chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient received expired vaccine, no AE; Initial information received on 18-Aug-2020 regarding an unsolicited valid non-serious case from other healthcare professional .  This case involves a four-month-old female patient who was administered an expired HIB (PRP/T) VACCINE [ACT-HIB] (lot number not reported, expiry date 12-Aug-2020) (expired product administered) via an unknown route in an unknown administration site on an unknown date for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.  It was an actual medication error case due to expired vaccine used.  At the time of reporting, no adverse event was reported.  Lab data, corrective treatment and outcome: not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out . 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.  There will be no information on the batch number for this case.
fever; really tired; He has slept through the day/sleeping constantly; his whole body is sore; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 29-year-old male patient received bnt162b2 (BNT162B2, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 11:00 (Batch/Lot Number: ER8734; Expiration Date: 31Jul2021) as DOSE 2, SINGLE for COVID-19 immunisation (at the age of 29-year-old). No additional vaccines administered on same date. The patient did not have any medical history. The patient had not received any other vaccine within 4 weeks. Family Medical History Relevant to AE was None. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (dose number 1, lot number; EP7534, Expiry date: 31Jul2021 on 16Mar2021 at 10.00) for Covid 19 Immunization. The subject did not receive other product. The patient was fine after his first dose of the COVID vaccine. The patient had a fever, took a Motrin at 1:02PM, because he needed to bring his fever down. Since taking the Motrin, his fever has improved. He was really tired: He had slept through the day. Last night he had dinner and drank coffee. He could feel his body come to a fever. Since then he had maybe been awake for two hours. He had been sleeping constantly. He felt like he got hit by a truck: Clarifies that his whole body was sore. He attributed to feeling like that to his fever. He felt better after taking Motrin. He did not have chills with his fever. He was not in too much pain. The patient underwent lab tests and procedures which included body temperature: 102 on 06Apr2021. The patient did not visit emergency room or physician Office. Therapeutic measures were taken as a result of fever and is whole body is sore. The outcome of events fever and his whole body is sore was recovering and for other events it was unknown.  No follow-up attempts are needed. No further information is expected.
Patient seen to receive the Pfizer BioNTech booster vaccine. Patient denied complications with the first and second dose of Pfizer vaccine. Denied allergic reactions to vaccines in the past. Patient received vaccine around 1425. At approximately 1435 patient reported a tightness in throat and stated, "her tongue felt too wide for her mouth". Patient said she took 25 mg of benadryl that she brought from home right after receiving vaccine. Vitals were stable with a blood pressure of 123/76, pulse 69 and pulse oximeter read 98%. Reported no shortness of breath or difficulty breathing. Denied itching and injection site did not appear swollen or red. Patient did not appear stressed or anxious. Writer examined tongue and mouth and it did not appear swollen. Vitals remained stable. At 2:45 patient's tongue and throat were reassessed. Patient's tongue appeared more swollen, speech was slightly impaired and voice more hoarse sounding. A rapid response was called. Epinephrine injection of 0.15 mg was administered. Epi pen expiration date was 06/2022. At 1447, blood pressure was 141/85, pulse 70 and pulse oximeter 97%. A clinic doctor arrived at the scene to assess patient and 911 was called. MD assessed patient's lungs, examined throat and tongue. EMS arrived at 1505. Upon EMS arrival patient's tongue had slightly improved but still appeared swollen. Patient also reported some numbness and tingling in her cheeks. Triage RN called patient's husband as requested by patient. Report given to EMS. EMS transported patient to hospital per protocol.
Checked blood pressure has always been about 130/60 but has been at  85 and 90 systematic since; vertigo and extreme dizziness; vertigo and extreme dizziness; This is a spontaneous report from contactable consumer (patient). A 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Ew0179), via an unspecified route of administration in right arm on 18May2021 at 13:00 (at the age of 42-year-old) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21May2021 at 12:00, a few days after shot experienced vertigo and extreme dizziness lasting about a week. Checked blood pressure has always been about 130/60 but has been at 85 and 90 systematic since. It was unknown whether treatment was received for events. The patient underwent lab tests and procedures which included blood pressure: 130/60 mmhg on an unknown date (Checked blood pressure has always been about 130/60 but has been at 85 and 90 systematic since), blood pressure: 85 and 90 mmhg on an unknown date in May2021. The outcome of vertigo and extreme dizziness was reported as resolved on 28May2021, hypotension was unknown.  Follow-up attempts are completed. No further information is expected.
Moderna 1st dose received 9/14/21. Moderna Second dose received 10/12/21. I conceived on or around 9/26/21 and had a positive pregnancy test one day before 2nd dose. I miscarried the pregnancy on 10/14/21, two days after 2nd dose.
This spontaneous report as received from a consumer refers to an unknown number of patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. The consumer reported about another parent's children who on an unknown date were vaccinated with a doses of GARDASIL (strength, dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown dates, the patients experienced health problems (unspecified). The outcome of adverse event was unknown. The relatedness between vaccination with GARDASIL and the event was not reported. This is one of 3 reports from the same reporter. Additional information is not expected.
Fever, chills, fatigue began about 7 hours after injection, continued on and off for almost 3 days
Approximately one hour post injection the patient started felling ill and had headache and muscle aches. The patient also had a sore throat.
Mom states that on 7/28/05 around 9:30 AM child awoke with 102.4 fever. Given Motrin. Approximately 10:45 AM, temp at 103.6. Child also appeared lethargic. Phoned physician. Taken to ER, while at ER, child threw up. Was admitted and testing was done. A trace amount of blood was found in the urine. Physician informed mom that thought possibly beginning of UTI. Child received 1.5 bags of IV fluids. Continued to run 101 temp throughout the night. Returned home around 1 PM on 7/29/05. Ran 99.0 temp throughout night. On Saturday, began on Septra as preventative measure for UTI. Complete recovery at this time.
Rash on side of body shingles like; Rash on side of body shingles like; This is a spontaneous report received from a non-contactable consumer. A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 06Apr2021 14:00 as single dose for covid-19 immunization in pharmacy or drug store. The patient medical history and concomitant medications were not reported. No Pregnancy.Prior to vaccination,  the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included Covid-19 vaccine, dose 1 for covid-19 immunisation. The patient experienced rash on side of body shingles like on 10Apr2021 with outcome of not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained
Mom states pt developed small, red bumps on torso and chin with mild itching. No fever was present. Mom took child to the doctor and was dx'd as a vaccine reaction. On 9/11/01, rash is fading.
12 hours after dose: fever, lethargy, headache, swollen lymph node (clavicle), and severely elevated blood glucose. Lasted 48 hours.   Moderate elevations in blood glucose and mild lymph node swelling lasted 14 days after dose.
I got my second shingles vaccine yesterday. Today i have chills; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th February 2021, the patient received the 2nd dose of Shingrix. On 9th February 2021, 1 days after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was unknown.   It was unknown if the reporter considered the chills to be related to Shingrix.  Additional details was reported as follows: The age at vaccination was not reported Age group was not reported but captured adult as per vaccine indication. The day before reporting date, the patient received Shingrix and on the day of reporting, experienced chills. No other information was available
not receive her second dose of Shingrix due to fear of being exposed to COVID; shingles; post herpetic neuralgia (PHN); This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 94-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, unknown arm). On 06-JUL-2023, the patient received the 2nd dose of Shingrix. In JAN-2023, 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: shingles) and post herpetic neuralgia (Verbatim: post herpetic neuralgia (PHN)). On an unknown date, the patient experienced social problem (Verbatim: not receive her second dose of Shingrix due to fear of being exposed to COVID). The outcome of the shingles and post herpetic neuralgia were not resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the shingles and post herpetic neuralgia to be related to Shingrix.     It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingrix.   Additional Information: GSK receipt date: 07-JUL-2023 The reporter was the patient.  She received her first Shingrix dose in early 2020, about one month before the COVID pandemic started.  She did not receive her second dose of Shingrix within the recommended 2 to 6 months due to fear of being exposed to COVID in the pharmacy or physician's office. About 2 years after her first Shingrix dose, in January 2023, she developed shingles with post herpetic neuralgia. The PHN continued.  One day before reporting, patient received her second Shingrix dose.  Nothing else was reported. The reporter did not consent to follow-up.
reaction post giving blood platelets that thinks could be related to vaccine; This is a spontaneous report from a contactable consumer(Patient).A adult male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported EL9263), via an unspecified route of administration, via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. on an unspecified date, The patient medical history and concomitant medications was not reported. The patient experienced reaction post giving blood platelets that thinks could be related to vaccine. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
On 1/1/97, the pt developed angioedema. Later he experienced hives. It was noted that his symptoms have persisted and recently had worsened. The pt indicated that he was discharged from the Navy because of this.
Visual distortion in both eyes. Kaleidoscopic effect. Distortion stayed in one spot on eye. If eye moved, distortion would follow movement of eye(s)
Administered some vaccine that were expired a week ago. It was kept in the fridge.; Patients were administered an "expired" vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered an "expired" vaccine) and PRODUCT STORAGE ERROR (Administered some vaccine that were expired a week ago. It was kept in the fridge.) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered an "expired" vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered some vaccine that were expired a week ago. It was kept in the fridge.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered an "expired" vaccine) and PRODUCT STORAGE ERROR (Administered some vaccine that were expired a week ago. It was kept in the fridge.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported.  The vaccines expired a week before administering it. The vial did not undergo any temperature excursions. The vials were stored in the refrigerator on 28-Feb-2022. The was administered with second booster dose.  No treatment were reported.
This case was reported by a healthcare professional via a sales representative and described the occurrence of swelling of upper arm in a child subject of unspecified gender who was vaccinated with KINRIX. In February 2009 the subject received 1st dose of KINRIX in an unknown arm. At an unspecified time after vaccination with KINRIX, the subject experienced swelling of upper arm (the arm where the KINRIX was given). At the time of reporting the outcome of the event was unspecified. Th healthcare professional considered the event was probably related to vaccination with KINRIX. It was reported that 5 subjects in the age of 4 to 6 years received KINRIX within the last week and developed swelling in the arm where the KINRIX was given. No specific details were known at the time of reporting. Linked cases include A0770472A, A0770473A, A0770475A and A0770476A.
At 4pm, patient noted raised spot on arm at injection site. At 6pm, site was itchy and reddened, approximately the size of a quarter. Patient took Benadryl. At 2am, patient experienced an ache down arm and in fingers, with swelling under arm. Saw doctor at 9:30am on 5/23/12- diag. local reaction to vaccine, cellulitis. Prescribed Keflex 500 QID.
Client had an episode of dizziness , presyncope immediately after receiving his vaccine. Denied shortness of breath or chest pain . He reported tingling in his hands. He had not had breakfast prior to arrival  . He was offered water . His symptoms resolved within 15 minutes and he was able to leave after his symptoms were resolved.
Administer expired vaccine to patient, after the manufacture date of expiration/Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration/Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 78-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration/Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration/Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator was reported as unknown. Vaccine was expired on 07-Apr-2022.No  temperature excursions for the vials was reported. Total of 173 doses were reported with the lot number 070H21A.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up document was received and contains non significant information.
FLUZONE/PREVNAR given. After vaccine (R) leg red splotchy hive like rash. Ice applied observed x30 min clear Dr aware.
This case was reported by a physician via a sales representative and described the occurrence of abdominal pain in a 2-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). The subject concurrently received unspecified vaccines on the same date of receiving ROTARIX. On an unspecified date the subject received 1st dose of ROTARIX at 1.0 ml. Within 12 to 24 hours following ROTARIX administration, the subject developed severe abdominal pain and vomiting. The subject was hospitalised and the physician considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were improved, but the subject was still not feeling well and was on a proton pump inhibitor due to continued stomach pain. The physician considered the events were possibly related to vaccination with ROTARIX.
Reported joint pain & stiffness throughout entire body within 48 hours of receiving vaccine. Also reported nausea & vomiting without fever 6 days after receiving Tdap vaccine.
Patient with significant painful lymphadenopathy 2 days after first Covid vaccine, 18 days after second Covid vaccine
Extreme fatigue (sleeping continually), poor appetite, high fever (up to 103.7), extreme shaking, headache, symptoms lasting 5+ days, sore throat, red rash on face, night sweats. Treated with rest, liquids, and TYLENOL.
About 24 hours after injection, cellulitis about 2 inches in diameter noted 3 inches inferior of injection site. Notable swelling, warmth, redness and stiffness at the site.
I just noticed when I took a step it hurt and the more I walked the more it hurt. The pain is in the back of the thigh/backside. I am unable to walk on it, but it hurts.
p/immun mom states irritable & crying, one small red blotch on rt knee noticed, father noticed blotchy rash on stomach & back;Ate only one bottle milk also had a papaya salad made w/crab meat paste&fish sauce pt which had never eaten before
Information and follow up has been received from a health professional concerning a 68 year old patient with an allergy to tape and OMICEF, hypertension, hyperlipidemia, major depression and low back pain who on 16-OCT-2003 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot# not provided). Concomitant therapy included the flu vaccine (lot# not reported). On 16-OCT-2003, the patient experienced severe injection site reaction including redness, pain and swelling at the injection site. Subsequently, the patient recovered on 20-OCT-2003 from severe injection site reaction including redness, pain and swelling at the injection site. The patient also received pneumococcal 23v polysaccharide vaccine 5 years prior to this. Additional information has been requested.
Patient presented to the ED on 5/8/2021 and was subsequently hospitalized for Closed comminuted fracture of right patella. Patient presented to the ED on 5/28/2021 for chronic heart failure. These visits are within 6 weeks of receiving COVID vaccination.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: left hand tingling-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: left hand tingling
Patient was taken to hospital to receive medication for cough and congestion problems. While at the hospital, patient was given Pneumonia vaccine and complications started thus having to stay for observation and still at hospital. Patient experienced problems breathing and had to be intubated. Son states that he did not give permission for vaccine.
General post vaccine arm soreness to start  than Increasing redness. Warmth heat chills  , Dx  by ER  was cellulitis at injection site.  Before bed temp had gone up to 100.6
First shot gave me the covid 19 experience covid 19 experience; covid 19 experience; This is a spontaneous report received from a contactable consumer (Patient). A 44-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 04May2021 13:30 (Batch/Lot Number: EW0169) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications.  he patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. On an unspecified date in May2021, first shot gave her the covid 19 experience and drug was ineffective. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
very sore in their arm; felt off; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 3 patients. This is second of three reports. This consumer reported for sister of her boyfriend. A 68 (units unknown) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on 18Jan2021 as a single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient was very sore in their arm and felt off; in Jan2021. The events were reported as non-serious. The clinical outcome of very sore in their arm and everyone felt off was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021069652 Same reporter/products/events, different patients;US-PFIZER INC-2021069654 Same reporter/products/events, different patients