chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called pharmacy saying that she had severe pain in left arm following administration of vaccine. She describes it as severe bursitis resulting in an inability to move rotator cuff for 2 days post administration. Consult with orthopedic surgeon resulted in prescribed physical therapy for 8 weeks.
Red, hot under arm where vaccine was given. Urged patient to seek medical attention ASAP.
Hive like lesion @ injection site, treatment with Ibuprofen and ice pack.
got the first dose of Covid 19 vaccine last 15Mar2021 and tested positive on the next day; got sick; This is a spontaneous report from a contactable consumer or other non hcp (Patient's Mother) communicated to from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE,formulation:solution for injection), dose 1 via an unspecified route of administration on 15Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter states that her daughter got the first dose of covid 19 vaccine on 15Mar2021 and tested positive on the next day on 16Mar2021, the husband of her daughter was positive also that is why her daughter got sick in Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 16Mar2021. Reporter asked if her daughter needs to continue with the second dose. The outcome of the events was unknown.   No follow-up attempt are possible. Information about lot/batch number cannot be obtained.
Vaccine was stored in freezer past the allowed 2 weeks. Per Pfizer they only have data to support stability up to 21 days. which puts our vaccine out of proper storage requirements as of 9/21/2021. Patient received vaccine on 9/23/21. Dose is considered invalid and should be repeated.
w/in 1-2min p/vax became pale, c/o throat & tired;c/o sick @ stomach (nausea);BP 100/60, p88;4:15 BP 98/58, p 88;4:10 BP 98/60, p80;left w/return of color, eating, drinking, walking & appears totally recovered;
Day after shot I had a grapefruit size dark grey bruise on my shoulder that received shot. For next 3-4 months I had numbness of BOTH hands, fingers. Nerve pain in left shoulder and bicep. Weakness in grip of left hand and arm. Arm proceeded to get worse and in July of 2022 I went to ER because I woke up with racing heart heat and could not lift my arm at all, not even an inch.  Completely frozen shoulder. Orthopedic Dr prescribed steroids and physical therapy.  Shot caused extreme  inflammation in body all over. The shoulder  muscles atrophied. I also suffered with exczema and cracking skin eruption around my lips and mouth. Outbreaks of herpes sores on lips.  I have continued working with a fitness trainer and shoulder is about 90% better, still limited flexibility. I have lost strength with grip of fingers  on left hand. My grip is still weak. Limited mobility of shoulder still today. Occasional mild nerve pain still in left shoulder.
4PM mom called & stated that pt had been crying since 1030AM; inj given in rt upper thigh-small red area w/sl swelling-MD administered DPH & Advil; pt had less crying but no change in inj site
Upon waking up the day after my injection and getting out of bed, I had experienced severe chills all night and in the kitchen I felt light headed.  I walked toward the kitchen table and fainted.  As I fainted, I struck my head on the counter top.  My husband took me to bed where I was immediately conscious and I thought I felt better.  Ate lunch after I got up to eat soup, I fainted again, vomited and could not control my bowels.  My husband took me to the hospital where they did a series of tests- CT scans of my head and neck, X-rays  etc. and tests suggested all was normal.  The hematoma  on the back of my head was not of a concern.  I was checked out to go home a couple days later.
Pain at site and began having exacerbation of sickle cell crisis. Noted hives at injection site. Progressed to swelling to shoulder and under arm and chest. Presented to doctor 3/12 for treatment
Heart palpitations. Three or four times the day after getting the vaccine. Twice the following day and once the day after that. Felt like my heart was working harder the entire week.
A report was received from a health professional on 19Nov01, concerning a female pt who experienced total body hives, 7 days after receiving the Fluvirin vaccine on 09Nov01. Comedication taken by the pt included a Nicotine patch and Bupropion hydrochloride. On 16Nov01, the pt developed total body hives, 7 days after receiving the Fluvirin vaccine. Therapeutic measures taken as a result of this event included oral Prednisolone and Loratadine. The pt had previous influenza vaccinations (brand unspecified) with no adverse effects. The pt had not recovered at time of report. The reporter has assessed the relationship of the study medication to the event as possible.
arm itched; fatigue; could not swallow; Chest tightened; adverse event; general body itching; arm swelled; arm turned red; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (could not swallow), CHEST DISCOMFORT (Chest tightened), ADVERSE EVENT (adverse event), PRURITUS (general body itching) and VACCINATION SITE SWELLING (arm swelled) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DYSPHAGIA (could not swallow), CHEST DISCOMFORT (Chest tightened), ADVERSE EVENT (adverse event), PRURITUS (general body itching), VACCINATION SITE SWELLING (arm swelled), VACCINATION SITE ERYTHEMA (arm turned red) and FATIGUE (fatigue). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (arm itched). At the time of the report, DYSPHAGIA (could not swallow), CHEST DISCOMFORT (Chest tightened), ADVERSE EVENT (adverse event), PRURITUS (general body itching), VACCINATION SITE SWELLING (arm swelled), VACCINATION SITE ERYTHEMA (arm turned red) and VACCINATION SITE PRURITUS (arm itched) had not resolved and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up included non significant information as reporter contact details updated
Patient is 17.  Moderna not approved for patients under 18.  Patient was vaccinated at a Mass Vax event
Pt called 5/3 to report that immediately upon receiving the shot "she felt it going in and then up her body to the side of her face and down her leg" She stated she had congestion, headache, nausea, lethargy confusion, lightheadedness, "just felt out of it" and was having memory recall issues. She said that after about a week she had called her doctor's office, where a nurse had suggested perhaps she postpone her second shot if she still wasn't feeling well. The reason for her call to us on 5/3 was to cancel her appointment for the second shot, stating that she was still feeling like she couldn't remember things properly.. I informed her that I would do so and told her there were no concern with increasing the duration between shots but collected information to complete a VAERS  after inquiring if one had been completed by her physician, which she didn't think had been done.
Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a female patient (age not reported) who did not return for her IMOVAX RABIES (Batch number, expiration date, dose, route and site of administration was not reported) on day 7. It was reported that, she was several days late. The patients medical history and concomitant medications were not reported. It was an actual/potential medication error due to inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Chest pain on 2nd and 3rd nights after the vaccination for approximately 3 hours each episode.
fever of 102.3, chills, sweats, body aches, headaches- lasted 36 hours. Arm soreness lasted three days.  Supraclavicular lymphadenopathy is still present, 10 days later, on the same side as the injection.
Two weeks post vax, pt contracted hepatitis a virus. The reporting physician believed that the hepatitis a virus was not related to therapy with the hepatitis A vaccine. Additional information has been requested.
During 09/22/2022 medication council, patient reported her atopic dermatitis symptoms developed last year (2021)  after receiving a Pfizer Covid booster.
2nd dose administered 2 days early.    1st dose administered on 5/19/21.  2nd dose due on 6/9/21- but administered on 6/7/21
After client received the vaccine client stated that she feels dizzy and anxious.  Client has a history of anxiety attacks.  Vital signs obtained by EMS.  BP 131/85, HR 83, O2 sat 100%.  Client stated that she feels better.  Client discharged home.
Behavioral side effects and sleep disturbance, anger/rage which is very atypical for child starting within hours of vaccine administration. Similar reaction in previous years to flu vaccine per mom.
This is a non serious spontaneous case from a registered pharmacist in the USA who experience a Nose Bleed after receiving FluMist. The reporter did not provide causality between events and FluMist vaccination. At 9:45 am on Nov 10 2004, a 33 year old female received FluMist intranasally and experienced headache, runny nose, and slight fever on Nov 11 2004. On Nov 12 2004, the patient experienced nasal congestion and on the same day her runny nose resolved. The nasal congestion was unresponsive to Flonase (fluticasone propionate) and Deconsal (guaifenesin/pseudoephedrine). Her headache was treated with Tylenol (acetaminophen). On Nov 20 2004, the nasal congestion was on going. On the evening of Nov 20 2004, the patient experienced a severe nose bleed. She is scheduled for an ENT visit in Nov 24 2004. The patient has been using Ocean nasal (sodium chloride) nasal since Nov 11 2004. The reporter did not provide causality between events and FluMist vaccination.
Patient was in his usual state of health until the the middle of the night when he became very fussy, crying for 10 to 15-minutes.  Piercing cries.  He developed vomiting about 4-5 times, described as yellow in color.  He was seen at ER and an ultrasound showed ileocolic intussusception.  He was transferred to main campus ED for air enema to correct the intussusception.  He received Zofran and normal saline bolus.  In route, he had 1 episode of vomiting that is yellow in color.  He also had a stool that was bloody.  Enema successful and patient discharged.
Threw up 3 days after getting the COVID 19 vaccine; Feeling unwell; Having pain in his private area; This is a spontaneous report from a contactable consumer (patient's caregiver).  This 59-year-old male patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 22Jan2021 at a single dose on the left arm for COVID-19 immunisation. The patient was disabled. No additional medical history was provided. No relevant concomitant medications were provided. On 25Jan2021 (3 days after getting the COVID-19 vaccine), the patient threwup, once. After vaccine, the patient was feeling unwell and he was having pain in his private area. The outcome of the events was unknown.  Information about lot/batch number has been requested.
She feels all congested, like she has a sinus infection.; She feels all congested, like she has a sinus infection.; I have cold something like that; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Feb2022 (Batch/Lot number: unknown) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, with the first 2 doses of the Pfizer COVID-19 Vaccine and she had no side effects at all), for Covid-19 Immunization, reaction(s): "had no side effects at all"; Bnt162b2 (Dose: 2, with the first 2 doses of the Pfizer COVID-19 Vaccine and she had no side effects at all), for Covid-19 Immunization, reaction(s): "had no side effects at all". The following information was reported: SINUSITIS (non-serious), NASAL CONGESTION (non-serious) all with onset Feb2022, outcome "unknown" and all described as "She feels all congested, like she has a sinus infection."; NASOPHARYNGITIS (non-serious) with onset Feb2022, outcome "unknown", described as "I have cold something like that". Therapeutic measures were taken as a result of sinusitis, nasal congestion, nasopharyngitis.  Additional information: Reporter stated that, patient received the booster dose yesterday 01Feb2022. Patient had no side effects at all with the first 2 doses of the Pfizer COVID-19 vaccine but now she feels all congested like she has a sinus infection. Patient didn't take prior vaccination since last Apr. Patient didn't receive other medicines before in her life. Therapeutic measures were taken as a result of sinusitis, nasal congestion and nasopharyngitis with Mucinex and Tylenol.  The lot number for bnt162b2 was not provided and will be requested during follow up.
My cycle is very early; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "My cycle is very early".  Additional information: The patient was reported her in country. The patient did not reported other vaccine in four weeks. Their was no COVID prior vaccination and no COVID tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. received the fifth dose of DTaP (Sanofi) and fourth dose of IPV (IPOL). Approximately one hour after receiving the vaccine, pt. complained of itching. Mom noticed a fine raised red rash on his legs, arms, chest, and back, legs. His left shoulder area was very swollen. The rash was described as small and raised bumps. Mom treated with 2% hydrocortisone cream to his shoulder. Zertec elixer was given that morning for seasonal allergies in the morning. Mom also gave Motrin elixir 7.5 mg for pain after the injection.
She was advised to get the second dose at least 90 days after the transfusion; stomach feels like there is a parasite; intense migraines that is felt more on the right side of the head, States that it starts from the front going to the back/migraines are so severe she can barely open her eyes and she can no longer work; very bad nausea/nausea spells; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach feels like there is a parasite), MIGRAINE (intense migraines that is felt more on the right side of the head, States that it starts from the front going to the back/migraines are so severe she can barely open her eyes and she can no longer work), NAUSEA (very bad nausea/nausea spells) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She was advised to get the second dose at least 90 days after the transfusion) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach feels like there is a parasite), MIGRAINE (intense migraines that is felt more on the right side of the head, States that it starts from the front going to the back/migraines are so severe she can barely open her eyes and she can no longer work) and NAUSEA (very bad nausea/nausea spells). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She was advised to get the second dose at least 90 days after the transfusion). At the time of the report, ABDOMINAL DISCOMFORT (stomach feels like there is a parasite), MIGRAINE (intense migraines that is felt more on the right side of the head, States that it starts from the front going to the back/migraines are so severe she can barely open her eyes and she can no longer work) and NAUSEA (very bad nausea/nausea spells) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She was advised to get the second dose at least 90 days after the transfusion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   She taking pain medications that were prescribed by her doctor   This case was linked to MOD-2021-321028 (Patient Link).
Temp of 99 degrees began on 10/15/2009, axillary temp in the am 10/16/2009 was 101.5 degrees farenheight, vomited x1 10/16/2009.  No void over 18 hours, refused fluids.  Seen in our office today 10/16/2009 for fluids.  After 2 hours of pushing fluids pt voided.
Information has been received from a healthcare worker (certified medical Assistant (C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 28-JAN-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Administered booster dose instead of full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Administered booster dose instead of full dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Administered booster dose instead of full dose). On 26-Nov-2021, ACCIDENTAL UNDERDOSE (Administered booster dose instead of full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient is on steroid medication everyday. Treatment information was not provided.
Refrigerator went in and out of range while there was flu vaccine in it. Doses were administered - no adverse event This spontaneous case initially received on 02-Nov-2016, was reported by a health professional and concerns an 100 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 08-Sep-2016, the patient received AFLURIA for indication not reported. Dose regimen: Not reported. Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 08-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
102 fever when I woke up the next morning at 7:30am. Full body aches and tingling in my body by roughly 10am. It hurt to move at all by around noon so I laid still until about 5 pm. I started getting tachycardia in the evening maybe 8PM (high pulse rate) and then woke up in the middle of the night with an irregular heart beat, difficulty breathing and chest pressure. It hurt to lean forward so I went downstairs at about 3 AM to take a high dose of magnesium and water, then I laid on the floor for about an hour. It subsided around noon the next day.
Red, raised, site reaction, silver dollar size, warm, hurts to touch. No treatment. Outcome -n/a.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to 2018SA284709, 2018SA284710, 2018SA284711, 2018SA284707, 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284731, 2018SA284732, 2018SA284733, 2018SA284734, 2018SA284735, and 2018SA284736 (same reporter). This case involves a 5 years old patient (gender not reported) who was vaccinated with FLUZONE QUADRIVALENT (Batch number: UI997AA, expiration date: 30-JUN-2019) via intramuscular in the left deltoid on 02-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to incorrect product storage. It was reported that vaccines that were outside of the recommended temp range (below 32 F). It was not reported that the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Full body rash that occurred 10 to 14 days after injection. Nothing had changed with soap, detergent, diet, or medicines. Took Benadryl to manage rash symptoms. Rash lasted approximately 10 days.
Two days after flu vaccine 6 mos to 36 mos hair started falling out.