chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The injection site area red; The injection site area raised; Vaccination site pruritus; small bumps on arm / rash is 6 inches in diameter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (small bumps on arm / rash is 6 inches in diameter), VACCINATION SITE ERYTHEMA (The injection site area red), VACCINATION SITE INDURATION (The injection site area raised) and VACCINATION SITE PRURITUS (Vaccination site pruritus) in a 29-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 reaction.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE RASH (small bumps on arm / rash is 6 inches in diameter) and VACCINATION SITE PRURITUS (Vaccination site pruritus). On 27-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (The injection site area red) and VACCINATION SITE INDURATION (The injection site area raised). At the time of the report, VACCINATION SITE RASH (small bumps on arm / rash is 6 inches in diameter), VACCINATION SITE ERYTHEMA (The injection site area red), VACCINATION SITE INDURATION (The injection site area raised) and VACCINATION SITE PRURITUS (Vaccination site pruritus) 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.
Lt ant. thigh swelling & erythema around injection site 10-12 cm diam.
chills; head is pounding every day; throwed up couple of times; fever; cough; difficulty to breath; runny nose; feeling cold; muscle pain,body is hurting; throat soreness; "I am having a felling like I am going to die."; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (head is pounding every day), VOMITING (throwed up couple of times), PYREXIA (fever) and COUGH (cough) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced CHILLS (chills), HEADACHE (head is pounding every day), VOMITING (throwed up couple of times), PYREXIA (fever), COUGH (cough), DYSPNOEA (difficulty to breath), RHINORRHOEA (runny nose), FEELING COLD (feeling cold), MYALGIA (muscle pain,body is hurting), OROPHARYNGEAL PAIN (throat soreness) and FEELING ABNORMAL ("I am having a felling like I am going to die."). At the time of the report, CHILLS (chills), HEADACHE (head is pounding every day), VOMITING (throwed up couple of times), PYREXIA (fever), COUGH (cough), DYSPNOEA (difficulty to breath), RHINORRHOEA (runny nose), FEELING COLD (feeling cold), MYALGIA (muscle pain,body is hurting), OROPHARYNGEAL PAIN (throat soreness) and FEELING ABNORMAL ("I am having a felling like I am going to die.") outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.   This case was linked to MOD-2021-117942 (Patient Link).
Dizziness all day and all night since the second day of receiving the vaccine. I'm on day 14 and am still very dizzy!!!
Very Dizzy; temp. was 100.8°; Tried to vomit but there was nothing in my stomach; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Very Dizzy), PYREXIA (temp. was 100.8°) and VOMITING (Tried to vomit but there was nothing in my stomach) in a 73-year-old patient of an unknown 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 an unknown date, the patient experienced DIZZINESS (Very Dizzy), PYREXIA (temp. was 100.8°) and VOMITING (Tried to vomit but there was nothing in my stomach). At the time of the report, DIZZINESS (Very Dizzy), PYREXIA (temp. was 100.8°) and VOMITING (Tried to vomit but there was nothing in my stomach) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.8 (High) 100.8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 24-AUG-2016, the patient was vaccinated with expired dose of ZOSTAVAX lot # L000461 /expiration date-08-MAR-2016, subcutaneous, (expired product administered). No adverse event was reported. No concomitant medication was reported. The outcome of event was unknown. No PQC (product quality complaint) was involved. Additional information is not expected as reporter does not want to get connected.
s/p redness & swelling to inj site;bruising to axial area;h/a;tx w/ APAP;
Pt received Pfizer BioNTech 5-11 year old dose. Wrong formula; should have received 12+ Pfizer
Weak immune sys, Sickness, ear infections, sleep issues, sensory issues, autism.
1/1 started having mild pain left armpit, no swelling, pain worse 1/5
The patient receieved the vaccination at approximately 11:30. At 5 p.m. the patient's feet felt numb and her feet and hands felt edematous. The patient had hives on her hands and lower arms and also on her feet and lower legs. The patient was treated with Benadryl. The patient was also treated with Pulmicort aerosol for breathing difficulties.
I have no energy; dizzy / I didn't go down in the basement steps because I figured out  that I will pass out if I get down there; restless; slept a lot; I was really hot; tired / slept all day; got really cold couldn't get warm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Lot number: ER2613) at the age of 72 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation, reaction(s): "Didn't have side effects". The following information was reported: FEELING COLD (non-serious) with onset 20Mar2021, outcome "recovered" (23Mar2021), described as "got really cold couldn't get warm"; FEELING HOT (non-serious) with onset 21Mar2021, outcome "recovered" (23Mar2021), described as "I was really hot"; FATIGUE (non-serious) with onset 21Mar2021, outcome "recovered" (23Mar2021), described as "tired / slept all day"; RESTLESSNESS (non-serious) with onset 22Mar2021, outcome "recovered" (23Mar2021), described as "restless"; HYPERSOMNIA (non-serious) with onset 22Mar2021, outcome "recovered" (23Mar2021), described as "slept a lot"; ASTHENIA (non-serious) with onset 23Mar2021, outcome "recovered" (23Mar2021), described as "I have no energy"; DIZZINESS (non-serious) with onset 23Mar2021, outcome "recovered" (23Mar2021), described as "dizzy / I didn'tgo down in the basement steps because I figured out  that I will pass out if I get down there". Therapeutic measures were not taken as a result of feeling cold, feeling hot, fatigue, restlessness, hypersomnia, asthenia, dizziness.  Additional information: The patient also had Synthetic fibroid 75 mcg daily as concomitant medication.   No follow-up attempts are possible. No further information is expected.
Temperature to 101 degrees F with chills, relieved with Tylenol. Sore throat and runny nose, resolved by 11/5/10. Watery, blood-shot eyes, resolved by 11/5/10. Headache, relieved with Tylenol.
Since 10/14 I have had lack of appetite, queasiness and nausea. It is still going on today 10/23.
He's stopped talking w/words he babbles. He's stopped developing mentally. He's not recognizing pain. He not using utensils to eat. He get very frustrated
14 days after 1st Moderna COVID inoculation I developed redness around injection site.  A 3" radius area which at first itched.  I am now on 2nd day with same area, which is also somewhat swollen & warm. I have taken Benadryl tablet & applied Benadryl cream.
09Jun2022 tested + after a neg runny nose and fatigue, dizzy; 09Jun2022 tested + after a neg runny nose and fatigue, dizzy; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2021 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left 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: "Low WBC" (unspecified if ongoing), notes: idiopathic. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jun2022, outcome "unknown" and all described as "09Jun2022 tested + after a neg runny nose and fatigue, dizzy". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result; (unspecified date) Negative; (09Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 namely Paxlovid from 01Jun2022 to 05Jun2022 (lot number: FX2741)  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 in the case, an association between the reported events headache and the suspect product BNT162B2 cannot be ruled out.
PATIENT REPORTED ARM PAIN (NOT AT THE INJECTION SITE) BETWEEN HIS ELBOW AND SHOULDER THAT IS WORSE WHEN RESTING
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a male patient who received SHINGRIX for prophylaxis. On 26th November 2018, the patient received the 1st dose of SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were unknown. It was unknown if the reporter considered the injection site swelling and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced the swelling and slight pain at the injection site post vaccination.
I started on February 17th I started with hives.  It got worse in towards the weekend.  I started to take antihistamine.  The following week I went to the doctor, and he prescribed steroids.  I got things under control until the prescription ran out.  Then I got some over the counter medication which worked until I forgot to take it one morning and I started to itch again. On the 30th of March I went back to the doctor, and he referred me to an allergy specialist.  I went to them on May 3rd. I was taking Benadryl and Pepcid AC in the evenings before I saw the specialist.  They advised to stop taking them.  The hives came back.  He advised to take Zyrtec.  I am still having symptoms.  I have had symptoms for 3 months now.
severe chills shaking throughout the night Profuse sweating Headache All these lasted for 3days
This spontaneous report was received from a medical assistant via company representative and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-MAY-2017, the patient was vaccinated with a dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot# and expiration date were not reported). It was not specified was this the patient's first dose of GARDASIL 9. In approximately May 2017, the patient experienced unspecified rash (rash located on patient's body). The patient treated herself with a cetirizine dihydrochloridum (ZYRTEC), on an unknown date. At the reporting time, (reported as "today"), the patient's status was described as  "to be better". The relatedness between the event of rash and GARDASIL 9 was not reported. Additional information has been requested.
I had headaches, which I never have. I had brain fog and pressure in my head. After the second shot it got worse. It lasted until 2 weeks ago. The headaches lasted for about 2 or 3 weeks. The pressure in my head was very aggravating. I contacted the PA and she did not do anything. I took some Advil for the headaches. I went to physical therapy and to get a massage. They were working on my head to release the pressure. They said my spinal fluid was not moving. I had a chest x-ray and blood tests done and they were all clear.
Case number PHHY2011US66531 is an incomplete spontaneous report received from a nurse on 21 Jul 2011. This report refers to five patients of unknown age group and gender. They were given only the CYW-135 liquid component of MENVEO (batch number: unknown) intramuscularly on unknown dates. No other adverse event was reported.
Per patient report, 30 minutes after vaccine administration patient began feeling nauseated and dizzy. Patient called wife while driving home on the highway to tell her of the symptoms. Patient had a syncopal event which resulted in a car wreck. I followed up with the patient's wife by phone, she reported he had a split lip and was still nauseated. Patient sent home by EMS.
Covid hands; blisters on both hands bilaterally, & between & atop his knuckles & between his knuckles, & on knuckles/big patches of redness with tiny blisters on top of the patches; big patches of redness with tiny blisters on top of the patches / hands stay red for a long time; a lot of colitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (Covid hands), BLISTER (blisters on both hands bilaterally, & between & atop his knuckles & between his knuckles, & on knuckles/big patches of redness with tiny blisters on top of the patches), ERYTHEMA (big patches of redness with tiny blisters on top of the patches / hands stay red for a long time) and COLITIS (a lot of colitis) 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 Colitis and COVID-19.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid hands), BLISTER (blisters on both hands bilaterally, & between & atop his knuckles & between his knuckles, & on knuckles/big patches of redness with tiny blisters on top of the patches), ERYTHEMA (big patches of redness with tiny blisters on top of the patches / hands stay red for a long time) and COLITIS (a lot of colitis). At the time of the report, VACCINATION SITE REACTION (Covid hands), ERYTHEMA (big patches of redness with tiny blisters on top of the patches / hands stay red for a long time) and COLITIS (a lot of colitis) outcome was unknown and BLISTER (blisters on both hands bilaterally, & between & atop his knuckles & between his knuckles, & on knuckles/big patches of redness with tiny blisters on top of the patches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The blisters went away and patient's hand remained reddened for extended periods. The patient visited dermatologist, who admitted to having never seen this before. He prescribed multiple creams but none had been effective.  No concomitant medications were provided by the reporter.  Treatment information was not provided.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies were reported. Since an unspecified date in November 2014, doses of ROTATEQ, which were improperly stored (incorrect product stored), were administered orally to unspecified number of patients (dose, dose number, lot number and expiration date were unspecified). No adverse effects were noted. No concomitant therapies were reported. This is one of several reports received from the same reporter. Additional information is not expected, because the reporter not consent further follows up.
After receiving Covid-19 product Moderna NDC 80777-0275-99 RX team and RPh were under the impression that this product was to be used for booster doses. After due diligence and checking VARS it was found to be that this patient may have received 0.25ml of that product (rather than the recommended 0.5ml dose for boosters).  I will then contact the patients physician to see if they would like us to repeat the dose.
I had terrible pain in the calves of both legs but the left side more.  It began within two hours of getting the vaccine and worsened over the night.  I woke up at about 4:00 a.m. with a severe cramp in the left calf and I had to jump around until it loosened up.  It was extremely sore afterwards.  I was exhausted all day on Wednesday and my legs hurt the entire day.  By Thursday my legs were a little better and by Friday it was significantly better.  I am still feeling some pain in my left calf but it?s not all the time.
Jan. 15, 2021 here for annual physical and received a Tdap vaccine in left deltoid Jan. 16, called with pain and given advice to use warm compresses and take ibuprofen alternating with tylenol Jan. 22 called again with same complaint and given same advice PLUS call on Mon. if no improvement Feb. 8 called again with same complaint and given appt. for telehealth Feb. 8 telehealth appt. completed and patient prescribed Medrol dose pack and call back if no improvement March 4 called again with complaint of "hand pain" and given appt. for March 5 (seen for shoulder pain)- referred to PT March 8 called again with no improvement. Referred to Ortho on 3/9 March 10 called again with no improvement and advised ortho referral was placed March 13 saw ortho March 15 called again and states saw ortho on 3/13/but still no improvement March 16- was supposed to have a Facetime appt but cancelled it March 23 called again and still having problems (note says "hand" not "shoulder"). Nurse attempted to call her back but no response and a VM was left April 2 called again with continued pain. Nurse returned call on Mon. 4/5 then a series of back and forthes resulted in patient being advised she needs MRI.  April 6 conversation results in patient stating we should pay her medical bills.
she started having stomach pain; This is a spontaneous report received from a contactable reporter (Physician) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 21Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history.The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 28Dec2020, for COVID-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "unknown", described as "she started having stomach pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal pain upper. The reporter considered "she started having stomach pain" not related to bnt162b2. Additional information: Patient had a semi-quantitative total antibody test done on 06May2021 and her antibody titer came back as 2,500. Patient was unsure if this high of an antibody result is considered out of range or expected this long after receiving the second dose. She stated that per most of her colleagues typical antibody results are in the 300-400 range. Patient already received both doses of Covid19 vaccine. She now concerned with the spike protein levels that she had after three months that she took the covid19 vaccine (as reported).Few weeks ago she started having stomach pain and started taking Nexium. She did not feel this was related to the Pfizer COVID-19 vaccine. She had an upper endoscopy performed on 12May2021 for that stomach pain, result not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported event of abdominal pain.  There is limited information provided in this report.  This case will be reassessed once additional information is available.
Patient passed out as he went to stand up from the exam table, and fell to the floor face down, he received a small superficial abrasion to his lower lip, he was checked out by one of our doctors, vital signs were normal and he was able to answer questions, we kept him lying on the table for 15-20 minutes until the Dad felt comfortable that he was alright to leave.
Pt reports blistery spots on back, scalp, neck, buttocks,and face.
High grade fever ranging from 99 to 103 degrees F for 4 days; Chills; Body aches; Headache; Nausea; Constipation; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the right arm on an unknown date in Apr2021 (at the age of 43-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the right arm on an unknown date in Apr2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and pravastatin (MANUFACTURER UNKNOWN); all for unknown indication, from an unknown date and unknown if ongoing. On an unknown date in Apr2021, the patient experienced high grade fever ranging from 99 to 103 degrees Fahrenheit for 4 days, chills, body aches, headache, nausea and constipation. It was reported that symptoms started two days after shot was received. On an unknown date in Apr2021, the patient underwent body temperature test and the result was found to be 99 to 103 degrees Fahrenheit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events high grade fever, chills, body aches, headache, nausea and constipation was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
w/in 24hr of vax pt devel a pin-point, itchy rash over upper body;also devel an inj site rxn characterized by redness & swelling;pt treated self w/DPH;sx resolved w/in 1wk;this is 1 of 2 pt from this facility to devel a rash p/vax;