chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash across the middle of her back and under the breasts in the middle area like a triangle; muscle aches in her back that presented yesterday; redness at the injection site/The red area is 3" x 2" in size; tenderness at the injection site; muscle aches in her back /  back ache; This case was reported by a consumer and described the occurrence of injection site erythema in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rash (had rash like this presented in that area under the breasts in the past), allergic reaction (had an allergic reaction to another medication) and back pain (sometimes had a back ache).   On 6th January 2021, the patient received the 1st dose of Shingrix. On 7th January 2021, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site tenderness and muscle pain. On 8th January 2021, the patient experienced rash. In January 2021, the patient experienced back pain. On an unknown date, the outcome of the injection site erythema, injection site tenderness, rash and muscle pain were not recovered/not resolved and the outcome of the back pain was unknown.   It was unknown if the reporter considered the injection site erythema, injection site tenderness, rash, muscle pain and back pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix 2 days ago and experienced tenderness and redness at the injection site.   The red area was 3 x 2 in size.  The patient noticed a rash across the middle of back and under the breasts in the middle area like a triangle.   The patient said a rash like this presented in that area under the breasts in the past when she had an allergic reaction to another medication.   The patient had muscle aches in her back and although sometimes had a backache so was not sure if that was caused by the vaccine. The reporter did not consent to follow up.
two weeks after second dose- muscle spasms in legs, hips, thighs, back/buttocks; Raynaud's phenomenon hands and feet, muscle twitching, weakness in legs specifically, internal vibrations, muscle fatigue, tingling, pins/needles in arms, legs,
SEVERE PAIN IN UPPER RIGHT ARM NEAR SHOULDER.  INJECTION GIVEN ONLY AN INCH AND 1/2 BELOW SHOULDER.  CANNOT RAISE RIGHT ARM ABOVE 45 DEGREES AT THIS POINT.  TINGLING NERVE PAIN CONTINUES TO INCREASE AT THIS POINT.  ARM PAIN IS INTENSE AND REQUIRES PAIN MEDICATION EVERY DAY.  WOKEN FROM SLEEP WITH PAIN.  CAN NOT SLEEP ON RIGHT SIDE DUE TO PAIN.  ARE WEAKNESS IS SIGNIFICANT.
On 01/20/16, medical assisitant (MA) administered TDAP (Adacel) Lot#: U5214AA Exp: 12/04/17, Manuf: SP; and HPV9 (Gardasil) Lot#: L016429 Exp: 08/09/17 Manuf: Merck & Co vaccines. Per MA pt tolerated well immediately after administration. Pt's mother was present and stated the same. As stated by MA, she left the room door slightly open to be able to observe the pt, and mother was present with pt. Less than 4 minutes later we heard a loud scream, which was the pt's mother asking for help. MA was the first to respond, since she was near the room, and per MA she noted the pt was on the floor faced up, and called code blue.  All medical and nursing staff responded to code blue. Front desk called 911. Pt was conscious, A&O x 4, vitals WNL, and pt denied any pain. A bump on her forehead was noted and slight blood on her gums. Pt's mother stated she was looking at her phone, and from her peripheral vision she saw the pt falling down from exam table/bed. Pt's mother stated the pt fell face forward, and she turned her over. Pt's mother stated the pt gets nervous around blood and needles. She stated the pt has" fainted at school when learning about blood cells, and gets pale after receiving vaccines." Notified pt's mom to always alert anyone giving her vaccines or drawing her blood of this. About 8 min later the paramedics arrived and assessed pt. Per pt's mother, she was given the option to have the ambulance take pt to hospital, or stay and take pt to the ER within the pt's insurance network. Pt's mother stated she would stay and take the pt to ER herself. Paramedics left and pt was continuously assessed by Dr., and myself for about 45 min. Vitals were WNL, pt was A&O x 4, and still denied any pain 0/10. Pt was provided with water and cold compresses. At 4:06 pm Dr. okayed pt to go. Discharge instructions provided to pt's mother, by Dr.   Pt's mother verbalized understanding.
Headache, muscle and joint pain - 4 days; diarrhea - 1 evening
Chief Complaint: SOB.  Tested positive for COVID.  Decadron Remdesivir .    Death due to Covid 19
Breakthrough COVID diagnosis. Rapid test performed 2/23/2022 and 2/24/2022 both positive. Runny/stuffy nose, cough, both mild.
Discrete follicular erythematous macules and small pustules scattered over chest and back. Associated with mild lymphadenopathy and skin tenderness.
Red Blotch; Arm Pain/ on the outer arm above the elbow crease; Decreased Mobility of Arm; This case was reported by a consumer via call center representative and described the occurrence of red blotches in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. In August 2019, 1 day after receiving Shingrix, the patient experienced red blotches, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the red blotches was recovered/resolved and the outcome of the pain in arm and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the red blotches, pain in arm and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient had no previous history with trouble in left arm. The patient received Shingrix dose in left arm sometime in August 2019. The next day, she developed a big red blotch approximately 3 inches below shoulder that was approximately 3 inches wide and 4 inches long. The patient was unsure when red blotch resolved but sated, it took a while for it to go away. She also reported, pain and decreased mobility in her left arm since receiving Shingrix even after icing. She described arm pain as it was on the outer arm above elbow crease and when in bed, she was not able to turn on arm because of pain when placing arm under pillow and had difficulty raising arm above head due to this. The patient consented to follow up ad provided her physician's address.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 07Nov2021 as dose 3 (booster), single (Lot number: Unknown) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Apr2021 as dose 2, single (Lot number: Unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic (type 1 for 29 years, well controlled)" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG taken for type 1 diabetes mellitus.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovering", and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received treatment from 18May2022 to 23May2022 for COVID-19. other medication in 2 weeks product was Insulin and brand was Humalog. Other medical history includes Diabetic (type 1 for 29 years, well controlled).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
(L) upper arm - shoulder to elbow swollen, tender 5cm around injection site, eryth up to 12cm away from injection site, firm up to 10 cm from inj site.
A nurse reported that a 68 year old received a vaccine on Jan 12, 2000. Pt developed injection site reaction characterized by a 3 to 4cm area of redness and warmth. She was treated with Kelflex, on 1/19/2000, she was treated with Rocephin IM, after she developed little red spots and redness that extended down to the forearm. She was treated with Medrol dose pack.
rash on left arm, where they got vaccinated; It itches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on left arm, where they got vaccinated) and VACCINATION SITE PRURITUS (It itches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included VERAPAMIL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE RASH (rash on left arm, where they got vaccinated) and VACCINATION SITE PRURITUS (It itches). At the time of the report, VACCINATION SITE RASH (rash on left arm, where they got vaccinated) and VACCINATION SITE PRURITUS (It itches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included diabetes medication, and allergy pills.
Started with itchy face after receiving vaccine on 10/14/14. Took Benadryl 1 tax and few  hours later symptoms resolved.
Gradual cough developed throughout daytime hours, spiked quick fever of 103.4 at 1 PM that afternoon.  Pediatrician seen 2 hours later, diagnosed with H1N1 virus.
I received my vaccine on Friday. When I woke up Sat I had a fever of 101.0 F and body aches and chills so  back I could hardly move. Over the next 3 days all the other symptoms went away but the body aches are still here. I still feel pain all the time every where and my skin if touching it I feel bruised. The pain is not so bad that I can't tolerate it but its a constant ache that does not go away also when I am walking up and down stairs i feel like I am weak and cant extend my legs all the way.  The pain does subside with Tylenol but it just does not go away.
Patient received 1 dose of Moderna COVID-19 on 02/23/21 then patient visited pharmacy and requested 1 dose of COVID-19 Pfizer was administered as if it was his first dose of COVID-19 on 05/08/21. Then patient goes to the pharmacy for his second dose of COVID-19 Pfizer and it was administered on 05/29/21. patient received a total of 3 doses of COVID-19. 02/23/21 Moderna, 05/8/21 Pfizer, 05/29/21 Pfizer. Patient was advised not to request the booster.
PATIENTS WHOLE ENTIRE ARM TURNED BLACK AND BLUE DISTALLY FROM THE INJECTION SITE WHICH COINCIDED WITH WHERE THE PHARMACIST HAD HIS HAND AROUND HER ARM. A WEEK LATER, SHE STILL HAD REMNANTS OF THE BRUISING IN THE PATTERN OF 5 FINGERS
I woke up with extreme pain in the opposite arm of receiving my vaccine (right arm). I got up and my husband drove me to the hospital room on 05/08/2022. They performed a CAT scan and chest x-ray on me to ensure I wasn't having a heart attack. They also took blood cultures. They couldn't determine what was causing the pain, but they sent me home with naproxen to help moderate the pain and informed me to follow up with my doctor after leaving. I went to my doctor on 05/10/2022; he scheduled me for a nerve conduction study on 07/13/2022, but I have been speaking to my doctor regularly until then in regards to recent swelling I've noticed.
Flu like symptoms; Tiredness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Tiredness) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Polymyalgia. Concomitant products included PREDNISONE for Polymyalgia.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Tiredness) had resolved.            Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Dizziness following vaccine No LOC 132/86, 61, 18, 98%
Started feeling extremely fatigued and breathless just 10 min after the shot, it lasted just one minute and felt better after that 1 min. Later in the day felt chills and very light feverish and fatigue.
Extreme heavy menstruation  and blood clots developed in June, no period in July and August, heavy period and heavy clots in Jan 2022z
Patient had nausea and vomiting X3, dry heaving and spitting up saliva after receiving flu Mist vaccine. Pt was sweaty, hot and dizzy. No SOB or fainting.  VSS, 5:55pm 120/78, 6:05pm 122/76, 6:14pm 120/74.  Cool towel applied to neck and forehead. sat with pt and advised deep breathing. Pt has history of this the last 2 out of 3 years when getting flu vaccine, shot or mist.  Pt felt better and sent home with mom at 6:30 pm to f/u with peds.
Developed multiple erythematous patches/hives to R lower abdomen covering an area of approximately 17cmx28cm in size.  Patches are erythematous, pruritic and appear to have a central clearing.  Pt tried applying a topical anti-fungal cream initially, but it did not help.  Also applied a regular topical emollient which also did not help.
Pt recvd vax & devel aching & pain was @ the site of the MMR inject; lt arm site of the MMR was observed to lightly warm w/sl tenderness still present; lt arm site of MMR still had some tenderness;
On clinic visit 03/22/05 for #2 Influenza; mother reported that with immunization on 01/25/05, child had a "reaction". The reaction occurred about 1/2 hour after arriving home, child was shaking and skin was red and blotchy. Seen by doctor and temperature was 102-103 degrees. Given antibiotic for possible ear infection, used tylenol/ibuprofen overnight and had no further temperature.
Pt recv vax on 9/29/97; subsequently pt exp nausea &vomiting,  continued headache & dizziness.
Fever 103.5.      Chills.       Achy bones.         Nausea.         Diarrhea.         Weakness continues still 1 month.        Heart palpitations
VAC. SHOT:  1531, 1540:  C/O HEADACHE (2:10 PAIN LEVEL) AND LIGHTHEADEDNESS (FEELING "OFF").   VS:  LEFT ARM :  174/102; RIGHT ARM:  160/100; P:  88; O2 SAT R.A.:  95%; T:  98.2. MONITORED FOR 30 MINUTES BY STAFF AND ESCORTED BY RN TO E.R. TO BE FURTHER ASSESSED.
Stiff neck on side of neck near arm of vaccination. This lasted 24 hours. Simultaneously, an itchy hives-rash appeared on neck and shoulders on side near arm of vaccination. The hives still remain one week later, excrutiatingly itchy. Dermatologist saw rash, suggested Zyrtec OTC.
Chills, fever (101 degrees), headache, soreness,  stuffy nose.
Pt vaccinated with DTP developed redness around injection site w/slight temp 101. child now doing fine.
Information has been received from a healthcare professional concerning an 80 year old retired white female with coronary artery disease, chronic congestive heart failure and no known allergies who on 09/07/2004 was vaccinated intramuscularly with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 647636/0944N).  On 09/08/2004, the patient developed a red, swollen arm that hurt for 2 days.  It was reported that the patient recovered.  No additional information is expected.
Hives head to toe. Received flu shot and Pfizer booster 10/27/2021 at 4:30 pm
Red blotch area; Has been sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 10th September 2020, the patient received the 1st dose of Shingles vaccine. On 13th September 2020, 3 days after receiving Shingles vaccine, the patient experienced red blotches. In September 2020, the patient experienced pain. On an unknown date, the outcome of the pain was recovering/resolving and the outcome of the red blotches was not recovered/not resolved.   It was unknown if the reporter considered the pain and red blotches to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient via interactive digital media. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The reporter stated that after receiving the vaccine, it had been sore but was better each day. The reporter noticed a red blotch area under the shot area on the day of reporting. The reporter had questioned if they were contagious from the shot. The follow-up was not required.
The MMRV vaccine was given and it was expired as of 06/16/22. The assistant did not scan the vaccine before administering and this is how the mistake happened.
Eight days after the Covid Moderna injection, I had intense itching at the injection site.  Upon investigating, I had a huge welt 2 1/2 inches in diameter that itched obsessively.  The center of the welt was a white spot that was probably the injection site.  Several peripheral red spots were evident, probably from the intense itching.  I had noticed no issues in the days leading up to the 8th day.  I have only put aloe gel on the site.  Ready to report to my Primary.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-OCT-2017, the patient was administered ZOSTAVAX 19400 plaque-forming units (PFU) vial, lot # M039453 with expiration date on 19-DEC-2017, subcutaneously in the left arm (dose was not reported), for prophylaxis recommended by physician. Other suspect therapies included sterile diluent for injection (strength, dose, route of administration, indication, lot # and expiration date were not reported). On 26-OCT-2017, the patient experienced a rash on her left arm. The pharmacist reported that rash looked like an injection site reaction that was red in color and not raised. The patient did not seek medical attention. It was unknown if any treatment was given for the events. The outcome of the events was unknown. The relatedness between the events, ZOSTAVAX and sterile diluent was not reported.
Highest temp measured 103, local rxn @ inject site, wheezing began AM 14FEB91 (recvd HIB 12FEB91), screaming episode lasting greater than 3 hrs;
2 hours after injection: sore arm.  Relief within 24 hours 12 hours after injection: mild headache lasting 12 hours
No additional AEs were reported; Nurse called and reported that a patient's vaccine schedule was interrupted.  The patient received the first dose of GARDASIL 9 in 2015 (unknown lot and expiry), second dose in 2/2022 (unknown lot and expiry), and third dose (w006229  9/15/2024) tod; This spontaneous report was received from a nurse and refers to a patient of an unknown age or gender.  The patient's medical history, concurrent conditions, concomitant therapies and previous drugs reactions or allergies were not reported.  On an unknown date in 2015, the patient was vaccinated with dose 1 of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose description, lot #, expiry date, and route of administration were not provided). On an unknown date  in February 2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose description, lot #, expiry date, and route of administration were not provided). On 17-NOV-2022, the patient was vaccinated with dose 3 of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot #W006229, expiration date: 15-SEP-2024 (dose description, and route of administration were not provided) all 3 doses as prophylaxis (Inappropriate schedule of vaccine administered). No additional adverse event were reported.
Fever, chills, body aches, swelling at site. Onset several hours post vaccination. Seen in ER that evening about 1800.
Patient has been losing consciousness anywhere from 1 to 10 times daily. She has lost consciousness while bathing, driving and just standing. She is following up with her primary care doctor and has been to the Emergency Room for this once.
arm soreness, body aches, neck/back pain, headache, chills/sweats and fatigue
General illness.  Drowsiness.  Headache.  Full body muscle soreness, with greater soreness at the injection site.   Symptoms lasted until the next morning.
Right after shot, within minutes, began mild cough. Persisted throughout next days. Two days later on Friday, suffered major asthma attack with trouble breathing, major coughing. Have had coughing and trouble breathing with more asthma attacks in the following days. Used albuterol nebulizer, asthma inhalers to cope.
Eye twitching (Nystalgia), arm and leg jerks, excessive crying and irritability, hypersensitivity.
pt states rt arm started hurting about 5PM & it was swollen from shoulder to elbow 3/4 of cir of arm; arm red, hot & swollen & itching & painful; felt had fever; had malaise;
Pt had 3 seizures on 10/29/01 and was hospitalized.
Pain, redness, swelling, warmth 7x6cm right arm. Treatment: Cephalexin 250mg Cap. Take 1 cap po TID, Hydrocortisone 2.5% oint. apply small amt to affected area QID.
Redness, soreness, itching, warm to touch at site of injection -- 4" x 2".
Lymph node swelling to right axillary with pain that radiates to the right breast, down the right arm, and around the back to the right shoulder blade. Pain limited daily activity to the right arm. Pain decreased for about 12 hours and then the pain returned again around 06:00, Thursday 1/14/2021 with lymph node larger than previous day. Area is tender and painful with every day movements. Will consult with primary health care provider if pain/swelling does not improve or gets worse.
pt devel elevation of temp of 105 R, pt was taken to ER where Ped a profen given & elevation of temp was reduced; elevation of temp lasted 2 hrs;
6 hrs post vax, felt malaise that lasted into Friday all day.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP/high Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for influenza immunisation, on 14Sep2023 as dose number unknown, single. The following information was reported: MALAISE (non-serious) with onset 12Oct2023 at 15:00, outcome "recovered" (Oct2023), described as "6 hrs post vax, felt malaise that lasted into Friday all day.". Therapeutic measures were not taken as a result of malaise.  Additional information: Patient received vaccine in PRIVACY clinic.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Red warm circular induration measuring 72mm in diameter w/ redder induration measuring 32mm in the center of larger induration at left upper arm.