chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/2/2021  observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  urticaria.   Assessment : Time of assessment Alert and oriented.No visible rash observed.   Actions taken:  Vitals sign taken  VAERS form obtained and completed by RN.  BP- 1203- 141/95, P- 83, O2- 97%, 1218- BP- 132/79, P- 82, O2-97%, , 1233= BP- 138/75, P- 75, O2- 100%.       Medications administered: Loratadine (Claritin) 10 mg  by mouth. Time: 1210. Administered by RN. Famotidine (Pepcid) 10 mg by mouth. Time: 1215. Administered by RN. Diphenhydramine (Benadryl) 25 mg capsule, by mouth. Time: 1220. Administered by RN.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.       Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/2/2021 11:39 AM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: EP7533   NDC: 59267-1000-2       Electronically signed  Immunization on 4/2/2021   Detailed Report  Note shared with patient
Pt complained of significant swelling the size of a fist, lasting greater than 1 week.
Information has been received from a genetic counselor, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 33 year old female with no drug allergy who had a history of a still birth and a fetal demise. On 20-MAR-2012 the patient was mistakenly vaccinated with a dose of VARIVAX (Merck) and was 14 weeks pregnant. There was no concomitant medication. There was no lab performed. The LMP was approximately on 18-DEC-2011. EDD was on 18-SEP-2012. A call back received from the reporter who reported that the patient had not delivered a baby yet. She confirmed that the patient was administered with VARIVAX (Merck) on 20-MAR-2012 when she was 14 weeks pregnant and was exposed to the at second trimester. She stated she would call us back after the delivery regarding the health status of the baby. Additional information has been requested. Follow up information received via a telephone call from the reporter regarding the patient who delivered a healthy boy baby via repeat C-section on 12-SEP-2012. The infant's weighed 7lbs.4oz and length of 20.7 inches. The infant had no congenital anomalies. The delivery had no complications. The patient's last menstrual period (LMP) and Estimated Date of Delivery (EDD) was reported to be 10-DEC-2011 and 15-SEP-2012 respectively. Upon internal review C-section was considered medically significant event. Additional information is not expected.
This case was reported by a physician's assistant and described the occurrence of worsening of generalized body itching in an adult male patient who received hepatitis A inactivated & hepatitis B recombinant vaccine (Twinrix). The patient's past medical history included hepatitis C. On an unspecified date in February 2004, the patient received the first dose of Twinrix. "Just after the first dose of Twinrix," on an unspecified date in February 2004, the patient experienced generalized body itching. The itching "continued during the month following the first dose of Twinrix." On an unspecified date in March 2004, the patent received the second dose of Twinrix. Immediately after the second dose of Twinrix, the patient experienced worsening of the body itching. The patient was examined at a physician's office and was treated with Medrol. The physician's assistant considered the events to probably be related to vaccination with Twinrix.
Horrible body aches, burning joints, fatigue, headache, earache, malaise, loss of appetite, constipation and difficulty urinating 102.1 left ear, 101.9 right ear, lasted 24 hours, felt like I was dying Thursday all day and night. Friday felt very weak, constipation continued, tired.
JOINT PAIN ALL OVER; PINS AND NEEDLES SENSATION; This spontaneous report received from a patient concerned a 20 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: social alcohol user, and non smoker, and other pre-existing medical conditions included: The patient did not have any history of drug abuse or illicit drug use. The patient experienced anaphylaxis to flu vaccine at 6 months of age when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-SEP-2021, the patient experienced pins and needles sensation. On 12-SEP-2021, the patient experienced joint pain all over. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pins and needles sensation on 11-SEP-2021, and had not recovered from joint pain all over. This report was non-serious.
This spontaneous report as received from a registered nurse refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 17-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was purchased with Medicaid-VFC (public fund). The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
punctured IPOL - administered to a patient post excursion with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old male patient who was administered ipol post excursion with no reported adverse event while receiving vaccine ipv (vero) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis a vaccine (hepatitis a vaccine) for Prophylactic vaccination; hepatitis b vaccine (hepatitis b vaccine) for Prophylactic vaccination; measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination; and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) for Prophylactic vaccination.  On 03-Oct-2022, the patient received a dose of suspect ipv (vero) Suspension for injection 0.5 ml (milliliter) Once (lot V1A024M, expiry date 17-Feb-2024) (strength: unknown) via intramuscular route in unknown administration site for Immunization.   On 03-Oct-2022 the patient was administered ipol post excursion with no reported adverse event (poor quality product administered) (latency: same day).  No lab data reported.  Action taken was not applicable.   At time of reporting, the outcome was Unknown for the event     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 the 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 interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
p/vax pt devel a red, pinpoint rash on neck, trunk & arms;
Pt called the pharmacy and said the injection site swelled up and was itchy.  Per AE protocol, pt was advised to take Benadryl and ice injection site.  The next day, pt said itching has subsided but there is still some swelling.
Child stopped breathing before needle withdrawn from leg; 2nd DTP second Adverse event; Experienced cyanotic, not arousable, stridor, & wheezing present, pallor, lethargic w/blank stare for next 15-20min, poss sx scheduled CAT & EEG;
I don't know for sure if it is related, but I developed rash on my arms, legs, neck, sides, and back after 1st shot, then symptoms started to subside. Got 2nd shot and rash came back as well as hives all over my body and now I've have hives and rashes for a few weeks. Prior to being vaccinated I was not prone to rashes and I had never in my life had hives for any reason. I contacted my dermatologist and she said it is possible the hives and rash could be related to the COVID-19 Vaccine, as I had a strong reaction (I had fever, muscle aches, chills, fatigue, headache, plus large rash and tenderness around the injection site for 2 days after the 2nd shot) and I don't have a history of rashes, allergies, or hives. My co-worker suggested I fill out this form and report it. So I am.
Patient received PEDIARIX on the right thigh, PEDVAXHIB and PREVENAR on the left thigh. After about 5 minutes of vaccine administration, the whole right leg turned cherry red and also few red blotches developed on the left leg. No further redness/rashes observed in any other parts of the body, no difficulty breathing or shortness of breath as well, child was under observation for about an hour and the redness on both legs disappeared. Mom also remembered and stated that the last time the child received her vaccine last 1/12/2017, she also observed child developed some red blotches only on both legs that night. No fever or any other symptoms.
Initial information has been received from a physician and follow up information has been received from a nurse concerning a female patient between the ages of 11 and 19 who was vaccinated with a dose of Gardasil, it was reported that the patient sat for a minute (after receiving the injection) and when she got up to leave she fainted in the hallway. Her outcome was not reported. The physician reported that lot numbers were not available, however the physician will forward other information including the lot numbers. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow up information has been received from a physician, a nurse and a healthcare professional, concerning a 17 year old, female student, with no significant medical history and no known allergies, who was vaccinated IM, on 26-APR-2007 at 1:15pm, with the first dose of GARDASIL (Lot #65617/0384U). There was no illness at the time of vaccination. It was reported that the patient felt lightheaded immediately (at 3:15pm) after receiving the injection and sat, or was laid on the floor. It was confirmed that the patient had recovered on the same day, 26-APR-2007. No further information is expected.
Flare-up of Ulcerative Colitis - started 4 days after 1st shot. Got worse immediately after 2nd shot.  Diarrhea, extreme bloating, gas trapped in GI tract, inflammation of GI tract. Extreme abdominal cramping. GI dr confirmed generalized small-bowel dysmotility as a consequence of the vaccine. Also confirmed mild flare of Ulcerative Colitis and was given Prednisone as treatment.   Also 1 week after vaccine developed sharp pain in lower back left side of skull, could not turn head.  Went to neurologist, diagnosed with occiptal neuropathy and given nerve block injections to treat.
Developed petechiae on upper ear lobes and elbows on and off 2 weeks after receiving Varivax.
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patients' pertinent medical history, drug reaction or allergies were not reported. On 05-FEB-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017, (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Dizziness - like I was drunk and had no alcohol. My back and hips started to ache. I was on a bike ride and I felt like I couldn't get enough air, like an elephant was sitting on my chest. I felt weighted down like a lead vest was on me. The fatigue has lasted 4 days. Nausea. Shoulders and neck are achy. After the first shot three weeks ago, I had a migraine and nausea for three days and these symptoms I just described.
Dizziness, Headache, Myalgia, Arthralgia, ErythemaMultiform, NauseaVomiting, chills, loss appetite, localized arm swelling pain redness Narrative:  Other Relevant History:
The day after receiving my third dose, I felt extremely fatigued. The following day I felt itching and burning on the right side of my face and neck. Later that evening, I saw breaking out on my arms and upper torso. From then on, it filled in very quickly with a heavy rash down my legs and badly on my back. Monday, I went to my Primary Care Physician, and was diagnosed that the rash was drug related. The only different thing I had done, was receive my vaccine. I received a prescription for prednisone and was told to continue taking Benadryl. As of today, the rash is still moderate on my back, legs, and arms. It has disappeared from my face and neck though.
Fever 100.3 degrees Fahrenheit; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever 100.3 degrees Fahrenheit) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21N and 246A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ASCORBIC ACID (VITAMIN C ACID), ZINC and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 11-May-2021, the patient experienced PYREXIA (Fever 100.3 degrees Fahrenheit). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever 100.3 degrees Fahrenheit) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Body temperature: 100.3 (High) 100.3 F high.   Treatment information  provided was 6 tablets of aspirin 81mg   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Outcome was updated to resolved.
Shortly after my first dose I felt an unusual feeling throughout my upper body but wasn't sure if was related to the vaccine or not. When I went for my 2nd shot 3 weeks later my left arm was still very sore and I wondered if I should get the shot in my right arm but decided to continue with the left arm because I didn't want two sore arms. Two weeks after my 2nd dose of the vaccine I went to the ER with chest pains. After numerous tests and continued problems with my left arm I have been diagnosed with frozen shoulder syndrome (adhesive capsilitis) and mild left ventricular dysfunction and sleep apnea.  Feeling fatigued, out of breath and heart palpitations.   I have had 2 echo cardiograms, a sleep study, calcium test, breathing test, nuclear stress test and I will be going for a cardiac MRI on December 10, 2021.  I have had an MRI on my left shoulder to confirm frozen shoulder syndrome and I have had a steroid injection via live x-ray and have been going to physical therapy.  I still don't have full use (range of motion) of my left arm.
pt recvd vax 7SEP95 had fever 101.8;14SEP95 fever was 102-103;vomited x 2;not eating or drinking;APAP did not being fever down;15SEP95 mom took pt to the MD;still had fever 103;PE was neg;lethargic;still not eating;gait, irritable, rash;
Systemic: SWELLING AT ELBOW OF VACCINE ARM-Mild, Additional Details: PT NOTICED SWELLING IN HER LEFT ELBOW (VACCINATED ARM) APPROXIMATELY 1 HR AFTER VACCINES GIVEN. GAVE BOTH FLU AND COVID IN SAME LEFT ARM BY TECHNICIAN. DOUBLE CHECKED AND SITE IS APPROPRIATE (NOT CLOSE TO BURSA). PT EXPERIENCES NO PAIN AT INJECTION SITE, ANYWHERE ELSE ON ARM,  NOT  EVEN AT AREA OF SWELLING. SWELLING IS SOFT (IE WATER BLISTER) AND UNPAINFUL. PT LEFT PHARMACY FEELING FINE, FOLLOW UP PHONE CALL FINDS HER STILL NOT IN PAIN AND FULL USE OF ARM.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 145/101 (High) 145/101 and 113/89 (Inconclusive) 113/89.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details included pill for hypertension. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-051827 (Patient Link).
pain in my armpits-mainly in the armpit of the shot; High back pain; Sore arm; Chills; Sweats; Heart palpitations; Nausea; Diarrhea; Tired; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28Mar2021 08:00 (Lot number: ER8730) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Factor V" (unspecified if ongoing); "MTHFR" (unspecified if ongoing); "Hemochromatosis" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; FARXIGA; SYNTHROID; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LEXAPRO. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Sore arm"; CHILLS (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Chills"; HYPERHIDROSIS (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Sweats"; PALPITATIONS (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Heart palpitations"; NAUSEA (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Nausea"; DIARRHOEA (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Diarrhea"; FATIGUE (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Tired"; HEADACHE (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Headache"; AXILLARY PAIN (non-serious) with onset 29Mar2021 08:00, outcome "unknown", described as "pain in my armpits-mainly in the armpit of the shot"; BACK PAIN (non-serious) with onset 29Mar2021 08:00, outcome "unknown", described as "High back pain". Therapeutic measures were not taken as a result of pain in extremity, chills, hyperhidrosis, palpitations, nausea, diarrhoea, fatigue, headache, axillary pain, back pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
Lost of balance, nauseas, heavy of acute vomiting, incoordination of leg movements, lost of vision, lost of stability and equilibrium. High pressure (blood) 145/90. Two weeks in home. Anti-vert and AVAPRO.
Pt appeared nervous during vaccination, but appeared to tolerate well for about a minute or two.  Pt advised to remain seated. Pt lost consciousness, tensed her muscles and began to shake. This lasted about 10 seconds. Her mother and myself touched and aroused pt. Advised pt to remain seated another 15 minutes. Pt reported feeling dizzy and sweaty. Pt remained alert and oriented and was able to walk out of office after resting 15 minutes.  Pt sat in waiting room during check out. She reported feeling okay and was able to walk out with her mom.
Nausea became constant at 3:00a on 2/11/2020 & still persists; vomited at 4:30a & again at 5:20p on 2/11/2020 & none since; constant headache began on 2/11/2020 after my first vomit at 4:30a & headache still persists; night sweats on 2/11 & 2/12/2020 when in deep sleep;  sore, hot, red & swollen left arm spreading downward half-way to elbow.  Been taking Aleve for headache but not helping
MA reconstituted Hib component with MMR diluent and did not mix with DTaP/IPV solution.
Swelling and pain started within 1/2 hr after shot given - extreme by night fall. Advised to use ice and aspirin. Red blotches appeared on entire upper arm following day. Chills the first night. Pain replaced by itching after 2 days. All symptoms gone after a week.
pt recv vax OCT98 & immediately felt cold, exp sweating & became unconscious for 45min;pt was told that instead of receiving the vax IM may have gotten it TV by unauthorized personnel;
This spontaneous report as received from Licensed Practical Nurse refers to a patient of unknown age and gender. On 21-MAY-2013 the patient was vaccinated with PNEUMOVAX23 (lot # exp date: H017759, 04-JUL-2014) (dose, route and indication were not provided), which was exposed to 70 degrees Fahrenheit for a maximum of 63 hours. No concomitant medications were reported. No adverse effect noted. Additional information has been requested.
2 days after receiving shot i experienced  weakness in my left leg, difficulty walking, abnormal movement in my leg like continuous movement in my legs when standing still or setting. These events are still ocurring daily  after 3 weeks
in eve of 3/30/99 had fever 104 chills, pain in rt arm. over next 6 days pain in both arms, wrists, legs & hips. seen in ER 4/6 & clinic on4/7 4/12 still had fever 102 & pain. Symptom free 4/16.
Patient complained to nurse that he vomited after eating macaroni salad around 1700. Nurse noted he had facial and tonsil swelling. Stated he felt like something was in his throat. Nurse gave him 50mg of Benadryl and took him to the ER. Upon arrival to ER pt c/o right lower leg pain over his tibia/fibula, pt given ibuprofen.
Intermittent terrible aching in left and right shoulders down to both elbows, to shoulder blades, interfering with sleep and walking still continuing to today.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: Pt fainted about 2 minutes after getting their COVID vaccine.  We had him sit with his feet up. We checked blood pressure about 5 minutes after and found he was hypotensive (109/71).  Called the ambulance was was released by them.