chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is fully vaccinated.  COVID + on 12/3/2021.  Hospitalized from 12/7-12/19/2021. Presented with dyspnea.  SpO2 88% on RA. She initially presented to an urgent care facility on 12/3, admitting to cough and myalgias for seven days. fever of 100.8 initially on arrival.  Patient admitted with respiratory failure due to COVID pneumonia.  Multidisciplinary team consulted and placed on remdesivir/decadron and lovenox.  Patient continued to deteriorate and went into renal failure.  Continued to require high flow oxygen and was decided by family to enter into hospice care.  Patient passed away with comfort care.
The pt experienced cold and flu symptoms. Pt treated with Azithromycin, Etodolac and Guaifenesin.
8/5/2019 6:36PM PT HAD INJECTION SITE PAIN RIGHT AWAY.  HOWEVER, 8/6/2019 PT FOUND REDNESS PATCH ERYTHEMA AT LOWER LEVEL OF INJECTION SIDE AND MORE TOWARD TO THE BACK OF UPPER ARM IN THE MORNING.  THE ERYTHEMA SIZE WAS ABOUT 1X1 INCH.  PT'S INJECTION SITE IS CLEAR AND NO REDNESS. THE ERYTHEMA WAS ITCH AND PAIN.  ALSO PT'S RIGHT WRIST LATERAL SIDE HAD ONE BLISTER LIKE A BEAN SIZE. PT REPORTED TO US ON 8/7/2019 IN THE EVENING.  I RECOMMENDED PT TO SEE HER DR.  SHE MADE AN APPT AND NEVER SAW HER DR.  8/8/2019 I FOLLOWED UP WITH PT.  PT SAID SHE FELT A LOT BETTER.  PT NEVER HAD FEVER OR CHILLS.  PT'S HUSBAND TOLD ME THIS DETAILED INFORMANTION .
I went to my yearly mammogram in December and it was abnormal. I did a sonogram and it came back as breast cancer in my right breast. I had lumpectomy. I have to do chemo and radiation.
Rash at injection site  Rash & itching on upper chest, neck & back on night after administration of vaccine until today Caladryl topical lotion applied & I took oral Benedryl
Persistent pain at site of injection (5 1/2 months elapsed). Physician diagnosed paresthesia; loss of sensation (numbness to touch) centered on site of injection, measuring 10 cm x 9 cm; pain in muscle at site of injection.
1328 - patient c/o "hard to swallow", felt heart racing & dizzy 1330 - BP 166/115 HR 130 SPO2 100% 1356 - BP 156/116 HR 105 SPO2 100% 1340 - BP 174/108 HR  81  SPO2 100%; allegra 60mg given PO 1348 - BP 149/106 HR  92  SPO2 100% 1356 - BP 152/103 HR  99 SPO2 100%
I getting hot feeling in my face. It feels like my face is on fire but I don't have a fever. Then, I get chills. As the day goes on it get worst. These symptoms is are still ongoing since a year ago.
Vaccines were given 12:43 pm on 11/9/18. The next morning, after removing the band aid, the patient noticed the skin was red around the band aid. That evening (more than 24 hours after the injection),the redness had spread to surround the injection site and was about 3-4 inches long and 1.5-2 inches wide.It was warm to the touch and sensitive." Sleeping on the arm was bothersome".The next day, the reddened area was smaller in size but there was a paler halo around area and was raised.The redness and halo lasted a few more days. The entire "rash" was gone in less than 1 week.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M016193, expiration date: 24-APR-2018 (strength, dose, route were not reported) for prophylaxis (incorrect product storage).Adverse effects were reported. The temperature was between >8C - 25C, for a time frame of 5 hours, 30 minutes. There were no previous temperature excursions. The call was  because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004386: US-009507513-1701USA004702: US-009507513-1701USA004703: US-009507513-1701USA004704.
Patient experienced 2 seizures (generalized tonic clonic) 1st lasted for 1 min. 2nd lasted for 3 mins on the day she received flu shot, did not have fever at the time of seizures.
No adverse event; patient who received 1st dose of Moderna vaccine on 04-Jun-2021/second dose of Moderna vaccine on 04-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient who received 1st dose of Moderna vaccine on 04-Jun-2021/second dose of Moderna vaccine on 04-Mar-2022) and NO ADVERSE EVENT (No adverse event) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 026221B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 04-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Mar-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient who received 1st dose of Moderna vaccine on 04-Jun-2021/second dose of Moderna vaccine on 04-Mar-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient who received 1st dose of Moderna vaccine on 04-Jun-2021/second dose of Moderna vaccine on 04-Mar-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient who received 1st dose of Moderna vaccine on 04-Jun-2021/second dose of Moderna vaccine on 04-Mar-2022).    No concomitant medications were reported.  The patient received 1st dose on 04-Jun-2021, lot no. 05DC21A.  No treatment medications were reported.
got vaccinated, I have shingles right now/ Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received shingles vaccine and was having shingles at present. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Anaphylaxis seen in ER ref to allergist for further investigation. 7/30/02-ER Summary confirms diagnosis of anaphylaxis treated with Solu-Medrol, Benadryl, and epinephrine with abatement of symptoms.
itching on both fore arms; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th September 2021, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. The patient received a dose of Shingrix vaccine and about a week later patient experienced itching on fore arms, No rash occured it just itches. The patient asked if they had heard of other reports of this and could this be a side effect of the vaccine. Follow-up would not be possible as no contact details available.
Mom received all 3 COVID-19 shots from Pharmacy: (1) 1st Moderna COVID-19 shot (Lot #043B21A) on 19 April 2021; (2) 2nd Moderna COVID-19 shot (Lot #003C21A) on 17 May 2021; (3) 3rd Moderna COVID-19 shot (Lot #037F21A) on 7 December 2021.
Patient received two doses of the Pfizer Bivalent covid Vaccine. No ADRS observed.
11/04/2020 06:20 am patient, went to bathroom and felt light-headed. Experienced vertigo upon getting a glass of water and fell to the floor, spilling water all over self. Patient proceeded to get ready for work. Called into work and stayed home. Did not take temp. Felt 'fine' but 'no business going to work'. Took it 'easy', rested, low energy and did not push self, even though felt better. Patient pushed water, protein. No rash, raised, etc at injection site. Patient refused to have flu shot during the same date of shingrix shot.   After first injection site of the shingrix in the left arm, soreness right at injection site (1st week of August 2020). Soreness lasted approximately 2 weeks.
Had all the symptoms of a bad case of the flu. 9 hours after the vaccine, started getting light-headed, very tired (went to bed), woke up 3 hours later with extreme chills, followed by a fever for a few hours. Slept through the night. Woke up and muscles were sore all over. Continued to be very tired and light headed. By 5:00 PM, the symptoms had subsided. I woke up 2 days after the vaccine injection and felt 100%.
COVID-19; COVID-19; This is a spontaneous report received from contactable consumer. The reporter is the patient.  An 82-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 82 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 had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "recovered with sequelae" (Mar2023) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included nirmatrelvir/ ritonavir (PAXLOVID) from 11Mar2023 to 15Mar2023.
Was given the Gardasil shot in December 2007. In January 2008, diagnosed with Supraventricular Tachycardia (SVT): Blacked out/lost consciousness in the shower, woke up with a heart rate of 250bpm. Stayed for 45 minutes until given a shot of Adenosine. Required an Ablation (April 2008). Happened twice more after the first ablation (1 time requiring a double dose of the Adenosine shot). Will be having a second Ablation March 12, 2009. Also losing hair in clumps, chest pains similar to being stabbed 2-3 times a day (around the heart, but all over the chest area.) 3/13/09-records received-office visit 3/3/07 and first vaccine provided lot#0388U , vac #2 given on 8/14/07 lot#1060U and 3rd received 12/14/07 lot#1266U. Office visit 5/8/08-seen for gyn check up regular menses. ablation 4/08 for SVT. Taking oral contraceptives. 4/8/09-records received for DOS 4/17-4/18/08-DC DX: orthodoronic AV re-entry SVT. Recurrent drug resistant narrow complex tachycardia referred for electrophysiologic evaluation and successful ablation. First epidsode on 1/19/08 with sudden onset of lightheadedness with rapid palpitations and chest discomfort.Remote history of syncope that sounds vasovagal in nature.  Follow-up: I have had 2 cardiac ablations, and still suffer from chest pains.
Evening of 10/12/23 after receiving shot injection site reaction occurred.  A red circular rash about 4" in diameter appeared that was warm to touch.  Patient took some OTC Tylenol and applied ice.  She monitored it over the next week before reporting it to the pharmacy on 10/19/23.  At the time patient reported the reaction the circular rash had faded and was barely visible, but you could still tell where it had been.  She said it was a little bit itchy so recommended that she take benadryl but warned that it may cause drowsiness.
Started hallucinating the night of receiving the vaccination, back aches, joint pain, and fatigue.
patient c/o of "feeling of throat swelling", 25mg PO Benadryl given. symptoms persisted and patient given EpiPen 0.3mg autoinjector and transferred to ED via EMS.
pt recv vax; difficulty breathing, a strangling sound, v occurred 3 hr p/ vax & lasted approx 3 hr that noc;
Swollen lymph gland under left armpit/upper arm No treatment, subsided within 3 days
Rec'd immun 6MAR91, same day developed temp 102- tylenol given; temp varied, up & down w/meds; Also runny nose, cough; continues to date; similar rxn p/immun of DTP/OPV on 2JAN91; Had ear infect dx by MD;
Patient felt pain during vaccination, then had a tingling sensation along her left jaw. Administered liquid benadryl oral.
Chills, very tired, "black mark" on tongue now resolved, no appetite, unable to sleep at night or daytime, vomited all night on Monday; lost 7 lbs in less than 48hrs after taking the vaccine, unable to hold down water-drinking Pedialyte for hydration.  Lt Arm injection site is hard, slight redness, still painful. Vaccine given in medial deltoid but swelling and inflammation is noted above in superior deltoid region. Tues 3/16/21: she saw PCP, was given prednisone by PCP.    COVID test on 3/16/21 by PCP:  negative
This spontaneous report as received from a pharmacy student refers to a 52 year old female patient who was allergic to macrolides, tetracycline, morphine and salicylates. The patient had experienced pain and swelling at the injection site in the past after receiving unspecified flu vaccines. On 19-SEP-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (in the left arm, 0.5 ml, intramuscularly, lot # H014653, expiration date, 19-APR-2014). Concomitant therapies included budesonide, SYMBICORT, XOPENEX, ibuprofen, SINGULAIR and NEXIUM. In September 2014 (exact date unspecified, reported as after receiving expired PNEUMOVAX 23) the patient was experiencing swelling and pain of her left arm. The patient was told to apply ice packs to her arm and to take BENADRYL. The patient sought medical attention via calling the pharmacy. The outcome of events was not reported. The relatedness between events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Headache, Fever, CHILLS, FATIGUE Narrative:  Other Relevant History:
No adverse effects reported; inadvertently received first doses of VARIVAX and PROQUAD; inadvertently received first doses of VARIVAX and PROQUAD; This spontaneous report as received from a nurse refers to a 19-month-old patient of unknown gender. No information on patient's pertinent medical history and drug reactions or allergies was provided.  On 28-OCT-2019, the patient was inadvertently vaccinated concomitantly with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019463, expiration date 24-JUN-2021, dose, route of administration and anatomical location were not provided) and with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S017251, expiration date 01-DEC-2020, dose, route of administration and anatomical location were not provided), both for prophylaxis. Concomitant therapies included sterile diluent. The nurse confirmed misuse was related to human error and not product confusion. No adverse effects reported.  This is one of 2 reports from the same reporting source.; Sender's Comments:  US-009507513-1911USA000786:
This initial spontaneous case, was received from a pharmacist on 31-MAY-2017 and concerns a female patient of unspecified age. On an unspecified date, the patient received Influenza Virus Vaccine Polyvalent (dose, route of administration, anatomical site, batch number, expiration date: not reported). On an unspecified date, the patient experienced local reaction, which included hives and swelling at the general area of injection. Also the patient had swelling in the arm pit of the injection arm. Her health care provider advised her to refuse influenza vaccination in future. The patient recovered from the adverse event on an unspecified date. The reporter assessed the causality of the events and the influenza vaccine as related. This report was not serious. Significant case correction was received on 14-Jun-2017: New event was added (swelling in the arm pit of the injection arm). Description to be coded was updated for the events local reaction, which included hives (from hives to injection site hives) and swelling (from swelling to injection site swelling) at the general area of injection. Causality assessment of the events was updated from unassessable to related.
Flu like symptoms.  Slightly elevated temp.  Headache.  Generally felt bad.  No energy.  Symptoms lasted for 5 days with day 3 being the worst day.  General decrease in stamina for approximately 3 months afterwards
Red papular rash (L) chest, trunk & upper back. Afebrile.
First dose of vaccine was Moderna and second dose was Pfizer. No adverse reactions noted at this time
Pt recvd 1 dose of Engerix-B & exp a raised 1-2 cm maculopapular rash on 1 arm from shoulder to wrist "same arm that was injected"; arm still bright red with eruptions;
Coldness running down my arm - right after I had the shot; could feel it going down my arm. And then I didn't feel anything until I got a cold sensation around my neck. Something was telling me there was something going on. I called the AARP nurse and she ran me through the protocol and told me to go to hospital. (I had gone there the first time after the first shot which was 2/17/2021 - four days after that shot - 200 something over /90 something. They treated me for high blood pressure that time).  And they put me on certain medication and it would last so long and the last doctor decided it was anxiety. So far, what that doctor gave me seems to be working. Twice a day, I take Carvedilol - 12.5 mg and then I take Amlodipine twice a day and that is 2.5 mg twice a day. Midday - Olmesartian 40 mg and for the anxiety, they changed me to Clonazepam 0.5 mg. I take that about 03:00pm. Wexela - inhaler - twice a day if needed. It will keep me from spiking later.  I went to ER four times after the second vaccine. I was hospitalized twice. My blood pressure was real high. I was hospitalized twice and I had home care when I got home. My blood pressure is better than it was after the second vaccine but it's still about 20-30 points above where it used to be.
- 36 hours after vaccine he had seizure - taken to emergency room - absence seizure - admitted to hospital for 24 hours - transferred to another hospital. 12/4 and 12/10/2009 ED record for 11/11/2009, patient with sx of unresponsiveness and a blank stare. Transferred to another facility which had pediatric service Neuro exam wnl but abnormal EEG rx'd Diastat DC DX Seizure d/o 12/31/2009 Pediatric H&P and Neuro Consult records for 11/11/2009, no changes to VAERS.
Paxlovid rebound. Patient tested positive for COVID via PCR 5/10; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Paxlovid rebound. Patient tested positive for COVID via PCR 5/10) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Psoriatic arthritis, Hashimoto's thyroiditis, Drug allergy, Drug allergy and Penicillin allergy. Concomitant products included ESTRADIOL from 30-Jun-2021 to an unknown date, MEDROXYPROGESTERONE (PROVERA [MEDROXYPROGESTERONE]) from 06-Apr-2022 to an unknown date and PHENTERMINE from 25-Apr-2022 to an unknown date for an unknown indication.   On 19-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) at an unspecified dose. On 05-May-2022, the patient experienced COVID-19 (Paxlovid rebound. Patient tested positive for COVID via PCR 5/10). At the time of the report, COVID-19 (Paxlovid rebound. Patient tested positive for COVID via PCR 5/10) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 28-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 23-May-2022, COVID symptoms returned. The patient was on antibiotics from 23-May-2022 to 28-May-2022 with no improvement. Isolation was continued and the patient was given OTC medications.  Company comment: This spontaneous case concerns a 36 years female, with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 52 days after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 11-may-2022 to 15-may-2022.Patient.After 8 days of paxlovid symptom started,patient is on antibiotic no improvement, She was tested positive 13 days after the treatment with Paxlovid. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 36 years female, with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 52 days after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 11-may-2022 to 15-may-2022.Patient.After 8 days of paxlovid symptom started,patient is on antibiotic no improvement, She was tested positive 13 days after the treatment with Paxlovid. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Left shoulder swelling and redness, not painful. Icepack, monitor x SX of infection.
Pt received the first dose on 1/21/18 and came in today 4/17/18 to receive her second dose, she said was given at the back of her arm and not in the deltoid muscle (the first dose).
Fever, slight delirium, body aches, muscle soreness, fatigue, mental fog
On 11/26/2022, I wasn't feeling good overall. I felt like I was getting a cold. My nose was really stuffy and then it would run and then go back to stuffy. It was like that for a few days. I didn't have a headache or anything, but I just felt very congested. I started using a saline solution in my nostrils and I would sometimes feel a little better, but it just wasn't clearing up. This went on for a good seven or eight days like that and I was developing a cough. I called my doctor's office the following Friday, 12/01/2022. I got an appointment with his assistant later that day. I didn't have a fever and was negative for COVID-19. He prescribed me coughing pearls and advised that I continue with the saline spray. He also prescribed an antibiotic but told me to hold off and not take it if I didn't need it. By Monday, I was still feeling badly, so I did begin the Z PAK. I took that for five days and by the end of that I felt a whole lot better.