chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case reported upper arm to elbow becoming increasingly itchy with a welty rash. Peaked 10/27; Worsened with hot shower, improved with application of hydrocortisone cream.  Resolving today, but still present (10/29). Reported to School Nurse, who directed this teacher to call RN at Public Health Department.
Fever 102-103 followed by measles-like rash over torso on 11/07/2011.
Arm hurt; A spontaneous report was received from a consumer concerning a 52-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm hurt/ Pain in extremity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Mar 2021, approximately one day prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On 10 Mar 2021, the patient experienced the event arm hurt.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 12 Mar 2021 the outcome of event, arm hurt was resolved.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (A big red mark at the injection site) and VACCINATION SITE PRURITUS (Itchy) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (A big red mark at the injection site) and VACCINATION SITE PRURITUS (Itchy). At the time of the report, VACCINATION SITE ERYTHEMA (A big red mark at the injection site) and VACCINATION SITE PRURITUS (Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
I was fine for a few days. On day 3, I started to get bad headaches. By the weekend I was vomiting, couldn't see, and had the aura. I messaged by neurologist and she gave me a steroid pack, which resolved the issue in about 2 days.
When patient presented for COVID booster she reported experiencing hives beginning approximately 15 minutes following her first dose of Pfizer on 4/27/21 (lot EW0172). She states she took an antihistamine and her symptoms resolved by that evening. Patient did receive a second dose of Pfizer (lot EW0186) on 5/18/21 and reports no allergic reaction following the second dose. She states her only side effects with the second dose were arm pain and fatigue. When she presented for the second dose, she reported that her hives began more than four hours following the first dose, so timing is unclear.
This spontaneous report as received from a medical assistant concerning multiple unspecified patients. On an unknown date the patients were vaccinated with multiple doses of improperly stored GARDASIL 9 lot # M023169, expiration date 13-JUN-2018 and M030380 expiration date 01-FEB-2019 for prophylaxis. The temperature was 32°F to 35°F for 72 hours. No adverse events and no product quality complaint were reported. This is one of several reports from the same source.; Sender's Comments:  US-009507513-1707USA000692: US-009507513-1707USA000693: US-009507513-1707USA000691:
Received anthrax vaccination late morning Dec 8, 2007. Started feeling bad approx 2230 with "facial redness, shortness of breath, puffiness around throat, and rash around injection site. Member took Advil 400 mg. When speaking with Dr., member states he feels "back to normal."
She reports she had a COVID-19 vaccine 2 weeks ago in her RUA.  She just noticed the area on her arm yesterday because it was feeling tender to the touch.  There is currently an approximate 2 in x 2 in circular area on her RUA deltoid. It is warm to the touch. It is not painful, other than just tender to the touch. She denies: chest pain, dizziness, headache, hives, any other new symptoms or concerns since the injection
migraine; This is a spontaneous report from a contactable consumer, the patient, reported for herself. A 41-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EN9261), via an unspecified route of administration in the left arm on 17Feb2021 16:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was none. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to BNT162b2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced migraine on 18Feb2021 at 15:00 and that lasted until Friday night on 19Feb2021. The patient did not receive treatment for event, migraine. The outcome of event, migraine was recovered on 19Feb2021.
Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 12-FEB-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
child recv vax 4/30/99 & mom took child to park & had to change diaper w/o proper handwashing technique;5/3/99 mom devel diarrhea, fever 100.5, chills, body aches;
head is about to explode; every bone in my body hurts; my eyelids hurt; my nail beds hurt; i have no appetite; sharp pain woke patient out of sleep; low grade fever; im tired and sleepy; A spontaneous report was received from a healthcare professional concerning a 57-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events head is about to explode, low grade fever, sharp pain woke patient out of sleep, every bone in my body hurts, my eyelids hurt, my nail beds hurt, im tired and sleepy, i have no appetite.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   head is about to explode, low grade fever, sharp pain woke patient out of sleep, every bone in my body hurts, my eyelids hurt, my nail beds hurt, im tired and sleepy, i have no appetite.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not applicable.  The outcome of event(s), head is about to explode, low grade fever,sharp pain woke patient out of sleep,every bone in my body hurts,my eyelids hurt,my nail beds hurt,im tired and sleepy,i have no appetite was unknown.
After the patient received the vaccine, she experienced R check numbness. 1/30(2 days post-vaccine) the pt took Aleve and the numbness went away halfways through the day. 2/1 was first day without numbness. Her face still feels tight on the affected side.
Pain at injection site 9 days after injection in morning. Rash & itchiness starting later same evening. No treatment.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date between 07-NOV-2017 and 20-NOV-2017, the patient was vaccinated with an improperly stored dose of M-M-R II for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The temperature excursion was from 9 degrees Celsius (°C) to 25 °C, for a time frame of 6.5 hours, without a previous temperature excursion and was called because of a data logger. There was not product quality complaint or adverse event involved.
Information has been received from a licensed practical nurse concerning a male with arthritis who in October or November 2007 was vaccinated with pneumococcal 23v polysaccharide vaccine. Concomitantly the patient was vaccinated with influenza virus vaccine (unspecified). It was reported that in January 2008, the patient developed right arm pain. The patient had a diagnosis of arthritis. The patient's arthritis was monitored by the physician; however, the date of the last office visit was unspecified. The nurse did not have access to the patient's medical record when reporting the adverse symptoms. Follow-up information indicated that the patient was diagnosed with serum sickness as a result of the vaccination with PNEUMOVAX 23. The patient experienced muscle and joint pain, episodes of "joint lock up", extremely dry skin, and an onset of aging. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information is not available.
Information has been received from a registered nurse concerning a "late teens" female who, "about 4 months ago," in approximately December 2006, was vaccinated with her first dose of Gardasil vaccine (yeast) (dose and date not reported). Subsequently the patient fainted about six hours after receiving her first dose. Patient reported experience when in office for second dose. Additional information has been requested.
The following morning we had to take him to urgent care as he had difficulty breathing.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the parent.  A 3-year-old male patient received BNT162b2 (BNT162B2), on 16Jul2022 as dose 2, single (Batch/Lot number: unknown) at the age of 3 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1: MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset 16Jul2022, outcome "unknown", described as "The following morning we had to take him to urgent care as he had difficulty breathing.". Therapeutic measures were taken as a result of dyspnoea.  Additional information: I am writing because my 3 year old son received the second dose of your COVID19 vaccine on Saturday 16Jul2022. The following morning, we had to take him to urgent care as he had difficulty breathing. They gave him a dose of Decadron (dexamethasone). Will this impact his antibody response and attenuate the effectiveness of his vaccine protocol.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On 4/20/12 patient came in contact with the smallpox vaccination site of another vaccinee (received SPV lot # VV04003A on 4/16/12) Vaccinee was allowing his SPV site to "air out" with no bandage on the site while in his work station when patient came from behind and tried to wrestle and his forearm came in contact with other vaccinee's smallpox vaccination site. The pt noted a small white lesion on his right forearm on 4/22/12. He reported to medical on 5/4/12 for evaluation. The provider determined that the pt most likely had a contact transmission and the HC was notified. The pt has no contraindications to receipt of the SPV. 5/14/12 specimen was collected for PCR.
Pt recv vax on 11/16/98; on 11/17/98 pt exp erythema (circular) & indurated area; tx=Dicloxicillin
Pt was seen in the clinic for a rash that started 10 days after MMR shot.  The doctor that saw him gave him a course of steroids.  The rash lasted about 11-12 days.
No symptoms; "patient who had been administered PNEUMOVAX 23 in November 2017  was accidentally  administered PNEUMOVAX 23 again on 12/2/2019."; "patient who had been administered PNEUMOVAX 23 in November 2017  was accidentally  administered PNEUMOVAX 23 again on 12/2/2019."; This spontaneous report was received from a physician referring to a patient of unknown age.      The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On an unspecified date in November 2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, frequency, route of administration, lot # and expiration date were not reported) as prophylaxis. On 02-DEC-2019, the patient was was accidentally administered pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) again, lot # R012550, expiration date 25-JAN-2020, intramuscularly. It was verified that the administratiobn was not a result of product confusion, and it was reported that the patient did not experience symptoms.
I experienced bloating, vomiting, abdominal pain, constipation, and acid reflux
This spontaneous report as received from a consumer refers to a female patient of age 81 years with allergy to prednisone. The medical history included sinus problems. The patient was vaccinated with, 0.65 ml ZOSTAVAX on APR-2012 given subcutaneously. No other co-suspects were reported. Concomitant medications included unspecified blood pressure medication, SYNTHROID and CRESTOR. On an unknown date in 2012, two weeks after vaccination the patient experienced bulges on hips and thighs. No treatment was given for the patient. The laboratory diagnostics procedure included blood work with results not provided. She sought medical attention and had a follow up visit. She talked to her doctor about it and he told her it was nothing to worry about. She reported that it did not cause her pain. The outcome of bulges on hips and thighs was not recovered. The relatedness for bulges on hips and thighs is unknown for ZOSTAVAX. Additional information is not expected.
Extreme hives aAll over body extremely painful feels like getting bit by a whole bunch of fire ants really bad red v hives
Spiked a fever, was told not to give medicine unless it reached above 102. We went to sleep and woke up around 1:30 to drink milk and stopped breathing, went completely stiff and would not respond until a few minutes later. Was very lethargic after. Felt extremely hot.
RIGHT ARM EXTREMELY SORE AT INJECTION SITE.  C/O MALAISE, MILD FEVER  SELF-TREATED W/ TYLENOL, COLD PACK TO ARM.
Increased symptomatic episodes related to inappropriate sinus tachycardia. Experiencing much more frequent symptoms.
tenderness at the injection site for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tenderness at the injection site for 2 days) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (tenderness at the injection site for 2 days). In January 2021, VACCINATION SITE PAIN (tenderness at the injection site for 2 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug reported. No treatment information was provided by the reporter.   This case was linked to MOD-2022-526482, MOD-2022-526483, MOD-2022-527361 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2022: No newinformation received, MI SD attached.
Vaccination given 10/6/03 LD. ER visit on 10/7/03 with c/o pain, swelling, bruising. Given cephalexin, Darvocet, Benadryl. Return to clinic 10/7/03 PM, given Decadron and Prednisone 30 qd x10. 10/8/03 improving. 10/10/03 swelling lower with extensive bruising.
Developed a very red and very large area at the injection site; This case was reported by a consumer and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included axillary lymphadenectomy (lymph nodes removed from both armpits). Concurrent medical conditions included breast cancer.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Last week from the date of reporting, the patient received Shingrix in an unknown arm. The patient was breast cancer survivor and had lymph nodes removed from both armpits.  The patient was at risk for lymphedema and avoided needles in the arms when possible.  The patient developed a very red and very large area at the injection site.  For the second injection in several months, the patient asked if there someplace else the vaccine might be injected besides the arm and still maintain the same percentage of protection.
Received vaccine 11/07/02 @ 2 pm, 11/08- 98 AM noticed single skin eruption on face, Progressed to red, swollen lump @ injection site, Developed "boil" type lesions, upper back, back of neck
Information has been received from a registered nurse concerning a 17 year old female who on an unknown date, received  her second dose of GARDASIL IM 0.5mL (lot # not reported).  On 31-MAR-2009, the patient developed an injection site soreness and pain.  The patient had no other symptoms.  No lab diagnostics studies were performed.  The patient's injection site soreness and pain persisted.  The patient sought medical attention by calling the nurse.  No further information is available.
Guillain-Barre Syndrome; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a female patient who received Flu Seasonal TIV Dresden (Flu trivalent vaccine) for prophylaxis.   On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu trivalent vaccine, the patient experienced guillain barre syndrome (serious criteria death and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was fatal. The reported cause of death was guillain barre syndrome.   It was unknown if the reporter considered the guillain barre syndrome to be related to Flu trivalent vaccine  Additional details were received as follows: The age at vaccination was not reported. The patient had a flu injection in 1978, and experienced Guillain-Barre Syndrome, and died on 23rd August 2018. The reporter consented to follow up. This case was linked with case US2019170062, reported by same reporter.; Reported Cause(s) of Death: Guillain Barre syndrome
Headache, Myalgia, malaise/fatigue, chills without fever Narrative:
Pain and numbness is injection arm, face went numb, tingling and numbness in extremities, paralysis in arms and legs for about 10 minutes, swelling in lips, had stroke like symptoms, unable to walk on her on for a few days.  Unable to balance herself, pain in arm and back has became numb.
Erythema multiforme; A spontaneous report was received from a physician concerning a 23-years-old male patient, who received Moderna's COVID-19 Vaccine, and who experienced erythema multiforme.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 13 Jan 2021, approximately ten days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 unknown lot number intramuscularly for prophylaxis of COVID-19 infection.   On 23 Jan 2021, the patient started getting erythema multiforme. Treatment for the event included antihistamine and topical steroid cream.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event erythema multiforme was unknown.; Reporter's Comments: This case concerns a 23-years-old male patient, who experienced a serious unexpected event of erythema multiforme. This event occurred 11 days after first dose of mRNA-1273, lot # unknown.  Treatment details was not provided. Very limited information regarding this event has been provided at this time.  Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Patient was given Pfizer on 5/6/21, however patient received Moderna as first dose on 4/12/21. Patient was monitored for the  standard 15 minutes, and no adverse reaction was noted. Patient stable  and notified of error.  Patient verbalized understanding and was discharged home.
No other adverse effects were reported in any patients; An unknown number of patients, received an unknown number of doses of VARIVAX following a temperature excursion; This spontaneous report has been received from a physician assistant concerning an unknown number of patients of unknown age and gender. The patients' concomitant therapies included sterile diluent. The patients' concurrent conditions and previous medical history were not reported.    From 30-MAR-2020 to 26-APR-2020, varicella virus vaccine live (oka/merck)(VARIVAX), was exposed to a range of temperature excursion between -4°C up to 0°C for 30 minutes. Information was extracted from data logger.   On 08-MAY-2020, two  patients were vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S021321, expiration date 09-JUL-2021 for prophylaxis (dose, strength, formulation and patient route of administration were not reported) following a temperature excursion (product storage error). A total of 17 hours of maximum temperature excursion was reported of of -9°C to 8°C (0°C).  On 05-JUN-2020, an additional patient (reported as employee) was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S021321, expiration date 09-JUL-2021 for prophylaxis (dose, strength, formulation and patient route of administration  were not reported) following a temperature excursion (product storage error). A total of 28.5 hours of maximum temperature excursion was reported.  Due to the defrost cycle approximately once every 26 hours, there was a 30-60 minute excursion above -15°C. On most of those days, the amount of time spent between 0°C and -9°C is 30 minutes  No other adverse effects were reported in any patients.   This case was non-valid due to lack of patients' identifiers.  This is one of two  reports received from the same reporter.