chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a adult male patient who received DTPa (Reduced antigen) for an unknown indication. Co-suspect products included SHINGRIX for prophylaxis. Concurrent medical conditions included gluten intolerance. In July 2018, the patient received DTPa vaccine. In September 2018, the patient received SHINGRIX (intramuscular). In August 2018, less than a year after receiving DTPa vaccine and not applicable after receiving SHINGRIX, the patient experienced injection site itching and injection site swelling. In October 2018, the patient experienced pruritus, erythema, rash and lip soreness. On an unknown date, the outcome of the injection site itching and injection site swelling were recovered/resolved and the outcome of the pruritus, erythema, rash and lip soreness were recovering/resolving. It was unknown if the reporter considered the injection site itching and injection site swelling to be related to DTPa vaccine. It was unknown if the reporter considered the pruritus, erythema, rash and lip soreness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient's wife. The patient received SHINGRIX vaccine in September 2018 and received DTaP vaccine in July 2018. In August 2018, the patient experienced swelling and itching around injection site after receiving DTaP vaccine. The patient experienced itchiness, redness and spots specific to the back area, lip soreness and facial redness as well as itchiness 1 month after SHINGRIX administration. Itchiness seems worse at night. The reporter did not consent to follow-up.
"Client awaiting his wife who was was being observed for 30 mins 12:17 Dizziness and 12:18 syncope few secs  rescue called   regained consciousness diaphoretic, Bp 87/50, Hr 63 reg, Sats 95%, resp 15. Placed on stretcher, place on Ekg monitor  sinus rhyth"
Information has been received from a pharmacist concerning a child who in approximately September 2004, was vaccinated with a dose of varicella virus vaccine live.  Before vaccination, the child was exposed to another child that received the vaccine in approximately August 2004.  In approximately September 2004, the patient experienced spots.  Unspecified medical attention was sought.  A product quality complaint was not involved.
she had a procedure Bone graft; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 05Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She had her 1st dose of Covid 19 Vaccine on 05Mar2021 but on the 18Mar2021 she had a procedure Bone graft and took Amoxicillin 500mg on 19Mar2021. She has 2nd dose scheduled on 31Mar2021 that is more than the usual 21days interval between doses. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Initial misuse report received from a healthcare professional on 11 July 2013. A 2-month-old patient (gender and date of birth was not reported) had received dose of ACTHIB and PENTACEL vaccine at same visit on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Patient admitted to neurology ward on 19 Mar 2007, after presenting with weakness and numbness in all limbs that began 09 Mar 2007. Pt complained of poor balance, difficulty ascending stairs, lifting his legs, removing shoes and buttoning uniform. Pt was admitted for Guillain-Barre, presumptively, ruled-in by EMG study and was treated with IVIG. Discharged to home 03/23/07.  5/10/07 Received medical records from hospital which reveal patient experienced tingling of fingers & toes for 3.5 weeks preceded by a viral illness w/cough, fever, myalgia & pt seen in ER on 2/19/07.  When viral illness resolved, developed severe right occipital HA.  10 days prior to admit patient noted weakness & pain of legs.  Difficult to initiate movement & had unsteady gait.  Admitted 3/19-3/20/07.  Exam revealed symetrical weakness of UE & LE, areflexia & distal sensory loss.  Patient refused LP.  Treated w/IVIG x 5 doses started in hospital & completed as outpatient.  FINAL DX: Guillain Barre syndrome.
2 months following vaccine administration patient developed Bell's Palsy. Treated with Valtrex and prednisone.  7/26/07 Received call from pcp w/additional patient information.  States Lyme test initially reported as neg has now been determined to be positive.  Feels Bells palsy secondary to Lymes disease & not related to vaccine.  8/31/07 Reviewed pcp medical records which included vax records & corrected vax info.  VAERS database updated w/same.  Office note of 4/4/07 reveals patient healthy on day of vax, only concern was acne.  Returned on 6/7/07 w/left side facial weakness x 4 days.  Unable to lift left eyebrow or close left eye.  Unable to smile on left side. Tx w/antiviral & prednisone, eye drops & eye patch at night.  Returned 6/26/07.  Lyme titers had returned (+).  Facial numbness & weakness had improved.  Smile remained slightly asymmetrical but able to lift eyebrow & squeeze eyes shut.  Tx w/antibiotics & received 2nd dose Gardisil.  Returned 7/24/07.  Had completed meds & symptoms had improved & smile now symmetrical. FINAL DX: Bell's Palsy secondary to Lyme's disease.
13 days after vaccination the patient developed Erythema Nodosum; painful, flat and raised red lesions on the lower legs with associated pain when bearing weight and muscle weakness. Per his mother he had one tactile fever and also complained of low back pain.   Patient has no other symptoms; no headache, dizziness, runny nose, congestion, sore throat, cough, shortness of breath, N/V/D, constipation.
Onset of apparent seizure disorder on 7/19/01. Doc 207958 states no further seizures but still on anticonvulsants.
pt recv vax & devel an inj site rxn characterized by redness & induration 48 to 72hr p/vax;pt also devel fever ranging from 103 to 104;this is one of six patients from this site w/the above rxn;
Myocarditis.  Went to hospital 12/9 after experiencing chest pains 12/8 and 12/9, discharged 12/10.  Pending follow-up with cardiologist and cardiac MRI.  Treating with 975mg of Aspirin 3x daily.
Headache, Myalgia, Arthralgia, Fever, fatigue, fever 102.8 with second dose....symptoms with both doses Narrative:
Pressure in upper arm (feels like a  BP cuff at about 15 above systolic) for 15 sec - 1 minute. Then tingling in moving down my arm for another 15 sec - 2 minutes. This repeated 3-4 times an hour for several days. Now it is down to about once an hour.
TEMPERATURE EXCURSION. vaccine (Covid) was stored in the freezer longer than manufacture recommendations. Patient did not have any adverse reactions.
Had not received flu shot x 12 yrs. Received both shots around 18:30, then went to work. Began with scratchy sensation in throat about 2 hrs after immunizations. Progressed to difficulty breathing/swollen throat. Took BENADRYL which loosened up cough. Woke up next day with face swollen, "puffy". Took BENADRYL ATC x 3 days until it resolved.
Pt became lightheaded following vaccination, diaphoretic, then unresponsive, she then opened her eyes and began talking
Really bad headache; Throwing up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).   A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 10:50 (Lot number: Unknown) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (ongoing), notes: Verbatim: High blood pressure, Additional Information for Other Conditions: Caller reported that the patient was diagnosed with high blood pressure about a year ago.; "Flu shot" (unspecified if ongoing), notes: patient gets the flu shot yearly but never gets sick. The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 16Apr2021 05:00, outcome "not recovered", described as "Really bad headache"; VOMITING (non-serious) with onset 16Apr2021, outcome "not recovered", described as "Throwing up".  Additional Information: Reporter seriousness for Really bad headache: Unspecified. Reporter seriousness for Throwing up: Unspecified. The reporter is patient' daughter. The reporter said that she was calling on behalf of her mother because her mother doesn't speak English.  It was reported that the patient was really sick. The patient had a really bad headache and was throwing up. The patient contacted her physician and the physician instructed the patient to call Pfizer. The patient woke up around 5 AM on 16Apr2021 with a headache and that the headache has just gotten worse and worse.  The patient began taking the sleeping medication and blood pressure medication at the same time about a year ago. The patient was taking concomitant products- unspecified blood pressure medication (Start: Unspecified Stop: Ongoing) due to high blood pressure. The patient began taking blood pressure medication about a year ago. Investigation Assessment: not provided. The patient's physician said the blood pressure medication was not going to let the patient sleep so the physician prescribed the sleeping medication as well. Vaccine Lot Expire Date: Unknown. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as N/A, first dose. There was no additional Administered Vaccines. There was not any AE(s) did not require a visit to Emergency Room and Physician Office. There were no prior Vaccinations (within 4 weeks). There were no AE(s) following prior vaccinations. There was no family Medical History Relevant to AE(s) and relevant Tests reported. The patient called her doctor to see what to do about the headache and vomiting but the patient's physician said they didn't have an answer for her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She got her vaccine, had immediate pain and swelling, had fever, and had a hard lump under her skin like a large strawberry and itchiness, lots of it.  The hard lump has somewhat subsided.  At the injection site the area has grown and it is the size of a fingernail now.  It is red, lump is smaller, but is still present and itchy.  She has not taken anything for it, and has not gone to her doctor.  She has sent a photo and a message and waiting for that response.   Had tetanus vaccine at the same time in the same arm.  Says the wound itself looks like a flesh eating thing that is a bizarre wound.  She has had shingles in the past, about 10 years ago and asked the nurse at the time if it mattered if she had had shingles in the paste or not, and she was informed that it did not.   This area is now a wound not just an injection site, it did scab over and it's below skin level and is now a crater.  The scab will fall off, and the itching is intense so she may be scratching it in the night.    She got her 4th vaccine a week ago and had a fever, chills which is how she felt after the shingle shot as well, but no other reactions.
Fever, headache, ear pain, swelling, tenderness and redness at site of injection (baseball size) with lump in center.  Tightness in chest, difficulty breathing. Elbow and shoulder joint pain, nauseated, feeling faint.
severe muscle cramping; pain on the site that he have the injection; his neck he also having the hard time moving; muscle issue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 68 year-old male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Lot number: EN8732) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes type 1" (unspecified if ongoing); "Type 2 insulin dependent" (unspecified if ongoing); "Multiple sclerosis (MS)" (unspecified if ongoing); "allergic reaction: Gadolinium a contrast dye(Suspect captured)" (unspecified if ongoing); "allergic to peanut butter" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Lot Number: EN6206), for Covid-19 immunisation. The following information was reported: MUSCLE SPASMS (non-serious), outcome "unknown", described as "severe muscle cramping"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain on the site that he have the injection"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "his neck he also having the hard time moving"; MUSCLE DISORDER (non-serious), outcome "unknown", described as "muscle issue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter called on behalf of her husband who was sitting in waiting area right now, he had the second dose of vaccine yesterday (31Mar2021), and she was trying to determine whether or not having an adverse reaction and should get seek medical attention. He was getting some severe muscle cramping as well as not aches but pain on the site that he have the injection, and his neck he also having the hard time moving but again he did have a muscle issue to begin with so right now he respiration seems to be fine, his oxygen level seem to be fine he has had have allergic reaction on the past to other things such as Gadolinium a contrast dye(Suspect captured) also we find out he is allergic to peanut butter.  No follow-up attempts are possible. No further information is expected.
Headache, fever, joint pain and muscle aches. Temp was 100.1 in the evening of the 18th.
I had a fever of about 101 degrees Fahrenheit, congestion, a cough, fatigue, and weakness. My blood sugar was higher than normal, and I struggled to keep it down. I got in contact with my doctor who suspected I had a secondary infection. She prescribed me antibiotics, but I still didn't feel any better. It took about three weeks for me to feel normal again.
COVID breakthrough. I had a rash and it lasted six weeks after I got COVID. I also had a lot of discomfort in my knees and hip.
Patient insisted on getting 1st booster dose (07/19/2022) although just vaccinated for 2nd dose only 3 days ago (07/16/2022) stating that they needed a booster to be able to travel.
Patient reported redness and swollen pain at injection site starting the day after the injection. Answering colleague pharmacist at the pharmacy recommended patient to take pain medications like Tylenol and ice the affected area for up to 3 days. Pharmacy to follow up with patient in 3 days.
No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-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 EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) 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 EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:master case
fever, fatigue, headache; treated with ibuprofen. symptoms lasted approximately 5 days.
Information has been received from a registered nurse concerning a patient who was vaccinated with measles virus vaccine live (-) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Subsequently the patient experienced an unknown event.
Father brought child into clinic on 09/27/2010 at 12:30 pm complaining of swelling and pain in Left leg that started after vaccines were given. States L leg began to hurt and swell almost right after shots. Leg has been swollen and painful- no redness or itching. Child refuses to walk. Pain is worse in the evening and makes child cry. No meds were given. Seen by Dr. when brought in. L leg swollen from thigh to knee- no redness. L leg- 32 cm 8" above knee cal R leg 29.5cm in same place. Child is limping and dragging L foot when asked to walk. Parent speaks only foreign language- interpreter used (telephone). Advised Ibuprofen 200 mg q 6 hours (dose and meds given) Cool compresses to thigh Recheck in 24 hours
Rash 20 min after administration. Parents treated with BENADRYL and resolved. Rash over arms legs and hands only.
This is a spontaneous report from a contactable healthcare professional. A 2-month-old patient of an unspecified gender received PREVNAR 13 via an unspecified route of administration on an unspecified date for immunization. The patient's medical history concomitant medications were not reported. On an unspecified date, the patient experienced a fever of 102.5 F and also developed a red knot and swelling on leg. The child was brought to emergency room for treatment. Outcome of the events was unknown. Information on batch and lot numbers has been requested.
Pain NOT tenderness in R arm rated 6-7/10 with movement and radiating into neck. I worked out this morning hoping the movement and circulation would improve the pain but no improvement. Unable to lie on R side secondary to arm pain. Developed chills, fever 101.1, muscle aches throughout body, and headache. No nausea or vomiting.  Took ibuprofen to hopefully help the pain and aches. Will take tylenol if the fever persists.
1/22/22 presenting today for Sore Throat (SORE THROAT, NASAL CONGESTION, HEADACHE AND EYES BURNING FOR 3 DAYS. ) and Covid-19 Positive Patient presents today for sinus congestion cough sore throat and headache x3 days.  Also endorses a burning sensation to his eyes   Fatigue body aches and chills.  Reports of sick exposure from his wife who tested positive for COVID on Thursday.  Already received COVID-vaccine.  He tested negative for COVID at his PCP office 2 days ago and was given Dextromethorphan-Guaifenesin 60-1200 MG. Pt has not started this medicine.  He is wanting to get retested for COVID as symptoms are not getting better.  Taking over-the-counter cough/flu meds with mild improvement.  Denies nausea vomitin
Took tetanus shot on May 9th 2014. On June 8th 2014 half of my face was numb Rt side. Saw PCP, referred to neurologist; two MRI's done, trigeminals were enhanced. Two lumbar punctures, a CT of chest, chest X-ray, labs done. No medical diagnosis determined. Discharged by neurologist but mouth still numb.
Neuropathy, peripheral Neuropathy. Severe pain, itching and burning in top of foot and right upper back.  No previous history or symptoms of peripheral nerve damage or neuropathy.
She was ding well until 5/15/20 when mother noted a red firm lump on the left leg where the injection was given. The red lump is still present. She has red bumpy rash around it. She has no fever.  No joint swelling. She is eating fine. Patient was prescribed hydrocortisone ointment and Benadryl for reaction.
After the first vaccine I had an early menstruation then skipped the following month (February) period,  March I had very heavy flow. I also had body aches and strong cramping. This it ver abnormal for me. It's been 10 months since I received the Covid-19 vaccine  and I continue to have body aches, heavy flow, and strong cramping during each of my monthly cycles.
Her doctor diagnosed it as shingles; She started with blisters on her tongue.; blisters in her mouth; She also had blisters on her chin as well on same day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TONGUE BLISTERING (She started with blisters on her tongue.), ORAL MUCOSAL BLISTERING (blisters in her mouth), BLISTER (She also had blisters on her chin as well on same day) and HERPES ZOSTER (Her doctor diagnosed it as shingles) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, the patient experienced TONGUE BLISTERING (She started with blisters on her tongue.), ORAL MUCOSAL BLISTERING (blisters in her mouth) and BLISTER (She also had blisters on her chin as well on same day). On an unknown date, the patient experienced HERPES ZOSTER (Her doctor diagnosed it as shingles). At the time of the report, TONGUE BLISTERING (She started with blisters on her tongue.), ORAL MUCOSAL BLISTERING (blisters in her mouth), BLISTER (She also had blisters on her chin as well on same day) and HERPES ZOSTER (Her doctor diagnosed it as shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.  No treatment medications provided.
He felt very bad the night he received the 2nd shot of Pfizer covid-19 vaccine on April 27. He even joked he probably would die that night. He also complained that despite his protest, the person who administered the shot insisted to inject on his shoulder joint.  He developed a bigger-than-quarter-size bruise on his right inner arm the next day. He was feeling tired the following days. On May 4 around 3:30, I heard he was making loud noises. I came to his side immediately. At the time I thought he was making louder than usual snores. I nudged him gently but he didn't respond.  After about 15 seconds, the sound stopped, and he had no breath. I then called 911 within 10 seconds, tried to do CPR on him. It took EMS 6 minutes to arrive even though we live very close to a fire station in a well-accessed urban area. EMS worked on him for about 30 minutes before transported him to hospital. They continued to work on him for a while. He never regained breath.
Same day symptoms fever, myalgia, arthralgia, shortness of breath, leg swelling, transaminitis, hyponatremia. Found to have pericardial and pleural effusions.  Proteinuria and hematuria on urine test. Kidney biopsy performed confirmed diagnosis of fibrillary glomerulonephritis. Diagnosed with serum sickness like reaction