chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (Shingles) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Treatment of the event included gabapentin.
SIGNIFICANT PAIN AND DISCOMFORT - OUT OF A SCALE OF 1 TO 10 IT'S A 9. SWELLING - LEFT UPPER ARM TWICE THE SIZE OF MY RIGHT ARM. UNABLE TO LIFT ARM UP MORE THAN A FEW INCHES. I HAVE TAKEN 6 ADVIL OVER 12 HOURS AND APPLIED ICE PACKS FOR PAIN & SWELLING. ARM FEELS BETTER USING ICE PACK AND TAKING ADVIL.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions and concomitant medication were not provided. On unknown dates the patents were inadvertently vaccinated with doses of improperly stored (7 Fahrenheit, cumulated time of 3 weeks) VARIVAX (lot # L031066, expiration date 18-AUG-2017, dose and route unknown). There were no temperature excursions previously. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information is not expected since we have no consent to contact the nurse.
This spontaneous report as received from a health worker refers to a patient of unknown age. The patient was inadvertently vaccinated with live (Merck) VARIVAX (dose, route and lot # not reported) instead of ZOSTAVAX on an unknown date. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Throat started to close on my way to work right after, tongue started to swell and also had trouble breathing. I had to pull over on the side of the road and call 911 before they had arrived I found my Benadryl and took 4 i was instructed to go to the hospital but i elected not to and went home and rested. I got home trying to rest at 2pm and then at 3 began to feel the same symptoms and took more Benadryl and went to bed.  Again on the 12th i felt the same and went to mather hospital and had to get a steroid and was advised by there staff to not get the second dose or any other dose related to this type of vaccine.
Right lower deltoid ----> lower bicep approximately 18 x 18cm erythema/warmth with 3 x 5cm induration, PO Bactrim x 10 day, cool compresses, Benadryl.
In early January developed central pain in upper abdomen. Pain was episodic, ranging from 1 out of 10 to 6 out of 10. An ultrasound was performed that found nothing followed by CT with no cause found. Did contract COVID-19 in 2019.
A non-serious spontaneous case of a full dose of vaccine given in one nostril has been received from a pharmacy technician concerning a 14-year-old female, subsequent to FLUMIST. No medical history or concomitant medications were reported. The patient received the entire 0.2 ml of FLUMIST in one nostril on 19-Sep-2009. The reporter indicated there were no observable changes in the patient after receiving the FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information received on 15-Oct-2009 and incorporated into the narrative: no adverse events observed.
About 9 PM on 05-13-04 the patient began to have a bad taste in her mouth, and pain and swelling in her left arm. By the morning of 05-14-04 the swelling and pain in her left arm had worsened and progressed to pain all over her body. She also developed fever, chills, nausea and headache. She was unable to lift her arm or attend work on 5-14-04.
Before COVID-19 test,  had a coughing spell all night long. Took Home test came back negative at first, then next day took another test and it was Positive. Been having diarrhea before testing positive for COVID-19. Called Dr. and  he prescribed  Paxlovid, my diarrhea became  worse,  now it's subsided. I'm getting better but am still fatigued, have been still coughing but not as severe. Cold medicine helps relieve coughing.
Diagnosed with Shingles and prescribed valacyclovir, gabapentin, and naproxen
This case was reported by the mother of a consumer and described the occurrence of loss of making eye contact in a 4 year old male subject who received DTAP (unknown manufacturer) injection for prophylaxis. On 28 March 2005, the subject received DTAP (single dose). On 14 April 2005, following administration of DTAP, the subject experienced loss of eye contact and began to dress himself backwards. At the time of reporting, the outcome of the events was unknown.
low grade fever; arm soreness; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever), PAIN IN EXTREMITY (arm soreness) and INJECTION SITE SWELLING (swelling at the injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (low grade fever), PAIN IN EXTREMITY (arm soreness) and INJECTION SITE SWELLING (swelling at the injection site). At the time of the report, PYREXIA (low grade fever), PAIN IN EXTREMITY (arm soreness) and INJECTION SITE SWELLING (swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Beginning on the 8th day after the vaccine, the injection site became red, swollen, itchy and warm.  The redness and swelling  became  worse on the 9th day. During the 10th day after vaccination the area was more red but had less swelling and was less itchy. By the 11th day the selling was gone, was mildly itchy and slightly red.  All symptoms were gone on the 12th day.
Tiredness, chills, body aches, nausea - started about 12 hours after injection - duration was 12-18 hours. Essentially flu-like symptoms.
Information has been received from a registered nurse (RN) concerning an 18-month-old female with no pertinent medical history or allergies, who on 14-OCT-2005 was vaccinated subcutaneously with a dose of Varivax (lot# 648083/0072P). Concomitant vaccinations included MMR (manufacturer unknown), Hib conj vaccine (OMPC) (manufacturer unknown), influenza virus vaccine (unspecified) and concomitant therapy included sodium fluoride. On 27-APR-2006 the patient developed chickenpox with 40-50 lesions. She had a fever but it resolved. Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. It was noted that two weeks prior to the rash, she was exposed to chickenpox and shingles. At the time of the report the patient had not recovered from the chickenpox. No product quality complaint was involved. Additional information has been requested.
Patient has fever, cough, sore throat, shortness of breath, chills, headache, and runny nose
PRODUCT STORAGE ERROR; ADMINISTERED JANSSEN COVID-19 VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLE TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 11-JAN-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported. On 11-JAN-2022, the patient experienced administered janssen covid-19 vaccine after the product was exposed to multiple temperature of excursion. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered janssen covid-19 vaccine after the product was exposed to multiple temperature of excursion and product storage error was not reported. This report was non-serious. This case, from the same reporter is linked to 20220649370, 20220649804, 20220649704, 20220650014, 20220650111, 20220649137, 20220649421, 20220649488, 20220649803, 20220649884, 20220649915, 20220649417, 20220650185 and 20220649626. This report was associated with product quality complaint: 90000237042.
J96.00 ACUTE RESPIRATORY FAILURE 2/12/2022 AORTIC VALVE REGURGITATION    HX OF SYNCOPE J96.00 ACUTE RESPIRATORY FAILURE 2/12/2022 SICK SINUS SYNDROME
Body aches, chills, nausea, arm soreness and swelling, low grade temp and weakness. Encouraged Benadryl cream to the area and Tylenol for fever/pain.
Patient states 15 mins after influenza vaccine was administered she had numbness down the left side that didn't go away. She went to ED on 10/10/12 at 1821. Provider ordered labs which were negative CBC, urinanlyasis, ALT, AST, BMP which were all within normal limits. Encouraged to f/u if symptoms got worse. Patient went to clinic and was seen on 10/11/12 with symptoms of numbness of left side which patient states has gotten worse with left eye drooping. Mg, B12, Folate, TSH and Antinuclear lab testing ordered and all are within normal limits. She was instructed to f/u the next day if condition check. She came on 10/12/12, patient state same however left side cheek and eye was drooping. Neurologist was consulted and pt was started on Neurontin on 10/12 and MRI of brain was ordered. MRI was negative.
10/30 Tingling in hands and feet. 11/2 While brushing teeth in morning, had sudden left facial drooping. Went to ED, dx w/Bell's Palsy, tx Valtrex and Prednisone. 11/3 Saw neurologist, suspected GBS, but no symptoms. 11/4 Facial drooping began on right side, paresthesia bilaterally in hands and feet, blurred and double vision, mild headache. Dx Guillain-Barre Syndrome. Tx Claritin, Privigen, Potassium.
Nausea at 7:30, two bouts of emesis at 07:55 AM.
This spontaneous report was received from a registered nurse and refers to a 5 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 03-OCT-2016, the patient was vaccinated with an improperly stored PROQUAD lot # M022402 with expiration date of 01-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 6 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.
This case was reported by a physician via call center representative and described the occurrence of fever in a adult male patient who received Shingrix for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown dose). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The reporting physician was the patient. The patient experienced a fever of 102 degree F for 2 days. The physician mentioned the adverse event as an aside and did not provide further details about lot number and vaccination dates. Lab Comments: On an unknown date, the patient did laboratory test.
Malaise, muscle ache, joint pain, abd pain, vomiting, swollen lymph node, headache, lightheadedness, dizziness. Symptoms improved. Went to ER on 1/16/21, Covid test neg.
Had shingles and did get the shot/Suspected vaccination failure; Had shingles, did not show a rash; He is very miserable; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles two years ago).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling miserable. On an unknown date, the outcome of the vaccination failure, shingles and feeling miserable were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.     Additional Information: GSK receipt date: 30-Oct-2022 Reporter's comment: The case was received from the patient's wife via interactive digital media. The patient did get the shot because he did not want to get them again. The patient stated that surprised that you could get them and they did not always show a rash.  The patient was very miserable. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient stated that they had about 4.5 inches of swelling and they experienced discomfort while sleeping. The swelling has started to go down on 10/28/15. They have not taken anything for the swelling.
It was reported that a female pt received a Fluzone SV '99-'00 vaccination on 12/2/99. Reportedly, several days, post vax, the pt developed a rash on her arms and face which lasted approx. 3 weeks.
On 1-31-08 a day after I received the shot, about 12:30 my top lip started to swell & by 3:00 it was all across top lip & my bottom lip.  I went to emerg. room - 4 1/2 hr.  Was told I had reaction from shot not to ever get it again.  They had to treat me.  You can call them for results & med. given to me. 2/22/08-records received for DOS 1/30-2/1/08-ER Records DX: Angioedema suspect secondary to ACE inibitor. Do not feel this is related to racent vaccine. C/O upper lip swelling, nose tingling.
Secondary amenorrhea. Only had 3 periods since receiving shot. Directly after receiving vaccine it was 4 months before my first menstrual period, 12/22. Then 1month later, 1/22, I received the second. I got the Pfizer booster shot on 1/11/22.  After that it took 3 months for my next menstruation, 4/22. Currently have had a period since April. 4 months.
STILL HAVING ALOT OF PAIN THE PAIN IS SO BAD THAT IT INTERFERES TRYING TO GET THINGS DONE AROUND MY HOME. DOCTOR DID GIVE A INFLAMATOR MEDICINE BUT DID NOT HELP.
Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a first dose of GARDASIL. Subsequently, two days post vaccination, the patient experienced shortness of breath to the point that she needed to be hospitalized. The duration of the hospitalization was unknown. It was reported that the patient planned to receive the following doses of GARDASIL. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information is not expected.
Patient hospitalized for papillary thyroid carcinoma within 6 weeks of receiving covid vaccination.
Headache, Myalgia & Fever Narrative:  Per nursing report: "2nd dose of Moderna vaccine last Friday on 1-29-21. Reports became ill while at work Friday night and was not able to come to work on Saturday night due to c/o headache, body ache and flu-like symptoms. Employee states had to visit urgent care on 2-3-21 due to severe headache. Employee also states ran a temp of 103.0 last weekend. Continues to c /o residual headache this morning to right temporal lobe with fatigue. "  Other Relevant History:
Patient rec'd immunizations on 3-4-10. On 3-5-10, patient developed a fever (101.3), swelling, redness and pain in the left upper arm. She saw her MD on 3-6-10, who diagnosed an Immunization Reaction. KEFLEX was ordered, cool compresses and BENADRY.
within 4 hours after getting vaccine - I started to experience tingling in both lower arms, which spread to both feet/toes and both toes/hands over the next 24 hours - it has been almost 4 weeks since my vaccine and I am still experiencing tingling and also having pain/pressure on my fingers/toes and legs/arms feel heavy at times - like they are in a bucket of cement that I am dragging around
Arm red, little swelling, and warm. Spoke with patient tonight. She said that she had taken IBU after leaving the pharmacy and the site does not feel as warm and not as red. Patient said if she was still concerned tomorrow, she would seek medical attention.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Called ambulance after checking all vitals, oxygen and EKG all results were normal and they concluded he was just nervous from the vaccine.
Patient got 2nd dose of moderna, after  few minutes she was experiencing heaviness in her chest and slight shortness of breath. monitored her blood pressure for 20 minutes. Finally after 20-30 minutes she started feeling better. Patient said she doesn't take her blood pressure medication daily, takes only as needed. counseled her to take it daily. Tried checking with her after couple of hours, unable to  reach her on the phone
OCCASIONAL EYE DRYNESS; EYES HAVE BEEN ON FIRE AND IRRITATED; EYES ARE RED; EYES ARE PUFFY; VOMITING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect drugs included: dupilumab ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On an unspecified date, the patient experienced occasional eye dryness, eyes have been on fire and irritated, eyes are red, eyes are puffy, and vomiting. Treatment medications (dates unspecified) included: alclometasone. The action taken with covid-19 vaccine was not applicable; and action taken with dupilumab was not reported. The outcome of the occasional eye dryness, eyes have been on fire and irritated, eyes are red, eyes are puffy and vomiting was not reported. This report was non-serious.
No adverse event; 1 dose was administered after being at room temperature for more than 24 hours. This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose was administered after being at room temperature for more than 24 hours.) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (Dose 1 with batch no.: 027A21A.) on 04-Mar-2021, MODERNA COVID-19 VACCINE (Dose 2 with batch no.: 026B21A.) on 01-Apr-2021, MODERNA COVID-19 VACCINE (1st Booster with batch no.: 041J21A.) on 16-Dec-2021 and MODERNA COVID-19 VACCINE (2nd Booster with batch no.: 059A22A.) on 23-Jun-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE and MODERNA COVID-19 VACCINE.    On 29-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 29-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose was administered after being at room temperature for more than 24 hours.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose was administered after being at room temperature for more than 24 hours.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (1 dose was administered after being at room temperature for more than 24 hours.).    No concomitant medication was reported.  Reportedly, 1 dose was administered after being at room temperature for more than 24 hours. The patient did not report any side effects.  No treatment information was provided.
Patient called to complain her arm was still sore on September 1st which was 8 days after her vaccine. She complained that the site was still red and had a "little heat" to it.
lymph nodes under arm where she received the shot was swollen; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes under arm where she received the shot was swollen) and VACCINATION SITE PAIN (vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroiditis and Diabetes.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 19-Apr-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 20-Apr-2021, the patient experienced LYMPHADENOPATHY (lymph nodes under arm where she received the shot was swollen). At the time of the report, LYMPHADENOPATHY (lymph nodes under arm where she received the shot was swollen) and VACCINATION SITE PAIN (vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medicines was not reported by reporter   Treatment information was not provided
Pounding heart beat 8 hr after GARDASIL felt like heart "jumping" in throat. Dx PVC's no treatment, decreased caffeine
Varicella rash, Benadryl prn, Tylenol prn.