chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experiencing arm pain; Fever of 101.3; I feel tired; This is a spontaneous report from a contactable consumer (Patient).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: unknown, Expiration date were not provided), dose 1 via an unspecified route of administration on 25Aug2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and Concomitant medications were not reported. The patient experienced experiencing arm pain, fever of 101.3 and i feel tired on Aug2021. Reporter stated, I am calling regarding a side effect to see if it is normal, I had the (first dose) vaccine yesterday. When paraphrased the concern, Reporter stated, I am experiencing arm pain and that's subsiding, but I have a fever of 101.3 and patient asked I feel tired, so is that normal, I feel tired is that normal, I am going to take Tylenol or should I go to the ER (Emergency Room), answer the question, 4th all day should I go to the Emergency Room or just take Tylenol (treatment). I will just over again, this is just "ridiculous" (further not clarified). The patient underwent lab tests and procedures which included fever of 101.3 (body temperature) on Aug2021. The outcome of the events was unknown.  The lot number for the vaccine, was not provided and will be requested during follow-up.
approximately 8 hours after getting my two shots started to feel a little achy, which I expected.  I took two Tylenol and went to bed about 10:00. I woke a couple hours later in horrible pain throughout my whole body. I hurt so bad I couldn't stand it. I took some Nyquil hoping to go to sleep. Then I tried to get in a warm bath, due to my arthritis I could not sit in the tub. I was absolutely miserable. My arthritic knees were throbbing. I put Capsaicin cream on them to no avail. I used ice pack, to no avail. My right foot with the tendon problem was throbbing. My skin was painful to the touch. I tried using lotion, to no avail. When I finally dosed off I had terrible night mares about wanting to kill myself. In my dream I was having a conversation with my deceased aunt, mother, and late husband.  This lasted All day Sunday and Monday. I was able to get up and around yesterday but still foggy. I am better today and finally able to function. Please tell me what I can do next time to prevent from going through this again. Horrible1
According to parents woke up next day with leg pain then had trouble breathing - taken to hospital ER - Dx Hyperventilation according to MD. 1/8/2010 ED records for 7/24/2009, patient with c/o's joint pain, tx; toradol DC Dx Arthralgias, reaction to vaccine
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years, 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: "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient received Paxlovid treatment from 03Jul2023 to 08Jul2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300251541 Same patient, different drug/ AE;
COVID 19 Treatment; COVID 19 Treatment; 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 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GH9703), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Lot number: FK9893), 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: "hyperlipidemia" (unspecified if ongoing), notes: other medical history: hyperlipidemia; "osteoporosis" (unspecified if ongoing), notes: other medical history: osteoporosis. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She received other medication in 2 weeks. On 23Apr2023 she received paxlovid (lot number: GG1442) for COVID 19 Treatment which stopped on 24Apr2023. Known allergies included Nothing serious.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) 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 MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information was not provided.
High fever ( highest 102.6 within 72 hrs.  ). Took Tylenol (100mg every 8 hrs and  400 mg of ibuprofen every 3 hrs starting at 10:30 pm on 1/8/21.  Severe arm pain for 24 hrs.  Nausea, body aches, chills, swollen and painful lymph nodes in neck, blurry vision (first 48 hrs), skin sensitivity, loss of appetite, and moderate to severe joint pain.  Also some behavioral issues ( irritability, anxiety).
Patient was given a booster of Pfizer 7 days too early according to guidance for approved vaccines.
pain in her left arm after getting covid vaccine; injection site "achiness"; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 11Aug2021, this case contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program COVAX US Support. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 20Apr2021 (Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included allergy to dyes like for MRI, allergy to alcohol, allergy to sulfite containing foods, allergy to narcotics, Sjogren's syndrome, Raynaud's phenomenon, schleroderma antibodies, spider bite or gets stung, and the patient reacted to everything a person with mastocytosis reacts to. The patient was immunocompromised and had multiple allergies, neck and back problems. The patient's concomitant medications were not reported. The patient previously took versed and experienced drug hypersensitivity, epipen for spider bite or stung. Other historical vaccine includes shingle vaccine for immunization in which the patient became sick and influenza vaccine for immunisation and had experienced pyrexia. The patient also previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 29Mar2021 (Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient started noticing injection site achiness in May2021 that had not gone away. The patient did not have any allergic reaction to the vaccine, but her left arm/hand would ache sometimes. She stated that she knew that the achiness was not from her neck and back problem because she felt it where she had received her injection. The patient stated that she can use it, but it still ached where she got the shot. The patient was asking if there was a booster dose, and if not, and when there would be, and if it would be the same as the other two doses of the Pfizer BioNTech Covid-19 Vaccine. The patient was asking if the booster would cover Covid-19 variants, especially the Delta Variant. The patient stated that she would be first in line for the booster if and when it was available. The patient was asking if current doses of the Pfizer BioNTech Covid-19 Vaccine were effective against circulating Covid-19 variants, especially the Delta Variant. The patient asked how long protection from the first two doses of the Pfizer BioNTech Covid-19 Vaccine lasts and how long her side effect of injection site pain would last. The patient also asked if someone was exposed to the Delta Variant or any other Covid-19 variant, how long would it take before that person would test positive for Covid- 19. The patient asked if breakthrough infections with variants had occurred after being fully vaccinated with the Pfizer BioNTech Covid-19 Vaccine. The outcome of the events was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow up.
This spontaneous report as received from a physician refers to a 47 year old patient with no history of chicken pox. On 05-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported). It was reported that it was medically necessary for zoster vaccine and requesting vaccination due to family have had zoster attacked. Additional information has been requested.
Pt went to the hospital with covid 05/30. She was on bipap at 100%.  Pt ended up passing away 06/11 at 5:32 pm.
patient has terrible place on her arm where immunization was administered - bad skin reaction nearly one month later. still red with scabbing and itching.
RASH, ON INSIDE RIGHT THIGH, DISSIPATING BUT STILL PRESENT ON SEP-13-2011
17Sep90 pt vax w/ expired material.  29Oct90 vax 2nd dose w/out reaction.
This spontaneous report was received from a other health professional (licensed practical nurse) refers to unspecified patients of unknown demographics. Since 08-OCT-2014 these patients were administered with improperly stored RECOMBIVAX HB. All these patients experienced incorrect product storage as all of them were administered with improperly stored RECOMBIVAX HB. No adverse effects were reported. No product quality complaint (PQC) was involved. Outcome of the event, incorrect product storage was unknown. Reporter considered the event, incorrect product storage to be not related to RECOMBIVAX HB. This is one of several reports received from the same source (MARRS # 1502USA002815 and MARRS #1502USA002021). Additional information has been requested.
CHIEF COMPLAINT Fatigue and nausea   HISTORY OF PRESENT ILLNESS Patient is a 72 y.o. female with a past medical history significant for metastatic Meckel cell carcinoma on pembrolizumab, CKD stage 4 status post renal transplant x2, immunosuppressed state secondary to prednisone and sirolimus, hyperparathyroidism secondary to renal disease, diabetes mellitus type 2, coronary artery disease, hypertension, and obstructive sleep apnea who presented to ED on 08/26/2021 after experiencing fatigue and nausea of 1 week duration.
more painful than the flu shot; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (received first dose on an unknown date and experienced pain, refer case US2021AMR188159).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received flu shot and experienced pain. The patient received the second shingles shot and felt like he/ she had the flu for a day. This case is one of the 4 cases reported by the same reporter.
pt recvd vax & w/in 2-3hrs p/vax exp nausea & was weak & chilled;addl exp pain @ inj site;sx resolved;
This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates approximately in November 2016, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M007307, expiration date 30-NOV-2017, lot # M007311, expiration date 30-NOV-2017, lot # M007298, expiration date 19-NOV-2017 and lot # M019691, expiration date 02-NOV-2017 (dose was not reported). No adverse effects were reported. Product quality complaint was not involved. The administered doses of ROTATEQ were stored in the temperature of 47.7 degrees Fahrenheit for 45 minutes on 18-NOV-2016, then in the temperature of 47.5 degrees Fahrenheit for 15 minutes, in the temperature of 48.4 degrees Fahrenheit for 30 minutes and in the temperature of 31.6 degrees Fahrenheit for 5.5 hours (1 cycle) on 19-NOV-2016, then in the temperature of 29.7 degrees Fahrenheit for 11 hours (1 cycle) and in the temperature of 33.4 degrees Fahrenheit for 15 minutes (1 cycle) on 20-NOV-2016. Data logger was involved. There were no previous temperature excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.
Received 2nd Moderna COVID-19 dose on 5/8.  Experienced sore calf and sore groin around 6/17.  Woke up morning of 6/21 with lower left leg pain and ended up passing out twice in 20 minutes (15 minutes unaccounted for).  Experienced extreme sweating and shortness of breath.  Called 9-1-1 and was treated by paramedics, then taken to ER.
5 cm x 6 cm red, indurated lesion at site of vaccine.  2-3 mm raised, red papule at injection site.  1st noticed 48 hrs after vaccine admin.
Information has been received from a registered nurse referring to a 6 month old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On 13-SEP-2016, the patient was vaccinated with a dose of M-M-R II (lot # L027591 with expiration date 23-JUL-2017; dose and route were not reported) and a dose of VARIVAX (lot# M023383 with expiration date 11-AUG-2018; dose and route were not reported) (product use issue). No adverse effect was reported. There was no product quality complaint (PQC) reported. Additional information has been requested.
Patient came in for a Moderna vaccine. PT was not of age of 18 to be eligible for the vaccine.  Pt should have been offered the Pfizer vaccine.  However, the patient's paperwork went through the pharmacist and grad intern and the DOB was missed 3 times and still got the Moderna vaccine.    Pt was fine and did not experience any issues after the shot.  Called the mother and mother said that the pt wanted the Moderna vaccine. And also the doctor was advised of the error and said it was ok and that pt should receive the 2nd dose and stated per the CDC guidelines that off label use can be used for patients 12-17 yr old.
Had TD given on 8/19/02. Came in on 8/10/02 complaining of pain in left hand, fussy, dizziness and fever. Questionable reaction to TD. Dx reaction to TD; R/O cellulitis. Put on Amoxil.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Mild injection site pain after the 1st booster dose) in a 71-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Mild injection site pain after the 1st booster dose). At the time of the report, VACCINATION SITE PAIN (Mild injection site pain after the 1st booster dose) outcome was unknown. No concomitant medications were mentioned. No treatment details were reported. This case was linked to MOD-2022-547041 (Patient Link).
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 15-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) dose, route and anatomical location were not provided. There was no concomitant medication provided. On unknown dates, the PNEUMOVAX had temperature excursions for 72 hours with lowest recorded temperature of 28F (-2.2 Celsius) and 32 hours with highest recorded temperature 47 F (8.3 Celsius). The vaccine status was reported as "in excursion", and was storage in a Refrigerator (R). There was no product quality complaint involved and no adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Right ear hearing effected. Echoing effect heard when I spoke and reduced volume when listening to others. Resolved in 3 days. Left ear not effected.
ABOUT 15 MIN AFTER INJECTION BEGAN TO NOTICE ITCHINESS AND TINGLING OF TONGUE, THROAT, PALATE AND LIPS - TOOK BENADRYL 25 MG
24 hour after administering vaccine, patient went to help his friend move. His lips swelled and there was some swelling at the administration site.
Patients mother called clinic this morning, 07/20/2022 and stated that patient had swelling on the facial area. Patients mother stated that it just began when she woke this morning. Mother stated that patient was acting normal and had no signs of dyspnea.
On 3/23/01 at 11:00, first noticed upper arm being red and swollen. Child does not seem to be in pain. Advised cool compresses today and warm compresses tomorrow/right arm.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 03-SEP-2013 at 07:30, ZOSTAVAX lot # J003360 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 72.0 hours. On 10-SEP-2013 at 17:30, ZOSTAVAX lot # J003360 was exposed to -13C for an estimated total time out of range of 10 hours. On 10-SEP-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J003360, Exp. Date: 21-JUN-2014). No adverse experience had been reported. This is one 182 reports from the same source. Additional information has been requested.
Localized fluid filled blisters (several) at injection site that appeared after administration of varicella iz. given on 8/29/19
SEVERE SINUS HEADACHE; FEVER; FATIGUE; This spontaneous report received from a consumer concerned a 27 year old male. The patient's weight, height and medical history were not reported. 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced severe sinus headache. Treatment medications (dates unspecified) included: paracetamol, pseudoephedrine hydrochloride and guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever and fatigue on 11-APR-2021 and had not recovered from severe sinus headache. This report was non-serious.
She took Pfizer covid vaccine and both boosters; She took Pfizer covid vaccine and both boosters; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (unspecified if ongoing); "heart condition" (unspecified if ongoing); "sore throat" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She took Pfizer covid vaccine and both boosters". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; positive, notes: She was still positive for COVID.  Clinical course:The doctor and her believe she had an adverse response that put her in the hospital. She came back from being out of the country and got COVID on the plane. A week ago Sunday is when she flew back. She had a sore throat before she came back. She called her HCP office 4 or 5 days after she came back because she tested positive for COVID and her HCP wrote a prescription for Paxlovid. She is fully vaccinated with the Pfizer BioNTech vaccine and two booster shots. She is surprised that she had COVID.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is in follow-up to report(s) previously submitted on 9/24/2007. Information has been received from a physician concerning an 80 year old white male with a history of chronic lymphocytic leukaemia (on no treatment with stable blood counts) and no known allergies who on 18-JUL-2007 was vaccinated SC in the left upper arm with a first dose of ZOSTAVAX (Merck). The vaccination was recommended by the V.A. On 29-JUL-2007 the patient developed a facial pain. On 31-JUL-2007 the patient sought medical attention and was diagnosed with herpes zoster of the facial nerve. No further information was provided. Follow-up information received from the physician indicated that the patient was seen on 10-SEP-2007 with continued improvement in the zoster. It was noted that the patient had no adverse events following prior vaccination. Additional information has been requested.