chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna Dose 1 2/8/2021 (011M20A) Moderna Dose 2 3/5/21 (013A21A) COVID Positive 7/12/21  7/12/21: Presented to ED. History is obtained from patient as well as by personal review of records. Pt. is 73-year-old with known history of essential hypertension for many years. She reports that her blood pressures were well controlled for a long time on amlodipine 5 mg daily. She was initially seen at convenient care for headache of 2 days duration.  Pain involved front and back of head. Associated with nausea.  She felt unwell.  Symptoms became worse at 14:00 hours on 7/12/2021.  She denied previous history of similar headache.  She is on arthritis and takes ibuprofen regularly.  While undergoing evaluation in emergency department her blood pressure was as high as 201/98.  Head CT was negative.  Blood pressures were controlled with IV hydralazine. Patient denied focal motor weakness.  No focal sensory loss.  Denied double vision or other visual problems.  No difficulty with swallowing.  No difficulty with speech.  Denied  anosmia or lack of taste.  7/14/21: Patient is a 73-year-old female who presented to the hospital with a headache.  There was some associated nausea with this and in general the patient had started feeling unwell with some myalgias and joint pain symptoms as well.  CT scans were performed which showed no obvious signs of stroke and the patient had no other focal neurological complaints.  Ultimately the patient tested positive for COVID-19 and was admitted to the hospital and started on treatment for this with zinc, vitamin-C, vitamin-D and remdesivir.  Patient remained afebrile and did not eat oxygen while admitted to the hospital.  On the morning of 07/14/2021 the patient was starting to feel better and was otherwise felt medically stable for discharge home.  Patient did receive both dose of the moderna vaccine and despite that the patient did contract COVID-19 will need quarantine for 7-10 days.  This discussed which indicated understanding.
Diluent for Hib vaccine was expired by 5 days. Sanofi said to repeat dose as soon as possible. Dose repeated with in date vaccine/diluent 2 days later. RN. No adverse reaction/outcome for patient.
1324- Patient received vaccine dose and moved to the post-vaccine monitoring area. Approximately 1326 felt unwell, told the RN monitoring that he would like to get a drink.  She walked to the water fountain with Pt. 1330 he felt light headed and dizzy, he was assisted to the floor and elevated his feet. 1335 was able to stand and sit in wheelchair and taken to the emergency room. During transport to emergency room stated he did not feel well, he felt "funny", cold sweats, dizzy, blurry vision. Patient never lost consciousness or became unresponsive. Care transitioned to Emergency Room staff.
Pt reports instant SOB at time of injection. Pt has epinephrine autoinjector for B12 reactions. Pt insisted on epi administration. Epi administered at 13:00.
Approximately 5 minutes after receiving vaccines became pale and lethargic after crying.  4/8/08 Reviewed hospital birth medical records of 9/23-10/27/2007.  4/15/08 Reviewed vax record which corrects date of vax to 1/22/2008, lot #s correct as reported.  Office note of 1/22 revealed patient experienced severe crying immediately after vax & then pale w/vasovagal response.  Sent to hospital for overnight observation & patient recovered well.
I knew that I had been exposed by a COVID-19 patient, so I started testing myself. I tested positive for COVID-19 on 10/22/22.  I had a sore throat, cough, fatigue, and congestion.  I contacted my doctor, and he prescribed 5 days' worth of Paxlovid.  By 10/26/22 I was completely back to normal. I am having cold like symptoms right now, but I tested negative for COVID-19.
Donor had headache and muscle aches with no treatment.  Donor reported events 5 days after immunization.
The first day I was fatigued and achey for a few hours and wanted to go to sleep very early.  The following two days my arm was sore at the injection site but that went away in a couple days.  3 days post vaccination, my right axilla and median and ulnar nerves were extremely sensitive for 3 days but that subsided.  6 days post vaccine I started to get extreme fatigued, low energy and feel like my nerves were hot.  I got a covid test which was negative because I was not feeling well.  Then 9 days post vaccine I started to feel very fatigued, achey, and I couldn?t sleep well and like my nerves were burning up all over my body.  I had to call out of work due to brain fog, fatigue, nerve heat, difficulty concentrating.  I took my temperature during all this and it was 97.7.  My hands felt very hot and I could wash them under warm water because the water felt way too hot.
Vomit, head ache, chills, joint pain, fatigue, back pain, muscle pain, nausea,
patient had not reported any symptoms; Pharmacist called and reported that one dose of PNEUMOVAX 23 had been administered after a temperature excursion.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions or concomitant medications was not provided.   On 09-AUG-2023, the patient was vaccinated with an improperly stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX), frequency reported as "1dose", as prophylaxis; lot number W021636 has been verified to be a valid number for Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), expiration date was reported as 10-OCT-2023, but upon internal validation was established as 01-OCT-2023 (dose, route of administration, and anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion 56.4 degrees Fahrenheit for 12 hours. There was no previous temperature excursion reported. There was no other symptoms or adverse effects reported.
Tinnitus; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported at unspecified site 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 tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tinnitus was not reported. This report was non-serious.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L016959 with expiration date of 12-MAR-2018, lot # L045117 with expiration date of 06-OCT-2018 and lot # L027733 with expiration date of 13-SEP-2017 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. It was reported by the nurse, that RECOMBIVAX HB was exposed to a temperature of 34 degrees F for 12 hours. The aforementioned vaccine had never been involved in any previous temperature excursion. Data logger was stated. Furthermore, no adverse event symptoms were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient found by mother at 4am the next morning to have high temperature and having trouble breathing. Patient was taccycardic at 170 and was taken to the hospital where his blood pressure was extremely high.  Patient was discharged from hospital today (9/25) after staying overnight 2 nights to reduce blood pressure.  Please contact mother for more information..
High fever. Extreme body aches. Extreme Sweating and chills. 103.9 fever for three days. Headaches. Took Tylenol for fever, but only brought it down to 102.6
pt recvd vax & devel a wheal & flare @ the inject sit which was described as white welts in a flat red area;
ACKING IN SHOULDER AND ARM/ SOME LEG, REALLY BAD WHEN TRYING TO SLEEP,OR LYING DOWN, NUMBNESS IN LEFT HAND AT TIMES, FINGERS TINGLE IN LEFT HAND, WEAK ARM, TROUBLE LIFTING ARM,VERY SORE.... WHAT CAN I TAKE FOR THE PAIN?
1) Fever, hot/cold sweats coming and going for about 60 hours, never broke 102. Tylenol already taking to keep sinuses open and in control assisted with this. ** 2) Sinus headaches that didn't seem to go away despite the Tylenol and Sudafed, which led to nausea and vomiting. As of 5/2 9 am EDT I believe I have an explanation: The Sudafed was doing too well, possibly due to the loss of water. Tried multiple variations to identify the cause: Increase water intake (no change), increase Sudafed (seemed to make worse), decrease Sudafed (seemed but help but then the drainage and discharge caused similar results). The current working solution has been to maintain the normal regiment but make sure to supplement moisture in the nasal passages with a saline nasal spray.
Client has experienced tinnitus since 10/4/22, the day after receiving his Shingrix vaccine. He has never experienced this before, denies any major medical conditions, hx Covid infection, or history of tinnitus. He denies taking antibiotics at the time and doesn't normally take any medications. He did see his primary doctor who "didn't have much to say" and a hearing doctor who checked his hearing and "didn't have much to say", per client. The ringing in his ears "comes and goes" but has persisted daily.
Shortness of breath.   Pain in chest.   Heartbeat irregular.  Extreme fatigue.   Lethargic.  Dizziness and fainting.
This case was reported by a consumer via call center representative and described the occurrence of immunocompromised in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced immunocompromised (serious criteria GSK medically significant), renal disorder, shingles and product supply issue. On an unknown date, the outcome of the immunocompromised, renal disorder, shingles and product supply issue were unknown. It was unknown if the reporter considered the immunocompromised, renal disorder and shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received 1st dose of SHINGRIX 8 months prior to the report. The patient was immunocompromised due to kidney transplant and was facing constant issue of shingles. The patient was unable to receive 2nd dose of SHINGRIX due to product supply issue.
Exactly 9 days after initial shot, red rash appeared around vaccination site, hot to touch and slightly itchy
The day after the covid vaccine, I had severe fatigue. The next two days after the fatigue, I had nausea and vomiting throughout the day.
Initial unsolicited report received from a non-health care professional on 19 January 2016. This case involves a male patient (age unknown) who was vaccinated with a dose of INFLUENZA VACCINE (FLU VACCINE) (manufacturer: unknown, batch number, expiry date, route and site of administration were not reported) on an unspecified date (reported that he received the vaccine "this year"). Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced flu A. It was reported that the patient saw the doctor. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none. Addendum on 15 February 2016: Upon second medical examination of the case during internal review, a significant correction was performed on 15 February 2016 to change the event coding of flu A from influenza A virus infection to flu-like illness and change the seriousness to No and Workflow Case priority to Class 4.
This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received KINRIX (batch number 99A7M, expiry date 3rd September 2016). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: This product has been exposed to temperature outside of the required temperature range and the efficacy of this product outside the temperature range has not been established. This customer purchased one 10 pack of this product therefore it was administered to ten patients. The ages and genders of the patients are unknown at this time. This case is one of the 9 cases reported by the same reporter for the same vaccine.
Headache, Fever, NauseaVomiting, chills, night sweats Narrative:
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 20-MAY-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R029815 with expiration date in 18-JUN-2020) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000965:
Headache, muscle ache, fever, chills, nausea; All moderate level; able to perform normal activities with some discomfort. Lasted throughout the day; gone by next morning.
Vaccine exp. use by date = 10/7/22 8 weeks follow defrost VS Exp. date 10/31/2024
she got sick; her skin hurt; didn't sleep well; headache; body aches; fever 100.9 degrees F; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (she got sick), PAIN OF SKIN (her skin hurt), INSOMNIA (didn't sleep well), HEADACHE (headache) and MYALGIA (body aches) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included HIV infection (which patient contracted from her husband.), Chronic fatigue, Chronic bronchitis, Chronic pneumonia, Degenerative joint disease, Seasonal allergy, Penicillin allergy and Immunocompromised. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) for Degenerative joint disease, BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for HIV disease, EPINEPHRINE (EPIPEN) for an unknown indication.    On 20-Aug-2021 at 12:45 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021 at 8:00 PM, the patient experienced ILLNESS (she got sick), INSOMNIA (didn't sleep well) and HEADACHE (headache). 20-Aug-2021 at 8:00 PM, the patient experienced PAIN OF SKIN (her skin hurt). 20-Aug-2021 at 8:00 PM, the patient experienced MYALGIA (body aches), PYREXIA (fever 100.9 degrees F) and CHILLS (chills). On 22-Aug-2021, ILLNESS (she got sick), PAIN OF SKIN (her skin hurt), INSOMNIA (didn't sleep well), HEADACHE (headache), MYALGIA (body aches), PYREXIA (fever 100.9 degrees F) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, Body temperature: 100.9 (High) At 8 PM, 100.9 degrees F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient treatment information include no medication for events.   This case was linked to MOD-2021-337213 (Patient Link).
10/26/07-Headache, soreness, tingling down L upper arm.  11-2-07 Tingling, stinging sensation L shoulder/neck.  11-3-07 Tingling, stinging L side face.  Sensation moved 11-5-07 to R side face.  Headache continues.
This spontaneous report as received from a physician refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (therapy type: Digital data logger) (lot # L033343 with expiry date of 13-SEP-2017), at a temperature of 33 F for a time frame of 8 hrs 20 min cumulatively (incorrect product storage). The physician reported there was a previous temperature excursion, which was cumulative total since unspecified time in March 2016. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Moderna COVID?19 Vaccine EUA  Patient received COVID-19 vaccine booster dose on 4/6/2022. No symptoms or adverse events noted during administration and observation.  No adverse events reported by the patient to date.  On 5/4/2022 discovered that dose administered is past the expiration or beyond-use date.  Manufacturer contacted to report event and  to obtain re-vaccination guidance.
Patient came in having tenderness under left armpit. Upon examination, patient had what looked like a swollen lymph node. Patient had swelling of about the size of a baseball at left armpit. This was compared  to his right side which looked normal. Instructed patient to seek a physician for further examination.
Day 1: Sore arm Day 2: Sore arm Day 3: back to normal  Day 4: armpit pain and palpated lump in armpit  Day 5: worse armpit pain radiating into arm, neck, chest and back  Day  6: same pain as day 5  Day 7: extremely severe pain in armpit,  palpated larger lump. The pain is more extreme in my arm and neck.
Chest tightness developing within 4 hours of administration, resolved overnight. Widespread urticaria that lasted about 1.5 weeks, resolving with oral prednisone.
Muscle soreness lasting more than 2 weeks and difficulty with range of motion when lifting arm.
Pt stated injection site started becoming red and warm to the touch 1 day post injection and lasted for 2 days. Seen by civilian provider and was diagnosed with cellulitis. Patient given Keflex 1 pill QID x 7 days.
Swollen lymph nodes, swollen tonsils, high fever over 100°, lethargy, joint pain, migraine headache. Sore throat. Nausea.
Patient presented to the ED and was subsequently hospitalized for atrial flutter within 6 weeks of receiving COVID vaccination.
7MAY97 mom reports bumpy rash around inj site & then all over jaw, both sides & face & chest, threw up, fever 28APR, groggy x 2 days;10MAY97 rash on cheeks, now has chickenpox;
Patient started having generalized weakness, fatigue, fever and headache after the second dose of his Moderna Covid-19 vaccine. These symptoms persisted throughout the next day. However, two days after the second Covid-19 shot patient developed severe chest pain that resulted in presentation in the ED. There was associated shortness of breath and diaphoresis. He was treated with Colchicine and Ibuprofen. He was also started on metoprolol because he had an 11-beat run of non-sustained ventricular tachycardia. He was discharged home on the fourth day to follow up with cardiology as outpatient.
Hospitalized (11.1.21);  COVID-19 vaccine (11.1.21);  fully vaccinated  Discharge Provider: Doctor Primary Care Provider at Discharge: Physician Assistant Admission Date: 11/1/2021 Discharge Date: 11/3/2021 PRESENTING PROBLEM: COVID-19  HOSPITAL COURSE: Patient is a 55 y.o. female with a history of inflammatory arthritis and chronic obstructive pulmonary disease, who is not oxygen dependent, presents today with increasing shortness of breath and cough. She had received 2 doses of Pfizer vaccine for COVID-19.  Patient reported onset of fever, fatigue productive cough and shortness of breath 3 days ago. She noted coughing up green sputum.  She denied any chest pain, abdominal pain, nausea or vomiting, diarrhea or urinary symptoms.  She used her home inhalers without any improvement.  She tried to get into her PCP office but they had no openings so she scheduled a tele medicine visit today.  She noted the provider instructed her to be seen in the emergency department due to her coarse lung sounds and wheezing.  She proceeded to Emergency Department for evaluation.   Patient was hypoxic at 85% on room air and placed on 1 L of oxygen to maintain sats above 90%.  Laboratory studies unremarkable. EKG showed normal sinus rhythm with nonspecific ST and T wave abnormality. No change from previous EKG. COVID-19 positive.  Chest xray demonstrated hyperinflated lungs without acute cardiopulmonary process.  She was given IV Decadron and albuterol treatments but continued to require 1 L of oxygen.  Given her continued hypoxia she was transferred via EMS to Big Rapids Hospital for further care and treatment of chronic obstructive pulmonary disease exacerbation secondary to COVID-19 Pneumonia.  Patient was weaned to room air on 11/2 though her work of breathing warranted further monitoring. On 11/3 she had some dyspnea with exertion but was feeling well at rest; she felt confident to go home.  She will be discharged in stable condition on room air with a medrol dose pack and guaifenesin.  She understands she is recommended to follow up with her PCP to ensure resolution of Covid-19 with concomitant COPD exacerbation.