chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pneumonia of both lower lobes due to infectious organism. He received loading dose of micafungin subsequently changed to flucanzole for fungal pneumonia coverage given his immunosuprresion. Hospital course was complicated by worsening acute hypoxemic respiratory failure and also developed severe thrombocytopenia (45k) with epistaxis complicating oxygenation via Hi flo NC.  Patient was moved to ICU on 01/14 for continuous CPAP with breaks. Since he did not improve on 8 days course of  IV meropenem, doxycycline and fluconazole and so it was discontinued. Patient was started on Solu-Medrol 1 g IV for 5 days due to concern for interstitial pneumonitis from Keytruda and treated for pneumocystis pneumonitis with clindamycin and primaquine. He will complete a total of 21 days for clindamycin and primaquine.  He also need to complete a tapered dose of prednisone.  Oxygen DME will be set up through Medical for his home O2 needs.   ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
2 hours after injection I began to develop uncontrollable shivering and chills. Within three hours of injections I was feverish and had muscle spasms at injection point. At 4 hours post injection I had a fever of 101 degrees Fahrenheit. 8 hour after injection I had a fever of 103 degrees Fahrenheit. All symptoms including fever ranging from 101 to 103 degrees persisted until afternoon of the third day post injection. Following the break of the fever and persisting up through current day I have trouble taking full breaths, especially under strenuous activity and consistently have a tight feeling in my chest.
This spontaneous report as received from a physician refers to a 47 years old female patient. The physician mentioned the patient did not respond to RECOMBIVAX HB therapy (therapy date, dose and route not reported). The patient did not seek medical attention. At the time of this report the patient's status was not known. Additional information is not expected.
I started another period 7 days later; this period is heavy and has more intense cramping.; I started another period 7 days later; this period is heavy and has more intense cramping.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 17:00 (Lot number: FF2589) at the age of 28 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "I was diagnosed with COVID", start date: Mar2021 (unspecified if ongoing), notes: I was diagnosed with COVID in Mar.; "filshie clamps on my Fallopian tubes" (unspecified if ongoing), notes: I am not on any birth control or hormones, I have filshie clamps on my Fallopian tubes is all. There were no concomitant medications. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Dose Number: 01, Administration time: 03:00 PM, Vaccine Location: Left arm, Lot number: F63180), administration date: 15Aug2021, when the patient was 28 years old, for covid-19 Immunization, reaction(s): "7 days after my vaccination I started my period again & it lasted 5 days.". The following information was reported: DYSMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 15Sep2021 19:00, outcome "not recovered" and all described as "I started another period 7 days later; this period is heavy and has more intense cramping.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysmenorrhoea, heavy menstrual bleeding. The patient had her period a few days before getting her 1st dose, 7 days after vaccination, started her period again & it lasted 5 days. Now, after 2nd dose, started another period 7 days later; this period was heavy and had more intense cramping. Between Aug and this 17Sep, patient had 3 periods. Before getting first vaccination, her periods were always 30 day cycles and regular. Patient was not on any birth control or hormones, had filshie clamps on my Fallopian tubes was all. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, was the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Follow-up attempts are completed. No further information is expected.
Feeling hot; Cold; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), FEELING HOT (Feeling hot) and NASOPHARYNGITIS (Cold) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not reported).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever), FEELING HOT (Feeling hot) and NASOPHARYNGITIS (Cold). At the time of the report, CHILLS (Chills), PYREXIA (Fever), FEELING HOT (Feeling hot) and NASOPHARYNGITIS (Cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided. Treatment information was not provided.
Case number PHEH2012US015198 is an initial spontaneous report received from a physician on 29 Jul 2012: This report refers to a patient of unknown age group and gender. This patient given only the CYW-135 liquid component of MENVEO vaccine (batch number: unknown) on unspecified date. No other adverse reaction was reported following this administration error.
Pt received hepatitis vaccine in right deltoid, soon after arm started to ache and now she is unable to put arm above head and has pain with lifting her arm
Received vaccine on 1/18/02; reports body swelling on 1/19/02. Also broke out in a pustular rash on 1/19/02. On 1/20/02, reports difficulty breathing in the evening.
Patient fainted approximately 10 minutes after immunization was given.  Before syncope, he asked for water as he was feeling strangely.  He was seated when he fainted and he simply slumped in the chair.  He was unconscious for about 2 minutes before regaining consciousness.  He declined calling 911 but a employee who is EMT certified evaluated the gentleman.  Pulse was found to be low.  911 was called and the patient was further evaluated by city EMT personnel.  They did not transport the patient for further care .  He left the premises within 30 minutes of the syncopal episode under his own power.
Within 2 hours of infanrix hexa injection of the vaccine to the left upper thigh, the patient experienced non-blanchable petechiae like area to the right lower leg and large area of purpura to bottom of right foot. Patient was advised to come back to pediatrician office for assessment. Reference was made to condition called "discolored leg syndrome."
Vial Mix up,  Janssen diluted and given instead of Pfizer.  Patient called and notified. working on plan to give appropriate 2nd dose vaccination
Patient had vasovagal syncope  ( due to anxiety) after being vaccinated roughly 5-10 minutes afterwards while sitting in post observation area. His mother was with him and propped him up from falling out of the chair until I and my other staff could assist. Propped his feet up with another chair, provided and ice pack and a bottle of water. Patient was fine after sitting for an additional 5-10 minutes.
sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), . The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), as dose 1, 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: That all of her shots including the 3 boosters she had had were all Pfizer. She had absolutely no complications and only a sore arm after each shot. That made her want to always use the same pharma company going forward.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300035212 same patient/event, different vaccine dose;US-PFIZER INC-202300035213 same patient/event, different vaccine dose;US-PFIZER INC-202300035214 same patient/event, different vaccine dose;US-PFIZER INC-202300035215 same patient/event, different vaccine dose;
Flu like symptoms; Feeling badly; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), FEELING ABNORMAL (Feeling badly), CHILLS (Chills) and PYREXIA (Fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), FEELING ABNORMAL (Feeling badly), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), FEELING ABNORMAL (Feeling badly) and CHILLS (Chills) had not resolved and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is on several concomitant medications and stated it will be available if necessary.
This case was reported by a consumer via call center representative and described the occurrence of cardiac insufficiency in a 65-year-old male patient who received ROTARIX (batch number ROT001, expiry date 31st December 2018). Co-suspect products included SHINGRIX (batch number SHG001, expiry date 30th August 2020), TWINRIX (batch number TWIN001, expiry date 13th September 2018), BREATHE RIGHT NASAL STRIPS ADVANCED (batch number BREATH01, expiry date 1st January 2022) for snoring and ADVAIR inhalation powder (batch number ADV003, expiry date 1st June 2018) for chronic obstructive pulmonary disease. On 15th December 2017, the patient received the 1st dose of ROTARIX (catheter) 10 mcg/mg. On 1st March 2018, the patient received the 1st dose of SHINGRIX (injection) 50 mg. On 27th February 2018, the patient received the 1st dose of TWINRIX (injection) 33 mcg/mg. On 25th February 2018, the patient started BREATHE RIGHT NASAL STRIPS ADVANCED. On 20th February 2018, the patient started ADVAIR (inhaled) 100 mcg/mg once daily. On 1st March 2018, 76 days after receiving ROTARIX, an unknown time after receiving SHINGRIX, 2 days after receiving TWINRIX, 4 days after starting BREATHE RIGHT NASAL STRIPS ADVANCED and 9 days after starting ADVAIR, the patient experienced cardiac insufficiency (serious criteria hospitalization and GSK medically significant). On 2nd March 2018, the patient experienced arterial fibrosis and nausea. On 3rd March 2018, the patient experienced felt faint. On 4th March 2018, the patient experienced shortness of breath. ROTARIX was continued with no change. SHINGRIX was continued with no change. TWINRIX was discontinued. ADVAIR was discontinued on 2nd March 2018. On 2nd March 2018, the outcome of the arterial fibrosis was recovered/resolved. On 5th March 2018, the outcome of the cardiac insufficiency was recovered/resolved. On an unknown date, the outcome of the nausea, felt faint and shortness of breath were unknown. It was unknown if the reporter considered the cardiac insufficiency, arterial fibrosis, nausea, felt faint and shortness of breath to be related to ROTARIX, SHINGRIX, TWINRIX, BREATHE RIGHT NASAL STRIPS ADVANCED and ADVAIR. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.
high fever w/gen sz for approx 30min or more;this happened about 30hr p/vax;
Dizziness; My arm hurt hurt real good; Loss of appetite; I wanted to sleep a lot; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN IN EXTREMITY (My arm hurt hurt real good), DECREASED APPETITE (Loss of appetite) and HYPERSOMNIA (I wanted to sleep a lot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Diabetes. Concomitant products included INSULIN for Diabetes.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced DIZZINESS (Dizziness), PAIN IN EXTREMITY (My arm hurt hurt real good), DECREASED APPETITE (Loss of appetite) and HYPERSOMNIA (I wanted to sleep a lot). At the time of the report, DIZZINESS (Dizziness), PAIN IN EXTREMITY (My arm hurt hurt real good), DECREASED APPETITE (Loss of appetite) and HYPERSOMNIA (I wanted to sleep a lot) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   The patient has a lot of side effects with medicines. Moreover, when she take her insulin shot, it puts her out and go right to sleep.  No treatment information was provided. Sender's Comments: This case concerns a 73-year-old, female patient with history of hypertension and diabetes non relevant for the case, who experienced the unexpected non-serious adverse event of special interest of hypersomnia. The event occurred on the same day after the first dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was unknown since the event occurred after the first dose and there is no information about the second. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.
Patient came to pharmacy requesting a shingles vaccine the pharmacist administered vaccine and have administration realized patient had already received the Shringrix series 1st dose  7-17-2020 and 2nd dose 9-15-2020. Pharmacist called patient and no reactions to this 3rd vaccine
The initial event started the night of the vaccine with sore arm, tired, achy ,fever and lasted about 36 hours. Swollen lymph nodes on left side (neck) for two weeks, I could not lift my arm (24 hours). Unable to go to work for 2 days. By the third day, felt fatigue and tired but able to work. Thyroid nodules was biopsied because it was so swollen and painful. Took Tylenol for the pain, warm compresses to get relief.
Mother calls per phone, reports right thigh is swollen, red with a hard knot in the same area of the shot he was given 10/21/2002. Child has not been ill or febrile since immunizations. local reaction began same day of injection 10/21/2002 and continues today 11/1/02.
No side effects were reported; HCP calling to report that expired MMRII was inadvertently administered to a patient today, 11/1/2023. HCP reports the vaccine had not experienced any temperature excursions. No side effects were reported. No additional information/clarification prov; This spontaneous report was received by a pharmacist reporting a patient with 49 years old of unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.  Health Care professional (HCP) was calling to report that expired Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)albumin status rHA (route was not reported) (0.5 ml, lot# U022174, expiration date: 14-JUL-2023 for prophylaxis) was inadvertently administered to this patient today, (01-NOV-2023). Additionally patient received sterile diluent (MERCK STERILE DILUENT) 0.5 ml.      HCP reported the vaccine had not experienced any temperature excursions. No side effects were reported. No additional information/clarification provided. No additional Adverse Event (AE)/no Product Quality Check (PQC).
Five minutes post injection pt c/o dizziness and blurred vision.  BP decreased.  Symptoms started subsiding after 5 minutes.  Discharged to home with no further complaints 20 min post injection.
Headache, Myalgia, Arthralgia, Fever,  chills, arm swelling and arm pain Narrative:
Pt reported left arm pain and swelling on 4/21/21.  She received the J&J COVID vaccine on 4/6/21 and had an ultrasound done which showed an acute left axillary vein thrombosis
Patient passed out in grocery store approx 5 minutes after receiving vaccine. Patient reports not having meal in >6 hours. Passed out for 3 seconds. Patient was diaphoretic and pale.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the parent. A 17-year-old female patient received BNT162b2 (BNT162B2), on 07May2021 as dose 2, single (Lot number: EW0171) at the age of 17 years for Covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (First Covid vaccine: 16Apr2021, Vaccine Lot Number: EW0153), administration date: 16Apr2021, when the patient was 17-year-old, for COVID-19 immunization, reaction(s): "urinary retention". The following information was reported: URINARY RETENTION (medically significant), CONDITION AGGRAVATED (medically significant) all with onset 28May2021, outcome "not recovered" and all described as "The symptom of urinary retention has gotten worse ever since". The event "the symptom of urinary retention has gotten worse ever since" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of urinary retention, condition aggravated. Clinical course: The consumer's daughter received Pfizer Covid vaccine. Two days after receiving the first dose, the consumer's daughter could not urinate and had to be taken to an ER room to have a catheter placed in her bladder to release her urine. Then she was normal. She developed the same symptom again after 2nd. The symptom of urinary retention had gotten worse ever since. The consumer was inquiring about his 17 year old daughter, who had the first two shots of the Pfizer Covid vaccine, the first one in Apr2021 and the second one 3 weeks later. The consumer reported his daughter did receive a booster of the Moderna Covid vaccine. Reported that two days after the first vaccine, his daughter experienced urinary retention. A catheter was placed in the emergency room, and it resolved. 3 weeks after the second dose this event happened again. Stated that the symptoms of urinary retention has gotten worse, despite going to many doctors, who had no explanation for the event. Reported his daughter was released from the emergency room. He reported his daughter went to several doctors such as a Urologist and Primary Care doctors and there was no explanation for the event. He stated that this was a booster vaccine that was given to his daughter. He stated that his daughter had continued symptoms after this booster as well. Prior Vaccinations (within 4 weeks), no other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Sender's Comments: Linked Report(s): US-PFIZER INC-202200828361 Same patient, drug, and event separated in time.
Post vax, given on 8/14/00, pt awoke on 8/16/00 with severe headache and rash on his chest. During the day, this spread to his arms and legs. His headache did not respond to Tylenol. Mother called health dept. on 8/17/00 to ask if MMR would cause this severe headache and she was advised medical follow-up ASAP. Seen in ER and started on doxycycline and Ultram for headache. Remains ill at this time.
Woke up shivering uncontrollably, headache, muscle weakness.  Temp got to 102.8 even after taking Tylenol.  Sudden onset of nausea and threw up several times in a row, but it stopped.  No respiratory issues.  Severe symptoms subsided by midday Sunday.  Did get Covid test that afternoon, which was negative.  Low fever for another day along with weakness.  My arm was sore for several days, but that was not unexpected.
Information had been received from a physician concerning female, who in April 1999 was vax with varicella, concomitant therapy included cisapride and cimetidine. On June  2, 1999, the pt experienced a varicella like rash consisting of approximately 7 pustular lesions on the chest but no fever. The patient also experienced itching.
This case was reported by a physician via call center representative and described the occurrence of injection site edema in a 18-year-old female patient who received BEXSERO. On 10th August 2017, the patient received the 1st dose of BEXSERO. In August 2017, less than a month after receiving BEXSERO, the patient experienced injection site edema, injection site erythema and injection site tenderness. The patient was treated with BENADRYL (nos). On an unknown date, the outcome of the injection site edema, injection site erythema and injection site tenderness were unknown. It was unknown if the reporter considered the injection site edema, injection site erythema and injection site tenderness to be related to BEXSERO. Additional details were reported as follows: The patient experienced subcutaneous edema, erythema and tenderness of the deltoid at the injection site. The patient was advised to apply ice and take BENADRYL. No further medical intervention was required. The exact injection site was not reported. The lot number was unknown.
This spontaneous report was received from a registered nurse and refers to an 11 year old male patient. The patient's medical history included hives as the reaction to unspecified penicillin. The patient did not have pertinent medical history. On 18-JAN-2016, the patient was vaccinated with a dos of GARDASIL 9 lot # L017407, expiration date 15-AUG-2017, intramuscularly (strength and dose were not provided). The patient did not take any concomitant medication. On 29-JAN-2016, the patient developed a rash and hives on the armpits and ankles that eventually spread over his entire body by an unspecified date in 2016. On an unspecified date in 2016, the patient received LOTRISONE cream as the treatment for the rash and hives. The patient recovered from the rash and hives on an unspecified date in 2016. Then, the treatment with LOTRISONE was discontinued on an unspecified date in 2016. On 25-MAR-2016, the patient was vaccinated with another dose of GARDASIL 9 lot # L024993, expiration date 17-OCT-2017, intramuscularly (strength and dose were not provided). On 28-MAR-2016, the patient developed a rash an hives on only the back of the arms and armpits. Then, on an unspecified date, the patient was started on LOTRISONE cream therapy for this new case of rash and hives. At the time of the reporting, the patient was recovering from the new rash and hive. On an unknown date, the patient underwent "strep test" but no result was provided. The patient sought medical attention via seeing the physician. The relatedness between the events and GARDASIL 9 was no reported.  Additional information has been requested.