chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Exhausted; Fever; Felt sick/ so sick; Every bone in body ached, like the flu-type; Could not sleep; Dizzy; Arm hurt; Nauseous; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Felt sick/ so sick), BONE PAIN (Every bone in body ached, like the flu-type), INSOMNIA (Could not sleep), DIZZINESS (Dizzy) and PAIN IN EXTREMITY (Arm hurt) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037H22B, 001B21A, 031B21A and 002F21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic (had been a diabetic for 50 years) and Immunocompromised.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, the patient experienced ILLNESS (Felt sick/ so sick), BONE PAIN (Every bone in body ached, like the flu-type), INSOMNIA (Could not sleep), DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm hurt), NAUSEA (Nauseous) and PYREXIA (Fever). On 27-Jul-2022, the patient experienced FATIGUE (Exhausted). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 27-Jul-2022, INSOMNIA (Could not sleep) had resolved. On 28-Jul-2022, ILLNESS (Felt sick/ so sick), BONE PAIN (Every bone in body ached, like the flu-type), DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm hurt), NAUSEA (Nauseous), FATIGUE (Exhausted) and PYREXIA (Fever) had resolved.            No concomitant medications were reported.  On 14-Oct-2021, the patient received the Moderna vaccine booster dose.  The patient called primary clinic and reported that the patient needed to receive the Novavax shot. An appointment was booked for the patient for that purpose. The patient went in the clinic and had received the shot, but it showed that the patient had received the Moderna vaccine but they had incorrectly put the date as 20-Apr-2022 because the patient got it on 26-Jul-2022.  The patient never had any adverse reaction to any of the previous COVID shots. The patient had discussed it with the primary clinic, and they would get back to the patient on 08-Aug-2022. The patient experienced severe reactions to this latest dose of Moderna vaccine.  These side effects got a hold of the patient. The patient could not sleep and was up all night with all these symptoms. In the next morning, the patient was still up and, also, the patient was exhausted. The patient described the side effects were just as bad as when they started the night before. The patient was afraid and hence called the community health plan hotline. The patient was able to sleep on that night, and the patient felt fine on the next day.   This case was linked to MOD-2022-624006 (Patient Link).
inconsolable crying for 5 hrs p/17MAY95 vax; no treatment;
7/10/17 An 8 year old male patient received an adult dose of GSK Engerix B vaccine in his right deltoid. This was a repeat 3rd dose due because the 3rd dose was given too soon after the 2nd dose by another health care facility. 7/13/17 Nurse called dad and informed him of vaccine error and what he may expect and to watch for. Dad said patient, ?Is doing well.? Dad had no questions or concerns. He was told to call if any concerns arise which he voiced understanding. No adverse event at this time, reporting wrong dose (1.0 ml vs. 0.5 ml).
had a breakthrough with Covid; had a breakthrough with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (consumer's daughters friends mom) received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "had a breakthrough with Covid".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Small rash started day after second shot 4/22/2021, 2nd day after receiving second shot 4/23/2021 rash formed to blisters. Went to doctors 4/24 was diagnosed with shingles along my T11.
Employee reported fever, chills, severe muscle pain, muscle spasms, muscle weakness and fatigue.
Redness at injection site lasted 7 days until 1/19/21 resolved,  then appeared red again on 1/21/21, after scratching the site.  Took over the counter antihistamine and iced site to reduce swelling.
Headache began 12 hours after shot.  Fever Hot/cold sweats Severe nausea  Body aches Extreme fatigue
injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The reporter stated that, within a day of vaccination, the patient experienced injection site pain. The injection site pain resolved within 2 days. The reporter consented to follow up.
Sore arm; pain at injection site; This is a spontaneous report from a non-contactable consumer. A 49-years-old non-pregnant female patient received first dose of bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Left on 11Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not provided. Not known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. On 11Feb2021 patient experienced sore arm and pain at injection site. The patient did not receive treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
This initial spontaneous report was received from a physician referring to a 8 week-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 15-SEP-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Subcutaneous injection over the left triceps; Area became red and devleoped an immune response; Area became red and devleoped an immune response; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a subcutaneous injection over the left triceps and the area became red and developed an immune response.  The patient's medical history was not provided. Concomitant medications were not provided by the reporter.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 by subcutaneous injection in the left triceps prophylaxis of COVID-19 infection.   On 05 Jan 2021, the patient's injection site became red and developed an immune response which resolved in 24 hours. No treatment information was provided for the events.  Action taken with mRNA-1273 in response to the events was not provided.   The events, subcutaneous injection over the left triceps, was considered resolved on 05 Jan 2021. The events, area became red and developed an immune response, were considered resolved on 06 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown) and who experienced Subcutaneous injection over the left triceps with and associated non-serious and expected event of Area became red and developed an immune response. Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
crying immed p/inj;c/o extreme muscle weakness beginning about 4PM;t102 @ 9PM along w/paleness;vomited beginning @ 11PM & cont for 12+hr;MD consulted APAP & Advil given;MD recommended reporting to clinic;
Itchy ears and lips are swelling and itchy. Hives. Was rec for loratidine for 5 days. IF not helping by 3 PM, then would use steroids. Prednisone 40 mg /d for 5 d.
Injection site reaction- redness, swelling, pain, throbbing to left arm started day after vaccine administered
Rash at injection site on Lt upper leg top injection - (DTaP given Lt leg upper site) size of a quarter.  No fever.  Not bothering pt.
PT presents 4 days after immunization w/onset of poor appetite, poor feedings, "fussiness since shots" per mom. She subsequently developed excess secretions (URI?), hypotonia, weak cry, lethargy, poor suck. Hospitalized 1/13/03 infections, neurologic, metabolic work up negative.
Patient had localised erythema swelling and bruising at injection site. Treated with IM steroid and oral prednisone taper. Give sympathetic warm compress.
Have some swelling and pain under right arm towards PT's back. She's usually woken up from sleep at least once per night she she rolls on to the side. This has continued for at least 2 wks.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (route of administration, lot # and expiration date not reported). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt reported waking Saturday morning with leg spasms on right side that subsided by noon.  Sunday and Monday pt reports lesser spasming on the right side  leg, arm, and hand which also subsided by noon.  Pt was referred to PCP.
Felt very tired and dizzy at 1 pm on the day after (4/22) the shot, fell asleep, woke up at around 4 pm with severe chills. Woke up at 3:30 am on 4/23 with a fever of 101.9. Took Advil. Fever was 100.6 in the morning. Had a splitting headache and severe body aches the entire day and night and took Advil as directed. On 4/24 I was still light-headed and fatigued but no fever. By the evening I felt much better. By 4/25 I was 100% back to normal. Thank you.
Upon entering, the patient was retrieved and asked to sit in a chair. Demographic information was verified by someone along with the nurse. The nurse continued to verify if the patient had any allergies to medication, latex, and or band-aid adhesive. The client noted no allergies, at which time the nurse also verified any medication use. The nurse then asked if the patient had taken any covid vaccines Janssen, Pfizer, or Moderna at which time the client stated, ?I received my first covid Vaccine months ago.? The client was appropriately cleaned using an aseptic method and vaccinated using moderna lot# 022c21a. The patient was then monitored for 15 minutes. The vaccine was tolerated well with no adverse reactions. moderna safety case MOD 21-10163
p/vax pt devel 4inch diameter bruising, couldn't lift arm, flu sx, fever, body ache, couldn't breath felt like throat was closing up;felt like someone had split pelvic bone;pneumonia vax given same day arm very tender, couldn't be left;
Extreme soreness and pain in in arm near injection site. Unable to move arm the following day with difficulty 2 days post vaccine Fever Headache
Information has been received from a 26 year old female consumer with migraine headaches, who on approximately 31-OCT-2006 ("end of October or beginning of November 2006"), was vaccinated with the first dose of Gardasil (yeast). Concomitant therapy included propranolol HCL for migraine headaches. Subsequently, the patient "became pregnant at the end of November 2006," and reported " a normal pregnancy with no adverse side effects". The approximate LMP date was 30-NOV-2006, with an estimated due date of 06-SEP-2007. Additionally, on approximately 28-DEC-2006 ("approximately six weeks ago"), the patient was diagnosed with lupus (not further specified), and daily injections of LOVENOX were initiated as treatment. Unspecified blood tests were performed (results not reported). At the time of the report, the patient had not recovered. Upon internal review, the patient's diagnosis of lupus was considered to be an other important medical event. The patient sought unspecified medical attention. Additional information has been requested.
patient was administered a dose ofMMR II and V ARlV AX that was reconstituted with 0.9%; A 9-month-old pediatric patient was administered a dose of MMR II and VARlVAX; No adverse event reported; This spontaneous report was received from Registered nurse referring to a 9-month-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-FEB-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, at a dose of 0.5 milliliter (lot #u006488, expiration date: 26-FEB-2023)(Product administered to patient of inappropriate age), and (varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliter (lot #u025202, expiration date: 13-AUG-2023), both vaccines administered for prophylaxis (strength, and route of administration for both vaccines were not provided). The reporter stated that the vaccines were reconstituted with sodium chloride 0.9% (formulation, dose description, lot #, expiry date, route of administration, and indication were not provided) instead of the company supplied diluent (Product preparation issue). No additional adverse event was reported.
At 5:15 on 4/11/21, patient had a slight headache and laid down  At 6:30, patient's wife woke him. Patient then noticed that he could not move his legs or toes, it was as if his toes were frozen.  Patient's wife and niece began messaging his legs for about 30 minutes. They were able to slide his legs over the side of the bed and helped him stand. After that he was able to walk without assistance. Patient has been advised to NOT receive the booster per his PCP. Patient presented this report to the pharmacy on 1/27/22.
This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 18-year-old female patient who received BEXSERO. On 19th JULY 2016, the patient received BEXSERO. On 20th JULY 2015, 1 day after, receiving BEXSERO, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown. It was  unknown if the reporter considered the injection site erythema and injection site warmth to be related to BEXSERO. Additional details were provided as follows: The reporter stated that, the patient experienced red, warm, large spot on arm in which the patient received BEXSERO. Minimal adverse event information was provided to the reporter.
Grandmother called baby developed 25 cent size red area on Rt thigh early evening after receiving PREVNAR 13 on Rt leg. Was fussy with low grade fever x 2 days. Symptoms improved.
Headache, Arthralgia, CHILLS AND FELT HOT WITH FATIGUE AND LOSS OF APPETITE Narrative:  Other Relevant History:
Right and left palms of hand yellow under the skin. Right and left top of hand yellow under skin. Underside of Right and left wrist yellow under skin. As of 9/1/2021 symptoms seem to be subsiding but not completely. No treatment as of yet.
nauseous; severe pain; fever; This case was reported by a pharmacist and described the occurrence of nausea in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2020, the patient received the 2nd dose of Shingrix .5 ml. On 18th December 2020, 1 days after receiving Shingrix, the patient experienced nausea, pain and fever. On 18th December 2020, the outcome of the nausea, pain and fever were recovered/resolved.   The reporter considered the nausea, pain and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had nausea, pain and fever. The reporter consent to follow up.
19MAY91, pt c/o stiffness of neck & aching of bones & body; Had swelling, redness & puffiness of cheeks & ear; Mom phoned MD & was advised DPH PO & Cordaide lotion to face & ear area; Pt also stung by bee Sunday PM;
Warm to touch; Itchiness at injection site; Hardness; Red/brown circles; Raised skin/ swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE ERYTHEMA (Red/brown circles) and VACCINATION SITE SWELLING (Raised skin/ swelling) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE ERYTHEMA (Red/brown circles) and VACCINATION SITE SWELLING (Raised skin/ swelling). At the time of the report, VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE ERYTHEMA (Red/brown circles) and VACCINATION SITE SWELLING (Raised skin/ swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details was not reported by the reporter.
body aches; headaches; fever reaching as high as 102.2; Severe nausea; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular route, administered in left arm on 16Jan2021 (at 26 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included seasonal allergies and asthma both from unspecified date. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (Lot number: EJ16851) via intramuscular route, administered in left arm on 26Dec2020 at 16:45 (at 26 years old) as single dose for COVID-19 immunization. The patient did not have COVID prior to vaccination. The patient was tested for COVID post vaccination. Nasal swab for COVID was negative. On 17Jan2021 at 02:00, approximately 12-16 hours after the second dose, the patient experienced body aches, headaches, fever reaching as high as 102.2 lasting for 3 days, and severe nausea for 6 days; all non-serious. No treatment received for the events. Outcome of the events was recovered on unspecified date in Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Woke up with a red itchy face. I take zyrtec so I just decide to wait and see.  It was red and pin point rash on my upper cheeks Saturday.  On Sunday the rash and itch moved to my chin.  Not really concerned, just documenting.
Gave covid19 vaccination, at approximately 1015am and went and sat in the vaccination waiting area. At approximately 1025 patient reported that she was feeling like her heart rate was racing and she felt dizzy. RN and NP started to monitor patient in the waiting area. On the monitor, patient's HR was 144 while sitting. patient admitted to feeling nervous/ anxious prior to getting vaccine and stated she also had a allergy to Contrast. NP continued to monitor vitals every 5-10 min. patient's symptoms started to improve. Pharmacist identified a possible correlation with an ingredient in contrast and the vaccine and a rapid response was called. Rapid team gave patient Benadryl and patient was monitored in the clinic for approximately 1 hour with continued improving symptoms. Husband, was called to give her a ride home.
Patient came into the office on 5.28.21 to receive her 2nd shingrix. I confirmed with patient that she has not received her 2nd shot. Ptatient confirmed she did not get the 2nd shot just the one. She was recieving on 5.28.21 was the 2nd shot. Upon chart documentment I come to find out that she had 2 shots in her chart I called pt immediately to once again confirm if she reccieve the 2nd shot. Pt state she is 99.9% certain she did not get the 2nd Shingrix vaccine at the office on 02-07-2020 pt felt this was a error as she knows she didn't get vaccine on this day 2-7-20. informed pt that I report the 3rd shot to management and as this is a 2 dose vaccine step and with this being the 3rd on her chart I would need to report even if she did not receive the shot on 2.7.2020 as she stated. I called on 5.15.2021. pt stated 5.31.21 times she felt fine just had a reported on 5.31.21 other than that she was fine
had first of his COVID-19 vaccines 1/5/2021 and tested positive for COVID-19 on 1/10/2021
Primary n cardiologist increased my metoprolol to 75 mg Nuero doc has put me on buspar to try to control tremors using scopolamine patches help with dizziness
Woke up at 430a the next morning with vomiting, sweating, heart racing, headache, dizziness and fever.  Felt better during that next day but the following night woke up with diarrhea, vomiting, heart racing, dizziness, and brain fog.  No further episodes.  Arm was sore.
Patient experienced sweating, was pale, vision changes and headache. immediately sat down again, apply juice and crackers were brought, MD brought into room to evaluate patient. After sitting for a few minutes and juice, patient reported feeling much better, was no longer pale or sweating. Patient was encouraged to sit an additional few minutes to ensure resolved symptoms, and instructed to move slowly upon standing. Patient confirmed upon standing, symptoms resolved and no further complaints. Patient exited clinic.
While advancing the plunger into the barrel  of the syringe, the needle adapter came off and vaccine was noted on the recipients arm and my glove. The recipients arm was then cleaned and bandage was applied.
Follow up report received from a Healthcare professional on 08 May 2012. Local Reference number: 12-0185.
patient blacked out on the day after she got the shot and again the following day.  She also had a red arm and swelling for about 7 days. She had weakness for 7 days.