chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized (11.29.21);  COVID-19 positive (11.29.21);  Fully vaccinated PLUS BOOSTER Admission Date: 11/29/2021 Discharge Date: 12/1/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Confusion [R41.0] Hypotension due to medication [I95.2] COVID-19 [U07.1] Pneumonia due to COVID-19 virus [U07.1, J12.82] HOSPITAL COURSE: No notes on file The patient is a 77 y.o. male who presented with a fever and fall at home.  He tested positive for COVID-19 in the emergency department on November 29th.    Patient is improving daily..  His blood pressures have normalized. He remain on room air.  Afebrile times 24 hours, cough-resolved;   no cough at this time.   He has been running fevers this morning.  No nausea or vomiting or diarrhea. PT/OT had recommended subacute rehab initially.  He does not want to do that.  He states he does have a daughter who will assist him at home.  We will set up home nursing/PT/OT for him. Patient has not required any oxygen since admission.  He has not used albuterol since admission.  Transition to oral Decadron.  Will continue this for total of 10 days.  Discontinue remdesivir upon discharge.  Patient will be discharged home.  Advised to maintain quarantine until December 8th which will be 10 days from the date he tested positive. Advised follow-up with his physician in the next week.  He will be discharged in stable medical condition. December 1st:  Patient has not required any oxygen since admission.  He has not used albuterol since admission.  Transition to oral Decadron.  Will continue this for total of 10 days.  Discontinue remdesivir upon discharge.  Patient will be discharged home.  Advised to maintain quarantine until December 8th which will be 10 days from the date he tested positive.
red marks on her thighs that would gradually turn black and blue; bruises or a rash on her leg; hives; red marks on her thighs that would gradually turn black and blue; red marks on her thighs that would gradually turn black and blue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), when the patient was 62 years old, for Covid-19 Immunization. The following information was reported: SKIN LESION (non-serious), ERYTHEMA (non-serious), SKIN DISCOLOURATION (non-serious) all with onset Oct2021, outcome "unknown" and all described as "red marks on her thighs that would gradually turn black and blue"; RASH (non-serious) with onset Oct2021, outcome "unknown", described as "bruises or a rash on her leg"; URTICARIA (non-serious) with onset Oct2021, outcome "unknown", described as "hives".  Additional information: After the second vaccine, about 3 days later or maybe 4, she started getting red marks on her thighs and thought maybe they were hives. she didn't do anything about it. Then, she noticed in the shower that they were changing colors. It would start out red and they were in all different shapes like oval, round, there was like no specific shape, Then, it would turn gradually into a black and blue colour and disappear. Then, a whole new batch of spots would appear. She states she tried to take a picture every day, but what only shows up is a red spot or a black and blue spot. she wanted to try and get it documented. She is scared. She is 62 years old and she is very nervous about what she put in her body.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case number PHEH2013US017767 is an initial spontaneous report received from a physician on 19 Aug 2013 and a follow up report from the health care professional received on 23 Sep 2013. This report refers to a 11-year-old male patient. His medical history and concomitant medications were not reported. On 07 Aug 2013, he was vaccinated only with an intramuscular dose of MenCYW-135 liquid component of MENVEO (batch number: M12132) at a dose of 0.5 ml in the left deltoid region without being reconstituted with Men A lyophilized conjugate. It was reported that the patient was doing well and he would be re-vaccinated in the next vaccination schedule as there was no plan for a foreign travel at this time. No adverse reactions were reported following the mal-administration. Follow up report received from the health care professional received on 23 Sep 2013: The patient's present condition was updated.
Information has been received from a Registered Nurse referring to 5 unspecified patients. Information regarding concurrent conditions and medical history was not provided. On unspecified dates, the 5 patient was vaccinatted with doses of improperly stored PNEUMOVAX 23 lott # K004483, exp. date: 16-AUG-2015 (dose, dose number, route and application site were not reported). Concomitant therapy was not reported. No adverse effects reported. Additional information is not expected because the reporter gave no consent to be contacted.
a pear shaped red sport at the injection; a little bit of soreness at the injection; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (a little bit of soreness at the injection) and VACCINATION SITE ERYTHEMA (a pear shaped red sport at the injection) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE PAIN (a little bit of soreness at the injection). On 26-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (a pear shaped red sport at the injection). On 17-Jan-2021, INJECTION SITE PAIN (a little bit of soreness at the injection) had resolved. On 29-Jan-2021, VACCINATION SITE ERYTHEMA (a pear shaped red sport at the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
Injection site swelling; Redness at injection site; Tenderness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Tenderness at the injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE for Hypertension.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Tenderness at the injection site). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at a dose of unknown. At the time of the report, VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Tenderness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
lightheaded, dizzy; fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of DIZZINESS (lightheaded, dizzy) and FATIGUE (fatigue) 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) at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (lightheaded, dizzy) and FATIGUE (fatigue). At the time of the report, DIZZINESS (lightheaded, dizzy) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication and treatmentinformations were provided.
pain; inflammation; swelling; bruising; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (pain), INJECTION SITE INFLAMMATION (inflammation), INJECTION SITE SWELLING (swelling) and INJECTION SITE BRUISING (bruising) 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 INJECTION SITE PAIN (pain), INJECTION SITE INFLAMMATION (inflammation), INJECTION SITE SWELLING (swelling) and INJECTION SITE BRUISING (bruising). At the time of the report, INJECTION SITE PAIN (pain), INJECTION SITE INFLAMMATION (inflammation), INJECTION SITE SWELLING (swelling) and INJECTION SITE BRUISING (bruising) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (pain), INJECTION SITE INFLAMMATION (inflammation), INJECTION SITE SWELLING (swelling) and INJECTION SITE BRUISING (bruising) 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 INJECTION SITE PAIN (pain), INJECTION SITE INFLAMMATION (inflammation), INJECTION SITE SWELLING (swelling) and INJECTION SITE BRUISING (bruising). At the time of the report, INJECTION SITE PAIN (pain), INJECTION SITE INFLAMMATION (inflammation), INJECTION SITE SWELLING (swelling) and INJECTION SITE BRUISING (bruising) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
24hr p/vax site & area-elbow red, swollen;pt c/o itching @ site;also s/o h/a;
Initial report was received on 08 March 2011 from a consumer who is also the patient. A female patient (age not reported) had received a DTAP vaccine (manufacturer, lot number, route and site of administration not reported) five years ago and "two weeks ago" was diagnosed with pertussis. She reported she had the vaccine five years ago but was "allergic to it and it didn't take". The patient also reports that her father is also "allergic to the vaccine". No further information was available at the time of the report. The patient's outcome was not reported. The reporter for this case is the same as for case 2011-01065. Documents held by sender: none.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Jansen product on 04/05/2021. Symptom onset is not specifically known, but the individual presented to emergency department with shortness of breath on 01/16/2022 and tested positive for COVID-19 via PCR test on 01/16/2021. They were hospitalized from 01/16/2022 to 01/22/2022, when they were discharged to home hospice. They died on 01/23/2021.
Sweats, muscle aches, headache, exhaustion Symptoms gone in about 12 hours, except exhaustion, which lasted about  16 hours.
I had my 4th COVID shot/I have arthritis and have been wheelchair bound. After the COVID booster, I was able to walk and climb upstairs for the first time; 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 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "arthritis" (not ongoing); "have been wheelchair bound" (not ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 3, Manufacturer: unknown, Lot Number: Not Provided), for Covid-19 immunization; Covid-19 vaccine (Dose Number: 2, Manufacturer: unknown, Lot Number: Not Provided), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1, Manufacturer: unknown, Lot Number: Not Provided), for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I had my 4th COVID shot/I have arthritis and have been wheelchair bound. After the COVID booster, I was able to walk and climb upstairs for the first time".  Additional information: Forwarded as an Adverse Event by the team. The patient had 4th COVID shot, had no negative side affects only was amazing good one. The patient had arthritis and had been wheelchair bound. After the COVID booster, the patient was able to walk and climb upstairs for the first time to see son_(withheld) bedroom. Painkillers never produced the results the vaccine did.  No Follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
throbbing pain in arm, no edema, sl redness (very small) arm felt heavy, whole body felt weak, dizziness, perspiration became nauseated, fell & lacerated rt side of forehead;
child unexpectedly moved. Doctor injected only half of the dose (0.25) with no reported adverse event; Initial information received on 19-Jan-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 2 years and 4 months old child  and unknown gender patient (10 kg) who unexpectedly moved. doctor injected only half of the dose (0.25) with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.25 (half dose)  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE injection (strength, frequency, lot U7196AB and expiry date was unknown) via intramuscular route in Left leg for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "child unexpectedly moved. doctor injected only half of the dose (0.25) with no reported adverse event" (incorrect dose administered) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was reported"Doctor tried to inject Menactra (series U7196AB) into the left leg (intramuscularly), but child unexpectedly moved. Doctor injected only half of the dose (0.25). Please advise, what should we do in this situation? Doctor suggests: enter another half dose (0.25) after 2 weeks. And then give a second dose after 3-6 months. Please, we need your advice."  Action taken with MENINGOCOCCAL VACCINE (MENACTRA) was not applicable.  It was not reported if the patient received a corrective treatment for the event (child unexpectedly moved. Doctor injected only half of the dose (0.25) with no reported adverse event).  At time of reporting, the outcome was Unknown for the event child unexpectedly moved. doctor injected only half of the dose (0.25) with no reported adverse event.  Reporter Causality: Related
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 07-MAY-2012, the patient was vaccinated VARIVAX dose 1, lot # 1273AA (dose, vaccination site, route, expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On 01-Mar-2022, the patient experienced FATIGUE (Tired). At the time of the report, FATIGUE (Tired) was resolving.            No concomitant and treatment medication were provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. There is no reasonable possibility of event tiredness with HUMIRA. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Neck pain, feeling of anxiety, heart raising, increased blood pressure Dizziness, weakness, LOC, seizure. Ambulance had to be called, taken to hospital. Still has intermittent neck pain and feelings of anxiety like another seizure is going to occur.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 05-FEB-2013 the patient was vaccinated with a dose of VARIVAX, 0.5 ml (therapy route and lot # was not reported). The patient was given VARIVAX instead of ZOSTAVAX. The patient was not experiencing any known symptoms. Additional information has been requested.
After getting the booster, I experienced rapid heart beat and sweating especially after consuming even small amounts of alcohol.
The pt received the vaccine and the following day experienced erythema, induration of right thigh of 15 x 20 cm. The pt was afebrile at visit. Four days post vax, the redness and induration was decreasing.
Big red rash and she still has in her face, neck collar bone; breaking out in big welts, started out in the right side of her face and went up the neck, back of neck, hairline, back, mouth and now breaking out in arm, hand, and wrist; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (breaking out in big welts, started out in the right side of her face and went up the neck, back of neck, hairline, back, mouth and now breaking out in arm, hand, and wrist), RASH ERYTHEMATOUS (Big red rash and she still has in her face, neck collar bone), CHILLS (chills) and PYREXIA (fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (Allergy to Poison Ivy.), Allergy (Allergy to Oak.) and Blood pressure high. Concomitant products included HYDROCHLOROTHIAZIDE, TELMISARTAN (TELMISARTAN/HYDROCHLOROTHIAZIDE) for Hypertension.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On 13-Jun-2021, the patient experienced URTICARIA (breaking out in big welts, started out in the right side of her face and went up the neck, back of neck, hairline, back, mouth and now breaking out in arm, hand, and wrist). On an unknown date, the patient experienced RASH ERYTHEMATOUS (Big red rash and she still has in her face, neck collar bone). At the time of the report, URTICARIA (breaking out in big welts, started out in the right side of her face and went up the neck, back of neck, hairline, back, mouth and now breaking out in arm, hand, and wrist) and RASH ERYTHEMATOUS (Big red rash and she still has in her face, neck collar bone) had not resolved and CHILLS (chills) and PYREXIA (fever) had resolved.            No treatments were provided.   This case was linked to MOD-2021-231517 (Patient Link).
pt recvd 2nd dose of vax & exp local stinging & tenderness @ inject site for a few minutes; treatment: none;
Rash and itching that started in my toes and traveled to ankles, calf area, thigh, torso and arms.  Terrible itching,, redness, blotchy skin,  Itching did not subside after several weeks and the rash became worse.  Seven months after 2nd Moderna vaccine I am finally beginning to not have itching and the rash is slowly disappearing.. Dr. biopsied 2 areas and pathology report showed skin eruptions due to drug reaction and one showed a viral connection that I was told was all related.  Beta blockers and ACE inhibitors can result in an adverse reaction of the rash however these medications were ruled out as I have been on for over 30 years and have never had a reaction and I am currently taking with no problems.
Sunday 12/16 pm-patient started spitting up after taking bottle pt. became limp-unresponsive-EMS were called and they thought possible seizure-Mom reports unresponsive x 30 minutes no apnea. No color change. Had choking episode before unresponsive (+) congestion, cough-EMS did not take to ER a fever in 2 days were o-Man brought back to clinic on 12/18/07