chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 2JAN98 & 25min p/vax c/o of a tight throat & was sent to ER for observation;pt recovered;
This spontaneous report as received from a nurse (registered nurse) refers to a patient of unknown age. The patient was inadvertently vaccinated with a dose of 2 ml vaccine, live, oral ROTATEQ (lot#669570/1456AA), on 18-JAN-2013 that had expired on 03-OCT-2012. No adverse effects reported. Additional information has been requested.
chills; nausea; This is a spontaneous report from a contactable consumer (patient's son). A female patient of an unspecified age (reported as 62, unknown units) received bnt162b2, lot number and expiration date were unknown, via an unspecified route of administration on 24Dec2020 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter asked if his mom can still go to work if she is feeling all of the symptoms. The reporter was calling on behalf of his mom (who speaks Spanish only) as she received the COVID vaccine on 24Dec2020. The patient started feeling nausea and chills as of 26Dec2020 until present. The reporter would like to know how long do the symptoms usually last. The outcome of the events was not recovered.  Information for Lot/Batch number has been requested.
Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Per immunizer, pt was given vaccination. Immunizer then turned around to give her brother vaccination. When he was turned around, he heard the patient's phone that she was holding dropped and that she had jerked her arm, which caused her phone to drop. When I went to the patient, she was crying and hyperventilating. I told her to put her head down and take deep breaths. I checked on pt in 15 min, was doing better but had burning sensation at injection site. Kept pt at pharmacy for 30 minutes.
21JAN92 sharp abdominal pain which stopped p/pt had bowel movement 1 time; It was a little thin-not watery; no fever, h/a, muscle pain or nausea; sl soreness site of inject duration 24 hrs;
Patient reports an "egg sized" area of redness surrounding injection site that appeared approximately 10 days after her dose. Area is red and itchy.  Also reports generalized itchiness in other areas of body.  Has not treated yet but says symptoms are improving.
Within ten days of getting the second dose of the vaccine in March I had problems with extreme stomach acid. I was having a lot of intestinal gas and pain below my ribs. I was given a prescription for Extra Strength Pepcid which helped the problem but when I stopped taking it for two weeks the gas returned.  I had a reaction to the Pepcid after getting back on it a few times. The fourth time I took it and I woke up in the morning feeling disoriented. Three days later I was also getting chills so I stopped taking. I am no longer able to take the Pepcid . After that I started to have problems with diarrhea which ended up causing me to be hospitalized on 08/20/2021. I had been called by my doctor because my Sodium levels were dangerously low.  I have never had any intestinal problems before. My sodium levels are better now after five months. I still have some gas problems and pain below my ribs. I am careful about my diet and that seems to help.
Pt recvd vax & 2 hrs later devel a fever to 105 & chills; pt became confused & weak & had malaise; seen in ER & was adm to hosp; WBC & all other labs were WNL; next day was afebrile & was discharged from the hosp;
patient felt exhausted; injection site felt like he'd be poked with a hot poker; severe reaction to his covid-19 vaccine; Body ache all over; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe reaction to his covid-19 vaccine), MYALGIA (Body ache all over), FATIGUE (patient felt exhausted) and VACCINATION SITE PAIN (injection site felt like he'd be poked with a hot poker) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D), SIMVASTATIN, DUPILUMAB, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and FEXOFENADINE HYDROCHLORIDE for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced VACCINATION COMPLICATION (severe reaction to his covid-19 vaccine), MYALGIA (Body ache all over) and VACCINATION SITE PAIN (injection site felt like he'd be poked with a hot poker). On an unknown date, the patient experienced FATIGUE (patient felt exhausted). On 06-May-2021, VACCINATION COMPLICATION (severe reaction to his covid-19 vaccine), MYALGIA (Body ache all over) and VACCINATION SITE PAIN (injection site felt like he'd be poked with a hot poker) had resolved. At the time of the report, FATIGUE (patient felt exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter. This case concerns a 68-year-old male with adverse events of Vaccine Adverse Reaction, Myalgia, Fatigue and Vaccination Site Pain with unknown days of Latency after mRNA-1273 vaccination and with co-suspect Dupilumab Subcutaneous injection for unknown indication. There is very limited information available as temporal association cannot be established (missing dates of administration of both Moderna COVID Vaccine and Dupilumab). No further information is expected at this time.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Source Document, Events added; Sender's Comments: This case concerns a 68-year-old male with adverse events of Vaccine Adverse Reaction, Myalgia, Fatigue and Vaccination Site Pain with unknown days of Latency after mRNA-1273 vaccination and with co-suspect Dupilumab Subcutaneous injection for unknown indication. There is very limited information available as temporal association cannot be established (missing dates of administration of both Moderna COVID Vaccine and Dupilumab). No further information is expected at this time.
Throat closing, tachycardia. Later fever 100.7, severe muscle aches, shaking chills, headache. Still muscle spasm and pain 8 days later.
Feverish, chills, hot flashes, muscle aches, joint pain, nausea, headache
Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. On unspecified dates the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L030867, expiration date 09-JUN-2018, dose and route unknown), which were under the temperature of 24 degree Celsius with time frame 838 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
balance was off; Headache; very weak; pretty incoherent; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (balance was off), HEADACHE (Headache), ASTHENIA (very weak) and INCOHERENT (pretty incoherent) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced BALANCE DISORDER (balance was off), HEADACHE (Headache), ASTHENIA (very weak) and INCOHERENT (pretty incoherent). The patient was treated with IBUPROFEN at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. On 02-Mar-2021, BALANCE DISORDER (balance was off) and INCOHERENT (pretty incoherent) outcome was unknown. At the time of the report, HEADACHE (Headache) and ASTHENIA (very weak) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Blood pressure measurement: increased (High) Blood pressure increased. On 02-Mar-2021, Heart rate increased: high (High) Pulse was high. On 02-Mar-2021, Pyrexia: 102 (Inconclusive) Fever 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications are not reported.
25-year-old female presents to the emergency room for evaluation.  Patient reports that this morning she was taking a warm shower.  She started having very fast palpitations and felt short of breath with associated lightheadedness.  This was very severe for approximately 2 minutes.  States she got out of the shower and had to sit down.  She put on her smart watch and states her heart rate was greater than 200 at that time.  After approximately 2 minutes her heart rate decreased in the 130-150 range and she had mild symptoms for approximately 30 minutes.  Her symptoms have subsequently resolved.
Patient felt anxious/nervous; jittery; occurred about 5 minutes after receiving vaccine; patient observed and given water; symptoms completely resolved over 10-15 minutes
Left deltoid redness, pain, tenderness, fever began about 5 hours post injection. Fever up to 103.  Admitted to hospital 2 days later with cellulitis, myositis, WBC 19,000. Treated with IV antibiotics, managed by ID consult.
SHORTNESS OF BREATH HOARSENESS WHEEZING PALENESS CHILLS  FEVER NAUSEA 12/8/2009 ED records for 11/2/2009, patient with c/o's SOB w/out exertion, cough, chest tightness, nausea and fever. Tx'd with IVF, IV Zofran, tylenol,  cardiac monitoring .Dc Dx Viral syndrome
severe Headache; fever; Initial information received on 30-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to case 2019SA210296.  This case involves Child male patient who experienced severe headache and fever, while he received vaccines HPV VACCINE, DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PARACETAMOL (TYLENOL [PARACETAMOL]).  On 25-Jul-2019, the patient received a 0.5 ml first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6522AB (Expiry date 29-Jan-2021) via unknown route in the left deltoid.  On 25-Jul-2019, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On 25-Jul-2019, the patient received a dose of suspect HPV VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious severe headache (headache) and fever (pyrexia) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and HPV VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was fever and severe headache.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for severe headache and fever.  Information on the batch number was requested.  List of documents held by sender: none.
Tiredness; Headache; Muscle ache at the infection area -right upper arm; Pain in the right armpit; Muscle ache at the infection area -right upper arm; sore arm; Lymph node in the right armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm right, administration date 17Feb2022 17:45 (Lot number: FJ6369) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Comirnaty (Dose 2, Lot number: EL3247, Administration time: 10:00 AM , Dose vaccine location: Left arm), administration date: 22Mar2021, when the patient was 52 years old, for Covid-19 immunization; Comirnaty (Dose 1, Lot number: EL3247, Administration time: 09:30 AM , Dose vaccine location: Left arm), administration date: 01Mar2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 18Feb2022 06:00, outcome "not recovered", described as "Tiredness"; HEADACHE (non-serious) with onset 18Feb2022 06:00, outcome "not recovered", described as "Headache"; MYALGIA (non-serious), INFECTION (non-serious) all with onset 18Feb2022 06:00, outcome "not recovered" and all described as "Muscle ache at the infection area -right upper arm"; AXILLARY PAIN (non-serious) with onset 18Feb2022 06:00, outcome "not recovered", described as "Pain in the right armpit"; LYMPHADENOPATHY (non-serious) with onset 18Feb2022, outcome "not recovered", described as "Lymph node in the right armpit"; PAIN IN EXTREMITY (non-serious) with onset 18Feb2022 06:00, outcome "unknown", described as "sore arm". Therapeutic measures were not taken as a result of fatigue, headache, myalgia, axillary pain, lymphadenopathy, infection.  Additional information: The patient had not received any other vaccine in 4 weeks. The patient had not other medications in 2 weeks. Patient had not covid prior vaccination and had not covid tested post vaccination. Patient had received the booster on (thursday) 17Feb around 17:45, and and events occurred was (friday) 18Feb. In early morning, around 6:00AM patient was experienced headache, sore arm etc. The lymph nodes part was a bit later during the day.  Follow-up attempts are completed. No further information is expected.
Patient came in pharmacy on 10/1/10 reported that she started to have a cold sore on left side of her tongue later that day of Flu vaccine; then cold sore became so swollen that she could not move her tongue. Patient monitored her symptoms and the swelling started to stop. Pt did not go to emergency. Pt is fine on 10/1/10. No treatment was recommended to patient.
The day after the vaccine I felt generalized body aches and extreme exhausted. I went to the ER they did a COVID test and it was negative. Had body aches just for 24 hours and felt fatigued for about 2 days and was back to normal again.
Received 0.5 ml of Moderna vaccine extra; Received 1st , 2nd dose of Pfizer vaccine and then took moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Received 0.5 ml of Moderna vaccine extra) and INTERCHANGE OF VACCINE PRODUCTS (Received 1st , 2nd dose of Pfizer vaccine and then took moderna vaccine) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CLOZAPINE, LITHIUM, HALOPERIDOL and DIPHENHYDRAMINE for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Mar-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received 0.5 ml of Moderna vaccine extra) and INTERCHANGE OF VACCINE PRODUCTS (Received 1st , 2nd dose of Pfizer vaccine and then took moderna vaccine). On 19-Mar-2021, EXTRA DOSE ADMINISTERED (Received 0.5 ml of Moderna vaccine extra) and INTERCHANGE OF VACCINE PRODUCTS (Received 1st , 2nd dose of Pfizer vaccine and then took moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
I contracted COVID-19. I experienced fatigue and mild congestion, which lasted for about 3 days.
optical neuromyelitis / blindness in one eye; This spontaneous report was received from a physician via a company representative, referring to an 11 year old female patient.  No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.    In March 2019, the patient was administered the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis.  On the same month, the patient was also administered the "TDAP"  and "Meningococcal " vaccines, (strength, dose, route of administration, lot number and expiration date were not reported) also for prophylaxis.  On an unspecified day in September 2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).     In November 2019 (also reported as "two months later"), the patient experienced blindness in one eye; the patient sought medical attention and was seen in the emergency department of an unspecified hospital where she was diagnosed with optical neuromyelitis (neuromyelitis optica spectrum disorder).  It was unknown if the patient received any treatment, or if any laboratory test was performed.     On an unspecified date, the patient recovered from neuromyelitis optica spectrum disorder.  The reporter did not assess the causal relationship between therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), "TDAP"  and "Meningococcal " vaccines and the event.        Upon internal review, neuromyelitis optica spectrum disorder was determined to be medically significant.
I started feeling this like pain on my ovaries like on my abdomen, so I felt it one time first; I started getting this bad pain on my back; I can't even walk, like since yesterday I have to take little steps, you know walking slow; The first 15 minutes my hand was like really evolving in red but it's normal like it's an arm; This is a spontaneous report from a contactable consumer or other non healthcare professional. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER, UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced to started feeling like pain on her ovaries like on her abdomen, so she felt it one time first causing adnexa uteri pain on an unspecified date with outcome of unknown , she started getting this bad pain on her back causing back pain on an unspecified date with outcome of unknown, she can't even walk, like since the previous day, she had to take little steps, leading to gait disturbance on an unspecified date with outcome of unknown, the first 15 minutes her hand was like really evolving in red but it's normal like it's an arm causing erythema on an unspecified date with outcome of unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
A non-serious spontaneous report of expired FLUMIST given to this patient was received from a certified medical assistant concerning a six-year-old female. Neither medical history nor concomitant medications were reported. On 26-Dec-2008, the patient and her brother received expired FLUMIST vaccine. The vaccine had an expiration date of 25-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 03-Feb: reporter confirmed no delayed occurring adverse events related to being given expired FLUMIST. Follow-up information received on 27-Mar-2009 included Product Complaint Investigative results. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customer not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication error that occurred shortly after the product expired.
No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In June 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medication was reported.  Dose was placed into the refrigerator initially on 04-MAY-2023. No treatment information was reported.  This case contains information for patient 8 out of 9.   This case was linked to US-MODERNATX, INC.-MOD-2023-729624 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729624:Master case
Mom stated on 1/30 child's left arm started showed marked swelling, and redness and was hot to the touch.The child ran a fever of 101. Mom took the child to her physician who stated it was an unusual vaccine reaction. He told her to give the cild Tylenol and Benadryl
The following temperature log was kept on Resident: 13.25:  99.7; 18:45:  100.3; 120:01:  101.5; 21:45:  99; 23:00:  100. Resident began to run a fever of  99.7, by 18:45 it was 100.3, and then he was administered tylenol and nausea medications since he was vomiting. He vomited both of these up and retemp check was done and it was up still, but then went up as high as 101.5. Tylenol was given again and this time he was able to keep it on his stomach. Fever was finally reduced and has not returned to that extreme. He was weak and a fall rick, so a sitter was placed in the room with him to keep him safe from falling. He would not wear his normal CPAP machine during sleep time. Feeling much better today.
This spontaneous case reported by a consumer, describes the occurrence of injection site pain (sore arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011M20A) for COVID-19 immunization. No medical history reported. On Feb 11, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced injection site pain (sore arm). At the time of the report, injection site pain (sore arm) resolved. Concomitant information and treatment information not provided. This case linked to MOD-2021-375328, MOD-2021-375329 (patient link).