chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was noted to have a temp of 100.5, 30 min after temp was taken she presented with a possible seizure. Mom described it as one arm sticking straight out and eyes blinking. The episode lasted about 20 seconds per mom. Recovered well, temp taken after was 100.7.
10/18/2010 developed itching all over body within 1 hour of shot & then hives appeared on nape of neck, saw Dr. & was given BENADRYL, f/u with PCP on 10/11/10. Saw dermatologist 10/22/10 as s/s persist, diagnosed with dermatographism, prescribed ALLEGRA BID & f/u in 1 month.
Patient was vaccinated on 2/16/2021 with 1st dose Pfizer, lot EN6201. Patient reported medical conditions include diabetes type II, hypertension, and Charcot Marie Tooth. Patient informed RN that she had mild swelling after receiving the 1st dose that resolved after 1 hour. Patient reported that she had taken her routine medication that included an antihistamine (patient would not specify type) and metoprolol. RN relayed information to PHN who texted PHN Supervisor and medical team. Per Dr, patient is to wait until 28 days post 1st Pfizer dose before receiving Janssen vaccine, it is not recommended to receive Pfizer 2nd dose. Patient was advised to consult with an allergist.
Moderna booster administered on 11/16/2021, expired on 11/7/21.  Mistakenly read expiration date as 11/17/2021.  No adverse event or outcome to recipient.
Edema to (R) thigh. Redness to (R) thigh. Warmth to (R) thigh.
The evening after immunizations were admin. child was extremely fussy & inconsolable. Mom noticed redness over left thigh. Was advised by Dr to admin TYLENOL, BENADRYL & apply ice pack to area after that pt fell asleep & slept fine.
Muscle soreness all over her body; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle soreness all over her body) and FATIGUE (Fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. L031321A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced MYALGIA (Muscle soreness all over her body) and FATIGUE (Fatigue). At the time of the report, MYALGIA (Muscle soreness all over her body) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.   This case was linked to MOD-2021-142546 (Patient Link).
Within an hour of the shot, I was unable to stay awake. It has been over a week, and I am still sleepy more then normal, despite taking narcolopsy medication and tons of caffine.
Patient initially bled at injection site. On 11/29/2010 (three weeks after immunization) she called to say she was still sore, had pain and numbness. Had taken Tylenol but did not help. Referred her to MD. His diagnosis arm pain -complication from vaccine. No redness, no fever, no swelling, no chills no decrease in arm strength but a liitle tingling. I am reporting this due to the fact that it is 3 weeks after injection and she still has complaints.
Headache, Sedation, Myalgia & NauseaVomiting Narrative:  Other Relevant History:
Paresthesia: numbness, coldness, weakness, tingling sensation, sneezing runny nose low grade temp.
1/29/21 Began with  2 x 2 inch red area, warm to the touch,  1/30/21 Red are became larger 1/31/21 Red Area continue to increase in size . Warm to the touch. No knots or bumps, no discomfort. 2/1//21 Red area increase to approx. 5 x3 inches, warm to the touch.  Developed a noticeable ache and itching.  Discussed with Infection control office (I work in the hospital) and discussed with 2 pharmacist. I made decision to take Pepcid, first dose 4:00 PM 2/2/21 Red area fading, surface temperature decreasing. Itching , ache resolved.
After vaccination pt complained about throat swelling. She was monitored and in bout 20 mins one dose Epi was administered. Pt was taken to hospital.  Through out the wait, pt was coherent no cutaneous (visible) reaction, didn't complain of airway block. She is on oxygen and at the time of incident only had albuterol inhaler on her. She was given 100% oxygen by EMS on arrival
pt recvd vax 30SEP92 between 130-2PM; 1OCT92 noticed red, raised bumps all over head; 2OCT92 chest full of welts & hives, legs, feet, hands, face were swollen; 2OCT92 seen by MD who recommended DPH; MD ?vax allergy or ? amoxicillin allergy;
Medication error client stated he felt fine didn't feel dizzy or have shortness of breath.  Vital signs taken every 15 minutes as per policy.  Client observed in vaccination booth for a hour.  HC and PM advised client per hotline we were going to call EMS to take him to the nearest hospital.  Client refused EMS and refused to go to the nearest hospital.  Left  on own with mother and father AMA and acknowledged the risk of refusing transport.
Right upper thigh with reddened, swollen area about the size of a baseball at injection site of DTaP, warm to touch, even through jeans per MOC, painful. Ibuprofen given and ice pack to reduce swelling.
Intercepted product storage error; This spontaneous case was reported by a consumer and describes the occurrence of INTERCEPTED PRODUCT STORAGE ERROR (Intercepted product storage error) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 300042460) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCEPTED PRODUCT STORAGE ERROR (Intercepted product storage error). At the time of the report, INTERCEPTED PRODUCT STORAGE ERROR (Intercepted product storage error) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
About 25 minutes later after injection, he developed hives, throat swelling, and shortness of breath. He was given 0.3 mg epinephrine IM and 25 mg of benadryl.  He states his are now resolving and he feels okay at 11:14pm.
rt side from waist to head edematous extreme pain rt arm reports unable to move d/t pain;fever, n/v;contacted MD;
The decedent suffered fever and malaise after the second dose on 04/13/2021.
Approx 4 hrs after immunization,infant became limp, pale, whimpering - lasted about 20 min. Upon exam child was still pale w/slow capillary filling, crying vigorously; normally responsive.
Injections at 11:00AM. Vomiting began at 19:30.  Again at 8:00, 8:15, 8:25, 8:50, etc. Called after hours physician, went to ER. Vomiting stomach bile continued until 10:15 when IV was given to re-hydrate and stop vomiting. Normal behavior resumed one week later. No more vomiting.
My arm was red, itchy and swollen to the size of a golf ball for a few days. Then the swelling went down to the size of a grape, and now since 3/15/21 it's swollen and itchy again, but with light redness.
Information has been received from a physician concerning a 11 year old female patient with a history of positive for lyme disease who on 29-SEP-2009, was vaccinated with the first dose of GARDASIL (lot # 562300/0100Y, expiration date: 19-APR-2011) (dose and site of administration not reported) and in December 2009, the patient was vaccinated with the second dose of GARDASIL (lot number, dose and site of administration not reported). Concomitant therapy included cyproheptadine hydrochloride  and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid vaccine. On unspecified date, the patient started experiencing migraines after GARDASIL administration which then subsided after a month and came back after a second dose in December 2009. The patient sought unspecified medical attention. No treatment was given for the treatment of the adverse event. At the time of the report, the patient had not recovered. Follow up information has been received from a health care professional concerning the female student patient with no pre-existing allergies, birth defects, medical conditions or illness at time of vaccination who on 01-DEC-2009, at 16:03, was vaccinated intramuscularly with the second dose of GARDASIL (lot number: 662724/0313Y). On 06-OCT-2009, at 14:57, the patient experienced migraines. At the time of this report, migraines were ongoing. Laboratories and a computed axial tomography were recommended. The patient was also referred with a neurologist. The patient sought unspecified medical attention. Migraines were considered to be disabling by the reporter. Additional information has been requested.
3" x 3" erythema & swelling, warm to touch. Tx: cool compresses & Benadryl.
Redness in both arms after vaccines. No fever or discomfort. Warm to touch.
PATIENT FAINTED IMMEDIATELY AFTER INJECTION AND SEIZED FOR 3 SECONDS. THE EMS WAS CALLED IMMEDIATELY AND THE PATIENT WAS TAKEN FOR MEDICAL TREATMENT IN AN AMBULANCE.
Elevated white blood cells count; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (Elevated white blood cells count) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 1. On 21-Jan-2021, the patient experienced WHITE BLOOD CELL COUNT INCREASED (Elevated white blood cells count). At the time of the report, WHITE BLOOD CELL COUNT INCREASED (Elevated white blood cells count) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, White blood cell count: elevated (High) elevated.     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.   Concomitant medication was not reported. Treatment medication was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
20-30 minutes after administration, developed 9 cm diameter area of redness/swelling at site of VARIVAX injection with diffuse pruritis and hives - including trunk and extremities.
Experienced drip on arm before injecting the vaccine; Less dose given; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Experienced drip on arm before injecting the vaccine) and UNDERDOSE (Less dose given) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007CZIA) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (Experienced drip on arm before injecting the vaccine) and UNDERDOSE (Less dose given). At the time of the report, UNDERDOSE (Experienced drip on arm before injecting the vaccine) and UNDERDOSE (Less dose given) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment drugs were reported.
She was RER. She did not receive cranial XRT. Our working diagnosis is diffuse, patchy neuritis with ascending myelitis probably due to intrathecal MTX vs. vincristine peripheral neuropathy vs. Guillian-Barre secondary to the influenza vaccine vs. CNS relapse. We can send viral titerswhich ones would you recommend? CMV, EBV?   We have an adverse event in a 4 year old Hispanic female with high risk ALL (secondary to initial WBC of 50.2 /ul at diagnosis)  being treated in the maintenance phase of CCG 1961.  On 12/1/03, JP received IT MTX and VCR IVP (bili 0.3 that day) without problem. She was also given an influenza vaccine IM.  On 12/8/03, she presented to clinic with complaints of irritability, dysuria, constipation, and a low grade fevercultures were obtained and patient was given empiric therapy with Ceftriaxone. UA/UC and blood culture were negative.  Father called again on 12/11/03 to say that patient was not walking well and she had been incontinent of urinethese symptoms started 12/10/03. She was seen in the office the day the father called and her gait was very ataxic with foot drop. DTR in LE were +1-+2 and symmetric. There was no clonus. Father reported that she had been incontinent of urine and stool. He believed that she was incontinent of loose stool due to the Miralax given 12/8/03. We questioned whether this was due to a vincristine peripheral neuropathy vs. Guillian-Barre. JP was referred to Neurology who saw her that afternoon and requested a CK and MRI of the spine with and without Gadolinium. The CK was drawn on 12/12/03 and was normal. Neurology scheduled her MRI for 12/17/03. The father did not call to report any worsening of symptoms until 2 am today (12/17/03) when he called to say that her abdomen was distended and she was compalining of abdominal pain. He also reported that she was not walking at all and that he had been carrying her everywhere since 12/14/03. She came to the emergency room and her PE was remarkable for paraplegia, inability to sit up, and decreased strength in her upper extremities. She has no respiratory issues. JP was catheterized for 500cc of urine. Her MRI shows no compression and she has diffuse, but patchy neuritis with ascending myelitis. She is in the PICU for observation of her respiratory status and was started on Decadron 4 mg IV q 6 hrs after a BMA and LP were performed. Her CSF shows 4 WBC, 14 RBC and gram stain is negative. CSF glucose is 56 mg/dl. Right now all of her chemotherapy is on hold. Do you have any further suggestions regarding her management at this point? Are there any medications that could be used as a "rescue?" We really appreciate your input.
Patient had an itchy rash on face and neck that lasted 2-3 days after receiving the HPV vaccine.
Hives on both arms, wrists to shoulder. Hives on chest and upper back. Treatment...benadryl and OTC hydrocortizone.   Hives started on arms and spread to chest and upper back, under arms. Skin very warm to the touch and chills. I am still dealing with hives and chills...little, if any improvement 03/08/2021.
Patient complained of high fever on 8/7 of 106.4 orally. Left arm at injection site warm, hard, and red at the back of arm where PROQUAD was given sub. Q fever went down 8/8, patient was seen 8/8 by Dr. Patient was given MOTRIN for fever.
On the day of the vaccine injection, I experienced a headache and muscle soreness. The next morning, I had a persisting headache, hot flashes, loss of appetite, and muscle ache.
Patient collapsed in the parking lot as he was making his way to his car.  Paramedics performed CPR for over 10 minutes. AED was utilized however, NO shock was advised.
On the day of administration, about 19:00, noticed swelling, redness and felt hard to the touch without fever. (Fever of 102.7F today) and took to ER on 8/13/02 at 20:00 and was told  to watch child and let him rest.
Within 30 mn of receiving vaccine lips swelled, burning tongue and lips, itching face, nausea and vomiting.  Used Benadryl and loratadine with relief within 40 mn.  Swelling last couple of hours and resolved without any subsequent sequelae.
Pt had swelling of his eyes, welts all over his body, turned very pale and he was very lethargic. Pt was seen at ER and given Prednisolone per mom.
Temperature of 100.3 on 9/9/02. Eye lids puffy with red dots on 10th. Seen in our office the morning of 9/14/02 for petechial rash, generalized, but worse on arms and legs. Referred to ER. Evaluation with Hematology/Oncology was done. Idles and physical exam negative for ITP malignancy.
Information has been received from a PA concerning a female who on 20OCT2003 was vaccinated IM in the left deltoid with the first dose of pneumococcal 23v polysaccharide vaccine. The PA reported that on 20OCT2003, the pt's left deltoid became swollen, red and very painful after being vaccinated. Unspecified medical attention was sought, but no lab/diagnostic tests were performed no prescription drugs were required to treat the pt's events. At the time of this report, the outcome was unknown. Additional information has been requested.
Area around eyes beginning to swell; This is a spontaneous report from a contactable consumer. A 65 (unspecified units) age of female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 15Apr2021 as UNKNOWN DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On an unspecified date, the patient had experienced area around eyes beginning to swell. The outcome of the event was unknown.  Follow-up (27Apr2021): This is a follow-up spontaneous report received in response to the mail sent regarding the confirmation of below mentioned query. This response included: Screenshot attached.
nurse inadvertently administered frozen infanrix to patient.; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 2-year-old patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th May 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follow: The patient was administered with frozen vaccine Infanrix which was kept on temp ranging from 8.2 to 13.4 Celsius for 7 hours, which led to incorrect storage of drug. The mobile cooler went too cold. The medical assistant wanted to know, if the patient could be re-vaccinated. The vaccine details were available. The reporter consented to follow up. This case is one of the several cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021100519:same reporter US-GLAXOSMITHKLINE-US2021100514:same reporter US-GLAXOSMITHKLINE-US2021100517:same reporter US-GLAXOSMITHKLINE-US2021100518:same reporter US-GLAXOSMITHKLINE-US2021100515:same reporter US-GLAXOSMITHKLINE-US2021100510:same reporter
Patient developed syncope approximately 15-20 minutes after administration of DTAP/IPV, Hib, PCV vaccinations. Symptoms self resolved and patient was taken to ER. In ER, patient developed further syncope X1 with bradycardia and required normal saline bolus. Admitted overnight for observation. No further interventions required.
01/31/11 tingling of lips, tongue, arms, hives on chest & axillary area, slight swelling lips, tongue. 20 mins after vaccine. Drove self to pharmacy for BENADRYL - took 25 mg x 6 at one time. Symptoms improved quickly & resolved in 24 hrs.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 at 10:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: possibly sulpha" (unspecified if ongoing), notes: Known allergies: possibly sulpha. The patient's concomitant medications were not reported. Past drug history included: Statin, reaction(s): "Allergy_Statin", notes: I am on a statin but didn't take while on the Paxlovid. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Seriousness criteria-Caused/prolonged hospitalization, Seriousness criteria-Disabling/Incapacitating, Seriousness criteria-Congenital anomaly/birth defect was No. The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was yes. The patient previously receive a COVID-19 Vaccine was yes. COVID-19 Treatment, Treatment start date was 29Nov2022 and stop date=04Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Started with numbness and lack of being able to move thumb of left hand.  Later had swelling in most of rest of arm although mostly lower in arm than injection site.  Swelling in arm is starting to go away, but patient is still unable to move thumb well.
No adverse reaction, Dr. looked up vaccine error on CDC website and no repeat of dose required and no reactions expected.
This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On unspecified dates in 2016 (reported as starting on or after 11-FEB-2016), the patients were vaccinated with improperly stored doses of MMR II (lot # K024035, expiration date 26-NOV-2016, exact doses and route of administration were not reported). The vaccines were exposed to temperature of 46.8F for 2 hours. No previous temperature excursion was reported. No adverse effect was reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
t102 & inconsolable crying for 4 hrs occurred about 10 hrs p/inject;
This spontaneous report as received from a pharmacist refers to a 52 year old male patient, with no drug reactions/allergies and unspecified chronic pain resulting in a recent unspecified surgery. On 19-JUL-2013 the patient was vaccinated intramuscularly with ZOSTAVAX (lot # J001700, exp. date 08-MAY-2014) (dose unspecified). Concomitant medications were not provided. Pharmacist reported that patient called and presented to the pharmacy because the injection site in which the ZOSTAVAX was administered was warm, swollen and had a knot in it. The patient, reported that the administering pharmacist, administered the ZOSTAVAX intramuscularly rather than subcutaneously on the back portion of the deltoid. It was reported that the pharmacist, "always gives the vaccine that way" if subcutaneous syringes are not available (MARRS case # 1307USA015759). The unspecified pharmacist used a "25 gauge, 1 inch needle". Reporter stated that the patient's arm was still red, warm and swollen. The outcome of injection site warm, knot at the injection site and injection site swollen and red was reported as recovering/resolving. The relationship between the ZOSTAVAX and the events was not reported. No lab diagnostics studies were performed. Additional information has been requested.