chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I felt lightheaded and my arm was immediately very sore. I stayed on site for 1/2 an hour and then drove home. While driving, I had a very strong sensation of intense heat internally, mostly in my chest area and a tingling sensation down my left arm. I flagged down a driver who called an ambulance to my location. I stayed in the ambulance about 20 minutes till my family came. During that time, I felt slightly nauseous but the sensation of internal heat ceased. I had no further discomfort.
My throat was sore for two days, I had a lot of postnasal drip. I saw the doctor she thought I had a sinus infection and put me Augmentin to try and help get rid of the infection. I do have a bit of postnasal drip, but I am feeling better an occasional cough here and there. I expect a full recovery by the end of the month.
had covid in Feb; had covid in Feb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2022, outcome "unknown" and all described as "had covid in Feb". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2022) Positive, notes: Also had Covid in Feb.  Clinical course: Patient had Covid in Feb and would never get another shot on tell anyone else to get it. Patient gave up a lot and almost my life getting your shot.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Two hours after vaccine, patient was at home. He felt dizzy and nauseated. He passed out, woke up 2 hours later and stated he was unable to walk. After a short time, he went to bed for 2 or 3 hours. All symptoms resolved except for decreased appetite.
circulatory collapse;anaphylaxis;lethargy, tachycardia, P 120, red rash on lower extremities;
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 55 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (codeine and sulfa). The patient previously received of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin and batch number not reported, expiry: unknown) dose and start date of therapy not reported, 1 total, administered for prophylactic vaccination.  It was unknown if the patient experienced any adverse reactions following the administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received dose number 2 of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on 18-APR-2022 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 55 years old. No concomitant medications were reported. The patient was not taking any medication within 2 weeks of starting Covid-19 treatment. On an unspecified date in 2022, the patient had suspected covid-19 infection with symptoms of very bad after taste and suspected clinical vaccination failure (dose number in series 2). The patient was treated with Paxlovid (nirmatrelvir/ritonavir) (form of admin and route of admin were not reported, batch number NDC00069108530, expiry: unknown) dose not reported, administered 01-JUN-2022 till 05-JUN-2022 for Covid-19 treatment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint.; Sender's Comments: 20220644891-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Pain in the arm; Can not lift up the arm; feels like having covid-19 desease; Also feels nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), HYPOKINESIA (Can not lift up the arm), SUSPECTED COVID-19 (feels like having covid-19 desease) and NAUSEA (Also feels nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the arm), HYPOKINESIA (Can not lift up the arm), SUSPECTED COVID-19 (feels like having covid-19 desease) and NAUSEA (Also feels nausea). At the time of the report, PAIN IN EXTREMITY (Pain in the arm), HYPOKINESIA (Can not lift up the arm), SUSPECTED COVID-19 (feels like having covid-19 desease) and NAUSEA (Also feels nausea) outcome was unknown.            No concomitant medication was provided  No treatment medication was provided This is a Spontaneous case concerns of female patient of unknown age   with no medical history, who experienced the unexpected Nonserious event of   Pain in extremity and Hypokinesia, unexpected   AESI of   Suspected   COVID-19 without laboratory confirmation and expected nonserious event of   Nausea from unknown date after   third dose of vaccination with mRNA-1273. No additional information is available at the time of this report. The rechallenge not applicable as the events occurred after the third dose and no other dose is expected at this moment. The benefit-risk relationship of mRNA-1273 in not affected by this report.   This case was linked to MOD-2021-403865 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Dec-2021: follow up received contains non significant information: Email added; Sender's Comments: This is a Spontaneous case concerns of female patient of unknown age   with no medical history, who experienced the unexpected Nonserious event of   Pain in extremity and Hypokinesia, unexpected   AESI of   Suspected   COVID-19 without laboratory confirmation and expected nonserious event of   Nausea from unknown date after   third dose of vaccination with mRNA-1273. No additional information is available at the time of this report. The rechallenge not applicable as the events occurred after the third dose and no other dose is expected at this moment. The benefit-risk relationship of mRNA-1273 in not affected by this report.
Mild headache; Mild fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Mild headache), FATIGUE (Mild fatigue) and PYREXIA (fever) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 002A21A) for COVID-19 vaccination.     The patient's past medical history included Sinusitis since 01-Jan-2013. Concurrent medical conditions included Drug allergy (Amoxicillin), Anxiety, High cholesterol, Nausea, GERD, Depression (mild) and Drug allergy. Concomitant products included ALPRAZOLAM (XANAX) from 01-Jan-2001 to an unknown date for Anxiety, ESCITALOPRAM OXALATE (LEXAPRO) from 01-Jan-2017 to an unknown date for Depression, OMEPRAZOLE from 01-Jan-2001 to an unknown date for GERD, SIMVASTATIN from 01-Jan-2010 to an unknown date for High cholesterol, PROMETHAZINE (PHENERGAN [PROMETHAZINE]) from 01-Jan-2010 to an unknown date for Nausea.   On 08-Mar-2021 at 12:05 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021 at 2:05 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced HEADACHE (Mild headache) and FATIGUE (Mild fatigue). At the time of the report, HEADACHE (Mild headache), FATIGUE (Mild fatigue) and PYREXIA (fever) had resolved.            Patient managed symptoms with Motrin/Tylenol not specified).  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-052006 (E2B Linked Report). This case was linked to MOD-2021-051162 (Patient Link).; Sender's Comments:  MOD-2021-052006:Same reporter/unknown patients (Invalid case)
She tested positive for COVID-19 on 11/8/22. She was congested, coughing, lethargic, and had loss of appetite. We took her to the ER and they contacted the COVID-19 team and they had us take her back home and wait for the COVID-19 team to call us. They called the next day and scheduled her to come in and start taking remdesivir. She took that for 3 days. No other medications were prescribed. She is feeling much better now. We kept her home from school until 11/21/22.
8/21/2023 - 8/23/2023 (2 days) Date of Admission: 8/21/2023  Discharge Date: 08/23/2023 Discharge Disposition: Home or Self Care  past medical is significant for bladder cancer, BPH, rheumatoid arthritis, cervical spine fracture involving C2-3, coronary artery disease status post stent and  hyperlipidemia presents emergency room complain of abdominal pain associated with nausea and vomiting and chest pain associated some shortness of breath  regarding COVID-19 infection patient requiring no oxygen no medication indicated treated as supportive care only
Patient received M-M-R II Intramuscularly instead of subcutaneosly; No adverse symptoms reported; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) intramuscularly instead of subcutaneously for prophylaxis (strength, dose number, anatomical location, lot number and expiration date were not reported).   There were no adverse symptoms reported.
PT WAS GIVEN MODERNA MONOVALENT 6  MONTHS TO 5 YRS BY MEDICAL ASSISTANT AS A BOOSTER DOSE
4 doses of the Moderna Covid-19 vaccine administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses of the Moderna Covid-19 vaccine administered after 30-day Use By Date) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses of the Moderna Covid-19 vaccine administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 doses of the Moderna Covid-19 vaccine administered after 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter does not had any information about the patient height. Patients had no allergies.  Patients were not taking any concomitant medications.  Moderna Covid-19 booster dose was administered to 4 patients in that deltoid muscle. Patients did not received any other vaccine within 1 month prior to Moderna and at the time of the vaccination and did not had any acute or chronic illnesses. The reporter could not provide any information about the First and the Second dose of the vaccine but they were Moderna. The patients did not received a third dose of the Moderna Covid-19 vaccine and they were not experienced any symptoms yet.  Vial was initially stored in the refrigerator on 18 Jan 2022. Vial did not undergo any temperature excursions.  No treatment medications were provided. Patients did not tested positive for Covid-19.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2022: Reporter details were updated
Noted soreness evening of vaccine. Today area is slightly itchy but not painful. No pain in shoulder joint. No N/V, no other areas of redness or rash, no difficulties breathing. Reports reaction like this in past, but not every year. Presented today for evaluation. Injection site reaction measuring 11cm  x 9.5cm pale pink in color, slightly warmer to touch than surrounding skin, mild swelling noted. No induration. Lt shoulder with full ROM and strength.
Pt received undiluted 0.2mL (15mcg) dose. Monitored for 30 minutes, no adverse reaction witnessed. Counseled by Dr. on side effects. Parent of child verbalized understanding. Will return to clinic in 8 weeks for dose#2.
patient received vaccination around noon and approximately 8-10 hours later developed swollen eyes, lip and tongue numbness, intermittent blurry eyes, nausea.  She has taken Benadryl, Singulair, Zyrtec without relief of symptoms.  No difficulty breathing.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4525305-00 (Agency).  A 49-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jul2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset Jul2022, outcome "recovered" (2022) and all described as "COVID-19". Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event COVID with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Possible.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Healthy 45 year old woman had stroke has no underlying conditions and no one has in family history.  Female is never sick and is very healthy she takes care of her body doesn't smoke and gets plenty of exercise.
Pain started in lower lumbar spine about three hours after vaccination and progressively worsened. About 1:00 AM Friday morning, the pain became excruciating making walking almost impossible. Attempting to walk resulted in the worse pain I have ever experienced and caused me to double over with tears in my eyes. The pain would subside if I just stood still.  It took me nearly five minutes to shuffle to the bathroom. By Friday noon, the pain was slightly less  although still excruciating. It continued to lessen and was tolerable by Saturday morning although bending at the waist still caused very sharp, shooting pains. It was only slightly noticeable on Sunday and continued to improve fir the next few days; however, bending was a priblem for the remainder of the week.
Legs swelled up and turned red. Leg swelling was so bad I couldn?t put my shoes on for one week after the shot and it didn?t return to normal for a few weeks after the shot.  I also had night sweats beginning the night I received the Pfizer shot and they have continued - every night, since that time and currently have them.  I also had moderate to severe pains in my hips, low back and legs more so, but all over my body it was painful in my muscles.  This has not completely gone away.  My strength in my legs and back was also less and created a limitation in my walking- I normally walk 10,000  steps everyday, but have to stop every 3,000 steps and sit down because of the pain and reduced strength in my hip and back.  had headache and mild coughing, but that went away.
This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-MAY-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018) (dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (°F) to 77 degrees Fahrenheit (°F) (60.33 °F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003053: US-009507513-1807USA003054: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Patient called day after vaccine was given (11/11/2017) with a complaint of redness, swelling and heat on and around the whole arm of the injection site.
Severe skin itching and rash on the entire body from neck down to feet. Rashes move from one location to another within a few hours.
Diarrhea - about two hours latter receiving the vaccine  Rash around the neck - about 8 hours after receiving the vaccine
fatigue; Minor Muscle pain (After Second Shot); joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Minor Muscle pain (After Second Shot)), ARTHRALGIA (joint pain) and FATIGUE (fatigue) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced MYALGIA (Minor Muscle pain (After Second Shot)) and ARTHRALGIA (joint pain). On 26-Apr-2021, the patient experienced FATIGUE (fatigue). On 28-Feb-2021, MYALGIA (Minor Muscle pain (After Second Shot)) and ARTHRALGIA (joint pain) had resolved. At the time of the report, FATIGUE (fatigue) had not resolved.         This case was linked to MOD-2021-025176 (Patient Link).
This was the second shot, given  on February 5, 21 days after the first one,.   I was  totally bedridden for several days, getting up only for necessities  I lived on Ibuprofen.  I would get up, take two Ibuprofen, and sit for an hour before I could func.   My arm hurt.  The worst part is that my brain felt as if it were all swelled up, pushing against my skull.   I could not perform  normal tasks  at all ,  until the last couple of days.   I could not think, reason or remember at all until the last 2-3 days,  I had to get substitutes to teach my classes.  I could not write nor communicate  nor pay my bills.  I have a manuscript overdue.  I am now staying at night with friends, for neither they nor I trust me to function normally alone.
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. The Health District, per guidance from the Department of Health (DH), Centers for Disease Control and Preventio (CDC), and Pfizer have determined that the dose of vaccine that you received is valid.
07/30/2021 Shocking pain in arm especially around injection site; 08/01/2021 Cluster bumps on right side of neck; 08/14/2021 to 08/15/2021 Excruciating painful body shake; high body temperature.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022; No adverse event; The patient administered the vaccine after the 30 days by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022).    No concomitant medications was provided by the reporter.  Patient received half dose. The vial had not undergone any temperature excursions. The vial was initially stored in the refrigerator on 04-jun-2022.  No treatment medications was provided by the reporter.
Anxiety, itching in the right arm, odd sensation in the right side of face and neck.
Patient had missed dose.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided were as follows: Age at vaccination was not applicable for this report. The Agent was called to state that previous caller had reported an adverse event. Caller was no longer on the call. Agent stated that patient had missed the dose. The agent did not provide any other information about patient or event.