chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID Vaccine Breakthrough CAse  Pfizer Dose 1 2/27/21 (EN6198) Pfizer Dose 2 3/20/21 (ER2613) Pfizer Dose 3 11/5/21 (FF2593) COVID Positive 12/6/21  12/5/21: Patient is 44-year-old female with no significant past medical history who presented to the emergency department for shortness of breath or difficulty breathing associated with nausea and vomiting and diarrhea of 1 hour duration.  Prior to incident patient has been in her usual state of health.  Denied any fever or chills prior to that, no sore throat or runny nose, no chest pain or palpitations, reported shortness of breath with cough and difficulty breathing 1 hour prior to presentation, no abdominal pain but reported nausea and vomiting with diarrhea also 1 hour prior to presentation, no lower extremity swelling, no joint pain or rash.  Did denies smoking, no alcohol use, no recreational drug use, she received Pfizer vaccine and booster, booster was given 1 month ago.  She is full code.   In ED, fever of 102.5, hypoxia as low as 87% and was put on 5 L by nasal cannula.  CT angiogram ruled out pulmonary embolism and showed bilateral lung opacities.  COVID-19 antigen positive.  D-dimer 0.75  12/9/21:  patient is a 44-year-old female with no significant past medical history who presented to the emergency department for shortness of breath or difficulty breathing associated with nausea and vomiting and diarrhea of 1 hour duration.  In ED, fever of 102.5, hypoxia as low as 87% and was put on 5 L by nasal cannula.  CT angiogram ruled out pulmonary embolism and showed bilateral lung opacities.  COVID-19 antigen positive. D-dimer 0.75   Patient admitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia.  Patient is vaccinated against COVID-19.  Patient was requiring up to 6 L test anemia.  Patient on biotic moderate severe, Decadron and 1 dose of Actemra on 12/07/2021.  Patient had a persistent leukocytosis, peripheral smear did acute process.  C diff is negative.  Leukocytosis slightly improved.  Clinic today.  Patient has been improving significantly.  Patient will be discharged home on room air.  Patient did not qualify for home oxygen walk.  Patient will be discharged on antibiotic and Decadron.  Will order COVID-19 home program.
IMMEDIATE 10 MINUTES IN TO 2 HOURS LATER I FELT DIZZY, NAUSEA, LIGHT HEADED, PRESSURE IN EYES, BURNING SENSATION FROM EARS TO THROAT, BLOOD PRESSURE WENT HIGH TO SYSTOLIC PRESSURE OF 180'S, EXTREME PAIN AT INJECTION SIGHT, WAS GIVEN ZOFRAN AND BENADRYL AT 1HR MARK. LATER IN EVENING I HAD FEVER, EXTREME PAIN AT INJECTION SITE  AND TO THE NECK AND BACK AND DOWN TO FOREARM, NEXT DAY I HAVE EXTREME PAIN IN ALL PREVIOUSLY MENTIONED AREAS AND FATIGUE AND OVERALL BODY ACHES AND SINUS PRESSURE
Woke up with vertigo on Thursday.  It got worse throughout the day, so called doctor.  Had a appt on Friday since I couldn't drive to the doctor.  PA called in prescriptions for vertigo (meclizine) and nausea (ondansetron).  Prescriptions delivered the following Monday.  Haven't taken them yet this week because I don't want to be drowsy during work.  PA also instructed me to pull up videos online for Epley maneuvers for me to do at home.
10jan90 pt vacc.  on 17jan90 developed paresthesia/loss of deep tendon reflexes in lower extremities followed by paresthesias in upper extr.  pt hosp w/ muscle paralysis. dx GBS 19jan90 underwent plasmapheresis.walking over 50ft difficult.
Member states 3 days after vaccination, experienced chest pains throughout chest & back.  Continued for 3 days.  Member seen by Dr  on 11/28/2011.
unsure how much of 0.1 mL patient received; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th April 2022, the patient received the 1st dose of Shingrix. On 27th April 2022, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.   Additional Information: GSK receipt date: 29-Apr-2022 Reporter's comment: Pharmacist reported that the patient came for first dose of Shingrix series. During administration, the patient jerked and pulled arm away and the syringe fell on the floor.  There was 0.1 mL gone from the syringe (0.4mL remaining in syringe).  There was also some liquid on the floor, so unsure how much of the 0.1 mL the patient actually received.  The reporter did not had lot number and expiration date information available.  At the time of reporting, the patient had not been redosed.  Consented to follow up. Additional Supportive Information: During administration, some liquid of the vaccine fell on the floor and it was unsure how much of 0.1 ml, the patient actually received, which led to accidental underdose.
Kinrix given not at age 4-6, given at 4 and 6 months old; Kinrix given at 4 and 6 month age; This case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 2nd dose of Kinrix, Kinrix Pre-Filled Syringe Device, the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and extra dose administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient received Kinrix vaccine at the age of 4 month and 6 month. The reporter wanted to know If the patient was given Kinrix vaccine earlier in the vaccination series and not at age 4 between 6 years, can you provide data if that was ok or the office need to repeat the doses using Pediarix vaccine. This patient was from another health system that joined their practice that was administered Kinrix in this way. The reporter did not provided lot number, expiration date and patient identifier. The reporter did consent to follow up. Additional Supportive Information: The patient received Kinrix who was younger than the indicated age which led to inappropriate age at vaccine administration. The patient received extra dose of Kinrix in error, which led to extra dose administered. This case had been linked with US2023015601 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023015601:Same reporter
Severe chest pain  (9/10)reported on the first day. Also Severe pain at the injection site.
Patient seen for routine follow up on 9/28 and feeling/doing well and labs normal including LFTs.  on 10/14 had intradermal 0.1ML MPV vaccine (2nd dose) and some hours later developed burning jaw pain and presented to the ED and was found to have LFT elevation and CPK elevation. he left the ED against medical advice but returned on 10/15 and had full workup including labs/imaging that did not reveal cause for rhabdomyolysis
On 1/26/2021, resident had an elevated blood pressure of 183/102 and he was cold and clammy.   Resident sent to ER via 911.  He was sent home that same day.  On 1/27/2021, resident found sitting in his apartment with a facial droop, slightly slurred speech and left sided weakness.  Resident had also fallen the previous night and on the morning of 1/27/2021.  Resident transported to the ER for evaluation and treatment and was admitted with diagnosis of  TIA; rule out stroke.
RIGHT ARM FEELS LIKE IT WAS COMPLETELY ASLEEP TRIED TO PUT WEIGHT ON IT AND COLLAPSED; NAUSEOUS; TINGLING FINGER TIPS, HANDS AND FEET; FINGER TIPS FEELING LITTLE NUMB/RIGHT ARM FEELS LIKE IT WAS COMPLETELY ASLEEP; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's past medical history included: marijuana use, and concurrent conditions included: alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient takes birth control but was perfectly healthy. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 08-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-AUG-2021, the patient experienced flu-like symptoms. On 11-AUG-2021, the patient experienced tingling finger tips, hands and feet. On 11-AUG-2021, the patient experienced finger tips feeling little numb/right arm feels like it was completely asleep. On 13-AUG-2021, the patient experienced nauseous. On 14-AUG-2021, the patient experienced right arm feels like it was completely asleep tried to put weight on it and collapsed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, had not recovered from tingling finger tips, hands and feet, finger tips feeling little numb/right arm feels like it was completely asleep, and right arm feels like it was completely asleep tried to put weight on it and collapsed, and the outcome of nauseous was not reported. This report was non-serious.
I'm currently 34 weeks pregnant. The reaction I have is a large itchy red bump at injection site. It has grown from Quarter size to now a bit bigger than a ping-pong ball and seems to be spreading more. Arm is sore as well.
Pityriasis across chest; went away without treatment in about 10 days. It wasn't itchy or painful.
he started experiencing shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 3, Booster, unknown manufacturer), for Covid-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset May2022, outcome "not recovered", described as "he started experiencing shortness of breath".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
soreness behind the eyes; experiencing chills; body aches; Headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of EYE PAIN (soreness behind the eyes), CHILLS (experiencing chills), MYALGIA (body aches) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE PAIN (soreness behind the eyes), CHILLS (experiencing chills), MYALGIA (body aches) and HEADACHE (Headache). At the time of the report, EYE PAIN (soreness behind the eyes), CHILLS (experiencing chills), MYALGIA (body aches) and HEADACHE (Headache) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported that patient received Moderna COVID-19 vaccine on Tuesday and last night patient was telling she had been experiencing chills, body aches, soreness behind the eyes and headaches.  Treatment information was not provided.
first vaccine dose on 30Mar2021/ tested positive on 09Apr2021/ he didn't have any symptoms/he got covid; This is a spontaneous report from a contactable consumer (patient). This consumer reported adverse events for him and his wife. This report is for the patient himself.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 30Mar2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received his first vaccine dose on 30Mar2021 while his wife received her first dose on Sunday, 04Apr2021. The Tuesday after the wife received her first shot, she didn't feel good and then Wednesday "she was feelin bad" and Friday, 09Apr2021, the patient took her to the ER and she tested positive. The patient informed that he didn't have any symptoms but when they were in the ER, he was tested because he was around his wife and he also tested positive on 09Apr2021, even though he didn't have any symptoms. He stated having read a paperwork that stated one shouldn't get the second shot if one has covid. The patient wanted to know when or if they can get the second shot. The patient also asked if he got covid because he had the first shot and if "the vaccine becomes live in the system after 7 days" or if it could give someone covid and cause them to test positive. The outcome of the adverse event was unknown.  Information on the lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021427001 same reporter/drug, different patient/AE
While administering the 2nd dose of the Pfizer Covid-19 vaccine series the ¨vanishing needle" syringe malfunctioned, after depressing the syringe plunger the needle retracted prematurely, spilling a majority of the vaccine on to the patient´s arm, less than 0.1 ml administered to patient. Using a new syringe, the full dose of the Pfizer Covid-19 Vaccine administered in opposite arm.
Swelling of wrists and ankles.  Extreme stiffness and pain in wrists, ankles, knees.  Significant pain in both hands, arms and wrists.  Exponential increase in  symptoms of Raynaud's syndrome in both hands and carpal tunnel in both wrists.  All events listed started approximately  two weeks after second COVID vaccine shot.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 51-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included allergy to DELSYM cough medicine, which causes hives. On 01 February 2011, 07 March 2011 and 10 August 2011 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (1 ml, unknown route, unknown deltoid). On 21 September 2011, 42 days after the 3rd vaccination with ENGERIX B, 7 months after 2nd vaccination with ENGERIX B, and 8 months after 1st vaccination with ENGERIX B, the subject experienced not responding to therapy. The subjects titers were drawn on 21 September 2011 and were 0.2 (units not provided). This case involves a pharmaceutical product complaint. The healthcare professional reported that she had seen an increase in non-responders to vaccination with ENGERIX B and was concerned about the vaccine. It was noted that all the vaccines are monitored by several methods for temperature excursions. The healthcare professional reported 7 cases of not responding to therapy following Hep B vaccination. This is case 6 of 7 (see case IDs A0947199A, A0947239A-A0947242A, A0947244A for details of the other reports). Follow-up received from the reporting healthcare professional on 18 October 2011: On 21 September 2011, the subject's hepatitis B surface antibody was less than 0.22 mIU/mL (immunity was noted by the healthcare professional as greater than 0.99). All 3 doses of ENGERIX B were administered intramuscularly, and doses 1 and 2 were given in the left deltoid, with dose 3 administered in the right deltoid.
Dizziness, mild cough, nausea, low grade fever, and sore arm.
At time of the shot nurse noticed an immediate bump at the injection site. Patient then started to have rash down arm.  Ice was applied. Benadryl 25 mg was given.  At the time no throat issues.  Patient drinking water without difficulties.  Rash progressed to neck area.  Patient then complained of lump in throat.  Additional 25mg Benadryl given.  Patient also very anxious and says gets hives and feel lump in throat with that.  Patients rash started to improve and lump resolved.  Rash almost resolved by time of leaving.  Patient felt much better and refused hospital transport.
Hives a week later all over my body 24/7 constant itching and scratching. Now currently on two medications everyday to calm the symptoms.
swollen lymph nodes; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The caller wanted to ask if developing supraclavicular lymphadenopathy was a expected reaction to the vaccine. No treatment medications were provided.
Nose bleed approximately 90 minutes after dosage, extreme fatigue ongoing for 5 weeks, pulling sensation in left shoulder area with limited range of motion, chest discomfort/pressure began approximately 2 weeks after dose,  I had a complete physical with lab tests completed the day before the injection with none of the issues listed above. Nose bleed resolved the next day, chest pressure has subsided, range of motion is improved but not 100%, fatigue is still ongoing but slightly improved  *I asked the pharmacist to submit this report last month but I don't see anything on the spreadsheet that matches my information.
patient received expired FLUBLOK QIV/ no adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Media Information (under reference number 00814739).  This case involves 56 years old female patient who was administered with an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 03-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (total, once, lot QFAA2017 and expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (same day latency).  It was reported "There were 16 patients that were administered the expired Fluzone. The Director was going to transfer me to her assistant to obtain all the patient info. Instead I was transferred to her extension and she did not answer it, I got voice mail. I left her a message as to the specific info that we need and options to get it to us: email or call. I have no info on all of these patients. Some of the patient's birthdays were not available."  At time of reporting, no adverse event was reported and the outcome was unknown for the reported 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.
Vaccines were administered. Patient reports upper arm pain in the left upper arm that has been ongoing since getting her first COVID vaccine in March. She states her arm was swollen almost immediately after the first vaccine, she did not report this to anyone.   Patient reports pain is worse with lying down, aching and tingling pain, constant pain like needles are sticking in her arm, and hurts when raising her arm up putting on her clothes.  She reports no problems after the 2nd vaccine which was given in her right arm.  She states that the arm did swell right after the injection but is not sure how long it took for swelling to go down.
Headache, body ache, low grade fever, fatigue - all for about 12 hours.  Concerning - rapid pulse 96 and over for 19 hours. Lump under right arm forming.
Narrative: Patient experienced dyspnea, muscle pain, fever, and headache after receiving the second dose of the COVID-19 vaccine.
This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 26th February 2019, the patient received the 1st dose of SHINGRIX. On 26th February 2019, less than a day after receiving SHINGRIX, the patient experienced shoulder pain, headache, neck pain, mobility decreased and pain. On an unknown date, the outcome of the shoulder pain, headache, neck pain, mobility decreased and pain were not recovered/not resolved. It was unknown if the reporter considered the shoulder pain, headache, neck pain, mobility decreased and pain to be related to SHINGRIX. Additional details were provided as follows: At the day of reporting, the patient received the dose of SHINGRIX and experienced pain in the shoulder, at the top of her head and neck. The patient could not lift her arm because of the pain. The reporter did not consent to follow-up.
Sore arm right away; developed a lump above my left clavicle that was initially the size of half an inch in diameter - round; felt like a cyst. Had our dr check it out. My dr wanted to see me .Found  It was lymph node that was activated. No treatment. Very sore; whole region around the lymph node really sore and tender to the touch  Had a hard time lifting arm up because it would slide under my clavicle and it really hurt. . Now it is down to the size of a pea. can still feel it  but the pain has subsided. My doctor has seen 12 people so far who has had that reaction.