chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered just the liquid portion of the Pentacel vaccine/no AE; Initial information received on 14-Jun-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 6 months old female patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that administered just the liquid portion of the Pentacel vaccine/ no AE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  On an unknown date, the patient received a dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U6327AA and expiry date: 19-Sep-2020 via intramuscular route in the right thigh.  It was a case of actual medication error due to inappropriate reconstitution technique.  It was unknown if the patient had any adverse 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 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.
06/10/2021 I had a lot of fatigue and joint pain that started it all. Later had itchiness on my legs that turned out to be varicose veins. I also experienced headaches. When I got to see my doctor, it was determined I had arthritis through a MRI exam. (03/22/2021) My back pain was an issue as well. Was prescribed Gabapentin but it gave me too many negative effect and started trying natural alternatives and special exercises. As of today, I have started taking Move Free triple action, CoQ10, and Magnesium Citrate. I have an appointment coming up in June for my back and disc degenerative disease. I get blood tests often but never just for my adverse event.
Shortness of breath; A spontaneous report was received from a consumer concerning a 76-year old male patient who received Moderna's COVID-19 vaccine and experienced shortness of breath  The patient's medical history included cancer. No relevant concomitant medications were reported.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the patient experienced shortness of breath.  He wondered if he should take his cancer therapy.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event "shortness of breath " was unknown.; Reporter's Comments: This case concerns a 76- year-old male patient with a medical history of cancer, who experienced a non-serious unexpected event of Dyspnea. The event of Dyspnea occurred approximately one day (same day) after first dose of mRNA-1273, lot # unknown. Treatment was not reported. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. Of note, patient's underlying malignancy may have been contributory.
left shoulder /deltoid muscle is painful, extremely tender to touch . throbbing  unable to rest against shoulder, ie  in bed / wearing shirt. no erythema noted  pain initiated at 24 hours after injection of JAB #2 discomfort continues despite NSAID use/ ibuprofen
Flu-like symptoms: runny nose, sore throat, nasal congestion, cough, headache, chest congestion
A mother reporter that her 15 month old daughter received her fourth dose of Hib-Titer on 3/2/01. Subsequently, at the age of 30 months and with a history of several bouts of pneumonia and flu, the child did not have a normal antibody response to Hib-Titer. The reporter noted that her daughter's level was specified as intermediate. No further information was available at the date of this report.  Follow up on 06/17/2003: "From initial information received on 02/12/2003, it was reported that a 2-month-old female patient received first doses of ACTHIB, (UA772AA), given in the left leg, IPOL (W0332), given in the right leg, TRIPEDIA (U0845DA), given i the left leg, and PCV-7 (489749), given in the right leg at 16:30 on 01/06/2003.  On 01/10/2003, patient experienced poor appetite, poor feeding, poor sucking, fussiness, developed excess secretions - possibly upper respiratory infection, hypotonia, a weak cry and was lethergic.  Patient was hospitalized on 01/18/2003.  It was reported that the patient did not recover.  Patient's lab/diagnostic tests for metabolic, infectious and neurologic work ups were all negative.  Patient's botulism toxin was reported to be pending.  Patient also received 2nd dose of HBV, (5366D2), given in the left leg on 11/07/2002.  It was reported that the patient had no illnesses was nottaking any medication, or had any pre-existing diagnoses at time of vaccination.  From additional information received on 06/04/2003 from the reporting physician, it was reported that the "patient proved to have botulism, is regaining some milestones, but still has po difficulty".  No further information was provided at this time.
Information has been received from a physician and a licensed practical nurse concerning an 18 year old female who on 11-OCT-2006, 21-FEB-2007, 21-JUN-2007 and 18-AUG-2009 was vaccinated with her first, second, third and fourth dose of GARDASIL respectively (lot # are 653735/0688F, 655165/1425F, 657868/0523U and 661952/1129X respectively).  Suspect vaccination included a second dose of VAQTA (inactive) (dose 2).  Concomitant therapy included MENACTRA (lot#U2866AA) and ADACEL (lot # 3068AA).  The nurse stated that she did not see the third dose of GARDASIL documented in the patient's vaccination chart.  The nurse stated the patient was given the fourth dose of GARDASIL in error.  On 18-AUG-2009, after the patient had received the vaccination she felt dizzy and had syncope.  The patient had loss of consciousness for about 10 seconds.  The patient regained consciousness.  The patient was pale, blood pressure 110/70, Oxygen Saturation on room air 98%.  Oxygen was administered, Oxygen Saturation increased to 100%.  The patient was observed for 30 minutes with blood pressure 102/62.  When the patient stood she felt dizzy.  The ambulance was notified and the patient was taken to hospital.  The patient was not admitted to the hospital.  Per the physician the patient had a seizure after the fourth dose vaccination and was taken to the ER, subsequently the patient was fine.  Upon internal review, the seizure was determined to be other important medical event.  Additional information has been requested.
headache; fever; shivering & amp; muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2022, the patient received the 2nd dose of Shingrix. In April 2022, less than a week after receiving Shingrix, the patient experienced headache, fever, shivering and muscle pain. On an unknown date, the outcome of the headache, fever, shivering and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the headache, fever, shivering and muscle pain to be related to Shingrix.     Additional Information: GSK receipt date: 27-Apr-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient self-reported this case. The patient had received 2nd dose of Shingrix one day before the reporting and had headaches, fever, shivering and amp and muscle pain. The patient asked that how long did these effects lasted. Did not consent to follow-up.
Complained of chest tightness, shortness of breath, closing of throat.  Checked blood pressure 114/76, pulse of 64. Administered 2 diphenhydramine 25mg and observed for a further 30 minutes.  Appeared normal when they left the pharmacy.
Pfizer-BioNtech COVID-19 Vaccine  swollen eyelids both upper and lower of the eye,  severe pain, watery eyes , redness in the eye and pus discharge.  Currently being treated with painkillers and antibiotics
fever, chills, body aches, headache, nausea, vomiting, fatigue
Seriousness criteria other medially significant (OMIC). A 59 year old female pt, with no concurrent illnesses, and a past medical history of asthma, diabetes, and allergy to Daypro, Septra, and Rocephin, had received a right deltoid IM injection of Fluzone SV lot number U2283AA, on 11/30/06. Six to eight minutes post immunization, the pt became tomato red, had shortness of breath, blood pressure increased to 210/110, and anaphylaxis. She was treated with two doses of epinephrine for fifteen minutes, IM Benadryl, IM Dexamethasone and oxygen. She was transported to the emergency room where she was observed, and then sent home. Diagnostic tests performed were not reported. The subject had not received any other vaccinations with four weeks of vaccination on 11/30/2006. At the time of this report, the pt had recovered.
Arm is red and swollen. Dr. gave cephalexin and prednisolone.
PT NOTICED HER LEFT ARM (WHERE VACINNE WAS ADMINISTERED) BECAME DISCOLORED 2 DAYS AFTER RECEIVING THE VACCINATION.  THE AREA OF DISCOLORATION WAS UNIFORM & APPROXIMATELY 3 INCHES BY 2 INCHES.  THE COLOR WENT FROM BEET RED TO A LIGHTER RED OVER THE COURSE OF 2 DAYS.  THE DISCOLORATION WAS NOT ACCOMPANIED BY PAIN, WEAKNESS, SWELLING, SKIN ERUPTIONS NOR TENDERNESS.  THE REDNESS IS NOW COMPLETLEY GONE AFTER ABOUT 2 WEEKS.  THE PATIENT AT NO TIME FELT ILL.
Covid infection.  Sneezing, cough, sore throat, runny nose, gastric distress (nausea followed by diarrhea), skin tenderness, taste and smell lost their connection to pleasure/satisfaction for about 5 or 6 days.  Could taste but couldn?t enjoy or feel satisfied by what I ate.  Strong symptoms lasted 3 days.   Very Slight cough remaining after 5 weeks.
At 09:48 the patient stated that she felt flushed and nauseated. The patient became very pale and complained of stomach pain and being hot. The nurse took the patient's vitals. BP was 100/80, HR 77, and O2 99%. The patient was asked to lie down. The patient was given a snack and some water. The symptoms started to resolve within 5 minutes of onset. Vitals were taken again at 09:55, BP 102/68, HR 103, and O2 99%. The patient was asked to stay 15 minutes in order to make sure she didn't have any other issues. When the patient left she stated that she felt much better and didn't feel hot or have anymore stomach pain.
11 year old male received 1st dose of Pfizer Covid-19 vaccine and was inadvertently administered 12+ dose of Pfizer instead of 5-11 year old dose.
Information has been received from a pharmacist intern via Pfizer (company # 2016112624) referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot number, expiration date, dose and route were unknown). Concomitant medication was unspecified. On an unknown date, after receiving PNEUMOVAX 23, the patient developed swelling. The outcome of swelling was unknown. The reporter stated that since the patient had a previous reaction to PNEUMOVAX 23, he want to know if the patient could received PREVNAR 13. The causality of the event was unknown. Additional information has been requested.
Myocarditis: shortness of breath, chest pain, brachycardia, weaker heart beats. Fever
High blood pressure     Nausea     Loss of appetite     A metallic taste in your mouth     Fatigue     Weakness     Trouble thinking     Sleep issues     Muscle twitches and cramps     Chest pain     Shortness of breath, like fluid builds up in the lungs
Headache, Myalgia, Fever, swollen glans; swollen left side of face; neck ; tongue Narrative: dose 1-day 1-4-pain r arm inj site; day 1-2- ha; fever; myalgia; swollen glands; day 3-7- swollen glands; l face and ear and tongue dose 2-day 1-5 pain in both arms(inj in left arm); day 28 -35 pain in r arm; day1-14-ha; fever; myalgia;swollen glands;ear issues
Hospitalization: 5/6/2023 - 5/8/2023 (2 days) Presentation to the ED: generalized weakness COVID + date: 5/6/2023  Treatment: supportive therapy.  Discharge to: home.  EW0178 8/26/2021 FK9895 4/16/2022 061F22A 10/12/2022
Left thigh anterior edematous, erythematous, warm to touch, tender. Rx: BENADRYL 12.5mg/5ml every 6 hours as needed. Cephalexin 250mg/5ml: 5ml every 12 hours for 10 days. Patient improved as of 5/10/18.
Insomnia - my husband also got the vaccine and we were unable to sleep the entire night.
Covid vaccine arm - 3-4 inch of bump/swelling around where shot occured. Additional severe back pains that impacted leg and back comfort.
WITHIN 5 MINUTES OF RECIEVING THE VACCINE THE PATIENT FAINTED. MYSELF AND ANOTHER PHARMACIST SAFELY GOT HIM TO THE GROUND. WE TOOK HIS BLOOD PRESSURE WHICH WAS FINE. WE BELIEVE IT WAS JUST FAINTING DUE TO GETTING A VACCINE.  WE GAVE HIM WATER AND GATORADE AND WITHIN 10 MINUTES HE WAS BACK TO NORMAL.
Arm pain at injection site on day one and two after injection, that went away.   Swelling, redness, heat, rash, and pain at injection site beginning on day 10 after injection.  Along with headache, fatigue, confusion, dizziness, feeling faint, beginning on day 10 after injection.
Narrative:  COVID infection following COVID vaccine series 08/26, Pfizer,  dose #1 09/16, Pfizer, dose #2 12/29 COVID swab, result: detected 12/25 pt cc:  chills, cough, fever, rhinorrhea, exposure: wife 12/29 CXR impression: No focal  consolidation. 12/28 lactic acid: 0.84 12/28 PT: 11.9 12/28 APTT/INR:  31.2/1.06 12/28 pt admit to Medicine cc: cough, dx: COVID infection,  Neutropenia, COlorectal Cancer LOS: 2 days 12/29 PROCALCITONIN: <0.05  1/4 clinically resolved
SHOULDER BURSITIS FOLLOWING INJECTION.  INJECTION IN AM, LIMITED RANGE OF MOTION BY EVENING. VISITED PRIMARY CARE PHYSICIAN FOLLOWING DAY.  PRESCRIBED STEROIDS. OUT OF WORK OVER WEEKEND.
This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 73-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 21st February 2021) for prophylaxis. On 6th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, 1 day after receiving SHINGRIX, the patient experienced allergic reaction, swollen tongue and throat swelling. On an unknown date, the outcome of the allergic reaction, swollen tongue and throat swelling were unknown. It was unknown if the reporter considered the allergic reaction, swollen tongue and throat swelling to be related to SHINGRIX. Additional details were provided as follows: Pharmacist reported a call was made to a patient about getting her second SHINGRIX vaccine. The patient informed the pharmacist at that time that she had an allergic reaction of swollen tongue and throat with the vaccination. The patient was believed to have notified her physician. The patient noted she awoke the next morning with the swollen tongue and throat. The reporter was consented to follow up.
Redness, Swelling of immunization site - tender. No fever within 12 hrs of immunization.
Pt developed a bump the size of a nickel and the bump had other little bumps inside it from eraser size and smaller.  Color is reddish to pinkish and its 5 dots like a smiley face on side of left arm by SQ.  Still present.
SORENESS OF THE LEFT ARM AND A HEADACHE AND IT LASTED 1 DAY. AND I HAD A LITTLE FATIGUE. THE NEXT MORNING I WENT TO THE ER, THEY CHECKED ME OUT TO SEE IF I HAD COVID AND THEY SAID NO IT WASN'T. SO THE NEXT MORNING I WOULD BE FEELING WELL IN 2-3 DAYS AND THE NEXT MORNING I WAS FEELING BETTER.
vaccine was exposed to 76-degree Fahrenheit for 5 days/ no AE; Initial information was received on 13-Sep-2021 regarding an unsolicited valid non-serious case received from a Pharmacist via Medical Information (Reference number- 00766806) and transmitted to Sanofi on 13-Sep-2021.  This case involves a 60-year-old female patient reported that INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] was exposed to 76-degree Fahrenheit for 5 days with no adverse event (Product storage error).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 09-Sep-2021, the patient received a 0.5 mL (once) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT7319LA and expiry date 30-Jun-2022] via unknown route in left deltoid for prophylactic vaccination.  It was reported, "Caller states they had a temperature excursion, in which a box of unopened pre-filled syringes of FLUZONE QIV were left out on the counter for 5 days, reaching room temperature of 76 degrees Fahrenheit. He then states nine of these doses were used on patients."  It was a case of actual medication error due to incorrect product storage (latency was on same day).  At the time of reporting, patient had no adverse 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 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.
BODY ACHES IN LEGS; FULL BLOWN CHILLS/FREEZING; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced body aches in legs, and full blown chills/freezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches in legs and full blown chills/freezing was not reported. This report was non-serious.
Fever of 101.3 for 12 hours--second day, fever of 99.8; third day, no fever.  Soreness, redness (Red patch on arm 4"x6".  Still presenting on third day), swelling.  Flu-like symptoms with brain fog, body aches, fatigue, loss of appetite, nausea, strong headache, strong muscle pain--day one.  Second day--fatigue, low grade fever, nausea, and brain fog remained.  Third day--brain fog, fatigue, loss of appetite.  Experienced same with Shot 1.  Full recovery occurred after 7 days.  Brain fog presented as serious confusion--making wrong turns when driving, not recognizing surroundings, getting lost, not comprehending instructions and information.  No previous brain issues or reduced cognitive ability.  ER administered Vertigo medication to address brain fog after Shot 1.
2 weeks after shot #1. Redness & bruising at injection site. Red welt was warm to the touch, swollen, about 3" diameter - kind of egg shaped. Bruising in the center. Muscle sore for a couple days. Welt temperature returned to normal after about 3 days. Redness lasted a few days longer, gradually fading.
Moderate to sever Joint pain HA PHOTOPHOBIA  Moderate soreness and swelling at injection site
A day after receiving the Moderna COVID19 shot in my right arm, I broke out in patches of  hives in various part of my body.  I had a patch on my right chin,  on the right side of my neck, my right arm, my right leg, on both of my breast, and on both  of my areola and nipples. I also had an patch of hives above my best area on my right side.   These patches were extremely itchy. I took Benadryl; however, the benadryl did not help.
When I first received shot my left arm start hurting. I was in contact with someone that had COVID-19 , which I was  tested positive with COVID-19.
WHEN DONOR RETURNED HOME FROM FACILITY NOTED LARGE RED AREA 2X2 WITH A HARD AREA TO CENTER. TENDER TO TOUCH. DONOR STATED APPLIED COLD COMPRESSES TO SITE.
RASH AROUND THE SITE AND SOME REDNESS AND SWELLING NEAR THE SITE. SOME BENADRYL WAS SUGGESTED.
This spontaneous report was received from a nurse referring to a multiple patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # M037248 with expiration date on 21-FEB-2019 (dose and route of administration were not provided) for prophylaxis; or with improperly stored ROTATEQ orally, lot # M041814 with expiration date on 27-JUN-2018 and lot # M041184 with expiration date on 31-MAY-2018 (dose was not provided) for prophylaxis. The doses of RECOMBIVAX HB and ROTATEQ were exposed to a temperature excursion of 9 degrees Celsius (°C) to 25°C (13.5°C), during a time frame of 5 hours 47 minutes, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1709USA009285.
eceived a box of expired Fluzone High Dose for Jun 30, 2022 and gave all 10 doses. with no reported adverse event; Initial information received on 21-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA392579(CLUSTER) and 2022SA400367(CLUSTER).  This case involves Elderly of an unknown gender patient who was given expired  INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] for with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ772AA, expiration date: date: 30-Jun-2022) via unknown route in unknown administration site for Immunization.  On an unknown date, the patients developed a non-serious "received a box of expired Fluzone high dose for Jun 30, 2022 and gave all 10 doses. with no reported adverse event" (expired product administered) (latency: same day).  Action taken: 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.