chrisvoncsefalvay/vaers-outcomes huggingface dataset:
excessive crying; pain/burning with injection; This spontaneous report was received from a medical assistant and refers to a 15-month-old patient of unknown age. The patient was vaccinated with 3 doses of pneumococcal vaccine conj 13v (CRM197) (PREVNAR 13). The patient's concurrent conditions and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, administered for prophylaxis (strength, lot #, expiry date and route of administration were not provided).  On an unknown date, the patient experienced excessive crying (crying) and pain and burning with injection (vaccination site pain). At the time of reporting, the outcome of the events was not provided.   The causal relationship between the events and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was not provided.   This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2303USA002603:same reporter link US-009507513-2303USA002536:same reporter link
Increase in blood flow from head to feat, muscle weakness and numbness all over, dizzyness, impending doom/emotional. Took 25mg of benadryl.  Symptoms resolved 60mins later.
FEELING SPACEY; PEA-SIZE LUMP UNDER LEFT ARM; ITCHY UNDER LEFT ARM; INJECTION SITE PAIN LEFT ARM; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included gout, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced injection site pain left arm. On 07-MAY-2021, the subject experienced pea-size lump under left arm. On 07-MAY-2021, the subject experienced itchy under left arm. On 16-MAY-2021, the subject experienced feeling spacey. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain left arm on 07-MAY-2021, and had not recovered from pea-size lump under left arm, itchy under left arm, and feeling spacey. This report was non-serious.
9/21/22,-woke up with extreme fatigue, headache & nausea, slept most of the day.  9/22/22- symptoms same, plus nasal congestion & cough & abdominal pain. 9/23/22-symptoms same, plus chest congestion now & vomitting.  Reached out to my PCP & was prescribed Plaxovid.  9/24/22-symptoms decreasing slightly (head, body aches & nausea better.)  9/25/22-symptoms slightly better (fatigue less, nausea subsided, body aches and headache gone.)  9/26/22-all symptoms improving.
Client received 2nd dose COVID vaccine @ 12:00pm, complained of feeling burning sensation in chest and lower back, with pressure in head @ 12:02pm.  Client placed in chair, vital signs stable.  Burning sensation in chest and lower back resolved at 12:09pm, head pressure lessened.  Client left for home @ 12:34pm, with headache, advised to follow up with primary care if symptoms not resolved at home or worsen.
Patient received dose of vaccine on 4/7/21. Patient noted area of blanchable redness on 4/16/21 about 2 inches distal to the vaccine site. Area of redness is 3.5 cm x 4.5 cm. Slight swelling, tender to touch, and slight itching. No drainage, opening of the skin, or flaking. Unclear if related to vaccine, but given uncertain etiology and proximity to site of injection reporting as possible adverse reaction. Plan for patient is to currently monitor, and advise office with new or worsening symptoms.
Dizziness immediately post-vaccination. Resolved with IV hydration. Awakened by spouse in the middle of the night on 8/1/2021 because upper and lower extremities were so cold that he felt like he was dead.  He reported moderate chills and difficulty getting warm. He required bed warming and layers of clothes rather than normal bed cooling. The chills have persisted into the late afternoon.
Extreme soreness over entire left arm making movement difficult; pain radiated to right shoulder. Also body aches all over, chills, teeth chattering, severe and uncontrollable body spasms, dizziness and vomiting.
Caller has really bad allergies; This is a spontaneous report from a Pfizer-sponsored program. A Non-contactable Female consumer reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced really bad allergies. She got it and her Brother and his wife got it. At the time of this report, the outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 12MAY97 & 17MAY97 pt devel a sore throat, 102 fever, malaise & sore legs;
reports developing fever and bodyaches on 1/31/2022.  received covid booster on 1/29/2022.
This spontaneous report was received from a consumer regarding a young male patient of unknown age. Patient's pertinent medical history, drug allergies/reactions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with M-M-R II for prophylaxis and sterile diluent (manufacturer unknown) for unknown indication (doses, routes, lot #s, and expiration dates unknown). The reporter stated that she knew "personal event" that occurred with the young male patient (adverse event). It was unspecified as to what this "personal event" was entailed. The outcome of adverse event was unknown. The causality assessment of adverse event with both suspect therapies was unknown. No product quality complaint was involved. This is one of two reports from the same reporter (1709USA002309).
patient received inoculation 9/20/2021 and started having symptoms around 0400 09/21/2021. symptoms include fatigue, weakness, body aches (generalized), and nausea/vomiting. he has a 103F orally in office
itchiness at the injection site; swelling at the injection site; tightness of the skin at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
STROKE; MEMORY LOSS; This spontaneous report received from a consumer via social media through company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient vaccinated with covid-19 vaccine ad26.cov2.s from an unspecified manufacturer (dose number in series 1), (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 01 in total, administered for prophylactic vaccination. No concomitant medications were reported.  No adverse events were reported following vaccination with covid-19 vaccine ad26. cov2. s (dose number in series 1). The patient received 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, start therapy date were not reported, 1 in total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced memory loss and suffered a stroke. The hospital said the vaccine caused his stroke (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the memory loss and stroke was unknown (dose number in series 2) This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211258504 and 20211260708.; Sender's Comments: V0: 20211258923-covid-19 vaccine ad26.cov2.s -stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Given second dose of flu vaccine. No adverse signs or symptoms. Vitals monitored x 4 days.
PFIZER COVID VACCINE #3 GIVEN 9/8/21, LOT #FC3182; patient passed away at home with COD: complications of COVID 19; no medical records on this patient; PCP unknown.
Odd episode of crying followed by severe chills (it was a warm night) that lasted several hours, then followed by severe body aches that lasted almost 24 hours. Also some shortness of breath and feeling like chest was tightening. I was 35 weeks pregnant at the time and by the next morning had reduced fetal movement.
Red rash, large swelling on right arm from elbow to shoulder and almost around arm. About 1 in from touching- very sore, painful. Temp 101.5 degrees- chills, felt very ill- To doctor 2 days.
Patient received Pfizer covid vaccine injectioin, patient was then observed in pharmacy waiting area.  after around 5 minutes, patient had nausea, then started to have something resembled seizure: loss consciousness, stiffening of body, eyes rolled backwards, lasted around 5 seconds.  Then she gradually regained consciousness.  She breathed heavily at first then slowly back to normal breathing.  Patient was able to talk to her parents logically.  Pharmacy staff called 911, paramedics arrived. Per paramedics, patient's  vital signs were normal, checked blood pressure, glucose level, pulse, heart rhythm.  Patient and her family was advised to follow up with primary care provider.  Family said they will bring patient to physician for evaluation.
Feeling miserable; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling miserable) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling miserable). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Feeling miserable) had not resolved. Not Provided      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.   The concomitants include  Blood pressure medication  and Diabetic medication.   This case was linked to US-MODERNATX, INC.-MOD-2021-090387, US-MODERNATX, INC.-MOD-2021-090392 (E2B Linked Report). This case was linked to MOD-2021-090279 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090392:Husband dose 1 case US-MODERNATX, INC.-MOD-2021-090387:
10 days after vaccine developed large - 5cm area of erythema and swelling at injection site, fever, and  generalized papular rash.
This spontaneous report as received from a consumer reporting her daughter a 14 year old female patient with a medical history of heart murmur who on 14-AUG-2012, was vaccinated with GARDASIL dose 1 (dose, route and lot # not provided). On 15-OCT-2012, was vaccinated with GARDASIL dose 2 (dose, route and lot # not provided). On 02-DEC-2012, was vaccinated with GARDASIL dose 3 (dose, route and lot # not provided). No concomitant medications were reported. The Consumer stated that on 09-DEC-2012 (1 week after 3rd dose of GARDASIL), her daughter was coughing a lot for 1-2 months, had a headache, was dizzy, and the arm hurt so bad for several hours after receiving the 3rd dose of GARDASIL. The patient sought medical attention by office visit. The patient was treated with a medication with codeine for cough. On unspecified date, the patient recovered from adverse events. The relatedness adverse events was unknown for GARDASIL. Additional information has been requested.
On the 9th day following the vaccine, I experienced itching, burning and redness at the injection site.  That continued for 24 hours in varying degrees and continues to the time of this reporting.
Proximately 3 or 4 AM the next morning I started getting diarrhea after laying in bed for several hours with cramps. Proximately 6 AM I took Gas-X and about seven I took Pepto-Bismol for diarrhea. And the cramping I had was severe. I felt nauseous but nothing came of it.Then I got uncontrollable shakes. My husband put about 4 to 5 blankets on me and set me next to the open fire place. The shakes would not go away. Got back in bed my husband placed all the blankets on top of me and got in bed with me, Tried to wrap his body around me to get me warm. My teeth were chattering arms legs entire body. After two or three hours of this shivering finally went away. The entire day I was so drained I hardly could get out of bed. Slept most of the day. During the chills my husband wanted to call 911 twice I begged him not to and he didn't.  We never took my temperature my husband said my head was cold.
his wife tested positive for Covid-19 last night and she was vaccinated.; his wife tested positive for Covid-19 last night and she was vaccinated.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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 18Jul2023, outcome "unknown" and all described as "his wife tested positive for Covid-19 last night and she was vaccinated.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2023) Positive, notes: wife tested positive for Covid-19 last night. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Reporter was asking about the extended expiration date of their Paxlovid that shows May2023 expiration date. Caller also asked if the medication was still good since it's still July. Reporter mentioned that his wife tested positive for Covid-19 last night and she was vaccinated.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
pt exp aches & pain;pt recv vax & woke up next day w/aches & pain in the muscles;antinuclear antibody was 1:640 & sed rate 38;negative double stranded DNA negative;negative anti ribonucleoprotein;Bouchard's & heberden's node;dx arthralgias;
Pfizer-BioNTech COVID-19 Vaccine EUA  Day 1  Arm sore at injection site.    Day 2 Chills and fever overnight, with intense body aches and soreness.   Fever and aches all day.   Managed with ibuprofen. Fever and chills again at night.  Day 3 Still very sore and tired but better than the day before.  Bruise at injection site, and rectangle under it on left arm - a red rectangle that felt warm and hurt like a bruise.   Broke out in an itchy rash that evening, in my back and neck. Red small itchy bumps.  Did have chills and fever in the night, but not as bad as the first two nights. But after the fever broke got a SPLITTING headache in the night.  Day 4 Not as sore during the day.   Took a shower in the afternoon and the rash spread all over neck, chest, and back, down towards waistline all around.  Called doctor. Said to take benadryl, and come into the office if rash continues/spreads.  Go to ED if tongue or throat swell.  Day 5  Still tired and sore, but much better. Green bruise at injection site, and red rectangle that is warm and sore under it.   Rash is less red or itchy, but small bumps still present.  Red rectangle on arm started to itch around 7 and got bumpy.  Took benadryl to manage the itchy rash again.
Child received immunizations on 4/23/07.  On 4/24/07 and 4/25/07 child ran a fever (parent did not know how high it was).  On 4/25 child had a seizure and was taken to emergency room for care.  Child came to Health Center on 4/27 for follow-up at which time she had completely recovered.
DTaP in left arm on 04/17/06. Today is red, swollen, tennis ball size 4/20/06 5/12 x 6cm Per mom am in clinic 4/20/06 2:10 PM, Cellulitis-Cephalexin. RXN to DTaP.
Injection site muscle pain, spasm for 2 weeks. Decrease range of motion because of pain, treated with ibuprofen, physical therapy and Medrol dose pack.
Patient given 0.5ml instead of the correct dose of 0.3ml. Patient experienced fever, headache, joint pain, and injection site pain
sick a little bit; like a flu for the first 2 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick a little bit) and INFLUENZA LIKE ILLNESS (like a flu for the first 2 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2021, the patient experienced ILLNESS (sick a little bit) and INFLUENZA LIKE ILLNESS (like a flu for the first 2 days). On 27-Jul-2021, ILLNESS (sick a little bit) and INFLUENZA LIKE ILLNESS (like a flu for the first 2 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant drugs were reported.  No Treatment information  were reported.
had covid vaccine arm was tired; Tired when it was hot; second dpse 1-Apr-2021 and booster dose on 17- Aug- 2021; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (had covid vaccine arm was tired), FATIGUE (Tired when it was hot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dpse 1-Apr-2021 and booster dose on 17- Aug- 2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) On 17-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose 1-Apr-2021 and booster dose on 17- Aug- 2021). On an unknown date, the patient experienced MUSCLE FATIGUE (had covid vaccine arm was tired) and FATIGUE (Tired when it was hot). At the time of the report, MUSCLE FATIGUE (had covid vaccine arm was tired), FATIGUE (Tired when it was hot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dpse 1-Apr-2021 and booster dose on 17- Aug- 2021) outcome was unknown.            Patient received booster dose of moderna on 17-Aug-2021 No concomitant medication was provided by reporter. No treatment medication was provided by reporter. It was unknown if the patient was enrolled in a Covid-19 vaccine trial.
Patient reported light-headedness approximately 15 minutes after vaccination. He said it was mild, but felt like when he doesn't eat and gets light-headed. I asked patient to remain seated and got him some water. He drank the water and after approximately 5 minutes said he felt fine. Reported no dizziness or light-headedness. I asked him if he would like to remain in observation for longer, but patient said he was ready to go home and repeated that he felt fine. He said that he would call if he had any questions or concerns.
fever on day two, and severe rashm with small bumps, it does not look like hives, because the bumps are very small, almost like hundreds of bug bites, severe itching, very uncomfortable, benadryl and over the counter hydrocordisone given per doc. suggestion, helped with itching, but sill has the rash.
This spontaneous report as received from a registered nurse refers to a 19 year old patient (unspecified gender). On 20-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
immed felt ill w/hot feeling in head, pressure in ears & eyes; devel sense of constriction in throat & clammy hands; later devel emesis; returned to clinic p/20 mins of sx;
This is a spontaneous report from a contactable nurse via Pfizer sales representative. A child male patient received at the age of 11-year-old the 1st dose of TRUMENBA, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history was not reported. Concomitant medication included the 3rd dose of GARDASIL at the same time on an unspecified date for immunisation. On an unspecified date after receiving TRUMENBA, the patient vomited and developed low grade fever with outcome of unknown. The nurse stated patient had not had any problems with first two doses of GARDASIL. No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Case number PHEH2016US008605 is an initial spontaneous report received from a nurse on 05 Apr 2016. This report refers to a 15 year old male patient. Past medical history and concomitant medications were not reported. This patient under the age of 18 was vaccinated with FLUCELVAX (batch number: 174087A) on 01 Dec 2015 instead of FLUARIX (batch number: 9JX2N, Expiry date: 16 Jun 2016) at 0.5 ml intramuscular. No adverse event was reported following this maladministration. The reporter stated that, there was no specific order for a specific flu vaccine. The order for unspecified flu vaccine and patient was administered FLUCELVAX. Follow up report from nurse received on 31 May 2016: Suspect drug FLUARIX and its details (dose and route) new event (wrong vaccine administered) and deleted the event inappropriate age at vaccine administration. Follow up report from nurse received on 22 Jun 2016: Added suspect drug FLUARIX details (batch number and expiry date).