chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Black, hairy tongue; Nausea; Loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), TRICHOGLOSSIA (Black, hairy tongue) and NAUSEA (Nausea) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Stomach discomfort.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced AGEUSIA (Loss of taste). On an unknown date, the patient experienced TRICHOGLOSSIA (Black, hairy tongue) and NAUSEA (Nausea). On 28-Sep-2021, AGEUSIA (Loss of taste) had resolved. At the time of the report, TRICHOGLOSSIA (Black, hairy tongue) had resolved and NAUSEA (Nausea) had not resolved.      This case concerns a 86-year-old female patient with no relevant medical history, who experienced the unexpected non-serious events of ageusia and trichoglossia and expected non-serious event of nausea. The events occurred on the 5 months after receiving second dose of Moderna mRNA-1273 vaccine. The rechallenge is not applicable as the event Covid-19 occurred only after second dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  No concomitant medications were reported.  Treatment medications included compounded mouth wash which cleared up the hairy tongue and nausea pills.; Sender's Comments: This case concerns a 86-year-old female patient with no relevant medical history, who experienced the unexpected non-serious events of ageusia and trichoglossia and expected non-serious event of nausea. The events occurred on the 5 months after receiving second dose of Moderna mRNA-1273 vaccine. The rechallenge is not applicable as the event Covid-19 occurred only after second dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This report described the occurence of possible epilepsy in a 12 month old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined for prophylaxis. This report was received from the subject's mother and has not been verified by a physician or other healthcare professional. The subject was adopted in March 2003; her medical history was not available. Concurrent conditions and medications were not reported. The subject was reportedly immunized prior to adoption. However, because immunization records were not available, the childhood immunization schedule was repeated. On 5/23/02, the subject received her first injection of Pediarix; this was the second dose in the immunization series against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis. On 5/23/03, the subject also received injections of Haemophilus influenzae type B conjugate vaccine and 7-valent pneumococcal conjugate vaccine. On 5/26/03, three days post immunization, the subject reportedly had a seizure. The mother stated that the subject was not there. When she finally did come to, the child just had a blank stare for a while. The subject was taken to the local emergency room. Unspecified lab analyses and computed tomography of the brain were performed. Reportedly, the CT revealed a calcium deposit on the subject's brain that was probably from a previous infection. Emergency room physicians reportedly think she has epilepsy. The subject was referred to a neurologist. The seizure resolved on 5/26/03. The outcome of the possible epilepsy was unknown as of 5/28/03. Seizure and possible epilepsy are considered to be medically serious (OMIC).  Received on 06/16/2003: "On 05/29/2003, the subjects mother provided the lot number of pediarix that had been administered."  Follow up on 07/11/2003: "The physician indicated that the initial seizure resolved with unspecified sequelae on 05/26/2003.  The physician considered the possible epilepsy and seizure to be serious because they jeopardized the patient or required intervention.  The physician considered the events to be possibly related to Pediarix administration or to the old hemorrhage or infection detected on head CT.  Seizure and possible epilepsy are considered to be medically serious."
STIFFNESS IN THE NECK; HEADACHE; TIREDNESS; SORENESS IN THE INJECTION SITE (LEFT ARM); MUSCLE ACHE; This spontaneous report received from a consumer concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 30-JUN-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 01-JUL-2021, the subject experienced stiffness in the neck. On 01-JUL-2021, the subject experienced headache. On 01-JUL-2021, the subject experienced tiredness. On 01-JUL-2021, the subject experienced soreness in the injection site (left arm). On 01-JUL-2021, the subject experienced muscle ache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stiffness in the neck, headache, tiredness, soreness in the injection site (left arm), and muscle ache. This report was non-serious.
Flu-like systems; stiff; achy; feverish; nauseated; other vaccine same date product=Flu Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 38-year-old female patient received bnt162b2 (BNT162B2), administration date 21Oct2021 (Batch/Lot number: unknown) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm, administration date 21Oct2021 (Batch/Lot number: unknown). Relevant medical history included: "Endometriosis" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: EFFEXOR; GABAPENTIN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 27Mar2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 17Apr2021, for COVID-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 22Oct2021, outcome "recovering", described as "Flu-like systems"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 22Oct2021, outcome "recovering", described as "stiff"; PAIN (non-serious) with onset 22Oct2021, outcome "recovering", described as "achy"; PYREXIA (non-serious) with onset 22Oct2021, outcome "recovering", described as "feverish"; NAUSEA (non-serious) with onset 22Oct2021, outcome "recovering", described as "nauseated"; OFF LABEL USE (non-serious) with onset 21Oct2021, outcome "unknown", described as "other vaccine same date product=Flu Vaccine". The action taken for influenza vaccine was unknown. Therapeutic measures were not taken as a result of influenza like illness, musculoskeletal stiffness, pain, pyrexia, nausea, off label use.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID since the vaccination.  Follow-up attempts completed. No further information is expected.
Mouth and face Shingles; still suffering with pain; sore throat; fatigue; This is a spontaneous report from a contactable consumer (patient). An 89-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, on 27Jan2021 10:00 at a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included atorvastatin (LIPITOR [ATORVASTATIN]). The patient previously received first dose of BNT162B2 on 06Jan2021 11:00 AM for COVID-19 immunisation (lot number: EH9899, arm left); and cipro and experienced allergies. On 21Feb2021 12:00 PM, the patient experienced mouth and face Shingles and was hospitalized from 28Feb -1Mar (name) Hospital for 1 day. Still suffering with pain, sore throat and fatigue. The events resulted to a doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received included IV#s for 24 hours, brain scan. The facility where the vaccine was administered was in a military Base. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. COVID test on 28Feb2021 with unknown result. Outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: itchiness at site of injection, mild
4-17-07 MMR & Varicella 4-17-07 (Routing slip attached (mother is ill) 4-19-07 Light colored area (L) iz site (white/puffy) fine light rash 4-20-07 Temp 103 reduced with Tepid bath & Tylenol. Reported LE and UE reported to PHN. 4-23-07 Saw doctor-Dx & Tx for pharyngitis-no s/s MMR/Varicella. 5-1-07 Daily reports from mother-doctor notified of immunization
7X8 cm sharply demarcated warm red 3X in 11cm tender no induration. Pt given "flu shot" at another facility.
felt cruddy for a few days afterward; This is a spontaneous report from a contactable physician. A female patient of an unspecified age (Age: 35; Unit: Unknown) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown, Expiration Date: Unknown) via an unspecified route of administration on 09Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced got her blood tested for the igg and igm titers for the covid spike protein and her levels were undetectable, felt cruddy for a few days afterward on Jan2021. The patient underwent lab tests and procedures which included blood test: unknown results on 27Jan2021 blood tested for the IgG and IgM titers , investigation: unknown results on She even had the lab re run her test results, sars-cov-2 antibody test: undetectable on 27Jan2021 Covid Spike Protein and her levels were undetectable. The patient stated she felt cruddy for a few days afterward. On 27Jan2021 she got her blood tested for the IgG and IgM titers for the Covid Spike Protein and her levels were undetectable. She even had the lab re run her test results. She has asked several infectious disease doctors and they had no answer. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Two days post vax, the pt developed a mild rash. It was noted that the pt had a few bumps and that only one of the lesions vesiculated. Additionally, it was reported that the rash was only slightly itchy and the pt did not experience a fever of nausea.
I did not have problems with vaccine, but I got COVID-19 in July. I had a home test, and it was positive. My husband had it first and I was required to take the test within 5 days before I returned to work. The doctor put me on PAXLOVID. It was like a bad cold; I had a rebound after the PAXLOVID. Then, I got a sinus infection, I went to ear, nose & throat specialist, and then I was start having balance problem (I was falling) I was put with antibiotics, the sinus infection resolved, I was still having balance issues and I am doing therapy, and I also had fatigue.
This spontaneous report as received from a pharmacist refers to 4 patients of unknown demographics. The patients medical history and current conditions were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (LOT# and expiry date not provided), 0.5 ml via intramuscular. On an unknown date the patient experienced improperly stored PNEUMOVAX (4 doses) have been administered to 4 patients and no adverse effects reported. Also reported that the pharmacist called to report the second temperature excursion and reported that improperly stored PNEUMOVAX 23 have been administered since first excursion. Product quality complaint was not involved. The outcome of the event was unknown. Additional information has been requested.
Child had swollen/hard bump at injection site and fever of 103.5. Child given 130 mg ADVIL and 750 mg of ROCEPHIN/Ceftriaxone. Child observed 1 1/2 hrs and temp down to 100.5, pt give TYLENOL/ADVIL for home. Child came back in on 1-16-13 for follow up with no fever, pain, redness or swelling.
Vaccine was administered to pt and immediately following pt became pale and diaphoretic, and eyes rolled back and pt began to collapse. Pt was assisted into a laying position on exam table and ice pack was applied to back of neck. Pt aroused within a few seconds and layed for another 5 minutes. She was assisted to sitting position and was given apple juice and she was able to drink it. PA-C did enter exam room and check on pt after syncopal episode. Pt remained for 30 minutes of observation after episode. Color returned after juice was given and pt had no further c/o. Vital signs taken and were stable.
Incident details: Per Drs. (Medical Director) email sent out on 9/1/22-"the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older. Any patients that are currently scheduled to receive a booster should wait until we have the bivalent booster on hand". The patient was seen in office on 9/2/22 and received a booster dose of the monovalent mRNA COVID-19 vaccine (Pfizer) by RN in error as patients are now only supposed to receive the bivalent booster per Drs. email. Patient was due for booster at the time they received it, however the bivalent booster was not yet stocked.  Possible Cause: Possible cause of the incident is that an email was sent out regarding the discontinuation of monovalent Covid boosters until Private receives the bivalent booster doses. This was overlooked by management and staff, as previous changes to clinic processes is usually discussed in a meeting. Also 'monovalent' and 'bivalent' are new terms that have not previously been used when discussing booster vaccines.   Corrective Action: Corrective action included notifying staff and providers of the recent change regarding COVID vaccines and were notified to stop giving COVID booster doses until the Clinic receives the bivalent vaccines. Staff and providers were notified via email, skype, and verbally. Incident reported to VAERS.
He said when he had his injection his arm is very sore and felt like its gonna fall off; He said when he had his injection his arm is very sore and felt like its gonna fall off; This is a spontaneous report from a contactable consumer. This report is for doctor of consumer.    A male patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization.The patient medical history and concomitant medications were not reported. The patient had his injection his arm is very sore and felt like its gonna fall off. The outcome of event was unknown,
Narrative: COVID infection following COVID vaccine series 04/12 Janssen, dose #1 06/28 CXR impression: No acute cardiopulmonary process. 08/17 pt cc: No symptoms exposure: unknown 08/16 COVID swab, result: detected 08/16 SARS-COV-2 Variant Sequencing result: pending 09/01 CT Chest impression: Tiny bilateral pulmonary nodules and high risk patient . 6 month follow-up CT chest recommended.
PT received M-M-R and Engerix-B vaccine in the right arm and Varivax on the left arm. pt fainted as soon as I finished giving Varivax. PT regained consciousness in about 15 seconds. EMS was called and pt was taken for further evaluation (pt had very low BP). Mom reported that patient was doing ok a couple of hours later.
blisters; Redness/erythema; Fever; This spontaneous case was reported by a pharmacist and describes the occurrence of BLISTER (blisters), ERYTHEMA (Redness/erythema) and PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX in 2017. Concurrent medical conditions included Hypertension (no medication report were provided) since 2010 and High cholesterol since 2015. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE), PRAVASTATIN and EZETIMIBE for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Mar-2021, the patient experienced BLISTER (blisters), ERYTHEMA (Redness/erythema) and PYREXIA (Fever). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) on 12-Mar-2021 for Antihistamine therapy, at a dose of 500 mg twice a day. On 05-Apr-2021, BLISTER (blisters), ERYTHEMA (Redness/erythema) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.2 (High) fever  101.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-073502 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-MAY-2021 contain significant information including patient demographic information, suspect product information, concomitant medication, treatment medication, events outcome unknown to resolved.
Patient reported experiencing redness, tense, hotness, itching and pain from upper arm to wrist later in the day of the vaccination. She thinks it's the phenol in the vaccine that caused the reaction.
Received Flu shot on November 15, 2007. Developed fever that night. On November 16, had fever and generalized muscle soreness, most pronounced in shoulders. November 17 and 18: progressive loss of strength and motor function in the hands, fatigue, continued fever and increasing muscle soreness. November 18th: fever resolved, but saw physician at clinic for continued soreness, fatigue, and loss of motor function in the hands. Referred to Neurology on November 20. Diagnosed with Parsonage-Turner Syndrome (acute brachial neuritis). Motor function in hands resolved without treatment within 2 weeks following visit with Dr., with minor residual weakness.  Fatigue continued to present.  01/18/2008 MR received for Clinic visits 11/18/07 and 1/02/2008. Pt c/o fever, bil hand pain initially then hips and ankles, and muscle weakness.  Weakness to hands (L>R) noted on PE. Reflexes 1+ in upper extremities, 2+ lower. Seen by neurology 11/20/07 for EMG and NCS DX: Acute Brachial Neuritis. Seen again 01/02/08 with fatigue and nausea since visit in Nov.  Exam WNL.  Impression: Nausea, Possible GERD, Fatigue
2 day p/vax pt exp local rxn of 3.5x6.5 cm area of warmth,erythematous, raised lesion.
Localized pain, swelling, redness, and rash including over right biceps area of right arm  after injection.  All symptoms were present through day 3 after injection.  It seems better on day 4.  Taking Benadryl for symptoms.
Started to feel as if I were getting a little car sick (I was a passenger at the time.) Then the nausea kept getting worse and about 10 minutes after I felt it coming on, I felt so much worse. Laid down and after about 5 minutes I felt a lot better. Then an hour later I sat back up and almost immediately felt sick again. So I laid back down for the rest of the night and felt much better. Never had a reaction to flu shot before and I get them every year. Called pharmacists where it was given but they said nausea isn't a symptom. Then looked on CDC website where I saw that it is a possible reaction. It sucked.
Advised only to expect soreness at the injection site 2-3 days (Pharmacy needs to review all possible symptoms with patient) adverse reactions: exacerbated existing neck pain, still seeing physical therapist sore neck & arm(arm pain at injection site lasted for over a week) extreme headache achy body (Including arm) extreme fatigue (Slept following afternoon through to next day, spent following day resting) overall feeling of illness Second dose: 05/14/2019- similar fatigue, arm soreness short lived 3 days (right arm), developed cold sore on lip where previous sores manifest with stress (on the right side of my lip)
Headache, fatigue,  sore muscles,  lungs burning,  fever, cough and I was all ways hungry
Swelling in ankle; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of JOINT SWELLING (Swelling in ankle) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Swelling in ankle). At the time of the report, JOINT SWELLING (Swelling in ankle) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.  Action taken with the drug in response to events was not applicable.
rash and pain on left side of her chest that went from front to back; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and RASH (rash and pain on left side of her chest that went from front to back) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Diabetes.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 10-Jan-2021, the patient experienced RASH (rash and pain on left side of her chest that went from front to back). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown and RASH (rash and pain on left side of her chest that went from front to back) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was treated with Tylenol. No concomitant medications were provided.   Reporter did not allow further contact
Asthma returned, worsening ADHD, heart condition started (I suspect the ADHD medication.)