chrisvoncsefalvay/vaers-outcomes huggingface dataset:
47y.o. female with PMH of asthma, who presented to the hospital complaining of chest pain and shortness of breath. She also complains of cough, body aches and sore throat for last few days . She came to the ER for evaluation. She was tested positive for COVID . She was placed on oxygen 2 L NC and was admitted with consult to pulmonary and ID. She was placed on po steroids and started on paxlovid by ID. She had low grade fever yesterday. No N/V/D or abdominal pain . CTA PE negative for any acute process or PE, she is feeling better now, on RA , labs stable, D dimer improving , we will discharge her home today after home o2 eval. Will discharge on paxlovid for 4 more days and prednisone for three days. managed expectantly. She was then stable for discharge home with instructions to maintain aggressive oral hydration. She was additionally given information on isolating for positive COVID test. I attempted to contact microbiology lab to obtain cycle threshold from her positive test, however I was unable to contact them. Patient was recommended for continued COVID isolation at home with repeat testing. If she has 2 consecutive negative rapid tests, this is reassuring that her PCR was a hold over from previous positive infection and isolation can be successfully removed. On a final note, patient asked for appetite stimulant. She stated that cannabis-derived appetite stimulants were not successful for her in the past including Marinol. Main barrier to her nutrition is her lack of taste and smell which is secondary to previous chemotherapy. She was given a trial of low-dose Remeron. Patient was discharged home in stable condition with no restrictions on diet or activity to continue medications and follow up with physicians as listed below.
Patient seen today due to mom's concern of swelling and redness at site 2 days post immunization and redness increasing in size, warm to touch, and pain when walking. Redness measures approximately 6x8 in in diameter on RVL. Patient dx with cellulitis and tx with ABX.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 38 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Oct2022 at 15:45 as dose 4 (booster), single (Lot number: 051D22A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "Chronic depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codine, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Dec2022) Negative; (09Dec2022) Negative; (17Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid from 02Dec2022 to 06Dec2022.
pt recvd vax & 5 days p/vax exp inc irritability; afebrile; no evidence of sepsis or breakdown of surgical repair; doubt relationship of demise to vax but due to proximity, felt necessary to report;
This case was reported by a consumer via call center representative and described the occurrence of chills in a 53-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (experienced after receiving 1st dose on 19th September 2018, refer case US2018175499). On 3rd December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 4th December 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fever, joint pain, general body pain and influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, fever, joint pain, general body pain and influenza-like symptoms were unknown. It was unknown if the reporter considered the chills, fever, joint pain, general body pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: A day before the date of reporting at 2 pm, the patient received SHINGRIX on the left arm. On the day of reporting, the patient woke up with chills, fever, joint ache, body ache and flu like symptoms. The reporter had given consent to contact her physician. No further details were provided.
Vaccinee rec'd 3 doses of Engerix-B following exposure to Hepatitis B & didn't seroconvert;
Narrative: arm pain for 1-2 days headache for one day, diarrhea on 1/20/21 for one day - all symptoms have resolved  Other Relevant Hx: Symptoms:  Headache, Diarrhea & injection site pain Treatment:
arm swollen red and warm to touch. Pt states arm is achy and painful. Has improved since date of inj. advised to toake Benadryl and ice
Developed severe pain in left shoulder and periscapular area on 8/12/19 with limited shoulder ROM and scapula winging that was not improving with NSAIDS, ice/heat, and rest. Diagnosed with Parsonage Turner Syndrome on 8/21/19 by sports medicine provider and given prescription for gabapentin for pain control.
vaccine was administered without issues; several minutes after administration, pt was sweating, flushed, light headed and said her chest felt heavy. pt remained seating and was instructed to rest, water was offered, pt took 50mg benadryl and still wasn't feeling good, 911 was called; pt did not lose consciousness, EMT evaluated pt (didn't notice any hives but pt may have been hyperventilating) and ended up transporting pt to hospital
Possible Endo Or Pericarditis; Possible Endo Or Pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Possible Endo Or Pericarditis) and ENDOCARDITIS (Possible Endo Or Pericarditis) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 PERICARDITIS (Possible Endo Or Pericarditis) (seriousness criterion medically significant) and ENDOCARDITIS (Possible Endo Or Pericarditis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (Possible Endo Or Pericarditis) and ENDOCARDITIS (Possible Endo Or Pericarditis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant and treatment information provided.  Company Comment: Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
I had a sore arm for a couple of days and that was it. I started not feeling well on 12/11/2022 I had a runny nose and sore throat. It was progressed to fullness in the ears, headache and runny nose. I went to an urgent care and was diagnosed with a sinus infection and double ear infection.  I was prescribed prednisone for my symptoms. I tolerated the medication. As of today, I still have drainage in the back of throat.
breakout with itchy rash all over body; breakout with itchy rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (breakout with itchy rash all over body) and PRURITUS (breakout with itchy rash all over body) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.    Co-suspect product included non-company product zytec for an unknown indication.    Concomitant products included SALBUTAMOL (ALBUTEROL HFA), ALPRAZOLAM (XANAX), APIXABAN (ELIQUIS), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN (LIPTOR [ATORVASTATIN]), BUMETANIDE (BUMEX), MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC), COLECALCIFEROL (VIT D3), GABAPENTIN, LANSOPRAZOLE, LACTOBACILLUS ACIDOPHILUS (LACTOBACILLUS) and PRIMIDONE.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started zytec (unknown route) at an unspecified dose. On 17-Jan-2021, the patient experienced RASH (breakout with itchy rash all over body) and PRURITUS (breakout with itchy rash all over body). At the time of the report, RASH (breakout with itchy rash all over body) and PRURITUS (breakout with itchy rash all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Steroid shot and Zyrtec
stomach pain / cramps; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain / cramps) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain / cramps). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain / cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Follow up received on01-May-2021. Consumer stated she is good  and declined further follow-up
This is a spontaneous report received from a contactable physician via a Pfizer sales representative, and from a contactable nurse on behalf of physician.  An 89-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot# M27555, Exp date 30Apr2017), intramuscular in left deltoid, on 01Dec2015 at 11:06 AM, at 0.5 ml single, for immunization. Relevant medical history included Cipro allergy with nausea, doxycycline allergy with generalized rash, allergy to sulfonamides with rash. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000), from an unspecified date and ongoing; cyanocobalamin (VITAMIN B-12), from an unspecified date and ongoing; isosorbide mononitrate (unspecified trade name), from an unspecified date and ongoing; carvedilol (unspecified trade name), from an unspecified date and ongoing; furosemide (unspecified trade name), from an unspecified date and ongoing; warfarin (unspecified trade name), from an unspecified date and ongoing; cetirizine (unspecified trade name), for itching, from an unspecified date and ongoing; hydroxyzine hydrochloride (HYDROXYZINE HCL), for itching, from an unspecified date and ongoing; melatonin unspecified trade name), from an unspecified date and ongoing; digoxin (unspecified trade name), from an unspecified date and ongoing; lisinopril (unspecified trade name), from an unspecified date and ongoing; calcium citrate, colecalciferol (CALCIUM CITRATE-VITAMIN D3). The patient did not have illness at time of vaccination. On 01Dec2015 the patient experienced arm was very red and swollen. Therapeutic measures were not taken as a result of the reported events. The events recovered on an unknown date after about a day. The reporting nurse assessed that PREVNAR 13 had a causal effect to the adverse events. Follow-up (07Oct2016): New information received from a contactable nurse on behalf of physician includes: patient's age, causality assessment, PREVNAR 13 details, vaccination details, event onset date, illness at time of vaccination details, relevant medical history, concomitant medications, treatment for events details. Follow-up attempts completed. No further information expected.
Vomited 20 times in <12 hours, 5-6 episodes diarrhea so far
This spontaneous report was received from an unspecified person via company and refers to two patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX 23 (dose and route of administration were not provided; lot # M038359, expiration date: 13-MAY-2018). On an unknown date, the patients experienced major swelling in their left elbow area. Both patients were given antibiotic to reduce swelling. No other medical attention was required and the patients were fine at the time of the report. The outcome of the events was not reported. The relatedness between vaccination with PNEUMOVAX 23 and the events was not reported. Follow up information was received from the office manager on 11-APR-2017. The second patient was a female (initial was provided). She was vaccinated on 10-APR-2017. On an unknown date in February 2017, she experienced swelling in her elbow and redness. Therefore, on 13-FEB-2017, she visited the physician who drew a line around the swelling and redness on the patient's elbow and told her to call back if it got any worse. The patient did not call back. On an unknown date in 2017, the patient recovered.This is one of two reports received from the same reporter. Additional information is not expected as no further information is available. Sender's Comments: US-009507513-1703USA000721.
suspected vaccination failure/had the Shingles vaccine and the virus was aggravated; Neuropathy; widespread shingles; pain, sore, pain over my entire body, painful and aggressive/residuals still flaring up with sores; blistering; irritation; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure/had the Shingles vaccine and the virus was aggravated) (serious criteria GSK medically significant), neuropathy (Verbatim: Neuropathy) (serious criteria GSK medically significant), shingles (Verbatim: widespread shingles), pain (Verbatim: pain, sore, pain over my entire body, painful and aggressive/residuals still flaring up with sores), blister (Verbatim: blistering) and skin irritation (Verbatim: irritation). The outcome of the vaccination failure was unknown and the outcome of the neuropathy, blister and skin irritation were not reported and the outcome of the shingles was recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, neuropathy, shingles, pain, blister and skin irritation to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, neuropathy, shingles, pain, blister and skin irritation to be related to Shingles vaccine.   Additional Information: GSK receipt date: 18-Mar-2023 The case was received from the patient via interactive digital media. The patient was an old and can tell that he/she had been whooped, stabbed, shot and blown up, his/her memory might be fading, however he/she remember no pain and irritation such as given by the shingles. The patient had the Shingles vaccine a few years ago and had a more rare form known as widespread shingles where he/she had sores, blistering and pain over his/her entire body. They said shingles might last for weeks but in his/her case it was 4 1/2 months before he/she started seeing some relief. Here the patient a year later still dealing with the extended damage done, neuropathy and some residuals still flaring up with sores. In the patient's case, apparently the virus was aggravated by the interaction with the Covid vaccine which caused them to manifest in a more painful and aggressive manner, needless to say, the patient 's physician advised him/her not to get any of the boosters for Covid due to possible further complications.  But yes, painful, ugly pain in the ass shingles were. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
PATIENT AWAKENED DURING NIGHT WITH EXTREME CHILLS, HEADACHE, FATIGUE,  FREQUENT DIARRHEA, URINARY FREQUENCY.  THIS HAS NOT RESOLVED OR IMPROVED IN 6 DAYS AFTER VACCINATION #2
DEATH  OF PATIENT REPORTED ON 04/07/2021 AT 11:25PM
pt recvd vax & 3 days p/vax exp red vesicular rash on arms, legs w/itching; resolved in 3 wks w/discoloration;
No side effects from first vaccine except soreness to site. This time around I was too lethargic for three days to get out of bed. I had a rash around site that progressed up to the right side of my face and also right side of my lower back the following day. The rash was also accompanied by blotches and is still there only on the side of the injection. I had metallic taste for on and off the first 2-3 days. I am feeling a bit better, well enough to work today. Still very fatigued. On Thursday I also had a 102 fever that Motrin and Tylenol didn't help me at all at night. I finally stopped sweating yesterday. The blotches are now improving . Only thing that remains is the fatigue.
Expired dose of boostrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 28-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number HF2YA, expiry date 15-JUL-2023) for prophylaxis.   On 18-JUL-2023, the patient received Boostrix. On 18-JUL-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Expired dose of boostrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 18-JUL-2023 A nurse reported that she administered an expired dose of Boostrix to a patient on 18 July 2023, which led to expired vaccine used.  At the time of reporting, repeat dose had not been administered.  The vaccine administration facility was the same as primary reporter The reporter consented to follow up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 19:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm 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's relevant medical history included: "High blood pressure" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "reflux" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; SINGULAIR; PRILOSEC [OMEPRAZOLE MAGNESIUM]. Past drug history included: Drixoral for drug use for unknown indication, reaction(s): "Known allergies: Drixoral". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Oct2022 at 18:30, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Oct2022) Negative, notes: I tested negative and had no symptoms three times starting on Sunday, 09Oct2022; (13Oct2022) Positive, notes: Then in the afternoon of Thursday, 13Oct2022, I started to have symptoms, took another test and tested positive immediately; (Oct2022) Negative, notes: I tested negative and had no symptoms three times starting on Sunday, 09Oct2022; (Oct2022) Negative, notes: I tested negative and had no symptoms three times starting on Sunday, 09Oct2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient tested negative and had no symptoms three times starting on Sunday, 09Oct2022. Then in the afternoon of Thursday, 13Oct2022, she started to have symptoms, took another test and tested positive immediately. Patient was treated with Paxlovid from 04Oct2022 to 08Oct2022 for treatment of COVID-19. Patient was on Birth control.  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.
Bloody stool; Blood in urine; This is a spontaneous report from a contactable consumer reported for himself. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL8982 (reported as looks like EL8982 or 1982), on 29Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient got his COVID shot on Friday and he have no problem with the shot as far as the shot itself. On Sunday which is two days later, he had first blood in his stool when he went to the bathroom, no fever and then this morning went he urinated, at the end of the urination he has some blood there too, like that. The only adverse effect he have was bloody stool and blood in his urine. Yesterday (31Jan2021), he had no temperature, no fever stuff like that, only blood in his stool and urine, then this morning, next day, three days, blood in his urine. No Investigation Assessment. no treatment for the events. Outcome of the event was unknown.   Information about batch/lot number has been requested.
they have no record of the patient ever receiving a 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th October 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: they have no record of the patient ever receiving a 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 26-Oct-2023 Reporter was the son calling on behalf of the patient.  The reporter reported that they had no record of the patient ever receiving a 2nd dose. Reporter had no further information about lot/expiry, route of administration, or location of administration. Did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.