chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She explained she had a "sore arm" after the first dose; 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 74 -old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tylenol for back pains; Cortisone for back pain; Tylenol for not feeling well. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She explained she had a "sore arm" after the first dose". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: removed the event "Circumstance or information capable of leading to medication error".
Medium size hive (at injection site) appeared immediately after varicella vaccine was given. Rash appeared the next day (at injection site) and lasted for 3-4 weeks.
Approximately 12 hours after 2nd dose, I developed the chills; Approximately 12 hours after 2nd dose, I developed the chills and a 101.8 temperature; had discomfort at the injections site; This is a spontaneous report from a contactable consumer (Patient).  A 42-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection; Batch/Lot Number: EL3248), dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 10:30 as dose 2, single (At the age of 42-years) for covid-19 immunisation. Historical vaccine included received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 24Feb2021 11:00 (at the age of 42-years-old) as single for COVID-19 immunization. Medical history was reported as none. Allergies to medications, food, or other products were reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported and Rainbow Light Mens One multivitamin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 22:00 approximately 12 hours after 2nd dose, the patient developed the chills and a 101.8 temperature, had discomfort at the injections site. Since the vaccination, the patient was not tested for COVID-19. On 16Mar2021 the patient underwent lab tests and procedures which included body temperature: 101.8. The patient did not receive any treatment for the events. The outcome of the events was recovering.   Follow up #1(PRD 20Mar2021) This is a follow up spontaneous report in response to mail trail sent regarding the confirmation of below mentioned query. This reported included that.  The awareness date was 16Mar21.  No follow-up attempts are needed. No further information is expected.
Low-moderate pain below abdomen followed by frequent and excessive passing of wind for about 4 hours. Peptide pills reduced problem and permitted sleep. Food ingested during the day was very unlikely to be the cause. Condition disappeared by 8:00 am 2/6/21.
Shortness of breath - difficulties getting a full breath Feeling of tightness in chest Extreme fatigue Heart palpitations  Occasional shakiness Slight discomfort in abdominal organs
Information has been received from a nurse practitioner concerning a 12 year old female who in October 2007, was vaccinated with Gardasil (lot # not reported).  In October 2007, two days after she was given Gardasil the patient presented with a swollen thigh.  The patient then progressed to lymphadenopathy.  As of 05-Nov-2007, the patient's swollen thigh and lymphadenopathy persisted.  Unspecified medical attention was sought.  Additional information has been requested.
On Friday April 30 I developed a herpes rash on the right side of my face following my trigeminal nerve which was much larger and more intense than I have ever had in the past. This progressed until Monday, May 4 into a large scab. I had the typical symptoms of a Herpes outbreak: feeling out of sorts, fatigue, pain at the rash site
On Jan. 6th, one week after my 1st dose, I got a severe migraine. I don't know what caused it.  On Jan. 28th, a day after my 2nd dose, I had redness at the injection site, about the size of a silver dollar.
Information has been received from a pharmacist referring a 22 year old female patient who was not pregnant. On unknown dates the patient had received three doses in the series of RECOMBIVAX HB (lot#, dose and route unspecified). On an unknown date the patient had titers drawn after vaccination and the titer for Hepatitis B was 10 mIU/ml. The patient felt that this was too low and requested another series of Hepatitis B vaccine. This had not been administered to the patient yet. No adverse effect was reported. The outcome of the event was unknown. Additional information is not expected because the reporter refused additional contact.
June 24, 2022 she woke up very weepy and cranky, and that progressed throughout the day. She is usually very cheerful. She also had trouble sleeping. The next day on she Saturday morning woke up with a fever. On June 26th her fever broke around 3:00PM.
I know that sometime that evening I was typically sore but the next day I wasn't feeling so great. I had fever, body aches, chill which lasted for 12 hours. Other than my teeth; I got horrible pain I couldn't brush. I couldn't chew anything; I was restricted to a soft diet because it was too painful to chew or even use my water pick. About a week or two later I developed a sore on the roof of my mouth. That's when I went in to see (my dentist). 360-degree X-ray. He couldn't give a explanation but he saw the sore and said my gums were inflamed. I was given antibiotics in my mouth. A week late I was still in horrible pain. He saw me again and seen just the inflammation but no explanation. April 2nd I started to feel better, I could brush and use the water pick. The pain was a 10 at first and then went to a 3.
Information has been received from a licensed practical nurse concerning a 67 year old patient who was vaccinated on unspecified date  instead of VARICELLA virus vaccine (MSD). No adverse effect was reported. Additional information is not expected.
No additional adverse events; Vaccine was inadvertently administered; This spontaneous information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.  In 10-DEC-2019, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection as prophylaxis (lot number: 1621934 with expiration date: 29-JAN-2022) (strength and route of administration were not reported) (incorrect product storage).  The reporter was unable to provide the temperature excursion timeframe or estimated temperature the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was exposed to. The call was not because of the data logger.
Day off and day following-soreness at vaccination site, exhaustion, inability to concentrate, muscle/joint aches. Day after was chilled, confirmed slight fever 99.89 in early evening.
Shortness of breath, weight loss, general difficulty breathing ,onset gradually started after Moderna Dose 1. Currently being treated. I'm going to the clinic, on 06/28/2021. I have been diagnosed with Interstitial Lung disease. I have never had a problem with respiratory prior to the Moderna Dose 1.
She was administering the medication to the patient the product leaked with no reported adverse event; Initial information received on 18-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old female patient who was given the MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI to the patient the product leaked and incomplete dose was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (dose, formulation, strength: unknown) (lot U7294AA, Exp date: 23-May-2024) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "she was administering the medication to the patient the product leaked with no reported adverse event (incorrect dose administered) (latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  It was reported "caller states she was administering a dose to a patient when the product leaked out from the tip of the syringe. Caller is not sure how much vaccine product the patient may have received and would like to know if they should revaccinate. Caller states they withdrew the product from the vial using one of their own syringes. She stated they expelled the air bubbles from the syringe like she normally would, and did not notice any leaking at the time. However as she was administering the medication to the patient the product leaked and is not sure how much product the patient may have received.  The product leaked out from where the syringe and needle connect Leaking".   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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.
mild flu symptoms; This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter stated they experienced mild flu like symptom after receiving a dose of Shingrix. The reporter did not consent to follow up.
Right arm pain at site of Quad Flu shot. Pain worsened with arm feeling like it weight a ton and sudden movement feeling like arm would shatter. Experienced return of shingles with pain at arm site shooting up neck and down back like electricity. And shingle pain around chest area with chest outbreak of bumps. Shingles now gone but continued knot of pain at shot site. Treatment - aspirin/ADVIL, Heat.
Injection to vocal chords for spasmodic dysphonia caused drainage to lungs and may only be because of the shot itself. No treatment was issued. Advised to be careful drinking, currently seems to be tapering off.
A nurse reported that a female pt inadvertently received a triple dose of Cholera Vaccine on 6/8/99 and subsequently developed an injection site reaction characterized by pain and redness which persisted as of 6/10/99. This is 1 of 2 pts from this facility who experienced this event following receipt of the vaccine.
Large red swelling (average handprint size), itchiness, sore to touch, warm to touch. All around injection site.
p/vax pt had numbness in lt arm that lasted not very long;pt describes sharp pain from elbow to shoulder on lt arm lasting a short time only because stops activity soon p/pain begins this happens w/any reaching action;constant ache;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 02Jan2021 as dose 1, single (Lot number: EL1283) and on 22Jan2021 as dose 2, single (Lot number: EL9261) at the age of 41 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Nov2021 as dose 3 (booster), single (Lot number: 069F21A) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: allergies; "varicose veins" (unspecified if ongoing); "suspicious thyroid nodule( w/u pending)" (unspecified if ongoing), notes: suspicious thyroid nodule( w/u pending); "known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: ASMANEX, start date: 31Dec2017; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Jan2015. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received treatment with Paxlovid from 24Jul2022 to 28Jul2022 for treatment of Covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Breakthrough case admission after three vaccines  Moderna 2/24/2 Lot# 010A21A;  Moderna 3/24/21 Lot# 017b21a;  Moderna 12/16/21 lOT# 078j21a
Angioedema; This literature-non-study case was reported in a literature article and describes the occurrence of ANGIOEDEMA (Angioedema) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Polyethylene Glycol and Polysorbate Skin Testing in the Evaluation of COVID-19 Vaccine Reactions: Early Report. Annals of Allergy, Asthma & Immunology. 2021     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant). At the time of the report, ANGIOEDEMA (Angioedema) 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.   Treatment medication included steroids and antihistamines  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.  Critical details to include patient's medical history, mRNA-1273 administration date and onset date of the event is lacking.  No further information is expected.   This case was linked to MOD-2021-075562, MOD-2021-075577 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.  Critical details to include patient's medical history, mRNA-1273 administration date and onset date of the event is lacking.  No further information is expected. MOD-2021-075562:Same Literature Article MOD-2021-075577:Same Literature Article
Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had chickenpox twice). Previously administered products included Shingles vacine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick). The outcome of the sickness was not reported.   The reporter considered the sickness to be possibly related to Shingles vaccine.     The company considered the sickness to be possibly related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received both doses of Shingles vaccine. The patient experienced sick from the second dose. The patient stated that it was better than suffering from shingles. The patient have had chickenpox twice, so he/she convinced that he/she did the right prevention. Follow-up would not possible as no contact details were available. According to narrative verbatim the causality was conservatively captured as possible
Around 15 hours after getting my Moderna Booster shot  I started experiencing intense flu like symptoms and felt sicker than I have ever felt in my adult life. I had achey muscles and joints, I had chills and sweats, nauseua and was incapacitated to the extent where I could not move from bed for 2 days. I had to call out sick from work which is something I have never done. I finally felt well enough to get to work and eat food on the 3rd day after the booster.
This is a prospective pregnancy case. This 37-year-old female subject was enrolled in a study. The subject received BOOSTRIX (intramuscular) .5 ml on 13th July 2015. Concurrent medical conditions included thyroid disorder. Concomitant products included SYNTHROID and Prenatal Vitamins. The subject's last menstrual period was on 7th December 2014 and estimated date of delivery was 12th September 2015. The subject received BOOSTRIX at week 31 of the pregnancy and during the third trimester of pregnancy. On 13th July 2015, 12 hrs after receiving BOOSTRIX, the subject developed fever (Non-serious). Additional event(s) included dehydration on 14th July 2015, vomiting on 14th July 2015 and vaccine exposure during pregnancy. The outcome of fever was recovered/resolved. The outcome(s) of the additional event(s) included dehydration (recovered/resolved), vomiting (recovered/resolved) and vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. Additional details were provided as follows: The patient received Tdap vaccine and unable to verify the brand name for Tdap. The reported batch number is (C4506AC or O4506AC), but this was not able to verify the Tdap vaccine as a GlaxoSmithKline vaccine. On 13th July 2015 (around 10 or 11 PM), 12 hours after receiving BOOSTRIX the patient experienced fever (a little over 100 degrees F). On 14th July 2015, 1 day after vaccination the patient experienced vomiting and dehydration. The patient was fine by end of the following day. The patient visited to her obstetrician due to fever and vomiting and the obstetrician stated that the patient was also dehydrated.
Fever, chills, shaking, full body pain, sweating, dry mouth, headache, dizziness
Px reported painful knot in arm just below injection site. And extreme shivering evening of injection site. No fever lasted 2 1/2 hours.
Information has been received from a physician concerning a patient who in March, 1999 was vaccinated SC with one does of varicella virus vaccine live. On 06/06/2000 the patient developed a localized patch under her left axilla which the reporting physician "thinks may be herpes zoster". The area was noted to be painful and causing the patient discomfort. Additional information has been requested.
Tired, sleepy, weakness, off work 2 days. Very hard to wake up.
left arm and left hand numbness/left side of her face went numb; she could feel the nerve that goes from her eye to the corner of her mouth tightened up; Tongue either went numb or was swollen; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (left arm and left hand numbness/left side of her face went numb), FACIAL DISCOMFORT (she could feel the nerve that goes from her eye to the corner of her mouth tightened up) and HYPOAESTHESIA ORAL (Tongue either went numb or was swollen) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced HYPOAESTHESIA (left arm and left hand numbness/left side of her face went numb), FACIAL DISCOMFORT (she could feel the nerve that goes from her eye to the corner of her mouth tightened up) and HYPOAESTHESIA ORAL (Tongue either went numb or was swollen). On 08-Jan-2021, HYPOAESTHESIA (left arm and left hand numbness/left side of her face went numb), FACIAL DISCOMFORT (she could feel the nerve that goes from her eye to the corner of her mouth tightened up) and HYPOAESTHESIA ORAL (Tongue either went numb or was swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I experienced a breakthrough case of COVID-19, nausea, nasal pressure, congestion, coughing, mucus.
As soon as I got my vaccine I felt like she hit something wrong because my arm automatically started hurting also I started getting pain under my armpit and my breast and I have to keep my arm up because if I put it up it hurts even more. I have 2 days I don?t sleep because of the pain. I even went to the hospital because I was afraid it had something to do with my heart I got it checked out and they told me it was a nerve that the girl had hit like if she applied the vaccine wrong.
Pt reports developing moderate throat irritation and moderate hives with moderate difficulty breathing 3 days s/p receiving  Pfizer COVID vaccine. He was seen at our clinic and was given 10-day course of Prednisone PO and he got better.
Worsening, not improving pain like she was "punched in the arm". Arm pain and weakness continuing without improvement > 2 weeks.
Low grade fever (99.2 degrees) on day of vaccine administration. Fever resolved but returned on 7/18/10 to 101 degrees. Fatigue present since vaccination (7/15/10-7/19/10).
7DEC94 tc from mom states pt devel temp ranging from 102.6-104 w/in 24 hrs p/vax; no prev problems or fever w/vax reported; mom also states pt became frustrated in past wk w/memory gone; mom believes pt not acting as used to prior to vax;