chrisvoncsefalvay/vaers-outcomes huggingface dataset:
completely round rash an inch wide on the opposite side of the injection spot that itches now and then but never goes away; This is a spontaneous report received from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9262, expiry date: unknown) via an unspecified route of administration, administered in left upper arm on 27Jan2021 11:00 AM as dose 2, single for COVID-19 immunization (at the age of 75-year-old) at hospital. The patient's medical history and concomitant medications were not reported. No family medical history relevant to AE(s). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection, LOT: EL1284 expiry date: unknown) on 06Jan2021 11:00 AM via unspecific route of administration in left upper arm as dose 1, 0.3 mL single, for COVID-19 immunization (at the age of 75-year-old). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine, and no AE(s) following prior vaccinations. No additional vaccines administered on same date of the Pfizer suspect. On an unspecified date in Feb2021, within a week or less of the injection the patient experienced completely round rash an inch wide on the opposite side of the injection spot that itches now and then but never went away in the inside of his arm versus the outside part of his arm where he got the injections and it might had been 3 days, it was came back from 27Jan2021 and he knew it was only there from the second injection. It was reported that, it was not rough, it was smooth, no bumps. It was started 3-4 days after the injection, it was grown in size, it was redder and more irritating. He did not pay much attention it, if it had appeared a couple days after, he expected it to fade and it never really faded. He was not wearing different shirts or anything, he had been wearing the same one. It looked like a cause and effect from the vaccination. Patient took Pfizer COVID Vaccine to protect himself from the virus. On an unspecific date, the patient underwent lab tests and procedures which included blood count: all came back fine. He had blood work every 3 months all came back fine, cholesterol blood pressure and things of that nature. It was nothing related to the COVID vaccine. The patient had not visited the emergency room for the event. The event resulted in doctor or other healthcare professional office/clinic visit which includes he had seen a dermatologist for the event about 3 weeks ago, approximately, and he saw it, and said it is not like rashes he has seen with the vaccine and thought it was an irritation of some short. The outcome of the event was not recovered.  No follow up attempts are needed. No further information is expected.
Fine red rash uppear immediate 1x on face after Hep B Adult given. Client was given BENADRYL L25mg PO with wow ounces of sterile water, and was given another BENADRYL 25mg POT over the next six hours. Client immediately went to her health care provider. "My doctor was not there and I seen another doctor the rash had went away on my face." Recommended to have blood work done immediately to see if you are allergy to any component in the vaccine (Hep A Adult, ENGERIX-B Adult. Also on 09-17-2018 client took the PPD skin test Manu Factor (PAR), (Lot No) 315566. (Ex. Date) 12-2019 TB skin test was given (LFA).
Pressure h/a top of head 1/2-1 hr p/ inject.Rx w/ advil.Advil given p/ next 2 inject & 2x did not reappear.
Pt vaccinated with DTP experience persistant crying for over 3 hrs the evening following her second immunization. No treatment was given since event was reported two months later.
Received ROTATEQ vaccine 8-15-12. Parents started noticing blood in BM's the day after the vaccine given. The blood has continued as of 8-27-12.
11 hours after vaccine at Hospital, started to get a severe case of chills.   Almost uncontrollable for 1 and 1/2 hours.  major soreness of joints and low grade fever which lasted most of the night.  Temperature was 100 this morning, but has gone done some now.  Beginning to feel better slow but sure! This is the second vaccine booster.
Second shot gave him a bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Second shot gave him a bad headache) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Second shot gave him a bad headache). At the time of the report, HEADACHE (Second shot gave him a bad headache) had resolved.            Reporter has mentioned, Patient's nephewhad really bad headache after second dose, and lasted for 12 hours and went away.  No relevant Concomitant medications information was given by Reporter.  No Treatment medication information was given by Reporter.   Reporter did not allow further contact
On Saturday - 10-5-13 - attended a symphony - had trouble standing at approx. 9:30 - pain in legs. At 10:30 PM walked the dog - severe pain in legs - legs began to swell - called MD - instructed to take temp - 100.7 - reaction continued through Sunday and Sunday night. Temp that evening was 100.4 - saw MD on Mon - thinks it is reaction from vaccine. 10-9 much improved.
pt recvd vax; denied allergies but was very anxious about receiving inject; p/a few mins pt relaxed & vax was given; c/o could not see; flushed, pupils were dilated; P98; anxious; numbness to the lips; poss allergy;
I do not think this is an adverse reaction at all.  My lower back started swelling and having pain.  My chiro is caring for me.  I reported this on my form because it asked for new symptoms.   The only reaction I have had is my left arm has remained and still is very painful and the pain is deep into my arm at the exam site.  I have not told my PCP.
PRESSURE IN THE HEAD THAT HASN'T RESOLVED FOR 4 DAYS (FLOATING HEAD FEELING). PAIN IN NECK THAT IS TRAVELING FROM SHOULDERS TO ARM.
Redness with increased warmth tenderness. Approx 6" x 4" with injection site in center. Sent to walk in clinic. Question cellulitis. Had previous reaction to bandaid. Treated with antibiotics x 10 days through walk in care. Symptoms resolved.
Pt recv vax on 7/23/97; on 4/16/99 pt exp varicella, lymphadenopathy, fever
Worst vaccine response ever. Like having full-blown flu. Knocked on my back. So bad I don't want 2nd shot.
No additional adverse effects reported; dose of expired but properly stored PROQUAD was administered to a female patient; This spontaneous report was received from a nurse rand refers to a female patient of unknown age.  Information regarding the patient's drug reactions or allergies, concomitant therapies and patient's pertinent medical history was not provided. On 20-AUG-2020, the patient inadvertently received a dose of expired but properly stored measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (rha) (PROQUAD) injection, lot # S005074, expiry date 18-AUG-2020, for prophylaxis (concentration, dose, dose number, route of administration and frequency were not reported). The vaccine was reconstituted with properly stored sterile diluent. No additional adverse effects were reported. No product quality complaint (PQC) was involved.
This spontaneous report as received from a Registered Nurse refers to a 12 month old patient of unknown gender. On an unknown date the patient was vaccinated with VARIVAX injection (dose, route, lot# and expiration date unknown). On the same day the child was also given PROQUAD (Merck) vaccination (dose, route, lot# and expiration date unknown). No adverse effect was reported. Additional information has been requested.
Johnson & Johnson Vaccine:  Tired and sleepy with a headache starting at 6:45pm April 8. Then his arms started to have pain and aching in the body more on the arm where he did not get the shot. This happened around 8:30pm. Patient chest started to ache. He went to bed. The entire night he experienced aches and pains in his body, his stomach and hips. When he woke up at 8:00 am on April 9 his legs and the back of his thighs were aching. He could barely move. He took two Tylenol that morning. He continued to experience aching in his body all day. He said it felt like flu like symptoms. Then he took more Tylenol that evening. By 9:30pm he started feeling better. He woke up Saturday, April 10 feeling better.
warm to touch; rash of 2in diameter developed at injection site; redness; injection site on right arm started itching; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (injection site on right arm started itching), VACCINATION SITE RASH (rash of 2inch diameter developed at injection site) and VACCINATION SITE ERYTHEMA (redness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. OT06L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site on right arm started itching). On 22-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE RASH (rash of 2in diameter developed at injection site) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (injection site on right arm started itching), VACCINATION SITE RASH (rash of 2in diameter developed at injection site) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information provided.
Information has been received from a certified medical assistant (C.M.A), referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, these patients were vaccinated with improperly stored VARIVAX (lot # M002061, expiration date 12-JAN-2018; dose and route were not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Two new shots and I still has the Shingles/ suspected vaccination failure; Shingles in left ear; Shingles; Painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Zostavax (had many years ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Two new shots and I still has the Shingles/ suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: Shingles in left ear) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Painful). The outcome of the vaccination failure was unknown and the outcome of the herpes zoster otitis externa and shingles were resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, herpes zoster otitis externa, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received two new shots Shingles vaccine and still experienced shingles on his or her back and it was very painful. The patient stated that he or she also had shingles several years back on his or left ear and came outside around his or her earlobe ran up side of his or her face and got very close to the left eye. The patient reported that it was very terrible pain ever he or she had. The patient stated that he or she do not wish anyone had shingles and please everyone get the shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
5/24/04 7:30 PM MOM NOTICED RED,SWOLLEN,WARM AREA AT INJECTION SITE ON RIGHT UPPER ARM,ABOUT 2-3" IN SIZE. HE FELT WARM AS THOUGH HE MAY HAVE A FEVER THOUGH MOM DIDN'T TAKE HIS TEMPERATURE.  SHE GAVE HIM MOTRIN AND PUT HIM TO BED.  5/25/05 7:00 AM FELT FINE ALTHOUGH RUNNY NOSE. REDNESS,WARMTH, AND SWELLING CONTINUES.
Tenderness to touch, itchy, large red area, warm to touch, treated with antibiotic, Zyrtec and warm compresses, just started today.
No adverse event; Received Monovalent instead of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster).    No concomitant information was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-669144 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669144:MOD-2022-669144(Husband case)
Pt. in tent 23 at 2:05 pm at observation line.  Complained of right eye.  Paramedic assessed the pat. Once symptoms subsided pt. was released to leave.
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of injection site redness in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included MMR II (non-gsk); non-GSK manufacturer given on 18 August 2011; varicella virus vaccine (non-gsk); non-GSK manufacturer given on 18 August 2011. On 18 August 2011 the subject received a dose of KINRIX (unknown route, right thigh) as the final Dtap dose in the series. On 18 August 2011, within 12 hours after vaccination with KINRIX, the subject experienced injection site redness, hotness at injection site and swelling injection site. The subject was treated with diphenhydramine hydrochloride. At the time of reporting the events were improved. The healthcare professional considered the events were probably related to vaccination with KINRIX. Follow-up information received on 27 September 2011 indicated that the events were not considered to be serious. They were improved at the time of reporting and probably related to vaccination with KINRIX.
Around 10:15 P.M. on 3-3-2021 my hands became very cold.  When going to bed I had uncontrollable chills for around 20 minutes under a bedspread, quilt, and sheet.     Around 2:30 A.M. on 3-4-2021  I woke up very hot.  My fever was 103.2.  Getting up at 8:30 A.M. my fever was 103.3.  Around 2:30 P.M. I took two Ibuprofen capsules.   My fever started coming down.   I awoke at 8:00 A.M. on 3-5-2021 and my fever was 102.7.  I took 500 mg of Acetaminophen and by 3:00 P.M. my temperature was back to normal.  On 3-6-2021 my temperature was normal all day.
p/vax pt was told face looked flushed. later in day c/o chills. next day pt cont'd to c/o of chilling. felt hot, temp 99f, face flushed. given tylenol
I had uterine cramping the next morning 6/12 I woke up to it. Later that evening I started to experience heart palpations only when I laid down. Pain in the left arm beyond the injection site, entire left arm and left chest around where my heart is located. I had break through bleeding not related to my mensural cycle that lasted for a day, it was moderate and not anything severe. Extreme fatigue, all of which I was surprised. Also at one point experienced pain in my left scapula and that was really it. But the symptoms lasted I would say a little over a week. So I went to the Doctor, a Hematologist because I have sickle cell disease and Beta Thalassemia.
Information has been received from a pharmacist concerning a male in his 40s, with no medical history and no allergies, who, 15 years ago, in approximately 1991 was vaccinated with a complete series of hepatitis B virus vaccine rHBsAg (yeast). IT was reported that the patient had a "recent" anti-HB titer, in approximately 2006, which was negative. It was noted that the patient was not ill. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information form a health professional indicated that the patient received one additional dose of hepatitis B virus vaccine rHBsAg (yeast) (Lot # 653364/1121R) on 16-Feb 2006 due to the negative titer. concomitant therapy included fluticasone propionate (+) salmeterol xinafoate (ADVAIR) for an undisclosed condition. It was reported that since 16- Feb 2006 the patient has had neck and back pain. It was noted that he had also shoveled snow during that time and it was not known if the pain was from the vaccination or from the snow. The patient has taken ibuprofen (ADVIL) or ibuprofen (MOTRIN) without relief. NO other information was provided. Additional information has been requested.
Even though on 24hr rotation of Tylenol and Ibuprofen, my son had 2 mini seizures after the 3 shots he was given, one of those being the MMR vaccine.  One week later he was struggling to breathe and diagnosed with bronchiolitis and put on an inhaler.  Next, he had a 5 min seizure.  He ran a fever  99-102 for the next 4 days and then, 11 days after the shots, he broke out with a rash resembling the rash sometimes caused by the MMR vaccine.
Head ache,  joint and muscle pain, soreness at injection site, fatigue, nausea.
Incredibly itchy; Developed hives in random places in body, hives behind ears, back of head and neck/reappeared in different parts of the body; Ringing in left ear; Flu-like sickness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Incredibly itchy), URTICARIA (Developed hives in random places in body, hives behind ears, back of head and neck/reappeared in different parts of the body), TINNITUS (Ringing in left ear) and INFLUENZA LIKE ILLNESS (Flu-like sickness) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 028L20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced URTICARIA (Developed hives in random places in body, hives behind ears, back of head and neck/reappeared in different parts of the body) and TINNITUS (Ringing in left ear). December 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like sickness). On an unknown date, the patient experienced PRURITUS (Incredibly itchy). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency and HYDROCORTISONE for Hives, at an unspecified dose and frequency. In December 2021, TINNITUS (Ringing in left ear) and INFLUENZA LIKE ILLNESS (Flu-like sickness) had resolved. At the time of the report, PRURITUS (Incredibly itchy) outcome was unknown and URTICARIA (Developed hives in random places in body, hives behind ears, back of head and neck/reappeared in different parts of the body) was resolving.            No relevant concomitant medications were reported.  Treatment information included Antihistamines.   This case was linked to MOD-2022-439515 (Patient Link).
a headache; her whole body sore; it put her back in bed; has been running a fever; feeling awful; her whole body achy; she has weakness in her leg; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (has been running a fever), FEELING ABNORMAL (feeling awful), PAIN (her whole body achy), ASTHENIA (she has weakness in her leg) and HEADACHE (a headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included INSULIN, ATORVASTATIN, METOPROLOL, OMEPRAZOLE, SUCRALFATE, Janumet                                                        Sitagliptin-metformin, METHOCARBAMOL, ACARBOSE, GABAPENTIN, FERROUS SULFATE, HYDROCODONE and LISINOPRIL for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PYREXIA (has been running a fever), FEELING ABNORMAL (feeling awful), PAIN (her whole body achy), ASTHENIA (she has weakness in her leg), PAIN (her whole body sore) and BACK PAIN (it put her back in bed). On 07-Apr-2021, the patient experienced HEADACHE (a headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (has been running a fever), FEELING ABNORMAL (feeling awful), PAIN (her whole body achy), ASTHENIA (she has weakness in her leg), HEADACHE (a headache), PAIN (her whole body sore) and BACK PAIN (it put her back in bed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.