chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Nov2022 as dose 5 (booster), single (Lot number: GJ6796) at the age of 58 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (30Jan2023) Negative, notes: Tested negative for Covid-19 on 30Jan2023; (04Feb2023) Positive, notes: Tested positive again for Covid-19 on  04Feb2023. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received treatment with paxlovid from 25Jan2023 to 29Jan2023. The patient had no known allergies, did not report administration of any concomitant medication within 2 weeks of Paxlovid therapy.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300058285 Same patient, different product and event;
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Headache-Medium
Headache; Fever of 99.6; chills; Body Aches/Achiness; Corona virus infection; tested positive for COVID; This case was reported by a consumer via call center representative and described the occurrence of headache in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date).   On 16th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 17th January 2020, 1 days after receiving Shingrix, the patient experienced headache, fever, chills, general body pain, covid-19 and coronavirus test positive. On 18th January 2020, the outcome of the headache, fever, chills and general body pain were recovered/resolved. On an unknown date, the outcome of the covid-19 and coronavirus test positive were unknown.   It was unknown if the reporter considered the headache, fever, chills, general body pain, covid-19 and coronavirus test positive to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself. The patient received the dose of Shingrix on left arm and 1 day after the vaccination patient had a headache, a fever, chills and body aches. The fever was reported as 99.6 degree F. The patient also stated that he was tested positive for COVID. The symptoms of headache, fever, chills and body aches lasted for one day. The reporter did not consent to follow up. All information was not available at the time of reporting. Note: The vaccination and event onset and outcome year was not clear if it was 2020 or 2021, hence year was conservatively kept as 2020 with respect to reported description. The clarification has been raised for the same.
immediately after injection I began to sweat. then about 2 hours post injection, I began feeling nauses and close to vomiting. bad headache with Dizziness with light making the headache worse, I also would have intermittent chills then feel flush like my face was  burning.   I could not turn my head to fast I would get very Dizzy and more nauses.  If I kept in one position in a semi supine state I felt ok not great but could tolerate it.  I also had to keep the bright lights out of my  eyes.
spure of neuropathy; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program.  A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Feb2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. Previously, on an unspecified date, the patient took the first dose of the vaccine for COVID-19 immunization. On 12Feb2021 the patient experienced spure of neuropathy. Patient wanted to know if she can take prescribed "Metanx", that was prescribed before vaccine but not really taking this medication. The final outcome of the event was unknown. Information about lot/batch number has been requested.
Pt began having swelling of the right thigh at the injection site the day after receiving the vaccine.  Redness continued to worsen and the patient was seen in the office yesterday. Diagnoses with either a hypersensitive reaction or an infection. Told to start childrens Claritin and if not better today to start the Keflex today.
This is a 71y.o. female with PMH significant of HTN, type 2 DM, hyperlipidemia, PE, uterine sarcoma with lung metastates, recurrent TIAs, who was brought in by EMS for altered mentation and abnormal uterine bleeding. Admitted for L MCA stroke with slurred speech, facial droop, and RUE weakness. History of multiple strokes since September. Presented with significant AUB with Hb of 6. Received 2 units pRBC in ED. CT head showed findings suggestive of recurrent stroke. Patient and family requesting comfort care only. Hospice consulted, initially not in hospital candidate as symptoms were adequately managed by palliative care. Comfort medications were started and patient was kept comfortable. She was reevaluated by
Pt recvd Hep B vax & exp arrhythmia (PCV's & PAC's) in approx MAY91;
Difficult to arouse, entire body jerked when touched, arms flaccid, after arousing res sat bolt upright, stare blankly, would not speak & flopped head back onto bed. Would not answer when spoken to. VS 140/72 P66 R20 T97.6. After a few minutes res body would jerk entirely after few minutes res would open eye yell out with garbled speech.
pt devel red blotches on mouth et cheeks, filling w/white fluid, afeb;mom denied pt exp any other sx;
flu; pneumonia; chronic sinus infection; Initial information received on 16-Jan-2021 regarding an unsolicited valid serious social media case received from a consumer.  This case involves male patient who experienced flu (influenza), Pneumonia, chronic sinus infection (chronic sinusitis), while he received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious flu (influenza), Pneumonia, chronic sinus infection (chronic sinusitis)  (Unknown latency) following the administration of INFLUENZA VACCINE. Pneumonia was assessed as medically significant as per important medical event list. The patient was hospitalized for these events.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for all events.  There will be no information available on the batch number for this case.; Sender's Comments: This case involves male patient of unknown age who experienced flu (influenza), Pneumonia, chronic sinus infection (chronic sinusitis), while he received vaccine INFLUENZA VACCINE from unknown manufacturer. The time to onset is also unknown. There is, moreover, no information regarding patient's medical history, condition at time of vaccination and lab tests ruling out alternate etiologies. Based upon the reported information, the role of suspect vaccine cannot be assessed.
Patient given vaccine without dilution of vial, thus receiving six times the normal dose. Patient notified immediately upon realization at the pharmacy (30-60 minutes post injection). Patient monitored with phone calls throughout the weekend. Pt reported fever of up to 102F Friday/Saturday & treated with Tylenol, but is otherwise doing well at time of this report.  Polices, procedures, and re-education implemented to prevent for future vaccines.
expired vaccine accidentally administered/ no AE; Initial information was received on 13-Oct-2021 regarding an unsolicited valid non-serious case from pharmacist and consumer/non-healthcare professional via call center via Medical Information (Reference number- 00810513).  This case involves a 72-year-old male patient was vaccinated with an expired dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (expired product administered).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL); HEPATITIS A VACCINE (HEPATITIS A VACCINE); and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for prophylactic vaccination.  On 13-Oct-2021, the patient received a 0.5ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot number: R2A741M and expiry date: 05-Oct-2021) via an intramuscular route at a the left arm for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  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 guidelines. 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.
2 days after experienced eye soreness in right eye; 2 days after experienced eye soreness in right eye, headache caused by eye pain.; Continued swollen and twitching right eye even after 5 days of receiving vaccine.; Continued swollen and twitching right eye even after 5 days of receiving vaccine.; Itchiness & small rash clusters on several parts of the body occurred 1 hour after vaccine was administered; Itchiness & small rash clusters on several parts of the body occurred 1 hour after vaccine was administered; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 12:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease with hypothyroidism and known allergy to crab. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 13:15, 1 hour after vaccine was administered, the patient experienced itchiness and small rash clusters on several parts of the body and continued swollen and twitching right eye even after 5 days of receiving vaccine. On 24Apr2021, 2 days after vaccination, the patient experienced eye soreness in right eye and headache caused by eye pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchiness, small rash clusters on several parts of the body, eye soreness in right eye, headache caused by eye pain and continued swollen and twitching right eye were resolved with sequelae on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Coughing, headache, diarrhea, vomiting,  congestion, fever,  body aches. All came on within two hours of each other.
This case was reported by a healthcare professional via a sales representative and described the occurrence of swelling of upper arm in a child subject of unspecified gender who was vaccinated with combined KINRIX. In February 2009 the subject received 1st dose of KINRIX in an unknown arm. At an unspecified time after vaccination with KINRIX, the subject experienced swelling of upper arm (the arm where the KINRIX was given). At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with KINRIX. It was reported that 5 subjects in the age range of 4 to 6 years received KINRIX within the last week and developed swelling in the arm where the KINRIX was given. No specific details were known at the time of reporting. Linked cases include A0770473A, A0770474A, A0770475A and A0770476A.
lump in the arm; chills; fever; nausea; headache; arm is sore; rash in the arm that is a big square, like a big band aid, about that size; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of NEOPLASM (lump in the arm), CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and HEADACHE (headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She had had COVID-19 and was treated with plasma). Concomitant products included TAMOXIFEN, LEVOTHYROXINE and HYOSCYAMINE SULFATE (LEVSIN) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (fever), NAUSEA (nausea), HEADACHE (headache), INJECTION SITE PAIN (arm is sore) and RASH (rash in the arm that is a big square, like a big band aid, about that size). On an unknown date, the patient experienced NEOPLASM (lump in the arm). On 31-Jan-2021, CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and HEADACHE (headache) had resolved. At the time of the report, NEOPLASM (lump in the arm), INJECTION SITE PAIN (arm is sore) and RASH (rash in the arm that is a big square, like a big band aid, about that size) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
TRANSIENT ISCHEMIC ATTACK= AFFECTED FACE, WITH PARESTHESIAS, BLURRY VISION, GENERAL WEAKNESS, WHICH RESOLVED IN A FEW MINUTES.
Fever or 101; trouble talking; not able to move right side of body; dizzy.
Within an hour I experienced a rapid heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old non-pregnant female patient received first dose of bnt162b2 (Solution for injection, Lot Number: EM9810), via an unspecified route of administration in left arm on 06Feb2021 11:15 as single dose for covid-19 immunisation. Medical history included covid-19 from beginning of Nov2020. There were no concomitant medications. On 06Feb2021 12:15, the patient experienced within an hour I experienced a rapid heartbeat. The patient did not receive any treatment for the events. The clinical outcome of the within an hour I experienced a rapid heartbeat was recovering. No follow-up attempts are possible.
Itchy red blustery bumps appeared gradually over about 6 hours. They were on my arms, legs, neck and collar Rea and scalp. The next morning they were receded and no longer itching.
pt recvd vax;cried for 3 hrs w/ high pitched cry;no oth sxs;mom called MD who recommend to cont apap  & observation;crying stopped; 7dec94 no crying;
The pt recvd a typhoid vax,observed 30-45 min /p vax.During this time pt exp inject site pain, which worsened.Pt d/c.@ 12:23 found on floor in barracks,appeared confused & post-ictal, to ER where hospitalzed.d/c dx of poss sz,meds Dilantin.
my arm is little sore yesterday; This is a spontaneous report from a Pfizer sponsored program. Female consumer (patient) reported for herself that: A 71-year-old female patient received of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine, Formulation: Solution injection; Lot number: unknown; expiration date unknown), via unspecified route of administration on 03Jun2021 (at the age of 71-year-old) as first dose, single dose for COVID-19 immunization. The patient medical history included hypertension.Concomitant medications were not reported. The patient wanted to see the dates if she can take that medication. The patient received Amitriptyline on regular basis on unspecified date. The patient wanted to see if she can take that medication Amitriptyline on regular basis. The patient received her first dose earlier today 03Jun2021 and her second dose was scheduled on 24Jun2021 which is exactly 21 days apart, the correct dose was scheduled however she forgot to ask her vaccination provider if she can take her evening medication which is Amitriptyline medication, she said pain reliever for her. The patient had arm is little sore yesterday but right now she seems to be okay, and she wanted to see if she can take that medication. She takes Amitriptyline on regular basis, indication of Amitriptyline is to helps with sleep and pain with the muscle, it is a muscle relaxer and helps her to sleep. On unspecified date, the patient experienced my arm is little sore yesterday. The patient seriousness reported as unspecified. The patient did not receive lab tests. The outcome of the event is recovering on unspecified date.  Information about lot/batch number has been requested.
began running a low grade fever; This spontaneous report was received from a nurse who refers to himself - a male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, after he received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the patient began running a low grade fever.  The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
pressure in her head; fever; nausea; chills; body aches and muscle pain; joint pain; bad intense headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (pressure in her head), PYREXIA (fever), NAUSEA (nausea), CHILLS (chills) and MYALGIA (body aches and muscle pain) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced HEAD DISCOMFORT (pressure in her head), PYREXIA (fever), NAUSEA (nausea), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (bad intense headaches). On an unknown date, the patient experienced MYALGIA (body aches and muscle pain). At the time of the report, HEAD DISCOMFORT (pressure in her head), PYREXIA (fever), NAUSEA (nausea), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (bad intense headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to INC.-MOD-2021-090357 (E2B Linked Report).; Sender's Comments: INC.-MOD-2021-090357:
Case number PHEH2015US022027, is an initial spontaneous report from a health care professional received on 26 Oct 2015. This report refers to a 3 years and 6 months old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 157104) intramuscularly on 22 Oct 2015. No adverse event was reported.
early and prolonged menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of OLIGOMENORRHOEA (early and prolonged menstrual cycle) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced OLIGOMENORRHOEA (early and prolonged menstrual cycle). At the time of the report, OLIGOMENORRHOEA (early and prolonged menstrual cycle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.
Exposed to cousin with varicella 12/23/02; Child had varivax on 07/21/99; Fever q HS - (99 ax) No recent meds or Tx; Scattered macular papular rash trunk extremities; no real papules or crusting
Upon awakening the morning following the vaccination, patient c/o pain and aching in the groin bilaterally. The patient was evaluated by his physician and treated for an infection of unknown cause with prescribed antibiotics.
Developed a itchy rash and that night should became very sore and by the next morning there was a hot, red chicken size lump that was very painful. By the evening of March 27 the lump was the size of my palm (4 inches across) and still extreme itchiness.  The lump, and itchiness did not go away until Monday the 29th and the rash and pain didn't go away until the 31st
Started to get bad headace's that would last 2-3 day's about 2 wks ago. I never had this problem before.
I had a sore arm for a couple of days. I went to the ER.  They found a blood clot in my right lungs.
Redness, swelling, hot to touch 3-4 cm lump in muscle and irritation
At 12 hours - woke up with sore arm.  At 24 hours - vaccination site started swelling and bruising.  At 36 hours - swelling increased, redness/bruising now 2 1/2" wide x 1 1/2" high.  At 48 hours - swelling still increasing (long, wide bump) and redness/bruising now 3 1/2" wide x 2 1/2" high.  Very painful, weakness in arm, overall body fatigue.  Then, on 4th day, swelling and redness/bruising started decreasing, pain lessened.
Caller stated that she received her vaccine on 02/20/21 and the next day the injection site became red and oval in shape measuring 1x4 inches, not sore or discomfort of any nature. Then today 02/23/2021 the redness extended to the rest of the arm and still no discofort of any nature. Patient asked to follow up with her PCP for further evaluation.
I noticed a significant vaginal prolapse while showering, 11/12/22, the day after of receiving a Pfizer bivalent vaccine 11/11/22. There was no prolapse 11/10/22 and I did not notice one 11/11/22. I did nothing different in between the time of the vaccine and the following evening. I spent most of my day laying on the cough with a low grade fever. The prolapse has subsided by the time I went to my visit my PCP on 11/17/22 so no labs were done.