08Jan2021. Patient was transported to ER for evaluation. Upon re-evaluation in ER, patient felt back to baseline and was discharged. The outcome of event was recovered.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
3x3cm reddened area to injection site. Although this would not be concerning as isolated event, cell members who received dose from this vial had similar or worse reaction.
Information has been received from a licensed practical nurse concerning a 21 year old male patient who was inadvertently vaccinated with a 1st and 2nd dose of Hepatitis B vaccine recombinant in 1997 and in June of 1998, respectively. Subsequently, the patient's liver function tests were increased. The patient sought unspecified medical attention. Follow up information from a licensed practical nurse indicated that the patient had mononucleosis, which "explained his increased liver function tests. The patient was not admitted to the hospital. The patient is fine now."
Refusal to eat, screaming and crying inconsolably including high-pitched screaming, fever. Infant breastfed only 3 times on 08/29/2014 and 08/20/2014. She screamed and arched her back whenever offered the breast, where previously, even with a cold, she sought comfort in breastfeeding and ate regularly and predictably over 8-10 times over a 24 hour period. Extreme personality shift evidenced by the screaming and inconsolable crying and refusal to eat. Previous to receiving these vaccines, my child would wake smiling and giggling and never refused to eat or sleep nor was prone to prolonged crying or irritability. She was a notably easy-going, pleasant baby who now requires significant soothing before she will breastfeed. She was taken to an urgent care doctor on 08/30/2014 who found no signs of dehydration or infection and offered no explanation for her refusal to eat or irritable symptoms.
This spontaneous report as received from a licensed practical nurse refers to some patients of unknown age and gender. The patients' pertinent medical history and drug reactions were not reported. The nurse stated that in 2001 COMVAX had the 4-dose schedule, then the vaccine was on backorder and on unknown dates, some patients did not receive the 4th dose of COMVAX (also reported as "Hepatitis B"; dose, route of administration, lot# and expiry date were not reported). No adverse effects were reported. Additional information has been requested.
Sore arm; Irregular heartbeat; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEART RATE IRREGULAR (Irregular heartbeat) and FATIGUE (Fatigue) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0321B21H) for COVID-19 vaccination.     No medical history was reported by the reporter. .  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), HEART RATE IRREGULAR (Irregular heartbeat) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm), HEART RATE IRREGULAR (Irregular heartbeat) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was reported.
No adverse event reported, this is a report to inform patient received a vaccine that was adminstered beyond the use date. Vial was adminstered after the 30 days under refrigeration.
5 inch by 3 inch red patch, hard, hot, painful and swollen. Beginning to resolve somewhat today, October 13, 3:30 PM. Still painful and warm but areas slightly smaller and less swollen. Received a flu vaccine at the same time, same arm.
Headache outside of left eye, radiated to left side of head. Fairly severe pain, I don't usually get headaches.
Death; unconscious; in and out of consciousness; weak, very weak; blood pressure was very low; little light headed; A spontaneous report was received from consumer concerning a 88 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a little light headed/ dizziness, weak, very weak/asthenia, blood pressure was very low/ hypotension, in and out of consciousness/depressed level of consciousness, unconscious/ loss of consciousness and passed away.  The patient's medical history was reported as heart issues. Concomitant medications taken by the patient included levothyroxine, isosorbide, acetylsalicylic acid, metoprolol, furosemide, warfarin, antibiotics.   On 3 Mar 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 015M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 3 Mar 2021, when the patient got home the night, after getting the shot, patient was a little lightheaded, she seemed to be okay on 04 Mar 2021 and 05 Mar 2021. Patient had complained of being weak and her blood pressure was very low on 08 Mar 2021. She was progressively started getting weaker. On 09 Mar 2021, she was very weak and was in and out of consciousness. Patient was taken to the hospital, and she became unconscious and  then passed away. Patient passed away on 09 Mar 2021.  The patient died on 09 Mar 2021. The cause of death was unknown.  Plans for an autopsy were unknown.   Treatment activities for event was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events,  unconscious, a little light headed, weak, very weak,  blood pressure was very low, in and out of consciousness was unknown. The outcome was considered fatal.; Reporter's Comments: This is a case of sudden death in a 88-year-old female patient with a history of heart issues, who died 6 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age. The medical assistant reported that GARDASIL, PNEUMOVAX23 (MARRS# 1312USA005447), RECOMBIVAX (MARRS# 1312USA005448) and VAQTA (MARRS# 1312USA005449) were improperly stored. On unknown date unspecified patients vaccinated with improperly stored GARDASIL. No adverse effects reported. It was unknown if the patient had sought medical attention. This is one of four cases from the same reporter. Additional information has been requested. This is correction information. The LLT and PT of the primary event was recoded to incorrect storage of drug.
heart palpitations; Pfizer first and second shot; weakness; dizziness; headache; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations), ASTHENIA (weakness), DIZZINESS (dizziness), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer first and second shot) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (first and second shot). Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Blood pressure high (its controlled and take medication.), Penicillin allergy and Sulfonamide allergy (sulfa).    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Dec-2021, the patient experienced ASTHENIA (weakness), DIZZINESS (dizziness) and HEADACHE (headache). On an unknown date, the patient experienced PALPITATIONS (heart palpitations) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer first and second shot). At the time of the report, PALPITATIONS (heart palpitations) had not resolved, ASTHENIA (weakness), DIZZINESS (dizziness) and HEADACHE (headache) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer first and second shot) had resolved.            Concomitant medication include unspecified medication for high blood pressure.  No treatment medication was reported.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not specified. On 20-AUG-2015, the patient was vaccinated with an improperly stored (incorrect product storage) (Oka/Merck) VARIVAX (dosing details unspecified). The physician provided lot/expiry date information for two improperly stored lots of (Oka/Merck) VARIVAX (lot number K011798 with expiry date 21-AUG-2016; lot # L011082 with expiry date 01-APR-2017). It was unspecified from which of these two lots the patient received the improperly stored dose. No adverse events were reported. Product quality complaint (PQC) ws not reported. Additional information has been req2uested.
she felt lethargic; had a terrible headache; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patients second dose scheduled on 11Feb2021 and was asking if she can take the vaccine earlier. On an unspecified date, the patient felt lethargic and had a terrible headache. The outcome of the events were unknown.  Information on the lot/batch number has been requested.
The pt requested urgent appointment today due to shingrix vaccine reaction. She was given the second dose yesterday and has had low grade fevers as well as redness and pruritus to the site of injection on the right bicep.Start Triamcinolone Acetonide Topical cream, 0.1%, 1 app, applied topically to right arm, 3 times a day, 7 day(s), 30 Gram          Start Zyrtec tablet, 10 mg, 1 tab(s), orally, once a day, 10 days, 10 Tablet          Start Benadryl tablet, 25 mg, 1 tab(s), orally, 4 times a day, 10 days, 40 Tablet
patient says that after the receiving the flu shot her left arm continues have a dull pain and is still not going away
Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318, expiration date: May2021), via an unspecified route of administration in the left arm on 31Jan2021 at 12:30 at a single dose for COVID-19 immunization. The vaccination was done at a hospital. The patient's medical history included Reynold's syndrome (21 years old at diagnosis), Sjogren's (diagnosed at 30 years old), mixed connective tissue disease (diagnosed around 30 years old), and fibromyalgia (late 40s at diagnosis). There were no concomitant medications. The patient previously received a tetanus shot for immunization on an unspecified date and was allergic to the tetanus shot. This happened when she was 21 years old. The patient also got the new pneumonia shot on 12Jan2021 in her left arm for immunization at the age of 65 years old. The patient got her first dose of BNT162B2 on 31Jan2021. The patient stated she was supposed to get second vaccine 21Feb2021 but that she went to emergency room 13Feb2021 with extreme right eye pain and numbness in lip. She was diagnosed with Bell's palsy. The patient stated that she was not admitted to the hospital, and she just seen in the emergency room. It was reported that it initially worsened, that her eyes were definitely worse until a week later she was scheduled to see her physician and on Wednesday 17Feb2021 she started taking eye drops and now they have not gotten any worse. The doctor said it was not known if it was caused by the vaccine, and stated the patient has certain autoimmune problems Reynaud's, Sjorgen's and mixed connective tissue disorder, all diagnosed prior to vaccine. The patient had no family history relevant to the event. There were no relevant tests. The outcome of the event was not recovered.
Severe rashes all over the body; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 08Apr2021 at 17:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to pollen and dust. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6204) via an unspecified route of administration in the left arm on 18Mar2021 at 14:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021 at 15:00, the patient experienced severe rashes all over the body after about 4 days of vaccination. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event and included treatment with steroids medication and lotion. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe rashes all over the body was recovered on an unspecified date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Pt had her second COVID vaccine on March 27th 2021,  On April 4th 2021,  the patient went to the ER due to shortness of breath, dizziness, and racing heart rate.  After patient participated in physical activity she had to lay down afterwards due to the shortness of breath.  Pt spent 2 days in the hospital after being diagnosed with bilateral pulmonary embolisms.  Pt was started on Xarelto and was discharged from the hospital on April 6th.
This spontaneous report was received from a female consumer referring on herself with sulfides allergy and codeine allergy. The patient's medical history included breast cancer. On 06-NOV-2009, the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported). No concomitant medications were reported. There was not lab diagnostics studies performed. The patient stated that approximately every 4 months she experienced left side neuropathy with numbness of hip. She has been experienced this ever since she received her ZOSTAVAX injection (onset date reported as March-2010). The patient also stated she broke out of rash. The patient had a healthcare professional visit and was treated with ZOVIRAX ointment. At the time of this report the patient's outcome was recovering. Additional information has been requested.
I had a lot of stomach cramps, muscle cramps and I was very tired. Since May, I have passed out 2 dozen times and been to the hospital numerous times. They did blood work and they say that I am anemic now. They did and iron infusion. My blood counts are weird and they think I might be bleeding somewhere. They are wanting to put a small camera in my small intestine.
Was notified on 09/01/22 at 2:50pm that we are to no longer administer monovalent vaccines.
Approximately 2 minutes after receiving the vaccine (Tuesday, September 19), the client stated he vomited.  VIS sheet and package insert were reviewed with him.  Was instructed if symptoms worsen to seek medical care.  On Friday, September 22, spoke with clients supervisor who stated client had been sent home from work on Thursday, September 21 because of dizziness.  Also spoke with client on same day and he stated that on Thursday, September 22, he had vomiting and dizziness.  He also stated, he fell at his home and cut his head.    By Friday, September 22, he stated he continued to have mild dizziness, but it was improving, he also was having a head ache and stomach ache.    As it was three days since the vaccine was administered and was late Friday afternoon when the conversation took place, client was instructed to follow up with a physician for evaluation.  While doctor visit may not have been necessary, as a safety measure, he was instructed to follow up with a physician.    Unsure if doctor visit was made.
This spontaneous report as received from a pharmacy technician concerning a currently 71 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 15-APR-2014, the patient was vaccinated with ZOSTAVAX lot # J007208; expiration date: 20-SEP-2014, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with ZOSTAVAX that was exposed to 43.1 F for 29 hours on 03-MAR-2014. This is one of four reports from the same reporter. Additional information has been requested.
All of the symptoms I have for Myalgic Encephelomyelitis got worse right away and never improved from that point, I also got a fever, and within the next couple of years, I developed multiple chemical sensitivities, hypothyroidism, circadian rhythm disorder, various GI issues including gastroparesis, and orthostatic intolerance.
Had the shots, still got it/suspected vaccination failure; Still got it; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included PREDNISONE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and PREDNISONE. 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 was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 28-Feb-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated anything, he/she had the shots and still got them which lasted 5 to weeks, even with the antiviral and prednisone. Additional supportive information: It was unknown if the reporter considered the shingles to be related to antiviral and prednisone. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As per narrative it seems that after receiving the antiviral and prednisone, the patient got the shingles, therefore, prednisone was coded as suspect and antiviral was not coded because it was reflecting group.
Muscle aches arm, legs Headaches, chills Glands in neck  (left side) swollen, continues to enlarge and is sensitive to touch.