chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left leg was cold and my right leg warm to the touch. I was freezing., nausea; left leg was cold and my right leg warm to the touch. I was freezing., nausea; left leg was cold and my right leg warm to the touch. I was freezing., nausea; left leg was cold and my right leg warm to the touch. I was freezing., nausea; Arm hurt really bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt really bad), PERIPHERAL COLDNESS (left leg was cold and my right leg warm to the touch. I was freezing., nausea), SKIN WARM (left leg was cold and my right leg warm to the touch. I was freezing., nausea), FEELING COLD (left leg was cold and my right leg warm to the touch. I was freezing., nausea) and NAUSEA (left leg was cold and my right leg warm to the touch. I was freezing., nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt really bad). On 05-Mar-2021, the patient experienced PERIPHERAL COLDNESS (left leg was cold and my right leg warm to the touch. I was freezing., nausea), SKIN WARM (left leg was cold and my right leg warm to the touch. I was freezing., nausea), FEELING COLD (left leg was cold and my right leg warm to the touch. I was freezing., nausea) and NAUSEA (left leg was cold and my right leg warm to the touch. I was freezing., nausea). On 05-Mar-2021, PERIPHERAL COLDNESS (left leg was cold and my right leg warm to the touch. I was freezing., nausea), SKIN WARM (left leg was cold and my right leg warm to the touch. I was freezing., nausea), FEELING COLD (left leg was cold and my right leg warm to the touch. I was freezing., nausea) and NAUSEA (left leg was cold and my right leg warm to the touch. I was freezing., nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurt really bad) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No new significant information was provided. The reporter's contact information was updated.
Pt came in for her first dose of the Pfizer vaccine. She told her vaccinator that she was allergic to bees and penicillin, she was instructed to wait for 30 minutes after her shot instead of 15 minutes. As she waited in the Waiting room, the volunteer noticed that she was itching and approached her to see if she was okay. She said that the pt removed her mask and her lips were swollen and she began holding her throat while wheezing "allergic". The volunteer notified the RN who came to the pts side. The patient gave herself her own EpiPen and later our RN administered a second dose. O2 was started and 911 was called. She lost consciousness and we placed her on the ground and began manual breathing treatments until the fire dept arrived. They began to administer medicine until the EMT arrived and took her to the hospital.
swelling, discomfort lt axilla-size of quarter to half dollar;cleared spontaneously;mom reported rxn by phone;pt was not seen;mom also located record that had TD 23MAY95;
Local swelling + pain at site of injection 8x10cm area (L) upper arm.
Lymph nodes became swollen within about 4 hours. At hour 8, I noticed sore bumps on my left buttocks. At that point, I went to see my PCP, who then suggested a Midwife/OBGYN. I went in to see one and she thought it was vaginitis and took a sample. I had a lot of candida infection and started taking medication. I also took acyclovir to speed out the herpes outbreak and then it started to ease up. I have been feeling in general more tired and muscle fatigue. Lab work was done because sex was painful. My OBGYN thought to give me progesterone to help with that.
dizzy / light dizziness / light headed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy / light dizziness / light headed) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A1) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Blood pressure high.    On 25-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced DIZZINESS (dizzy / light dizziness / light headed). At the time of the report, DIZZINESS (dizzy / light dizziness / light headed) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided.
L arm was red, swollen, and felt warm. Pt mom denied any pain or any other symptoms. Pt's mom was advised to apply warm pads on to area ad to follow up if no improvement was made.
had a 3 day migraine; This case was reported by a consumer via licensee and described the occurrence of migraine in a 53-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   The patient's past medical history included blood pressure high, hypothyroidism, anxiety and depression. Concurrent medical conditions included diabetes. Concomitant products included lamotrigine (Lamictal), levothyroxine sodium (Synthroid), duloxetine, methylpropylpropanediol dinitrate, acetylsalicylic acid (Aspirin), gabapentin, colecalciferol (Vitamin D3), cyanocobalamin (Vitamin B12), lisinopril, metformin hydrochloride, insulin detemir (Levemir), melatonin, memantine hydrochloride (Namenda), black cohash extract/herbals/green tea extract/minerals/phytoestrogens/vitamins/, docusate sodium (Colace), paracetamol (Tylenol) and ibuprofen.   On 12th August 2020, the patient received Tdap Vaccine. On an unknown date, less than 9 months after receiving Tdap Vaccine and an unknown time after starting Lamictal, the patient experienced migraine. On an unknown date, the outcome of the migraine was recovered/resolved.   It was unknown if the reporter considered the migraine to be related to Tdap Vaccine.  Additional details were provided as follows: The patient's ethnicity reported The patient had medical history such as diabetes form 2016, blood pressure high, hypothyroidism, anxiety and depression. On 12th August 2020, the patient received Tdap Vaccine. On an unknown date, less than 9 months after receiving Tdap Vaccine , the patient experienced migraine. On an unknown date, the outcome of the migraine was recovered/resolved. The patient received concomitant medications such as lamotrigine (Lamictal) 100mg once a day, levothyroxine sodium (Synthroid) 75 mg once a day for hypothyroidism, duloxetine 120 mg once a day for depression, methylpropylpropanediol dinitrate 15mg once daily for depression, acetylsalicylic acid (Aspirin) 81 mg on Monday , Wednesday and Friday for pain , gabapentin 200mg once a day for diabetes, colecalciferol (Vitamin D3) 5000IU Tuesday , cyanocobalamin (Vitamin B12) 1000mcg tuesday, lisinopril for high blood pressure, metformin hydrochloride 500mg in morning and 100 mg in evening for diabetes, insulin detemir (Levemir) 28 unit at bedtime for diabetes, melatonin 0.5mg-1.5mg , memantine hydrochloride (Namenda) 10mg tablet twice daily, black cohash extract/herbals/green tea extract/minerals/phytoestrogens/vitamins/ 500mg once a day, docusate sodium (Colace), paracetamol (Tylenol)  for pain,azo capsule and ibuprofen. On 07th April 2021 patient took covid-19 vaccine and experienced events. The reporter consented to follow up.
This spontaneous report as received from a pharmacist refers to an adult patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on 25-AUG-2014 the patient was vaccinated with (Oka/Merck) PROQUAD (strength, route not reported) lot # K007798 instead of M-M-R II. The reporter also stated that PROQUAD that was administered to the patient was improperly stored. No symptoms reported. The outcome of events reported as unknown. No product quality complaint was involved. Additional information has been requested.
Rashes spread around on my arms, chest and on my legs/took a biopsy and came back and said it was 'drug induced; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 23Feb2021 (Lot number: EN6201, Expiration Date: 20Jun2021) at the age of 79 years as dose 1, single and administered in arm, administration date 29Mar2021 (Lot number: EN6205, Expiration Date: 20Jun2021) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN. The following information was reported: DRUG ERUPTION (non-serious) with onset 26Mar2021, outcome "unknown", described as "Rashes spread around on my arms, chest and on my legs/took a biopsy and came back and said it was 'drug induced". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of drug eruption.  Additional information: She took a biopsy and came back and said it was 'drug induced' and just another day she took couple other samples. Therapeutic measure for rash taken was prednisolone and patient have been through a whole lot of stuffs that did not work. Patient got rash that started 10 days after his first shot of the Pfizer BioNTech COVID-19 Vaccine and was still continued after his second COVID-19 vaccine and his doctor gave him medication to help and he still have the rash and he was taking steroids now to try to get rid of it." Medication for the rash was prednisolone and he had been through a whole lot of stuffs that did not work. The patient had been through couple of drugs (unspecified medications) steroids, and it did not work. Dermatologist gave a prescription for steroids, 50 mg for 4 days, 40 mg for 4 days and 30 mg for 4 days. Patient do not have any symptom of the COVID, all the patient had was the reaction.  No follow-up attempts are possible. No further information is expected.
Headache, blackout, difficulty breathing, syncope with tonic-clonic limb motion that lasted a few minutes;  occurrence was approximately 15 minutes after vaccination.
Adacel was given to 5 year old, no AE; child received Adacel instead of Daptacel, no AE; Initial information received on 19-Feb-2020 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves a five year old female patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6273AA, Exp. Date 24-Apr-2021) via intramuscular route in the left deltoid for prophylactic vaccination instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  At the time of report, no adverse effects had been observed.  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.
Case number PHEH2013US012492, is an initial spontaneous report received from the physician on 07 Jun 2013. This report refers to a 17-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A12011) intramuscularly on 03 Jun 2013. On the morning of 04 Jun 2013, she began to experience intermittent dizziness and nausea that lasted for an hour at a time. It was reported that the events were debilitating to the patient. The event outcome was reported as condition unchanged. The seriousness and causality was not reported. No additional information was available.
Area of 2 inch diameter around and including the injection site is raised, firm, warm, and red. Area feels tender.
All he wants to do is sleep all day long/ he is sleepy; He is very sick; This is a spontaneous report received from a contactable reporter (consumer).  An 85 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in deltoid left, administration date 12Mar2021 (Lot number: EN6204) at the age of 85 years as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing); "He fell over a month ago and hurt his back" (unspecified if ongoing). Concomitant medications included: PHENOBARBITAL; PHENYTOIN; ZOCOR taken for blood cholesterol abnormal. The following information was reported: SOMNOLENCE (non-serious) with onset Mar2021, outcome "unknown", described as "All he wants to do is sleep all day long/ he is sleepy"; ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "He is very sick".  Additional information: The reporter was the patient's wife. Vaccination facility type was pharmacy/drugstore. Reporter stated, "He fell over a month ago and hurt his back and that's all." The patient was also taking vitamins. Reporter stated, "He don't want to get the Covid, but when I had Covid, my son had Covid, he never got it." Reporter stated that the event happened "2 or 3 days later." Reporter stated, "A week ago Friday, my husband got the Covid vaccine. All he wants to do is sleep all day long. Now listen to me, he did not get Covid because I had it in December and he never got that. He's been in good health and I got my paper out and there was no side effect that says he wanted to sleep all the time and I am talking about sitting in his chair and he is sleepy. I don't know what to do about it. He is very sick, and I don't understand this. I wouldn't mind reporting it. I don't know if you are getting anything like this. I want to know what to do about it."  No follow-up attempts are possible. No further information is expected.
allergic reaction with the Pfizer BioNTech Covid-19 vaccine; 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 41-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction with the Pfizer BioNTech Covid-19 vaccine".  Additional information: Consumer's mother wanted to know if Paxlovid can be crushed. Consumer's mother mentioned in passing that her daughter had an allergic reaction with the Pfizer BioNTech Covid-19 vaccine and asked if Paxlovid can be crushed. Her daughter also will be getting Epipen after getting vaccinated and she finds it hard to swallow Paxlovid. Caller asked if there are alternatives aside from Paxlovid tablets. Caller asked when Paxlovid is prescribed (if her husband is diabetic and had covid symptoms, can he take Paxlovid)  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
hives down bilateral exposed skin - Benadryl oral tab provided with relief.  Hives disappeared by 12:45PM
This spontaneous report as received from a healthcare worker, refers to unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, since 12-JUN-2015, the unspecified number of patients were administered an unspecified number of improperly stored doses of PEDVAXHIB (lot #K025002, expiration date 20-JUL-2017) (dose, frequency, route of administration and indication were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a consumer concerning a friend who was vaccinated with a dose of ZOSTAVAX. Subsequently, the patient experienced fatigue, knee swollen and pain in arm, shoulder and wrist and knee pain. At the time of report, the outcomes were unknown. There is another patient had similar symptoms after received ZOSTAVAX (WAE #0803USA03918). Additional information has been requested.
Patient given booster dose of Moderna  monovalent after policy changed on 9-3-22 when bivalent was not yet available.  No adverse reaction or complaints reported by patient.  Will update when bivalent is in stock.
Sore arm at injection site; aching body; shivering all day 10/2/19.    Took Excedrin, helped a little.
Swelling at injection site on left hip (large welt)                            Symptoms lasted for four days Fever Chills Nausea Vomiting Fatigue Muscle and joint pain
Patient states that she got vaccine on 06/07/2021 in morning, and by that night there she had some itching, redness, swollen on left leg. patient states that there are multiple red blotches all over left leg. Patient hasn't been to doctor yet for treatment of AV.
Patient received vaccinations and while sitting she stated she felt dizzy. I laid her on exam table and she felt better. BP 104/58.BP sitting 104/62 and BP standing 99/67. Patient drank water and ate crackers since she hadn't eaten since breakfast. I walked patient to car and stated to her to go eat something and if symptoms worsened to go to ER.
Started with severe chills.  Developed headache and stomach upset.  Very tired and fatigued.
swelling during all the night; tingling during all the night; it looked like the hives; Then she woke up in the morning and had a rash all over the body; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING (swelling during all the night), PARAESTHESIA (tingling during all the night), URTICARIA (it looked like the hives) and RASH (Then she woke up in the morning and had a rash all over the body) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (swelling during all the night), PARAESTHESIA (tingling during all the night), URTICARIA (it looked like the hives) and RASH (Then she woke up in the morning and had a rash all over the body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SWELLING (swelling during all the night), PARAESTHESIA (tingling during all the night), URTICARIA (it looked like the hives) and RASH (Then she woke up in the morning and had a rash all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was not on any concomitant medication.  The vaccine was administered on the patient left arm, which was the non dominant arm.
received a double dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (received a double dose of the vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included ADD and Anxiety.    On 11-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (received a double dose of the vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (received a double dose of the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications included an unspecified ADD (Attention deficit disorder) medication and an anxiety medication.  No treatment drugs were reported.
On way out of the office, pt felt dizzy and fell on floor, hitting the back of the head. Physical exam afterwards was normal with stable BP and vital signs. Pt continued to be dizzy and was transported to ER.
No adverse effect; Altered dosing schedule: patient had Gardasil 9 on 8/11/2016, 6/30/2017 and 7/30/2019; This spontaneous report was received from a physician refers to a 19 years old patient (age at second vaccination). The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-AUG-2016 the patient was vaccinated with first dose, on 30-JUN-2017, patient was vaccinated with second dose and on 30-JUL-2019 patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R003557, expiry date: 20-NOV-2020) 0.5 milliliter (0,2,6) for prophylaxis (inappropriate schedule of product administration) at an altered dosing schedule). No adverse effects reported (no adverse event).  This case is linked to case# 1907USA016663 (same reporter and different patient).; Sender's Comments:  US-009507513-1907USA016663:
This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-APR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, lot # L027076, expiration date 25-MAY-2017 (dose was not reported) and PEDVAXHIB lot # L035880, expiration date 11-AUG-2018 (dose and route of administration were reported). There was no adverse effect reported. No product quality issue was involved. Administered dose of vaccine experienced the temperature excursion of low - 28 degrees Fahrenheit for 5 hours on 22-APR-2016. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Initial case was received from a health care professional on 07 October 2009.  A 52-year-old female patient experienced hypotension, difficulty breathing, generalized weakness, and hearing loss after receiving an injection of FLUZONE No Preservative 2009-2010 (lot number U3174EA) on 30 September 2009.  The patient had a history of hypertension, right hip replacement, B-12 deficiency, and depression.  On 02 October 2009, two days post-vaccination, the patient presented with a blood pressure of 70/40.  She also complained of difficulty breathing and generalized weakness.  On 03 October 2009, she noticed a decrease in hearing.  She was hospitalized, and was undergoing a diagnostic work-up at the time of the report.  According to the reporter, BUN, creatinine, liver function tests, and amylase were all elevated.  Documents held by sender:  None.
Received H1N1 mist on 10-26-09 and developed left eye blocked tear duct on Tuesday night (within 48 hours). Went to doctor & Dx with blocked tear duct and infection. Tx with antibiotic and steroid. Returned to doctor on 11/2/09 for increased swelling and pain-required lancing and drained. 11/19/09 Returned to office and eye drained again. Continued on antibiotic. No infection at present 11/23/09.