chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient she is currently on hold from Prolia until she is given the ok from prescriber to resume in February. Prescriber wants her on hold until she is finished both her covid shots. Patient had covid this year and was in the hospital for 5 days, which damaged her lungs and heart and now on a pacemaker. She got her first covid shot last saturday 12/4/21 and her BP dropped to 66, she went to hospital to make sure it wasn't her pacemaker.
12:30 Post vaccination reports generalized chest pain w/no associated symptoms, NAD, denies any sob/dizziness; medical monitoring x 30 min, rest, po hydration offered; vitals assessed: BP 114/87 P64 RR20 O2 sat 98% RA. "Some" chest pain persists post monitoring w/ recommendation for ER evaluation/ treatment w/relative decline. Released from facility w/daughter.
3rd time getting Covid-19; 3rd time getting Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 84-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 83 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown), on 22Feb2021 as dose 2, single (Batch/Lot number: unknown), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: Sep2021, stop date: Sep2021; "COVID-19", start date: Aug2022, stop date: Aug2022. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (Sep2023) and all described as "3rd time getting Covid-19".  The clinical course was reported as follows: The elderly patient was in great health and doesn't take any medications. He has always had the Pfizer vaccine for Covid-19 and stated that he was up to date on the vaccines. In Sep2023, approximately 10-12 days ago he had the third round of Covid-19. He was now negative for Covid-19. He informed that over the last 3-4 years he had Covid-19 three times (he got Covid-19 the 1st time in Sep2021, 2nd time in Aug2022, and 3rd time last week in Sep2023). Every 12 months he has had Covid-19. No treatment was received except resting and tea. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 125/80, notes: normal range; SARS-CoV-2 test: (Sep2023) Positive; (Sep2023) Negative. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300300966 same patient/drug/AE, different dose number/event onset date;US-PFIZER INC-202300301887 same patient/drug/AE, different dose number/event onset date;
cancer has spread to pelvic area and possibly kidneys; ureter stenosis; fever; chills; diarrhea; increased muscle weakness; fatigue; decreased activity; elevated creatinine; i don't feel that great; This is a spontaneous report received from Pfizer sponsored program student. A contactable other HCP and a contactable consumer (patient herself) reported that a 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation; sunitinib malate (SUTENT), via oral route of administration from 03Mar2020 and ongoing, at 25 mg, daily (once daily) for renal cell carcinoma. The patient's medical history and concomitant medications were not reported. It was reported that after COVID vaccine, the patient experienced fever and chills, diarrhea, increased muscle weakness, fatigue, decreased activity, elevated creatinine, ureter stenosis on an unspecified date. The PET scan today showed cancer has spread to pelvic area and possibly kidneys and patient stated "I don't feel that great.'' md aware. The patient underwent stent placement for the event ureter stenosis, and it was resolved after stent placement. The action taken in response to the events for sunitinib malate was dose not changed. The outcome of the events ureter stenosis, fever, chills, diarrhea was recovered on an unspecified date and it was unknown for other events.   Information on the lot/batch number has been requested.; Sender's Comments: Based on known disease pathophysiology, the event of Neoplasm progression, stenosis ureteral are assessed as not related to BNT162B2, and more likely due to underlying medical condition of kidney cancer.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Moderna vaccine as given as indicated above but recorded in chart as Pfizer-BionTech COVID-19 vaccine, resulting in second dose being given as Pfizer-BionTech vaccine rather than Moderna
breasts look lopsided.; extremely uncomfortable; could barely sleep; left breast firm, tight; Aggressive capsular contracture of breast implant; left breast firm, tight, and swollen.; breast got progressively larger, firmer, tighter, and more uncomfortable.; a cyst-like bump between  left arm pit and bicep; This is a spontaneous report from a contactable other healthcare professional, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Concomitant medication included unspecified medications for birth control taken from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via an unspecified route of administration in the left arm on 25Feb2021 (at the age of 36-years-old) as a single dose 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 four weeks prior to the vaccination. On 24Mar2021, the patient noticed a cyst-like bump between her left arm pit and bicep. It gradually had gotten smaller since then and at the time of this report it was very tiny but was still there. On 05Apr2021, the patient experienced sudden/ aggressive capsular contracture of breast implant and noticed left breast felt firm, tight, and swollen. No discomfort but it felt different. Her two breasts were not visibly different at this time. Each day for the next 5 days after this her left breast got progressively larger, firmer, tighter, and more uncomfortable. On 10April2021, the patient could barely sleep because left breast felt so uncomfortable. It looked significantly different and her two breasts look lopsided. The left breast was pushed up very high and looked huge compared to the right. She was extremely uncomfortable and only way to fix that may be surgery. Surgeon said he had never seen a case come on as sudden and "impressive" as this. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with SINGULAIR from 08Apr2021. The clinical outcome of the event a cyst-like bump between left arm pit and bicep, aggressive capsular contracture of breast implant, left breast firm, tight, and swollen and more uncomfortable, breasts look lopsided, extremely uncomfortable and could barely sleep were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
5/10/03: Onset headache at base of skull - self treated with ASA. 102 degrees F temp (headache). 5/11/03: Sore throat, continued headache, general malaise. 5/12/03: Flu-like symptoms: ache all over, sore throat, pounding headache. 5/13/03: Continue with same - to bed "real sick". 5/14/03: Symptoms continued. Self treated with ASA. Called Health Dept to report symptoms. Told to discontinue ASA. 5/15/03: Seen by private physician. Pt told likely exposed to flu after vaccination and immune system weakened due to it being challenged by vaccination. By PM feeling a little better. 5/16/03: Achy but no headache. 5/17/03: 95% well. 5/19/03: Back to work. Off work 5 days total. Very rare for this patient. Scab still on as of 5/19/03. No erythema. This is day 28.
Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 48-year-old male. Neither medical history nor concomitant medications were reported. On 24-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
Flu-like symptoms; Chills; mild fever; achy joints; This is a spontaneous report from a contactable consumer (Patient). A 51-years-old male patient received BNT162B2 (COMIRNATY; Formulation: Solution for injection, Batch/Lot Number: EL3248), via an unspecified route of administration, administered in Arm Left on 12Feb2021 08:00 (at the age of 51-years-old) as dose 2, single for COVID-19 immunization. Medical history was reported as none. No other vaccine was given in four weeks. No known allergies were reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Historical vaccine included BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EL3248), via an unspecified route of administration, administered in arm left on 22Jan2021 08:00 (at the age of 51-years-old) as single for COVID-19 immunization. There were no concomitant medications was given in two weeks. On 13Feb2021 02:00 the patient experienced flu-like symptoms, chills, mild fever and achy joints. Patient did not receive any treatment for events. The outcome of the events was recovered on an unspecified date and month of 2021.  Follow-up (25Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation for Pfizer receipt date. Response received and awareness date was confirmed as 13Feb2021 the day after the vaccine was administered.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Narrative: Patient received 2nd vaccine at an outside facility  on 04/20/21 and reported N/V since getting vaccination.
24 hours following vaccine administration pt. developed irritability and choreoathetoid type movements of upper extremity
Pt. returned to our office on 5/30/23 with left sided facial swelling.  Mother reported facial swelling started the 3 days after vaccination, increased in size 4 days later and she also had mild nasal congestion. On June 5, she presented to our office again with much increased facial swelling which was very firm. She also was noted to have pallor, bruising on her face and legs, and  an enlarged liver and spleen
Parent called to report the child broke out in hives from head to toe. They called their family doctor and were told to take otc Benadryl. The hives resolved without further treatment. As of 10/13/23 child is without hives. No other symptoms were noted by parent.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 63-year-old patient who received SHINGRIX (batch number P57AA, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 9th March 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, erythema of extremities and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were unknown and the outcome of the erythema of extremities was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, erythema of extremities and injection site pain to be related to SHINGRIX. Additional details were provided as follows: After receiving the 2nd shot of SHINGRIX on Saturday before reporting date on left arm, the patient experienced normal side effects of redness, localized swelling in area around the injection site and pain, but at the time of reporting, the patient experienced that, the stripe of redness had begun at the edge of primary swelling was heading towards chest by leaving the generalized area. The stripe of color begun at the edge of the swelling was approximately 1 to 2 inch wide and about an inch and a half to 2 inch long. The patient just wanted to make sure that there was not some type of infection developing that was traveling in bloodstream. The patient's oncologist suggested to receive these vaccines before beginning rituxan infusions.
Information has been received from a certified medical assistant concerning a 19-year-old female with allergic reaction to antibiotics and a history of seizures who was vaccinated with her first dose of RECOMBIVAX HB (manufacturer unknown).  Concomitant therapy included CARBATROL and NEURONTIN. Subsequently the day after vaccination, the patient experienced a pre-seizure visual aura with no accompanying seizure. It was noted that the patient never had a seizure with this aura, the date and duration of the aura was unclear. Subsequently, the patient recovered from pre-seizure visual aura. The series was not continued. The patient's medications at the time of this event were unknown. Additional information to report. Additional information has been requested.
I started feeling a pressure from my shoulders up into my head. My ears had so much pressure like I was on a plane but they wouldn't pop. I had zero congestion though. Went to Dr the 8/20/2021 and had a fever of 99.7 & was told I was having inflammation from the vaccination & to take some muscle relaxers for 7-10 days. The pressure in my head and ears was so bad I went to Dr a week later & she said she has also been seeing this and I am having inflammtion from the vaccination.  No fluid in my ears & externely everything looked fine. She said my eustachian tubes were inflammed. She suggested nasacort, sudafed, & 600 mg of ibuprphen daily for the next week.Also had a slight case of TMJ from the imflammation so told to try soft foods for the week as well.  Went back to Dr. & she decied we try Predniose for 10 days.  40 mg for 5 days and 20 mg for 5 days.  I made it without any releif to day 6 and ended up going to the ER for chest pains & the headache.  They took a CT Scan, chest xray, blood work, & covid test.  Everything came back looking good so said they also believed I was having an adverse reaction to the vaccination.  They then put me on Lorazpam for 5 days to try to sleep because the back of my head is so paingul and they pressure in my head gets worse as the time goes on.  They also suggested ibuprophen & acetaminophen as well.  MRI was done a few days later & everything came back looking good with that too.  I am still having pressure in my head, shooting pains in neck, muscle pain in my shoulders & some pain in my right arm.  I am trying to get into more doctors but everyone is backed up.
Mild headache and nausea one day after first dose. After the second dose I had fever greater than 101 with nausea and fatigue about 15 hours after the injection. About 36 hours after the injection I had a rash from my shoulders to my calves but it wasn?t itchy. After about 48 hours the rash extended up my neck and my lips became hot and tingly. I took some Benadryl and went to the emergency room and the physician stated it was hives gave me Allegra Benadryl and prednisone to start taking if my symptoms do not improve in 24 hours. I did not have any lip or tongue swelling or breathing difficulties. About 60 hours after the vaccine the rash started to recede and  the the fever came down.
Weakness in hands, feet and legs; Facial numbness and drooping 30 mins after injection; Facial numbness and drooping 30 mins after injection; This is a spontaneous report from a contactable consumer (patient).  A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 12Mar2021 14:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization at age 26 years old. The patient was not pregnant at the time of vaccination. The patient had covid prior to vaccination. No known allergies. Patient was not tested post vaccination. There were no concomitant medications. No other vaccines in four weeks and no other medication in two weeks. On 12Mar2021 14:30, 30 mins after injection, the patient experienced facial numbness and drooping 30 mins after injection. On 13Mar2021 02:00, weakness in hands, feet and legs starting 12 hours after injection. Treatment was not given for events. The patient had not recovered from the events.    Information about lot/batch number has been requested.
Initially, after the first shot, I felt fatigued. Ten days later, I woke to neck and face tremor with shaking in lip on 5/17/2021. Each night since I have have tingling and electrical sensations in neck, mainly on the left but have noticed it on my right a couple of times as well. I woke to a tremor sound in my left ear another night. Face sensations and lip shaking on two additional occasions and the other nights, a tingly, electrical current type tremor. These last only a short moment but it's scary. I have never had any health issues. I also have mild twitching at night in legs and arms. Maybe I am more sensitive and attuned now but I think that is also related to these other symptoms.
very sleepy all day following vax only awoke for a few swallows @ feeding exam nl 24 hrs p/vax;
pt recvd vax;2-4hrs later T 102;apap given q 3 hrs per mom;1st noc T inc to 106;to er;given pediaprophen;T remained 102 w/ meds until am of 3rd day;mom stated pt had convulsive movements w/ T;
PAIN IN THE LOWER RIGHT SIDE STOMACH; SWOLLEN STOMACH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced pain in the lower right side stomach, and swollen stomach. The action taken with covid-19 vaccine  was not applicable. The outcome of the pain in the lower right side stomach and swollen stomach was not reported. This report was non-serious.
Patient received an adult dose of Hep A (1.0 ml). Mom was informed. On 3/23/18 I called mom to follow-up. She said there was no issues more than normal. Patient didn't complain of arm soreness more than usual.
Fever, rapid heart beat, chills, aches in all joints, extreme headache, fatigue, sleepy.
experienced vertigo; tightness on the chest; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (experienced vertigo) and CHEST DISCOMFORT (tightness on the chest) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot in September 2020.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (experienced vertigo) and CHEST DISCOMFORT (tightness on the chest). At the time of the report, VERTIGO (experienced vertigo) and CHEST DISCOMFORT (tightness on the chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Left thigh and redness and swelling one hour after injection, erythema ensued 2 days later was treated for cellulitis.
Marine father received smallpox vaccine 01/27/05. Patient - daug came in contact with vaccine site 02/06/05. She touched her forehead and broke out with one lesion mid forehead 02/12/05. Father received vaccine at Camp Pendleton Base.  Information from Follow-up report states: Daughter didn't receive vaccine. Inadvertent contact with Father's smallpox vaccine occured 2-12-05. Father had rec'd smallpox vaccine 1-27-05 for military service.
Post second vax which was hepatitis A IZ, this child fainted and lost consciousness. BP and pulse remained nml. No respiratory distress or resuscitation was needed. He was placed in supine position with leg elevation. Cold compresses applied. He regained consciousness within two to three minutes and left clinic unassisted.
Small erythema and warmth 1 inch x 3/4 inch posterior left arm.
large round red circle at injection site. Non-painful, no itching.  Unsure when it developed.