chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle aches; Chills; Nausea; do not feel all that great; This case was reported by a consumer and described the occurrence of muscle pain in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th July 2019, the patient received Shingrix. On 19th July 2019, 1 days after receiving Shingrix, the patient experienced muscle pain, chills, nausea and feeling unwell. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the muscle pain, chills, nausea and feeling unwell were unknown.   It was unknown if the reporter considered the muscle pain, chills, nausea and feeling unwell to be related to Shingrix.  Additional information received were as follows: The patient did not felt all that great and had muscle aches. The patient was told that they would be happy to transfer this conversation to one of our product specialists.They could answer the questions. The pharmacist told that anything they chat about should not be taken as medical advice.  The pharmacist would refer the patient to their health care provider as their primary resource for patient care. The pharmacist provided link for Shingrix package insert. The pharmacist was using this document to research your question. The pharmacist told that majority of solicited local adverse reactions and general adverse events seen with Shingrix had a median duration of 2 to 3 days. The pharmacist asked for any question and assistance. The pharmacist thanked for sharing your experience with them and told the patient that they may receive a letter from their safety department. The patient told the pharmacist that the patient just was taking advil and it seemed to help.
~20 minutes after vaccine was given pt was not fell asleep and would not wake up easily.  Grandmother states that this lasted for ~20 minutes. Upon arrival to office he was sleepy but arousable with normal VS. Within 10 minutes he was normal.
Head ache, nausea, arm swelling, arm pain, couldn't lift arm, kidney pain, face swelling, uti.
Employee sent an email on 06/16/2022 @ 1126 complaining of "feeling very dizzy, room spinning, like I had a of alcohol kind of spinning, It is making me feel like I'm going to be sick" Employee was called right away.  She was able to speak in full sentences without any difficulty. She did not complain of shortness of breath or any other adverse effects.  She wanted to know who long the dizziness will last.  I explained that one of the adverse effect of Janssen was dizziness, no information was given about the duration of the dizziness. I offered to call an ambulance if she is not well, but she declined.
Day after injections mom noted reddness R upper thigh 6/20/2007 Increased reddness, warm to touch. 6/21/07 Reddness fading, less tender, no fever pts father recent Hx of MRSA. Started on Amoxicillin
Per patient, symptoms began approximately 7 days post vaccine administration. Initial symptoms were cysts on bilateral wrists. Pt went to urgent care and was diagnosed with cysts of unknown etiology. Patients symptoms progressed to involve additional joints of knees and ankles. Symptoms included swelling, pain and pitting edema on bilateral knees. Symptoms are transient between joints. Sometimes ankles or knees or wrists. Pt. went to see her primary care where they did lab work to rule out arthritis among other diagnoses. Lab work negative for arthritis, per pt. Pt was prescribed prednisone, Zyrtec, and several different vitamins and minerals. Symptoms are still ongoing.
Myalgia, Fever, CHILLS, AND COUGH Narrative:  Other Relevant History:
Flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Flu symptoms). At the time of the report, INFLUENZA (Flu symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was nor provided No lab data was provided by the reporter
flu-like symptoms; chills; nausea; legs have felt rubbery when I got out of bed.; legs are a little prickly; felt tired/tiredness; sore arm; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient, reported for self)  A female patient of an unspecified age received first dose of BNT162B2 (BNT162B2- PFIZER-BIONTECH-mRNA COVID-19 VACCINE, Formulation: solution for injection, Lot/Batch number: not reported), via an unspecified route of administration on 22Jan2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not report-ed. The patient (reporter) stated that she received the 1st dose of the Pfizer COVID 19 vaccine on Jan 22. She initially felt tired and had a sore arm. She felt good for about 5-6 days, then on Jan 28 she started to get flu-like symptoms. She began to get chills, tiredness and nausea. She has felt like that off and on since then. The patient mentioned that her legs have felt rubbery when she got out of bed. Patient was feeling better for today (as reported), but her legs were a little prickly. The clinical outcome of event, legs were a little prickly was unknown; the outcome of other events were recovering;   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
c/o lump on rt thigh, hot, hard painful to touch, pt cries when thigh touched according to mom;
Cellulitis of right ankle 03/02/2023 took cephalexin 500mg 4 x times a day for 7 days, then resolved.
Stomach started hurting really bad; Feel flu like; Bodyaches; I have a really bad headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach started hurting really bad), INFLUENZA LIKE ILLNESS (Feel flu like), MYALGIA (Bodyaches) and HEADACHE (I have a really bad headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by reporter.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach started hurting really bad), INFLUENZA LIKE ILLNESS (Feel flu like), MYALGIA (Bodyaches) and HEADACHE (I have a really bad headache). At the time of the report, ABDOMINAL PAIN UPPER (Stomach started hurting really bad), INFLUENZA LIKE ILLNESS (Feel flu like), MYALGIA (Bodyaches) and HEADACHE (I have a really bad headache) outcome was unknown.            No Concomitant Medications were provided. No Treatment Medications were provided.
This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 26-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-JUL-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-JUL-2022). No concomitant product use was reported. Patient received half dose. The vial had not undergone any temperature excursions. The vial was initially stored in the refrigerator on 04-Jun-2022. No treatment information was provided.
Body and joint aches, nausea,  temperature elevated by 1.5 degree F
Information has been received from a nurse concerning her 21 year old daughter with no pertinent medical history who, on approximately 22-NOV-2006, received the first dose of Gardasil. There was no concomitant medication. On approximately 29-NOV-2006, the patient developed tonsillitis. The patient was treated with penicillin. Subsequently, the patient recovered. On 22-Jan-2007, the patient received the second dose of Gardasil. On approximately 01-FEB-2007, "ten to fourteen days later", the patient developed tonsillitis. She was treated with ZITHROMAX and recovered "a couple of days after starting ZITHROMAX". On 22-MAY-2007, the patient received the third dose of Gardasil. On approximately 01-JUN-2007, the patient developed tonsillitis. She was treated with AMOXIL. Diagnostic studies performed after the third occurrence of the tonsillitis in June 2007 included a "strep screen" and a "mononucleosis spot", both of which were negative. The patient recovered on 11-JUN-2007. The reporter indicated that for all three occurrences, the patient's tonsils were coated with "white stuff". Additional information has been requested.
Headache, Arthralgia, NauseaVomiting, sweaty , feels hot, body aches Narrative:
The day after receiving the vaccine I did experience significant flu-like symptoms, but felt better the next day.  Two days later, upon the slightest movement, I had EXTREME STIFFNESS (in neck) AND PAIN in back and sides of neck, back of head, right side of head, right forehead.  No other symptoms (fever, etc.).  On April 29, 2022 I went to an Urgent Care facility and  was prescribed "IC METHYLPREDNISOLONE 4 mg DOSEPK" (6 tabs on day 1, decreasing by 1 tab each day - 6 days) and IC CYCLOBENZAPRINE 5 MG TABLET (2 tabs daily - 7 days).  I was also instructed to apply heat to the area and to take Tylenol for pain, which I did - frequently.  Tomorrow, 5/5/2022, will be the 6th day on the prescriptions.  Just today, 5/4/2022, I began to feel some relief and feel as though the pain and stiffness is starting to decrease.
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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Body ache; Chills; Fever 101.5degree F; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), CHILLS (Chills) and PYREXIA (Fever 101.5degree F) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced MYALGIA (Body ache), CHILLS (Chills) and PYREXIA (Fever 101.5degree F). At the time of the report, MYALGIA (Body ache), CHILLS (Chills) and PYREXIA (Fever 101.5degree F) outcome was unknown.            No concomitants were reported. No treatment was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
delayed menstrual cycle; pre-cramping feeling; A spontaneous report was received from a 37-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced delayed menstrual cycle and pre-cramping feeling.   The patient's medical history included seizure disorder, allergies, depression and anxiety. Concomitant medication was not reported.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (batch #039K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 23 Dec 2020,  the patient experienced delayed menstrual cycle. The patient stated she has the symptoms as if she's going to have her period, pre-cramping feeling, but it hasn't come yet. No treatment information provided.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of events, delayed menstrual cycle and pre-cramping feeling, were not reported.; Reporter's Comments: This case concerns a 37-year-old female patient with medical history of seizures, anxiety, and depression,  who received their first of two planned doses of mRNA-1273 (Lot 039K20A), and who experienced the non-serious unlisted events of delayed menstrual cycle and pre-cramping feeling.  Based on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Day 4 - Left underarm lymphe node painful Day 16 - Cold sore (Herpes Simplex HSV1) - Taking acyclovir 2 tablets 12 hours apart
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information about the patient's relevant medical history and concomitant medication was not reported. On 23-MAR-2015 the patient was inadvertently vaccinated subcutaneously with an expired dose of ZOSTAVAX (0.65 ml; lot # J012657, expiration date 10-JAN-2015). No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
This spontaneous report as received from a certified nurse practitioner refers to a patient of unknown age and gender. The patient was vaccinated with first dose of PNEUMOVAX23, intramuscularly, on 11-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. Nurse reported that patient was being administered PNEUMOVAX23 when some of the dose came out of the barrel of the syringe while the needle was in the arm of the patient. No adverse effect reported. Additional information has been requested.
shoulder pain and limited range of motion.  Left arm was sore after the vaccine 2 weeks but the symptoms grew worse and now I have shoulder pain and limited range of motion.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 61 year old of unknown race female. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised. The patient was previously treated with covid-19 vaccine  (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 23-AUG-2021) dose was not reported, 1 total administered at right arm on 11-MAR-2021 for prophylactic vaccination. It was unknown if patient experienced any adverse events following vaccination with covid-19 vaccine (dose number in series 1). It was reported that be on an unspecified date between her dose number in series 1 and dose number in series 2, the patient's doctor drew her blood and it was normal. The patient received covid-19 vaccine (dose number in series 2)(suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: 11-APR-2022) dose was not reported, 1 total, administered at right arm on 29-NOV-2021 for prophylactic vaccination. Concomitant medications included tofacitinib citrate (Xeljanz 5mg twice).  On 16-JAN-2022, the patient reported that after receiving booster dose she developed covid which was confirmed by rapid and PCR (polymerase chain reaction) test. On 16-JAN-2022, the patient tested positive by rapid test at home (confirmed covid-19 infection). On 19-JAN-2022, the patient tested positive by PCR test (confirmed clinical vaccination failure) (all events with dose number in series 2). On 22-JAN-2022, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 26-JAN-2022, Laboratory data included: COVID-19 virus test (NR: not provided) Negative.  The action taken with covid-19 vaccine  was not applicable. The patient recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint.; Sender's Comments: V0:20220250779-COVID-19 VACCINE -confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
rashes all over his body from his trunk down to his belly; This is a spontaneous report received from a contactable pharmacist. A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient experienced rashes all over his body from his trunk down to his belly on an unspecified date. Pharmacist was asking about administration of the second vaccine dose to a patient who reported having a reaction to the first dose. Patient reported that a few hours after having his first vaccine dose he experienced rashes all over his body from his trunk down to his belly. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pharmacy intern gave a dose of the Arexvy adjuvant to a patient, without reconstituting it with the antigen; pharmacy intern gave a dose of the Arexvy adjuvant to a patient, without reconstituting it with the antigen; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 89-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number x723b, expiry date 08-DEC-2024) for prophylaxis.   Concurrent medical conditions included leukemia (was diagnosed before getting Arexvy).   On 18-SEP-2023, the patient received Arexvy. On 18-SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: pharmacy intern gave a dose of the Arexvy adjuvant to a patient, without reconstituting it with the antigen) and inappropriate dose of vaccine administered (Verbatim: pharmacy intern gave a dose of the Arexvy adjuvant to a patient, without reconstituting it with the antigen).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-SEP-2023 The patient was a physician. Pharmacist reported a pharmacy intern gave a dose of the Arexvy adjuvant to a patient, without reconstituting it with the antigen, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. Reporter noted a couple presented to receive doses of Arexvy. One patient received a fully reconstituted dose of Arexvy and the other patient received the adjuvant portion without being reconstituted with the antigen. The reporter was uncertain which patient received the full dose or which patient received the adjuvant only. The reporter consented to follow up. No other details were provided.
increased redness, warmth to right deltoid, pain.  Pain shooting down arm from deltoid area
Rt. thigh 1.5 x 2 cm area of erythema & induration on rt lateral thigh. Non tender, without fluctuance, no streaking. Rx clindamycin 10.5mg PO TID x 7 days.
arm pain; headaches; joint pains; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), HEADACHE (headaches) and ARTHRALGIA (joint pains) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), HEADACHE (headaches) and ARTHRALGIA (joint pains). At the time of the report, PAIN IN EXTREMITY (arm pain), HEADACHE (headaches) and ARTHRALGIA (joint pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information for the events was reported.   This case was linked to MOD21-035030, MOD-2021-021841 (Patient Link).   Reporter did not allow further contact
she experienced flu like symptoms such as fever, nausea, headache, and fatigue after receiving the first dose of GARDASIL; she experienced flu like symptoms such as fever, nausea, headache, and fatigue after receiving the first dose of GARDASIL; she experienced flu like symptoms such as fever, nausea, headache, and fatigue after receiving the first dose of GARDASIL; she experienced flu like symptoms such as fever, nausea, headache, and fatigue after receiving the first dose of GARDASIL; she experienced flu like symptoms such as fever, nausea, headache, and fatigue after receiving the first dose of GARDASIL; This spontaneous report was received from a consumer who refers to herself, a 36-year-old female patient. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On an unknown date in 2006, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (exact dose, route of administration, lot number and expiration date was not provided).  On unknown date in 2006, the patient experienced flu like symptoms such as, fever, nausea, headache, and fatigue after receiving the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  The outcome of the events was unknown. The causality assessment was not provided.
Delayed Localized Hypersensitivity Reaction, red raised patches on area if injection. Patches were slightly itchy, no other symptoms noted.
Breakthrough case admission after 2 vaccines  Moderna 6/26/21 lot# 051C21A;  Moderna 7/27/21 Lot# 051C21A
mom gave a hx of t105; taken to ER had t104 ax; dx viral;