chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 15 minutes started to experience numbness on the left side of my face. Then with 30 minutes the whole left side of my face then my left arm.; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Within 15 minutes started to experience numbness on the left side of my face. Then with 30 minutes the whole left side of my face then my left arm.) 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.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced HYPOAESTHESIA (Within 15 minutes started to experience numbness on the left side of my face. Then with 30 minutes the whole left side of my face then my left arm.) (seriousness criterion hospitalization). At the time of the report, HYPOAESTHESIA (Within 15 minutes started to experience numbness on the left side of my face. Then with 30 minutes the whole left side of my face then my left arm.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient was admitted in the hospital for test and to make sure patient was not having a stroke. Patient had numbness off and on throughout the night not lasting more than a few minutes. Patient was advised by primary care physician to not take the second vaccine. Patient still had numb patch in the back of patient's head at times but this may not have anything to do with the vaccine.  No treatment information was provided.  Company Comment: This case concerns a patient of unknown age and gender, with no medical history, who experienced the unexpected serious event of Hypoaesthesia. The event occurred on the same month after the first dose of mRNA-1273 Vaccine which resulted in hospitalization. At the time of the report the outcome was not resolved . The rechallenge was not applicable as the events occurred after the first dose and no information about second dose is available The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender, with no medical history, who experienced the unexpected serious event of Hypoaesthesia. The event occurred on the same month after the first dose of mRNA-1273 Vaccine which resulted in hospitalization. At the time of the report the outcome was not resolved . The rechallenge was not applicable as the events occurred after the first dose and no information about second dose is available The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
pt recvd vax & exp itching @ the inject site following vax; No further details were provided;
This spontaneous report was received from a Registered nurse regarding a 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Headache that began the afternoon I received the 1st dose. By that evening or the next, I also had muscle tightness in my neck and traps (upper shoulders). The headache was made worse with reading. By the second week, I had symptom of heart pounding with minimal exertion. I also continued to have headache, neck and upper trap tightness, jaw tightness and dizziness. I have had the headache since the day of the 1st dose of the vaccine. All of my symptoms worsened when I tried a migraine medication (Topamax) for 3 days and had very low blood pressures and heart rate changes.  I have since been diagnosed with double vision. I wore a halter monitor for two weeks and am awaiting the results.
Facial swelling. Pt states her back began hurting that same night but she went to bed. She awoke with facial swelling and tingling. She denies throat swelling or any anaphylactic symptoms. States she usually has back pain with swelling, so she feels it is swollen all over. DEPO MEDROL 80mg IM RG given in office to treat. Instructed to obtain BENADRYL to take as directed if continued swelling.
Congestion, headache, nausea, complained of feeling cold, sweaty these symptoms lasted approx. 30 hours also complained of numbness/tingling left hand this lasted approx. 12 hours. All symptoms started 11/4/10 at 2:30 AM.
Patient is under the age for the vaccine approval. Patient received the vaccine as an error or misfill.
COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna, vaccine brand=Pfizer / BioNTech; vaccine brand other=Moderna, vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2021 at 10:00 as dose 1, single (Lot number: EL3302), in right arm and on 02Mar2021 at 10:00 as dose 2, single (Lot number: EM9809) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Nov2021 at 14:00 as dose 3 (booster), single (Lot number: 058E21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin & hydrocodone. There were no concomitant medications. Past drug history included: Hydrocodone, reaction(s): "known allergies: Hydrocodone", notes: known allergies: Penicillin & hydrocodone. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 19Nov2021 at 14:00, outcome "unknown" and all described as "vaccine brand other=Moderna, vaccine brand=Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: Tested and was negative two days in a row; Negative, notes: Tested and was negative two days in a row. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Known allergies was reported as Penicillin & hydrocodone. Other medical history was None. Patient took no regular meds. Other medication in 2 weeks was reported as No. Anti viral details (Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 14Dec2022, Treatment stop date: 19Dec2022, Lot number: GG2065, Indication: Treatment of COVID-19) was reported. Adverse event was reported as Paxlovid rebound. Took the paxlovid as directed. Tested and was negative two days in a row. Symptoms restarted without fever, but burning sinuses, congestion, dry cough, fatigue, metallic taste returned to mouth. Patient had Not recovered. No treatment was taken for adverse event.
Narrative:  Patient reported worsening liver function after 3 doses of covid vaccine. Patient also reports blood shot eyes and itching every morning.
Pt recv vax on unknown day; post vax pt exp red/warm/ inflamed vax site & lymphadenopathy; dx=local infection
intense coughing; later much mucus and congested sinuses with later much yellow discharging along with mucus; later much mucus and congested sinuses with later much yellow discharging along with mucus; blood under skin when skin is itchy( a normal condition); blood under skin when skin is itchy( a normal condition); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 at 18:00 as dose 1, single (Lot number: HU4664) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "CHF" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "diabetic" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Known allergies: Weeds" (unspecified if ongoing), notes: known allergies: weeds-itching. Concomitant medication(s) included: SYNTHYROID; ELIQUIS; METOPROLOL; PANTOPRAZOLE; GLI. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex". The following information was reported: PRURITUS (non-serious), SKIN HAEMORRHAGE (non-serious) all with onset 17Oct2023 at 12:00, outcome "not recovered" and all described as "blood under skin when skin is itchy( a normal condition)"; COUGH (non-serious) with onset 17Oct2023 at 12:00, outcome "not recovered", described as "intense coughing"; SINUS CONGESTION (non-serious), RHINORRHOEA (non-serious) all with onset 17Oct2023 at 12:00, outcome "not recovered" and all described as "later much mucus and congested sinuses with later much yellow discharging along with mucus". The events "intense coughing", "later much mucus and congested sinuses with later much yellow discharging along with mucus" and "blood under skin when skin is itchy( a normal condition)" required emergency room visit. It was unknown if therapeutic measures were taken as a result of cough, sinus congestion, rhinorrhoea, pruritus, skin haemorrhage.  Additional information: Patient didn't receive any other vaccine in four weeks. Prior vaccination, patient was not diagnosed with COVID-19. Post vaccination, patient was not tested for COVID-19.
redness; burning on my outer ear; This case was reported by a consumer and described the occurrence of erythema ear in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced erythema ear and burning sensation in ears. On an unknown date, the outcome of the erythema ear and burning sensation in ears were unknown.   It was unknown if the reporter considered the erythema ear and burning sensation in ears to be related to Shingrix.  Additional details were provided as follows: The patient was reporting or him/herself. The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. Couple of days after receiving Shingrix, the patient experienced redness, burning on outer ear.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. No information on their medical histories, concurrent conditions or concomitant drugs was provided. On an unkonwn date, the patients were inadvertently vaccinated with doses of improperly stored M-M-R II, (dose and route of administration were not reported, lot # K014833 and expiry date 14-SEP-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Three days after Influenza vaccine, my mom's vocal cords were both paralyzed. She had to be intubated and given a tracheostomy. She never recovered.  2/12/07 Received medical records from hospital which reveal patient experienced SOB & abdominal pain on 11/2/06.  ENT consult revealed fixed vocal cords & required emergency entubation then tracheostomy.  G-tube placed for nutrition. Throughout hospitalization, had intermittent a-fib & nonsustained v-tach.  Patient was noted to be depressed & was evaluated by psych. Pt was transferred to SNF unit for rehab. 2/15/07 Received Death Certificate from daughter which reveals COD as cardiopulmonary arrest; COPD; & CAD.
Case completed Covid vaccine series in April 2021, and was hospitalized in October 2021 for Covid.   * Acute hypoxemic respiratory failure due to COVID-19  Assessment & Plan Presented with an approximate 7-day history of cough and progressive shortness of breath.  Left-sided pulmonary infiltrates seen on chest imaging.  Covid positive on a home kit, around 10/19.  Borderline febrile and hypoxic upon arrival, needing 3 L.  Completed Moderna vaccine series in April.  -Patient received dexamethasone and remdesivir. At time of discharge stopping dexamethasone based on guidelines. Also, for him he was having some p.m. hyperglycemia that was likely related to steroids, which is 1 additional reason to avoid going on -Discussed IS use, prone positioning, and ambulation around his hospital room.  -Full code -Patient subjectively feels somewhat better as of 10/27. On day of discharge was at 3 L, but at times seem to be improving on room air. Well recommend home oxygen, patient will monitor his own oxygen as above and use oxygen to keep levels at 90% or greater.
Pt described sx's of shakes, chills, feeling "cold to the core" and weakness later in day approx 730 pm. She wrapped herself in warm blankets and warmed herself at home. She states she awoke in the AM fine.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 13-OCT-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
ON 07/27/2027 AT 620PM Pt. calls to report that she had episodes of tingling to her fingers of the left hand intermittently on the fourth day after Moderna vaccine administration. Pt. also reports that she had episodes of tingling sensation of the fingers of the right hand, right after administration of the Moderna vaccine which was administered to the right arm on 07/23/2021. After 30 min wait pt . stated that tingling of the right hand fingers had resolved. On 7/27/2021 during the phone conversation pt was instructed to fu with her PCP for tingling sensation of the fingers and if indicated by pcp referral to neruologist for eval of tingling sensation of her fingers . Pt verbalizes understanding and in agreement with plan.
Fully vaccinated.  Lot # of vaccines not listed.   COVID breakthrough infection with inpatient hospital stay.
Large red rash at site and around it. Larger swelling around that area extending to back of arm/2in. long 1in. wide. Second area 5in. long by 2 in. wide. Swollen, itchy. Benadryl and calamine lotion prescribed by Dr.
Anaphylaxis; Rash all across her leg; Swelling; Itching; Red; Hot; A spontaneous report was received from a consumer concerning a 22-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events anaphylaxis, rash all across her leg/rash, swelling, itching,/pruritus, red/erythema, hot/feeling hot.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030M20A) Intramuscularly on right leg for prophylaxis of COVID-19 infection.  On 10 Mar 2021, the patient experienced the event(s) anaphylaxis symptoms of  swelling, itching, rash all across her leg. It was red, and hot.S he was a very fragile person with many syndromes and so they took her to the doctor. She was feeling better on 14 Mar 2021. Treatment for the events were none.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), anaphylaxis, rash all across her leg, swelling, itching, red, hot were reported as recovering on 14 Mar 2021..; Reporter's Comments: This case concerns a 23-year-old female who experienced a serious expected event of anaphylactic reaction along with unexpected rash, erythema, pruritus, swelling, and feeling hot. Event onset occurred on Day 6 after the first dose of mRNA-1273. Treatment not reported. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
High pitched screaming from 8-11PM, face purple; sudden onset, sudden stop; could not comfort pt;
The dose for the Moderna vaccine is 0.5 mL. The patient inadvertently received an overage of 0.01 to 0.02 mL. The manufacturer instructed us to inform the patient that this could potentially lead to side effects that could be local or systemic. The patient did not report any adverse reactions.
Dose from vial that was opened on 18June2021 was administered on 21June2021; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose from vial that was opened on 18June2021 was administered on 21June2021) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose from vial that was opened on 18June2021 was administered on 21June2021). On 21-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Dose from vial that was opened on 18June2021 was administered on 21June2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 18June2021 a vial of Moderna vaccine was opened and didn't label with time or date and didn't discard. It was left refrigerated over the weekend. Concomitant product information was not provided Treatment information was not provided Action taken with mRNA-1273 in response to the events is not applicable
Parsonage-Turner syndrome; This is a serious spontaneous case reported by other health care professional (nurse) to Regulatory Authority (reference number: SEQ19-06209) and initially received on 05-Nov-2019, concerning a 55-year-old, male patient.  The patient's medical history was not provided. The patient did not take any concomitant medications.  On 30-Sep-2019, the patient was administered Flucelvax QIV [Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 261211 and expiration date: Jun-2020] for prevention of seasonal influenza.  On an unspecified date in Oct-2019, about week and a half after vaccination, the patient experienced pain in back by left should blade. The patient stated that his left hand went numb and he had no strength. The patient also reported pain and loss of motor skills in his left arm. It was stated that doctors were calling this Parsonage-Turner syndrome. The patient consulted with Sports Medicine Doctor as the pain in his left arm was preventing him from sleeping.  At the time of initial reporting, event outcome was considered not recovered/not resolved since it was reported that the syndrome would be resolved within 3 years, according to patient's physician.  The reporter assessed the case as serious and did not provide causality assessment to Flucelvax QIV.  Company comment: The patient experienced neuralgic amyotrophy week and a half after vaccination with the suspect product Flucelvax QIV. Chronology is plausible. No medical history and diagnostic findings were provided. Reportedly, the patient did not take any concomitant medications. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced neuralgic amyotrophy week and a half after vaccination with the suspect product Flucelvax QIV. Chronology is plausible. No medical history and diagnostic findings were provided. Reportedly, the patient did not take any concomitant medications. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
PT appear to have a Focal Seizure and syncope ensue. PT hit his head but no abrasion. Pt awake and alert. Reported feeling tightness in chest and anxious before passing out. Rescue Team contacted ; PT refuse transfer. Vitals in all normal range; BP:120/70 HR:98 Spo2: 97-98. Pt monitor longer in oberservation by Nurse and Rescue Team REFUSE Transport vitals taken before leaving site. Vitals before leaving site: BP:122/77 HR:90 Spo2 97-99.Pt was able to be ambulatory and leave site
Severe itching, redness, swelling. Swelling went away. Itching has been continuous even on today.
Flu like symptoms including HA, muscle aches, diarrhea, loss of appetite starting suddenly 2-3 hrs after vaccine, continuing x 2 days then resolved. Also describes violent muscle "shaking" and rust colored urine during this same period.
Case number PHEH2013US002510 is an initial spontaneous report received from a pharmacist on 24 Jan 2013. This report refers to multiple patients whose identifiers were not reported. These patients were vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on unknown dates. On unknown date, these patients experienced hard under the skin. The outcome of the event was not reported. No further information was provided.
After initial shot.. has right arm pain...  approx 2 weeks later began getting hives/rashes over my back and arms.  Each day it continues to get worse showing up more all over my body. HELP!  its terribly painful and itchy
experienced the vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "experienced the vertigo".  Additional Information: Reporter stated that dads wife being a nurse and even she said her co-workers who are nurses as well said they experienced the vertigo. I guess the vertigo is common.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.