chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe Headache-- time course -- Treatment: sinus pain & pressure medicine or migraine Itching at site of injection-- time course: 3 days -- Treatment: applied oatmeal lotion to soothe Fatigue -- time course: a week-- Treatment: Rest  Pain at site of injection -- time course: a week -- Treatment: pain medicine Swelling at site of injection -- time course: 3 days -- Treatment: Ice Joint pain (in knees) -- time course: off and on for a week--Treatment:  pain medicine body aches  -- time course: off and on for a week -- Treatment: pain medicine
Headache; injection site pain; has pain in her arm that has kind of moved toward her armpit and it is a struggle there in the underarm area; has pain in her arm that has kind of moved toward her armpit up to her elbow; has pain in her arm that has kind of moved toward her armpit and spread to her left breast; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 18Mar2021 10:00 (Lot Number: EP7534; Expiration Date: 31Jul2021) (at the age of 33-years-old) as dose 1, single for covid-19 immunisation. Medical history included polycystic ovaries (PCOS autoimmune disease) diagnosed when she was a teenager at age 16 years. There were no concomitant medications. There were no prior vaccinations within 4 weeks of COVID-19 vaccine. Adverse event following prior vaccinations included maybe she gets injection site soreness or a 24-hour cold but not every time, once in a blue moon, patient stated it's like the flu shot and patient does not have name, dose of the vaccinations. Patient stated she wanted to report a symptom she was having. She got the 1st shot on 18Mar2021 and she did have a 24-hour headache that went away. The headache started within 2 hours after the shot on 18Mar2021 and was gone by the end of the day 19Mar2021. She had injection site pain from the get-go on 18Mar2021 and would say she noticed it first closer to maybe her left breast, that she was wearing a sports bra and thought it may be too tight. She had pain in her arm that has kind of moved toward her armpit and it was a struggle there in the underarm area in Mar2021. It was her armpit up to her elbow and spread to her left breast in Mar2021. Patient stated that was maybe 3 days after and the arm injection site was still hurting, that she didn't feel underarm until 3 days later. The pain was up to her elbow and she noticed that about a week later, that it traveled into her armpit and out to the side of her arm to her elbow about a week later. This was all on the left side which was where she got the shot. The events did not require emergency room and physician office visit. During supplemental form patient stated she read an article that said all the symptoms should clear within 6 weeks and if it persists to see somebody and she was holding out, but she was a little nervous as the symptoms are the same as breast cancer. She stated then again it pretty much followed the shot and she was just hoping it was a side effect from the shot. Patient just wanted to report this, and she read an article back in January and was wondering if there have been other reports of swollen lymph nodes. The outcome of the event headache was recovered in 19Mar2021 and outcome of all other events was unknown.  No follow up attempts are possible. No further information is expected.
Fever 104 & irritability x 24 hrs; no siezures; lots of crying;
A Cyclic Vomiting Syndrome Episode was triggered 1 hour after receiving vaccine.; causing a migraine which triggers my CVS episodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old male patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Lot number: ER8729) at the age of 18 years as dose 1,single for covid-19 immunisation. Relevant medical history included: "Cyclic vomiting syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CYCLIC VOMITING SYNDROME (non-serious) with onset 06Apr2021, outcome "recovering", described as "A Cyclic Vomiting Syndrome Episode was triggered 1 hour after receiving vaccine."; MIGRAINE (non-serious) with onset 06Apr2021, outcome "recovering", described as "causing a migraine which triggers my CVS episodes". The events "a cyclic vomiting syndrome episode was triggered 1 hour after receiving vaccine." and "causing a migraine which triggers my cvs episodes" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of cyclic vomiting syndrome, migraine.  Additional information: A Cyclic Vomiting Syndrome Episode was triggered 1 hour after receiving vaccine. We suspect it was triggered by the vaccine potentially causing a migraine which triggers my CVS episodes. I was in the ER for 11 hours to receive care due to episode. The patient  did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a health professional (Medical Assistant) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. The health professional reported that on 26-MAY-2015, the patient was vaccinated with the third dose of improperly stored GARDASIL intramuscular injection (strength, dose and lot number or batch number unspecified). The details of administration of the first and second dose of GARDASIL were not informed. No concomitant medications were reported. No adverse experience was reported. Product quality complaints (PQC) involved was reported as Yes. The outcome of the events was unknown. The reporter's causality for the events was not provided. No additional information was provided. Additional information has been requested.
Swelling of left leg and redness after vaccine. Itching at vaccine site BENADRYL used for itching.
Chills and fever of 100.6 at 2:00 AM on 2-13-21. Took Ibuprofen 400 mg. Fever gone by morning.
For about two weeks after the shot I felt a needle like sensation in my left arm. The feeling returns every 2-3 weeks.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2  (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0150) via an unspecified route of administration in the arm left on 07Apr2021 at 18:30(at the age of 36-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0179) via an unspecified route of administration in the arm left on 28Apr2021 at 18:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient had no known allergies. 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. The concomitant medications included probiotics (unspecified) from an unknown date for an unknown indication. On 28Apr2021, for about two weeks after the first dose, the patient felt a needle like sensation in the left arm. The feeling returned every 2-3 weeks. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event needle like sensation in the left arm was unknown at the time of this report.
Feeling pretty bad; Have no energy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling pretty bad) and ASTHENIA (Have no energy) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling pretty bad) and ASTHENIA (Have no energy). At the time of the report, FEELING ABNORMAL (Feeling pretty bad) and ASTHENIA (Have no energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.   Reporter did not allow further contact
24-48 hrs after vac administered. Lymph nodes under (L) arm and l(L) side of neck became swollen and sore. 36 hours after vac admin. ran a temp 99.8 X 3 days.
ALL OVER BODY ACHES; JOINT PAIN; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced all over body aches, joint pain, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the all over body aches, joint pain and fatigue was not reported. This report was non-serious.
No additional adverse effects were reported in the patient.; Nurse reports that a patient received an expired dose of VAQTA; This spontaneous report was received from a Registered Nurse, referring to a patient of unknown age and gender.The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 14-JUL-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) syringe (also reported as "vial 50" conflicting information) 1 ml (strength, route, frequency,and anatomical location were unknown) with lot # S001832, and expiration date 12-MAY-2020 for prophylaxis. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S001832; expirationdate: 12-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Fatigue; Pain at injection site; Joint soreness; Headache; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 06Apr2021 at 17:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and had no known allergies to food, medications and other products. Concomitant medications included birth control medication (unspecified). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021 at 19:00, the patient experienced fatigue, pain at injection site, joint soreness and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events fatigue, pain at injection site, joint soreness and headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Three days post vaccination of yellow fever patient had very redness, heat, and tenderness at the site of vaccination. Symptoms lasted for 3-4 days.
On 01/07/2021 in the morning I got a rash on my face. My face felt itchy I had bumps on my face & it was very red. It went also to my neck. I had to take Benadryl & it resolved the same day.
The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 12-MAR-2021, the patient was vaccinated with an improperly stored dose of hepatitis rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1 (units not provided), per oral route (strength, dose#, frequency, and anatomical location were unknown) with lot # 1691301 and expiration date 12-DEC-2021 for prophylaxis. The patient was asyntomatic.  The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9  degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes;  on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes.  There was no digital data logger involved, and no previous temperature excursion. The Vaccines program did an audit, and they were unaware of the excursions.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002850: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003500: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003503: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003540: US-009507513-2105USA003541: US-009507513-2105USA003542: US-009507513-2105USA003543:
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            No relevant concomitant medications reported. Other treatment included alcohol.
Unable to fall asleep the night of the second dose.  Felt progressively worse as night went on.  By 3am, had fever, chills, couldn't stop shaking or get warm, had headache, skin sensitive almost hurt when touched.  Felt too bad to get out of bed but eventually got up, took acetimetophen, drank water, added clothes and blankets and returned to bed.  Body kept tensing up very tightly so that all muscles were constricted/tights and impossible to relax.  This continued for a few hours.  By morning, I thought I was starting to feel better.  These symptoms returns for a second round about 2pm that afternoon and continued until about 6pm.  On the nights of 2/3, 2/4 and 2/5, I wake up around 3am extremely hot and sometimes damp, despite air temp of 66 to 68 degrees.  This resolves after about an hour and body feels normal.
The most severe reaction started the evening of March 26, 2021. It was a red patch on mid back and appeared to have a blister. It was extremely itchy. More patches developed over March 27, 28, and 29th.I self treated using Benadryl, Pepcid, cortisone cream and memetasone furoate cream.  On March 27 at about 6pm I was able to secure a doctors appointment for March 29th.  At the appointment I was given the regiment of one Claritin tablet in am, one 20 mg Pepcid in pm,  Hydroxyzine  25mg at bedtime and to continue use of memetasone cream as needed.  Rash has resolved. Still using meds as I felt itchy yesterday
Information has been received from a physician, concerning a female patient who was vaccinated with the second dose of GARDASIL vaccine (yeast) and afterwards complained of pelvic pain. The physician thinks she may have been experiencing it prior to getting the second dose but he will have to check the charts. The patient sought medical attention. There was no product quality complaint. Additional information has been requested.
Approximately 4 hours after immunization, pt experienced severe crying, eyes rolling back, apnea, pallor, limpness, this reoccurred 2 hours later and pt was rushed to the hospital and admitted.
Bruising, petechiae. Seen in ED 2/13 and thrombocytopenic on labs. Platelet count of 2 (10E9/L). Diagnosed with idiopathic thrombocytopenic purpura. No hospitalization or treatment. Platelet counts followed intermittently per hematology recommendations from 2/19 to 4/2 at which time platelet count resolved independently. Never needed to see hematology. Followed by PCP.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6205), on 29Mar2021 as dose 2, single (Lot number: ER8733) and on 10Dec2021 as dose 3 (booster), single (Lot number: FJ8762) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "High Chlolestrol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetnus booster, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Paxlovid were taken as therapeutic measures as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid from 07Jul2023 to 11Jul2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300251680 Same patient, different event/drug;
9x9cm area of redness/induration @ site of DTAP vax on rt thigh  2 days p/vax;
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild.
patient had a very rapid pulse rate that continued throughout the evening and night until the next morning; very sore arm; Extreme muscle pain; Chills and aches; Chills and aches; Extreme Headache; This is a spontaneous report from a Contactable consumer Consumer or other non HCP, (patient reported for self). A 73-year-old (non-pregnant) female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: TR8737), via unspecified route of administration, in the left arm, on 06Apr2021 at 08:30 (at the age of 73-years-old), as dose 2, single for COVID-19 immunization. The patient's medical history included slow atrial fibrillation and allergies to medications, food, or other products includes: THC (tetrahydro cannabinol) and raw nuts, carrots and apples. Concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had earlier received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: EL9369), via unspecified route of administration, in the left arm, on 16Mar2021 at 08:30 as dose 1, single for COVID-19 immunization. On 06Apr2021 at 20:00, twelve hours after receiving the second dose of the Pfizer vaccine, patient had a very rapid pulse rate that continued throughout the evening and night until the next morning. In addition, patient had a very sore arm, extreme muscle pain, chills and aches and an extreme headache. The patient underwent lab tests and procedure which included heart rate measurement: rapid pulse rate on 06Apr2021. Since the vaccination, patient has not been tested for COVID-19. No treatment received for the adverse events. The events were non-serious. Outcome of the events was reported as not recovered.   No follow-up attempts are needed. No further information is expected.
Vaccines were administered into right shoulder joint, not deltoid muscle. Each vaccine was given independently and both were given too high, missing the deltoid muscle. Immediate severe pain presented in my right shoulder and I could not move my own arm without assistance for 48 hours. 7 days later severe pain and reduced mobility persisted. Visited doctor and was advised to take ibuprofen to reduce swelling. 21 days later, pain still present with reduced mobility.
Symptoms of a fever (chills, sensitive skin, headache, dizziness) beginning ~12hrs after the injection and subsiding ~ 24hrs after the injection. 48hrs after the injection began to experience ?Covid arm?.  Red swelling that is warm to the touch and slight itchiness.  Extends around from the tricep to bicep and mostly below the injection site, down to near the elbow. No pain besides that of a normal IM vaccination.  Currently still experiencing the symptoms, but not taking any treatment as none are necessary.
10-6-20 left arm injection site red, hot to touch, golf ball sized swelling, malaise. 10-7-20 left arm sore, lethargic, headache, congestion, nasal drainage. 10-8-20 lethargic, whole body shaking/chills, sore throat, nasal drainage, headache, productive cough, sinus and tooth pain. 10-9-20 green/yellow nasal drainage, cough with green/yellow secretions coughed up. 10-10-20 all symptoms continue.  Followed treatment advice of primary MD from 9-7-20 office visit for possible sinus injection which was nasal lavage and otc Claritin. 10-10-20 symptoms have continued and worsened.  Primary MD suggested office visit to evaluate symptoms.