chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I experience dizzy vertigo like symptoms after getting the second shot.  Lower back pain and cough.
Feeling weak, stomach pain, difficulty breathing, warm to touch and sweating. treated by having patient lie down with legs elevated and given a sip of Gatorade.
7 days after vaccine there was lip swelling, tingling, and sensitivity that lasted a week. Patient did not have previous lip fillers or anything like that.
No additional AEs were reported; A patient received improperly stored vaccine.; This spontaneous report was received from a healthcare worker and refers to a 8-week-old patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 23-AUG-2022, the patient was vaccinated with 1 dose of improperly stored (Product storage error) rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (exact dose and frequency were not reported) as prophylaxis. The patient received only 1 dose, but the healthcare worker did not specify which lot (of the following two) the patient actually received: lot number W002562 and expiration date 12-OCT-2023 or lot number W004504 and expiration date 16-JUN-2023. The suspect vaccine was improperly stored for 34 minutes in temperature of 11.3 degrees Celsius. No additional adverse events were reported, no further information provided.
Pt felt anxious.  17:30 took Xanax 10mg, O2 sat 98% RA, BP 128/82, HR 85
ADVERSE EVENT: 11 year - old female was vaccinated on May 22, 2021 with Pfizer Vaccine (LOT # EW0191).  TREATMENT: No treatment for adverse events per guest and her mother.  I am here with her today for the second one. You have to give it to her." On-Call MD was consult. OUTCOMES:  Educated and explained to patient's mother and 11 year-old patient that this is not the ideal situation. However, as long as they understood the benefits and the risks of being vaccinated without knowledge of the effectiveness and efficacy of this vaccine in this age group we would provide the patient with the second dose of the Pfizer Vaccine.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2008, the patient was inoculated with ZOSTAVAX at a physician's office as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2011, the patient was treated at the same physician's office for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This spontaneous report as received from the healthcare worker refers to an multiple unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 (lot number: 1011846 and expiry date: 16-JUN-2017) (dose, frequency and route of administration was not reported). No concomitant medications were reported. No adverse events were experienced. The outcome of the reported events was unknown. No product quality complaint (PQC) was filed. This is one of the 4 reports from the same reporter. Additional information has been requested.
PATIENT STATES LEFT ARM WAS RED, SWOLLEN, HOT TO TOUCH, AND PAINFUL AT AND AROUND SITE OF INJECTION. AREA MEASURED APPROXIMATELY 50MM.
Patient came to the pharmacy to receive her second vaccine of Pfizer. After received her dose she told Immunization technician, that she feels that she will faint. After she fainted she received alcohol swabs to inhale. Tech called me and I told the personal to close the pharmacy, call 911 at 12:25 pm, 1 technician to write all the incident and page with white code. I called the pharmacy manager, put the patient on the floor with her feet elevated and put cold pad below her head. Patient's mother told us that she is hypoglycemic patient and she don't eat her breakfast and gave her an orange soft drink at 12:30pm. The paramedics arrived at 12:35 pm and they took blood pressure, oxygen and glucose and everything was fine. Patient and her mother declined to go to the hospital and go to sandwich shop.
my torso was covered with a rash/rash spreadof over my entire body/she developed widespread, sevre erythrodermic skin eruption; She had skin biopsy conforming lichenoid drug eruption; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Apr2021 13:00 (Lot number: ER8731) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety /Depression", start date: 2009 (ongoing); "Anxiety /Depression", start date: 2009 (ongoing); "Hysterectomy", start date: 2011 (unspecified if ongoing), notes: Pertinent details: Hysterectomy. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, single, Time:01:00 PM, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: ER2613), administration date: 24Mar2021, for COVID-19 Immunization. The following information was reported: RASH (medically significant) with onset Apr2021, outcome "recovered" (2021), described as "my torso was covered with a rash/rash spreadof over my entire body/she developed widespread, sevre erythrodermic skin eruption"; DRUG ERUPTION (non-serious) with onset 2021, outcome "unknown", described as "She had skin biopsy conforming lichenoid drug eruption". The event "my torso was covered with a rash/rash spreadof over my entire body/she developed widespread, sevre erythrodermic skin eruption" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: biopsy: (2021) having a reaction to a medication, notes: A biopsy was taken from my skin is and it was determined I was having a reaction to a medication; biopsy skin: (23Sep2021) lichenoid dermatitis, notes: Lichenoid Dermatitis, compatible with lichenoid drug eruption. Therapeutic measures were taken as a result of rash.
Fever started one hour after the injections. Fever persisted during the day and there was emesis the same evening. Minimal local reaction. Malaise and lethargy lasted for 72 hours, and then resolved abruptly.
no energy; slept 20 hours one day; body aches; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extreme fatigue), ASTHENIA (no energy), HYPERSOMNIA (slept 20 hours one day) and MYALGIA (body aches) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-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 FATIGUE (extreme fatigue), ASTHENIA (no energy), HYPERSOMNIA (slept 20 hours one day) and MYALGIA (body aches). At the time of the report, FATIGUE (extreme fatigue), ASTHENIA (no energy), HYPERSOMNIA (slept 20 hours one day) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Individual donated plasma and then received the Twinrix vaccination.  She became pale, diaphoretic and lost consciousness for approximately 3-5 seconds.  She recovered almost immediately.
Left upper arm erythematous 6x7 cm also itchy and warm to touch.
Multiple days waking up with left arm/hand/fingers numb/asleep, varies Random parts of legs feel distinct tight pressure point/slight pain Went to hospital once for possible blood clot in leg but was negative on blood test and physical examination
Patient reported low PO intake diarrhea and fevers after her 2nd COVID vaccine. She presented to hospital on 2/26/21, pt with Hx of advanced Diabetic Neuropathy and CKD 4, Presented w/AKI- needing dialysis she feels this was due to her vaccine related volume loss and resulting ATN, SKII HD dependent.
This case was reported by a other health professional and described the occurrence of extra dose administered in a elderly female patient who received FLUARIX. On an unknown date, the patient received .5 ml. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional information: Two doses of FLUARIX within one hour of each other.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 8-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified). On 2 March 2001, 2 July 2001 and 2 May 2003, the subject received 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (unknown). The 2nd dose and the 3rd dose were given too late, which led to an inappropriate schedule of vaccine administered. At an unspecified date, anti-HBS titers were tested and showed a result lower than 10 mlU/mL. The subject did not respond to therapy. Since at the time of reporting the subject was entering at the medical assist school, she presented to have single ENGERIX-B dose. Follow-up information received by a pharmacist (initial reporter) on 16 October 2014: The patient received a booster dose on 12 June 2014 and was instructed to get her titers retested after 20-30 days.
I woke up with an excruciating headache (with light sensitivity) that did not initially respond to Tylenol. Although I did not have a fever, I had temperature regulation issues all night - alternating between hot and cold - and woke up sweaty.  Headache responded to Advil in the morning but I still have a minor lingering headache a few hours later.
Pt devel rash on upper body only x 4 days; Seen by MD x 2 visits - cleared w/use of Mycogen cream; no fever;
Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a four-months old female patient who was vaccinated with only a 0.5 ml of DTaP/IPV liquid portion from first dose of PENTACEL lot C5527AA (also vial Lot = C5527AA and ACTHIB powder = C5426AA); expiry date: 04-Oct-2019 via intramuscular route in the left thigh on 26-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included PREVNAR 13 for Immunisation; and ROTAVIRUS VACCINE for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. Patient only received the DTaP/IPV liquid portion and not the ACTHIB Lyophilized powder portion of the vaccine. It was unknown whether the patient experienced any adverse reactions or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
This case was reported by a physician via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX. 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 pain, injection site erythema and injection site blisters. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site blisters were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site blisters to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported but the patient was in her 60's. No concomitant vaccines were given.
In Dec 04, Mom reported pt had depressed areas on his right leg from immunizations earlier. Also says Dr is discussing surgery for this. Dr's report attached. 04/05 Now saw in clinic and leg is better. Father uncertain which leg it occurred. Med Notes: 04/19/05, dad stated there was a problem with last vaccines, however there are no notes in computer. However RN knew of situation and dad stated there was a report done. Dad was unsure of which leg, he made call home to mom, she stated it was left leg, now all appears normal. RN did use Right thigh for HBV.
Woke up next morning with hard, swollen, round, red lump at the injection site.
Debilitating myalgia and spasm. The pt experienced adverse clinical symptoms after each anthrax vaccine dose, then reproducible muscular pain, spasm and weakness began after the 3rd shot. He previously had received the anthrax vaccine during the Gulf war, but there is lack of documentation as to know how many doses and at what intervals. He had been experiencing symptoms of Gulf war illness which included joint pain and short term memory loss at the time he received the repeated series of anthrax doses. On 06/08/1999, 3-4 days after shot, the pt experienced painful cramping in legs and had difficulty walking. Had bilateral burning in the calves, as well as tightness and twitching in the back, neck and chest muscles. Went on sck call 10-15 days in the 6 month period between shot 3 and 4. Was diagnosed with muscle strain and given NSAIDS. Was unable to sleep, experienced fasciculations and muscular pain at night. Symptoms lessened but did not resolve. Muscle spasm, intermittent twitching, occasional muscle jerking in back, arms, hands, neck and legs. Insomnia, depression, hypercholesterolemia, exertional dyspnea, elevated CPK levels. An annual follow up report received 6/26/2003 adds: Continued to have continuous myalgias, paresthesias, arthralgias and muscle spasm. Walks with a cane. Is being medically discharged from the military. Muscle biopsy negative, EMG "bland myopathic process". The follow up received on 12/31/03 states pt continues to have debilitating myalgia, polyarthralgias and peripheral neuropathy. Ambulates with cane. Cannot perform duties within the military setting and is in the process of being medically separated from the service.  12/14/05 3-page correspondence from patient described muscle stiffness of calves. 6-page medical record described crying spells, weight gain, and hypertension.
I had to have IV adenosine to convert my heart back to normal sinus rhythm. My heart rate was 199 per minute (SVT).
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Medium
Pt has Tdap 2 days later he developed rash on both hands, extensor side involving 4 distals. Parents applied topical ointment. One month later, he developed rash behind both ears. No fever. To ER for evaluation.
TC 4FEB92, mom states 4AM t103; 415AM full body tremors, including extremities, eyes blinking; stopped breathing 416AM dad adm CPR 2 puff then full cry; taken to ER-released 8AM t100.2; dx febrile seizure secondary to DPT;
Patient who was administered an expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient who was administered an expired dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient who was administered an expired dose). On 28-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient who was administered an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Intense muscle soreness after moderate resistance training.  Training period was 4 days after vaccination, delayed onset muscle soreness (DOMS) began 48 hours after exercise and soreness remained intense for 24 hours, then began to resemble normal DOMS thereafter (but still abnormal for moderate exercise).  Symptoms were particularly noted for the pectoral muscles after a chest workout, including intense pain while performing normal day-to-day functions (sitting, standing, bending up/down and left/right, lying down for bed).  Symptoms persisted for ~24 hours, then began to subside and became more easily manageable.  Workout consisted of light weights (<50% one rep max) and high repetitions (15-20 reps), which is my normal routine (performed regularly for years).
Myalgias, arthralgias, low grade fever, headaches, generalized lymphadenopathy (axillary, epitrochlear, cervical). I had similar reaction to 3 prior doses of Pfizer, except lymphadenopathy was new with dose 4). Onset of symptoms was within a few hours with each dose, lasting 3-5 days, unable to work or do usual activities.
one day after the second dose,  she complained about having a hard time breathing and headache. comes and goes with the shortness of breath.  today she was sent home bc her headache worsen and difficult breathing .her heart rate is 120/min and hard time breathing worse when she lies down.
Pfizer covid 19 vaccine vial was mixed with 1.4 ml instead of 1.8 ml of diluent. Spoke to patient's mother on 04/11/2021 and she reported that the patient had a sore arm. Provided counseling.
Pt c/o "heart racing, some mild nausea and mild headache." Pt stated "I think I got myself worked up and over thought it after vaccine was given. I know how I do with medicines and reactions and got upset." Benadryl Elixir given Pt under care of allergist, no Rx for allergies, just uses OT Benadryl when symptoms start
Patient had never received any covid19 vaccines. Intended to administer Pfizer primary dose.  The bivalent pfizer booster formulation given. Vials look same. No adverse effect, patient doing fine.  Informed patient and medical director. Contacted Help for guidance.
HIVES AND RASH ON LEGS, ARMS, ABDOMEN, RIB CAGE, FACE - TOOK BENADRYL AT HOME TO HELP WITH THE ITCHING, DID NOT REQUIRE SEEKING FURTHER TREATMENT
Patient developed rhinorrhea and loss of taste/smell.   She had a positive PCR for COVID-19 on 3/1/2021.  Received Pfizer vaccine on 1/20/2021 (lot EL3248) and 12/30/2020 (lot EL0142).
High fever 103 degrees; Arm totally immobile with severe pain; Lethargy; Headache; Chills; Same symptoms as when I had Covid in March 2020
Headache, followed by weakness, dizzyness and vomitting Went to the ED 2/26/2021 and 2/28/2021.  Treatments Sodium Chloride 0.9% 1000md, Metoclopramide , Dexamethasone Sodium Phosphate and Diphenhydramine HCL
pt describes itching of lips 2 - 21/2 hours after vaccine. No rash seen, itching of trunk, arms, back etc. Continued to 9-29-09 @ 1500. No rash , no hives seen. Itching prevented sleep. No other sx. History taken can not identify other sources of pruritic.
He c/o of infected tooth on 01/23/21, antibiotics began Swelling in both hand began on 01/30/21. Resident c/o of itching in arm. Antibiotics discontinued, benedryl given as needed.  Symptoms resolved 02/02/21
Date and time of adverse event: 24 March, 2021 3hrs after started arm sore, muscle lakes, fatigued, fever, shortness of breath. All symptoms resolved except shortness of breath, getting better. List all vaccines given on the date listed (including how vaccine was given and where (body site) vaccine was given: Patient states she started to experience symptoms 3 hours after she received her vaccine. Sore arm, muscle aches, fatigue, fever, shortness of breath. All symptoms resolved except shortness of breath which is continuing to improve. She is just calling to report her symptoms, so no one else will take this vaccine.
No adverse effect reported; patient received improperly stored VARIVAX; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 20-AUG-2019, the patient was vaccinated with an improperly stored  dose of varicella virus vaccine live (oka/merck)(VARIVAX)  lot # S005078 expiration date 19-FEB-2019 or lot # R019237 expiration date 04-JUL-2020 (strength, dose, frequency and anatomical location were not provided) for prophylaxis. The reporter had not clear which lot # was given to the patient, since both lot # had temperature excursion. The varicella virus vaccine live (oka/merck)(VARIVAX) was reconstituted with properly stored sterile diluent. The administered doses of the vaccines were stored with the temperature  between -14 degrees centigrades to -10 degrees centigrades (mainly at -9.74 degrees centigrades), the time frame was unknown by reporter. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effect reported.
This was my second shot. After my first shot the only, minor side effect was mild pain at the site of the shot. However my second shot was entirely different.  Pain in the site of the shot was almost immediate. Only 10 hours after my shot, I felt very tired, no appetite, nausea, had chills throughout the night and head ache. Next day stayed in bed all day with head aches (not very bad) but extremely tired, no appetite, pain behind both eyes. Next morning (right now as I am writing this) I feel a lot better, still has pain behind my eyes (not bad) but feeling more energetic. Appetite still not great.
Hives on Face, neck, chest 45 following the injection.  Benadryl 50 mg Q 6 hours x3.
PT RECEIVED VACCINES FROM HOSPITAL. WITHIN 15 MIN PT BECAME PALE AND STARTED TO C/O OF THE FOLLOWING S/S FEELING LIKE GOING TO PASS OUT. STOMACH PAIN, DIZZY, BLURRED VISION, HEARING MUFFLED. PT WAS GIVEN SOME COLD COMPRESSES TO THE BACK OF THE NECK AND FACE AND WATER TO SIP ON. WITHIN 5 MIN, PT COLOR RETURNED TO NORMAL AND HER S/S BEGAN TO RESOLVE. WITHIN 10 MIN ALL SYMPTOMS THAT WERE REPORTED HAD RESOLVED. EDUCATION ON THE SIDE EFFECTS FROM THE VACCINATIONS AND CONTINUED MONITORING ADVISED. DR. NOTIFIED. 92% O2 SATS 97.4 T; 1B R.