chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bottom of his feet and palms of his hands are super itchy; Back hurts; Arms / hand hurts like having arthritis; Fatigue; Cold sweat, feels clammy; Flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu), PRURITUS (Bottom of his feet and palms of his hands are super itchy), COLD SWEAT (Cold sweat, feels clammy), BACK PAIN (Back hurts) and PAIN IN EXTREMITY (Arms / hand hurts like having arthritis) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced INFLUENZA (Flu) and COLD SWEAT (Cold sweat, feels clammy). On 24-Nov-2021, the patient experienced BACK PAIN (Back hurts), PAIN IN EXTREMITY (Arms / hand hurts like having arthritis) and FATIGUE (Fatigue). On 29-Nov-2021, the patient experienced PRURITUS (Bottom of his feet and palms of his hands are super itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy, at a dose of 1 dosage form. On 25-Nov-2021, BACK PAIN (Back hurts), PAIN IN EXTREMITY (Arms / hand hurts like having arthritis) and FATIGUE (Fatigue) had resolved. At the time of the report, INFLUENZA (Flu), PRURITUS (Bottom of his feet and palms of his hands are super itchy) and COLD SWEAT (Cold sweat, feels clammy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.
3/10/18. Presents with rash over anterior/posterior thorax. Also involving axilla and neck. Rash is itching.
Lymph node swollen underneath arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node swollen underneath arm) in a female patient of an unknown age 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) at an unspecified dose. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymph node swollen underneath arm). At the time of the report, LYMPHADENOPATHY (Lymph node swollen underneath arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was available. No treatment Medication was available.
This spontaneous report as received from a pharmacist refers to a 57 year old female patient with tetracycline allergy. ON 08-NOV-2013 the patient was vaccinated with ZOSTAVAX (0.6ml) (lot number J006158, expiry date 30-AUG-2014) subcutaneous in the right arm. The concomitant medications were reported as none. On 08-NOV-2013, the patient experienced rash at injection site. On 13-NOV-2013 the patient experienced bumps at injection site and 2 bumps with itching on an unspecified wrist. There were no lab diagnostic studies performed. The patient sought medical attention and had visited a pharmacist. The patient was treated with ALEVE and col compresses at the injection site. The outcome of rash at injection site and bumps at injection site and 2 bumps with itching on an unspecified wrist was reported as not recovered. Additional information has been requested.
C/O DIZZY, CANT SEE ANY THING, CODE GREEN CALLED, TRANSFFERED TO COT, SX RESOLVED, REFUSED TRANSPORT
pt recv vax; approx 25 mins p/ vax, devel stomach cramps, HA, n, dizziness; resolved p/ emetrol given  & slept for 8 hr;
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 10:10 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 10:10 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 31.74.  No concomitant medications were reported.  The vial was initially stored in the fridge on 19-Apr-2021, moved to clinic on 27-Apr-2021 and proposed beyond use date was 19-May-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On 27-Apr-2021, at 09:00 A.M., the temperature recorded was 35 degree Fahrenheit, that has been reached by the vial.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Apparent localized shingles outbreak on skin of left arm near vaccine site. Patient started on VALTREX treatment.
The patient was given a Varicella vaccination which expired 13 days prior to administration. The manufacturer was contacted and "confirmed internal stability data to support the potency of the dose through the date it was given. The patient does not need to be revaccinated and there is no additional risk to the patient beyond the normal adverse effects associated with the vaccine." The patient was notified and suffered no adverse effects from the Varicella vaccination.
BODY ACHES; BURNING UP; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced burning up. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, body aches, and burning up. This report was non-serious.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were reported.  Treatment information was not provided.
Patient had chills for 3.5 days, no fever.  MIgraine for 11 days.  All joints were affected (felt like sticking a knife into them).  Severe fatigue.  Patient thinks vaccine excaberated his RSD.  Pain in right hand and left foot still remains.
eyes started  getting crusty and watery/can barely open her  eyes or see for 30 minutes to 1  hour  in the morning; eyes started  getting crusty and watery; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of EYELID MARGIN CRUSTING (eyes started  getting crusty and watery/can barely open her  eyes or see for 30 minutes to 1  hour  in the morning), LACRIMATION INCREASED (eyes started  getting crusty and watery), FATIGUE (fatigue) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     The patient's past medical history included Peripheral neuropathy. Concurrent medical conditions included Sinus disorder NOS (Patient state that she takes cold medications for her sinus allergy.).    On 22-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYELID MARGIN CRUSTING (eyes started  getting crusty and watery/can barely open her  eyes or see for 30 minutes to 1  hour  in the morning), LACRIMATION INCREASED (eyes started  getting crusty and watery), FATIGUE (fatigue) and HEADACHE (headache). The patient was treated with ACETYLSALICYLIC ACID (ASPIRINE) for Headache, at an unspecified dose and frequency. At the time of the report, EYELID MARGIN CRUSTING (eyes started  getting crusty and watery/can barely open her  eyes or see for 30 minutes to 1  hour  in the morning) and LACRIMATION INCREASED (eyes started  getting crusty and watery) outcome was unknown and FATIGUE (fatigue) and HEADACHE (headache) had not resolved.            The  cold medications are concomitant medications.   This case was linked to MOD-2021-132097 (Patient Link).
Caller returning call with patient information regarding improperly stored vaccine administration; This spontaneous report was received from an other health care professional referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On an unknown date, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA)(PROQUAD) 0.5 milliliter (mL) (route of administration was not provided), lot number T005406, expiration date 12-AUG-2021, as prophylaxis.    The improperly stored dose experienced a temperature excursion of -9.5 degrees Celsius (C) for 8 hours and 53 minutes, and -10.1 C for 6 hours and 40 minutes, with no previous temperature excursions. The call was due to a digital data logger.
Severe body aches, chills, sweating, massive headache, diarrhea, exhaustion, brain fog for 7 days
Patient received first dose of Moderna COVID-19 vaccine today at approximately 07:35 hours. Approximately 5-8 minutes after receiving vaccine patient experienced dizziness, head "fullness", headache Left>Right, tingling and numbness of the lips and diaphoresis. Patient verbalizes a history of Anaphylactic reaction to Aspirin as a child. Patient does have anxiety and took anti-anxiety medication this morning. ERT was called at approximately 07:49 time. Disposition: Emergency response team arrived and assumed care of patient. Patient WAS transported to emergency department via wheelchair for further evaluation at 07:59.  In ED patient received diphenhydramine 50mg po. Was monitored and discharged.
Localized erythema, warmth, and induration measuring 7 cm by 7 cm, but no pain (and no whole-arm swelling).  Site of Tdap (Adacel) was left shoulder (deltoid).  No purulent drainage, fluctuance, or previous reactions to Td.  Last Td was more than 2 years ago.
Immunization given @ approx. 9:00am on 04/13/06 swelling of neck, tongue and throat at 10:30pm on 04/13/06 in E.R. 11:15pm given IV solumedrol, IV Benadryl, (sub q) epinephrine and showed significant improvement within 1-2 hours. Hospitalized overnight, discharged, symptoms returned 04/23/06 treated in E.R. and discharged, symptoms resolved. 06/27/2006-3 page DC Summary and 10 page ED report received from Bay Regional Medical Center-DC DX: acute allergic reaction probably secondary to immunizations.  ED report documented patient noted to have swelling of neck, tongue and throat. Onset 10:30 p.m. the evening of 4/13/06 (date of vaccination). Onset abrupt and worsening to point that his tongue would not even fit in his mouth. Patient stated he could not swallow but had no difficulty breathing. RX in ED included IV Solu-Medrol 100 mg and subsequent 40mg IV, and Benadryl, epinephrine 0.3mg SQ. Observed in ED for 2 hours, swelling decreasing, admitted for observation. Physical exam revealed little redness around the site of the immunizations but not marked. No known allergies, avoid aspirin and anti inflammatories due to hemophilia. Temperature in ED 99, tonsils 2+ without inflammation. Small less than 1 cm nodes scattered across the anterior and posterior chains of the neck. Remainder of physical exam normal. DC instructions included Medrol Dosepak and Benadryl OTC to obtain at local pharmacy. krk
Soreness at arm of injetion; Itching at the site of injection; Headache; tired; Rash at the site of injection,rash moved down to arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness at arm of injetion), VACCINATION SITE PRURITUS (Itching at the site of injection), HEADACHE (Headache), FATIGUE (tired) and VACCINATION SITE RASH (Rash at the site of injection,rash moved down to arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness at arm of injetion), VACCINATION SITE PRURITUS (Itching at the site of injection), HEADACHE (Headache), FATIGUE (tired) and VACCINATION SITE RASH (Rash at the site of injection,rash moved down to arm). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Headache, at a dose of 1 UNK. At the time of the report, PAIN IN EXTREMITY (Soreness at arm of injetion), VACCINATION SITE PRURITUS (Itching at the site of injection), HEADACHE (Headache), FATIGUE (tired) and VACCINATION SITE RASH (Rash at the site of injection,rash moved down to arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Developed a circular rash at injection size 8 days after vaccination. Site was mildly itchy, visibly red and approximately 3 inches in diameter. Rash has continued to fade but is still present now 11 days after vaccination. (I am pregnant, 8 weeks gestation at time of vaccine shot, est due date 10/28/2021.)
pt recv vax 11APR97 & 23APR97 pt devel induration & a hot sensation @ inj site (size of a dollar coin), fever of 102.8, nausea, 20-25 pox, irritable, fatigue, weight loss (5-10lbs in 2 days), & loss of appetite;
I received my first dose on  3/3/21 and the adverse reaction occurred from 3/10/21 through 3/19/21.  My side effects included: headache, fatigue, congestion, dizziness, nausea, diarrhea, chills, myalgia(lots of muscle pain), joint pain and swelling, overall weakness throughout body.
pt admitted to hosp as a transfer from local Community Hospital with HRF secondary to COVID; had been given Regeneron and dexamethasone; had been symptomatic x 2 wks; O2 supplementation; during hosp stay, pt removed O2 and sats went to 50%; pt was intubated; no improvement; clinically worsened; poorly responsive to unresponsive; experienced cardiac arrest; ACLS initiated and ROSC obtained; pt was transitioned to comfort measures, extubated and she passed away in the hospital
agitated; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 and dose 2 via an unspecified route of administration on 06Apr2021 and 27Apr2021 respectively, both as single for COVID-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced agitated on an unspecified date. The patient received both doses of the Pfizer Biontech COVID19. Her first dose was on 06Apr2021 while her second dose was on 27Apr2021. She reported that not even an hour ago, she had an antibody test and the result was she had no antibody (negative). She reported that her pharmacist would call them since she received a negative antibody test. She also mentioned that she knew someone who had COVID and was not vaccinated who showed antibody. She wanted to know if they have some information on receiving a negative antibody after being fully vaccinated and if she was covered or protected. The patient further reported that she was in an agitated state right now as she received both doses and did not have any antibodies. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 11Aug2021. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Recombinant Zoster (Shingles) Vaccine and Pneumococcal Polysaccharide Vaccine.  The first night symptoms were just swelling, redness and hot to touch at the site.  The next two days, I felt achey and very tired.  I didn't run a fever but my skin hurt like I was.  Today is the 4th day and the swelling has gone down a little and I'm not as fatigued but both shot sites have large red circles and are very tender and itchy.
Administered reconstituted vaccine refrigerated more than 6 hours; This non-serious case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-APR-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Administered reconstituted vaccine refrigerated more than 6 hours). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 26-APR-2023 The reporter was a medical doctor. The reporter wanted to know about the information of if reconstituted Shingrix vaccine was refrigerated but outside the 6 hours window and then accidentally administered to the patient. The reporter confirmed that this was an attempt at the patient's first dose of Shingrix. The reporter was unable to provide any additional vaccine details at the time of reporting. The reporter did consent to follow-up. The Shingrix vaccine was reconstituted and refrigerated but outside the 6 hours window and then accidentally administered, which led to incorrect storage of drug.
Global amnesia. Husband took me to specialty hospital ER. Cat scan and exams done. Taken to their facility for observation, telemetry etc overnight
No adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 43-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    Concomitant medication was not reported.  Patient ID was reported as 5696088.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Reportedly, in this report the patient was eligible for COVID-19 vaccine. Breakdown of doses were reported as 37 doses from Lot 059H21, 26 doses from Lot 065K21A, and 12 doses from Lot 058A22-2A.  Treatment medication was not reported.