chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm red, swollen between shoulder & elbow starting 2 days after vaccination site of MMR on right arm also red 2 1/2 inch circumference. Seen in clinic on 3/30/04 at which time the reaction was reported to immunization nurse. Doctor states she contacted PMD's office on 3/29 and was told to give antihistamine. Doctor advised 3/30 to offer Tylenol & cold compresses & to contact PMD if symptoms worsen or do not resolve in next 24 hours. Telephone call to doctor left arm has returned to normal. Some redness at MMR site.
Pt was given Pneumococcal 0.1ml intradermal for PPD in left arm and had redness at site of 1 1/2" X 2". No treatment required.
This spontaneous report was received from a physician via a sales representative concerning a patient of unknown age and gender. Information about medical history, concurrent conditions, drug reactions or allergies was not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiry date were not provided) (reported as "maintenance vaccine"). Concomitant therapies were not reported. On an unknown date the patient developed a case of shingles after receiving the ZOSTAVAX (reported as "post vaccination"). There were no other symptoms reported. It was reported that the patient sought medical attention and had an office visit. There was no product quality complaint involved. The outcome of shingles was reported as recovered on an unspecified date. The reporting physician did not provide the relatedness between ZOSTAVAX and the event. Additional information has been requested.
EXPIRED VACCINE INJECTED; SYRINGES HELD AT ROOM TEMPERATURE; This spontaneous report received from a health care professional concerned multiple patients. 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: 201A21A and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced expired vaccine injected. On 10-APR-2021, the subject experienced syringes held at room temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine injected and syringes held at room temperature was not reported. This report was non-serious.
Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from non-health professional (office staff). This case is linked to cases 2019SA071131, 2019SA071147, 2019SA071148, 2019SA071146, 2019SA071150, 2019SA071151, 2019SA071152, 2019SA071153, 2019SA071154, 2019SA071155, 2019SA071156 (same reporter). This case involves a pediatric patient of an unknown demographics who was accidentally administered with FLUZONE HIGH DOSE (prefilled syringes) lot UJ043AB (expiry date: 22-May-2019) via unknown route in unknown administration site instead of FLUZONE QUADRIVALENT on an unspecified date (during the 2018 - 2019 Flu Season) given during Well Child Check Ups or Vaccine visits. The patient's past medical history, medical treatment(s), vaccination(s), concomitant therapy and family history were not provided. It was an actual medication error case due to wrong vaccine administered, inappropriate age at vaccine administration and overdose. No side effects had been reported. 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 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. List of documents held by sender: none.
no adverse event; The patient was inadvertently administered a dose of VARIVAX that had been improperly stored; This spontaneous report was received from a practice manager referring to a patient of unknown age and gender.      The patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not provided.  On 10-MAR-2020, the patient was inadvertently administered a dose of varicella virus vaccine live (oka/merck) (VARIVAX) that had been improperly stored (dose, frequency, route of administration not reported; lot # S021322 and expiration date 09-JUL-2021), for an unknown indication. It was reported that the lot of vaccine was reconstituted with properly stored Merck's sterile diluent (lot # and expiration date not reported). The storage temperature of the vaccine was -8.3 degrees Celsius and the time frame was 24 minutes. There was digital data logger involved.  No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA005878:
Patient presented to the ED and was subsequently hospitalized on 3/6/2021 with ataxia and acute kidney injury. Patient received second dose on 3/12/2021. Patient presented to the ED and was subsequently hospitalized on 3/29/2021 with acute cystitis with hematuria. These visits are within 6 weeks of receiving COVID vaccination.
pt went to urgent care for complains of allergic reaction. Red patches all over the body, concentrated on arms and trunk
Pain under last rib; Upper abdomen and breastbone very painful; Couldn't take a deep breath; Reflux; Sore arm; A Spontaneous case was received from consumer , concerning a female patient  of age 61, who received Moderna's COVID-19 vaccine experienced Pain in extremity/Sore arm, Chest pain/ Pain under last rib, Musculoskeletal pain/ Upper abdomen and breastbone very painful, Dyspnoea/ Couldn't take a deep breath, Reflux gastritis/ Reflux.  The patient's medical history was not provided. The Patient's concomitant medications were vitamins pills.  On  21Jan2021 , prior to the onset of events, the patient received his first of two planned doses of mRNA-1273 (Batch number : 043L20A) via intramuscular route for COVID-19 infection prophylaxis.  On 21Jan2021, the patient had a sore arm. On 21Jan2021, she immediately developed pain under the last ribcage (lasted from 22 to 23Jan) and then hours 19 to 24hs later the upper abdomen and center of chest became very painful. Didn't have difficulty breathing but was difficult to make a full expansion because of pain. After the 48hs everything except GI area had improved and started using omeprazole and Gaviscon.  The action taken in response to the events, Pain in extremity, Chest pain, Musculoskeletal pain, Dyspnoea, Reflux gastritis was unknown.  The outcome of the events, Pain in extremity, Chest pain, Musculoskeletal pain, Dyspnoea, Reflux gastritis was considered to be unknown.  The treatment medications reported to be taken by the patient were omeprazole and Gaviscon.
Right arm, it's been 10 days now and full neck is stiff, both right and left side of the neck is impacted; Motion of the next obstructed and painful movement; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 19Apr2021 at 15:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not take any concomitant medications. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 10May2021 at 10:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07May2021, at 12:00 the patient experienced stiffness in the neck (left side), motion of the next obstructed and painful movement. It was continuing after 10 days of second vaccination. The patient experienced the neck was impacted from both right and left side. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with pain killer medication (self-prescribed) but now does not help. The clinical outcome of the events of stiffness in the neck and motion of the next obstructed and painful movement were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Experience extreme pain in shoulder and arm since 4/30/2021. No relief at all nothing has helped ease the pain.
Client received her Janssen COVID booster vaccine (lot # 1855194, exp. 4.9.22) on 11.09.21 at 1645. At 1648, client reported that she was feeling dizzy, a little sleepy, had a ringing in the ear with her skin pale and diaphoretic, and was transferred to the anti-gravity chair in semi-fowler position at the vaccination room by vaccinator RN & PHN with A & O x 4. Second PHN came to assist with client. Client denied SOB or any signs and symptoms of anaphylaxis. Client told she didn?t eat since 0800 and had only a snack. At 1650, RN took client?s vitals: BP 86/56, P 50, O2 Sat. 99 %. At 1700, RN took client?s vitals: BP 105/69, P 87, O2 Sat. 99 %, R 15. Client denied any reactions to her first Janssen COVID dose except feeling a little sleepy with after received the vaccine. At 1700, she told she has headache, feeling a little sleepy, has no ringing in the ear, has no dizziness, has no SOB, has no redness, has no swelling on any parts of her body. Client drank water and juice provided without any issues. At 1705, client was transferred to a wheelchair to EMT station due to still feeling a little dizzy again. PHNs and RN continue to assist with client at the EMT station. At 1717, EMT took client?s vitals: BP 116/86, P 88, O2 Sat. 98 %. At 1717, client reported she has a lower stomach cramping with a pain level of a 7 due to client was not able to have a bowel movement. At 1720, client reported nauseous with A & O x 4 and that she has a history of constipation. At 1725, EMT took client?s vitals: BP 98/64, P 84, O2 Sat. 99 %, and client stated ?feeling nervous and anxious? with still having dizziness and lower stomach cramping and feeling cold. RN elevated her feet and client stated she had gas. At 1731, client reported all her symptoms are improving. At 1733, she sat up in the anti-gravity chair and EMT took her vitals: BP 98/76, P 83, O2 Sat. 99 %, T 97.4 F and denied any symptoms. PHN educated client on S/S of anaphylaxis and when to call EMS. Client verbalized understanding. At 1735, client got up from the anti-gravity chair unassisted and left the HCF vaccination site with her parents driving her home.
11/1/19 at 8:14 am, Patient called and said her shoulder has been hurting ever since she received the influenza vaccine on 10/9/2019. She said she did not schedule an appointment with her Primary Care Physician nor took any medication for this pain but did use warm compress on her arm as needed. She was informed to either see her Primary Care Physician or go to Urgent Care for Worker's Comp. She said she will go to Urgent Care.
Information has been received from a physician regarding to a female patient of unknown age. Patient's medical history was not provided. On an unknown date, the patient's husband was vaccinated with 0.65 ml one shot dose of ZOSTAVAX subcutaneous, (lot number was not provided). No other co-suspects were reported. No concomitant medications were reported. The physician stated that he had a male patient, who received the ZOSTAVAX vaccine with no adverse reactions. The patient's wife presented herself with a mild rash, which was diagnosed as shingles. This happened about 2 weeks after the vaccine was given to her husband. The patient's outcome was unknown. Additional information has been requested.
expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient took booster dose. The date on which the vial was initially stored in the refrigerator was 01-Dec-2021. The vial did not undergo any temperature excursion issues.  It was reported that some patients had reported of having flu-like symptoms after receiving the vaccination, but the reporter did not have details on that.  No concomitant medication details was provided. No treatment medication details was provided.
By 10:30 I was extremely nauseous. Nausea continued, getting worse every time I stood or walked, until around 4PM. I felt motion sickness from riding in an elevator or on an escalator. Diarrhea: I had a loose stool around 11AM, and that continued until 11PM (not responding to an OTC anti-diarrheal). By the evening my anus was swollen, painful, and bloody from the number of times I'd had to use the bathroom. Stomach pain: possibly related to the diarrhea/gassiness, my stomach ached very badly until around midnight. It was physically painful to swallow water, soup, etc. (but I kept drinking in order to avoid dehydration). Fever: Around 9PM I took my temperature and it was 100.4F. By 11PM it was 101.1F. Fortunately, the fever broke overnight. Muscle cramps: possibly related to the fever, my back and stomach muscles cramped up to the point where it was difficult to move. I took a warm bath, which helped, but then I started shivering because of my wet skin & fever. By 1AM I was feeling gassy, but the diarrhea had stopped.
Vaccine breakthrough infection; has COVID; has COVID; This is a spontaneous report from a contactable consumer (patient's sister). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced vaccine breakthrough infection, and has COVID. It was reported that the consumer's brother who had the Pfizer COVID-19 vaccine and had breakthrough and has COVID and was hospitalized. The consumer did not want to do a report without the patient's permission. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Pt recvd 3 doses of Engerix-B on 29JAN91, 28FEB91 & 1JUL91 & 13SEP91 lab test indicated did not convert; recvd a booster dose of Engerix-B on 17SEP91;
At exact moment of injection, I had a metallic taste in my mouth. Immediately following injection, I felt lip tingling and numbness. I visited the ambulance on site, no treatment necessary per EMTs because I was without rash or lip/tongue swelling.
At 5:45 I suddenly felt weak all over and had to lay down. Within 15 minutes I started shaking uncontrollably from body chills. Within a half an hour I had a 102.5 fever. After 2 hours the chills had dissipated but my fever was at 103.5. I took acetaminophen and slept fitfully all night. The next morning at 6:00 my fever was still 102 and I felt weak. By mid morning the fever was finally gone and I was exhausted and mildly nauseous for the rest of the day.
Received second dose of Pfizer COVID vaccine on 1/17/2021 at about 10:30 am. Started having soreness in arm, headache, and fever of 99.4 at about 2:30am on 1/18/2021. Side effects persisted all day on 1/18/2021 but relieved with acetaminophen 325mg every 6 hours. All side effects resolved by morning of 1/19/2021. Around 4:30pm on 1/19/21 started having pain in left axilla which was due to swollen lymph node. The pain and swelling progressed over the evening and pain radiated to chest, throughout left arm, and shoulder. All of these side effects continued all day on 1/20/21 but started getting better around 6pm. All side effects resolved by morning of 1/21/2021.
Wrong vaccine administered. Gardasil was ordered but PCV20 was administered. No harm to patient. Patient mom, provider and clinic manager are aware. No further action is needed.
Her arm is sore and swollen. Chills, Body aches down her spine, 99.5 temperature. She feels the vaccine is causing depression.
pt rcvd vax; pt devel hives after vax; pt had low grade t & was given APAP; RN thought hives were allergic reaction to soap & suggested benadryl;
10/03/18 PATIENT had vaccination in Left arm. Both vaccines were injected into the same deltoid per patient request. On 10/5/18 the patient was treated in a local hospital for Cellulitis.
Fever to 102F lasting 24 hours.  Onset approx 7 hours after the vaccination accompanied by chills, fatigue, headache.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (Lot number unknown). Subsequently the patient fainted. It was unknown if the patient sought medical attention. At the time of this report, the patient's outcome was unknown. This one of the several reports received from the same source. Follow-up information has been received which reported that the 15 year old female student with no pre-existing allergies, birth defects or medical conditions on 15-JAN-2010 at 5:00 p.m was vaccinated intramuscularly into the right arm with the second dose (also reported as 1st dose) of GARDASIL (Lot # 663454/0672Y). Secondary suspect therapy included vaccination subcutaneously into the left arm with the second dose of VARIVAX (Merck) (Lot # 665196/1075Y). It was reported that the patient fainted after received the vaccine. The patient's outcome was not reported. No further information is available.
Local rxn about 2CM in diameter characterized by redness, warmth, pain & induration;
A non-serious spontaneous report of chills and fever has been received from a physician's assistant concerning a seven-year-old male subject subsequent to FLUMIST. No medical history or concomitant medications were provided. On an unknown date, the patient received FLUMIST. Two days later, the patient developed chills and fever. No outcome was provided.
Itching below the injection site; Red rash below the injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PRURITUS (Itching below the injection site) and VACCINATION SITE RASH (Red rash below the injection site) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 10-May-2021, the patient experienced VACCINATION SITE PRURITUS (Itching below the injection site) and VACCINATION SITE RASH (Red rash below the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching below the injection site) and VACCINATION SITE RASH (Red rash below the injection site) outcome was unknown.            The concomitant medications were reported as unknown medications for blood pressure, cholesterol and muscle spasms. The treatment information was not provided.  The medical history of the patient is given as blood pressure, cholesterol and muscle spasms.  The action taken with mRNA 1273 with the events was considered as not applicable.
pt recvd vax 16JAN95 t105.8 started jerking; called an ambulance was administered CPR; when ambulance driver got there was stiff as a board, turning blue; no response for ambulance people; convulsed for 5-6 hrs; was adm to ICU;
This spontaneous report as received from a registered nurse refers to a patient of unknown age who in 2007 was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL, in May 2012, was vaccinated with her second dose of GARDASIL and on 23-JUL-2012, received her third dose of GARDASIL (lot numbers not reported). No adverse effects were reported. Additional information has been requested.
Two weeks after booster shot, my skin began to become very itchy and then broke out into hives. My skin became very sensitive in which I needed to take an antihistamine to stop the itching. Even with the antihistamine, my skin was still very sensitive to touch, scratch or heat (such as in the shower) and would become inflamed and red.
Patient received flu vaccine 11/12/21 and started to feel fatigued right before covid vaccine on 11/19/21. He reports shortness of breath that finally resolved today. He is still fatigued, congested and has a headache that improves with tylenol