chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; Sore arm; energy increased; This spontaneous case was reported by a patient and describes the occurrence of ENERGY INCREASED (energy increased), NAUSEA (Nausea) and INJECTION SITE PAIN (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Mononucleosis. Concurrent medical conditions included Epstein Barr virus positive mucocutaneous ulcer, Sleep difficult, Fibromyalgia and Chronic fatigue syndrome.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced ENERGY INCREASED (energy increased). On an unknown date, the patient experienced NAUSEA (Nausea) and INJECTION SITE PAIN (Sore arm). At the time of the report, ENERGY INCREASED (energy increased), NAUSEA (Nausea) and INJECTION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant medications were provided No Treatment information provided
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 24-NOV-2014, the patient was vaccinated with an improperly stored GARDASIL (lot # H020901, expiry date 05-JUL-2015) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Severe Vasovagal reaction with syncope.  He has a past history of the same but assumed he had outgrown it based on recent experiences.
This spontaneous case was initially received on 12-Oct 2015. The case report was received from a Health Professional and concerns a 17 year old female patient. The patient has a medical history of Anxiety. The patient is otherwise healthy with no chronic illnesses. The patient has received the flu vaccine in 2010 that covers swine flu. The reporter confirms the patient has always received intramuscular flu immunisations and has never had the intranasal one, FLUMIST. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 09-Oct-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On Oct-2015, after starting treatment with AFLURIA the patient experienced Swelling, Aches, Redness, Fever / Fever is 103.6/Temperature oral was 103.6 degrees Fahrenheit/Oral temperature 103 F. On 10-Oct-2015, after starting treatment with AFLURIA the patient experienced Dizziness, Felt tired, Headaches, Redness at the injection site / Injection site redness. On 11-Oct-2015, after starting treatment with AFLURIA the patient experienced Chills. The patient has received the flu shot before but it was the first time she has had this reaction. The reporter is unsure if the patient has had AFLURIA before. The patient has not received any other vaccinations in the last three months. Acetaminophen 1000 mg and ibuprofen. The patient's mother was able to get the fever down using cold cloths. On 11-Oct-2015, the patient was treated with ibuprofen 600 mg. The mother states she would be taking her daughter to the hospital now. Reporter's assessment: Not reported.
first / vaccine November 2019 / unable to get the 2nd vaccine because of COVID; This case was reported by a other health professional via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient was unable to get the 2nd dose of Shingrix because of Covid. The reporter asked if the patient should repeat that and get both vaccines or if just take the 2nd vaccine now.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Same day erythema consistent for 9 days on upper left thigh. Erythema measures 4 x 3 cm .
Narrative:  Patient presented to ED with chief complaint of L-sided chest discomfort that began shortly after obtaining his 2nd COVID-19 vaccination (Moderna, R deltoid) on 6/22, Patient denies any similar symptoms after his first vaccination. Patient reported "dull" pain in his L chest area without any radiation (just involves his entire L pectoral region).stating "It feels just like I pulled a muscle after working out, but I haven't been working out or doing anything that would cause this." Patient was worked up for myocardial infarction or other cause - benign physical exam, normal vitals, ECG without concerning findings, CXR unremarkable, Troponin 0. Patient was discharged without incidence. Patient presented again to ER on 6/29 stating pain was persistent even with OTC pain medication use (ibuprofen). At the time additional work up was all negative (troponing, EKC, CXR, D-dimer) and patient was discharge home again without any further complaints
red, itchy, sore area lt deltoid being noticed 2 to 3 days p/vax;MD dx cellulitis vs local allergic rxn;rx ATB & pt reports resolution when contacted on 29OCT96;
Vaginal bleeding/irregular bleeding; bloody noses; spotting; This is a spontaneous report from a contactable Nurse (patient).  This  30-years-old female patient received at hospital bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1  administered in Arm Left on 17Feb2021 (Batch/Lot Number: EM9809) as SINGLE DOSE, and dose 2 on 07Mar2021 (Batch/Lot Number: EN6206) administered in Arm Left  as SINGLE DOSE for covid-19 immunisation. Age at vaccination 30 years. Medical history included ongoing spotting (she has had her tubes tied in the past /She continued to have spotting even after the period was over). The patient got 1st dose on 17Feb2021 and developed Vaginal bleeding, bloody noses.  She said she was having a period every 2 weeks, and "spotting" every other day. The she got 2nd dose on 07Mar2021, and experienced nose is bleeding and vaginal bleeding again.Then it was added she completed both; and keeps having irregular bleeding. she received the first dose of the Pfizer COVID 19 vaccination 17Feb2021 at an unknown time in the left arm. On that day she noticed irregular bleeding, spotting. Mentioned she has had her tubes tied in the past and so she called her gynecologist who made an appointment for her. Then she got her regular period two weeks later to she cancelled that appointment. She continued to have spotting even after the period was over. She mentioned this to her gynecologist twice and he said to wait and see. She received the second dose 07Mar2021 at 16:50 PM in the left arm. She noticed today on 10Mar2021 she was having vaginal bleeding and spotting with bright red blood and also a nose bleed. Mentioned she also noticed blood with sex. She was concerned and plans to contact her HCP next because her brother had osteosarcoma at 16 years old  and she has a cousin who had thrombocytopenia. Seriousness criteria provided -Other medically important conditions. The outcome of the events was not recovered.; Sender's Comments: Based on available information and known drug profile it is unlikely  that the reported "vaginal bleeding, spotting with bright red blood and nose bleed" were due to bnt162b2.  These are probably intercurrent medical conditions.  Case will be reassessed of additional information is received.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Had TDAP/Menactra in (L) Deltoid on Wed 7/1/09, on 7/2/09 had headache, on 7/3/09 headache gone but had rash, redness, swelling & hot to touch on (L) Deltoid.  R arm measures 8 3/4" (L) arm measures 9".  Given instructions to take Benadryl 25-50 mg after 6 hrs.  Given Keflex to take only if are gets worse.  Warm/cold compresses.
Patient reported these symptoms to pharmacist (myself) on 12/19/18. He stated that he had left arm pain the night he received the vaccine. Patient stated he could not lift his arm and his pain level was about an 8-10 on a scale from 1-10. Saturday morning (12/15/18) patient stated he felt "okay" then had strong flu symptoms, joint pain, and fatigue. He slept most of Saturday and then Sunday (12/16/18) he started to fell better again. On Monday (12/17/18) he noticed red bumps on his neck and applied cortisone cream. As of 12/19/18 he was feeling better just had the red bumps on his neck.
Started to feel lousy around 3 PM on day of shot. Sort of expected that. Arm did not hurt when given shot but began to hurt. Feeling body aches (expected that too). Second day, awoke feeling pretty lousy but thought if I took IBUPROFEN throughout the day it would decrease symptoms. Had little effect on how bad I felt and I was driving a 300 mile route for work. As day progressed I felt worse. Started getting severe chills and the 93 degree weather felt good. Felt feverish, arm swelled a lot and was extremely hot to touch and ached something terrible Not just the site but my whole arm. Swelling was size of my whole hand. I felt dizzy, sleepy, and had a bad headache. Felt like an arrow through my head and that a tomahawk had smashed  the top of my head. I was a bit queasy too. Went home, ate small supper and went to bed. Did not get out of bed the third day. Even 3 doses of 800 milligrams of IBUPROFEN di not make me feel any better. Symptoms continued all day. Food tasted terrible. Dizzy and confused feeling when I  got up to use the bathroom. Arm swelling did not dissipate and keep cool packs on it all day on and off. Head felt terrible. Body ached. Symptoms subsided forth day and about 3 PM began to feel normal again.. ARM is still swollen 5 th day.
headache, swollen neck glands, runny nose, cough, watery eyes, fatigue, hives, gastrointestinal problems, low grade fever
A physician reported that a male child received an injection of Prevnar and 16 days later, became "unresponsive and floppy". The child was seen in ER and admitted to a hospital with suspected sepsis. He was treated with fluids and "was responsive by the next day". The reporter indicated that "all tests were negative" for sepsis and meningitis and his blood work was "fine". He recovered. The physician stated that he did "not suspect Prevnar" and that he had consulted with an infectious disease specialist who agreed with his conclusion.
The mother came to the office with the pt at 2:15 pm stating "allergic reaction to shots" from earlier in AM. The pt received the vaccines around 11:30 - 11:45 on 2/27/01. The pt was presented with right entire face was raised and red. Treated with epinephrine and Benadryl.
I developed flu-like symptoms that lasted about 3 days. At one point, I felt like I was going to pass out and called 911.
Acute pancreatitis causing nausea, vomiting and decreased oral intake for 3-4 days starting 10 days after the 2nd dose of COVID vaccine. Patient was hospitalized for IV hydration and anti-emetics. Variety of tests were done to exclude other causes of pancreatitis in the patient,  which were negative. Most logical explanation at that point was vaccine induced pancreatitis.
expired doses of IPOL was administered to the patient with no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional.  This case was linked with case 2020SA360209 (same reporter)  This case involves a 10 years old male patient who received a 0.5 ml dose of expired IPV (VERO) [IPOL] (lot number: P1F54, expiry date: 07-Dec-2020, dose 1) via intramuscular route in the right arm on 14-Dec-2020 for prophylactic vaccination (expired product administered).  Medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for prophylactic vaccination   It was an actual medication error due to the expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  Reported asked whether the vaccine should be repeated or was viable until the end of the month if label reads Dec7 2020.  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.
The pt experienced vagal symptoms, diaphoretic, syncope. No long term problem. The pt was "ill" and nauseous for 3 days post vax.
Fever (max 102.7), chills, headache, sore arm for 36 hours.
The patient did not have a reaction he just received the vaccine 20 days after the 1st dose
In the 2 1/2 days immediately following my second shot I had muscle aches, some head ache, and fatigue, These went away as expected, but on day nine post-injection I experienced exactly the same symptoms, lasting for about 3 1/2 days. I saw practically nothing on line describing symptoms that far out from injection date. That is why I am submitting this report.
THE PATIENT COMPLAINED ABOUT SORE ARM AND HEAD ACHE THAT LASTED FOR 2-3 DAYS AFTER GETTING THE SHOT.
- Constant thirst **I hadn't read about this anywhere as a side effect so felt like I should report it. I am certain its related to vaccine because I don't ever experience this and there isn't anything else unusual about my last few days that would have made my mouth dry and feeling thirsty all day  - Arm pain increasing throughout the day - very sore, moves into shoulder blade
received both doses, shingles came back/suspected vaccination failure; diagnosed with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had recurring shingles for 18 years).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 6 months after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had recurring shingles for 18 years. It was not diagnosed until recently. The patient received first and second dose of Shingles vaccine this past summer and unfortunately shingles came back a few days ago. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available. This past summer was considered as summer of 2022 and TTO captured as consider as less than 6 months conservatively.
Within a half hour the patient could feel a tightness in her bronchial passageway. She does not feel like it was life threatening. In about half an hour after onset of symptoms, the patient began to cough. In the evening she began wheezing with little bits of mucous. Patient sought treatment from pharmacist via phone and primary care physician after hours via phone (nurse practitioner provided phone support). Nurse advised that the patient visit urgent care. Patient declined. Patient took ibuprofen.
Injection site soreness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The reporter indicated that almos every patient she had vaccinated with Shingirx, expereicned soreness at injection site. The reporter was unable to provide any additional information because the consumer was not in the pharmacy at the time of call.  The reporter consented to follow up.
Pulsatile tinnitus in one ear; This is a spontaneous report from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 20Mar2021 (Lot number: EP7534) at the age of 59 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN6198, Anatomical location: Left arm), administration date: 27Feb2021, when the patient was 59 years old, for COVID-19 immunisation.  The following information was reported: TINNITUS (non-serious) with onset 03Dec2021, outcome "recovered", described as "Pulsatile tinnitus in one ear". The event "Pulsatile tinnitus in one ear" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sore arm that same day; day of injection - also diarrhea for a week ; minor breathing problems for two weeks - took Imodium for diarrhea
I had a severe reation to my first dose which required Benadryl and medics to evaluate me so I took 50 mg 30 min prior this 2nd dose. I recieved my injection around 5:00 pm and was placed under observation to monitor for reaction. Within 7 minutes I had a rash on my chest, arms and neck. I was taken to an observation room accompanied by my mother who had my epi pen. Withing 1 minute of moving to the room my tongue began to swell. I gave the nurse permisoon to inject me in my left thigh with a syringe of epinephine from the clinic's suppy. 911 was called and I was transported to the Hospital where I recieved a pepcid injection, zofran for extreme nausea from the epinephrine and underwent observation for 2.5 hours. I was release 4/23/2021 and wass prescribed prednisone 20 mg 3xs daily for 5 days to help calm my reaction. I was told at the hospital that my throat was also very red upon arrival.
Pt states hair fell out after taking vaccine, next day sustained fever over 100 degrees last for 2 days. She had severe upper + lower leg cramps, joint pain, itching with no rash lasting 1 week. Had taken flu shot in past with no problems.
Confirmed Breakthrough Case  COVID-19 (Moderna) 1 03/12/2021 Pharmacy  Moderna 040A21A   COVID-19 (Moderna) 2 04/09/2021 Pharmacy  Moderna 016B21A   COVID-19 (Moderna) 3 11/05/2021 Pharmacy  Moderna 017F21A   COVID-19 (Moderna) 4 06/10/2022  Hospital Moderna 037A22B
2.5 hr p/vax pt retching, flushed face, blurred vision, HR 120/regular;radial pulse 20 irregular;no rxn @ site of vax;seen by MD airway & lungs clear;HR dec;during 45min visit devel local erythema @ inj site;edema of hands;
5 minutes after vaccine, developed dizziness and headache.  Headache was position, every time she moved her head she developed a focal right sided frontal headache with any head movement, of 7/10 severity.  This was associated with dizziness.  Both would improve when she was still.   Vitals were stable, BP 130/80, Busle 80's O2 sat 95%.  Neuro exam was non focal.  After about 1 hour of observation she then developed chest tightness, and without any improvement in headache and dizziness.  She was transported by ambulance to ER
Itchiness at left upper arm; Redness at left upper arm; Swelling of left upper arm; Pain at injection site; This spontaneous case was reported by a non-health professional and describes the occurrence of PRURITUS (Itchiness at left upper arm), ERYTHEMA (Redness at left upper arm), PERIPHERAL SWELLING (Swelling of left upper arm) and VACCINATION SITE PAIN (Pain at injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 13-Aug-2021, the patient experienced PRURITUS (Itchiness at left upper arm), ERYTHEMA (Redness at left upper arm) and PERIPHERAL SWELLING (Swelling of left upper arm). On 06-Aug-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, PRURITUS (Itchiness at left upper arm), ERYTHEMA (Redness at left upper arm) and PERIPHERAL SWELLING (Swelling of left upper arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient called in to report about her experience after receiving first dose of Moderna vaccine. She said she had pain at injection site for 3 days and then it went away. Her concern was that just last Friday, 13 Aug 2021, she started to had itchiness on her arm, redness, and swelling which all happened on her upper arm. She thought that she was having an allergic reaction and afraid to get the second dose.  Concomitant and treatment medications were not reported.   Reporter did not allow further contact