chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching; Got a rash on my chest; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and RASH (Got a rash on my chest) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PRURITUS (Itching) and RASH (Got a rash on my chest). The patient was treated with CORTISONE at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching) and RASH (Got a rash on my chest) outcome was unknown.            No relevant concomitant medications were reported.  Other treatment information included some shot that doctor gave to the patient.  Action taken with mRNA-1273 in response to the events was not applicable.
BLOOD CLOT; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, and batch number: unknown expiry: unknown ) dose, start therapy date were not reported, dose number in series was 1, 01 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot from the shot (dose number in was series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211256517 - COVID-19 VACCINE AD26.COV2.S- Blood clot. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
fever Dizziness, difficulty breathing, out of breath / very low energy loss of audible voice
Patient accidently given 0.2mL of adult Pfizer 30 mcg/0.3mL instead of peds Pfizer 10mcg/0.2mL. No known adverse events reported, or treatments needed that facility is aware of.
Tingling followed by numbness in tongue, mouth and throat; Tingling followed by numbness in tongue, mouth and throat; A spontaneous report was received from a consumer concerning a female patient of unknown age who was Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingling in tongue, mouth and throat and numbness in tongue, mouth and throat.   There were no medical history and concomitant medications reported.  On an unreported date in 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unreported date in 2020, the patient reported experiencing tingling followed by numbness in tongue, mouth and throat upon administration of mRNA-1273.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were unknown.  The outcomes of the events were unknown.; Reporter's Comments: This spontaneous report concerning a female patient of unknown age who experienced tingling in tongue, mouth and throat and numbness in tongue, mouth and throat. The events occurred the on an unknown date after the administration of the first dose of mRNA-1273 ((lot number unknown, expiration date unknown). Treatment provided and outcome are unknown. There is not enough information to assess the causal association between the event and the administration of mRNA-1273 vaccine as critical details such as the duration date of dosing and onset of the events was not provided. Main field defaults to possibly related'
A few minutes after receiving the vaccination, I could not move my left arm, and pain was intense in my arm, neck, and down back. Went to Dr. on February 1, 2021, and he prescribed pain medications, and gave me some exercises to do.
high pitched cry of less than 4 hr cont duration w/in 72 hr of vax; 4 days p/vax began w/abn eye movements; 5 days p/vax had brief jerking consistent w/sz activity; sepsis work up done & was neg; EEG was nl; No anticonvulsants given;
Immediately after the vaccine I felt fine. On April 19, I started to feel under the weather...stuffy nose, scratchy throat. a day later I started to feel chills and cough. I got tested on April 22 for COVID and the test was positive.
Pt passed put after vaccination with the Janssen COVID-19 vaccine.  Roughly 5 minutes after administration of the vaccine, the lady who accompanied the patient got the attention of the pharmacist.  Pharmacist ran out to assess patient and saw that he seemed unresponsive. Pharmacist then called for an EPIPEN, but pt woke up before the EPIPEN was ready.  No EPIPEN was given.  We then monitored the patient's BP every 10 minutes or so. Pt stablized after roughly 45 minutes to an hour and then left the store.
Brought to my attention that patient had syncopal episode and was escorted to exam room table. When I initially saw patient, she was awake, pale, diaphoretic but was alert and oriented to time, place, and situation.  We observed her for 30 minutes, and she became more pink, less diaphoretic but still clammy, and she had drank 4 oz water and had a lollipop in mouth. I checked initially for any bleeding of mouth, no obvious head injury. She was stable upon discharge. I suspect trypanophobia given patient's history with needles. Still encourage 2nd dose but inform injector, stay for 30 minutes observation, and 15 grams of sugar such as a soda or juice carton.   She was driven home in private car with an accompanied older female adult relative. Instructed on emergency care immediately for any increased difficulty breathing, chest pain, or increased weakness. Otherwise, anticipate common reactions, such as fever, body aches, and arm injection site pain to be treated with fluids, rest, and Tylenol as needed.
Initial report received from a healthcare professional on 14 January 2013. A 62-year-old female patient, who had no pre-existing physician diagnosed allergies, birth defects and medical conditions and her concomitant medications were not reported, had received first dose of FLUZONE (batch number: UT4466BA, route of administration was not reported) in left arm on 10 January 2013. The patient had no other illness at the time of vaccination. On 11 January 2013, the patient experienced area of redness with a hard lump under the skin, very warm to touch. Not getting larger. Corrective treatment was not reported. The patient had no laboratory investigations/relevant diagnostic tests. At the time of this report, the patient had not recovered from the event. Documents held by sender: None. Follow-up information was received from a healthcare professional on 15 April 2013. The patient had no further problems with no need for medical attention.
Pt exp pain, erythema, & edema @ the inject site p/vax; 30MAR92 seen in ER for incision & drainage of an abscess @ the site; cultures showed no growth;
Patient was given flu shot in arm and reported 2 weeks later that she was experiencing severe joint pain that started 2 days after the shot. It was suggested that shot may have been too high. Patient sought medical care at her doctor's office- was prescribed anti-inflammatory, exercises, & a sleep aid.  Reports pain improving.
Dizziness, mild nausea. BP 151/83 (pulse 71), 100% O2 sat. F/u BP 156/86 (pulse 67).
Narrative: COVID infection following COVID vaccine series 01/12, Pfizer, dose #1 01/30 COVID swab, result: not detected 05/18 COVID swab, result: not detected 02/02, Pfizer, dose #2 08/05 COVID swab, result: detected 08/06 pt cc: cough, diarrhea, fatigue, nausea, vomiting, fatigue, fever, loss of taste, myalgias, dyspnea, low o2 saturation, exposure: recently deceased spouse from COVID OR COPD 08/07-08/18 pt continue to have symptoms 0810 cxr impression: New bilateral pneumonia. 08/10 ED Admission dx: PNA 08/10 Medical admission dx: Bilat PNA 08/10 c-reative protein result: 11.076 08/11 procalcitonin result: 0.10 08/11 legionella result: negative 08/11 strep pneumoniae antigen result: negative 08/11 ESR 74 08/12 fibrinogen result: 602 08/12 DDIMER result: 0.57 0811 QUANTIFERON-TB result: negative 08/11 HIV result: non-reactive 08/11 SARS COV-2 IgG result: 0.20 08/12 ESR 35 08/12 fibrinogen result: 414 0812 DDIMER result: 0.43 08/14 ESR 31 08/14 fibrinogen result: 317 08/14 DDIMER result: 0.59 08/14 SARS-COVID-2 TOTAL AB SPIKE >25000 08/15 ESR 4 08/15 fibrinogen result: 321 08/15 DDIMER result: 0.57 08/16 fibrinogen result: 308 08/16 DDIMER result: 0.55 08/16 ESR 4 08/21 clinically resolved 08/26, Pfizer, dose #3
Child had acute onset of significant stuttering 2 days after receiving the KINRIX vaccine. Child had high fevers that night the vaccine was administered (102-103). Fever continued for several days.
Enlarged thyroid and sore throat. My dentist first noticed it and charted it was also off center. It get enlarged while swallowing. It last for about 6-8 weeks.
Patient was waiting for a 15 minute observational period. During the observation he started experiencing  dizziness, light headedness and loss of hearing.  Patient stood up to  notify  observation staff of his symptoms  and had a syncopal  episode and was moved to a cot. Patient soon regained consciousness  and observational staff took a first set of vital signs  with BP 128/72, O2 97%  and strong pulse of 108 Bpm. Patient continued having dizziness for approximately 10 minutes after the event occurred. Onsite medical staff offered an ambulance transport to a nearby medical facility  and patient reused against  medical advice. Medical  staff took a second set of vital signs  with BP 124/76, O2 99%, strong pulse 78 BPM.  Medical staff took patient out on a wheel chair and patient had a relative drive him home.
fever, chills, swollen lymph nodes in armpit under site of injection, which disappeared after 10 days.  Metal smell and taste which lingers.
Information has been received from a consumer concerning her daughter who in April 2008, was vaccinated with a dose of GARDASIL.  The reporter reported that her daughter fainted after receiving the GARDASIL.  Shortly after the vaccination, the patient experienced a debilitating anxiety attack and she was in a fragile state of anxiety.  The outcome was unknown.  Additional information is not available.
Vaccination received 12/10/21 in left arm, soreness in left armpit began 12/11/21, noticeable/visible swelling noted in left armpit 12/12/21 with selling increasing 12/13/21 (today) - no redness, no temperature increase in axilla or otherwise- tenderness has decreased despite increase in size of left axillary lymph node
A few hours after I received the shot, I began experiencing a sharp ?bolt? of pain that began at the base of my skull on the right side and would quickly surge up and over my head to around the front of my ear. A very distinct line of pain, like a surge of a headache passing up and over my skull. It would happen very regularly that first day, about every 1-5 minutes. The next day it was less frequent. Happening anywhere from 5 minutes to an hour apart, but I could have 1 to 5 bolds in a row. The unpredictability of the second day was much worse than the first. The third day I only had 2-3 bolts all day and none after that.
Around 2:00 AM the following morning pretty extreme pain in the right arm, then hot and cold, body aches. As the day went on started seeing blood in the urine started getting darker as the day progressed so Saturday morning I went to the ER.  No pain urinating, no infection,  unknown why blood in urine. As aches/pains wore off the urine cleared up.
I was unable to walk; Third dose: 01Sep2021; Third dose: 01Sep2021; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in right arm on 01Sep2021 (Batch/Lot number was not reported) as dose 3, single for covid-19 immunisation. Medical history included multiple sclerosis. The patient was not pregnant. The patient had no known allergies. Concomitant medications were not reported. The patient had any other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first and second dose of bnt162b2 for covid-19 immunisation on an unspecified date. On 01Sep2021, the patient experienced was unable to walk. The event was considered as disabling/incapacitating. The patient reported that today, 01Sep2021, she was unable to walk and she was walking everyday. The patient does have multiple sclerosis, but this was not a symptom for her, and she usually walk at least 1 mile/day. There was no treatment for the event. Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination, the patient had not been tested for covid-19. Outcome of event was not recovered.   The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Pt called on 08/05/2020 to report swelling and pain to the injection site.  She had also complained of some abdominal pain, but that was going on prior to injection.  Pt went to the ER for the abdominal pain and everything checked out fine.  She did take some ibuprofen for the pain.  The swelling and pain have subsided.
I have always loved beer but since the second COVID shot had zero desire to drink it; I felt drunk after only a few beers; very tired; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old (adult) male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 14Feb2021 at 11:00 hours (at the age of 52-years-old), as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 24Jan2021 at 11:45 hours (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient reported that he always loved beer but since the second COVID shot have had zero desire to drink it on 14Feb2021. On an unspecified date in 2021, in two occasions when he drank, he felt drunk after only a few beers and very tired. The clinical outcome of the events I have always loved beer but since the second COVID shot I had zero desire to drink it, I felt drunk after only a few beers and very tired was unknown at the time of report.   Information about lot number cannot be obtained. No further information is expected.
Large area of localized erythema, edema, and warmth with secondary cellulitis requiring IV steroids and IV antibiotics. Nausea, vomiting, fever 101, body aches. 09/23/2005 arm still aches, unable to do heavy lifting.
All over body hives and dermatographia appeared two weeks after the vaccine booster (moderna) and are still present
Macular-papular rash develops on 3/5/15 continuously on abdomen, neck, back and both arms. The rashes are erythematous and itchy. Negative for pain, cough, fever, diarrhea, joint swelling, vomiting, lymphadenopathy and wheezing.
Overall body soreness particularly in the right arm; Soreness particularly in the right arm; Tiredness; Stuffy nose; Dose received:3/ Dose number = 3; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 26-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in right arm, administration date 05Jan2022 at 11:00 (Lot number: FL3197) at the age of 26 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, SINGLE, Lot number: EL3247, Route of Administration: Intramuscular), administration date: 11Feb2021, when the patient was 26 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EL3247, Administration time: 10:30, Route of Administration: Intramuscular), administration date: 05Mar2021, when the patient was 26 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 at 11:00, outcome "unknown", described as "Dose received:3/ Dose number = 3"; PAIN (non-serious) with onset 06Jan2022, outcome "unknown", described as "Overall body soreness particularly in the right arm"; PAIN IN EXTREMITY (non-serious) with onset 06Jan2022, outcome "unknown", described as "Soreness particularly in the right arm"; FATIGUE (non-serious) with onset 06Jan2022, outcome "unknown", described as "Tiredness"; NASAL CONGESTION (non-serious) with onset 06Jan2022, outcome "unknown", described as "Stuffy nose". Therapeutic measures were not taken as a result of pain, pain in extremity, fatigue and nasal congestion.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a certified medical assistant to a 16 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL (lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported). No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
No adverse event; Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 18-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml).    Patient received 0.25 mL of Moderna bivalent booster dose.  No concomitant medication information was provided. No treatment medication were provided.
Approximately 5 minutes post vax, pt developed wheals on forehead and rubbing eyes. She was given Benadryl and epinephrine.
Client became weak, diaphoretic, numb/tingling limbs, almost lost conciousness
pt states that her arm and neck started bothering her after getting the vax.  She woke up shaking and had chills with no temp.  Today 3/9/2021 Pt says her arm and neck still hurt but she is getting better.
Heart rate up and down, fatigue,  deep breath pain in lung  Blood pressure up and down. Migraines and headaches  Diarrhea and
use of three dose of shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number CR5XF, expiry date 23-AUG-2025) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On 01-MAY-2023, the patient received the 3rd dose of Shingrix. On 01-MAY-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: use of three dose of shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 19-SEP-2023 A pharmacist called in to request information about the safety information available for the use of three doses of Shingrix. partial information was given, which led to extra dose administered. The Vaccine Administration Facility is the same as Primary Reporter. The reporter did not consent to follow-up.
RASH ON THE LEG; This spontaneous case was reported by a consumer and describes the occurrence of RASH (RASH ON THE LEG) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RASH (RASH ON THE LEG). At the time of the report, RASH (RASH ON THE LEG) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  On an unknown date, patient experienced rash on leg after vaccination. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient was given Pediarix vac. but was supposed to get a DTAP vac.
Fever that progressed to 104 by Saturday 10/19 as well as rash with small pimple like lesions on face and body.
reporter was giving vax & thought drew up HIB & instead drew up hep B when child had 3 prev doses;pt mom notified & will bring pt in next month for HIB vax; no side effects;
patient passed away on 1/12 at 1800 from a ruptured colonic mass.
Fifteen minutes after vaccination patient started to feel dizzy, light headed, fatigued, and "foggy" (decreased mental clarity), patient orientated, denies SOB/difficulty breathing. Pt lungs clear bilaterally, O2 98% on room air, BP 118/80 and HR 80 bpm at 3:12 pm. Pt advised to see PCP for evaluation but unable to obtain appointment. Pt advised to go to ER/urgent care for further evaluation, pt's husband taking her to Urgent Care .