chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from non-healthcare professional on 3 November 2014. A 54-year-old female patient, who has no relevant medical history and concomitant medications were not reported, had received a dose of FLUZONE (batch number was not reported, intramuscular in left arm) on 14 October 2014. It was reported that, the patient received Flu shots previously for many years but no adverse events were reported. It was reported that on 14 October 2014, few hours after receiving FLUZONE vaccine, the patient experienced pain in arm which was subsided after 24 hours but after that pain in the left upper arm was continued to increase again. The patient's pain was affecting her ability to lift arm as well as ability to sleep as she was not able to found any comfortable position. The corrective treatment was not reported and has no laboratory investigations. At the time of this report, the outcome was not recovered. Relationship "yes" as per reporter. Documents held by sender: none. Follow-up information received from a non-healthcare professional on 18 February 2015. The patient had fully recovered from all the events. It was reported that the pain had slowly subsided within one month. Follow up information received from a non-healthcare professional on 10 April 2015. It was reported that patient had no medical records and she is fine. List of Documents held by sender: None.
He received his 2nd dose of COVID vaccine (Pfizer) on 6/19. He developed a fever on 6/20 which lasted for a day. He then felt better on 6/21.  Then, on 6/22 at 1am, he woke from sleep due to chest pain. It was sharp and did not radiate anywhere, and not reproducible. He took 400 mg ibuprofen which improved his pain somewhat.  Denies any other fever, rhinorrhea, cough, SOB, difficulty breathing, n/v/d, dysuria or difficulty with urination.    Admitted 6/22 due to elevated troponin and abnormal EKG.  Troponin leak and MRI with findings consistent with myocarditis.  Had NSVT x 4 beats on 6/22.  He was treated with 5 days of Motrin 600 mg ATC.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 15-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454, expiry date 06-JAN-2017 (route and dose were not provided).  No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
My sons entire top potion of his leg, from directly beneath the knee up to the hip area swoll to more than two times its size.  The leg is very feverish and has red blotches throughout.  The doctor has called him in an antibiotic and we have to followup in 48 hours.
Patient experienced a tingling sensation in the pinky and ring finger of her left arm that gradually increased to a burning sensation that alternated with a cold sensation in the fingers.
Bleeding left arm; Scabs left arm; Itching left arm; A spontaneous report was received from a consumer concerning an 81-year-old, male patient who developed blooding arm and scabs/haemorrhage, itching/pruritus, and a scab..   The patient's medical history included heart disease, COPD and diabetes. Products known to have been used by the patient, within two weeks prior to the event, included hydrocortisone stick.   The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on 2 Jan 2021 intramuscularly for prophylaxis of COVID-19 infection. The patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) on 19 Feb 2021 intramuscularly for prophylaxis of COVID-19 infection.   The patient symptoms included itching (left arm), bleeding arm, and scabs.   Treatment information was not provided/unknown.   Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the events, hemorrhage, pruritus and scab were 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 event a causal relationship cannot be excluded. Further information has been requested.
This is a spontaneous report from a Pfizer-sponsored program from a contactable pharmacist.  A 72-year-old female patient of an unspecified ethnicity received PREVNAR 13 lot S35324 Expiry date: 01Aug2018, intramuscular on 19Oct2017 12:35 at 0.5ml intramuscular into left arm for immunisation. Medical history included cardiac disorder from an unknown date and unknown if ongoing. Concomitant medication included FLUZONE HD, Lot number: UI840AC Intramuscular in left arm on 14Sep2017. The anatomical Location of Administration of Pfizer vaccine considered as suspect: Left arm. Patient had injection on 19Oct2017 and is still having soreness and cannot lift arm above shoulder from Oct2017. The outcome of the events was not recovered. Also the patient stated that has had PREVNAR 13 before, resulting in inappropriate vaccine dose administered (outcome was unknown). The reporter assessed the events soreness and cannot lift arm above shoulder medically significant and related to PREVNAR 13. The pharmacist wanted to know if it is normal to experience pain this long after injection. Sender's Comments: A causal association between administration of PREVNAR 13 and the onset of events of "soreness and cannot lift arm above shoulder " cannot be excluded, considering the temporal association. 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.
leg pain, particularly in left leg; warmth in leg; tingling in leg; headache; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0165) via an unspecified route of administration in the left arm on 26Apr2021 at 08:15 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and sumatriptan (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0151) via an unspecified route of administration in the left arm on 05Apr2021 at 08:15 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. On 27Apr2021 the patient experienced leg pain, particularly in left leg, warmth, tingling in leg and headache. No Therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events leg pain, warmth and tingling in leg and headache were recovered with sequelae on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Before she left my office right after vaccine administration she noticed "numbness" of her "butt". Later that same evening she noticed numbness of the bottoms of her feet.
I was observed for15 minutes and I went home and around 05:30-6:00 pm, my body started to ache. I started having 102.8 - 103 fever. I was having severe chills - never experienced these kinds of chills before. I took Tylenol. I tried to still go to work but I by was having difficulty breathing and on January 11, I called my primary care Dr. and waited for appt but on January 13, there was no appt available and she told me to go ER. ER  part of medical group/hospital. They told me I might have COVID.  Dr said severe reaction to vaccine. I was still having trouble breathing. I have albuterol inhaler that I use as needed. I had it in my bag and I used that (and I had been using it when I was having trouble breathing but it wasn't helping like it could have ). They sent me home but I was still having trouble breathing. I had difficulty breathing for about about three days and then it resolved. I followed up with my PCP - video visit after two days after ER and then I had an office visit with her. After two weeks, I felt recovered. Although my right arm still have pain - pinching sharp pain in my arm that comes.
Case number HEH2014US017899 is an initial spontaneous report received from the pharmacist on 04 SEP 2014. This report refers to a 59 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145221) subcutaneously at a dose of 0.5 ml on 03 SEP 2014. It was reported that on the same day after vaccination, she experienced swelling under arm. The event outcome was unknown. The seriousness and causality were not reported.
MIGRAINE; CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced migraine, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and migraine was not reported. This report was non-serious.
This spontaneous report as received from a consumer refers to her son of unknown age. The patient was vaccinated with the first dose and the second dose of GARDASIL (lot #, route and dose were unknown) on an unknown date. It was now 2 months beyond the six months between the second and third dose. The reporter did not want to provide any demographics since there were no adverse events other than the missed dose. Additional information is not expected.
patient reports the stiffness has gotten worse, she doesn't think it could get any worse.; received her second dose yesterday 14Sep2021 and now her whole body is stiff.; This is a spontaneous report from a contactable consumer (patients fiance). A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FF2588, Expiration date: 14Sep2021), dose 2 via an unspecified route of administration, administered in Arm Left on 14Sep2021 13:10 (age at vaccination 44 years) as dose 2, single for covid-19 immunisation. Medical history included ongoing asthma. The patient's concomitant medications were not reported. Patient received historical vaccine Flu shot 2017 Flu Shot, ended up in the hospital because she got both strains of the flu. NDC, Lot, Expiration: Unknown Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: FA7485) via an unspecified route of administration on 24Aug2021 as single dose for COVID-19 immunization and experienced headache. The patient experienced received her second dose yesterday 14sep2021 and stiffness now her whole body is stiff on 15Sep2021, the stiffness has gotten worse, she doesn't think it could get any worse on an unspecified date. Reporter stated caller is calling on behalf of her fiance. Her fiance received the first dose on 24Aug2021 and had a headache after this that she still has from the first dose and received her second dose yesterday 14Sep2021 and now her whole body is stiff. And asking if this is a side effect. Patient not visited physician office or emergency room. The patient did not receive any treatment for reported events. The outcome of event was not recovered.  No follow up attempts are needed, No further information expected.
Pt recvd vax 24APR92 & w/in 1 hr exp diarrhea & flushing sensation; w/in 24 hrs exp dizziness & lightheadedness; nausea; visual acuity problems; general malaise; muscle aches; neck, back & shoulder stiffness; arthralgias; chest discomfort
Patient presented with hemoptysis and PE with symptoms starting 2-3 days after vaccination per son. Vaccinated on Monday, had left back pain Wed and hemoptysis Thurs that continued to admission on Saturday. Diagnosed with left lower lob PE. 1 day after the vaccine she had the usual flulike symptoms: joint pain, fevers. (Also, 1 month ago traveled here from Ethiopia on 15 hour flight)
Mild local reaction, brightly erythematous, swollen right upper arm with little tenderness.
Arm hurts; Little bit of itching under the injection site; Arm red where she got the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts), VACCINATION SITE PRURITUS (Little bit of itching under the injection site) and VACCINATION SITE ERYTHEMA (Arm red where she got the injection) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts), VACCINATION SITE PRURITUS (Little bit of itching under the injection site) and VACCINATION SITE ERYTHEMA (Arm red where she got the injection). At the time of the report, PAIN IN EXTREMITY (Arm hurts), VACCINATION SITE PRURITUS (Little bit of itching under the injection site) and VACCINATION SITE ERYTHEMA (Arm red where she got the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Claimant alleges he was given a Johnson & Johnson vaccine after already receiving both Moderna vaccines. Claimant stated he was feeling ill and became unresponsive. He fainted and was transported to hospital.
Unbearable stomach pain Uncontrollable sweating Throwing up  Went to ER two days in a row, continued to get worse, was admitted for a week.
He had an impressive head to toe maculopapular eruption involving much of his body as well as the palms and soles.  It involved his face, eyes, mouth, tongue.  We have photos.
Needle /syringe was faulty and injection came out of back of needle; pt did not receive dose; Prepared another dose and successfully gave immunization to pt because he did not receive faulty dose
Pt was to receive Hep B #3, and PPD. Vaccines to be given written correctly on record. I accidentally wrote Hep B #3 and IPV. Corpsman forgot to verify vaccines and gave pt IPV. Pt is not adversely affected by this event. Accidental oversight and entry.
PAINFUL ARM; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced painful arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful arm. This report was non-serious.
adverse effect heart palpitations, chills, shaking, talking out of head on Sunday, continuous coughing, couldn't stand, no fever or runny nose, severe migraine, no appetite
Left arm sore, stiff, and tired it led me to believe I was having a heart attack and had to go the ER the doctor at the time stated I didn't have a heart attack nor had any visible signs of heart damage
received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201274:Same reporter
Currently limited to local reaction: induration oval-70mm x 50mm-firm, hot, raised 1-2mm with central firm nodular 15 x 15 mm area-firm-not fluctuant-systemic exam otherwise negative no systemic sx.
Onset left arm swelling/ Erythema 1 day after vaccine administration - improved 1 day later.
Pt recv vax on 11/13/98; on 11/14/98 pt exp fever (101-103), warm/ red/ tender/ sore/ swollen vax site-LA, not eating; tx=Tylenol/ Motrin, antibiotics
the shingle shot caused me to get them/suspected vaccination failure; the shingle shot caused me to get them; nerve ending that are weak; This serious 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: the shingle shot caused me to get them/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: the shingle shot caused me to get them) and nervous system disorder (Verbatim: nerve ending that are weak). The outcome of the vaccination failure was unknown and the outcome of the shingles and nervous system disorder were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and nervous system disorder to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and nervous system disorder to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by patient via interactive digital media. The reporter stated that shingles shot caused him/her to get shingles.  The patient mentioned that if you had nerve ending that were weak that would happen, but they would not tell you that.  This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow up was not possible as no contact details were available.
I tested positive for COVID. Scratchy throat, heaviness in my upper chest, cough, low grade fever, running nose and fatigue. My symptoms are moderate.
patient states that she received her 1st covid vaccine on Wednesday, September 29th and felt fine until Friday, October 1st when she began to have flu like symptoms. Symptoms include chills, night sweats diarrhea and general malaise. She no longer has diarrhea. She states that today is the first day she is starting to feel better, one week post vaccination.
This case was reported by a nurse and described the occurrence of nonspecific reaction in a child patient who received KINRIX (batch number KB75Z, expiry date 20th March 2017). On an unknown, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced nonspecific reaction. On an unknown date, the outcome of the nonspecific reaction was unknown. It was unknown if the reporter considered the nonspecific reaction to be related to KINRIX. Additional informations received: No further information was reported regarding the event. 3 pediatric patients returned with moderate reactions to KINRIX. Nurse was not sure if it is a coincidence or a bad batch.
Cellulitis from injection of pneumovax 23 Treated with antibiotics (keflex x10 days)
Pain, redness, swelling over left deltoid. Fever, chills, and tachycardia.
pt recvd vax;started itching at waistline & cleavage;noticed hives;dph given for rash;took shower & rash spread;to MD;he stated hives were due to inject & not med;MD stopped amoxicillin & started "methylphendisolene";put calamine lotion;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Batch/Lot number: unknown), on 19Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 30Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "sleep apnea" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing). Concomitant medication(s) included: FEXOFENADINE; FLUTICASONE; FISH OIL; TURMERIC [CURCUMA LONGA ROOT]; CHOLECALCIFEROL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Product: COVID 19 Treatment; (Aug2022) Positive, notes: Rebound symptoms of COVID which occurred 3-4 days after finishing paxlovid; (Aug2022) Negative, notes: Tested positive again after having tested negative; (Aug2022) Positive, notes: Tested positive again after having tested negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: COVID 19 treatment start date was 08Aug2022 and stop on 12Aug2022. Rebound symptoms of COVID which occurred 3-4 days after finishing paxlovid, including cough, sore throat, congestion, fatigue. Tested positive again after having tested negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events VACCINATION FAILURE & COVID-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.