chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a RN concerning a 50 year old, or older, male with no allergies and a medical history of rabies who on 03Dec04, 19Jan05, and 03Aug05 was vaccinated IM in the deltoid with a first (lot648213/0596P), second (lot648212/0479P), and third (lot647985/0061R) adult dose of hep B virus vaccine rHBsAg (yeast). It was noted that the pt received a dose of rabies vaccine (unspecified) between the second and third dose or was given after the third dose of hep B virus vaccine rHBsAg (yeast). On 20Apr06, the pt had blood drawn and was found to have no immunity to the hep B antibody. Unspecified medical attention was sought and it was noted that the pt would receive the series again. A product quality complaint was not involved. The pt's experience was determined to be an other important medical event by the reporter (OMIC). Additional information has been requested.
Pt had erythema and inflammation with some pain at injection site. Symptoms began shortly after receiving the vaccine. Pt also exhibited flu like symptoms.
fatigue; fever; headache; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, fever and headache. On an unknown date, the outcome of the fatigue, fever and headache were recovered/resolved.   It was unknown if the reporter considered the fatigue, fever and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced fatigue, fever and headache. The reporter did not consent to follow-up. For the tolerance of 2nd dose, refer linked case US2021AMR000985.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR000985:same patient, 2nd dose
DOSE ADMINISTERED AFTER 30 DAY STORAGE BETWEEN 2-8 DEGREE C
Information has been received from a consumer concerning her son, approximately a 12 or 24 months old male who was vaccinated with MMR II (dose, route and site not reported). Subsequently the patient experienced a very high fever (105F). It was unknown if the patient sought medical attention. The outcome of fever was recovered. No further information is available.
Starting at 10pm patient had pain in arm and arm felt heavy. Patient then started having shakes and feeling of fever. Patient took temperature and it was 99. Patient has a baseline of 97.2 Patient then had symptoms lasting until around 3pm on 3/6. Symptoms included; shakes, feeling of fever, hot/cold, skin sensitivity (like needles when touched), fatigue, and back pain.
PE, ileus, bilateral pyelonephritis, H.Pylori, high blood pressure, positive ANA, swelling of multiple joints, arthralgia of multiple joints, Hashimoto?s thyroiditis, elevated TSH, 2 hospitalizations, right flank pain
Patient had NEVER received a vaccine prior to this vaccine. Patient had received multiple lidocaine injections by the dentist within 1 hour prior to being given vaccine. Youth developed body shaking, shivering, sensation of being hot and itchy  about 2 hours after the vaccine. Brought to medical unit of the facility where patient residing. Patient started scratching her face and arms. No rash was seen anywhere on her body. Afebrile. BP 120/88 during shaking. Clenching hands and sometimes toes. Eyes closed. Able to open eyes when asked to open eyes. Responded to and answered all questions. Fully oriented. Able to walk however when sitting or on exam table, curls over and shakes. Denied anxiety.
In the middle of the night on Tuesday morning, Oct. 24th, noticed some redness and itching in the underarm of the right arm, and some redness on the chest and areas of both arms. Then by 11am that Tuesday morning, began to notice bumps/inflammation appearing in the form of hives all over the body (arms, legs, face, hands) and very itchy. By 11:30am that day, took one pill of over the counter Benedryl-allergy medicine, rubbed body with over the counter hydrocortisone cream.  The itching subsided a little bit. Took another Benedryl pill at 4:30pm that day, then soaked for 30 minutes in an oatmeal bath. Hives continued to appear inflamed throughout the evening with mild itching, so by 10:30pm that night, took an over the counter pill of now "extra strength" benedryl, and rubbed cortisone 10 (soothing aloe vera) cream and the (intensive healing formula) cream.  Followed this regime the next morning by taking a standard benedryl pill at 7am, 11am, in which the hives and itching appeared to subside; however, by 3pm that day, some itching and flare up of bumps appeared again. Took another benedryl at 3:30pm, then added in the over the counter pill of Allegra 24hrs for hives at 6:45pm, which helped curve the itching of the hives, also rubbed both cortisone 10 creams, then added the Benedryl gel to rub on as well. Took another extra strength benedryl at 11pm, then followed this regime all of Thursday. Finally throughout the day on Thursday, the itching, soarness/irritation on the skin around the joints of the fingers, back of knees, and swelling of the hives completely subsided; however, I continued the regime of taking benedryl and applying the creams and gel throughout the night, and Friday morning. As of Friday morning and thus to the point of writing this report, the hives and itching have remained non existent.
Pt had no verbal response which is not normal for him was wheeling himself down the hallway and stopped and could not follow command even questioned drooping of face.  Pt assisted to bed and while waiting for the ambulance had seizure like activity.  Pt was transported per ambulance to the local Hospital.
Patient called and said she got the vaccine on 10/23 but as soon as she got home she got dizzy and fall on floor but she said she didnt break anything in her body and today she was feeling better and has some headache and felt tiered. so l told patient to monitor her symptoms and if she is doing better than no need to do anything but if she still has dizziness than to call Doctor and let us know or head to urgent care. patient said she was doing better. she had gotten shingles and prevnar 20 so I'm not sure what exactly caused this. she said that pharmacist didnt tell her to wait 15 minutes after so she left right away and I said I'm sorry  and she was not mad or anything.
Both times I received the shot I have suffered from severe mania. I have bi polar and rarely ever have mania. After both shots I had some of the strongest periods of mania than I ever have had. I didn't sleep for days after the shots and had very intense anxiety.
Lethargy began on 9/24/2019; head drops and "spasms" found shortly after. Then, after a few neglectful doctor's visits, patient's mother took child to the emergency room on 10/30/2019. Patient was diagnosed with Infantile Spasms and Global Developmental Delay on 10/31/2019.
This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. On 29-OCT-2014 the patient was inadvertently administered an expired dose of VARIVAX (Merck) (lot # H016600, expiry date: 05-SEP-2014), subcutaneous. No adverse effect was reported. Outcome of event is unknown. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with VARIVAX (Merck). Additional information has been requested.
Terrible pain in right arm and neck. Loss of Range of Motion, frozen shoulder. Bursal Effusion. High-grade bursal surface tear at the distal anterior aspect at the level of the footprint. Fluid is seen in the subacromial/subdeltoid bursa. Currently seeing a PM&R doctor for some kind of treatment. Appointment is tomorrow 12/15/17 to review MRI and figure out a Plan of Care. Currently in PT. Currently going for Medical Massage therapy. I had absolutely NO pain in my right arm prior to this shot. I was perfectly fine.
Pt noticed mild itching over injection site, and removed band aid. Next night, pt's wife noticed pt was hot to touch. Pt notes he had alcohol and was "buzzed." Wife drove pt to ER at 2000 hrs. Temp was 99 degrees F. Pt left w/out being seen due to wait time. Small lesions present under band-aid site. Pt occ gets hot flashes.
Pt was mistakenly given Moderna Vaccine as her 2nd dose, Her 1st dose was Pfizer
He had termors for day and ever since he has been passing out spontaneously going to see a neurologist this week.
Pt became nauseous and dizzy. Vitals checked, Zofran given. Pt monitored for 30 minutes. Pt reported feeling better. Pt ambulated out of clinic with steady gait.
This patient left to go to the elevator, and said she felt dizzy and fainted approximately seven seconds. BP 90/62 progressing after 5 min 90/68. HR 80, flustered. Had the patient lie down and put legs in the air for 10 min. Recovered fully vasovagal episode.
PT had a vagal response and had lightheadedness/dizziness and experienced some flushing/sweating post vaccine. Pt was given orange juice and water and was seated for 15 minutes and seemed to improve. Symptoms lasted roughly 10 minutes.
Her husband was diagnosed with shingles this morning and it was around his forehead; This spontaneous report has been received from the patient's wife, regarding to a male patient of unknown age. The patient's concurrent conditions, concomitant therapies, medical history and prevriously drug reaction or allergies were not reported.   in approximately 2014 (reported as around 5 years ago), the patient was vaccinated with one shot of zoster vaccine live (ZOSTAVAX) (lot #, expiration date, strength and anatomical location of vaccine were not reported), subcutaneously for shingles prevention. On 25-MAR-2019 (also reported as: this morning), the patient experienced shingles and it was around his forehead. At the reporting time, the patient had not recovered from the event. and had not sought medical attention for it.   The causality assessment between zoster vaccine live (ZOSTAVAX) and the event was not reported.
This spontaneous report as received from a pharmacist refers to a 9 patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of ZOSTAVAX, subcutaneous (dose, lot number and expiration date were not reported). No co-suspect and concomitant therapies were reported. ZOSTAVAX was exposed to a temperature excursion of 35F for 3 hours. No adverse effect reported. Additional information has been requested.
After giving last injection (which was gardasil) she said she felt like she was going to pass out then slumps into my arms.  She opened her eyes again after less than a minute.  BP 114/50 cool clothes to head water to drink.  Monitored for another 15 mins then sent home.
Patient states having severe pain in her entire arm, not just the injection site.  She also states extreme lethargy and chills and inability to function normally due to feeling so ill.  I explained mild symptoms are normal, however she maintained that this was an extreme reaction.
Infection; Breast cancer; A spontaneous report was received from a female consumer (demographics not provided) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events breast cancer and infection.  The patient's medical history was not provided. Concomitant product use was not provided.  On 09 Feb 2021, prior to the onset of the events the consumer received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient was diagnosed with breast cancer. The patient developed an infection and inquired if the antibiotics would affect efficacy of the vaccine. No treatment information details were provided.  There was no change planned to the dosing schedule of mRNA-1273 in response to the events.   The outcome of the events was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested. Causality of both events is assessed as unlikely related to mRNA-1273.
1 cm erythematous patch at site of injection, at 24 hours surrounding 7.5 cm erythema 48-72 hours. No systemic symptoms. No blisters. No fevers.
12 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus.    On 18-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021 at 10:00 AM, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old) 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 relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Initial additional. Added race, ethnicity, relevant history, route of administration of vaccine, event start time. Reporter, Nursing Director stated that Parent were aware and verbalized that there have been no side effects or reactions. Parent requests client be put in pediatric trial and wants client to have the second dose to be administered when due. Nursing Director declined and referred them to Moderna. On 16-Jul-2021: Follow up received on 16 Jul 2021 included no new information.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (12 year old male) for mRNA-1273 (lot number 048A21A)  with no associated AEs reported. FU1 does not change company comment or causality.
They gave me the vaccine in the morning, in the afternoon I felt a slight headache, later at 11 pm I felt joint pain, chills, fever, at 3 am I took a paracetamol and the symptoms decreased, at 9 am the next day My body felt cut, as if I were going to catch a cold, the joint pain was still there, my arm where the vaccine was applied hurt, I felt swollen axillary and cervical glands on that side and during that day I felt pressure on my chest and slight chest pain.
pt recv vax 22JAN96 & 23JUN96 pt devel a varicella-like rash w/35-45 varicella-looking lesions on lt side of trunk;reporter felt that there was a vaccine failure;tx w/med;lab eval revealed varicella IgG & IgM antibody of less than 1:10;
REDNESS AND SWELLING TO LEFT UPPER ARM DURING.  ALLERGIES- PCN, CODEINE.  WAS PRESCRIBED LEVAQUIN 500MG X1 PO DAILY AND NAPROSYN 500MG X 1 PO BID.  NO DIFFUCULTY IN BREATHING.  SITE IS RED AND TENDER TO TOUCH.
SCREAMED 8 DAYS AFTER DPT/OPV GIVEN 4-24-90. NORMAL NOW.
1 week after injection, slight itch and red blotch appeared around injection site, roughly 3 " long and 2 " wide.  No even border.  Very slight sensation of pain, like an echo of the original soreness that lasted about 4 days after injection. Area is warmer than the rest of the arm.
FAINTED, DIZINESS, NUMBNESS ARMS LEGS HADACHE, DISORIENTED- CALLED AMBULANCE PT WAS TAKEN TO ER AND WAS DICHARGED SAME NIGHT AFTER AN EVALUATION
A report was received from a health care professional on 11/07/03, concerning two vaccinees who developed local skin reactions at the site of injection, involving a red patch 3-4 inches wide, after receiving an unspecified brand of influenza vaccine on an unspecified date. On an unspecified date, the vaccinees developed a red patch 3-4 inches wide at the site of injection. No other information was available at the time of the report and the outcome was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Red rash appeared on left arm where the shot was given on day 10 after injection. The arm is red, warm, and slightly itchy.
Guillain Barre Syndrome; This case was reported by a consumer and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's relative. The age at vaccination was not reported. The reporter asked whether the patient could get guillain barre syndrome from a shingles shot.   The reporter stated that the patient received Shingles shot and experienced guillain barre syndrome .
Swelling & Redness at injection site. Bad headache Dr visit, assumed Allergic Reaction ER gave ABX Dr visit thinks Allergic Reaction Soreness Ok Range of motion
PT. STATES AROUND 09:45 WATCHING TV AND DEVELOPED TINLGING SENSATION TO LEFT JAW RADIATING TO LEFT FOREHEAD AND STATES THAT SHE DEVELOPED TINGLING SENSATION TO RIGHT SIDE OF FACE. PT. STATES THAT SHE HAS MILD NUMBNESS TO LEFT SIDE OF FACE NOW. PT. STATES SHE FEELS LIKE SHE IS GETTING BETTER, BUT IS STILL NOT 100 PERCENT. SHE STATES THAT SHE IS FEELING A LITTLE NERVOUS NOW.
Nurse at school said patient was lethargic, passed out & had to get a wheelchair. Patient did go to ER. Discharged diagnosis vasovagal episode.
No additional AEs.; TE for VARIVAX. Product administered after TE; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 22-FEB-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number W022605, expiration date 17-JUL-2024 (dose and route of administration not provided) for prophylaxis (product storage error). No adverse event was reported.  The vaccine underwent a temperature excursion of -4.5 degrees Celsius for 1 hour. No previous excursions were detected.
This spontaneous report as received from a medical assistant refers to an 18-year-old patient of unknown gender. No information about the patient's medical history and concurrent conditions were reported. On 27-JAN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K008931, expiry date 04-MAR-2017, injected in the right arm (dose and route of administration were not reported). Concomitant therapies included meningococcal conj vaccine (unspecified) and influenza virus vaccine (unspecified). Administered doses were exposed to the following condition: temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required correspondence was received.
States his arm is still tender where he received the pneumonia shot on 08/14. States within 24 hours his arm swelled up the size of a grapefruit, turned red, warm to touch, and then started to bruise. States he did not see a doctor, but applied ice and if finally was better by the third day. Symptoms: 1. Arm swelling see notes from chart
bruises at injection site/tiny bruise; persistent lumps/lump on their right thigh about 1.5cm; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. A 6-month-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 03Mar2022 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE BRUISING (non-serious) with onset 2022, outcome "not recovered", described as "bruises at injection site/tiny bruise"; VACCINATION SITE MASS (non-serious) with onset 2022, outcome "not recovered", described as "persistent lumps/lump on their right thigh about 1.5cm".  Additional information: Agent reports caller is a Licensed Practical Nurse with a question about Prevnar 13. Agent states caller wants to know if persistent lumps or bruises at injection site have been reported? States she is calling from a Pediatrician's Office and they have a 6 month old patient that received a dose of Prevnar 13 on 03Mar2022 and they still have a tiny bruise/lump on their right thigh about 1.5cm. States she wanted to ask if there are any reports of persistent bruises/lumps after this vaccine.  Follow-up attempts are completed. No further information is expected.
10JUN t103 oral, rash; 11JUN t104.6 rash, coryza, conjunctivitis, arthralgia, swollen lymph nodes; seen by MD; 12JUN t103-104; 13JUN t104.6 hallucinating & photophobia; 14JUN t102 rash fading; 15JUN t101; 16JUN t98.4; 17JUN h/a, rash fading
Left deltoid has mild soft tissue swelling with a 6cm round area of erythema.
shot was given on march 27th 2021. 10 days ago  and alot of weakness in right arm  i can hardly raise my right arm above my head. very weak that i can only hold it a there a few seconds. weakness seems to be in shoulder therefore making it hard to raise my right arm,  also now going on 10 days i feel very weak and tired fatigued every day . No energy.
It was reported that a 5 year old male received DTaP (Tripedia) vaccine. Pt developed a 12cm x 12cm area of erythema and induration to left arm. No vaccination date and adverse event onset date given. Pt recovered.
No adverse event. Received Hepatitis A vaccine and was not due for it until September 2018 (additional dose). NO treatment, no injury.
Fever. Chills. Dizziness. Vomiting.  Cramping
Woke up at 3:30 this morning, experiencing body aches, took 2 Advil .  Took 2 more Advil approximately 8:00 am due to same symptoms. Both times, symptoms had subsided after the Advil 'kicked in'.   At approximately 1:30 this afternoon, began feeling chilled , body aches , felt hot.  Took temp , was 100.4 , took 2 more advil .  Took temp at 4:00 pm, now reduced to 99.7 and body aches have resolved but still slightly chilled.  No new symptoms , NO difficulty breathing, etc.  , although my arm is sore but the Advil helps!
At site of injection edema, erythema and pruritus. No SOB, pain, H/A, dizziness. No trouble with vision, senses. Tx: BENADRYL, ice pack & TYLENOL.
I have a blister on my arm below injection site  and it?s red around the blister.
Started with quarter sized rash (Monday 9/16), when presented to pharmacy on Wed. 9-18, rash at injection site red, swollen, painful and about 8 in x 5 in wide. Referred her to MD.