chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm was swollen for a month; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen for a month) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2022, the patient experienced PERIPHERAL SWELLING (arm was swollen for a month). At the time of the report, PERIPHERAL SWELLING (arm was swollen for a month) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided. It was reported that the patient did the Moderna Covid-19 vaccine, arm was swollen for a month. The patient was not doing the booster.     Reporter did not allow further contact
Post vax, the pt complained of feeling weak and almost fainting. Skin pallor was noted and clammy. Cool wet cloth applied to forehead and Sprite soda was given. Pt's color improved and she felt better.
Product=COVID 19 Treatment, Brand=Pfizer; Product=COVID 19 Treatment, Brand=Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Nov2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure slightly elevated" (unspecified if ongoing), notes: Blood pressure slightly elevated; "Penicillin" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: 01Nov2009; AMLODIPINE, start date: 01Oct2021; FETZIMA, start date: 01Mar2018; ACYCLOVIR [ACICLOVIR SODIUM], start date: 01Jun2006; VIVELLE DOT, start date: 31Oct2003. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Product=COVID 19 Treatment, Brand=Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Tested positive after negative test two days earlier runny nose sneezing not same symptoms as original. Was cleared to travel on Day 10 by doctor w no symptoms New symptoms appeared more than a week later.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
About a week after receiving the vaccine I caught Covid. I had a dry, hard cough, muscle aches, and extreme fatigue. I had a little headache, but it didn't last very long. I had no fever that I am aware of. The fatigue was the most troubling. The cough made me check. I had tested positive twice at home. Then I went to the Urgent Care and received the Evusheld Antibody Infusion on May 31, 2022. I still currently have Covid.
Today ay 10:00am started feeling weak and tired. Also, my hands and body be an cold. I went to bed with very heavy covers and got re-warmed after about 2 hours. Feeling somewhat better this evening at 07:00 PM
The evening of the vaccines, the pt began crying as if in pain, doesn't was to put head forward. Questionable torticolis.
Information has been received from a Registered Nurse concerning a 63 year old female patient with hypertension and no relevant medical history and past drug history who on 08-FEB-2011 was vaccinated in her right arm with a 0.5 ml dose of ZOSTAVAX (Merck) (lot # 669537/1386Z; Expiration date: January 2012). Concomitant therapy included citalopram, bisoprolol (reported as "bisopol") and isradipine (reported as "isratapine") (also reported as no concomitant medications). On 08-FEB-2011, hours after getting the injection, the patient called the nurse with symptoms of a blister like rash on her waist in the front and on the sides, and no other symptoms. There was no relevant laboratory data. At the time of the report, the patient's outcome was unknown. Follow up information has been received from the nurse concerning the patient with penicillin allergy, who on 08-FEB-2011 at 12:00 was vaccinated with a dose of ZOSTAVAX (Merck) SQ in her left arm (also reported as right arm). The nurse reported that on 08-FEB-2011 at 16:45 the patient called to complain of a blistery rash around her abdomen in front and sides. On 09-FEB-2011 in the afternoon, the patient was worse; blisters had gone but rash spread. The patient's husband was having a surgery on 10-FEB-2011 so patient wanted to know if contagious referred to CDC (Centers for Disease Control) or country health. At the time of the report, the patient had recovered. No further information is available.
Adenopathy, swollen lymph gland in left armpit area about the size of bean bag. It started after first dose small at first about the size of a pea then 2 days after second dose it got considerably larger lasted for 6 days swelling decreased for about 5 days then swelling returned for another 8 days then went down again still hasn't fully went away but swelling is down to a tolerable state.
BodyAches, Sneezing, Runny nose, sorethroat, chills, low grade fever, nonproductive cough
PATIENT DESCRIBED GETTING A LUMP AT VACCINATION SITE THAT IS A BIT PAINFUL, BUT TOLERABLE AND UNCOMFORTABLE WHEN SHE LEANS ON IT WHEN SLEEPING. OTHER THAN THAT, NO OTHER SIDE EFFECTS.
Started a dry cough, shortness of breath wheezing. Dr. treated me with methylprednisolone, and ventoline inhaler....did not help I am now taking Singulair and Claritin.
Very fussy and tired throughout the day.  Had seizure approx. 10 hours after vaccinations were administered.
Had a mild fever since then; He has also had back pain; Pain in his bones; Chills; Sweats; Diarrhea; Stomach ache; This is a spontaneous report from a contactable female consumer. This female consumer reported for a 39-year-old male patient. A patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date after vaccination, the patient had a mild fever which was continued, he also had back pain, pain in his bones, chills, sweats, diarrhea and stomach ache. The patient was referred to HCP. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Case number PHEH2011US06697 is an initial spontaneous report received from a health care professional on 29 Sep 2011: This report refers to a male patient of unknown age group. He was vaccinated with MENVEO (batch number:M10061 and expiry date: Sep 2012) intramuscularly and with VARICELLA (batch number and manufacturer: unknown) into the same arm on an unknown date. After vaccination he experienced reaction at the injection site. No further information was available. Following internal non serious line listing review done on 22 Nov 2011 of the date received on 28 Sep 2011 it was noted that the listedness for event vaccination site reaction was incorrectly captured as listed. Therefore, it was correctly captured as unlisted.
Fever (first two days), chills (4 days), redness and itching at injection site (1.5 wks), lip swelling (1 day), peeling red rash on face and neck for (3 days)
T 99.7 930pm on 12.16/2009 rash started 12/17/09 330 pm. T 103.8 ax at 1000PM 12-17/09. Irritable beginning 12/17/09 at 300pm diffuse erythematous rash on trunk. Pt screams, pulls mothers hair, etc. Has intermittent periods of play, smiling, etc.
pt recvd vax & 3months p/vax devel chicken pox;these infants are reported as WAES95111934 & 9511135;No further details were provided;
Patient did not have an adverse reaction.  This VAERS submission is to report that patient was administered an expired vaccine (outside of the 12 hour window allowed to be left in room temperature).
Starting about a week after receiving the vaccine, he started having a flare up. We suspected this but not to this degree. It started with ticks in his face and body movements which progressively worsened over time. Then, he started to get pains in his legs and was unable to play sports due to his legs becoming too sore and exhausted. We used some of the topical medicine that we would normally use on his legs during a flare up: diclofenac sodium, which helped with the pain, then it would come back. He was unable to play sports he wanted to, and he still is unable to. Due to his pain/episode, he was unable to fully participate in the activities he loves. Not only that, he developed a heat intolerance and his face would turn red but he wouldn't sweat. He was unable to deal with the heat and eventually he would wake up in the morning with a swollen face like an allergic reaction due to being out in the heat to long the day prior. It took a few days for the swelling of his cheeks to go down. Now, we keep him in the shade more and watch him to keep him from the sun for too long. Also, he has started to complain about episodes where his heart felt like it was racing and he felt like he was out of breath. On occasion, I notice that his resting heart rate had been quite high. One time, his resting HR was up to 200. Since this flare up started, his anxiety has gotten worse. We saw his pain doctor 06/2022 who agreed it was a flare-up caused by the vaccination and the flare up has lasted much longer than usual. Also, he has had an increase in headaches, ticks, anxiety, heart racing, irritability, insomnia and leg pain. He takes migrelief daily, diclofenac sodium gel as needed and I am taking him to get acupressure. The acupressurist gave us a new multivitamin and the pain doctor gave us a new allergy medicine, hydroxyzine, which we will start ASAP. She prescribed it for him to help with his anxiety. 2 cysts in his brain (one on pineal gland and one on hypoglossal canal which they think is a perineural cyst. They are hoping it's an incidental finding and will continue monitoring it.
Had diarrhea; Started my period again. Which is obviously early given the 3 week period between vaccines; I had period cramps; I experienced intense stomach cramps so bad they woke me up through the night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Sep2021 (Batch/Lot number: unknown) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL. Vaccination history included: Bnt162b2 (Dose:01, Anatomical location: Arm Left), administration date: 23Aug2021, when the patient was 32 years old, for COVID-19 immunization, reaction(s): "Indigestion like symptoms", "Started my period 2 days later". The following information was reported: DIARRHOEA (non-serious) with onset 13Sep2021, outcome "recovering", described as "Had diarrhea"; MENSTRUAL DISORDER (non-serious) with onset 13Sep2021, outcome "recovering", described as "Started my period again. Which is obviously early given the 3 week period between vaccines"; DYSMENORRHOEA (non-serious) with onset 13Sep2021, outcome "recovering", described as "I had period cramps"; ABDOMINAL PAIN UPPER (non-serious) with onset 13Sep2021, outcome "recovered" (Sep2021), described as "I experienced intense stomach cramps so bad they woke me up through the night". Therapeutic measures were not taken as a result of diarrhoea, menstrual disorder, dysmenorrhoea, abdominal pain upper.  Additional Information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination Tylenol. After my first Pfizer dose 23Aug2021 that day I experienced indigestion like symptoms but didn't think anything of it and started my period 2 days later. My second dose was 13Sep2021 and that day I experienced intense stomach cramps so bad they woke me up through the night, that lasted 2 days, had diarrhea, then I had period cramps which I normally don't have due to birth control and started my period again. Which is obviously early given the 3 week period between vaccines  Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Came in noon 1/31/13 c/o sore spot in (L) armpit, same arm for shot. I saw no redness or edema or felt warmth of fever. Has no other complaints, noticed this soreness in morning 1/30/13. Instructed to watch, use a warm cloth, take ibuprofen, if concerned or increases to seek medical care. Ask client to update me.
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient was given vaccine, was okay and then about 5  minutes after vaccine passed out.  We had check her vitals and blood pressure was 96/60 and hr 84 O2 sat 100
allergic reaction red, swollen and itchy hands and face. swollen tongue ,hard to talk
Tingling/Itchy Sensation - Right Leg; Tingling/Itchy Sensation - Right Leg; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling/Itchy Sensation - Right Leg), PRURITUS (Tingling/Itchy Sensation - Right Leg), HEADACHE (Headache) and FATIGUE (Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 15-Jan-2021, the patient experienced PARAESTHESIA (Tingling/Itchy Sensation - Right Leg), PRURITUS (Tingling/Itchy Sensation - Right Leg), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with Human Tranquilizer (BENZODIAZEPINE RELATED DRUGS) for Self-medication, at an unspecified dose and frequency.   On 17-Jan-2021, PARAESTHESIA (Tingling/Itchy Sensation - Right Leg), PRURITUS (Tingling/Itchy Sensation - Right Leg), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved.       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.   Concomitant product use was not provided by the reporter.
Tdap received 12/17/2013. On 12/23/2013 developed erythema, warmth, tenderness, itching. Treated for cellulitis, rec antihistamine (19 x 8 cm area).
A report has been received from a Health Professional concerning a 52 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). The patient's concurrent disease(s) included immunocompromised, multiple myeloma and chemotherapy. Concomitant medications included acetylsalicylic acid. FLUMIST quadrivalent (intranasal) started on an unknown date. A 52 years old patient received FLUMIST quadrivalent which started on 20-Nov-2013. The outcome of the event received FLUMIST quadrivalent who was immunocompromised (52 years of age) is unknown. The report was considered to be non-serious.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 51 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 29-Aug-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 29-Aug-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.
Redness swelling, very painful in left arm. Went to ER and was given pain medication and antibiotics. Went back to ER on 9/26 because she was worse.
Patient is 8 Years old and received a dose of Covid Pfizer  that was meant for 6 months to 4 years of age. Dose was 0.2mg. Patient was suppose to get the vaccine that was meant for 5year to 11year.
diagnosed with shingles/had shingles in the past; Swolen neck and ears; Swolen neck and ears; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A 76-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), dose 2 via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as single for COVID-19 immunisation. Medical history included shingles in the past, 10 years ago, and had the vaccine for shingles on an unspecified date for immunization. The patient's concomitant medications were not reported. The patient previously received 1st dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) on an unspecified date for Covid-19 immunisation. On 28Mar2021, the patient felt discomfort in neck area, it was swollen. Swollen neck and ears. The patient went to the urgent care and was diagnosed with shingles. The events were assessed as non-serious. Outcome of the events was unknown. Events resulted in Emergency Room Visit.  Information on lot/batch number has been requested.
Information has been received from a consumer concerning her 18 year old sister with diabetes controlled by a diet and seasonal allergies who was vaccinated "about 2 1/2 months ago" with a 0.5 ml second dose of GARDASIL. There was no concomitant medication. Approximately on 03-SEP-2007 the patient was experiencing as extra heavy menstrual flow. The office did a Papanicolaou test. She was notified to come into the office because the pap smear indicated a positive human papillomavirus test. At the time of the report the patient had not recovered. Additional information has been requested.
Her appetite was down; little red spot and itching to touch on injection site; little red spot and itching to touch on injection site; felt big boost of energy; This spontaneous case was reported by a consumer and describes the occurrence of ENERGY INCREASED (felt big boost of energy), DECREASED APPETITE (Her appetite was down), VACCINATION SITE PRURITUS (little red spot and itching to touch on injection site) and VACCINATION SITE ERYTHEMA (little red spot and itching to touch on injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ENERGY INCREASED (felt big boost of energy), VACCINATION SITE PRURITUS (little red spot and itching to touch on injection site) and VACCINATION SITE ERYTHEMA (little red spot and itching to touch on injection site). On an unknown date, the patient experienced DECREASED APPETITE (Her appetite was down). At the time of the report, ENERGY INCREASED (felt big boost of energy), DECREASED APPETITE (Her appetite was down), VACCINATION SITE PRURITUS (little red spot and itching to touch on injection site) and VACCINATION SITE ERYTHEMA (little red spot and itching to touch on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant  medications were provided. The treatment information was unknown.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 05-NOV-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose number, route and lot# were not specified) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Patient approximately 10 minutes after receiving his second dose of the Pfizer vaccine begins to experience itching in the chest area, proceeds to be evaluated by the paramedic. Patient reports itching worsens and radiates to the mouth area manifesting a skin rash, Paramedic receives a medical order via telephone from Doctor to administer .25mg of dexamethasone at 1:55 the patient verbalizes feeling improvement, evidence of redness reduced in the chest area.
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 22-FEB-2017, the nurse reported that the patient was vaccinated with M-M-R II via an unspecified route, reconstituted with the appropriate diluent (strength, dose, Lot # and expiration date were not provided) for prophylaxis. Then, on 21-MAR-2017, the patient was inadvertently "vaccinated too early" (inappropriate schedule of drug administration) with VARIVAX subcutaneously, Lot # M037642 with expiration date: 01-SEP-2018, reconstituted with the appropriate diluent (strength and dose not reported) for prophylaxis. No adverse effect were reported. There was no product quality complaint involved. Additional information has been requested.
Soreness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number ZG47A, expiry date 12th December 2021) for prophylaxis.   On 16th January 2019, the patient received the 1st dose of Shingrix. On 17th January 2019, 1 days after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The patient noted soreness the next day after 1st dose of Shingrix.  The case has been linked with case US2019GSK077043, reported by same reporter for same patient.