chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discharge Provider: MD Primary Care Provider: DO Admission Date: 2/9/2023 Discharge Date: 2/12/2023   Clinical Narrative:   The patient is a 86 year male who presented to the emergency room with shortness of breath and low oxygen saturations.  He was COVID positive and felt to have a COVID 19 pneumonia.  Given his hypoxia he was admitted and started on Decadron and remdesivir hopes of preventing or slowing progression.  Is up needs improved almost immediately within the 1st day on admission.  He has done well would like to go home.  Is reasonable to stop remdesivir day 3-4 in this circumstance and to stop Decadron day 5. He be discharged home on continued treatment for community-acquired pneumonia and 1 additional day of Decadron.
Knot at area of injection along with redness and swelling. Used Tylenol, Benadryl and ice.
Arthralgia, Diarrhea, Chills, Injection site pain, Fatigue, Sore throat, Congestion Narrative:
This spontaneous report was received from a registered nurse and refers to unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 04-JAN-2017, 05-JAN-2017 and 12-JAN-2017, the patients were vaccinated with an improperly stored doses of PNEUMOVAX 23, lot number M040004 with expiration date 20-MAY-2018 (dose, route and anatomical location were not reported) for prophylaxis. Also on 23-FEB-2017, improperly stored PNEUMOVAX 23 were reported. On 03-JAN-2017, the vaccines were exposed to temperature between 32 Fahrenheit (F) (0 Celsius (C)) to 36 F (2C) during 9.5 hours; Also on 04-JAN-2017, 12-JAN-2017, 13-JAN-2017, 17-JAN-2017 to 19-JAN-2017, from 24-JAN-2017 to 25-JAN-2017 and from 30-JAN-2017 to 31-JAN-2017, the vaccines were exposed to temperature of 33 Fahrenheit (F) (0.5 Celsius (C)) during 10 hours each day all of them in the first cycle. In addition on 05-JAN-2017, 06-JAN-2017, 09-JAN-2017, 21-JAN-2017, 23-JAN-2017, 27-JAN-2017 the vaccines were exposed to temperature of 34 Fahrenheit (F) (1.1 Celsius (C)) during 10 hours each day in the first cycle. Finally on 10-JAN-2017, 11-JAN-2017, 16-JAN-2017 and 26-JAN-2017, the vaccines were exposed to temperature of 35 Fahrenheit (1.6 Celsius (C)) during 10 hours each day in the first cycle. It was also reported that the vaccines were also exposed to temperature between 32 Fahrenheit (F) (0 Celsius (C)) to 36 F (2C) during 80 hours (dates unspecified). No adverse events were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA007376: US-009507513-1702USA007377: US-009507513-1702USA002864.
09/04/2022 - Dog nipped finger on left hand. Treated with Neosporin. No signs of infection. 09/06/2022 - Tdap Vaccine given in right arm at Urgent Care. 09/10/2022- Severe muscle and joint pain began. Woke up with extreme pain in left elbow, forearm and tricep, and fingers. Upper arm felt itchy and but no rash. Tricep felt bruised and was sore to the touch. Elbow hurt to straighten and bend and doing the simplest tasks, like lift a skillet off the stove, was painful. Pain 4 to 5/10. Mild intermittent numbness  in left side of face also started. I experienced this sensation with Covid but at a much more severe level, but I have no history of chronic joint or muscle issues.  09/20/2022- PCP visit. Dr said it was most likely a reaction to the vaccine. Recommended ibuprofen and stretches. 09/22/2022 - Severe hip pain began. Both hips, butt and left thigh. Painful to sit, bend. I could feel the pain even while walking., however it didn?t limit my walking. Pain 4/10. 9/30/2022 - Lower back pain began. Itchiness in arm is mostly gone. 10/11/2022 - Follow up with PCP due to ongoing joint pain in elbow and hips. Recommended more stretching. Bloodwork to look for infection/ inflammation. 10/13/2022 - lower back pain worsens. Elbow  pain and hip pain persists.  10/23/2022 - stiff tight neck  and all over pressure/ tightness in head. Very uncomfortable feeling , but not as painful as elbow and hips.  10/26/2022-  Today, pain in the left arm/elbow  has been constant for the past 6 weeks but has lessened. Pain now about 2/10. It still hurts to use left arm. Pain in the hips has been daily for the past 4 weeks but has also lessened.  Now about 2/10. Lower back is about 2/10. Neck is still stiff and tight.  I don?t feel the ibuprofen helped the joints. The stretches and epsom salt baths help somewhat. However, when I tweaked my back out several years ago, a couple days of yoga  made it feel better. Yoga has not had the same immediate effect on this joint/ muscle pain but I will continue to do it. I follow up in 2 weeks with PCP.
Reactions to third dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reactions to third 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reactions to third dose). At the time of the report, VACCINATION COMPLICATION (Reactions to third dose) outcome was unknown.            No Concomitant drugs were reported.  No Treatment information  were reported.    Reporter did not allow further contact
Received Hepatitis A & Flu vaccine on 11/8/10 & that night developed fever & then next day noted jerky movements & becoming more frequent & seen at office 11/11/10 & referred to neurologist.
Redness and swelling at the site. Described as a cellulitis. Required 1/2 day off from work.
Felt unsteady after shot, with mild dizziness. Did not eat breakfast. Monitored her for 30 mins.
Hypoxia,  chest pain, and then 3 episodes of cardiac arrest.  No cardiac history.  Patient stated she was fully vaccinated with 2 vaccines and the booster.  Did not provide manufacturer.
Peripheral neuropathy, nerve pain, fatigue, heaviness of arms and legs. Spinal tap. Bloodwork, MRI
given 1ml dose instead of .5ml; A spontaneous report was received from a consumer concerning a 34-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and given 1ml instead of .5ml/accidental overdose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient was given 1ml instead of .5ml.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event given 1ml instead of .5ml was considered recovered.; Reporter's Comments: This report refers to a case of Accidental overdose for mRNA-1273.  There were no reported adverse events associated with this case.
Patient presented to ED 3/25/21 with right Bell's Palsy.  COVID-19 Positive.  Patient completed COVID-19 vaccinations on 1/12 and 2/2. COVID-19 Infection: #Suspected COVID infection: Onset date: unknown presented with: no symptoms.  Recent exposures: none.   initial CRP: 0.29, LDH: 215 D-dimer: 0.54 -Admit to hospital: contact/droplet precuations -Covid test date:  3/25/21 RA sats: 94% in ER. -empiric abx coverage: none -  No Remdesivir or Dexamethasone for treatment. -  Pt completed both COVID-19 vaccine doses 1/12 and 2/2/21.  Discharge planning Ambulatory O2 challenge daily: Last fever: none Home support for ADLs if needed: YES Medications: 30 day supply   R Bells' Palsy: -  R facial weakness with inability to close his R eye and sparing the forehead. -  Pt also evaluated by Clinic Telestroke and they feel his symptoms are consistent with Bells Palsy. -  CT head negative for acute bleed. -  MRI brain due to complaints of also dysphagia and some dysarthria.   -  Facial weakness seems moderate to severe given above findings as well. -  Lacrilube qHS and Artificial tears q2h PRN dryness R eye -  Prednisone 60mg daily x 7d -  Valacyclovir 1g tid x 7d per protocol.  Dysphagia: -  Could be due to severity of Bells Palsy. -  MRI brain to rule out acute CVA.   -  Speech and swallow eval: mild weakness on mouth on R but normal swallow.  Rec NDDI diet with clears and use of straw on L side of mouth.  DM2: -  A1c: 6.3 this admission. -  Outpatient Meds:  metformin -  CC diet. -  SSI for now.  HTN: -  Continue Norvasc.  BP controlled.  HLD: -  Continue ASA and Atorva.  RAD: -  Continue Advair.  MM: -  Will touch bases with Hematology.  BPH: -  Tamsulosin.  Glaucoma: -  Continue Travatan.  Hosp Issues: CODE STATUS:  FULL CODE Diet: NPO for now DVT Proph:  SCD boots  Disp:  Speech cleared pt stating he has no difficulty swallowing.  If the MRI brain is negative for an acute process, will plan to discharge the patient home today.  Notes: Two patient identifiers confirmed. Patient said that he was doing well without any medical issues and without concerns at this time. This nurs cm reminded patient about mask wearing, social distancing and frequest handwashing. Patient verbalized understanding. F/U Plan: Moderate Risk - 2 week post d/c f/u.  Electronically signed on: Electronically signed on:  2021-03-29
Shortly after I received my shot in my left arm,  I experienced numbness, loss of sensation, tingling, hot/cold sensations in my left arm extending down my hands to the fingertips.   These symptoms have not subsided.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Fever-Mild
11:00 AM - Received Vaccine 11:15 AM - Experience onset of headache symptom 11:30 AM - Experience full-onset of headache. Feels foggy, burning in head.  12:30 PM - First bout of chest pain. Intermittent tightness in the chest. Was able to feel at this time a sort of odd sensation in my chest that began this day and continued for the next 4 days.  1:00 PM - Second experience of chest pain. It was a pulsing pain I could feel with the heart beat. Lasted about 2 minutes, and resurfaced in later episodes.  1:00 PM - 6:30 PM - Continued to experience bouts of chest contraction. It was painful, not to the point of being unbearable. Throughout this time period the pain of the chest contractions worsened. Each of the episodes of pain/tightness would occur from 30 seconds to 3 minutes, and the reoccurance was 5 times between 1:00 & 6:30. By the last experience of this on August 5 around 6:30 the pain worsened and I was going to leave for the hospital. It was very concerning and not normal. There was no prior experience of heart palpitations or any issues in the last 4 months prior to the vaccine/heart episodes described here.   After August 5, the episodes continued about 4 times a day for 6 days. The frequency decreased after about 6 days to 2 times per day. Regardless of episodes of pain there was a persistent feeling of tightness in the chest for between one and two weeks after the vaccination.
The patient had received his vaccine, and and moved to the bench to wait 15 minutes post-vaccine. The patient got dizzy and went to the floor a few minutes after being seated. No other side effects or issues and the patient was fine after sitting a few minutes
Severe fatigue, body aches, severe lower back pain, and headache x 48 hours. Hair loss with regrowth starting at 2 months post vaccine.
left side of the face  swelling up , lump under the jawline and in front of the ear lobe; heaviness in the body; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (heaviness in the body) and SWELLING FACE (left side of the face  swelling up , lump under the jawline and in front of the ear lobe) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced ASTHENIA (heaviness in the body). On 06-Mar-2021, the patient experienced SWELLING FACE (left side of the face  swelling up , lump under the jawline and in front of the ear lobe). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of UNK dosage form. At the time of the report, ASTHENIA (heaviness in the body) and SWELLING FACE (left side of the face  swelling up , lump under the jawline and in front of the ear lobe) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
pt  says she developed hives and itchyness at the site of injection/ arm of injection.  She was taking benadryl to alleviate symptoms
Fever, chills, sore arm, headache, body aches. Took tylenol and ibuprofen. Resolved in about 36 hrs
Patient had received second dose of the Moderna COVID vaccine. Within less than 5 minutes of his observation period, patient began having uncontrolled movements of his arms and legs. Patient was A/Ox4 and denied any pain, shortness of breath, chest pain and any other medical complaints. 911 was contacted and EMS was notified. Patient has not experienced this in the past and has no known history of neurological disease according to family member on scene. Patient had no adverse reaction after his first dose of the Moderna vaccine. Patient reports no unusual change to daily routine or medication regime. Patient had no abnormal breathing, radial pulse was within normal limits and skin was warm and dry. Patient was unable to safely sit in chair and was moved to reclining chair where he was left in the semi fowlers position. Patient continued having uncontrolled movements approx. once every 10-20 seconds. Patient was able to talk the entire time and had no change in mental status. EMS arrived on scene and patient care was transferred.
Attendee received second dose Pfizer vaccine at 15:55 in the left arm.  Lot# EW0186. Attendee was directed to observation area.   At 16:00 voiced complaints of dizziness, and a rash was generalized on the chest and neck. No tachypnea or dyspnea.  Attendee was given 50 mg of Benadryl and an ice pack.  HR:  80's   BP:  184/88   O2Sat%:  97      16:05 - Attendee stated feeling better.    16:35 - Care Practitioner educated on home discharge/adverse reaction instructions and attendee was discharged to home with her family as her symptoms were completely resolved.  HR:  75   BP:  150/70   O2Sat%:  96
This case was reported by a consumer via call center representative and described the occurrence of feeling hot in a female patient who received SHINGRIX for prophylaxis. On 8th August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced feeling hot, tiredness, headache and pain. On an unknown date, the outcome of the feeling hot, tiredness, headache and pain were not recovered/not resolved. It was unknown if the reporter considered the feeling hot, tiredness, headache and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The day before reporting, the patient received a dose of SHINGRIX and was feeling feverish or warm, achy, tired and had a headache at the time of reporting. The patient did not wish to provide any additional information regarding the event and stated that she did not want to file a report as she expected these side effects.
A 42 year old woman, who is a nurse at the health care provider, received an injection of MassBiologics' Td vaccine (Lot #A090A) on October 25, 2016 intradermally in her left forearm instead of administering PPD. The patient experienced same day onset of injection site pain, erythema, and induration. At the time of the report, one day after administration, the patient had not recovered.  Treatment of the event was not reported. Sender's Comments: All adverse events reported in this case were assessed as non-serious and labeled, consistent with local injection site reactions causing tenderness, erythema, and induration described in the Td vaccine package insert.  The Td vaccine was administered incorrectly. MassBiologics performed a follow up with the primary source reporter in order to receive an update on the patient's recovery status. Details of the follow up are provided below: Follow up on November 28, 2016: The primary source reporter informed MassBiologics that her reactions had resolved completely. She also added that an administration error had occured because she had failed to read the product label completely and mistaken it for PPD. She clarified that she administered the dose for PPD and not the Td dose. Please note that report 'US-MassBiologics-AE1608' has been linked to this report. The events were similar events and were reported to MassBiologics at the same time by the same primary source reporter for the same Td lot. In the linked reports, both patients worked at the provider's office as nurses and were also the individuals that administered the doses to each other.
Information has been received from a registered nurse concerning a patient who on 06-Sept-1996 was vaccinated with a dose of varicella virus vaccine (lot # 617691/0569D).  Subsequently, on 24-Jan-1999, the patient developed chickenpox.  The patient was not seen in the office.  The reporter also indicated other patients were vaccinated with varicella virus vaccine live and developed chickenpox (WAES0409USA00600, WAES0409USA01045, WAES0409USA01046,WAES0409USA01047, WAES0409USA01048, WAES0409USA01049, WAES0409USA01050, WAES0409USA01051, WAES0409USA01055, WAES0409USA01053, WAES0409USA01054, WAES0409USA01056, WAES0409USA01057, WAES0409USA01058, WAES0409USA01059, WAES0409USA01060, WAES0409USA01061, WAES0409USA01062, WAES0409USA01063, WAES0409USA01064, WAES0409USA01065, WAES0409USA01066, WAES0409USA01067, WAES0409USA01068, WAES0409USA01069, WAES0409USA01070, WAES0409USA01071, WAES0409USA01072, WAES0409USA01073, WAES0409USA01074).  No further information is expected.
I took Benadryl and used my inhaler several times over the next 3 days I had the feeling Of swollen lips, tongue, throat, sore throat. Rash , itching and swelling of the cheeks and wheezing.  It has resolved. I also had a sore throat for 3 days and headache.
After my first dose of  J&J vaccine performed , I developed a cold, cough, runny nose, my eyes were red and nasal drainage, also had allergies.  I called my doctor to get medicine. I also had a Covid test which was negative. I am recovering of my symptoms today.
Rash/hives all over body, swollen eyes, trouble sleeping due to the itching/discomfort. Began ~10 days post booster shot, started course of Prednisone on 12/25/21 as well as 40mg Pepcid AC 2x day and Zyrtec 1x day, benadryl at night (50mg) - itchiness/hives continue as of 1/1/22 but decreased in severity - mostly hives and itchiness occurs at night. Still taking Benadryl at night and Zyrtec in the morning.
diagnosed with RA; after 2 starting doses, I got shingles/suspected vaccination failure; One of the side effects was shingles. Bad; This case was reported by a consumer via interactive digital media and described the occurrence of rheumatoid arthritis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and golimumab (Simponi Aria) for rheumatoid arthritis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and Simponi Aria at an unknown dose and frequency. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant), vaccination failure (serious criteria GSK medically significant) and shingles. The action taken with Simponi Aria was unknown. On an unknown date, the outcome of the rheumatoid arthritis, vaccination failure and shingles were unknown.   It was unknown if the reporter considered the rheumatoid arthritis, vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient took the shingles vaccine about 5 years ago from the date of reporting, was diagnosed with rheumatoid arthritis (RA), started taking Simponi Aria by infusion. The patient further stated that one of the side effects of it was shingles and the patient was thinking he/she would not get it because he had taken the vaccine. After 2 starting doses, he/she got shingles.  The patient said it was not a bad case, but bad enough. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting. It was unknown if the reporter considered the shingles to be related to Simponi Aria. No contact details were available.
p/vax pt exp varicella w/100 lesions & a mild temp;the reporting MD noted that pt recovered;
BLOOD CLOT IN AORTIC ARTERY; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose not reported, 1 total administered on 27-MAR-202 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced a massive blood clot in her aortic artery blocking all the blood flow to her legs then, pieces broke off and went to her brain and heart. On 28-MAY-2021 13:45 in afternoon the patient's life support was stopped. On 29-MAY-2021 at 2:01, 9 weeks after vaccination the patient died from blood clot in aortic artery. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:  This spontaneous report from consumer concerns a female patient of unspecified age/race/ethnicity who developed "massive blood clot in her aortic artery blocking all the blood flow to her legs then, pieces broke off and went to her brain and heart" 62 days after receiving Janssen COVID-19 vaccine.  The patient died on 63rd day post vaccination.  No other details reported.  The information available precludes a complete and meaningful assessment.  Considering the temporal relationship, the events are assessed to have an indeterminate relationship with the vaccination.; Reported Cause(s) of Death: BLOOD CLOT IN AORTIC ARTERY
received only the liquid portion; received only the liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA432A, expiry date 31st August 2022) for prophylaxis.   On 13th July 2021, the patient received the 1st dose of Menveo. On 13th July 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The nurse reported that a 11 years and 8 month old patient received only the liquid portion of the Menveo vaccine, which led to  inappropriate preparation of medication and inappropriate dose of vaccine administered. All patients identifiers were reported as well as batch number and expiration date. The reporter consented to follow up.