chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient started to feel flush in the face. She also reported a headache.  She was seen by the EMS on the premises today and they obtained vital signs. Patient had elevated blood pressure but reports this is normal. After being evaluated  for 30 minutes her blood pressure did improve and she reports feeling better. Nurse assisted patient to the car. Patient ambulated well to her car with no symptoms noted of change.
About 24 hours after receiving the vaccine, starting having chills; then later in the evening felt feverish, oral T=100F, and had arm significant pain to touch and with movement.
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 09-MAY-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number N034400 with expiration date in 10-MAY-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011434: US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1907USA001847: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001811: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
Fever to 40.1 degrees C approx. 20 hours after PENTACEL Vaccine. No additional symptoms.
was given 12+ dose instead of 5-11 dose - guardian stated swollen lymph glands right arm
In about 2 minutes got muscle cramp in arm. During night got fever, chills, nausea, headachy which lasted for 6 days. Shot was near shoulder in muscle in left arm. About Day 6, redness traveled down from shoulder area to near elbow, which went away after the second week. It will be one month tomorrow and the muscle in that upper arm is still sore since the beginning, like someone punched me in the arm and also like someone is giving me the shot all over again.
Case number PHEH2014US000610 is an initial spontaneous report received from a nurse on 02 Jan 2014 and a follow up report received from the nurse on 30 Jan 2014. This report refers to a 14-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated only with 0.5 ml of MenCYW-135 liquid component of MENVEO (batch number: A13014) intramuscularly in the right deltoid and did not receive MenA lyophilized conjugate on 31 Dec 2013 (14:10). No adverse event was reported following the mal administration. Follow up report received from the nurse on 30 Jan 2014: MENVEO batch number and site of vaccination and patient details were updated.
Parent noticed in am post vax that right leg was swollen and hot to touch (tennis ball sized lesion)
Mother noticed next morning - red spots on chest, abdomen & leg  BENADRYL PRN.
Employee c/o continued pain at injection site with use (R) arm or when rolls onto arm at NOC - awakens her. Rates pain 7/10. No numbness. Pain w/ROM. Full ROM - No induration, erythema.
My asthma has been SIGNIFICANT worse since getting the vaccine. I can?t exercise the way that I could just weeks before and it hasn?t changed even now 6 months later.  Exercise induced asthma stays with me for days now. I was running 2.5 miles and now I struggle to run for one minute.
First of all, I just went in to get my shingles vaccine at the request of my doctor. The pharmacist asked if I've had my flu vaccine, which I hadn't so I said no. She recommended I get both vaccines at the same time. She said it's better for your immune system if you get them both at once. Within an hour, I had the "common symptoms" from the Shingrix literature...redness and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever and upset stomach. On day three after the injection, I developed a shingles blister on the back of my neck. I called my doctor. She had me come in to verify it was shingles, which it was. Over the next 4 days I developed 8 more shingles blisters and a coldsore on my lip. My Dr. gave me a prescription for Valtrex but said not to take it unless I got significantly worse as it would make the vaccines less effective. At day 7, I started taking 1000 mg Lysine due to the coldsore. The other blisters dried up and scabbed over by day 9.  Today is day 17 and the blisters and coldsore are all gone except the one on the back of my neck. It still has a scab. I've since heard from several nurse friends that the pharmacist shouldn't have recommended I get bot the Shingrix and the Flu vaccines at the same time.
So I became pregnant 4/8/2021 and then 4/9/2021 I experienced bleeding and I thought I was going to miscarry. I got an ultrasound and they baby was fine and there was no bleeding in utero. I saw my OBGYN. On June 24th 2021 I experienced more vaginal bleeding. Once again I was in the clear, had an ultrasound, baby healthy and all. This is my second pregnancy, I became pregnant with my first in October 2019, I had no issues or complications at all. My first child was 7 lbs 6 ounces. My due date for this baby is January 2, 2022.
Patient noted 1-2 days after vaccine that her left upper arm was swollen, hot, and red distally down the arm.
First dose / on 05May2021 / second dose / on 05Jun2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number EZ4TD, expiry date 4th November 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 5th June 2021, the patient received the 2nd dose of Shingrix. On 5th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. On 5th May 2021, the patient received 1st dose of Shingrix. The patient received the 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule. The reporter consented to follow up.
pt recvd pneumococcal vax on 22NOV91 & a few hrs following vax devel swelling @ inject site; 24 hrs later entire outer aspect of the rt upper arm was swollen, red, warm & very uncomfortable; tx w/unspecified antihistamines & ice packs;
redness in site of injection; swollen arm the size of a baseball; incorrect site of injection: 2 hands down from the shoulder/incorrect route of injection: tissue instead of intramuscular; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE ERYTHEMA (redness in site of injection), VACCINATION SITE SWELLING (swollen arm the size of a baseball) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (incorrect site of injection: 2 hands down from the shoulder/incorrect route of injection: tissue instead of intramuscular) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 010M20A, 043L20A and 039F21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Diabetes, Heart disease, unspecified and Contrast media allergy (Contrast dyes). Concomitant products included HYDROCHLOROTHIAZIDE, CLOPIDOGREL BISULFATE (PLAVIX), ESTROGENS CONJUGATED (PREMARIN), FLECAINIDE and DILTIAZEM for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (incorrect site of injection: 2 hands down from the shoulder/incorrect route of injection: tissue instead of intramuscular). On 20-Apr-2022, the patient experienced INJECTION SITE ERYTHEMA (redness in site of injection) and VACCINATION SITE SWELLING (swollen arm the size of a baseball). On 21-Apr-2022, INJECTION SITE ERYTHEMA (redness in site of injection) and VACCINATION SITE SWELLING (swollen arm the size of a baseball) had resolved. At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (incorrect site of injection: 2 hands down from the shoulder/incorrect route of injection: tissue instead of intramuscular) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient never had tested COVID positive. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The patient did not experience a similar event in the past and did not seek medical care for the AE..  Treatment medications were not reported.   This case was linked to MOD-2022-547355, MOD-2022-547408, MOD-2022-547429 (Patient Link).
Information has been received from an 82-year-old male consumer with no known allergies and a history of an "existing auto immune disease" who in February 2007, was vaccinate SQ with a first dose of 0.65mL of zoster vaccine live (Oka/Merck). Concomitant therapy included PROTONIX. Subsequently, in July 2007, the patient was advised that the vaccination caused the reactivation of his pemphigus. Unspecified medical attention was sought and the patient had a biopsy performed. The results were not reported. At the time of the report the patient recovered on an unspecified date. There was no product quality complaint involved. Follow-up information from the physician indicated that the patient thought his pemphigus flared after receiving the vaccine. As per the physician "he was wrong." The skin eruption was unrelated to both his pemphigus or the vaccine. It was noted that the patient did not have a AE from the vaccine. On an unspecified date the patient recovered. Additional information is not expected.
Has heart problems; Low white blood cell count; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Lot number: GJ6665) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "Has heart problems"; WHITE BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "Low white blood cell count". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated that she took the bivalent vaccine at the end of Oct last year. However, she mentioned that one of her doctors told her that she should have not taken that bivalent COVID vaccine as there would be another COVID vaccine that has wider coverage. She called in regards to Pfizer COVID-19 vaccine bivalent formulation for adults. She wanted to know if there is a new bivalent COVID vaccine that was released. She also wanted to check if what she received was the bivalent COVID-19 vaccine. She provided the lot number GJ6665. She also asked if she would be considered immunocompromised as she had breast cancer before, has heart problems and low white blood cell count. She also asked about what is bivalent. Dose/Dosage Form was reported as Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), less or equal to 12 years - 15/15 mcg per dose.
Information received from a physician concerning a son of a nurse who was vaccinated with varicella virus vax live. Subsequently the pt developed chickenpox breakthrough.
Vaccinated with Menomune 4pm.  Late evening, developed rash (hives), SOB, wheezing, chest discomfort.  Treated at home with Benadryl that evening.  Seen by M.D. next day and given Prednisone.
Patient was administered an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, OLMESARTAN, AMLODIPINE, DULOXETINE and CETIRIZINE HYDROCHLORIDE (CETRIZINE) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-369137 (Patient Link).
Vial was stored in refrigerator on 17-Feb-2022 at 10:00 am, expired on 1-Apr-2022 and administered on 06-Apr-2022; 21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022 at 10:00 am, expired on 1-Apr-2022 and administered on 06-Apr-2022) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022 at 10:00 am, expired on 1-Apr-2022 and administered on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022 at 10:00 am, expired on 1-Apr-2022 and administered on 06-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  It was reported that 21 vials were initially stored in refrigerator on 17-Feb-2022 at 10:00 am and doses were administered 30 day use by date or after manufacturer date of expiry.  The vials did not undergo any temperature excursions.  It was reported that the vials likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.  No adverse events were reported.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up document contains no new information
From the day he received the shot he got an extremely high fever (we didn't have a thermometer but knew it was high). He was so hot to touch. This lasted for three-four days. Patient slept for three/four days straight minus waking up to nurse. He would not eat any of his snacks, he just wanted to nurse. This is not normal. He also did not act as if he was interested in anything but would rather scream most of the days after the fever broke around the fourth day. Once the fever broke, we took him to the ER for other reasons and found out he had an ear infection. About a month after pt developed a rash on his sides and it is not going up his to his under arms and also around his butt and thighs. They are red bumps and very splotchy. They mimic a small version of the measles (I'm assuming from photos I have seen).
Swelling of the left arm, pain at injection site, a  red rash 2 inches in diameter. Pain started in the morning of January 23, one week after vaccination, swelling and rash was noticed in the evening of January 23.
SHE WAS GIVEN MODERNA THAT HAD TEMPERATURE EXCURSION. MODERNA ASSURED THAT AT THE TIME OF VACCINATION THE VACCINE WAS FULLY ACTIVE.
Swelling, redness and discomfort which progressed to involve the left arm from the shoulder to the mid-forearm over 72 hours; no associated fever. Ice and Ibuprofen not particularly helpful.
Vaccinated a 17 year old; A spontaneous report was received from a health care professional concerning a 17-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was provided. Concomitant product use was not provided by the reporter.   On 02 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013A21A) for prophylaxis of COVID-19 infection.    On 02 Mar 2021, The patient experienced vaccinated at 17 years old. Treatment information was none.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of event vaccinated at 17 years old was considered resolved on 02 Mar 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number 013A21A) with no associated AEs reported.
My eyes are a mess / Skin around my eyes became very red; Fever; My eyes are still swollen; 5 days after the shot I got COVID; This case was reported by a consumer via call center representative and described the occurrence of erythema periorbital in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th August 2020, refer case US2021AMR007178).   On 29th November 2020, the patient received the 2nd dose of Shingrix. In December 2020, an unknown time after receiving Shingrix, the patient experienced coronavirus infection. On an unknown date, the patient experienced erythema periorbital, fever and eye swelling. On an unknown date, the outcome of the erythema periorbital, fever and coronavirus infection were unknown and the outcome of the eye swelling was not recovered/not resolved.   It was unknown if the reporter considered the erythema periorbital, fever, coronavirus infection and eye swelling to be related to Shingrix.  Additional details were provided as follows: With 1st dose of Shingrix, the patient had an eye reaction and doctor did not think it was due to the vaccine. It lasted on and off about a month or more. The patient stated his/her eyes were a mess. The patient got a fever and the skin around eyes became very red. Five days after vaccination, the patient had COVID and eyes were still swollen. Less than 2 months after vaccination, the patient had erythema periorbital, fever and eye swelling. The patient asked for antidote.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR007178:Same reporter US-GLAXOSMITHKLINE-US2021AMR007178:same reporter
This case was reported by a pharmacist via sales rep and described the occurrence of injection site warmth in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site warmth and injection site erythema were unknown. It was unknown if the reporter considered the injection site warmth and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The primary reporter stated to field representative that patient experienced warmth and redness at the injection site which was 4 to 5 inch in diameter just like a size of soft ball. No further details were provided by the field representative.
pt had inconsolable crying for 2 hrs; rt leg was swollen, red, warm to touch; pt was in obvious pain when leg was touched; cellulitis on rt leg;
About 3-4 hours after the vaccine (3/25/2021 at 4:20pm)  at approximately 8pm, I began to become exhausted and had a mild headache of a 1/10 pain. I thought  the symptoms could be because I had worked almost a full work day.  The next morning of 3/26/2021 at 6:30am, I woke up with injection-site pain (3-4/10 pain)  and a worse, but still mild, headache (3-4/10 pain). As the day progressed, I began to feel warm and clammy  but had no fever. I took acetaminophen at approximately 7:00pm on 3/26/2021.  By the time I woke up on 3/27/2021 at 9am, I felt symptom-free.
Pt described since last vaccine, headaches, fever, joint/body aches, several episodes of bilateral leg numbness/weakness resulting in falling down.