chrisvoncsefalvay/vaers-outcomes huggingface dataset:
large lump in arm opposite site of injection; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 31Mar2021 at 14:15 (at the age of 75-year-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN), telmisartan (MICARDIS), fish oil, tocopherol (OMEGA 3) and vitami (MANUFACTURER UNKNOWN); all from unknown date for unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in right arm on 10Mar2021 at 14:15 (at the age of 75-year-old) as a single dose for COVID-19 Immunisation and previously took docetaxel (TAXOTERE) on unknown date for unknown indication and experienced drug allergy. 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. On 01Apr2021 at 09:00 the patient experienced large lump in arm opposite site of injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event large lump in arm opposite site of injection was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
lymph swelling in arm pit so large that it hurt to apply deodorant; swelling at injection site; Redness too. Size of a golf ball.; This is a spontaneous report from a non-contactable consumer reporting for herself. This report was received via a sales representative.     A 38-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.   The patient medical history was not reported.   The patient's concomitant medications were not reported.  The patient experienced lymph swelling in arm pit so large that it hurt to apply deodorant on 2021 with outcome of unknown , swelling at injection site  on 2021 with outcome of unknown , redness too size of a golf ball on 2021 with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse concerning a male patient who in 2010 was vaccinated with a dose of 0.5 ml of PNEUMOVAX 23 (lot# not reported). The nurse stated that the patient after getting the vaccine, experienced nausea and vomiting for 36 hours. The patient sought unspecified medical attention. Additional information has been requested.
On morning of 8/5/2020, patient developed fatigue, headache, fever, photo-phobia, and nausea. He vomited three times before being seen at the clinic in the afternoon.  No known injuries or recent illnesses. Received Dtap #2 vaccination on 8/4/2020. This patient may be experiencing encephalopathy post vaccination. Recommended supplements to support patient's immunity.
Itchy injection site; Sore injection site; Red injection site; Swollen injection site; Hot injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE PAIN (Sore injection site), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE SWELLING (Swollen injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE PAIN (Sore injection site), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE SWELLING (Swollen injection site). On 17-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy injection site). At the time of the report, VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE PAIN (Sore injection site), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE SWELLING (Swollen injection site) 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.   Treatment details included antihistamine and steroid ointment.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient received Paxlovid for covid-19 from 18Jul2022 to 20Jul2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. The pharmacist reported that on 06-MAR-2017, the patient was administered an expired PNEUMOVAX23 (strength, frequency and lot number were not provided) at a dose of 0.5 ml, intramuscularly for prophylaxis, with expiration date of 16-FEB-2017. No adverse effects reported. The Physician called to inquire about potency of expired dose of PNEUMOVAX23 which was administered. No further information provided. There was no product quality complaint (PQC) involved. Additional information has been requested.
Longer than recommended time from first vial puncture to vaccination. Vial was punctured between 3&5pm on 6/6 and patient was vaccinated 6/7 between 1&2 pm. Vial  remained refrigerated. Attempted to contact patient 6/8. Consult requested, awaiting results from Janssen safety team regarding viability of vaccine.
Edema, red and warm to touch. Treated with antibiotics and Benadryl. Dx: cellulitis.
Injection site rash (7inches by 5 inches) 4 days after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Injection site rash (7inches by 5 inches) 4 days after vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE RASH (Injection site rash (7inches by 5 inches) 4 days after vaccination). At the time of the report, VACCINATION SITE RASH (Injection site rash (7inches by 5 inches) 4 days after vaccination) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
large, red rash on left arm surrounding injection site. rash is hot and spreading. I instructed on taking benadryl when she gets home to see if this helps the rash resolve and then to seek medical care for potential cellulitis
About 2" x 3" area of erythema with mild swelling and warmth to left deltoid at DTaP site.
Urticarial skin reaction developed ~36 hours after dose administration starting on groin and expanding diffusely. No airway compromise. Receiving oral antihistamine daily and IM methylprednisolone on date of visit (3/12) followed by 5 day oral steroid taper
6 days post administration, onset with localized hives 8 inch circle surrounding (L) deltoid injection site.
Redness and swelling at site of injection and down toward the elbow began on Thursday (8/22/19) she iced the area and took Benadryl, but the area remained swollen, red and became hot to the touch.  On Sunday, 8/25/19, she went to express care and was told to take zyrtec along with the benadryl and continue to ice the area.  She did this until Tuesday, 8/27/19, when she returned to express care and was given prednisone 20mg daily and was told to continue zyrtec and icing.  Today, 8/29/19, the redness and swelling have come down.  It is no longer hot to the touch, but her arm still feels strange.
numbness in left toes - mainly  middle toes; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; unknown) via an unspecified route of administration into left arm as first single dose for COVID-19 immunisation on 18Mar2021 at 10:30 (at the age of 62 years). Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, patient had not been tested for COVID-19. The patient had allergies from dust mites and grass. Concomitant medications included nexum (MANUFACTURER UNKNOWN) for unknown indication started from unknown date, floranase (MANUFACTURER UNKNOWN) for unknown indication started from unknown date, florachrome (MANUFACTURER UNKNOWN) for unknown indication started from unknown date, alegra (MANUFACTURER UNKNOWN) for unknown indication started from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 16:00, the patient experienced event numbness in left toes, mainly on middle toes. The clinical outcome of the event numbness in left toes was not recovered at the time of report.  No follow-up attempts are needed; information about lot number cannot be obtained.
SEVERE PAIN IN LEFT FOOT; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced severe pain in left foot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe pain in left foot was not reported. This report was non-serious.
Moderate fatigue, Moderate chills, Moderate nausea, Mild headache, Mild muscle aches, brain fog
Broke out in a rash on back that began similar to chicken pox and within 10 hours swelled into huge welps that also had redness expanding beyond the bumps. High pitched cry for several days and excessive crankiness and fussiness.
neck pain; swelling of lymph nodes; This case was reported by a physician via sales rep and described the occurrence of neck pain in a female patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included complex regional pain syndrome.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced neck pain and enlargement of lymph nodes. On an unknown date, the outcome of the neck pain and enlargement of lymph nodes were unknown.   It was unknown if the reporter considered the neck pain and enlargement of lymph nodes to be related to Bexsero.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The batch number of Bexsero was unknown. The GlaxosmithKline employee informed by the physician that, the patient experienced neck pain and swelling of lymh nodes, but the physician did not specify. At the time of reporting, the date of therapy and onset of event was unknown. The reporter consented to follow up.
microscopic lymphocytic colitis; This is a spontaneous report from a Pfizer sponsored program COVAX US Support from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (COMIRNATY mRNA, formulation: solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and dose 2 via an unspecified route of administration on an unspecified date (lot number was not reported) as dose 2, single for covid-19 immunisation; bismuth subsalicylate (PEPTO-BISMOL), via an unspecified route of administration from 02Nov2021 13:00 (lot number was not reported) to 02Nov2021 13:00, at unspecified dose for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date patient experienced microscopic lymphocytic colitis. Patient also stated that normally she had to be on a corticosteroid, Budesonide, to get rid of a flare up and her doctor was trying to treat it with something over the counter to see if it will help. Patient was taking Pepto-Bismol and not budesonide. Her doctor wants her to get the booster vaccine. She will be scheduled for the booster dose and has already had the first two doses of the Pfizer covid vaccine. Patient took her last dose of Pepto-Bismol at 13:00 and she was supposed to take it again before dinner. She could walk in at 10:00 03Nov2021 or at 5:00 02Nov2021 to the pharmacy for her booster dose but needs know if there was an interaction and if there was how much time was needed between the last time, she took Pepto-Bismol before she can get the booster dose. The action taken in response to the event(s) for bismuth subsalicylate was unknown. Therapeutic measures were taken as a result of microscopic lymphocytic colitis. The outcome of event was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Patient received Tdap vaccine 04/22/2020. Patient c/o pain at time of injection at injection site. Patient states after she got home 04/22/2020 around 11:30 it was hurting really bad, so she took some Tylenol. Patient texted this RN at 12:33PM 04/23/2020 stating that she took Tylenol around 0830 this morning due to pain in her right arm that radiates down to her right hand and up to her neck, shoulder and back. She took Motrin around 1030 as the pain continued. She messaged RN that is was still hurting at 12:33PM 04/23/2020.  She states she feels "a little sickish." She denies fevers. Patient states the injection site is swollen about the size of her palm.  Patient states her arm feels like it's on fire. FNp was notified about this event and recommended ice. RN notified patient to apply ice.
tingling, numbness left side of cheek and leftside of tongue Narrative:  Medical response called dr. responded with team. v/s@0906 97.5 99- 16- 163/88 0910 169/92 -102 0915 v/s 163/102-88 Benadryl 50mg given ( 25mg x2) given.  1000 156/71-71 1120 v/s 97.8 71-18-158/96 - feeling like nonvaccine shot sensation on left cheek & back of tongue 02 sat 100% 1125 re-assessed/ examined by MD 1139 released instruction by Dr. to eat lunch but stay in bldg. Dr will talk to employee before employee leaves today
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 71 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 13-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 13-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
Arm swell; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swell) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm swell). At the time of the report, PERIPHERAL SWELLING (Arm swell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.
On 10/10/13 patient received FLUMIST in error while she was 17 wks pregnant.
Watery eyes, sore throat, achy chills, throat issues within 2-3 hrs. Wheezing Took allergy medication  and contacted Dr 2 days later. Dr check her out as ok.
Received injections 2/15/06 prior to travel. 1 week later started with joint pain hips, knees, and ankles with some swelling in ankles. No redness. No heat or no other symptoms- which are continuing - to schedule appointment with PCP.
full blown stomach flu symptoms overnight; stomach ache; couldn't eat; puke evrytime; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (full blown stomach flu symptoms overnight), ABDOMINAL PAIN UPPER (stomach ache), DECREASED APPETITE (couldn't eat) and VOMITING (puke evrytime) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (NOS) (Patient was diagnosed with terminal cancer after receiving the first vaccine. She was not aware of this before receiving the vaccine.).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ABDOMINAL DISTENSION (full blown stomach flu symptoms overnight), ABDOMINAL PAIN UPPER (stomach ache), DECREASED APPETITE (couldn't eat) and VOMITING (puke evrytime). The patient was treated with DIMENHYDRINATE (DRAMAMINE) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISTENSION (full blown stomach flu symptoms overnight), ABDOMINAL PAIN UPPER (stomach ache), DECREASED APPETITE (couldn't eat) and VOMITING (puke evrytime) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by the reporter.   Patient's son gave her some unspecified homeopathic nausea medications which did not helped her much with the symptoms. Then he gave her Dramamine.   Reporter did not allow further contact
She was diagnosed with covid-19 on 11Sep2021; She was diagnosed with covid-19 on 11Sep2021; This is a solicited report from Regulatory Authority based on information received by Pfizer from the RA (manufacturer control number: 21K-163-4105766-00). A contactable consumer (patient) reported that a 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at the age of 45-years-old), dose 1 intramuscular on 20Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE and dose 2 intramuscular on 10Sep2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation; and Risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous in Jun2020 (Batch/Lot number was not reported), at unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient had received Pfizer covid-19 vaccination on 20Aug2021 and 10Sep2021. She was diagnosed with covid-19 on 11Sep2021. On 20Aug2021, she received first dose of COVID-19 vaccine manufactured by Pfizer Biontech. On 10Sep2021 she had received second dose of COVID-19 vaccine manufactured by Pfizer Biontech. The action taken in response to the events for Risankizumab was unknown. Causality for Skyrizi (Risankizumab): The reporter's causality for the event(s) of COVID-19 was not provided. Causality for COVID-19 vaccine per reporter was not reported.    The reporter's assessment of the causal relationship of the events with the BNT162B2  was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, The casual association between the reported event COVID-19 with suspected vaccine BNT162B2 cannot be completely excluded.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 19-MAR-2015, the patient was vaccinated with a dose of VAQTA (lot # K007827) 0.5 ml (expiration date, route and site of administration were not reported) that underwent temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Ep7533) via an unspecified route of administration in the left arm on 27Mar2021 (at the age of 60-years-old) at 14:45 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021, the patient had experienced sore arm. The clinical outcome of the event sore arm was unknown at the time of the report. No follow-up attempts are needed. No further information is expected.