chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt a little off for one day; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt a little off for one day) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced MALAISE (Felt a little off for one day). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. In January 2021, MALAISE (Felt a little off for one day) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not reported.  Treatment includes Ice also.  Patient had second dose on 26 Feb 2021 and also a third booster dose due to her comorbidities. She experienced various side effects after each dose.   This case was linked to MOD-2021-014607, MOD-2021-311452 (Patient Link).
A little fever/Feeling like Fever; Tired; Just goes queasy/ Nausea; Sluggish; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 (Lot number: FC3181) at the age of 14 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SLUGGISHNESS (non-serious) with onset Aug2021, outcome "unknown", described as "Sluggish"; HEADACHE (non-serious) with onset Aug2021, outcome "unknown", described as "Headache"; PYREXIA (non-serious) with onset 16Aug2021, outcome "unknown", described as "A little fever/Feeling like Fever"; FATIGUE (non-serious) with onset 16Aug2021, outcome "unknown", described as "Tired"; NAUSEA (non-serious) with onset 16Aug2021, outcome "unknown", described as "Just goes queasy/ Nausea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of sluggishness, headache, pyrexia, fatigue, nausea.  Additional information: Patient received 2 Tylenol for reported event however not specified for which events he received treatment  No follow-up attempts are possible. No further information is expected.
Fever, lethargy for 1 week, day 5 low grade temp 100.5 Narrative:
Received 12M shots Hib, PCV13, MMRV, influenza on (L) VL. MMRV was given to swollen leg.
Localized erythema and tenderness x's 2 days; cool compress/NSAIDS such as ibuprofen.
arm slightly sore; stomach gurgles after drinking water; hard and firm 3 inch circumference at the injection site; bad diarrhea that got worst after 24 hs; felt tired; Chills; arm pain after 2 hrs of the injection; slight stomach pain; Nausea; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain after 2 hrs of the injection), VACCINATION SITE INDURATION (hard and firm 3 inch circumference at the injection site), MYALGIA (arm slightly sore), ABDOMINAL PAIN UPPER (slight stomach pain) and NAUSEA (Nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm pain after 2 hrs of the injection), ABDOMINAL PAIN UPPER (slight stomach pain), NAUSEA (Nausea) and HEADACHE (slight headache). On 17-Jan-2021, the patient experienced VACCINATION SITE INDURATION (hard and firm 3 inch circumference at the injection site), DIARRHOEA (bad diarrhea that got worst after 24 hs), FATIGUE (felt tired) and CHILLS (Chills). On 18-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach gurgles after drinking water). On 20-Jan-2021, the patient experienced MYALGIA (arm slightly sore). At the time of the report, PAIN IN EXTREMITY (arm pain after 2 hrs of the injection), VACCINATION SITE INDURATION (hard and firm 3 inch circumference at the injection site), MYALGIA (arm slightly sore), ABDOMINAL PAIN UPPER (slight stomach pain), NAUSEA (Nausea), HEADACHE (slight headache), DIARRHOEA (bad diarrhea that got worst after 24 hs), FATIGUE (felt tired), CHILLS (Chills) and ABDOMINAL DISCOMFORT (stomach gurgles after drinking water) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Initial unsolicited report received from a non-healthcare professional on 27 August 2015. This case involves a female patient who was vaccinated with a dose of PENTACEL; a dose of ROTATEQ and a dose of PREVNAR ([dose, dose in series, expiry date, route and site of administration were not reported for all the vaccines) (batch number reported as C4772AA, C4855AA, K020183, L62072]) all on 12 July 2015. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had experienced fussiness (for 2 weeks), bulging fontanel and optic nerve palsy (went to ophthalmologist). Laboratory data and corrective treatment were not reported. On an unknown date, the patient was recovered from fussiness and optic nerve palsy. The outcome of the event bulging fontanel was unknown. Upon internal medical review, the seriousness of the event of optic nerve palsy was considered as other - important medical event. List of documents held by sender: none.
2:25 pm- Patient reports chest pain 8/10; shortness of breath; throat tightness
Incorrect Vaccine - TDaP (Boostrix) given instead of DTaP.
Pediarix, Boostrtix, Infanrix, Engerix-B, Kinrix, Havrix administered without shaking it; This case was reported by a other health professional via call center representative and described the occurrence of wrong technique in drug usage process in an unspecified number of patients who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Boostrix, Infanrix, Infanrix Pre-Filled Syringe Device, Engerix B, Kinrix, Kinrix Pre-Filled Syringe Device and Havrix. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Boostrix, Infanrix, Infanrix Pre-Filled Syringe Device, Engerix B, Kinrix, Kinrix Pre-Filled Syringe Device and Havrix, the patient experienced wrong technique in drug usage process. On an unknown date, the outcome of the wrong technique in drug usage process was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-Sep-2022 and 21-Sep-2022 Reporter's comment: Healthcare professional was aware that they should shake Pediarix before administration. Some of Healthcare professionals colleagues did not follow this instruction and administered the vaccine without shaking it. The consent to follow-up was granted. Upon callback to Healthcare professional, he reported that this had been happening with Boostrtix, Infanrix, Engerix-B, Kinrix, Havrix as well as not shaking before administration and had been going on for over a year. Additional Supportive Information: There were some healthcare professionals colleagues who did not followed the instruction and administered the vaccine without shaking it, which led to wrong technique in drug usage process.
Information has been received from a physician concerning a patient ("aged between 82-90 years") who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 641130/1161L).  In October 2002, the patient experienced swelling, pain and redness at the injection site.  Unspecified medical attention was sought.  A product quality complaint was not involved.  The physician also reported another patient that had similar reaction after being vaccinated with a dose of pneumococcal vaccine 23 polyvalent (WAES # 0210USA01570).  Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2021 as dose 3 (booster), single (Lot number: PF3594) at the age of 35 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL, start date: 18Nov2022, stop date: 20Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Severe hypertension: systolic consistently over 200 mmHg and diastolic, notes: Severe hypertension with systolic consistently over 200 mmHg and diastolic over 100 mmHg. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Reporter stated that, Report about Covid treatment. Patient was taking other medication in 2weeks. Patient received COVID 19 Treatment was Paxlovid. Treatment start date was 18Nov2022, Treatment stop date was 20Nov2022, Lot number was GE1498. Patient had no known allergies. Patient had Other medical history was obesity.  No follow-up attempts are possible. No further information is expected.
RED ITCHY FULL BODY RASH. ADMINISTERED DIPHENHYDRAMINE. OBSERVED FOR 20 MIN. NO IMPROVEMENT. CALLED 911. PATIENT ALERT, NO DIFFICULTY BREATHING.
About 5 minutes after vaccine given, patient fell. Patient was light headed. Blood pressure was low. Blood glucose was 97. Patient's breathing was shallow and labored. Patient sat down and EMTs were called. Patient was fine after sitting for 15 minutes.
First 24 hours severe headache and muscle aches, felt nauseous and extreme fatigue. After that same symptoms but  Much less severe but it is now Monday and I have head and body aches fatigue and feel nauseous
Patient is 14 year old and attended clinic where the Pfizer-BioNTech vaccine was administered instead of the correct Pfizer dose vaccine.  Patient tolerated vaccine well, parent (mom) is aware of the medication error.  Upon returning for 2nd dose, patient will receive the correct 30 mcg dose.   Our facility has also reviewed our processes and will implement a number of changes to ensure this mistake does not happen again.
Improper handling of vaccines; Sore arm; Felt tired; This is a spontaneous report from a non-contactable consumer, the parent. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Apr2021 at 16:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On an unknown date in Apr2021, the patient experienced a sore arm and felt tired after the first shot. The clinic where the patient took the first shot was put on evaluation pause to give vaccines due to improper handling of the vaccines. The reporter learned it in the newspaper and could not find more details. The local health department had recommended them to consider the patient's first shot invalid and asked to retake it. The patient had scheduled to take the second shot on 23Apr2021, at another clinic and the nurse there said they could discuss it when they were there whether the patient should take vaccine on 23Apr2021 (Friday) as a first or second shot. They were concerned about overdose or if it was necessary to re-do the first shot and should just treat the 23Apr2021 shot as the second shot. The reporter had requested for an advice. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm and felt tired were unknown at the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
2:15PM At approximately 2:10PM on 1/6/21 in observation area patient raised her hand. Writer and several other staff approached patient asking what was wrong. Patient appeared to be clammy, and stated: "I feel kind of dizzy, and now my hands feel tingly." Writer immediately alerted charge RN. Other staff stayed with patient and helped drink water, deep breathe. V/S checked. BP 142/97 HR-96 (apical) RR-17. Over a few minutes patient began to state she felt less "dizzy" and was starting to feel better. Patient being closely monitored for additional 15 minutes. Writer will re check V/S and patient before advising to leave observation. 2:30 BP 130/96 HR-72. Patient states: "I feel a lot better." Patient asked to wait an additional 10 minutes to be monitored. Patient in compliance. RN aware and did assess patient. Patient cleared to leave at 2:40PM 2:44PM Patient felt well enough to leave. Patient observed walking out of facility with no complications, no further concerns.
lumps in the arm where he had the injection; Lumps throughout the body and arm; Lumps burn, are itchy, hard and bright red; Lumps burn, are itchy, hard and bright red; Lumps burn, are itchy, hard and bright red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lumps in the arm where he had the injection), MASS (Lumps throughout the body and arm), BURNING SENSATION (Lumps burn, are itchy, hard and bright red), ERYTHEMA (Lumps burn, are itchy, hard and bright red) and PRURITUS (Lumps burn, are itchy, hard and bright red) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Arm operation (Right Arm Surgery).    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (lumps in the arm where he had the injection), MASS (Lumps throughout the body and arm), BURNING SENSATION (Lumps burn, are itchy, hard and bright red), ERYTHEMA (Lumps burn, are itchy, hard and bright red) and PRURITUS (Lumps burn, are itchy, hard and bright red). At the time of the report, VACCINATION SITE MASS (lumps in the arm where he had the injection), MASS (Lumps throughout the body and arm), BURNING SENSATION (Lumps burn, are itchy, hard and bright red), ERYTHEMA (Lumps burn, are itchy, hard and bright red) and PRURITUS (Lumps burn, are itchy, hard and bright red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided. The patient had symptoms that started within a couple of hours after receiving the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow-up received on 13-Aug-2021. Included updated Reporter Last name, State, City, Postal code, Patient Initial, Date of Birth, Gender, Relevant History, Concomitant medications-none,Route of Administration, Anatomical location and Additional events.
Febrile status epilepticus that lasted 6.5 hours and could not easily be controlled with medication in emergency room
Fairly rapid onset of localized swelling and warmth. Then over next 3 days spreading rash (raised) and systemic itching. Lt eyelid sl. red and swollen on 1-10-10 low grade temp 100.3 1st day. 01-8-10 through 01-11-10 (Cleared after taking CLARITIN per mom).
Pt claims her right arm became numb 2hrs after receiving PNEUMOVAX injection. Pt went to our local ER after two days of numbness. She said attending physician says I could have hit her nerve upon injection.
Immunizing technician inadvertently drew up/administered vaccine dose that had expired at 10pm on 7/20/21. Vial was taken out of fridge at 10am on 7/20/21 and punctured. Per manufacturer punctured vials are only good for 12 hours.
I am reporting my COVID 19 symptoms after getting my booster dose 3 on  01/11/2022. I had a moderate to severe for the first two days and then after the 2nd day, it started getting mild. I had fatigue, cough, sinus congestion, headache and lost of taste. It last at least 10 days. I tested negative on 04/15/2022. I still have the cough. I called my doctor and they prescribe the cocktail that help shorten my days.
Headache from days 2 - 6 Injection site inflamed and itchy, days 8-10
SEVERE RASH OVER ENTIRE BODY; This spontaneous report received from a patient via a company representative 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 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced severe rash over entire body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe rash over entire body was not reported. This report was non-serious.
Patient state that she was afraid of needles,  once injected about five minutes after she started to experience nausea , drowsy, and was lethargic and pale.
Narrative:  Patient first c/o L shoulder pain (near the injection site) without other distress. He then had a axillary temperature of 100.2 F. Since then, patient has been receiving APAP for said pain and fever. ~6 days post-vaccination, his temperature has decreased to 99.8 F (oral). Symptoms:  & Left arm pain (localized) Treatment:  ACETAMINOPHEN 650 MG Other Q6H PRN
Noticed welt 2 days after when lifted arm, itches, red. On 1/21/17 - No change in perimeter size less defined edges/border less lumpy/raised. Not feel bad. Only issue is look of it.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  NEUROPATHY ACUTE DVT, UNSPECIFIED VEIN ACUTE DVT OF LEFT POPLITEAL VEIN
No adverse event, but a medication error.  This 16 year old should have received the Pfizer BioNTech vaccine due to his age.  I informed his mother that he received the wrong vaccine.  They both agree to receive the Moderna vaccine on May 12th, understanding that for the son, this is an off-label indication.
Patient received his pfzier covid vaccine.  immediately after he had the vaccine administered, he stated that he started to feel very hot, dizzy, nausea and tingling down his arm that he received the vaccine in.  We immediately got a yoga mat, asked the patient to remove his shirt.  He fell to the ground.  We placed a cold pack under his head around the neck area and cold paper towels on his head.  We took his blood pressure it was 136/88.  He started to mention his chest hurting.  His past medical history includes fainting in the past (due to low blood sugars) and open heart surgery as a child.  He is currently under the care of a cardiologist.  More recently he has had several fainting spells which he believes is due to low blood sugar.  He stated he had eaten a good lunch around 11:30.  It was about 2:30 when this incident occurred.  We offered the patient, a banana, orange, chicken sandwich and water.  He ate the orange.  We called EMS.  When they arrived, they checked his blood sugar which it was 95.  He started to feel better and his wife drove him to the cardiologist.
Elbow Pain, Left Arm Swell, Chest Pain. Given antibiotics to help neutralize vaccine reaction.
This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown age and gender. On 29-DEC-2014 the patient was vaccinated with GARDASIL (lot # K005083, expiration date: 04-NOV-2016), .5 ml, doses (unspecified in series) intramuscular. No adverse effects were reported. Outcome of the event was not reported. Reporter considered the event to be not related to GARDASIL. This is one of several reports received from the same source (MARRS # 1501USA003826, MARRS # 1501USA004956, MARRS # 1501USA004957, MARRS # 1501USA004959 and 1501USA004958). Additional information has been requested.
Itchy throat, itchy tongue, cough on Benadryl  (hives with prior non bivalent booster)
Adverse reaction started 24 hrs after first vaccine, tachycardia.  Intermittent symptoms of tachycardia have continued every since.  After second vaccine, symptoms of tachycardia kept me awake 3 of 7 nights per week.  After third vaccine (booster), I developed cardiac SVT's and sought medical attention.
- EXTREME pain around the injection site & myalgia throughout body (debilitating, not just sore) -  Feels like a fever with extreme inflammation, but temperature measured within normal range - Headache - Digestive issues
Had normal side effects the day after, 12/25/20 slight fever, lethargy, not even sore arm. on the 27th, felt fine.  On 12/28/20, woke up not able to breath, oxygen saturation 83%, could not walk across the room without gasping for air, which lasted for about 2 days.  Could not reach her PCP due to holidays, was convinced she had COVID.  Went to drive-thru facility and got the COVID test on 12/28/20, negative on 12/29/20.  Then made another APT, went back on 12/30/20 had negative test again.  On 12/30/20 started feeling better, was not great but her 02 SAT's were about 90.  Stayed that way until 1/8/21, had FU from lumpectomy with surgeon, when she got up her left ankle/foot were very swollen and red looking.  Saw that Dr., and discussed the postop business and showed her the foot/leg told her to have it looked at.  Her PCP was closed, she went to radiology Dept in Hospital and found DVT in her left leg.  She was then told to go to the ER and ordered a CT scan, which showed pulmonary emboli in both lungs.  Put on heparin IV right away, later transferred to another hospital where CV surgeon on staff.  By that evening they decided that she was walking , talking and checking blood levels, kept her overnight and sent her home the next day.  Needed to be on blood thinners, and saw pulmonologist.  Has APT with hematologist this week.  Pulm told her to call and report adverse reaction.   Today, 1/26/21 her 02 SAT's are in the 99%, leg is still swollen, and is able to breath better.  On Eliquis which will prevent new clots, but the others should be absorbed.  Got 2nd dose on 1/21/21 and had only the classic side-effects for about 30 hours but was then fine.  Had fever, chills, nausea, sore arm, cough, but then was fine.  Same lot # as dose 2.
By Monday (03/26/01) afternoon, this patient's arm was red, and swollen around the injection site. This progressively got worse with redness going all the way down the arm. The patient saw her doctor on 03/30/01 with antibiotic treatment.
Swelling in joints.  Unable to raise arms or use hands for several days. Pain threw out body,  Length of time was 2/10/2021 to 2/27/2021.   On 2/28/2021 just feeling better and off Tylenol Extra Strength.