chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in the ankle joint; there is visible swelling in the left foot and pain; there is visible swelling in the left foot and pain; This is a spontaneous report from a non-contactable consumer (patient). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9269), via an unspecified route of administration on 05Feb2021 at 17:45 (35-year-old) as dose 2, single for COVID-19 immunisation at hospital. The patient medical history and concomitant medications were not reported. The patient had no known allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3246), via an unspecified route of administration on 13Jan2021 at 12:45 (35-year-old) as dose 1, single for COVID-19 immunisation at hospital. Prior to the vaccination, the patient was not had COVID-19. Since the vaccination, unknown if the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient communicated in an informal setting that he had pain in the ankle joint 1 week after taking dose 1 and again 1 week after dose 2. However, after dose 2, there was visible swelling in the left foot and pain, and he had to go to the ER on 10Feb2021. Patient was wondering if this was a reaction to the vaccine. The adverse event was resulted in emergency room/department or urgent care. The patient had received treatment was unknown. The outcome of the events was reported as not resolved.  No follow-up attempts are possible. No further information is expected.
Patient calls on tuesday am as our office was closed on monday.  She states she was in the emergency room over the weekend.  After receiving the flu shot on friday she had "roughness in her throat", difficulty breathing, dizziness and was sick to her stomach.  She was told in the er that she should not receivet the flu shot again.  She was prescribed generic benadryl, famotine 20mg, and prednisone 20 mg.  She did not have any symptoms in the area the injection was given which was the Right Deltoid.  Client does not recall when I spoke with her after the event if she had ever had the flu shot in the past, she thinks that she had not ever had one.
Tooth infection; Facial swelling; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (Tooth infection) and SWELLING FACE (Facial swelling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tooth extraction.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TOOTH INFECTION (Tooth infection) and SWELLING FACE (Facial swelling). The patient was treated with AMOXICILLIN for Tooth extraction, at an unspecified dose and frequency. At the time of the report, TOOTH INFECTION (Tooth infection) and SWELLING FACE (Facial swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Left deltoid area 3 x 3 inch red, warm, and swollen area.  Patient described difficulty raising left arm due to pain.  Appears to be extreme local reaction.
Hard swelling at site of injection; Vaccination site redness; This is a spontaneous report received from a contactable consumer, the patient. A 62-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6204) via an unspecified route of administration in the left arm on 08Mar2021 at 14:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included allergy to sulfa drugs. The concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021, the patient had a 2X2 inch hard red swelling at site of injection (vaccination site swelling and vaccination site erythema), which had appeared about 12 days after first injection. It was reported that it was the first, ever such reaction to a vaccine, either delayed or immediate. The redness began to subside after a few days and there were no other symptoms. The events didn't 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 events. The clinical outcome of the events vaccination site swelling and vaccination site erythema was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient received 2nd dose of vaccine on 3/11/21 at 1 pm and began to experience symptoms by 7pm that evening. Reported symptoms included headaches, body aches, and tiredness. No medications were used for symptoms per patient report. Patient did have mild adverse reaction to 1st dose as well: arm soreness.
temp up to 103.8 & local reaction redness & swelling to rt thigh;
Patient received vaccination on Friday afternoon. Saturday morning the skin around her eyes was itchy and red. One week later she still has symptoms.
Information has been received from a Registered Nurse referring to multiple unspecified patients. Patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored (Oka/Merck) VARIVAC (lot#, dose, route and dose number were not provided). No adverse effect was reported. This is one of several reports received from the same souce. Additional information has been requested.
Small blood clot in vein on back of hand. Was told to treat it with heat packs, and it went away within two days or so.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021 at 3:29 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 3:30 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 75.98 and 76.05. Concomitant products were not provided. On 02-Mar-2021, excursion time was 09 AM, 10 AM, 11AM, 12 PM, 02 PM and 03 PM  and temperature was 27, 29,32, 33, 35 and 36 respectively, total doses given for the day was 177, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 02-Mar-2021. 16 vial was moved to clinic on 02-Mar-2021. Vaccine BUD date was 26-Mar-2021. Vial was stored on cooler 1 , on 27-Oct-2021, Excursion duration At, 9 AM: 27, 10 AM: 29, 11 AM: 32, 12 AM: 32, 1PM : 36, 2 PM : 35, 3 PM: 36, 4 PM: 37 and 5 PM : 37. On 30-Mar-2021, excursion time was 09 AM and temperature was 33 respectively, total doses given for the day was 173, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 30-Mar-2021. 03 vial was moved to clinic on 30-Mar-2021. Vaccine BUD date was 22-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Swelling, redness that streaked downward towards elbow that has lasted longer than 3 days, and bruise at injection site.
pneumonia; Information has been received regarding a case in litigation concerning a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not provided.  On 18-APR-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) as routine health maintenance and prevention of shingles (vaccine schedule, route of administration, site of administration, lot number and expiration date were not provided).  On an unknown date (reported as "shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine"), the patient suffered pneumonia requiring multiples hospitalizations (on unspecified dates). As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to zoster vaccine live (ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company conduct, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the time of the report, the patient had not recovered from pneumonia.  The causality assessment between zoster vaccine live (ZOSTAVAX) and pneumonia was considered as related.  Upon internal review, pneumonia was considered as medically significant and disabling.
within 10 minutes of administration c/o throat itching and clearing, given 10mg of claritin PO per MD, after 10 minutes still itching MD ordered 8mg of oral methylprednisolone, around 25 minutes throat feeling worse so EMS called and auto injector epi pen 0.3mg was self administered. Left via EMS at 1200.
Day #1 headache, numbness to face and injection site.  Chills 1hr after injection. Day 2-5 posterior occipital headache, day 7 rash to injection site worsening, day 15 rash, red, raised hard, itchy, bulls eye in appearance.
I tested negative for COVID on 01/02/2022 and then on 01/07/2022 had another test done at the hospital which resulted in a positive test for COVID because my Oxygen levels dropped below 88%.
Headache, blurred vision, tremors, weakness, decreased o2 sats.  Was given EPI, Benadryl, and sent to ER
Vaccine given 5/6/03 at 9:00 AM, woke up 5/7/03 and left arm red, swollen, and warm in area shot was given. Applying ice, and giving Tylenol.
Sore Arm; he took his Velcour 5mg and he started shaking, started shaking like he was freezing; slept for 12 hours, which is unusual for him; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (he took his Velcour 5mg and he started shaking, started shaking like he was freezing), PAIN IN EXTREMITY (Sore Arm) and SOMNOLENCE (slept for 12 hours, which is unusual for him) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included SIMVASTATIN (ZOCOR) from 29-Oct-2021 to an unknown date for an unknown indication.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced TREMOR (he took his Velcour 5mg and he started shaking, started shaking like he was freezing). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm) and SOMNOLENCE (slept for 12 hours, which is unusual for him). At the time of the report, TREMOR (he took his Velcour 5mg and he started shaking, started shaking like he was freezing), PAIN IN EXTREMITY (Sore Arm) and SOMNOLENCE (slept for 12 hours, which is unusual for him) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided.   This case was linked to MOD-2021-370314 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Added reporter details, added patient initials, added product start date, added concomitant medication, added event details.
Rash on left side of back in one spot on Sunday 1-31-21, two days after vaccine was given in left deltoid.
Aches, stomach cramps and nausea. Occasional numb feeling in left hand. Parasthesias and weakness in extremity. Transient, recovered in 3 days.
pt recvd vax & had sudden chills; t; v 1x; weak; no med given; sl nausea on 12oct94; 14oct94 pt recovered;
This spontaneous report as received from registered nurse refers to a patient of unknown age and gender. On 27-DEC-2013 the patient was vaccinated with ROTATEQ dose 4, 2 ml, oral. Nurse reported that on 17-JUL-2013, patient was vaccinated with ROTATEQ vial dose number 1, 2 ml, (lot number and expiry date unknown) oral. On 30-SEP-2013 and 18-DEC-2013, patient received second and third doses as recommended in the prescribing information and also on 27-DEC-2013 patient received fourth dose. No adverse effects were reported. No further information was provided. The outcome of the event was unknown. Additional information has been requested.
The patient was started on doxycycline the morning of the event for an upper respiratory infection.  He had two syncopal episodes at home and when found on the floor, he was breathing but very poorly responsive.  No other issues.  He was then taken to the ER.
Mother called and said her daughter was given a H1N1 flu vaccination in her bicep, not her deltoid. Child had pain at the injection site as a result. Also c/o low-grade fever and body aches on 11/23/09. On 11/24/09 - pain at injection site.
Pt received varicella vaccine # 1 on 8-20-10 on 8-23-10 mother observed skin rash on thighs, arms and chest  some clustered some scattered solitary macular. No vesicles. No scratch marks pt not scratchy either.
Slight rash developed on upper thigh, increased up to buttocks and down the leg to knee. Rash began as very red and raised to lacy then became bruise-like. Onset at 2 days lasting up to 2 weeks. Continues with slightly lacy bruise like redness; not itchy. Afebrile not painful. No treatment given.
after administration around inj. site it became read, itchy, and burning, gave Benadryl and hydrocortisone cream left arm Still red when left office
Fever, chills, fatigue, severe headache, sensitivity to light   Tried normal routes of Ibuprofen but did not help until I took Benadryl on 11/19/2022 which was the only thing that helped.  I took Pfizer the first 2 vaccines but it seems every time I get a booster my reaction is getting worse. At least no vomiting this time
Began with general nausea and upset stomach. Started vomiting around 6:30 progressed to include watery diarrhea. Both continued pretty violently until around 10:30 PM. Terribly dehydrated! She then tapered off back to nausea and upset stomach through the night. This morning she is weak but recovering well.
soreness at injection site; soft lump under her left arm  pit; This case was reported by a pharmacist via call center representative and described the occurrence of local swelling in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 7X743, expiry date 22nd May 2021) for prophylaxis.   On 29th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th April 2019, less than a day after receiving Shingrix, the patient experienced local swelling. On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the local swelling and injection site pain were recovering/resolving.   It was unknown if the reporter considered the local swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced local swelling and injection site pain. Healthcare professional was transferred to MI vaccines for off label questions.
pt recv vax 1MAY96 & lab eval in JAN97 revealed negative VZV immune status;
Fatigue, nausea, vomiting, muscle pain, joint pain, headache, chills, fever
FLUAD(65+) Administered on 3/10/20 8/18/20 Patient reports she has a burning pain from shoulder to elbow that started when she got the Flu shot and is not Relenting this far out.
Chronic Post Herpetic Neuralgia; allodynia; Shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 15-SEP-2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered shingles with resulting chronic post herpetic neuralgia and allodynia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the product, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality assessment was considered as related by the lawyer.  The lawyer considered the events shingles with resulting chronic post herpetic neuralgia and allodynia to be disability.
Upon administration in the left arm of Moderna vaccine using  the DropSafe 3m 25 g 1 inch need, the needle disengaged with the syringe upon administration. The vaccine leaked out of the syringe, down the patients arm and on the floor. Needle was retracted from pt's arm. Pt tolerated well and had no complaints at the time.  Pharmacist  aware and assessed. It was determined that patient did not receive dose of vaccine given the amount that was leaked out.  Pt was provided a full dose of the vaccine administered in the right arm. Pt tolerated well.
Tremor on my torso on my left side, and now, as of today I'm getting tremor on my right side of the torso; my body is moving, its literally making movements; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 (Lot number: ER8730) at the age of 76 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 (When probed for the Date of vaccination for 1st shot, Consumer  stated, "February 26th 2021.", Lot number:EL3302, NDC number:59267100001), administration date: 26Feb2021, when the patient was 76 years old, for Covid-19 immunization. The following information was reported: TREMOR (non-serious) with onset 10Apr2021, outcome "unknown", described as "Tremor on my torso on my left side, and now, as of today I'm getting tremor on my right side of the torso; my body is moving, its literally making movements"; CHILLS (non-serious) with onset 10Apr2021, outcome "unknown", described as "chills". Therapeutic measures were taken as a result of tremor.  Additional information: It was stated, "he had some reactions, he was assuming its reaction to the second shot he had on 26Mar, 2 weeks later on 10Apr, he started developing, what he refer to as tremors or what happens when you get chills. A kind of movement in the torso of his body to the left side and for the last 2 weeks, almost 2 weeks and today was the 22nd, 24th will be 2 weeks, he have continued to get this sensations. Other way he can explain was when you get cold and when you get tremor or when you are scared, when you get chills. It was not the same kind of chills you get when you have a fever. He was not talking about that. It was the way the torso, his body was moving, it was literally making movements and it does this quiet often during day but not all the time and he just wanted to know if that was a somehow related to the 2nd shot or the 2 shots that he had, 1st shot was in 26Feb, 2nd shot was 26Mar, and 10Apr, beginning of this cycle. The movement of he do not know how to repeat this, like tremor on his torso on his left side, and now, as of today he was getting tremor on his right side of the torso, but not in the arms, not in the legs." When clarified if the consumer wants to know if the event was due to the covid19 vaccine dose, consumer stated, "Yes, they did start 2 weeks after 2nd shot, they could be from 1st shot, he do not what it was from, but he was calling to report it." The patient lab test in December 2020 and It was just to see if everything was normal. It was stated as adverse event comes and goes. The patient took baby aspirin orally (take 1 everyday, 10Apr) for treatment.   No follow-up attempts are possible. No further information is expected.
Pt stated it became red and raised, she could feel it in her muscle. About a quarter size area, stated she thinks it was hot to the touch but not sure.  Her arm hurt for about 2 weeks and it would wake her up at night
Patient received the immunization. After about 5 minutes he felt dizzy and passed out. He woke right back up and was able to sit in a chair to be observed for 30 minutes.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 29-NOV-2011, the patient was administered with a dose of VARIVAX (merck) (Lot # 0869AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.