chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare worker and refers to a 4 year old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 30-DEC-2015, the patient was vaccinated with an improperly stored M-M-R II (lot # K024035, expiry date 26-NOV-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Under tongue sore; Under tongue sore and swollen; Terrible right side back of headheadache; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration in the left arm on 03Apr2021 at 16:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to penicillin and sulfa based drugs. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration in the left arm on 13Mar2021 at 16:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 19:30, the patient experienced under tongue sore and swollen and terrible right side back of head headache on day 3 lasting several days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events under tongue sore and swollen and terrible right side back of head headache were not resolved at the time of this report.    No follow-up attempts are possible. No further information is expected.
who received their first Pfizer Covid vaccine dose and then tested positive for Covid after; who received their first Pfizer Covid vaccine dose and then tested positive for Covid after; This is a spontaneous report from a Pfizer sponsored program. A contactable reporter (Physician) reporting on behalf of 57-year-old female consumer (patient) reported that. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter states she has a patient (57 y/o female) who received their first Pfizer Covid vaccine dose and then tested positive for Covid after. The patient received monoclonal antibodies for treatment of the Covid infection. Reporter wants to know more information on administering the second vaccine dose. She mentioned that she wanted the patient to wait 90 days after the antibody treatment, but she is looking for any guidance that Pfizer has regarding this scenario. Dose of covid-19 vaccine or restart due to contracting the Covid-19 virus after her first dose of Pfizer covid-19 vaccine. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the limited information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Covid 19. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
dose number=3; Swollen lymph nodes and pain under arm; Swollen lymph nodes and pain under arm; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 at 08:45 (Lot number: 33130BA) at the age of 35 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: CABERGOLINE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: ER8729, Route of Administration: Unspecified, Anatomical Location: Left arm), administration date: 07Apr2021, when the patient was 35 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0164, Route of Administration: Unspecified, Anatomical Location: Left arm.), administration date: 05May2021, when the patient was 35 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021 at 08:45, outcome "unknown", described as "dose number=3"; LYMPHADENOPATHY (non-serious), AXILLARY PAIN (non-serious) all with onset an unknown date in Dec2021, outcome "not recovered", and all described as "Swollen lymph nodes and pain under arm". Therapeutic measures were not taken as a result of lymphadenopathy and axillary pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Pt developed diarrhea, vomiting, chills and he couldn't get out of bed the following day after receiving the vaccine. He felt like he had a stomach virus.
woke up shaking; sweating; felt kind of like the flu; could not eat anything; had a fever; was very nauseous; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (woke up shaking), HYPERHIDROSIS (sweating), INFLUENZA LIKE ILLNESS (felt kind of like the flu), FEEDING DISORDER (could not eat anything) and PYREXIA (had a fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066021A, 013L20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis, Blood pressure high and Lupus cystitis (She got lupus later on in life ). Concomitant products included AMLODIPINE and LOSARTAN for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced TREMOR (woke up shaking), HYPERHIDROSIS (sweating), INFLUENZA LIKE ILLNESS (felt kind of like the flu), FEEDING DISORDER (could not eat anything), PYREXIA (had a fever) and NAUSEA (was very nauseous). On 22-Aug-2021, TREMOR (woke up shaking), HYPERHIDROSIS (sweating), INFLUENZA LIKE ILLNESS (felt kind of like the flu), FEEDING DISORDER (could not eat anything), PYREXIA (had a fever) and NAUSEA (was very nauseous) had resolved.            She was prescribed with hydroxichloroquine and she chose not to take it  No Treatment Information was provided by the reporter.
Some of same symptoms as when I had Covid in November 2020 but more mild. Tired body aches upset stomach diarrhea.  No fever then or in November. Symptoms gone on day 3.
Approximately an hour after receiving this injection, the patient stated he began to have severe left arm pain with movement. There was no pain to palpation over the injection site. The patient states that the pain shoots down his arm to fingers, and is unable to move the shoulder/arm without significant pain, but still has appropriate strength in hand. He took ibuprofen and acetaminophen with minimal relief, and thus returned to the clinic a few hours later.
Information has been received from a physician concerning a 5 month old patient with a history of gastrooesophageal reflux who was vaccinated with the second dose of ROTATEQ, 1 ml. Concomitant therapy included PREVACID (TAP), routine vaccines and REGLAN (Unspecified). The patient experienced "intussusception" after receiving the second dose of ROTATEQ and had to be hospitalized overnight. It was reported that "patient is fine now." Unspecified medical attention was sought. No product quality complaint. Additional information has been requested.  8/22/08 Reviewed PCP office records of 6/23/2008 FINAL DX: ileocecal intussusception. Records reveal patient experienced vomiting & constipation on day of vaccination.  Slept in bassinet w/bottle on side.  Next vs of 7/24 was s/p overnight hospitalization for enema reduced IS.  Patient had projectile vomiting & reduced oral intake.    9/5/08 Reviewed hospital medical records of 7/9-7/11/2008. FINAL DX: Intussusception Records reveal patient experienced projectile vomiting, severe abdominal pain, irritability, crying.  Pt admitted for observation s/p enema reduction of IS.
PATIENT HAD NAUSEA AND VOMITING WITHIN 15 MINUTES OF GETTING THE VACCINE. SHE FELT BETTER AFTER DRINKING SOME WATER AND WAS STABLE WITHIN 30 MINUTES OF GETTING THE VACCINE.
Patient reported swelling at the site the size of a grapefruit a few hours after administration, cetirizine was given with improvement 4-22. Further notes on the reaction not found. Pain, Swelling. Cetirizine 10 mg once.
A female patient received bnt162b2 (Pfizer- Biontech COVID-19 Vaccine Formulation: Solution for injection), via an unspecified route of administration on 05May2021 16:30 as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included eczema ( I have eczema, its since I was a baby) , food allergy, food allergy, drug hypersensitivity and food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient experienced i had an uti on an unspecified date.  The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unspecified date.  I have anaphylactic shock. Penicillin - not sure my reaction, I have eczema, its since I was a baby. I was told I was allergic to it, probably itching because of the eczema, I haven't drank orange juice in a long time, it makes me itchy, that's probably what the reaction to penicillin was.  The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Intense headache and neck ache, body aches, chills, night sweats, probable fever but unconfirmed as I just haven't taken it with a thermometer, sinusitis and sinus tap pain, and a wracking cough that has worsened in the following 24 hours. Symptoms are all still worsening.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant therapy were not provided. On 05-OCT-2016, the patient was vaccinated with an expired dose of 19400 plaque form unit (PFU), 0.65 ml, expiration date: 17-JUL-2016, injection, subcutaneously. Lot number was not specified. The pharmacist stated, the ZOSTAVAX was stored correctly through administration. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Developed a small "welt" after 24 hours.  24 hours later, developed large area erythema, warmth, tenderness, fever, headache, nausea.  Treated for cellulitis.
Increased redness/warmth/swelling/itching at site of injections and swelling in axilla of injection arm.  When patient seen in office injection site swollen 7x9cm, warm to touch, and axilla swollen.  Patient stated increased itching still.
shortly p/vax felt lightheaded & had a cold rush from head to toes;the next morning ears itched & burned;then got hives all over body;took DPH & MD prescribed methyprednisdone;
very itchy; very red (about 3inches x 1.5 inch); fatigue; uncontrollable runny nose; chest tightness; wheezing; burning; swollen size of a quarter and hard; swollen size of a quarter and hard; painful to the touch; soreness in the whole arm; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning), VACCINATION SITE SWELLING (swollen size of a quarter and hard), VACCINATION SITE INDURATION (swollen size of a quarter and hard), VACCINATION SITE PAIN (painful to the touch) and PAIN IN EXTREMITY (soreness in the whole arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced BURNING SENSATION (burning), VACCINATION SITE SWELLING (swollen size of a quarter and hard), VACCINATION SITE INDURATION (swollen size of a quarter and hard), VACCINATION SITE PAIN (painful to the touch), PAIN IN EXTREMITY (soreness in the whole arm), RHINORRHOEA (uncontrollable runny nose), CHEST DISCOMFORT (chest tightness) and WHEEZING (wheezing). On 14-Apr-2021, the patient experienced FATIGUE (fatigue). On 20-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (very itchy) and VACCINATION SITE ERYTHEMA (very red (about 3inches x 1.5 inch)). On 14-Apr-2021, VACCINATION SITE PAIN (painful to the touch) and PAIN IN EXTREMITY (soreness in the whole arm) had resolved. On 16-Apr-2021, FATIGUE (fatigue) had resolved. On 18-Apr-2021, BURNING SENSATION (burning), RHINORRHOEA (uncontrollable runny nose), CHEST DISCOMFORT (chest tightness) and WHEEZING (wheezing) had resolved. At the time of the report, VACCINATION SITE SWELLING (swollen size of a quarter and hard), VACCINATION SITE PRURITUS (very itchy) and VACCINATION SITE ERYTHEMA (very red (about 3inches x 1.5 inch)) outcome was unknown and VACCINATION SITE INDURATION (swollen size of a quarter and hard) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported.
6AUG97 @ 6PM c/o severe lt leg pain & inability to walk;mom reported inconsolable crying @ 1AM on 7AUG97 for 2-3 hr;t103 ax;crying for 3hr in middle of noc;
Low grade temperature of 101 degrees F.  Flu like symptoms.  In bed all weekend.  Very weak.  (It's been so long-all the details are not clear.) The follow up received on 5/23/03 states "the doctor's office told me that they did not have the manufacturer or lot #. If you need need that info, you will have to call Dr."
Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Severe, Additional Details: Immediately before, during, or after vaccine administration, the patient started breathing very fast & loudly nasally while starring wide eyed straight ahead of himself & would not respond to his environment or commands. This lasted anywhere from 10-20 seconds. Once patient regained consciousness, he calmned down & began sweatting profusely. Paramedics were called & cleared him on the condition he call if he experienced signs & symptoms again & to follow up with his PCP.
01/08/2021 (2330): Chills and body aches came on suddenly and quickly. Tried to warm self and sleep. During the night continued to wake with body aches, chills, fever, dizziness, headache and fatigue.  01/09/2021 (0520): Spoke to Doctor and informed  of symptoms. Told to take tylenol and drink lots of fluids. Medication did seem to help with body aches. Had already been drinking lots of fluids. 01/09/2021 (0730): Feeling better. Still having Fatigue and headaches.  01/09/2021 (0900): Headaches, skin tingling, flashes of chills/fever, slight body aches. Noticed a dullness to sense of taste and smell. Continued for the rest of the day. Took tylenol again. 01/10/2021 (1130): Fatigue and slight bodyaches. 01/11/2021 (1300): Slight body aches. Was tested for COVID per Rapid test per work. Negative. 01/12/2021 (0600): Only symptom remaining is very infrequent body aches when exerting myself.
Moderna Bivalent Booster 0.25mcg was given which was wrong dosage, was to be given 0.5mcg.
After H1N1 FLUMIST was given that day I noticed that I started feeling itchy on my arms and around my neck. Noticed some rashes on my right hand and around my neck.
almost immed p/vax pt screaming&crying&holding breath UNTIL blue;then Sz which lasted about 4-5min;lethargic for about 15min after then seemed BETTER;mom took to ER&stated they did blood work 85894 swelling greater than fifty cents piece
Customer returned to pharmacy next day, said had fever last night over 100 degrees. Referred patient to contact MD.
Fever as high as 103. Headache. Diarrhea. Soreness at injection site.
Breastfeeding; This spontaneous report was received from a nurse practitioner, who was also the patient, who received Moderna's COVID-19 (mRNA-1273) vaccine while breastfeeding.    The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Dec 2020, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 23 Dec 2020, the patient reported that she was a breastfeeding mother to a 4.5 month old baby.  Action taken with mRNA-1273 in response to the event was not applicable.   The outcome for the event breast feeding was resolved on 22 Dec 2020.  Follow-up received on 28 Dec 2020 had no new information.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot #unknown), reporting Maternal exposure during breast feeding without any associated adverse events.
Patient began to notice a rash, heat, redness and soreness at site of injection the morning after the injection was administered.  Rash formed in approximately a 2 inch band around patient's arm over the next two days, then began to diminish.  Patient used ice on site and ibuprofen by mouth.
Left side of face swollen and purple and upper lip tingling and numb and stabbing pain in shoulder blades.  Swollen gland in throat too.
under arms nodes are swollen, and throat lympth nodes swollen and painful for 16 days
each time, only had sore spot to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), on 14Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (First dose, Lot. EN6200), administration date: 26Feb2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch"; bnt162b2 (Second dose, Lot. EN6206), administration date: 19Mar2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch". The following information was reported: PAIN (non-serious), outcome "unknown", described as "each time, only had sore spot to touch". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Each time, only had sore spot to touch and negative COVID-19 test (PCR) after the vaccinations.
Fever, chills, muscle/joint pain, headache, nausea (flu-like symptoms).  Started late on 10/24/21 and lasted until midmorning on 10/26/21.
12 hours later:  2 am -fever, chills, lethargy, bone pain persistent for 48 hours, Took one Tylenol For one week after the  shot: rhinorrhea, sore throat, no fever.
excruciating pain; useless arm for at least a year; shingles shot was incorrectly administered into my shoulder; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included eye operation. Concurrent medical conditions included trigeminal neuralgia (had surgery on eye which caused TGN. It seems to had gone into remission).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: excruciating pain), mobility decreased (Verbatim: useless arm for at least a year) and vaccine administered at inappropriate site (Verbatim: shingles shot was incorrectly administered into my shoulder). The outcome of the pain and mobility decreased were resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the pain and mobility decreased to be related to Shingles vaccine.     It was unknown if the company considered the pain and mobility decreased to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-JUL-2023 This case was reported by a patient via interactive digital media. The patient stated that the Shingles shot was incorrectly administered into his/her shoulder which caused excruciating pain and a useless arm for at least a year. The patient received Shingles shot incorrectly in shoulder, which led to vaccine administered at inappropriate site.
Had typical seizure for home after going to bed. 2 days after vaccine and had chills shortly after vaccine so may have been fever related
Patient received a vaccine not approved for individuals under age 18. no adverse reactions have been noted as of this date.
Lump in left armpit, size of a cherry tomato. Felt tender but not painful. Its gotten much smaller but still a little tender.
Two hours post vax, pt developed a vesicular rash over abdomen. He was instructed to take Benadryl 50 mg po x 1. He did not have difficulty breathing, hoarseness or pruritus. He was instructed to go to ER if symptoms worsened.
(1) Heavy legs - (3) Horseness, (2) Sore Throat, (4) Congested chest, (5) Cough, (6) Sinus congestion - All within 24 hrs - Lasted for 3 weeks - congestion like pneumonia - Took Musilex - Fever at onset