chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received the first CoVid-19 Pfizer vaccine on 1/23/21. I was very careful not to travel or be about the community after the shot. I felt soreness at the site as well as dull headache, malaise and joint discomfort beginning the next day, 1/24/21. The headache progressively worsened teh following weekend. By Sunday, 1/31/21, I had a stabbing headache 8/10 behind my eyes. I did not seem febrile. I was unbearably tired and sore everywhere. Monday 2/1/21, I was very sore, terrible headache that felt like ice picks to both eyes. I had difficulty staying awake, reading for work. By Tuesday, the body and headaches were 9/10, my vision was disturbed. I could not stay awake, I fell asleep at 4:30 pm and woke to my morning alarm at 7 am Wednesday. I felt less of a headache, but had lost my smell and taste senses and began a slight cough. I tested CoVid-19 positive on 2/4/21 with a pharmacy test. I was told to quarantine and go to the hospital if I had difficulty breathing.  I subsequently reached out to telemedicine and received HCQ, Z pack, prednisone, and ivermectin which I took as prescribed. I was also prescribed breathing treatments which I did not administer.   After quarantine and treatment, I tested again at pharmacy on 2/13/21 as Negative for CoVid-19.
I received the first dose of the Moderna covid-19 vaccine at on February 17. My arm was a bit sore for a day or two, which is typical for me after I receive vaccinations. I had no other symptoms -- no fever, tiredness, or achiness. Then 10 days after the vaccination, on Feb. 26, my arm at the vaccination site began to itch, and I noticed a slightly raised, red patch about 2.5-3 inches in diameter there. I still do not have any other symptoms, and the redness appears to be fading.
lt arm became red & painful around immun site;there was no streaking & the erythematous area was 4cm x 3cm lt arm was painful on movement;tx w/DPH & cold compresses;
Patient had history of feeling dizzy/faint from needle pokes. She thought she'd be alright- but 5 minutes after the vaccine, she got very pale and lightheaded. Staff eased her onto the floor (she did not faint or lose consciousness) and staff raised her feet up on a chair. Then after about 5 minutes on the floor, we had her sit up and helped her to a cot- continued to lay down another 15 minutes. She also had not eaten or had anything to drink yet that day (she was vaccinated at 11:15am). Given apple juice, which also helped her body recover. No injury was sustained.
Patient awoke with pain at injection site, went back to sleep in the AM of the following moring patient reports large red area surrounding injection site.  Called MD.  MD appointment on 10/21/10.  MD diagnosed cellulitis and started patient on Levaquin.
Pt vaccinated with DTP/OPV developed lethargy, weak cry, unresponsiveness, pallor, hypotonia, lasted about 1 day. All symptoms resolved except some hypotonia. No treatment.
tiredness; low grade fever; body aches; arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu unspecified (Flu vaccine).   On 8th October 2019, the patient received the 1st dose of Shingrix. On 8th October 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 9th October 2019, the patient experienced tiredness, low grade fever and general body pain. On an unknown date, the outcome of the pain in arm, tiredness, low grade fever and general body pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm, tiredness, low grade fever and general body pain to be related to Shingrix.  Additional information was provided as follows: The symptoms began to resolve after the 2nd day of vaccine. The reporter consented to follow up.
Blurred Vision Blurred vision, sharp eye pain, eye pressure, abdominal pain, chest pain, loss of vision, light sensitivity, fatugue Narrative:  Patient reports continued loss of vision/severe blurred vision and light sensitivity. Patient never required glasses/any vision correction previously and now requires prescription glasses and adjustment for light sensitivity
This spontaneous report was received from a vaccine coordinator referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reaction/allergies or concomitant information were not reported. On 03-OCT-2016, the patients were vaccinated with doses of improperly stored VARIVAX lot # L032391, expiration date: 26-AUG-2017 (strength, dose and route of administration were not provided). No adverse events were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Follow-up information has been received on 29-NOV-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA001898: US-009507513-1610USA003835: MERCK 1610USA003836:Mfr number.
Pt reports feeling fine initially. But 11 to 12 hours later at night, she felt severely nauseated. Also, pt fainted in the rest room that led to her ER visit. Pt also reports of hitting her head on the floor.
Several minutes after the injection, my right little finger was tingling.   ~0815 I was driving home and lost function in my right little finger. The left side of my jaw felt tight, the left side of my tongue felt thick, and my vision was blurry in both eyes. I also noticed that my heart was out of rhythm and beating rapidly. I had a near syncopal episode. I began having mid-sternal chest pressure. I drove to my home - took 50mg of liquid Benadryl and had someone drive me to the ER.  Symptoms started to resolve within 20 minutes of taking Benadryl.   I was seen at Medical Center.
Tons of cysts showed up in breast one week after second dose.  Not the breast on the side the vaccine was administered.  Also an infected  lymph node on the same side?    Maybe had something to do with vaccine.
Red slightly raised rash developed 1 week after immunization approximately 1 in below injection site.  Rash itches, and has been increasing in size. Started out slightly swollen (1/23), swelling resolved (1/25)
no adverse event; 12 month old pitent was administered a properly stored but expired dose of VAQTA; Information has been received from a medical assistant referring to a 12-month-old patient (gender unknown).  Information about concurrent condition, concomitant medication and medical history was not provided.  On 02-APR-2019, the patient was vaccinated with a properly stored but expired dose of hepatitis A vaccine, inactivated (VAQTA) (lot # R010368, expired date: 25-MAR-2019) (strength and route were not reported) for prophylaxis. No adverse events reported.
Lost "my" menstrual periods for 5 months.; Severe hot flashes; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 25Apr2021 at 13:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient's medical history reported as not applicable. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 04Apr2021 at 10:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Apr2021, the patient reportedly lost her menstrual periods for 5 months. In addition, she experienced severe hot flashes that caused her to believe she was in early menopause. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of loss of menstrual periods for 5 months and severe hot flashes. On an unknown date in 2021, the patient underwent papanicolaou smear test (PAP) and was abnormal with low non-HPV related results; also, it was reported that, the patient had a colposcopy and the biopsy which was done by physician and showed the same results (abnormal). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lost her menstrual periods for 5 months and severe hot flashes was resolved with sequalae on an unknown date in Sep2021.
Initial information received on 26-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 19 years old male patient who was given an expired second primary dose, 1ml on day seven of IMOVAX RABIES lot M1391, expiry date 24 Jul 2018 via intramuscular route in the left deltoid on 25-Jul-2018 for pre-exposure prophylaxis. The patients past medical history, concomitant medication and family history were not provided. It was an actual medication error due to expired vaccine used. It was reported that patient was vaccinated with expired IMOVAX vaccine on 25-Jul-2018 which expired on 24 Jul 2018. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Client reported sudden onset of headache, pressure behind eyes, and nausea around 1142a and itching reported at 1210p. MD recommendation to monitor apply ice and assess vitals and  zofran ordered by MD and administered by cal med. Client refused hospital transport and signed AMA.
She got her vaccine, she was fine until about late afternoon and by dinner she was so cold she was frozen, cold all over, aching, definite pain at the site of the injection.  She went to bed at 8:00 and at 12:00 she got up to use the bathroom, and was unbelievably weak and nauseated and she was completely diaphoretic from her top of her head to her toes and then fainted right next to the bed.  Her husband tried to get her up, she got up and fainted again.  Finally he got her back into bed, and usually they are up at 5:30 to 6:00 AM as they walk 3-4 miles a day, and she got up at 8:00 Am and still didn't feel real great, but feeling pretty decent now.
Redness at injection site, pain when moving injected arm, high level of fatigue, inability to get restful sleep, body aches, crying with no recognized physical or emotional cause
2nd dose delayed beyond 42 days; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose delayed beyond 42 days) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose delayed beyond 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose delayed beyond 42 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported.  Treatment medications was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received and updated non significant information such as contact information confirmed and case information updated.
Varicella-zoster vaccine administered at Pharmacy from prescription by Dr. Patient presented to the Emergency Dept on 03/08/2011 with a mildly pruritic, vesicular rash, mainly truncal and face, scanty bilateral lesions on an erythematous base, no systemic symptoms; patient not on any immunosuppressive medications. Direct fluorescent antibody testing of scrapings from base of vesicles was positive for varicella-zoster virus but negative for herpes simples antigen and negative herpes culture. Patient denied any recent exposures to anyone with zoster or chicken pox. He was evaluated an infectious diseases specialist along with the ID Fellow; he was prescribed valacyclovir.
About 20-25 minutes after injection as I was walking out I felt slightly dizzy, hot and nauseous. Lasted about 5 minutes and I felt OK to go home, but I would not have felt safe to drive after that (I had a friend drive me). This after and evening any exertion, causes the same symptoms now with a mild headache. I feel fine sitting down, but even mild activity brings back the nausea and dizziness in particular.
Tenderness and soreness at injection site immediately following injection. Next day and has continued through, swollen lymph nodes under armpit and side of chest area and in pectoral region. Unable to lower arm completely due to swelling and pain with pressure in area. Swelling beginning 1/9/2022 around 11:30am, first noticed and not relieved with ibuprofen or heat packs until some reduction indicated and noticed until 01/11/2022 around 7:15am.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 70-year-old male patient who received Influenza vaccine Quadrivalent for prophylaxis. Co-suspect products included ADVAIR HFA inhaler (batch number 8ZP0313, expiry date 30th September 2019) for chronic obstructive pulmonary disease and TAMIFLU (batch number UNKNOWN, expiry date unknown) for an unknown indication. In October 2017, the patient received Influenza vaccine Quadrivalent 2017-2018 season. On an unknown date, the patient started ADVAIR HFA (inhaled) 1 puff(s) twice daily (2 puff(s) daily). On an unknown date, the dose was changed to an unknown dose and frequency. In March 2018, the patient started TAMIFLU at an unknown dose and frequency. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2017-2018 season and not applicable after starting ADVAIR HFA, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza (serious criteria hospitalization), collapse of lung (serious criteria hospitalization and GSK medically significant), lung injury (serious criteria hospitalization), diminished lung sounds (serious criteria hospitalization), cough (serious criteria hospitalization) and oxygen consumption decreased (serious criteria hospitalization). ADVAIR HFA was continued with no change. On an unknown date, the outcome of the vaccination failure, influenza, collapse of lung, lung injury, diminished lung sounds, cough and oxygen consumption decreased were unknown. It was unknown if the reporter considered the vaccination failure, influenza, collapse of lung, lung injury, diminished lung sounds, cough and oxygen consumption decreased to be related to Influenza vaccine Quadrivalent 2017-2018 season. It was unknown if the reporter considered the influenza, collapse of lung, lung injury, diminished lung sounds, cough and oxygen consumption decreased to be related to ADVAIR HFA. Additional details were provided as follows: This case was reported by the patient's wife. The patient received flu shot in his left arm. In March 2018, the patient was diagnosed with the flu and started on TAMIFLU. Five days after receiving TAMIFLU, he had a coughing spell and he heard his left lung pop. The patient was diagnosed with a collapsed lung. He went to the hospital. In an effort to inflate his lung, a breathing tube was inserted but it blew two small holes in his lung. He was in the hospital for eight weeks. The reporter indicated that the patient had been on 24 hour oxygen since being discharged from the hospital. It was unknown if the reporter considered the collapse of lung, lung injury, diminished lung sounds, cough and oxygen consumption decreased to be related to TAMIFLU as well. The reporter was unable to provide any additional details related to the TAMIFLU because he no longer had the container. The reporter gave permission for his physician to be contacted.
Information has been received from a healthcare worker referring to two unspecified patients of unknown age and gender. On 14-SEP-2015, the patients were vaccinated with an improperly stored dose of PROQUAD (lot # L008355, expiration date 11-SEP-2016, dose and route were unknown) separately. No adverse effects reported. No PQC involved. This is one of two reports received from the same source. Additional information has been requested.
4 hours after receiving vaccine she had dyspnea, low oxygen saturation levels. EMS called and she was transported to local hospital, then air flighted to Clinic. She was diagnosed with COVID when she was admitted.
Large red spot on arm at the injection site for multiple days after second shot; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 20Apr2021 at 14:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration on 30Mar2021 at 15:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021, the patient experienced large red spot on arm at the injection site for multiple days after second shot. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were not taken as result of reported event. The clinical outcome of the event large red spot on arm at the injection site for multiple days after second shot was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
administration of only diluent portion of Menveo; administration of only diluent portion of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA960A, expiry date 31-OCT-2023) for prophylaxis.   On 12-SEP-2023, the patient received Menveo. On 12-SEP-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: administration of only diluent portion of Menveo) and inappropriate dose of vaccine administered (Verbatim: administration of only diluent portion of Menveo).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-SEP-2023 The medical Assistant reported the administration of diluent portion of Menveo (2 vial presentation) only to a 12 year old patient which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
I am a type 1 diabetic and almost all day my BG?s were in the 40?s.  I have never had that issue before.  I am usually high
Localized swelling, tenderness over injection site, also generalized fatigue, headache, joint pain, sore throat/ears/eyes
Local swelling and soreness - no redness. Fever to 103.3, chills, fatigue.
'My' face felt numb; Tingly from upper lip down into 'my' jaw and neck; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 14Apr2021 at 09:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient reported medical history which included hypothyroidism, high blood pressure (BP), anxiety, depression, allergies, and known allergy to amoxicillin. Concomitant medications included gliclazide (CLARITIN), levothyroxine sodium (SYNTHROID), buspirone (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN) and hydrochlorothiazide, lisinopril (LISINOPRID) for an unknown indication since an unspecified date and is unknown if ongoing. 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 vaccination. The patient previously took first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 24Mar2021 at 09:00 as a single dose for COVID-19 immunisation. On 14Apr2021 at 09:30 the patient's face felt numb/tingly from upper lip down into jaw and neck. This happened approximately 20 minutes after injection. The patient did not receive any treatment for the events of face felt numb/tingly from upper lip down into jaw and neck. The clinical outcome of the events 'My' face felt numb and tingly from upper lip down into 'my' jaw and neck was resolved after approximately 30 minutes from the event start.  No follow-up attempts are needed. No further information is expected.
vaccine administered during temperature excursion; No additional AEs; This spontaneous report was received from a Medical Assistant concerning a patient of unknown age and gender. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 07-NOV-2022, the patient was vaccinated with an improperly storage dose Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live Recombinant Human albumin (rHA) (PROQUAD) 0.5 ml administered subcutaneously (SQ) as prophylaxis, lot number W017571 with expiration date 29-NOV-2023. The vaccine underwent a temperature excursion of 7.8 F for 1 hours and 30 minutes with no previous temperature excursions (Product storage error). No additional adverse events were reported (No adverse event).
Dizziness, Headache, NauseaVomiting, entire left arm and hand is numb with 'pins and needles' feeling off and on, nauseated, dizziness when I stand up and a major headache. Narrative:
patient was diagnosed with bells palsy with in days of receiving flu and covid shots.  came to pharmacy today to ask if we should report this.  She reports that she has had flu shots for years without out event, whereas this is only her 3rd or 4th covid shot.  She still has some signs of Bell's Palsy, but states it is improving.
Day after refusing to bear weight on left leg. Complaining of pain in left knee with extension. No signs of redness, swelling or bruising. No inciting injury. Afebrile and a bit fussier in temperament.