chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a certified medical assistant concerning a 16 year old female patient with asthma, seasonal allergies, allergies to sulfonamide, aspirin, ibuprofen and ALEVE who on 04-AUG-2009 and 06-OCT-2009 was vaccinated IM with a first and second 0.5ml doses of GARDASIL (lot# 661046/0381X for 1st and 2nd doses). Concomitant therapy included YAZ, albuterol inhaler as needed, XYVAL, SINGULAIR, and ALLERX dose back. Within one week of 06-OCT-2009, the patient developed hives on her legs and left hip and swelling on her lips after receiving her second dose of GARDASIL. The second dose of GARDASIL was administered in her left hip. The patient sought medical attention through an office visit. On unspecified date, the patient recovered. Follow up information has been received from the certified medical assistant concerning the 16 year old female patient who on 06-OCT-2009 at 14:00 was vaccinated IM into the left gluteal muscle with a second 0.5ml dose of GARDASIL (lot# 661046/0381X) (exp: 10-DEC-2010). There was no known illness at the time of vaccination and no known adverse event following prior vaccination. On 07-OCT-2009 at 9:11 AM the patient developed hives on her legs that were larger than quarters and she also developed swelling of her lips. Medical attention was sought, the patient saw the physician. Subsequently, the patient recovered on an unspecified date sought, the patient saw the physician. Subsequently, the patient recovered on an unspecified date. No further information was available.
Child went to ER for fever and abdominal pain and admitted to hospital. On Aug 12, 2007 she had a diagnostic lab done with appendectomy and paracentesis. (Appendix was NL.). IV ABCS administered. Etiology for peritonitis unclear per discharge summary - Pt discharged from hospital 8/17/07 and is recovering at home as of this report. 10/18/07-records received for DOS-8/12-8/17/07-DC DX: Peritonitis, Status post appendectomy 8/12/07-admitted with abdominal pain and fever. Post appendectomy developed abdominal pain . Treated with IV antibiotics.
PATIENT GOT LIGHT HEADED AND NAUSEOUS IMMEDIATELY AFTER GETTING VACCINE
Received Gardasil LD and Hep A RD.  Walked out to waiting room where mother was waiting and sat in chair.  Approx 3 mins after vaccine was given pt turned pale and passed out for approx 3 secs. Aroused and stated he was thirsty and bottled cold water was provided. Sat in chair and became talkative and laughing.  After 15 mins stated he was well enough to leave with mother, and walked out of facility.
Very low platelets; Hard time walking; back problems; This spontaneous case was reported by a patient and describes the occurrence of PLATELET COUNT DECREASED (Very low platelets), GAIT DISTURBANCE (Hard time walking) and MUSCULOSKELETAL DISCOMFORT (back problems) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20O) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Breast Cancer). Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, PRAVASTATIN for Cholesterol, COLECALCIFEROL (VITAMIN D3), MENATETRENONE (VITAMIN K2 TOWA), COLECALCIFEROL, UBIDECARENONE (COQ10+D), MAGNESIUM, CLONAZEPAM, PARACETAMOL (TYLENOL) and HYDROCODONE for an unknown indication.    On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT DECREASED (Very low platelets), GAIT DISTURBANCE (Hard time walking) and MUSCULOSKELETAL DISCOMFORT (back problems). At the time of the report, PLATELET COUNT DECREASED (Very low platelets), GAIT DISTURBANCE (Hard time walking) and MUSCULOSKELETAL DISCOMFORT (back problems) outcome was unknown.            Treatment information include patient took 40 mg of prednisone for two weeks, then 20mg for 2 weeks, then alternate each day with 10mg one day and 5 mg the other day for 2 more weeks.; Sender's Comments: This case concerns a 87 year old female with relevant medical history of Breast Cancer who experienced the unexpected events of decreased platelet count, Gait disturbance and musculoskeletal discomfort which happened on an unknown date after vaccinaton with Moderna vaccine. The rechallenge for this case is unknown since there is no information re the first dose. The age and medical condition Breast carcinoma can be considered confounders for this case. The benefit -risk relationship of Moderna is not affected by this report.
about a week after injection the injection site got very swollen, extremely painful, and the skin around the injection area looks similar to an infection and started a white spot and has continued to get worse and looks now like an open wound that does not bleed.
fatigue; have a minor loss of energy after the second vaccine /had no energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 77 year-old male patient received bnt162b2 (BNT162B2), administration date 16Feb2021 (Lot number: EN6201) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Low RBC Counts" (unspecified if ongoing), notes: Verbatim: Low RBC Counts; "pancytopenia" (unspecified if ongoing), notes: Verbatim: pancytopenia. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number: 1, Administration date= 26Jan2021, Lot Number: EL3249), administration date: 26Jan2021, when the patient was 77 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue"; ASTHENIA (non-serious), outcome "unknown", described as "have a minor loss of energy after the second vaccine /had no energy".  Additional Context: Caller stated he already had 2 shots previously and only had a minor reaction such as fatigue from the second one. Caller reported history of low RBC counts and other immune deficiency characteristics such as pancytopenia. He didn't really have a reaction to the COVID vaccine 1 or 2. He did have a minor loss of energy after the second vaccine. He had just had no energy for a day. He just had fatigue for a day. He took it easy. He just wasn't quite right. No prior Vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Patient hospitalized on 5/6/2021 for total knee replacement. Patient hospitalized for left inguinal hernia repair on 5/7/2021. These visits are within 6 weeks of receiving COVID vaccination.
8 days after first dose I developed a sporatic measle like rash on my legs, arms, back, abdomen, scalp area. this started to subside just before my second dose at which time it became worse but eventually appears to stay along my spine (Back) and on the lower back of my scalp. It has been 7 months and I still have this itchy rash, mostly on my back and scalp but it does sporadically appear in different areas, abdomen etc.
Fatigue; A little headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and HEADACHE (A little headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue) and HEADACHE (A little headache). At the time of the report, FATIGUE (Fatigue) and HEADACHE (A little headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment medications was provided.
Swelling of the arm down towards the elbow accompanied with fever in the arm. Started say after i njection and still present 3 days after. Patient to start Benadry and TYLENOL to help with symptoms. Will monitor symptoms and seek treatment if needed. Will advise pharmacy of any changes.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old male patient who received FLULAVAL QUADRIVALENT 2018-2019 season for prophylaxis. On 26th September 2018, the patient received the 1st dose of FLULAVAL QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 27th September 2018, 1 days after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced fever, dehydration, lightheadedness, muscle pain, nausea, vomiting, diarrhea and fatigue. On an unknown date, the outcome of the fever, dehydration, lightheadedness, muscle pain and fatigue were not recovered/not resolved and the outcome of the nausea, vomiting and diarrhea were recovered/resolved. It was unknown if the reporter considered the fever, dehydration, lightheadedness, muscle pain, nausea, vomiting, diarrhea and fatigue to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional information was reported as follows: The patient reported that he had contacted his physician, but had not seen by his physician.
After vaccine pt showed signs of severe nausea, dry heaving, and dizziness. Pt laid down for 30min. Patient revealed of symptoms, vitals are stable.  Patient escorted by dad home.
Severe pain in left arm the first night. Pain and swelling of  lymph nodes in left armpit, left breast, and left side of neck for 2 weeks afterwards.  Continued milder pain and inflammation of left armpit and left breast as of 8/12/21
Endocarditis, open heart surgery with valve replacement, IV antibiotics. Patient concerned about possible side-effect of vaccine.
Arm was sore from the injection; Received his Pfizer/BioNTech COVID-19 vaccine Booster on 09Dec; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A male patient received bnt162b2 (BNT162B2), administration date 09Dec2021 (Formulation: solution for injection, Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "Received his Pfizer/BioNTech COVID-19 vaccine Booster on 09Dec"; VACCINATION SITE PAIN (non-serious) with onset 10Dec2021, outcome "unknown", described as "Arm was sore from the injection".  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a nurse refers to a 17 year old male patient with none pertinent medical history seasonal allergies. On an unknown date the patient was vaccinated with the first and the second dose of GARDASIL (lot #, doses and routes not reported). Concomitant medication included unspecified allergy medication (dosage and manufacturer unspecified). On an unknown date, after receiving his second dose, the patient experienced hyperhidrosis and extreme sweating. The nurse planned to give the patient the third dose of GARDASIL. The patient sought medical attention, he spoke to nurse. Unspecified treatment was given. None lab diagnostics was performed. The outcome of hyperhidrosis and extreme sweating was reported as not recovered/not resolved. Causality was not reported.
I had really bad fever 102.7, mild headache. When I woke up had a golf size lymph node on the left side on the arm pit. I was advised to keep warm compress to help with the swelling took about 4 days come down and fever left after 3 days. About 2 weeks after the vaccine started experiencing hot flashes it is coincidental that this happened around the vaccine.
No adverse effect; expired vaccine used; This spontaneous report was received from a nurse, concerning a patient of unknown age or gender.  The patient's medical history, concurrent conditions, drug reactions or allergies were not provided.   On 29-MAR-2019, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # R010368 with expiration date 25-MAR-2019, administered intramuscularly (strength, frequency, dose, and anatomical location were not provided) as prophylaxis.  No adverse effects were reported.
very fatigued/very exhausted; Got the 3rd dose without being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very fatigued/very exhausted) and OFF LABEL USE (Got the 3rd dose without being immunocompromised) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, PROPRANOLOL, MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), LORAZEPAM (ATIVAN) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 12-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced OFF LABEL USE (Got the 3rd dose without being immunocompromised). On 13-Sep-2021, the patient experienced FATIGUE (very fatigued/very exhausted). On 12-Sep-2021, OFF LABEL USE (Got the 3rd dose without being immunocompromised) had resolved. At the time of the report, FATIGUE (very fatigued/very exhausted) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-354336 (Patient Link).
The client reported that they received a first dose of Sinovac COVID vaccine (Lot# 6-202102005) on 03/21/21. The client states she received a second dose of Sinovac COVID vaccine, but does not have documentation of the second dose. The client presented to clinic on 12/29/21 where she was advised to start the Pfizer series over and received a fist dose of Pfizer COVID vaccine (Lot# FL3197). The client stated that 4 hours after the Pfizer dose she developed itching and a rash dispersed on her body. The client stated these symptoms lasted two days. The client took Benadryl which helped her symptoms.
Pt recvd 1st dose of vax on 28NOV90 & on 17DEC90 pt exp nausea, diarrhea & h/a; On 25DEC90 pt exp lower back pains radiating to neck & thighs which kept pt from getting out of bed;
heat going across back near bra strap; Still having discomfort from left shoulder to back of where the bra goes on; Pain has moved up and down on her left side; little pimple appeared; started having issues where she felt warmth in left breast; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (started having issues where she felt warmth in left breast), FEELING HOT (heat going across back near bra strap), MUSCULOSKELETAL DISCOMFORT (Still having discomfort from left shoulder to back of where the bra goes on), PAIN (Pain has moved up and down on her left side) and ACNE (little pimple appeared) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Breast lump removal. Concomitant products included SIMVASTATIN, DILTIAZEM, LEVOTHYROXINE, SPIRONOLACTONE, GLUCOSAMINE, UBIDECARENONE (COQ) and MULTIVITE FM OMEGA for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING HOT (started having issues where she felt warmth in left breast). On 01-May-2021, the patient experienced FEELING HOT (heat going across back near bra strap), MUSCULOSKELETAL DISCOMFORT (Still having discomfort from left shoulder to back of where the bra goes on), PAIN (Pain has moved up and down on her left side) and ACNE (little pimple appeared). The patient was treated with IBUPROFEN at an unspecified dose and frequency; GABAPENTIN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING HOT (started having issues where she felt warmth in left breast), FEELING HOT (heat going across back near bra strap), MUSCULOSKELETAL DISCOMFORT (Still having discomfort from left shoulder to back of where the bra goes on), PAIN (Pain has moved up and down on her left side) and ACNE (little pimple appeared) outcome was unknown. Not Provided
Rec'd PNEUMOVAX at 4:30 PM. C/O itchiness & hives at 5:39 pm. No cardio/pulm sx - (anxiety only) diffuse hives trunk & arms. Tx BENADRYL IM SOLUMEDROL IM BENADRYL & CLARITIN po at home.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The nurse reported that the patients received improperly stored (temperature excursion; 15 F, time frame: 12 hours) doses of VARIVAX of lot/batch # L021214 with expiry date 06-OCT-2017, lot/batch # L034370 with expiry date 08-SEP-2017 and lot/batch # L042817 with expiry date 10-JUN-3017 (Dose, strength, dose number, vaccination site and route of administration not provided) on unspecified date. Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of two reports from same reporter link. Additional information has been requested.
got Covid 19; This is a spontaneous report from a contactable consumer (Patient).A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection; Lot Number: unknown; expiration date: unknown), via an unspecified route of administration on an unspecified date as first dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she received first dose and 6 days later she got Covid. Her second dose was scheduled for Tuesday and she states she was not going to get it. She feels her natural immunity was better than the vaccine. she stated her natural immunity to Covid 19 was better than the vaccine what was the point of getting a second dose. She wants to know was there any information if she chooses to get the shot later maybe in the summer would she have to get two shots. The outcome of the event unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Redness approximately 2 inches across started yesterday (4/14/2021) at the vax site.  Today (4/15/2021), it has spread to about 4 to 5 inches across and is hot and itching.
Elevated ANA levels; This spontaneous case was reported by a patient and describes the occurrence of ANTINUCLEAR ANTIBODY INCREASED (Elevated ANA levels) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 prophylaxis.     Patient did not had allergies and has never tested/diagnosed with COVID-19. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for Drug use for unknown indication: JANSSEN COVID-19 VACCINE (Dose 1 , Lot 1805029) on 11-Mar-2021, JANSSEN COVID-19 VACCINE (Dose 2 and Lot 211D21A) on 01-Dec-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE and JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Lung disorder NOS (Being evaluated for a lung transplant).    On 01-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2022, the patient experienced ANTINUCLEAR ANTIBODY INCREASED (Elevated ANA levels). At the time of the report, ANTINUCLEAR ANTIBODY INCREASED (Elevated ANA levels) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2022, Antinuclear antibody: First ANA test was normal. On 20-Jul-2022, Antinuclear antibody: Came back elevated.         No Concomitant medications were provided.  It was reported that patient was being evaluated for a lung transplant. Patient elevated ANA may cause a potential disqualification for lung transplant as case was being evaluated by a clinical team.  Patient received Moderna booster and had no other side effects.  There were recent change in patient status such as improvement or worsening.  No treatment medications were provided.
EXPIRED VACCINE ADMINISTERED FROM THE VIAL AFFECTED DUE TO TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 19 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and  expiry: 21-SEP-2021) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-JUL-2021, the patient experienced expired vaccine administered from the vial affected due to temperature excursion. On 28-JUL-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered from the vial affected due to temperature excursion and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210916520, 20210916300, 20210916228, 20210913164, 20210916129, 20210916415, 20210915623, 20210915661, 20210913164, 20210915748, 20210915852, 20210916228, 20210916910, 20210916959, 20210915719, 20210916697, 20210917160, 20210915646, 20210917163, 20210916907, 20210916553, 20210916768, 20210917515, 20210917226, 20210916312, 20210916401, 20210916455, 20210916465, 20210916498, 20210916584, 20210916715, 20210916808, 20210916811, 20210917603, 20210916849, 20210916965 and 20210917074.
Left thigh swollen to quarter-size with redness & fever x 1 day. Swelling persisted about 2 weeks, gradually fading. No other sequelae.
Severe headache; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 13:00 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. Medical history and 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 for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient experienced severe headache. The event did not result in doctor or other healthcare professional office/clinic visit or emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event severe headache was resolving at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On 10/4/19, the patient reported that she experienced severe stiffness/soreness in the back and neck as well as soreness in the left arm that started the next day after vaccination. Patient was referred to her provider in case of adverse effect. Although body aches occur in 1 out of 3 patients, patient reported that her body ache resulted in her not being able to move her neck and back for a few days.  She reports icing it to little effect, but she explained that she may be "feeling a little bit better" as of 10/4/19.