chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; Moderna, Dose: 4 / Pfizer, Dose: 5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Nov2022 as dose 5 (booster), single (Lot number: FF8006) at the age of 33 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Sep2022 as dose 4 (booster), single (Lot number: AS7144B), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Hashimoto" (unspecified if ongoing); "Ehlers Danlos" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Known allergies: Melon" (unspecified if ongoing); "Known allergies: Adhesive" (unspecified if ongoing); "Known allergies: CT IV Contrast" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2022, outcome "recovered", described as "Moderna, Dose: 4 / Pfizer, Dose: 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "recovered" (May2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2023) Negative, notes: Tested negative and felt better after completing full course of Paxlovid. Therapeutic measures were taken as a result of Drug ineffective, Covid-19 which includes Paxlovid treatment from 30Apr2023 to 05May2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300188730 same reporter/patient, different drug/event;
fatigue, weakness, body aches, chills, vomiting, injection site pain, dizziness
Increasing erythema, edema, skin warmth around area of inoculation- left upper lat. thigh area noted day after shots were given.
Fever/chills/ headache & extreme body aches. Every single joint in my body hurt. Even my fingers and toes. It almost felt like Gout in my toes. It hurt to grip anything tight. For at least half the day on the 9th I had a difficult time walking due to extreme pain in my hips and lower back. Symptoms seemed to decrease in the late evening of the 9th. Today I feel better (2/10) but still have terrible headache and pain in my hips.
This case was reported by a physician via call center representative and described the occurrence of fatigue in a 44-year-old male patient who received ENGERIX B adult. Co-suspect products included ENGERIX B adult.  Previously administered products included Engerix B adult (1st dose in 13 AUGUST 2013). On 2nd December 2013, the patient received the 2nd dose of Engerix B adult. In May 2014, the patient received the 3rd dose of Engerix B adult. On 2nd December 2013, an unknown time after receiving Engerix B adult and not applicable after receiving Engerix B adult, the patient experienced drug dose administration interval too long. In 2015, the patient experienced fatigue and numbness in fingers. On an unknown date4, the patient experienced neck pain. On an unknown date, the outcome of the fatigue, numbness in fingers, neck pain and drug dose administration interval too long were unknown. It was unknown if the reporter considered the fatigue, numbness in fingers and neck pain to be related to Engerix B adult. Additional details were provided as follows: The patient received the 2nd dose of Engerix B on 2nd December 2014, which led to lengthening of vaccination schedule. A year later the patient began to experience numbness in fingers and fatigue. After receiving the 3rd dose of Engerix B in May 2014, the patient began to experience pain in his neck.
45 y/o female coming in for c/o reaction to flu shot x 3 days ago in the right upper arm/shoulder. Pt shows signs of redness and tender to palpation as well as warm to touch. Pt states was also experiencing cold like sx prior to receiving it and has a hx of intense muscle aches as she described in the area of where the flu shot was administered.
Pfizer given as #2 vaccine with Moderna previously  given as #1 vaccine. Patient denied any symptoms. No adverse reaction was noted.
Patient had swelling of the throat and swelling at injection site. Patient given 50 mg of Benadryl and 60 mg of Prednisone at ER. Patient given 40 mg of Prednisone x 3 days to take daily.
No other issues or concerns noted.  NO PQC.; Customer called to report that a patient received MMRII Intramuscular instead of Subcutaneous.  It was administered on April 15, 2022.  No other issues or concerns noted.  NO PQC.; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 15-APR-2022, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) via intramuscular instead of subcutaneous, for prophylaxis (strength, dose, frequency, lot# and expiration date were not reported) (incorrect route of product administration). No other issues or concerns noted, no PQC.
LEFT ARM SORENESS; HEADACHES; HIGH FEVER; NAUSEA; CHILLS; SHAKING; ACHING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient did not have any medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 25-MAY-2021) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced aching. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced shaking. On 20-MAR-2021, the subject experienced high fever. On 20-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100 F. On an unspecified date, the subject experienced left arm soreness, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aching, shaking and chills on 20-MAR-2021, and high fever, and nausea, and the outcome of headaches and left arm soreness was not reported. This report was non-serious.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported for the reporter's mother. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
7/30/12 ED: "Feeling out of it", "feeling like she was outside of her body", altered mental status, occasional episodes when she thought it she heard family voices in her head. 7/21/12 ED: Repeating things, repetitious motion, "out of it," --> admitted AMS, no seizures, neuro consulted for 3 episodes of unresponsiveness, lasting 20-40 mins. Jerkiness involving RLE, LUE, encephalopathy, fatigue, temperature increased.
Arm swelled up and is very sore.  Rash developed and is hot to the touch.
Reports distal parasthesias of both hands and feet with proximal radiation. Negative physical exam 11/3/09 Medical records received for date 10/23/09. DX: distal parasthesias. Pt. c/o parasthesia on feet, both hands, numbness tingling radiates proximally x10 days. Pt. parent concerned about GBS. Pt vax on 9/22/09 HPV VZV. Assessment: distal parasthesias. Pt to be seen by specialist.
tingling noted to arms and legs after receiving vaccine the next night  and diarrhea immediately after the vaccine
Pain, redness, swelling at injection site - left deltoid. Area was slightly bruised. Patient was feeling ok after injection and BP 102/62 Pulse 64 Resp. normal instructed client on 5/5 of allergic reaction and if injection site swelling or edema does not improve to see MD - called patient 3 hours after injection site given and patient said "injection site had improved - not as swollen and was feeling fine.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with improperly stored unspecified doses of oral, ROTATEQ (dose, lot number not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Bell's palsy; numbness & tingling of extremities; poss pos viral neuropathy;
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 15-FEB-2017, the patient was administered with an expired dose of M-M-R II (strength, dose, frequency and route of administration were not provided) (lot # L003858 with expiration date of 05-FEB-2017) for prophylaxis. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Patient had pertussis - like syndrome with Paroxysms of coughing starting 1 week after injections and lasting for 4 weeks.
Pt recvd 3 doses of Engerix-B & 15NOV91 it was determined that pt did not respond to the vax series;
Malaise, fever (low level), left deltoid pain, swelling, firmness, slight erythema (site of injection); painful and swollen l-sided axillary-supraclavicular lymph nodes.
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient was not reported. On 03-DEC-2014 the patient was vaccinated with a improperly stored dose of VAQTA (lot number J015882, expiration date 22-OCT-2015, dose and route were unknown). No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Pt called next day stating quarter sized erythema and localized tenderness. On 6/8 T=102.5 arm red and hot and was "hardly able to move it". Treated with cephalexin 500mg QID x 5 D.
Patient was inadvertently given the Johnson & Johnson vaccine instead of Pfizer. It was our 1st day giving this-- RN not used to paying attention to the 18 year old cut-off. After this occurred 18 & up was written on the J&J cooler and on the board behind the vaccination table. We also added signage of the exact DOB.
when I first got  it I remembered I felt off and a little dizzy so I laid down and my BP was high about 15 mins after, my right side of face and arm went numb, that went away but that night I had body aches headache fever chills and fatigued which was out of the ordinary for me. About two weeks later I tested positive for Covid. I'm still dealing with covid related symptoms but I don't think that was from the vaccine
no adverse event; Due to freezer issue on March 8th,2023, vaccine went possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes.; Reporting Lot 010H22A Bivalent, Due to freezer issue on March 8th,2023, possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes. ,; This spontaneous case was reported by a physician and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Due to freezer issue on March 8th,2023, vaccine went possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes.), PRODUCT TEMPERATURE EXCURSION ISSUE (Reporting Lot 010H22A Bivalent, Due to freezer issue on March 8th,2023, possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes. ,) and NO ADVERSE EVENT (no adverse event) in a 44-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Mar-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Mar-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Reporting Lot 010H22A Bivalent, Due to freezer issue on March 8th,2023, possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes. ,). On 27-Mar-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Due to freezer issue on March 8th,2023, vaccine went possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Due to freezer issue on March 8th,2023, vaccine went possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes.), PRODUCT TEMPERATURE EXCURSION ISSUE (Reporting Lot 010H22A Bivalent, Due to freezer issue on March 8th,2023, possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes. ,) 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 (Due to freezer issue on March 8th,2023, vaccine went possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Reporting Lot 010H22A Bivalent, Due to freezer issue on March 8th,2023, possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes. ,).    No concomitant medications were reported. Patient did not report any reactions. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-717499 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717499:Same reporter ,Daughter case
Arm hurts; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Arm hurts) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Arm hurts). At the time of the report, MYALGIA (Arm hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
1/11/2021: I experienced a bit of an itch on my right foot.  1/12/2021: Then felt it again the next day.  1/13/2021-1/30/2021: This itch traveled out of my foot and I started to feel this tingling sensations on my right leg. The tingling would come and go. It moved to my left leg and then my arms. I also felt the tingling in my elbows, fingers, neck, boob area, abdomen. My lower back felt tight too. I was also experiencing chest pains, like pressure on my chest that would come on throughout the day. Sometimes 1 a day sometimes 3 times a day. Pressure would come on for about 30 seconds to 1 minute then subside. I also had an increased heart rate (tachycardia). I received the second dose of Pfizer on 1/30 and experienced the ?typical? symptoms the next day.  On 1/31/2021 I had body aches, fatigue, low grade fever. The symptoms disappeared within 24 hours, and I did not feel any tingling on that day.  On 2/1/2021 in the evening, I started experiencing severe tingling in both lower extremities.  On 2/2/2021: I felt the tingling all over my body: legs, torso, forehead, back of head, vagina, tongue, back. I was experiencing severe chest pains. Heart rate was extremely high. On 2/3/2021: I went to the ER, and they sent me home with a referral to see a neurologist. Blood Pressure was extremely high (153/110). On 2/5/2021: I felt this horrible pin pricking sensation up and down my spine that went on for hours. Additionally, my right leg went numb and stayed numb until the next morning. On 2/6/2021: My right leg went numb again in the evening. It resolved in an hour.  I also began experiencing some muscle twitching. It started in my right leg but I can feel it in various parts on my body (thighs, buttock, calves, arms, hand, and right underneath armpit on my back).  I have burning mostly in my thighs, forearms (near elbows area), and upper shoulders. I have pin pricking sensations around my body. And I have muscle twitching in my arms, legs, back, and hand. Chest pains have resolved, blood pressure is back to normal, and my heart rate isn't so elevated anymore. I also have been experiencing some bad diarrhea the past two months (beginning on 2/19/21 until current)!
Reports severe fatigue 9 days after smallpox vaccination, 11 days after anthrax vaccination.  Also reports myalgias bilateral lower extremities.  Seen at clinic and was prescribed antibiotics.  The next day, he felt worse and noted R axillary and R side knots (presumed lymphadenopathy), erythematous, pruritic, papules over this area.  Also reported mild sore throat, stiff neck, and a headache.  Was seen at medical center and diagnosed with mononucleosis on 7/26/03.    Since that time, he reports his fatigue has worsened, headaches slightly improved,and lymphadenopathy/rash has resolved.  Over the past month, he reports that he has been diagnosed with acute sinusitis and strept throat.  He is currently being treated with penicillin.  Patient is concerned that the vaccinations somehow contributed to a weakening of his immune system and subsequent development of mononucleosis, sinusitis, and strept throat.
Passed out; Nauseas; Vomiting; This is a spontaneous case initially received from other health professional on 04-Mar-2019, concerning an adolescent female patient of an unspecified age.  The patient had no relevant medical history and concomitant medications at the time of vaccination.  On 03-Mar-2019, the patient was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 253823 and expiry date: 30-Jun-2019) for influenza prophylaxis.  On the same day, some minutes after the vaccination, the patient passed out. The patient experienced nauseas (as reported) and vomited. Patient felt better after a while and recovered on the same day with no injuries.  The outcome of the events was recovered on 03-Mar-2019.  The reporter assessed this case as non-serious.  Non-significant follow up received from the Medical Communications on 16-Mar-2019: It was reported that the reporter did not have a specific email address, because she was an intern at pharmacy. The reporter had refused to provide any additional patient demographics or personal information. No new information was received, hence no changes were done in the narrative.; Reporter's Comments: A female patient experienced loss of consciousness, nausea and vomiting, on the same day after receipt of Flucelvax QIVc. Considering the plausible temporal relationship between vaccination and reported events, plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The company assessed this case as serious (medically significant).
This spontaneous report was received from a medical assistant and refers to 6 unspecified patients of unknown age and gender. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On 12-JUL-2017 and 13-JUL-2017, the patients were administered 3 different doses of VARIVAX injection (lot # N014366 with expiration date at 09-MAY-2019, for prophylaxis; dose, route of administration and anatomical location were not reported), reconstituted with sterile diluent (STERILE DILUENT) (lot # N003192 with expiration date at 05-JUL-2019). The administered doses of vaccine were exposed to a temperature excursion between 47 degrees Fahrenheit (F) and 77 degrees Fahrenheit (F) on 09-JUL-2017, which lasted for a 12 hours and 10 minutes. There was no previous temperature excursion reported. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Lot number N014366 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck). Follow up information has been received on 22-AUG-2017, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.; Sender's Comments: US-009507513-1707USA002673:
Pt born premature w/hx cocaine & syphillis during preg; seen 15DEC in clinc nl exam x/for HR 160-170 sinus rhythm; referred for EKG, CXR; next am doing well but 5HR in crib sids & enlarged heart, aspiration, not moving, CPR, no heart beat;
no adverse event; Varivax administered after temperature excursion; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 27-JUL-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), at a dose of 0.5 milliliter (ml) (lot number T017685, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 21-MAY-2022), as prophylaxis (frequency, route of administration, anatomical location and vaccination scheme were not reported) (product storage error). The administered vaccine experienced a temperature excursion of 5.9F during a time frame of 8 minutes, as recorded by data logger. There was not a previous temperature excursion. No additional adverse events were reported.
The patient reported soreness at the injection site which initially improved the following day, but then increased beyond the injection site.  The patient stated that it radiated down his arm and has been consistently sore/painful since it started.  He cannot lift his arm straight up in the air without extreme discomfort/pain.
Elderly Testing to facilitate d/c back to medical facility: "data reviewed. Covid test prior to discharge to clinic returned positive last night.  Patient was moved to general medical unit.   Patient remains non-tachycardic, normal blood pressures, on room air. Denies any shortness of breath.  Temperature of 100.2, 101.1 recorded in last 24 hours." Primary x3 doses & no boosters
Headache 24 hrs after injection then vomiting multiple times, pt lethargic