chrisvoncsefalvay/vaers-outcomes huggingface dataset:
96 Y female h/o of Hypothyroidism, constipation, prior hx of diverticular abscess who was brought in to ED for evaluation of worsening generalized weakness for last 2 days and cough; patient admitted on 10/23/21.   Plan: 1) COVID Pneumonia; Symptom onset on 10/21/21.  COVID positive on 10/23/21. Patient remains stable 02 sats on RA. -ED discussed patient with ID on admission who recommended starting Remdesivir. Last dose Remdesivir on 10/27/21. - On Pepcid for GI prophylaxis - Patient received Heparin 5,000 units SQ q12h for prophylaxis during hospitalization.  On 10/29/21, I discussed options with daughter for one month for DVT prophylaxis vs SQ Lovenox for DVT prophylaxis vs no medications for DVT prophylaxis on discharge and daughter prefers no medications for DVT prophylaxis on discharge out of concern for side effects and she reports her mom does not like to take medications.  Patient has HHPT arranged . - Per Dr, on discharge, recommendation is for isolation for 20 days since symptom onset (through 11/10/21)   2)Bacteremia due to contaminant; Blood cultures from 10/23/21 1/2 blood culture Preliminary report gram + cocci in clusters.  Contaminant was suspected.  Final Blood cx report from 10/28/21 with viridans streptococci group isolated.  Per Dr on 10/28/21, most likely contaminant and he recommended stopping IV Ceftriaxone and no need to repeat blood cx unless patient becomes febrile.   IV Ceftriaxone was stopped on 10/28/21 and patient remained afebrile and WBC ct WNL at 5.6 on 10/29/21. Urine cx from 10/23/21 Final report: No growth at 24 hours   3)Weakness; likely in setting of COVID pneumonia. PT initially recommended HHPT.  Patient very deconditioned per RN and PT re-assessment on 10/27/21 recommended SNF.  Daughter prefers that patient come home with Home Health PT which PCC has arranged.   4)Cognitive impairment; patient remains awake and alert.   5)Hypothyroidism; stable. Prior TSH 7.7 from 3/10/21.  On Levothyroxine.   6)Rt knee pain; suspect most likely due to OA.  Continue Tylenol 500 mg PO TID PRN and Rx Voltaren gel 4 times a day PRN pain on discharge.   7)FEN: Na 139 and K 3.9 on 10/28/21.  Patient on pureed diet. Patient had poor PO intake during hospitalization; dietician recommended Boost supplements with breakfast and dinner.  Patient's daughter feels patient will eat better once she is at home.
Immediately after vaccine administration, patient briefly lost consciousness.  Lapse of consciousness lasted for roughly 10-15 seconds.  Patient did not fall out of chair or was at risk of head strike.  Patient fell sideways  in chair and body stiffened before regaining consciousness. Patient stated that on awakening, he had cramps in his legs.    I kept him in the consultation room until he had strength to move under his own strength.  Offered a bottle of water and held him in observation area for a total of 30 minutes.    As of today, 11/15/21 patient has reported that he has recovered and after incident experienced normal side effects associated with vaccine.
Immediately p/inject of IPV/lt leg became bright red from 1" above inject site lt thigh to 2" below knee; also had bright red area around lateral ankle measuring 2" diameter & area remained bright red x 15mins;
Noticed occasional increased/irregular heart rate, shortness of breath, discomfort in chest beginning around June 2.  Symptoms have continued occur multiple times a day since then. Taking NSAIDs (naproxen, aspirin) has helped, but symptoms do continue to come back.
*Moderna COVID-19 Vaccine *  Pt received his first dose of the vaccine on 2/12/21 at 5pm.  Two minutes after receiving the dose, while sitting in the observation area, he reported losing sensation in his left pinky finger and the finger turning white.  While showing and talking to the health care provider, the sensation and color in his pinky finger returned to normal.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-062436 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062436:CROSS LINKED WITH MOTHER CASE
46 patients received an expired dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (46 patients received an expired dose) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (46 patients received an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (46 patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  Date the vial was initially stored in the refrigerator was 23Sep2021 Date(s) of administration of vaccine are  24Oct2021, 25Oct2021, 26Oct2021, 27Oct2021, 28Oct2021.
Janssen COVID-19 Vaccine EUA  Fever of 101.7 at 10 am on 3/14/2021.  Started with chills at 3:00 am on 3/14/2021
metastatic breast cancer; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient herself) reported that A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection. Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single and second dose via an unspecified route of administration on 19Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced metastatic breast cancer (breast cancer metastatic) on an unspecified date. The clinical course as follows, it reported as Caller 65-years-old with metastatic breast cancer had both doses of the Pfizer covid-19 vaccine, with the second dose on 19Feb21. Caller has been watching (news channel name) and read a quarterly report and on page 25 read about Pfizer making a booster shot. Caller inquiring on third booster and how vaccines are recorded. The outcome of the event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This information was received from previous outreach RN and verbal handoff from another RN on seen that day. In paper documentation she states patient was given COVID19 Moderna vaccine 1st dose at 1308 and was awaiting her observation time when she began feeling her knees were itchy and have little red bumps that are listed as hives. Noted that patient was Alert and oriented times 4 and heartrate was 78 bpm. She was given 50mg of Benadryl IM at 1440.
Cellulitis, fever 24 hrs after vaccine - cellulitis started next day, initially thought, it was just a reaction to vaccine. Fever, tender axillary and cervical lymph nodes on left. Ceftriaxone about 48 hrs after started on doxy another ceftriaxone 72 hrs after.
itchy, red, swollen reported start of symptoms on 02-23-21 still having symptoms on 03-01-2021 (7 days)
I've had a strange feeling in my head for the past year. Best way to describe it I feel like i'm under water; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "I've had a strange feeling in my head for the past year. Best way to describe it I feel like i'm under water". The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "I've had a strange feeling in my head for the past year. Best way to describe it I feel like i'm under water".  Additional information: Description of event: The patient received all 3 Pfizer vaccines.The patient described as 'I have had a strange feeling in his head for the past year. Best way to describe it I feel like I am under water'.The patient had been to several doctors and can't explained why or give a remedy.There were a lot of people on line that had the same symptoms. All had their shots, all seem to think like the patient had that it's the result of the vaccine.The patient knew that there has not been enough studies, but with people being concerned that the probability of this feeling could be the result.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
felt sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (felt sick). At the time of the report, ILLNESS (felt sick) outcome was unknown.            No concomitant medications reported by investigator  No treatment medications provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable. Symptom text:  Patient reported that when she saw her Doctor her Doctor told her that  he had received both doses of his Moderna Covid-19 vaccine and that the Doctor felt sick after each dose. I am reporting this as a limited Adverse Event and the manufacturer of the vaccine is unknown.  Other Patient specific and product specific vaccine information is unknown at this time.   This case was linked to US-MODERNATX, INC.-MOD-2021-103953 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-103953:
Fever over 102.1 for72 hours Extreme muscle pain and weakness over entire body Chills and confusion Bedridden for 48 hours
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, dose number, route of administration, lot# and expiration date were not provided). On 26-JAN-2018, the patient was re-vaccinated with a dose of GARDASIL 9 (dose, dose number, route of administration, lot# and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001550: US-009507513-1806USA001551: US-009507513-1806USA001552: US-009507513-1806USA001553: US-009507513-1806USA001555: US-009507513-1806USA001556: US-009507513-1806USA001557: US-009507513-1806USA001558: US-009507513-1806USA001559: US-009507513-1806USA001560: US-009507513-1806USA001561: US-009507513-1806USA001547: US-009507513-1806USA001548: US-009507513-1806USA001549: US-009507513-1710USA003103.
Pt received the PPSV23 vaccine in office on 10/25/17, per pt report that night she began to have body aches, redness in her arm. Her arm began to swell and continued swell at injection site 48 hours after injection. Pt was seen at an urgent care on 10/27/17 was given antibiotic cream due to increased risk for infection due to her diabetes. Then she follow up in this office on 10/30/17 due to continues swelling and redness. Pt was advised on 10/30/17 to ice/heat and use NSAIDS on area until reaction cleared.
Immediately felt pain in left arm where shot was administered.  Then within minutes felt numbness on entire left side and also left foot was very numb.  My left arm  has been painful ever since and still now I have joint pain in other areas.
Fever FATIGUE LUMP UNDER OPPOSITE ARM Narrative: FEVER IS GONE BUT FATIGUE CONTINUES
4 hours after injection - started experiencing pervasive Tinnitus (ringing in the ears).  It has not stopped since that time.  I have seen my family doctor - and also had an initial visit with an ENT specialist.      Current advice is to limit caffeine - and wait and see if it subsides.
Pt received ZOSTAVAX SQ in arm on 09/12. Pt developed a red area. Per pt, area swelled like a balloon for 2 weeks and then resolved. Patient stated the skin of the swollen area peeled off. Pt contacted her PCP and her daughter, a physician, who both described it as a normal reaction. Patient still has an area of discoloration 2 inches, oval shaped, at site.
A physician via a company representative reported that a pt received Hib-Titer, Tri-Immunol and Orimune in the 1990's and subsequently, developed autism. As of the date of this report, no further information was available. This event was considered to be an "Other Important Medical Event".
Had extreme fatigue and was drowsy the following day. I ended up developing inflammation in my armpit area that is very tender to the touch.
Upon receiving Moderna COVID vaccine, patient became light headed and hypertensive ( BP 200/100).
Shortly after receiving vaccines, the infant began having fever and diarrhea she was seen and admitted to hospital on 1-27-17 and discharged on 1-30-17. Dx. with gastroenteritis and intussusception with dehydration secondary to rotavirus vaccine.
PT developed hives on scalp, face and hands 30-60 minutes after injection.  She did not treat the symptoms & they resolved by the morning of 11/5/08.
Chronic urticaria/Has head to toe hives; Losing a ton of hair; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), on 26Nov2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, lot EN6206. , left arm in morning), administration date: 22Mar2021, when the patient was 44-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, single, lot ER8733, left arm in morning), administration date: 11Apr2021, when the patient was 44-year-old, for COVID-19 immunization. The following information was reported: URTICARIA CHRONIC (non-serious), outcome "unknown", described as "Chronic urticaria/Has head to toe hives"; ALOPECIA (non-serious), outcome "unknown", described as "Losing a ton of hair". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria chronic.  Additional information: No other condition, product used, and no investigation performed. No prior vaccine within 4 weeks. Family medical history relevant to adverse events. When asked having side effects due to vaccine. Clarifies Pfizer Covid vaccine, not sure which one it would be, she had every shot and booster. Doesn't know how to let doctor know about side effects. Stated she has told the doctor. She was being affected and can't get information anywhere. She was working remote from home and was having to turn in doctor notes to do that and the issues with side effects are due to the vaccine. She needed supporting evidence to have this information. She was being affected from this vaccine. Weight was about like maybe 200. Clarifies 1st one was chronic urticaria that started probably within the last year and a half. Has been spending that time changing soap, detergent, hair care. She was practically using baby shampoo and has head to toe hives. Seems to be from heat. When has hives feels like little shocks under her skin. Outcome, she was fine as long as out of sun and heat. It recurs if she does those things. Losing a ton of hair - started happening about same time. It's just such a blur. Been at least a year or year and a half. Couldn't figure out what was going on. How many times and how severe takes nothing medication or changes. Seemed to happen around vaccines. Outcome, has lost a lot of hair, like balls out of it. She was not bald. About to break vacuum and it's all over the house. Quite a bit of hair and never had that problem before. States she noticed most during Bivalent vaccine she got on 16Sep2022. On 26Nov2021 received third dose of vaccine in the afternoon. has done telehealth. What should she do? She was going to discontinue vaccines because of side effects with what she is having.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300116319 same patient, different dose/event;
ometime between 32 to 36 hours passed from when the vial was opened until it was administered to this patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (ometime between 32 to 36 hours passed from when the vial was opened until it was administered to this patient) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (ometime between 32 to 36 hours passed from when the vial was opened until it was administered to this patient). On 04-Aug-2021, EXPIRED PRODUCT ADMINISTERED (ometime between 32 to 36 hours passed from when the vial was opened until it was administered to this patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications information was not reported. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Followup received  provided no new information.
A few minutes after the patient received dose 1 of the Janssen Covid-19 vaccine, the patient started having trouble breathing, her throat felt "swollen and thick", was shaky, had itchy hands, and her lip was swelling. Her blood pressure was 174/86 and her pulse was fluctuating in the mid-high 80s. I administered 1 tablet of diphenhydramine (25mg) and 1 dose of the 0.3mg epi-pen. After about 7-10 minutes, she said her symptoms started to level out and were no longer getting worse. Her lip swelling started going down by the time EMS arrived. I continuously checked her blood pressure, heart rate, and heart rhythm while waiting for EMS to arrive and take over her care. They took her to the closest emergency room for continued monitoring.
I contracted COVID19 12/30/2021 with symptoms of coughing, difficulty breathing, fever, severe fatigue which has lingered, headache, congestion, body aches, joint pain and I was ill around 10 days. Still seeking treatment for severe lingering fatigue.
Swelling at the injection site; Her arm was the size of an egg and it was hard; A significant drop in her platelet level; She was tired for 24 hours; This is a spontaneous report received from a contactable consumer (patient) and via a Pfizer-Sponsored program. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 25Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 27Mar2021 the patient experienced a significant drop in her platelet level and on unspecified dates the patient experienced swelling at the injection site, her arm was the size of an egg and it was hard and she was tired for 24 hours. The patient stated that she received the first dose of the Pfizer COVID-19 vaccine on 25Mar2021 and she then had routine blood work done on 27Mar2021 (also reported as 29Mar2021) which showed a significant drop in her platelet level. She stated that she normally had a platelet count on the lower side, but the platelets were quite a bit lower than the last bloodwork she had done. She stated that she had blood work last on 24Mar2021 which is why she knew. She stated that her platelets dropped after she got the first dose. She checked the internet for side effects of the vaccine and she did see that some people had reported that a lowered platelet count could happen. She stated that she was doing research to investigate if this was truly a side effect of the vaccine. She wanted to know if this had been reported before. She would like to know before she got the second vaccine. The patient also stated that she also had swelling at the injection site, her arm was the size of an egg and it was hard, and she was tired for 24 hours. The patient wanted to know if she would still need to wear a mask after having received both doses if she decided to go out in public or visit others and she wanted to know how effective the first dose was if she decided not to receive the second dose. The clinical outcomes of the events a significant drop in her platelet level, swelling at the injection site, her arm was the size of an egg and it was hard and she was tired for 24 hours were all unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
After receiving first dose of covid-19 Moderna at 3:27pm, a few minutes later the client felt dizzy and sat on the floor and had a vasovagal response. After inhaling ammonia, he responded and he was AAO x3, paramedics arrived and took vitals all WNLs. Client stayed in observation for 30 more minutes and left the facility feeling  ok.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 at 17:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Mar2021 at 09:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 05Oct2021 at 09:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Apr2022 at 15:30 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hepatic steatosis" (unspecified if ongoing), notes: Fatty liver; "lactose intolerant" (unspecified if ongoing), notes: I am lactose intolerant. The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergy: Erythromycin", notes: Erythromycin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.