chrisvoncsefalvay/vaers-outcomes huggingface dataset:
super achy; Kinda feels hot/cold; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, super achy and kinda feels hot/cold.    The patient's medical history as provided by the reporter included COVID-19. Concomitant medication were not reported.  On 22 Dec 2020, approximately one day prior to onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot # 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.  On 23 Dec 2020, the patient reported to feeling super achy and feeling hot/cold. The physician recommended APAP, however it was not confirmed as treatment.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events, super achy and kinda feels hot/cold, were not provided.; Reporter's Comments: This case concerns a patient with a medical history of COVID-19, who received their first of two planned doses of mRNA-1273 (Lot 025J20-2A), and who experienced the unlisted events of Pain and Feeling of body temperature change.  The events were considered related to the vaccine due to the temporal relationship.
Mom states child started with fever in 30-45 min after receiving vaccine, body got ice cold, then 12 hours later started vomiting that continued for two more days.  Then all resolved.
About 3.5 hours after the injection on May 18th my right leg became slightly numb and tingling (pins and needles kind of feeling).  By the next morning my leg was ok.  Then on Sunday, May 23rd my right leg began to tingle and go numb again.  Then the next morning (5/24) my leg was still numb/tingling and both my hands had a tingling sensation as well.
fatigue; muscle aches; fever; lump at the injection site; swollen at the injection site; red at the injection site; hot at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 59EA2, expiry date 13th September 2021) for prophylaxis.   On 19th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fatigue, muscle pain, fever, injection site lump, injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the fatigue, muscle pain, fever, injection site lump, injection site swelling, injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the fatigue, muscle pain, fever, injection site lump, injection site swelling, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient experienced fatigue, muscle aches and fever. The patient was concerned because she also experienced a lump underneath the injection site that got swollen, red and hot. All the events lasted for 7 to 10 days.
administered 0.2ml of the Moderna bivalent vaccine to a peaditric patient of 9 months old who had never been vaccinated before; no adverse event; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED (administered 0.2ml of the Moderna bivalent vaccine to a pediatric patient of 9 months old who had never been vaccinated before) and NO ADVERSE EVENT (no adverse event) in a 9-month-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (administered 0.2ml of the Moderna bivalent vaccine to a pediatric patient of 9 months old who had never been vaccinated before) and NO ADVERSE EVENT (no adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (administered 0.2ml of the Moderna bivalent vaccine to a pediatric patient of 9 months old who had never been vaccinated before) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (administered 0.2ml of the Moderna bivalent vaccine to a pediatric patient of 9 months old who had never been vaccinated before).    No concomitant medication was reported.  No treatment medication was reported.   Reporter did not allow further contact.
Fine rash to neck, chest, and arms accompanied by pruritus took Benadryl 25 mg every 4-6 hours as needed for itching. Saw FP provider 10/30/06 prescribed triamcinolone ointment.
Patient developed a scabbed area then ulceration on the skin at the site of the vaccination. No other symptoms.
I?ve had a floater in my OD eye since then. I went to the eye doctor & have a vitreous hemorrhage. I just talked to someone else that the same thing happened, so thought I?d better report it.
a stunned feeling and felt like she couldn't move; waited to get the 2nd shot 3 yrs later; had pain, swelling, and redness at the injection site; had pain, swelling, and redness at the injection site; had pain, swelling, and redness at the injection site; woozy; achy; fever; headache; nausea; weakness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On 18th June 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 18th June 2021, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced injection site pain, injection site swelling, injection site erythema, feeling dazed, woozy, pain, fever, headache, nausea and weakness. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, feeling dazed, woozy, pain, fever, headache, nausea and weakness were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   The reporter considered the injection site pain, injection site swelling, injection site erythema, feeling dazed, woozy, pain, fever, headache, nausea and weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. the patient received first shingrix vaccine and immediately she had a stunned feeling and felt like she couldn't move. About 2 hours after the first vaccine injection, she exhibited the following symptoms for about 24hours woozy,achy, fever, nausea, headache, and weakness.  The patient also had pain, swelling, and redness at the injection site for about 2 weeks. all of her symptoms have resolved. Due to the reaction to her first shingrix shot, she was hesitant to get the second shot and thus, waited to get the 2nd shot 3 yrs later, which led to drug dose administration interval too long. The patient reported that no symptoms with her second shingrix vaccine. No health care professional details were provided. The reporter did not consent to follow up
syncope for 10 seconds, dizzy and weakness. patient given water and rest. Symptoms resolved
3 days p/vax felt achy, began exp pain in joints;states pain extreme in knees by 12DEC95, sought medical treatment;pain also beginning in spine & neck getting stiff, Darvocet q 4-6 hrs rx, bed rest x 4 days
heart rate still up; felt horrible; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt horrible) and HEART RATE INCREASED (heart rate still up) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt horrible) and HEART RATE INCREASED (heart rate still up). At the time of the report, FEELING ABNORMAL (felt horrible) was resolving and HEART RATE INCREASED (heart rate still up) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) High.         No concomitant medications were reported.  No treatment medications were reported.    Reporter did not allow further contact
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (DILUENT MRK INJ) which was used for the reconstitution of PROQUAD (unknown lot# and expiration date). On an unknown date the patient was vaccinated with improperly stored PROQUAD (dose, units and frequency not reported) (lot # N020620 and expiration date: 22-JAN-2019) subcutaneously at a temperature from -14 degree Celsius ( °C) to -10 °C for 13 hours (product storage error). It was unknown whether previous temperature excursion was occurred for the PROQUAD or not. No data logger was involved. No adverse effects and no additional information was provided. No product quality complaint was involved.; Sender's Comments: US-009507513-1803USA004759: US-009507513-1803USA004761: US-009507513-1803USA004758: US-009507513-1803USA004757: US-009507513-1803USA004760:
Left thigh generalized swelling, (34 cm circumference vs. 31cm on right), warmth, redness, pain.
12:15pm: c/o itching in throat BP: 102/60 P: 68 O2: 100% No rash or other sxs Benadryl 25mg 1 PO given 12:45pm: itching of throat, (L) chin itchiness, small red bumps on (L) side of face forming No SOB BP: 122/80, P: 72 Benadryl 125mg 1 PO given 1:00pm itching of throat, lump in throat, decreased face itching decreased bumps 1:15pm decreased sxs overall BP: 118/62 let got home, ok to drive
This case was reported by a pharmacist and described the occurrence of application site knot in a female subject aged between 30 and 39 years old who was vaccinated with ENGERIX B (GlaxoSmithKline). In April 2011 (the week prior to reporting) the subject received unspecified dose of ENGERIX B at 20 mcg in the right arm. At an unspecified time after vaccination with ENGERIX B, the subject experienced application site knot (a knot in the arm where the vaccine was given). At the time of reporting the outcome of the event was unspecified. The ENGERIX B lot number was originally reported to be AHBV894BA and was noted to be incorrect on 03 May 2011 and corrected to AHBVB894BA.
has a temperature of 100.8; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 78-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EW0175) via an unspecified route of administration, administered in Arm Left on 24May2021 at 10:30 am as dose 2, single dose for covid-19 immunization (at the age of 78-years-old). The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EW0175) via an unspecified route of administration, administered in Arm Left on 03May2021 at 10:30 am as single dose for covid-19 immunization (at the age of 78-years-old). It was reported that after receiving the second dose of vaccine, the patient had a temperature of 100.8 on 25May2021 morning. He also stated that he had no other symptoms and was asking what he should do. On 25May2021, the patient underwent lab tests and procedures which included body temperature which result showed 100.8. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Large red area around where the vaccine was administered. Tender to the touch and warm.  Sore Shoulder.
Ever since vaccination shot, almost two months,  hives break out on torso, buttocks, legs whenever I exercise outdoors in temperature above 70 degrees. Hives subside with cold shower and rest, but recur whenever I exercise in temps above 70 deg outdoors. I do not get hives, or they are mild if I exercise outdoors in temps below 60 degrees. PCP Rx for MethylPREDNISolone 4mg 21s did not help.
Torso Hives Patient was placed Predinose 30 mg BID for 5 days and Benadryl 50 mg every 6 hours. Waited in office 1 hr after doses.
This spontaneous report was received from a female patient of unknown age, who was also a physician, reporting on herself. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date in the 1960's, the patient was vaccinated with a measles vaccine (manufacturer unknown) injection (dose, route of administration, lot # and expiration date were not reported). However on an unknown date in 2017 (reported as presently), the physician revealed negative titers for the measles vaccine (manufacturer unknown). On an unknown date, the patient experienced psoriasis.  The outcome of the adverse events and the relatedness between the adverse events and measles vaccine (manufacturer unknown) were not reported.  Additional information is not expected as the reporter's contact details were not provided.
He had a horrible small pox looking rash on his entire back and other parts of his body; This spontaneous case was reported by a consumer and describes the occurrence of SMALLPOX (He had a horrible small pox looking rash on his entire back and other parts of his body) in a 73-year-old male 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 SMALLPOX (He had a horrible small pox looking rash on his entire back and other parts of his body). At the time of the report, SMALLPOX (He had a horrible small pox looking rash on his entire back and other parts of his body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Nov-2021, Body temperature: 100 (High) 100. On 08-Nov-2021, Body temperature: 103 (High) 103.         No Concomitant medications were reported. No Treatment information was reported.  Seven days after Moderna booster dose, Patient had experienced disgusting rash pustules all over his body with tremendous itching. It started with a rash, but now it looks like smallpox. It was all over his back and front. It's itching, and he was up all night.He had fever of 100 yesterday 07Nov2021. Today 08Nov2021 it was 103.      Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow-up includes: Patient demographics (age, DOB),  Lab data were and event details were added.
During 30 minute wait, patient developed an itchy throat and reported a rapid heartrate. 25mg of Benadryl P.O administered, symptoms resolved during additional 30 minute wait with Nurse.
Employees @ reporting MD's office recvd Engerix-B & did not convert; attempting to obtain further info;
Information has been received from an office manager who reported that the GARDASIL vaccine (Lot #655604/0052X) leaked out of the syringe onto the nurse's pants before it can be given to a patient. No adverse effect reported. SR number 1-3094846504. No further information is available.
Sneezing runny nose, progressed to whelps, progressed to flushing and choking sensation. Resolved with antihistamine treatment in clinic.
25SEP 1015AM face flushed, soreness of arm (no redness or swelling but hot;6PM had temp 100.4, hands & feet all swollen;9AM went to ER;eyes swelling shut;30SEP97 MD told pt had had severe allerg rxn w/vigorous response;c/o whole body aches;
administration date=22Dec2020, dose number=1/administration date= 08Jan2021, dose number=2; arm so painful unable to stretch it out or to lift anything with that hand; arm so painful unable to stretch it out or to lift anything with that hand; This is a spontaneous report from a contactable other hcp. A 40-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot Number: EL3248, Expiration date: unknown),  dose 2 via an unspecified route of administration, administered in Arm Right on 08Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was administered the dose 1 on 22Dec2020 and dose 2 on 08Jan2021 (inappropriate schedule of product administration) with outcome of unknown). The patient has experienced severe pain where the patient is unable to stretch it out or to lift anything with that hand (pain in extremity) on 08Jan2021 with outcome of not recovered.  No follow-up attempts are needed. No further information is expected.
I received the shot and was told to wait 15 minutes and after about 5-10 I started feeling weird like I was going to faint and found a place to sit down and tried calling for the lady and next thing I know I woke up and several people were offering me water and had a cool napkin on my head . The pharmacy employee had called 911 and when they got there they performed vitals but I ended up fainting again when they asked me to stand up. I tried refusing going  to the hospital as my son was there and could drive but they took me anyway . I didn?t feel myself and was weak and just in a fog like state, didn?t feel back to myself for about a week.
Sore arm after received covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm after received covid vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm after received covid vaccine). In 2021, VACCINATION SITE PAIN (Sore arm after received covid vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624313 (Patient Link).
About 2 hours after vaccine, became unusually tired, and napped for 2 hours.  Felt fine when I woke up. Arm was mildly sore for about 2 days after the shot.   Beyond that no other noticeable symptoms.
Little tiredness; Last night some soreness in my arm; This is a spontaneous report from contactable consumer(patient) from a Pfizer-sponsored program. A 69-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot /Batch number: Unknown), via an unspecified route of administration on 04Feb2021 at 12:00 as 1st dose, single for COVID-19 immunization. Medical history included root canal. Patient had a dental appointment on 02Feb2021, and she was taking ibuprofen after the appointment. She is wondering when she can start taking the ibuprofen for her tooth pain. Patient stated that she was clear about if taking Advil is okay after you get the shot, it isn't okay to take it before. She had a dental procedure on Tuesday, a root canal, her mouth continues to be sore. It was reported that her dentist said she could take Advil and she didn't know at that time. Concomitant medication included ibuprofen taken for tooth pain from 02Feb2021 to 03Feb2021 16:00. It was reported that she stopped taking the ibuprofen at 4:00 on 03Feb2021. She was received her first dose of Pfizer-BioNTech COVID-19 Vaccine on 04Feb2021 at noon and experienced: a little tiredness and last night some soreness in my arm ( Feb2021), the same as if she had a flu shot. Her second dose is scheduled for 25Feb2021. She was advised to report any possible side effects after her second dose. The outcome of the events was unknown.  No further details provided. Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
This initial case was received from a nurse on 04 February 2014. Of note, the nurse also reported another patient with confirmed influenza following vaccination with FLUZONE; that event is captured in case 2014SA015529. A female patient in her "50's" (exact age not reported), with no reported concomitant medications or relevant medical history, received an injection of FLUZONE (lot number UH906AC) in October 2013. Approximately three months post-vaccination, during the week of 27 January 2014, the patient tested positive for A strain influenza, using rapid flu test "Alere BionixNOW Influenza A and B". The outcome was reported to be resolved. Additional documents held by sender: None.
Slight headache; my shoulder is sore at the injection site; my shoulder is sore at the injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Slight headache"; ARTHRALGIA (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "my shoulder is sore at the injection site".  Additional information: The patient had slight headache, did not have the bad adverse reaction but had headache and shoulder was sore at the injection site.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a RN concerning a 31 yr old female pt who on 15Jun04 was vaccinated with measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot647277/1035N). There was no concomitant medication. On 15Jun04, within 30 minutes post vaccination, the pt felt cramping in her stomach, dizzy, lightheaded, weak and jittery. The pt took acetaminophen (Tylenol), 100mg. Within the hour the pt vomited and developed diarrhea. The pt was seen by an occupational health doctor. They are unsure if MMR caused this. Subsequently, the pt recovered from cramping in her stomach, feeling dizzy, lightheaded, weak, jittery, vomiting and diarrhea. There was no product quality complaint involved. Additional information has been requested.