chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started having a dry like I was coming down with a cold.; I started getting aches and pain in my body.; I could hardly walk.; My muscles and my joints not so much my joints as much as my muscles were very sore.; Headache; I had slight fever.; My muscles and my joints not so much my joints as much as my muscles were very sore.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 25Mar2021 16:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 Immunization. Medical history included covid-19 from Jul2020 to an unknown date (first of all I need to tell you I had COVID myself the last part of July and I had it for almost four weeks in August and I finally got okay and did not have go to the hospital and didn't have the respiratory issue at that time) fluid around heart, scar tissue from an unknown date and unknown if ongoing (I have fluid around my heart and I have some scar tissue on my lungs). The patient's concomitant medications were not reported. The patient stated, "Well I want to hear not to get the Covid vaccine took the first shot on 25Mar2021, and the doctor recommended that I get the shot. Hence, I wanted to hear not got the vaccine and it was Pfizer vaccine. I came home that evening, we got it in the afternoon it was about 4 o clock in the afternoon when I got the shot but 8 o clock at night, I started having a dry like I was coming down with a cold and I started getting aches and pain in my body. I slept alright that night, it was not that severe, the next day I could hardly walk, my muscles and my joints not so much my joints as much as my muscles were very sore. I had a headache. I had slight fever which I never had real high fever when I had the disease itself. I had a fever and I thought it would go away well as the days went on but Saturday (date not specified), this I got shot on Thursday and by Saturday and Sunday (dates not specified) I thought I was not even going to be able to walk, it was so bad and it started subsiding and then on Monday (dates not specified) a little bit but it continued with the muscle ache and headache not the severe headache like I had when I had COVID disease but I still had a headache. So, now it finally went away yesterday (dates not specified). I felt better but I still had some underlying issues with the backs of my legs and backs of my arms in the muscle. So now I was supposed to go get the another shot on the 15th and I, I did not know if I should or if I should not get the second shot because I had such a reaction to the first one. I am afraid to go get the second one. So, I was calling to get advice on that." The clinical outcome of the event I had slight fever was recovered on an unspecified date, Headache was not recovered and remaining all other events was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
after receiving second dose of moderna almost immediately became red from neck/chest up through head, scratchy throat, lightheaded, nauseated, and told observation staff had hives after first vaccine. Recieved epinephrine and oxygen, ems activated and transported to the ER for evaluation
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA284510, 2018SA284495 (same reporter). Case was considered as non-case as no event was reported. Additional information was received on 02-Nov-2018 from Nurse. This case involves an patient of unknown demographics who received vaccine PENTACEL (batch number, expiry date, dose in series, route and site of administration not reported) which was inactive due to temparature stability on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to incorrect product storage and Deteriorated drug administered. No adverse event was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.
Fever 103, chills, body aches, dehydration, light headed, heart rate 150
5JUL94 mom ot pt informed that pt had a pos react to immun given on 15APR94;  elevated temp & pt eyes rolled back; foaming @ mouth;
INJECTION SITE REDNESS; PAIN IN THE INJECTION SITE; TIREDNESS; This spontaneous report received from a consumer concerned a female of unspecified age. 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: Unknown) dose was not reported, 1 total, administered on 04-APR-2021 on unspecified anatomical site for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 04-APR-2021, the subject experienced injection site redness. On 04-APR-2021, the subject experienced pain in the injection site. On 04-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in the injection site, injection site redness and tiredness was not reported. This report was non-serious.
Swelling of the arm from my shoulder to my elbow, goose egg swelling in one specific area of vaccine injection location, redness at the same site, aches in joints of other body areas, infection site redness, and puss/infection in the same area, loss of arm movement above chest level, all for 2 to 3 days of affliction.
This spontaneous report as received from a nurse refers to a 15 year old female patient with no pertinent medical history or drug reactions/allergies. On 16-JUL-2013 the patient was vaccinated with a dose of GARDASIL, 0.5 ml, intramuscularly, lot # not reported. There was no concomitant medication. On 16-JUL-2013, immediately after vaccination, the patient experienced debilitating migraine and vomiting, that lasted for 3 days. There were no lab studies performed. The patient's mother sought medical attention by contacting physician's office. The outcome of debilitating migraine and vomiting was reported as recovered/resolved on approximately 18-JUL-2013, reported as 3 days after she received vaccine. The relatedness between GARDASIL and adverse events was unknown. Upon reporter's assessment the debilitating migraine and vomiting were considered to be disabling. Additional information has been requested.
Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 29-OCT-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L028666; expiry date 04-NOV-2016, (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
fussy, irritable on 8NOV96;fine on 11NOV & 12NOV;fever on 13NOV & 14NOV;red rash w/hives beginning on 13NOV, worse on 14NOV;appt w/MD on 14NOV96;dx as virus;sx gone by 18NOV96;
post vaccine pt felt Left ear pain and swelling, then itching developed. PO diphenhydramine was administered and no relief was given. Patient was brought to ED for further work/up
Feel little dizziness; Ingested one dose of an expired Vivotif; Spontaneous report received on 28APR2021. Additional information was received on 04MAY2021.  A pharmacist reported that a 72-year-old male consumer "ingested one dose of an expired Vivotif" (PT: Expired product administered) and "feel little dizziness" (PT: Dizziness) following the administration of Vivotif. The consumer was receiving oral Vivotif (expiry date: Nov 2020) for immunisation. On 28APR2021 in the morning, the consumer ingested one dose of an expired Vivotif. On the same day, the consumer felt little dizziness after taking Vivotif. On 04MAY2021, the pharmacist stated that the patient had also followed up with the physician. The patient did not take any medication for dizziness, it resolved on its own. It was reported that the patient ended up receiving the injection for typhoid vaccine since Vivotif was unavailable. Action taken with Vivotif with respect to the reported events "feel little dizziness" and "ingested one dose of an expired Vivotif" was not applicable. The consumer had recovered from the reported event "feel little dizziness" while the outcome of the reported event "ingested one dose of an expired Vivotif" was unknown.  The pharmacist stated that as per their pharmacy profile, the patient did not have any medical history. In addition, he was not on any other medications.  Company Comment: A consumer took one dose of an expired Vivotif (expired product administered) and then felt dizziness which was resolved on its own. Since Vivotif was unavailable to the consumer, he ended up receiving typhoid vaccine injection. Dizziness is a known effect with Vivotif, and the causality is assessed as possible. The causality of expired product administered is assessed as not applicable to Vivotif due to the nature of the event.; Sender's Comments: A consumer took one dose of an expired Vivotif (expired product administered) and then felt dizziness which was resolved on its own. Since Vivotif was unavailable to the consumer, he ended up receiving typhoid vaccine injection. Dizziness is a known effect with Vivotif, and the causality is assessed as possible. The causality of expired product administered is assessed as not applicable to Vivotif due to the nature of the event.
my shoulder was sore, just like when i got the 1st and 2nd doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 10May2021 08:00 (Lot number: EW0167) at the age of 30 years as dose 1, single and intramuscular, administered in arm, administration date 01Jun2021 (Lot number: EW0191) as dose 2,single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "my shoulder was sore, just like when i got the 1st and 2nd doses".  No follow-up attempts are possible. No further information is expected.
patient reported that a couple hours after the immunization, she started to eat a salad.  she then began to feel that her throat was swelling, tongue swelling and it was hard to breathe.  patient took a Benadryl capsule.   she didn't report to the pharmacy or the dr office until another day she called the pharmacy on 09/23 and I called the dr on 09/25
Information has been received from a physician concerning a 10-week-old male with no other pertinent medical history on 11-JUN-2007 was vaccinated PO with a dose of Rotateq (Lot #655406/1114F) (patient was noted to have hiccups at the time of vaccination). On 11-JUN-2007, while being administered Rotateq, the patient spit it up and regurgitated some saliva. Unspecified medical attention was sought. No laboratory/diagnostic tests were performed. The patient recovered in 2-3 minutes. Additional information has been requested.
2nd dose right arm. Tender. A few days afterward the area began burning. Pain traveled upward into the right side of neck. Continues to burn off and on daily non-stop.
I developed palpitations after the vaccine. When I checked my pulse, it was at 150 and then dropped to the 30s. I was sent to the ER. I had an external cardiac monitor on for 7 days. It shows that I now have PAC and PVC. They wanted to admit me, but I did not want to be admitted. I was prescribed metoprolol 25mg, twice a day. I am still experiencing issues with palpitations.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: Patient reported developing carbuncles and followed up with urgent care, and then PCP - both prescribed antibiotics and prednisone.
Extreme sudden onset of  dizziness which required me to sit quietly for about 15 minutes to prevent possible falling.  After the incident passed, I felt out of sorts for the next hour or so and I went to bed (and slept well) commencing at about 10pm.
"COVID Toe" about 1 week after vaccination.  Sympotom subsided after about 5 days, but resurfaced again after about 5 days.
cough has worsened; chest feels slightly tight; runny nose; fatigued; This is a spontaneous report from a contactable other health professional (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration (left arm) 19Jan2021 15:30 at single dose for Covid-19 immunization. The patient's medical history included Covid-19 on 14Nov2020 to an unknown date and lingering cough; no known allergies. Concomitant medications were not reported. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she had Covid on 14Nov2020 and she have had a lingering cough from it. She got her first vaccine yesterday (19Jan2021) and her cough has worsened on 19Jan2021 at 17:30. She added that her chest feels slightly tight, she has a runny nose, and she was also fatigued but she stated that it was slightly expected. The patient asked if the cough and runny nose were normal as well. The patient underwent lab tests and procedures on 14Nov2020 which included Sars-Cov-2 test with positive result. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination.   Information about lot/batch number has been requested.
covid / first two dosage was last year that was moderna and the two booster was Pfizer; covid / first two dosage was last year that was moderna and the two booster was Pfizer; covid / first two dosage was last year that was moderna and the two booster was Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Infection" (unspecified if ongoing); "Immunity disorder" (unspecified if ongoing); "IGG immunity disorder" (unspecified if ongoing); "Heart disease" (unspecified if ongoing). Concomitant medication(s) included: TAMIFLU; CEFDINIR taken for infection. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Dec2021, outcome "unknown", DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "covid / first two dosage was last year that was moderna and the two booster was Pfizer". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Echocardiogram: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.Clinical course : If vaccine received: Yes. Other medication in 2weeks: No. Anti viral details: Product=COVID 19 Treatment, Brand =Paxlovid, Treatment start date=10Jun2022, Treatment stop date=14Jun2022, Indication=Treatment of COVID-19. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment?: No. Did you/the patient previously receive a COVID-19 Vaccine?: Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Folliculitis on bikini line, and in both armpits. There was a small lump in each area, with redness and swelling. Very tender lymph nodes in each area. Put Bactrim ointment on 3 times day for 5 days.
Per patient report on follow-up: admitted to hospital following initial vaccine on 12/29 with N/V and severe HA. Patient placed on Morphine for pain, now resolved. Admission occurred outside of hospital system providing initial vaccine.
diarrhea; woke up nauseous; vomiting; a low grade fever 99.5; Right arm started hurting; This is a spontaneous report from a contactable other hcp (Patient). A 35-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 25Jan2021 17:30 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 via an unspecified route of administration, administered in Arm Right on 31Dec2020 09:15 AM (Batch/Lot number was unknown) for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the right arm started hurting on Thursday 28Jan2021 then on Friday 29Jan2021 at 05:15 AM woke up nauseous and ended up vomiting (29Jan2021 at 05:15 AM) and with a low grade fever 99.5 (29Jan2021 at 05:15 AM) then on Saturday 30Jan2021 she no longer had fever and vomiting but did have diarrhea (30Jan2021) which stopped on 31Jan2021 in total she missed 3 days of work. No treatment was received for the events. The events were assessed as non- serious by reporter. The outcome of the events right arm started hurting, woke up nauseous were recovered on an unspecified date; events vomiting, a low grade fever 99.5 were recovered on 30Jan2021 and diarrhea was recovered on 31Jan2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient has developed what I would describe a large hives on his neck area and small ones on his face. Large red, raised, and dry patches.
blisters where the rash was but they were "separate" and on top of the rash; painful; itchy; "COVID arm" along with rashes on her chest, midriff, both legs, and both arms; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (blisters where the rash was but they were "separate" and on top of the rash), PAIN (painful), PRURITUS (itchy) and RASH ("COVID arm" along with rashes on her chest, midriff, both legs, and both arms) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history was not reported .    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced BLISTER (blisters where the rash was but they were "separate" and on top of the rash), PAIN (painful), PRURITUS (itchy) and RASH ("COVID arm" along with rashes on her chest, midriff, both legs, and both arms). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and ALOE VERA at an unspecified dose and frequency. On 01-Mar-2021, BLISTER (blisters where the rash was but they were "separate" and on top of the rash), PRURITUS (itchy) and RASH ("COVID arm" along with rashes on her chest, midriff, both legs, and both arms) had resolved and PAIN (painful) outcome was unknown.            No Concomitant medications were provided Treatment medication also includes Anti-itch medicines.    This case was linked to PT-MODERNATX, INC.-MOD-2021-045860 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Non-significant information, Patient's email address, case linking added.; Sender's Comments:  PT-MODERNATX, INC.-MOD-2021-045860:
FEVER, HEADACHE, EYES ACHING SWOLLEN SIGHT OF INJECTION CHILLS LOST OF WEIGHT.
This spontaneous report was received from a registered nurse and refers to a female patient of unknown age with hypertension, chronic obstructive pulmonary disease and diabetes mellitus. The patient's medical history included cerebrovascular accident. On 22-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 lot # N030111, expiration date: 21-APR-2019, for prophylaxis (strength, dosage and route were not provided). Concomitant therapies included atorvastatin, carvedilol, LASIX, LANTUS, PRINIVIL, metformin, potassium chloride, XARELTO and PEPCID. The registered nurse reported that on 23-JAN-2018, the patient was hospitalized due to a localized reaction at the injection site. Subsequently, the patient had a blood work, comprehensive metabolic panel and complete blood count but the results were not provided. After that the patient was diagnosed with sepsis secondary to cellulitis on an unspecified date in January 2018 and began treatment with intravenous vancomycin and then switched to ANCEF on an unspecified date. Finally, the patient was discharged from hospitalization on 25-JAN-2018. At the time of this report, the outcome of sepsis and injection site cellulitis was recovering. The causality assessment between the events and PNEUMOVAX 23 were not provided. The reporter considered the events to be life threatening and disabling. Upon internal review sepsis was determined to be medically significant.
Headache all day, body aches, fatigue, fever (although I didn't take my temperature).