chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster).    Concomitant medication details was not reported. Treatment details was not reported.  The reporter reported that they called the CDC and were instructed to go ahead and administer the other half of the dose (0.25ml) on the same day. This case contains information for the fifth adult patient out of 15 adult patients as described by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2022-658139, US-MODERNATX, INC.-MOD-2022-658159, US-MODERNATX, INC.-MOD-2022-658149, US-MODERNATX, INC.-MOD-2022-658161, US-MODERNATX, INC.-MOD-2022-658162, US-MODERNATX, INC.-MOD-2022-658150, US-MODERNATX, INC.-MOD-2022-658155, US-MODERNATX, INC.-MOD-2022-658156, US-MODERNATX, INC.-MOD-2022-658157, US-MODERNATX, INC.-MOD-2022-658173, US-MODERNATX, INC.-MOD-2022-658168 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658161:Adult patient 12, same reporter US-MODERNATX, INC.-MOD-2022-658159:Adult patient 10, same reporter US-MODERNATX, INC.-MOD-2022-658149:Adult patient 2, same reporter US-MODERNATX, INC.-MOD-2022-658139:Adult patient 1, same reporter US-MODERNATX, INC.-MOD-2022-658162:Adult patient 13, same reporter US-MODERNATX, INC.-MOD-2022-658150:Adult patient 3, same reporter US-MODERNATX, INC.-MOD-2022-658155:Adult patient 6, same reporter US-MODERNATX, INC.-MOD-2022-658156:Adult patient 7, same reporter US-MODERNATX, INC.-MOD-2022-658157:Adult patient 8, same reporter US-MODERNATX, INC.-MOD-2022-658173:Adult patient 15, same reporter US-MODERNATX, INC.-MOD-2022-658168:Adult patient 14, same reporter
Starting around 08/08/2022 swelling in the right knee went to emergency the next day; swelling progressed further, entire right leg was swollen.  X-ray didn't find anything referred to specialist nothing found; swelling subsided.
Vaccine administered on a Monday, patient told us that on Friday he fell and didn't have the energy to get up. He complained of muscle weakness at the ER and was given half a liter of fluids and was feeling better. Per the ER notes, he was thought to be dehydrated. Unclear if he may have been experiencing an early viral syndrome. He resumed ambulating without difficulty and was considered safe for discharge.
On Saturday it began with a very high sore throat behind my sinuses.  My nasal passages were swollen.  I had a headache and pronounced vertigo every time I shifted positions.  I eventually had a fever beginning day two or three and had fever each afternoon.  I was still in treatment for breast cancer and was prescribed Paxlovid.
Fever, HA, lightheadedness day following immunization. Returned for eval 0800 10/2/14 with above and worsening pain at site of PPSV 23 immunization. At (R) deltoid, erythema with sharp borders, pain, induration. Rx BACTRUM DS and Pen VK x 7 days, F/U in 4 days.
Information has been received from Pfizer, Inc. [2016385284] on 17-AUG-2016 via a consumer. A patient's mother reported her daughter was vaccinated with GARDASIL and experienced alopecia (MARRS # 0901USA02690). The patient's mother reported that according to the internet, 2000 girls had the same problem (alopecia). This is one of several reports from the same source. Additional information is not expected. Information was received via a business partner.
About Two hrs after the shot I had extreme pain in my bones and a fever. Had a difficult time sleeping and had a headache.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 9:04 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 9:04 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 24.62   Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 9AM temperature was 34 total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM:38, 9 AM:34, 10 AM: 38, 11 AM: 42, 12 AM:41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM:41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
drug induced lupus; This is a spontaneous report from a non-contactable consumer (the patient) A 38-years-old female patient received bnt162b2 (BNT162B2) unknown dose number, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  The patient medical history and  concomitant medications were not reported.  The patient experienced drug induced lupus  (medically significant) on an unspecified date with outcome of unknown.    Course of the event. The patient started experiencing lupus-like  symptoms within weeks of taking the Pfizer COVID-19 vaccine. Rheumatologist suggested it might be drug induced lupus and is running more tests  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2-3 weeks following COVID-19 vaccination the patient suffered a ruptured ovarian cyst. This was followed by a rash and intense pain. The patient is now unable to walk and in a rehab. Not clear if thes; 2-3 weeks following COVID-19 vaccination the patient suffered a ruptured ovarian cyst. This was followed by a rash and intense pain. The patient is now unable to walk and in a rehab. Not clear if thes; 2-3 weeks following COVID-19 vaccination the patient suffered a ruptured ovarian cyst. This was followed by a rash and intense pain. The patient is now unable to walk and in a rehab. Not clear if thes; 2-3 weeks following COVID-19 vaccination the patient suffered a ruptured ovarian cyst. This was followed by a rash and intense pain. The patient is now unable to walk and in a rehab. Not clear if thes; This is a spontaneous report from a contactable consumer. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in May2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included coeliac disease (known allergies: Celiac disease-related issues). The patient's concomitant medications were not reported. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination.Prior to vaccination,  the patient wasn't diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. In May2021, 2-3 weeks following COVID-19 vaccination the patient suffered a ruptured ovarian cyst. This was followed by a rash and intense pain. The patient is now unable to walk and in a rehab. The events resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage. The outcome of the events was recovering. Therapeutic measures were taken as a result of the events.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
CAREGIVER REPORTED THAT THE PATIENT WAS HAVING DIFFICULTY BREATHING AS OF THE AM OF 03/01/21 .
Arm pain at site of injections (left and right). Generalized weakness and aching. Possible low-grade fever overnight with increased urinary frequency. Generalized weakness and aching on day 2.
The pt experienced a reddened area on the right deltoid 2 1/2" in diameter and was tender to the touch with heat.
Severe headache; Vomiting (6+ times); Drinking anything made me sick; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old emale patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 (Lot number: FG3527) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included LISINOPRIL; LEVOTHYROXINE; ASPIRIN; KOACT. Past drug history included Morphine, allergy reaction. Vaccination history included'''=[/ Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown Location of injection: Arm Left, Vaccine Administration Time: 06:30 PM), administration date: 06Mar2021, when the patient was 61 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown Location of injection: Arm Left, Vaccine Administration Time: 06:30 PM), administration date: 28Mar2021, when the patient was 61 years old, for COVID-19 immunization.  The following information was reported IMMUNISATION (non-serious) with onset 19Nov2021, outcome unknown; HEADACHE (non-serious) with onset 20Nov2021 09:00, outcome recovered (Nov2021); VOMITING (non-serious) with onset 20Nov2021 09:00, outcome recovered (Nov2021); ILLNESS (non-serious) with onset 20Nov2021 09:00, outcome recovered (Nov2021). Therapeutic measures were not taken as a result of headache, vomiting, and illness.  Other medications in two week, Lisinopril, levothyroxine, aspirin, and koact.   Follow-up attempts are completed. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 59-year-old female patient who received SHINGRIX (batch number NR4Z4, expiry date 11th October 2020). On 21st May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, influenza-like symptoms, injection site warmth and injection site cellulitis. On an unknown date, the outcome of the extensive swelling of vaccinated limb, influenza-like symptoms, injection site warmth and injection site cellulitis were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, influenza-like symptoms, injection site warmth and injection site cellulitis to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on unknown arm. The health care professional reported that the patient experienced flulike symptoms that subsided but also had swelling of the arm about 6 into 4 inches. The health care professional was worried as it could be a cellulitis. The health care professional reported that the patient was experiencing number localized reactions only after receiving the 2nd dose. The health care professional did not have any patient information or lot number or expiry date.
POST VACCINE, REPORTED FLUSHING AND HEART PALPITATIONS/RACING HEART. BROUGHT BACK TO OBS VIA WC FOR VITAL CHECK. STATES HAS HAD THESE IN THE PAST AND HAVE RESOLVED UPON ARRIVAL TO OBS. VSS, ESCORTED TO EXIT WITH NO FURTHER ISSUES ONCE S/S RESOLVED COMPLETELY AT 1004. INSTRUCTED BY ON SITE MD TO SEEK FURTHER EVAL/TREATMENT IF RETURN/PERSIST/WORSEN.  0958 BP 135/85 HR 94 RR 18 SATS 100% RA 1000 BP 126/90 HR 88 RR 18 SATS 100% RA
he got the first dose on 04 Jun 2021, he was told that today he's scheduled for the second dose, but the doctor told him on Monday that he had low white blood cells; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on 04Jun2021 as dose 1, single for covid-19 immunisation in front of a hospital emergency department. Medical history included he had cancer. The patient concomitant medications were not reported. The patient stated that he got the first dose on 04Jun2021, he was told that today he was scheduled for the second dose, but the doctor told him on monday that he had low white blood cells on an unspecified date in Jun2021. The patient lab test included white blood cell count was low on an unspecified date in Jun2021. The outcome of the event was unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.
At or  around five AM I had chills and my body ached in addition I felt like someone had their hand around my neck, like it was being choked or squeezed,  I checked my temperature as I felt hot it was 99.8 I drank a lot of liquids and took ibuprofen. I had to miss work due to not feeling good upon returning to work I have still not felt well and I have been running a low grade or elevated temperature that has lasted until 10/23/2022 in addition I have a ringing in my ears.
Redness and swelling of right upper arm at injection site with slight itching. Patient said it started the same day of injection on 9/13/11 and was enlarging still when she reported to me at clinic on 9/15/11. Treated with cold compresses, OTC Hydrocortisone cream and oral BENADRYL 25-50 mg. She reported improvement on 9/16/11.
Pte. felt dizzy and was fainting.  She sat on a chair and her body became very still she rolled over her eyes and had jerky movements for a few seconds.
Chills began at 11:15p, by morning 1/27/2021 I had a fever of 101.1. Stiffness in joints, couldn't walk without losing balance in early a.m. No appetite. Vomited in early afternoon. Just a very sick feeling. Began feeling better during evening. Was just able to tolerate drinking water. Today (1/28)temp is 98.1. Feeling better, just a little weak.
Freezing cold; Low grade fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Freezing cold), PYREXIA (Low grade fever) and HEADACHE (Headache) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Freezing cold), PYREXIA (Low grade fever) and HEADACHE (Headache). At the time of the report, NASOPHARYNGITIS (Freezing cold), PYREXIA (Low grade fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment were reported.
PATIENT TESTED POSITIVE FOR COVID 19 ON 04/28/2021 RECORD NOTES:  4/30/21 Admitted to Med/Surg on 4/29/21. 59 y.o. who presents to the ED with c/o fever, chills, myalgia diaphoresis, decreased appetite, nausea, weakness and fatigue, with sudden onset today. He reports that he had COVID-19 back in January and was admitted for 3 days. He reports he had his COVID-19 vaccine. Pt. is on R/A SaO2 @ 95%. CXR reports" no evidence of acute process in the chest" Plan to DC to home today.  5/3/21 Pt was discharged home on 4/30/21, Note uploaded.   5/5/2021 @1045 - Called and spoke with patient. Says he is feeling much better. No more symptoms to report. told him I will still be following up with him for the duration of his isolation.  5/10/2021 @1130 - Spoke with patient. Told him he is at the end of his isolation period and just checking in on him and his symptoms. No symptoms. Says he feels fine. Asks if he can return to work - I said yes. Offered to email him a RTW letter. He said he may have his boss call me if he has any questions.
Client presented stating she felt like her heart was racing. Initial pulse 120 S/R. Talked for a few minutes and client stated no itching or shortness of breath. After 5 minutes pulse 86 S/R. After 10 minutes 78 S/R. Client stated normal resting HR of 65. She takes 12.5 HCTZ PO daily.
pain all over her body; nasal congestion; cough; feeling chills that night; This is a spontaneous report from a contactable consumer(patient). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration on 11Apr2021 as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), for covid-19 immunisation. The patient mentioned that aside feeling chills that night (11Apr2021), everything was normal. Eight days later (19Apr2021), she woke up feeling chills, pain all over her body, nasal congestion and today she wakes up having cough. The outcomes of events were unknown.   No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
THIS AM DAD NOTICED RED, RAISED RING, APPROXIMATELY 2"ACROSS, AROUND INJECTION SITE ON LEFT ARM.
Red, inflammed and hot to the touch, hard and size of baseball at injection site.  No fever.  Localized pain.
PT SAID WOKE UP AT 130 AM WITH FEVERS, CHILLS, BODY ACHES, BACK ACHE, CRAMPING, REDNESS AROUND INJECTION SITE. IMPROVED DURING THE NIGHT BUT STILL HAS LOWER BACKACHE. HAS TAKEN APAP THROUGHOUT DAY TO HELP BUT CRAMPING AND SHIVERS HAVE IMPROVED.
Awoke to use bathroom and upon sitting up in bed experienced strong dizziness.  Walked to bathroom, but was unsteady on my feet.  Sat to urinate and began perspiring, accompanied by slight tingling (flushing?) sensation throughout body and mild nausea (did not vomit).  After several minutes, perspiring, tingling and nausea subsided and I returned to bed, however dizziness continued until I lay in bed for a while.  Slept OK, but in morning, dizziness returned when I moved and sat up.  When using bathroom, symptoms similar to those experience the night before returned, but were not as severe.  Remained up, doing minor activities, but dizziness persists, especially when I move my head or bend over.  Symptoms persist at the time of this report (10:00 AM the day after vaccine was administered).
Patient describes having fever, chills, and rigors, also noted hard lump on left upper arm at the injection site 24 hours after booster vaccination. Fever, chills and rigors were gone approx 12 hours later but patient noted increased redness, swelling and pain at injection site. Patient appeared at the Emergency department on 11/11/2021 for evaluation as redness, pain and swelling continued and patient began to have itching in the area also. Dx: Inflammation of Left upper arm - injection site inflammation vs. infection TX: take OTC non-drowsy antihistamine daily x 14 d, OTC Pepcid 20 mg tabs 2 x daily x 14d, Vistaril 25 mg tab at HS prn, apply triamcinolone cream to area 2-3 x daily prn. Monitor inflammation area. Take Keflex 500 mg PO3 x daily for 7 days, F/U with pCP or ED for new or worsening symptoms.
arm pain after the immunization and still has arm pain.  patient has been to the doctor for regular visit and was examined and told by the MD that it can happen from immunization.
patient felt lightheaded and proceeded to become unconscious. Patient was unconscious for about 10 seconds or so and then regained consciousness. Pharmacist made sure patient was alert and aware of surroundings. Paramedics were called and patient was assessed at pharmacy and was deemed to be ok to leave.
The arm started hurting at around 10pm and took Tylenol. Woke up during night and noticed arm was swollen. Adenopathy  in armpit on that side.
Whole body rash, hives, and itching one hour after receiving vaccine. Whole body is itchy, red, and swollen.
Tingling, general flush, BP 132/82, HR 92 O2 98% - positioned supine, administered Benadryl IM
Pt recv vax on 1/6/99; on 1/7/99 pt exp red/ swollen/ hard/ hot/ painful vax site