chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling at the injection site; 1st dose of Shingrix on 19Sep2019 and has not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site swelling and incomplete course of vaccination. On an unknown date, the outcome of the injection site swelling and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported for 1st dose. The experienced swelling at the injection site after receiving 1st dose of Shingrix. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter consented to follow up.
Musculoskeletal effects  muscle pain in injection arm. Patient received prednisone from doctor visit.
Temp on & off X 4 days, rash on back and neck X 1 wk and spreading.
During the day on 01/17/21 noticed slight itching at injection site. Later on in the day, approximately 5pm, noticed small red patch at injection site with raised bumps, very itchy. Took photographs to document and emailed chief medical officer. In the morning on 01/18/21 red patch continued to itch and became more circular in shape. Completed telehealth session and physician stated it may be a delayed immune response to the vaccine. Prescribed hydrocortisone cream and antibiotic and stated I should also take antihistamine. Same day relayed this to the CMO and immediate supervisor. As of today, 01/19/21 after taking Zyrtec & applying cream, no change in size, itching subdued.
About 24 hours after the second Pfizer shot, I started to experience panting; I lay down in bed and still had a heavy feeling in my chest, like I wasn't getting enough air; I lay down in bed and still had a heavy feeling in my chest, like I wasn't getting enough air; My hands and ankles, followed by my lips and chin and neck started to go numb; I was cramping up due to hyperventilation; I was cramping up due to hyperventilation; I've missed 2 periods since the shots; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0177, Expiration date: not reported) via an unspecified route of administration in right arm on 23May2021 11:00 AM as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included codeine allergy, Had a bleeding ulcer 7 months prior and wondered if the ulcer was from covid-19. Concomitant medications were not reported. On 24May2021 10:00 AM, patient experienced abnormal breathing, chest heaviness, difficulty breathing, numbness localized, cramps, hyperventilation, delayed period. Adverse event resulted in: Emergency room/department or urgent care. Treatment was received for events. Patient also reported about 24 hours after the second vaccination, I started to experience panting. Up to that point, I was doing light household tasks because I felt pretty good. I lay down in bed and still had a heavy feeling in my chest, like I wasn't getting enough air. I decided to use a rescue inhaler(albuterol) to see if I could breathe more freely. I have not used one in about 7 years. I primed the inhaler and followed directions (the inhaler was within expiry). After I used it, I still felt I wasn't getting enough air. My hands and ankles, followed by my lips and chin and neck started to go numb, and I asked my husband to call 911. An ambulance came, and they took my vitals, and talked me through my breathing. The paramedics said I was cramping up due to hyperventilation. After a little while everything was ok. The numbness went away and also, I no longer had the shortness of breath that I had before I used the inhaler. Also I've missed 2 periods since the shots. No other vaccine administered in four weeks. No other medications administered in two weeks. No covid present prior vaccination. No covid tested post vaccination. The outcome of events was recovered on a unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.  Follow-Up (26Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
vaccination site pain; Tired; A spontaneous report was received from a consumer concerning an 80 years old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm and fatigue.  The patient's medical history included acid reflux, inflamed throat. Concomitant product use was not provided by the reporter.  On 27 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 029K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced tiredness and sore arm.  No treatment information was provided. No relevant laboratory details were included.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.  The outcomes of the tiredness and sore arm were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
pt give vaccine AM of 4/21.  woke up 4/22 w/ facial swelling, periorbit swelling and itchines.  Similar to sx after allergic reaction to foods, etc. (tho so far less severe). sx improving after zyrtec.  no lip swelling, throat itciness, shortness of breath or nausea/emesis.  After video visit, to use benadryl as needed and to ED if w/ worse sx, using epipen which she already has.
Patient developed contact dermatitis within hours of vaccination. Red, raised patches on her cheeks and legs and lighter pink dry patches on her arms and stomach.
White lines in the eye; sinus headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of eye abnormality in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (patient received  Zostavax at the age of 65 years old).   In JAN-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, several weeks after receiving Shingrix, the patient experienced eye abnormality (Verbatim: White lines in the eye) and sinus headache (Verbatim: sinus headache). The outcome of the eye abnormality and sinus headache were not resolved.   It was unknown if the reporter considered the eye abnormality and sinus headache to be related to Shingrix.     It was unknown if the company considered the eye abnormality and sinus headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-MAY-2023. The patient was self-reported this case. The patient reports that she started having white lines in her eyes.  The patient had folders in eyes (black specks in the eye and these were normal) but these look like white lines.  They were not sharp, they come in for about 5 minutes and goes. It started weeks after the vaccine, and it comes and goes, some last 3 to 4 minutes. The patient reports this never happened before. Patient reports she noticed this happened after getting the Shingrix vaccine and also mentioned during the call that she had a sinus headache. The reporter did not consent to follow-up.
Shingrix vaccination made you sore; This case was reported by a consumer and described the occurrence of pain in an unspecified number of elderly female patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The consumer reported that, if the 1st Shingrix vaccination made you sore then the second one would not be as painful and if the first one was not bad then the second one would be very painful. This case linked with US2019AMR206249, reported by same reporter.
Narrative: Per 4/12/21 primary care note: "Patient explained that she experienced a syncope episode the day after she received the Janssen coronavirus vaccine two weeks ago. pt reports she fell and hit her back causing a "fracture to my lower back". pt said she was evaluated for the injury and has medications for the pain. pt believes the syncope episode was due to the COVID vaccine she received the day before.
Patient reported chills, high fever (103 degrees Fahrenheit) on the afternoon that she received the vaccine. Pain spread beyond the site of injection to shoulders and hands. As of 10/23, patient reports continued pain throughout arm of diminished intensity and soreness/redness on the tongue.
Dizziness, Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, INJECTION SITE PAIN Narrative:
Information has been received from a physician concerning a female (age unknown) who was treated for a stiff neck prior to vaccination. On an unknown date the patient was vaccinated with a second dose of GARDASIL. Subsequently, "a few hours" after, on an unknown date, the patient experienced disorientation and dizziness. The physician did not want to provide any further details about the adverse event at the time of the report. No product quality complaint. Additional information has been requested.
Fatigue; mild soreness/arm sore/soreness in the arm; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 04Jan2021 15:00 at a SINGLE DOSE for covid-19 immunisation, naproxen sodium (ALEVE), via an unspecified route of administration on 04Jan2021 at an unspecified dose and frequency for an unspecified indication. Medical history included blood pressure abnormal, blood uric acid abnormal, hypersensitivity, blood cholesterol abnormal, all from an unknown date and unknown if ongoing. Concomitant medication included alopurinol (ALOPURINOL), 300mg take once daily by mouth for Uric acid, amlodipine besilate (AMLODIPINE BESILATE) 10mg; take once daily by mouth for blood pressure, atorvastatin calcium (ATORVASTATIN CALCIUM) 20mg; take one half daily by mouth for cholesterol, cetirizine (CETIRIZINE) 10mg take once daily as needed for allergy, omeprazole (OMEPRAZOLE) 20mg; take one twice daily by mouth for uric acid, losartan (LOSARTAN), 100mg; take once daily by mouth for Blood pressure. The patient called regarding the Pfizer COVID 19 vaccine. He received his first dose of the vaccine at the a Hospital. He added he had just taken Aleve before the vaccination. Then he was reading in his heart magazine and it said it could effect the efficacy of the shot if you take aspirin or ibuprofen. He was asking for more information about that and was it okay that he took Aleve. He clarified he received the first dose of the Pfizer COVID 19 vaccine on 04Jan2021 at 15:00 PM in the left arm. He took the Aleve at 08:00 04Jan2021. He reports he had no pain the first day, no soreness in the arm or anything. The next day he had mild soreness in arm like the flu or pneumonia shot. On the third day he was a little fatigued. But by the fourth day he was able to take his usual walk of three or four miles without being winded and he was fine. He was planning for the second dose 25Jan2021 at 15:00. The outcome of the event pain in extremity was recovered on 06Jan2021 and the event fatigue was recovered on 07Jan2021.
Pt experienced fever, chills, shoulder pain, nausea, joint and muscle pain. The next day the patient was lethargic and experienced swollen axillary lymph nodes on side of vaccination.
Chills; Minor body aches; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of the second episode of CHILLS (Chills), MYALGIA (Minor body aches), HEADACHE (Headache) and the first episode of CHILLS (Chills) 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 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced HEADACHE (Headache) and the first episode of CHILLS (Chills). On 02-Sep-2021, the patient experienced the second episode of CHILLS (Chills) and MYALGIA (Minor body aches). On 01-Sep-2021, HEADACHE (Headache) had resolved. At the time of the report, last episode of CHILLS (Chills) and MYALGIA (Minor body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  The treatment information was  not provided.   Reporter did not allow further contact
This spontaneous report was received from a researcher, and refers to an unspecified patient of unknown age and gender. Concurrent condition and medical history were not reported. on 04-MAR-2015, the patient received an improperly stored dose of ZOSTAVAX subcutaneously, lot # K007548; Exp date 23-AUG-2015 (strength, dose #, dose and anatomical location were not provide). There was not concomitant medication reported. No adverse experiences were reported. There was not a product quality complaint involved. At the time  of the report, the outcome of incorrect product storage was unknown. This is one of several reports received from the same reporter (1507USA005687 and 1507USA005587). Additional information has been requested.
Patient complained of lightheadedness, nausea and chills and stiffness to bilateral arms. VS with noted non-resolving tachycardia 126-140 bpm and elevated BP 140-150/80-90. EMS contacted and patient transported to hospital. Symptoms began at 3:25p and continued with EMS transfer at 3:50p.
nearly passed out while groceryshopping; Shaking; body feels Cold and then hot; sometimes sweating; i am not myself; head hurts; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (nearly passed out while groceryshopping), TREMOR (Shaking), FEELING OF BODY TEMPERATURE CHANGE (body feels Cold and then hot), HYPERHIDROSIS (sometimes sweating) and FEELING ABNORMAL (i am not myself) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DIZZINESS (nearly passed out while groceryshopping), TREMOR (Shaking), FEELING OF BODY TEMPERATURE CHANGE (body feels Cold and then hot), HYPERHIDROSIS (sometimes sweating), FEELING ABNORMAL (i am not myself) and HEADACHE (head hurts). At the time of the report, DIZZINESS (nearly passed out while groceryshopping), TREMOR (Shaking), FEELING OF BODY TEMPERATURE CHANGE (body feels Cold and then hot), HYPERHIDROSIS (sometimes sweating), FEELING ABNORMAL (i am not myself) and HEADACHE (head hurts) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information or concomitant medications were provided.
Palpitations, anxiety, shortness of breath, pressure on chest. No chest pains, however.  At least once every day.
Seizure activity about 30 seconds after the vaccine was given and the seizure activity lasted for about 30 seconds.
Pt said Left arm that got the Pneumo shot is hot and red and there is some swelling.
pt recv vax & 20 min post vax pt devel rhythmic head & body jerks;pt adm to hosp for diagnostic evaluation;pt was found to have OM & was treated;however testing for sz disorder was inconclusive;pt was treated w/phenobarbital & d/c from hosp
Felt dizzy two days later, it has continued and worsened over time. Diagnosed with a stroke.
tongue andlips swelled; n tongue andlips swelled; Broke out in hives; Headache; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 10Apr2021 at 10:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included seafood allergy. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 20Mar2021 at 15:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. 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 10Apr2021 at 10:45, the patient experienced broke out in hives, then tongue and lips swelled then headache. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events broke out in hives, then tongue and lips swelled then headache was recovered on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Itchiness, redness, swelling, pain. Applied hydrocortisone ointment and prescribed cephalexin 500mg , 1tab, PO, q 8hrs for 1wk.
Tingling down to fingers immediate on injection now has no grip, unable to raise L arm or to take off pull over shirt.
Patient received a fourth dose of measles virus vaccine live. The patient was a "non-responder" to the first three doses of measles virus vaccine live. After the fourth dose, the patient developed a fever, joint pain, and a headache. The patient had these symptoms for approximately 3 weeks. On 7/18/00, the patient was scheduled for a visit to a physician.
Right leg began to itch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Right leg began to itch) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Right leg began to itch). At the time of the report, PRURITUS (Right leg began to itch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information use was not reported.  Treatment information was not provided.       Reporter did not allow further contact; Sender's Comments:
I got multiple very painful ulcers on the roof of my mouth and just behind my right front tooth.
took home Ag test, Covid +; took home Ag test, Covid +; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 26-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 07Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 25 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 26Jan2023, outcome "recovering" and all described as "took home Ag test, Covid +". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jan2023) Positive, notes: home Ag test. Therapeutic measures were not taken as a result of covid-19, drug ineffective. Clinical course: patient developed symptoms - headache, body chills, soreness on 26Jan2023, took home Ag test (Nasal swab), Covid + on 27Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2, and the reported events covid-19, drug ineffective cannot be excluded.
nurse is about to administer a dose of IMOVAX RABIES 14 day shot on day 16 to her mother/ No AE; Initial information received on 13-Dec-2021 regarding an unsolicited valid non-serious case from a nurse.  This case involves an unknown age female patient who was about to receive a dose of RABIES (HDC) VACCINE [IMOVAX RABIES] 14 day shot on day 16 by a nurse (inappropriate schedule of product administration).  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient would receive a dose of suspect RABIES (HDC) VACCINE lot number and expiry date not reported via an unknown route in unknown administration site for post exposure immunization.  It was a potential medication error due to inappropriate schedule of vaccine administered (latency: same day).   It was reported "Nurse travels for work, and their mother is looking to get the rabies vaccination (nurse is fairly sure it is IMOVAX). Nurse is looking to administer the vaccination himself and says since they cannot store the vaccine on the road, if it would be possible to administer her 14 day shot on day 16 instead. The caller states that he will administer a dose today on the 13th and then on the 20th. He states that she is receiving IMOVAX for post exposure even though her test was negative just to be safe. He states that he will be giving her 14 day shot on day 16th because otherwise he would be unable to keep the vaccination at the correct temperature."  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 the 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.  There will be no information on the batch number of the suspect drug.
Large (2? x 6?)slightly swollen, very hot to touch area surrounding vaccination site. Difficult to find where to report. Only time I have ever had a family member receive a vaccine with out a number to call and report if an adverse reaction occurs. Like many who use these sites, no regular doctor or doctor attached to report to.
Wheezing, acute asthmas attacks, flare up of Herpes Simplex, shortness of breath, upper respiratory symptoms.