chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm started to itch on the same place they got the vaccine; Red spot; Hard lump; Little swollen; Warm  to the touch; Little back ache; Some redness that spread a little; Was a little sore; Tender; Tired; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (Some redness that spread a little), INJECTION SITE PAIN (Was a little sore), TENDERNESS (Tender), FATIGUE (Tired) and INJECTION SITE PRURITUS (Arm started to itch on the same place they got the vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MONTELUKAST for Allergy, ACETYLSALICYLIC ACID (BABY ASPIRIN), SERTRALINE and VITAMINS NOS for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Some redness that spread a little), INJECTION SITE PAIN (Was a little sore), TENDERNESS (Tender) and FATIGUE (Tired). On 04-Mar-2021, the patient experienced INJECTION SITE PRURITUS (Arm started to itch on the same place they got the vaccine), INJECTION SITE ERYTHEMA (Red spot), INJECTION SITE MASS (Hard lump), INJECTION SITE SWELLING (Little swollen), INJECTION SITE WARMTH (Warm  to the touch) and BACK PAIN (Little back ache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) for Adverse event, at an unspecified dose and frequency. On 28-Feb-2021, INJECTION SITE ERYTHEMA (Some redness that spread a little), INJECTION SITE PAIN (Was a little sore) and TENDERNESS (Tender) had resolved. On 01-Mar-2021, FATIGUE (Tired) had resolved. At the time of the report, INJECTION SITE PRURITUS (Arm started to itch on the same place they got the vaccine), INJECTION SITE ERYTHEMA (Red spot), INJECTION SITE MASS (Hard lump), INJECTION SITE SWELLING (Little swollen), INJECTION SITE WARMTH (Warm  to the touch) and BACK PAIN (Little back ache) 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.
Reported Reaction: tingly in hands and feet  " Time reported: 10:10am  " Patient was discharged at 10:40am with spouse. Patient stated that she felt fine. RN advised the patient to report to the ED if any symptoms returned.  No follow up needed. Patient received 2nd dose on 4/2/21 with no reported symptoms
Hives and swelling around mouth, dizziness and weakness aprox 1 hour after vaccine and still occurring 1 week later.
Symptoms: SkinRash Treatment: DIPHENHYDRAMINE 25 MG PRN Benadryl 25 mg every 6-8 hours as needed for itching
This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. There was not information regarding pertinent medical history, drug reaction or concomitant therapies. On an unknown date the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # M036728, expiration date 20-MAY-2018, 0 .5 ml (strength, frequency, route of administration were not provided) for prophylaxis. The reporter stated that the temperature range of the vaccine was >46 Fahrenheit degrees (F) but <77  Fahrenheit degrees (F) and the time frame was 2 hours and 40 minutes. There was not previous temperature excursion, this information was registered in a digital data logger. No symptoms were reported nor product quality complaint was not involved. Additional information has been requested.
VAX #1 - NO IMMEDIATE SYMPTOMS AT ALL.  12 DAYS AFTER THE VACCINE #1, I WOKE UP AND WAS VERY DIZZY AND FELL BACK INTO BED. EVENTUALLY ABLE TO WALK WITH HOLDING ONTO FURNITURE. LATER THAT DAY, NEURO EXAM CONSISTENT WITH POSITIONAL VERTIGO. NO HISTORY OF VERTIGO. EPLEY MAUEVER AND SOME IMPROVEMENT OVER THE NEXT FEW DAYS.  SECOND VACCINATINO RESULTED IN A FEW HOURS OF TYPICAL SYMPTOMS OF ACHES, ETC. THE FOLLOWING MORNING AND FOR THE NEXT WEEK THERE WAS  AN INCREASE IN THE VERTIGO. THIS PERSISTS AS OF TODAY, ALTHOUGH  I AM 90% BETTER OVERALL. i DO HAVE TO BE MINDFUL AND CAREFUL WITH HEAD MOVEMENTS  THAT PROVOKE VERTIGO.  THROUGHOUT ALL OF THE VERTIGO, I  HAVE DONE  'EXERCISES' TO IMPROVE SYPMTOMS AND CONTINUE TO DO SO.
side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (side effects) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown.
Rash around injection site approx 2 inches in diameter Injection site is slightly swollen and hurts to touch but does not hurt when moving my arm
My symptoms where very mild: fatigue, mild aches (especially in my upper body and including my eyes). OTC pain medication easily reduced my mild symptoms. 48 hours after the 2nd vaccine, I started spotting and experiencing strong menstrual cramps for about 15 minutes. During this time, the cramps felt very severe - a 9 out of 10 on the pain scale. I almost felt like I might throw up from the pain. But then it subsided to a 5 and took Midol and applied heat. The cramps returned at 5:00 pm.  Date of last cycle was approx 5/23. I don?t spot, so this stood out to me.
Mother reports that patient had a mild fever the night after the injections. The following night she began itching and the next evening the mother noted bumps on her feet and ankles. The bumps became urticarial and continued to spread. When I saw her 4 days post-vaccinations, she had hives in her axillas, her arms, her trunk, her lower abd and groin, very extensive on the L lower abd/groin, and legs ant and posterior.
A little of the vaccine and blood ran down the patients arm. (left); She states as the tech pulled the syringe back the needle detached and remined in the patient's arm; vaccine underdose; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE HAEMORRHAGE (A little of the vaccine and blood ran down the patients arm. (left)), DEVICE CONNECTION ISSUE (She states as the tech pulled the syringe back the needle detached and remined in the patient's arm) and UNDERDOSE (vaccine underdose) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050Z21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (A little of the vaccine and blood ran down the patients arm. (left)), DEVICE CONNECTION ISSUE (She states as the tech pulled the syringe back the needle detached and remined in the patient's arm) and UNDERDOSE (vaccine underdose). On 26-May-2021, VACCINATION SITE HAEMORRHAGE (A little of the vaccine and blood ran down the patients arm. (left)), DEVICE CONNECTION ISSUE (She states as the tech pulled the syringe back the needle detached and remined in the patient's arm) and UNDERDOSE (vaccine underdose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was provided by the reporter.  No treatment information was provided.
Monday 7-30-12 received shot in (L) arm. That night sore (L) arm. Began taking ADVIL every 4 hours. Tuesday 7-31-12 extreme (L) arm soreness with L ROM in (L) UE. At night began using moist heat on arm and neck. Wednesday 8-01-12 Unable to lift (L) arm, pain, swollen neck and armpit area.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic HTN" (unspecified if ongoing); "SVT" (unspecified if ongoing); "POTS" (unspecified if ongoing); "PVD" (unspecified if ongoing). Concomitant medication(s) included: LOPRESSOR; HYDROCHLOROTHIAZIDE; MAGNESIUM; POTASSIUM; GABAPENTIN; METHOCARBAMOL. Past drug history included: Ambien, reaction(s): "known allergies: ambien".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result; (19May2022) Negative, notes: Negative on 19May and 20May; (20May2022) Negative, notes: Negative on 19May and 20May; (23May2022) Positive, notes: Had positive test on 23May. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks was reported as yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202200755003 Same reporter/patient, different drug/events
varicella pneumonia; death; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions.  Subsequent to pt's inoculation, pt was treated by a healthcare provider for varicella penumonia. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had suffered serious injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages. On an unknown date, the patient died due to unknown reason. It was not reported if an autopsy was performed. The outcome of varicella pneumonia was unknown.  The reporter considered varicella zoster pneumonia to be related to Zoster Vaccine Live (ZOSTAVAX). The causality between the Zoster Vaccine Live (ZOSTAVAX) and death was not provided.   Upon internal review, the event of varicella pneumonia was considered to be medically significant.
Why does a magnet stick to my arm where I got the vaccine?"; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: VACCINATION SITE REACTION (non-serious), outcome "unknown", described as "Why does a magnet stick to my arm where I got the vaccine?"".  Additional information: Caller wanted to know "Why does a magnet stick to my arm where I got the vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
recvd vax & 12hrs a/onset of fussiness & temp to 103.5 R;
Fever now at 101 degrees; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) and PYREXIA (Fever now at 101 degrees) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 042L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included LEVOTHYROXINE, METFORMIN and INSULIN for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Low grade fever). On 12-Feb-2021, the patient experienced PYREXIA (Fever now at 101 degrees). At the time of the report, PYREXIA (Low grade fever) and PYREXIA (Fever now at 101 degrees) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: 101 f High.         Treatment medications were not provided by reporter.
his first was on 28Dec and his second was on 08Jan; antibody test shows no antibodies after taking two doses of the vaccine; This is a spontaneous report from a contactable physician. A 56-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration from 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR). The patient received the first dose of BNT162B2 on 28Dec2020. Reporter stated he got the first dose of the COVID 19 vaccine on 28Dec2020 and second dose on 08Jan2021. He took an antibody test yesterday (20Jan2021) which showed no antibodies and wanted this explained to him. He is on ADVAIR and had a steroid shot on 04Jan2021. He wanted to know if there is any data on patients using ADVAIR. He also wanted to know if he should take the second dose again or what he should do. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: showed no antibodies on 20Jan2021. The outcome of the event 'antibody test shows no antibodies after taking two doses of the vaccine' was unknown.  Information on the batch number/lot number has been requested.
generalized erythematous rash  w/vomiting w/in 24hr p/vax;
Marked pain and swelling or R shoulder within 2 days after vaccination -- worse by 10 days after administration.   He continues with pain and limited ROM  two months later.
experiencing muscle pain after taking the 2nd dose; 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 female patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Batch/Lot number: unknown) as dose 2,  single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: MYALGIA (non-serious) with onset Apr2021, outcome "unknown", described as "experiencing muscle pain after taking the 2nd dose". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Unsure if Vaccine was cause, but better safe by reporting it than sorry. Below is the timeline of the occurrences:   Child (age 12) Received HPV Vaccine on 4/9/18 Child reports that bumps below genitals began 12/2018 Child reports rash in genitals began 3/2018 Rash covered entire body by May, when mother was able to notice on 5/15/19 Went to Urgent Care 5/16/19, Dr. unsure of diagnosis, assumed skin infection No change with meds prescribed, follow up with doctor (saw a fill in Dr as Primary Dr was out) 5/20/19, received referral to dermatology Child dealing with hair loss from bumps now formed on head. Dermatology Initial Appointment 5/22/19- Dr. suspected Strep and Skin Disorder ? Does strep swab of buttock area and biopsy of two spots with rash Strep test came back positive for Strep Group B Colonization ? More common in pregnant women- Received diagnosis 5/28/19 Dermatology appt 6/11/19- no major change with meds, biopsy came back as strep rash  Dermatology appt 7/9/19- Still no change with bumps, rash subsiding.  Dermatology appt 8/20/19- no change with bumps, biopsy of bumps scheduled  Dermatology Appt 8/27/19- Biopsy performed on bumps October, 2019 received diagnosis of Follicular Mucinosis. (Rare skin disorder)   Currently using creams which have lessened the bumps, child suffers from bald spots still. Follicular Mucinosis has a healing time of at least 2 years in children.
Difficulty breathing; she sleeping up for about hour; bad body aches and pains; This is a spontaneous report from a contactable consumer or other non healthcare professional (parent). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number and expiry date unknown), via an unspecified route of administration on 06Jul2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On 07Jul2021, the patient experienced little bit difficulty in breathing, sleeping up for about hour, bad body aches and pain. The outcome of the events was unknown. The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.
She end up getting a fever all through the night which I was able to control with TYLENOL and keeping her cool. But my huge concern is that I notice that she would shake! There were times when should would wake up from her asleep from a shake and would cry hysterically. Saturday looked more "dazed", and shivering/shaking. "Her heart would come out of her".
High fever 103.7 the first night.  Took Extra Strength Tylenol every 6 hours through the night.  Fever dropped to 102F in the morning.  Still needed Tylenol to lower the fever the 2nd night.  Temperature was normal the next morning, but elevated again when Tylenol effects wore off.
The pt experienced severe vertigo, nausea, tiredness for over 1 1/2 weeks. This reoccurred several times over the next 5 months.
Injection site pain; Nausea; Fever (unknown temperature); Chills; Body aches; Bad headache; This is spontaneous report from contactable consumer, the patient. A 60-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL3248), dose number 2, via an unspecified route of administration in the right arm on 15Mar2021 at 01:00 PM, (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown, whether the patient was diagnosed with COVID-19, prior to vaccination. Since the vaccination the patient was not tested for COVID-19. The patient had no current illness. Past drug history included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL3248), dose number 1 via an unspecified route of administration in the right arm on 22Feb2021 at 01:15 PM, as a single dose for COVID-19 immunisation. Medical history included allergy to ibuprofen and breast cancer. Concomitant medications included daily vitamin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), 81 mg aspirin (MANUFACTURER UNKNOWN) all for unknown indication. On 15Mar2021 at 01:00 PM, the patient experienced bad headache, body aches, fever (unknown temperature), chills, nausea and injection site pain. The injection site pain was minimized. No therapeutic measures were taken for the events. The clinical outcome of bad headache, body aches, fever (unknown temperature), chills and nausea were unknown. The clinical outcome of injection site pain was resolving. Action taken with BNT162B2 was not applicable No follow-up attempts are needed. No further information is expected.
Patient reports his left arm/shoulder hurts and has been sore for over a month since his shot. He says it only hurts when he tries to raise his arms up. He says he has been taking Tylenol, but it hasn't been helping. He reported his reaction to his primary care provider Dr.  but Doctor, told patient to ask pharmacy for advice instead. Patient says he will try to reach a orthopedic doctor for a second consultation.
Possible autoimmune encephalitis. HSV ab negative. TSH 1.24  Thyroglobulin 52,  Thyroid Peroxidase Ab 36, HIV negative, ANA negative.
Mother reports child experienced temperature of 102 degrees Faherenheit. Blueish discoloration to upper lip and right hands both areas cool to touch. Then had brief ? loss of conscioussness with tremors, easliy aroused and sluggish after but over next hour or so increased level of alertness and activity.
Patient reported a sore arm for 3 days; This is a spontaneous report from a contactable nurse. This nurse reported that a patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number/Exp. date unknown), via an unspecified route of administration on unknown date at single dose for an COVID-19 immunisation. The patient medical history and concomitant medications were not provided. The patient reported a sore arm for 3 days on unknown date after vaccination. The outcome of event sore arm was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Information has been received from a physician concerning a pt who was vaccinated with PREVNAR, VARIVAX, and COMVAX on4/25/01. On 4/30/01 5 days later, the infant developed a nodule (less than 2.4cm) at the PREVNAR injection site on the R thigh. On 5/2/01, he was vaccinated with IPV in the R thigh, and MMR and DTaP in the L thigh. One week later (2 weeks post PREVNAR vaccination) the infant developed lymphadenopathy at the inguinal region, tenderness and swelling.
Injection site reaction greater than 4 inches with redness, pain, and swelling. Patient called PCP and was told to monitor rash and mark with a pen. Over the course of the next few days, the injection site reaction had subsided, and the patient has since recovered.
I had a sore, swollen arm, fever and no appetite after receiving the vaccine for about a week. In 08/2022, I have tinnitus in my left ear. It feels like it needs to pop all the time but it never does. Everything is muffled so I have hearing loss.  I have a follow up appointment with the ENT in a couple of months.