chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Upon awakening after the first moderna dose, patient discovered that her tongue felt swollen and raw.  Foods such as A1 steak sauce became intolerably spicy and all other foods lost their taste.  Patient had covid test prior a day prior to receiving the vaccine and had negative test results.  Patient's tongue has not improved over the 28 days from the first dose.  Has taken benadryll with no improvemet and is still mildly swollen.  Upon evaluation by pharmacist, tongue lacked bright red color.
I received my second shot for COVID-19 on March 1, 2021 at approximately 11:00.  I had no reaction until 2:00 am March 2, 2021.  At that time I was experienced severe pain throughout my body, joints, muscles, etc.  When I attempted to get up I was barely able to move without assistance.  This continued for 3 days.  I returned to work after the 4th day but was still experiencing severe pain throughout my body, especially my joints.  At that time my husband contacted the virus hotline and was told that what I was experiencing was normal and not to worry it will go away in a few days or possibly a couple of weeks.  It has now been a month and a half since I received the second shot and this past week, I experienced symptoms as severe as I had the first 3-4 days after receiving the injection.  My doctor has given several test and ordered several more in an attempt to determine what is causing the problem.  My doctor prescribed a medication for neuropathy that has helped with the pain slightly somewhat.  I am also constantly tired, my blood pressure and heart rate are also elevated  which may be caused by the pain I am experiencing.  Prior to my second shot, the only medical problem I had was my blood pressure has been elevated since I moved to a higher elevation, but this was completely controlled with one amlodipine a day.  Other than that my last physical my blood work showed absolutely nothing to be concerned about.  As a matter of fact, almost all of my levels were text book perfect.  I have always been very active and healthy.  This vaccine is the only thing that I have had or changed that could have affected my health so negatively.
Cannot lift my arm without serious pain. Aleve , Ben gay, ice packs. Heating pad.
Information has been received from a health professional concerning an approximately 10 year old white female who was vaccinated with a dose of Varivax. Subsequently, the patient developed a generalized rash with 50-200 lesions. This case was documented or evaluated by a physician. The child was not hospitalized. No additional information was provided. Additional information has been requested.
the rash became red and solid, itchy, swollen and it spread to her shoulder and elbow; the rash became red and solid, itchy, swollen and it spread to her shoulder and elbow; a trace of redness; a little bit of a rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a little bit of a rash), RASH PRURITIC (the rash became red and solid, itchy, swollen and it spread to her shoulder and elbow), SWELLING (the rash became red and solid, itchy, swollen and it spread to her shoulder and elbow) and ERYTHEMA (a trace of redness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031l20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced RASH (a little bit of a rash). On 20-Feb-2021, the patient experienced RASH PRURITIC (the rash became red and solid, itchy, swollen and it spread to her shoulder and elbow), SWELLING (the rash became red and solid, itchy, swollen and it spread to her shoulder and elbow) and ERYTHEMA (a trace of redness). On 15-Feb-2021, RASH (a little bit of a rash) had resolved. On 03-Mar-2021, RASH PRURITIC (the rash became red and solid, itchy, swollen and it spread to her shoulder and elbow), SWELLING (the rash became red and solid, itchy, swollen and it spread to her shoulder and elbow) and ERYTHEMA (a trace of redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant included High blood pressure med, Cholesterol med Treatment included Tylenol and benadryl cream
After my first dose, I experienced tachycardia which lasted one day. I rested for a couple of hours. Then a few weeks later or on about 01-13-2021, I had an episode where I blacked out, as per my husband I suffered an amnesia.  I had brain fog and could not remember what I had done the previous days. I went to the ER where they did a CT scan of my brain, which was negative. The CT scan showed no evidence of stroke.  I also saw a neurologist who could not find anything wrong with me and the tests that were performed also came back negative. He recommended for me to be off work. I have not been working for two months.
About roughly two weeks after receiving this vaccine I had a migraine. I had never had a migraine before so I went to urgent care, where they told me it would probably go away in a couple of days. It didn't, and I was having a whole horde of visual symptoms (floaters, flashing lights, photophobia, visual aura) so I went to Mass Eye and Ear ER about a week later. They did an examination of my eyes and told me it was all okay, and most likely due to a migraine. I assumed it would go away once more, but never did, with the symptoms continuing to become more frequent/severe. While the actual migraine part (head hurting to specify) would come and go, my visual symptoms never subsided. And despite MEE saying my vision was actually 20/15, so I could still objectively see fine, it was just not normal. I started to have vertigo, and more visual auras (a plain green line in my vision for a couple of minutes), and with these symptoms going on for about two weeks at this point, I went to an urgent care appointment at MGH, through my doctor. They administered some migraine medication (sumatriptan and zofran), but my visual symptoms did not improve. I was then sent to MGH er. They tested me for a whole myriad of things, as well as administering an MRI/MRA of the brain, and MRI of the spine, as well as performing a spinal tap, none of which yielded any significant findings. Many of my visual symptoms still persist, and the headache part, as well as vertigo, comes and goes. It has been almost a month since receiving the first dose and I am waiting to see if symptoms improve with the second. While it is obviously unclear as to whether this happened due to the vaccine or due to a third unknown factor, considering these symptoms developed roughly around the time you allegedly start to gain a significant immunity to COVID, and that no medical professionals have been able to find a clear reason for them, I feel as though it is possible and likely. (Also, I had previously had COVID, testing positive Jan 18th 2021, if that's of any relevance).
After I received my second vaccine shot, approximately 12 hours later I started experiencing symptoms such as: headache, chills, body aches, fatigue, and was lightheaded. Then approximately 24 hrs later a red mark started appearing on my right arm below the injection site. The red mark has become swollen and painful.
Rash/ fever developed 9 days after vaccines where administered. This information was reported by the pts mother via a phone call.
I developed a rash, dermatologist thinks reaction to bug bite, folliculitis, or vaccine. The rash is extensive, covers entire body, and itches. I was on Prednisone tapering dose twice, it still itches  and I cannot get the inflammation to calm down.  I developed blisters and open wounds from scratching the rash in my sleep and I now have cellulitis from one of the blisters and am antibiotics. I have used a variety of eczema and rash care products: so far CeraVe, Gold Bond Eczema,  Aveeno Bath, Aveeno nighttime baby eczema relief, and goats milk soap with manuka honey, calamine lotion, and ice help calm my skin. The rash is still here, since early June, 4 months.
April 2008, started experiencing symptoms of muscle weakness in arms and neck, they progressed to her throat and breathing muscles.  She died 08-21-08.
swole up; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer reported that a 77-years-old female patient received second dose of 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 77-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included sensitivity (not allergy) to iodine, penicillin which goes away by itself. The patient's concomitant medications were not reported. The patient previously took sulfur and experienced sensitivity which goes away by itself. On an unspecified date, the patient experienced swole up. When they went to see into her heart they gave her a lot of stuff, she swole up, they didn't tell her 100% that it was caused by the iodine. Also, an injection with painkillers made her swell up once. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
High fever of 102.5 that couldn't go down with ibuprofen or acetaminophen, achy joints, lethargic, loss of taste and smell.
Left armpit lymph-node got Swollen day after the  second dose of Pfizer vaccine and continues to stay swollen.
The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Medical Information (Reference number- 00303291) and transmitted on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA277871, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised. It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, no adverse event was 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.
Patient received expired medication. confirmed with manufacturer that dose maintained its efficacy. No follow-up needed. no adverse outcome.
Pt is 14 y/o and presented to COVID vaccination clinic with her parent for COVID booster. Mom thought pt was due for a 3rd vaccine given pt's high risk status due to her asthma. 3rd dose was given to patient on 12/10/2021. Mom called office on morning of 12/13/2021 stating pt's left arm was swollen and painful as well as patient was experiencing some swollen lymph nodes under her left armpit. Mom had been treating with pain reliever medications (Tylenol) and had sent patient to school that day.
10mm X 10mm raised, itchy welt on upper L arm. Office visit on 10/30/04.
This spontaneous report was received from a registered pharmacist concerning an approximately 65 year old male patient with no drug reactions or allergies. Current condition of the patient included hypertension. On 22-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date were reported as J004269 and 12-JUL-2014 respectively), subcutaneously in the right upper arm. Concomitant therapies included hydrochlorothiazide, LISINOPRIL, amlodipine, MOBIC, simvastatin (manufacturer unknown) and potassium supplement (unspecified). Approximately on an unknown date in September 2013, the patient developed a red rash at the injection site. The area of the rash was about the size of a quarter. There was no pain or itching. The patient sought medical attention (came into pharmacy). No treatment was provided and no lab tests were performed. The patient was not recovered from the red rash at the injection site at the time of report. The relatedness for red rash at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Within 5 min of administration to (R) glut (Quadrivalent IM Flu), pt c/o feeling dizzy. Seated pt - c/o stomach ache, then vomited. (+) pale -> recovered, VSS after 25-30 min. Sips of water.
Chills; Severe headache; Fatigue; Vomiting 2x; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 27Mar2021 at 08:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 06Mar2021 at 08:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included statin (MANUFACTURER UNKNOWN) and escitalopram oxalate (LEXAPRO). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 19:30, the patient experienced chills, severe headache, fatigue, nausea and vomiting 2x. Lasted about 36 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was taken for the reported events. The clinical outcome of the events chills, severe headache, fatigue, nausea and vomiting was resolved on an unspecified date in Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Case previously recorded as MA2009-3454. Initial case report received via MedCom from a health care professional on 30 OCT 2009: multiple pregnant female patients (no further information available) were vaccinated with 0.5 ml of S-OIV FLUVIRIN (batch no. unknown) i.m. on 29 OCT 2009. The vaccine may had been exposed to temperatures between 79 and 80 F. No adverse event was reported. MedCom ref. no.: NA09-007291. Follow up report received on 26 Apr 2010: There were two attempts to contact reporter, but no response received so far. Therefore the case was closed with a consideration as a lost to follow up.
Infant had a siezure, MOC describes infants eyes as rapidly moving, jaw opening and shutting, head, arms, body, and legs shaking, head arched posteriorly.  Episode lasted approximately 8-10 minutes.  Immediately following episode infant went limp.  Moc drove infant to the ER, they performed multiple tests.  Ct spent 5-6 hrs in the ER and then released.  Infant has had no more seizure activity since this time.
3 days after receiving flu shot (listed as   FLU VACCINE 6MOS AND OLDER PRESERVATIVE FREE IM) in records, sudden onset of shortness of breath. Symptoms still present daily as of December 20,2022
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), in Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Patient developed hives on 12/5 and swelling, hardness and tenderness (cellulitis) at site on 12/6.
pt recvd vax & h/a, lightheadedness, nausea, pain at inject site w/in 15 mins; low grade t 99; hives neck, chest, back & cheeks; erythema; edema; inc color @ inject site; tx O2 by NC, epi and meds.
This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre syndrome in a patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The patient developed Guillain Barre syndrome after receiving the flu vaccine (manufacturer not confirmed). The call got disconnected before any additional information could be obtained. The contact information for reporter was not obtained before call disconnected.
Pain and numbness in left arm since the vaccination (was just informed 11/21/14). Also lost feeling in left hand day after shot. Went to see Dr twice. Referred to another Dr. waiting to go for appointment.
Patient was administered Moderna 0.5 mL intramuscularly into right deltoid muscle around 3:30pm. Around 15 minutes later, patient experienced itchy rash on both arms, tingly feeling around stomach area and felt warm over the chest area. Patient also developed feelings of nausea and had pain 7/10 at the right arm of injection site. Patient was given Diphenhydramine 50 mg (1 mL) intramuscularly into left deltoid muscle around 3:50pm.
Not feeling well; Feels fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administration date 28Sep2021 (Batch/Lot number: unknown) at the age of 53 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE1, SINGLE), for COVID-19 Immunization. The following information was reported: MALAISE (non-serious) with onset Sep2021, outcome "unknown", described as "Not feeling well"; FATIGUE (non-serious) with onset Sep2021, outcome "unknown", described as "Feels fatigue". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This patient tends to faint. Post Tdap. Pt became pale & looked about to faint & was made to lay down, within 10 minutes, no longer pale. Other vx given (VARIVAX/MENACTRA) but pt made to lay down in between without problem.
Tingly/numbness down right arm to fingers on right side. Tingly/numbness feeling up shoulder/neck, cheek, lips, tongue. Mostly on right side. Cheek a little swollen. Sore arm. Headache on right side.
anaphylaxis; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis". In another study, anaphylaxis was confirmed after the first dose in 7 patients who received BNT-162b2 vaccine and 9 patients who received mRNA-1273 vaccine. The CDC had reported a rate of 2.5 cases per million doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. ,Linked Report(s) : US-PFIZER INC-202200681973 Same article/ drug/event and different patient: