chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had COVID in 12/2020.  When I got my first dose of the vaccine, I was told that I might have escalated symptoms since I had COVID in the past.  Within hours of the vaccine I had symptoms like I did with COVID, mostly diarrhea and GI upset.    I developed allergy symptoms(runny nose, congestion, eye swelling, redness, itchiness) within a few days of the vaccine.  I really noticed them around 8/7.  I thought that I was having seasonal allergies, so I didn't think about it much.  Unfortunately, my symptoms kept escalating, especially my eye pain.  I went to urgent care on 8/15/21 because I thought my "allergies" had turned intonpink eye.  That clinic did not have the right equipment to do a full eye exam, so the provider prescribed erythromycin ointment.  Despite using the ointment as prescribed, my eye symptoms continued to escalate.  On 8/16/21, I had photophobia, extreme pain, swelling, redness, and vision loss.  I went to a different urgent care that had the equipment to fully examine my eyes.  I was found to have a corneal ulcer.  These are usually caused by poor hygiene with contact lenses use or eye trauma.  I had neither of these, so it was a mystery as to what caused my ulcer.  I had to follow a strict regime on eye drops in order to prevent blindness.   On 8/17/21, I went to an opthamologist who confirmed the ulcer and prescribed more eye drops for treatment.  On. 8/20/21 I was due for my second COVID vaccine.  I happened to see that a rare side effect of the COVID vaccine from studies is unilateral corneal ulcers, which is what I have.  I consulted with my opthamologist before getting the shot.  Since we couldn't prove at that point it was due to the vaccine, I considered it safer to get the second dose as scheduled while under his care and on eye drop medications.  I got my second COVID vaccine on 8/20/21 at 2pm, and by 5am on 8/22/21 my left eye had swollen shut.  I was also having increased allergy symptoms, mainly congestion and a runny nose.   I called the on call doctor for my primary care office, who told me that as long as I was breathing OK and I wasn't losing vision again, then I was ok to manage symptoms at home.  I have an appointment with the opthamologist tomorrow for follow up.
Immediately after the second shot, injection site red and irritated. Within 24 hours the injection site was swelling.  The swelling has not gone down?3 months later I have a massive lump and chronic pain/spasms at site. I have tried anti inflammatory cream, pain pills, anti inflammatory pills, medical marijuana cream, CBD Oil, ice, heat?nothing has reduced the lump.
Thursday, day of 2nd vaccine dose: 1) Sore arm within a few hours of 2nd dose (9:00 AM), same reaction to 1st dose. 2) During fitness workout (5:30-6:30 PM), split second of dizziness. 3) At home (7:00) aggressive fever(temp unknown)/chills, dizziness; mild nausea 4) Bedtime (9:30) hallucination for about an hour Friday, day after 2nd vaccine dose: 5) Nighttime (2:00 AM) fever broke, no hallucinations 6) Remainder of day, fatigue (attributed to stress from issues 1-4)
patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021.; patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021.; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021.) and POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 10:48 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021.) and POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021.) outcome was unknown.        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.   On 22-JUN-2021, Excursion time was 8 AM, temp was 35 , total doses given for the day was 36, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 27-MAY-2021, vial was moved to clinic on 22-JUN-2021. 6 vial was moved to clinic. Vaccine BUD date was26-JUN-2021.  Vial was stored on cooler 1 , on 26-Jun-2021, Excursion duration At 9 AM: 35, 10 AM: 39, 11 AM:47, 12 AM:36, 1PM : 42, 2 PM : 43, 3 PM: 43, 4 PM: 37 and 5 PM : 46.  Vials only punctured right before administration  Concomitant products were not provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Treatment medications were not reported.
I tested positive for Covid 19 on Jan 22, 2023 - home test.  +fever, +chills, cough, sinus congestion, +body aches,  I was treated with Lageviro capsules.  48 hours after starting the Lageviro - I started feeling markedly improved.  I am back to my health base line.  But, I still have decreased sense of taste/smell from the first time I had Covid 19 in November of 2020.
hypotension, mild dehydration; fever up to 101, myalgia, malaise;
5x5 diffuse, mild blanching & erythema distal to site; 4cm indurated area @ inject site; no SOB, no axillary node involvement, no fever;
Pt. received FLUZONE ID on 1-6-13. Upon activating the safety device, a lot of liquid squirted out we contacted the manufacturer the next day 1-7-13 at 9:40 AM & they said to re-vaccinate. Second dose administered - PM. Pt. then called a couple of hours later stated hives around the mouth & swollen lips. She took BENADRYL and saw her doctor who gave her a steroid shot & 5 day supply of steroid.
Area around shot became hard, red, and very swollen, and very fevered, and blistered at shot site, and was very pain.
Patient stated the only symptom she had was the night after having the injection was arm pain at the site. She took TYLENOL and it relieved the pain. Nothing else has been reported.
6 doses of a Moderna Covid19 Vaccine that expired on 6Nov2021 were given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 doses of a Moderna Covid19 Vaccine that expired on 6Nov2021 were given) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 doses of a Moderna Covid19 Vaccine that expired on 6Nov2021 were given). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (6 doses of a Moderna Covid19 Vaccine that expired on 6Nov2021 were given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.  The vial was initially stored in the refrigerator on 5 Nov 2021.   This case was linked to MOD-2021-381146 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received and it contains information about patient and vaccine were updated. On 11-Nov-2021: Non significant follow up appended
Tetanus shot was given on 12/03/02. Over the weekend, employee started toexperience discomfort and redness @ site to left deltoid. Pt returned to clinic on 12/09/02. Her left upper arm @ injection site was reddened and hardened  (7 x 4.5 cm) and warm to the touch. Pt has seen by doctor. Pt also has enlarged lymph nodes the 7th of December, Pt improving.
having flashing in his eye; numbness in finger and toes; stomach ache; fever; chest pain; body chills; fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 13-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 13-year-old) as single dose (dose number unknown) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced having flashing in his eye, numbness in finger and toes, stomach ache, fever, chest pain, body chills, fatigue. Reporter is calling to report possible allergic reaction for her son after receiving Pfizer vaccine. Reporter states he had the vaccine on Monday and last night he started having flashing on both eyes, numbness in fingers and toes, stomach ache, fever, chest pain, body chills, and fatigue. Reporter states that she knows some of the symptoms are common but are the chest pain, flashing on both eyes, numbness of finger and stomach ache is unusual. The outcome of all events was unknown.  No follow up attempts are possible. No further information is expected.
Patient reported numbness and tingling of her extremities 4 days following vaccination.  Patient was ultimately diagnosed with cervical myelitis
4 days post vaccination developed 27 x 29mm raised red "bumpy" area on deltoid. Redness is resolving slowly.
redness @ site of inj-blisters, itching below inj;arthralgias;
Patients arm swelled up and appeared cellulitic 24 hrs after receiving KINRIX in right deltoid arm.
Only detail patient provided was that he was hospitalized potentially due to a reaction from Prevnar13.
Pruritic indurated and redness at vaccine site 24 and 48 hours later.
redness; swelling; itching at the injection site; Redness; swelling; itchiness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness), the first episode of VACCINATION SITE SWELLING (swelling), VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE ERYTHEMA (redness) and the second episode of VACCINATION SITE SWELLING (swelling) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 18-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness), the first episode of VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PRURITUS (itchiness at the injection site). On 27-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness), the second episode of VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PRURITUS (itching at the injection site). On 21-Jan-2021, VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PRURITUS (itchiness at the injection site) had not resolved. At the time of the report, VACCINATION SITE ERYTHEMA (redness), the last episode of VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PRURITUS (itching at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Lhermitte?s sign from cervical  to lumbar spine out both upper and lower extremities ,  hypersensitivity to skin and muscle, phantom vibrations and sensations, neck pain, eventual left side upper and lower extremity spasm and paralysis    Taken to ER, admitted to another hospital requiring ambulance ride and hour away , given high dose steroids, after release needed high dose steroid infusions  over the next week. , symptoms slowly decreased but continues to this day to a min to mod degree. MRI show 2 lesions to cervical spine.
Pain, erytheme at injection site in right deltoid. One week later had fever, malaise and extremely weak.
product was reconstituted sterile saline and not the diluent that comes in the package/no AE; Initial information received on 29-May-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a male patient(age not specified) who received HIB (PRP/T) VACCINE [ACT-HIB] which was reconstituted with sterile saline and not the diluent that comes in the package(product preparation error) via unknown route at an unknown administration site on an unknown date for prophylactic vaccination(batch number and expiry date not reported).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to wrong solution used in drug reconstitution.  At the time of reporting, no adverse event 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.  There will be no information available on batch number for this case.
9 days later big red blotch on arm and pian; lethargy; lack luster; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INJECTION SITE REACTION (9 days later big red blotch on arm and pian), LETHARGY (lethargy) and LIBIDO DECREASED (lack luster) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and PRAVASTATIN.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 20-Jan-2021, the patient experienced INJECTION SITE REACTION (9 days later big red blotch on arm and pian), LETHARGY (lethargy) and LIBIDO DECREASED (lack luster). At the time of the report, PAIN IN EXTREMITY (sore arm), LETHARGY (lethargy) and LIBIDO DECREASED (lack luster) outcome was unknown and INJECTION SITE REACTION (9 days later big red blotch on arm and pian) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information provided.
sore muscle near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore muscle near injection site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0448A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore muscle near injection site). On 27-Mar-2021, VACCINATION SITE PAIN (sore muscle near injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided .No treatment details were provided.   This case was linked to MOD-2021-099079 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Follow up received on 29MAY2021, Updated patient height, race, vaccine facility information
Ongoing nausea; Headache; Sore arm; Loss of appetite; Felt sluggish; Numb feeling all the way down arm to hand; Tingly feeling all te way down arm to hand; Nausea; A spontaneous report was received from Consumer concerning a patient 64 year old, female and who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced Headache, Sore arm, Loss of appetite, Nausea, Felt sluggish, Numb feeling all the way down arm to hand and Tingly feeling all the way down arm to hand  The patient's medical history was COPD.  Concomitant products were not provided.  On 24 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number unknown) viz intramuscular route for prophylaxis of COVID-19 infection. Patient stated she had mild side effects of headache, sore arm, loss of appetite and nausea. Patient stated she felt sluggish. Patient stated she had numb and tingly feeling all the way down her arm to her hand. Patient stated she has COPD.  Treatment provided was unknown.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event  Headache, Sore arm, Loss of appetite, Nausea, Felt sluggish, Numb feeling all the way down arm to hand, Tingly feeling all the way down arm to hand is unknown.  Follow up :  A spontaneous report was received from Consumer concerning a patient 64 years old, female and who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced mild intermittent nausea, sore arm, mild headache, ongoing nausea and nausea returned.  The patient's medical history was reported as borderline obesity, high cholesterol, mild COPD, Hepatitis C (15 years ago), foot surgery (3 years ago). The consumer stated she quit drinking alcohol 15 years ago.  Concomitant products was Lipitor unknown indication.  On 24 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number 022M20A), dose quantity 0.5 ml millilitre(s) viz intramuscular route for prophylaxis of COVID-19 infection. Patient stated five hours after the vaccination she experienced mild intermittent nausea. On 25Feb2021, she reported a sore arm, mild headache, and ongoing nausea. On 26Feb2021, she reported the events resolved. No treatment medications reported. She did not report these events to her HCP. On or around 01Mar2021, she reported the nausea returned and is ongoing.  Treatment was not provided .  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event mild intermittent nausea, sore arm, mild headache, ongoing nausea was Recovered / Resolved and nausea returned was Not Recovered / Not Resolved.
Maternal exposure during pregnancy; Paternal exposure during pregnancy; The baby has been diagnosed with Ventricular Septal Defect (VSD); This is a spontaneous report from a contactable consumer (patient's father). This consumer reported information for mother, father (reporter), and fetus/baby. This is the fetus/baby report. Only this case is serious.  A fetus patient of unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), transplacental on an unspecified date (administration time: 12:15AM) (Batch/Lot number was not reported) as DOSE 1, SINGLE and then transplacental on an unspecified date (administration time: 12:15PM) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The mother/father received the vaccine in a pharmacy or drug store facility on unspecified date administered in left arm. The mother/father had no other vaccine in four weeks but had other medications in two weeks (unspecified). The mother/father has no known allergies and no other medical history. The patient's medical history and concomitant medications were not reported. The patient experienced maternal exposure during pregnancy and paternal exposure during pregnancy on an unspecified date. The baby has been diagnosed with ventricular septal defect (VSD) on 29Oct2021. The father reported that they have fathered three healthy children before receiving the vaccine. After his wife and him were both 1 month removed from being fully vaccinated, they conceived a 4th child, who is currently due in Mar2022. The baby has been diagnosed with Ventricular Septal Defect (VSD) and they suspect, but of course can not prove, that the issue results from the vaccine. The events were considered as serious resulting to congenital anomaly or birth defect. No treatment was received for the events. Prior to vaccination, the mother/father was not diagnosed with COVID-19. Since the vaccination, the mother/father has not been tested for COVID-19. The patient had not yet recovered from the events.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101515655 same reporter/drug, different patient/AE (maternal case)
sharp pain; Initial information was  received on 07-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves patient (of unknown demographics) who experienced sharp pain (pain), while he/she received vaccine INFLUENZA VACCINE.  Medical history, concomitant, medical treatment, vaccination and family history were not provided.   On 31-Oct-2017, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported of unknown Expiration date) via unknown route at an  unknown administration site.  On 01-Nov-2017, the patient developed a non-serious sharp pain (pain) 1 day following the administration of INFLUENZA VACCINE.  Laboratory data was not provided.  Final diagnosis was pain.   It was not reported if the patient received any corrective treatment.  The patient outcome is reported as unknown for pain.  Information on the batch number is requested.
Got the vaccine within three weeks of infusion/ can we repeat thevaccination again as she is now 5 months from her last rituximab infusion; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got the vaccine within three weeks of infusion/ can we repeat thevaccination again as she is now 5 months from her last rituximab infusion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder NOS. Concomitant products included RITUXIMAB for Autoimmune disorder.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Got the vaccine within three weeks of infusion/ can we repeat thevaccination again as she is now 5 months from her last rituximab infusion). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Got the vaccine within three weeks of infusion/ can we repeat thevaccination again as she is now 5 months from her last rituximab infusion) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) COVID19 spike protein Ab which are negative.     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.   Treatment medication was not provided