chrisvoncsefalvay/vaers-outcomes huggingface dataset:
horrible headache kept getting worse; fever; vomiting every hour; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEADACHE (horrible headache kept getting worse), VOMITING (vomiting every hour) and PYREXIA (fever) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HEADACHE (horrible headache kept getting worse) and PYREXIA (fever). On an unknown date, the patient experienced VOMITING (vomiting every hour). At the time of the report, HEADACHE (horrible headache kept getting worse), VOMITING (vomiting every hour) and PYREXIA (fever) outcome was unknown.            No concomitant medication were provided by reporter  No Treatment was included.
13 days after the johnson&johnson covid vaccine pt. developed headache and leg pain.no sob or abdominal pain
sore injection site, body aches, low grade fever, general fatigue, swollen lymph nodes (neck), headache at base of skull, swollen and painful left nostril. Patient took 500mg of acetaminophen at 5pm and 9pm and again at 8am the following day. By 11am the next morning, all symptoms except the swollen and painful left nostril and sore injection site resolved. Swelling and pain lessened gradually around 11am and were fully resolved within 72 hours of the injection.
Extreme pain or weakness in arm, leg, buttock muscles. Pain worsens at night - ongoing for 2 months with periods of low grade fever, aches flu-like symptoms
also had a headache that increasingly got worse until EMS arrived; Patient had pain radiating down from injection site; This is a spontaneous report from a contactable healthcare professional reporting for a patient. A 19-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 31Mar2021 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. The patient did not have allergy to medications, food, or other products. It was reported as unknown about the pregnancy information. Prior to the vaccination, the patient diagnosed with COVID-19 was unknown. It was reported as unknown that the patient received any other vaccines within four weeks prior to the vaccination. Since the vaccination, it was unknown that the patient had been tested for COVID-19. On 31Mar2021 at 17:15 the patient experienced pain radiating down from injection site, headache worsened till EMS arrived. The event resulted in emergency room/department or urgent care. The treatment taken for the adverse events was unknown. The clinical outcome of the events pain radiating down from injection site and headache were unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Receiving expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving expired doses) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot#031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiving expired doses) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported by reporter.  Patient took second booster.  No treatment medication was reported by reporter.
Patient had swollen arm, spot raised up on shoulder, about as big around as the size of softball. It started the morning after your second dose of Moderna. Since then, it has not gotten any worse. The soreness has improved, but the raised up area on her shoulder has not.
Redness, Swelling, Warm to touch.  Patient started on Keflex 250ml/5mg 3ml q8h x7days. Follow up report received on 04/28/2005:  Reaction on left arm.
24 hours after receiving the Moderna vaccine, the patients wife found the patient lying on the floor. he could not move his arms or legs.
FEVER OF 102 EVENING AFTER VACCINATION, HAD A BLOOD PRESSURE DROP WHILE INPATIENT.BLOODWORK/CULTURES HAVE COME BACK NEGATIVE, TYLENOL BROUGHT FEVER DOWN EASILY, WAS GIVEN OXYGEN WHILE INPATIENT.
Progress Notes (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All     2/25/2021      Date:  2/25/2021                                                                                               Subjective a 77 y.o. female who was seen at Clinic today for her first  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience L hand numbness.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, rapid progression of symptoms and respiratory distress.   PMH includes DM, HTN, asthma.  Takes metformin and losartan around noon every day. She has not taken her bp medication yet today as she takes it with lunch.       ALLERGY REVIEW OF SYSTEMS:  Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, muscle aches, dizziness and headaches       Previous Reactions: none    Objective    Vitals Vitals:   02/25/21 1145 02/25/21 1201 BP: (!) 160/97 124/83 Pulse: 72   SpO2: 99%              Physical Exam Constitutional:      General: She is not in acute distress.    Appearance: Normal appearance. She is well-developed. She is not diaphoretic.  Neck:     Thyroid: No thyromegaly.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing.  Musculoskeletal:     Cervical back: Neck supple.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.     Cranial Nerves: No cranial nerve deficit or facial asymmetry.     Sensory: Sensation is intact. No sensory deficit.     Coordination: Coordination is intact.     Gait: Gait abnormal (walks with walker, steady gait).     Comments: +5/5 strength against resistance to both upper and lower extremities.        Assessment/Plan  Treatment included: water Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash)   Exam is stable/unremarkable. VS improved. Pt monitored for 20 minutes. She feels well. Possible more likely anxiety related than a local reaction. Pt aware to monitor and follow up with pcp if needed. Pt here with husband whom walked out with her. She declined wheelchair. She feels well.    APRN Electronically Signed 2/25/2021 11:59 AM
pt exp vasovagal like rxn, pale, cold, clammy, moving extremities & head from side to side & did not respond to questioning;BP 96/60;warm;
In the first two weeks on the 13th  I developed debilitating muscle pain and fatigue. Like I had a fever but I never got a fever.  Then I developed an eyelid twitch in my right eye that lasted for a week or so then resolved. Then I had chest pain sharp constant but that too resolved in a week or so. Now nearly 3 months out I have developed persistent muscle twitching primarily in legs and more so in right leg. My eyelid twitch has been back for awhile now maybe 2-3 weeks and it has been relentless. I have burning pain and tingling on and off particularly in legs but burning pain has occurred all over. Occasionally the soles of my feet if exposed to extremes in temp with burn. I have had trouble sleeping with brain fog. Memory issues as well. Persistent twitching and tremors like a shaking feeling have been most bothersome.
Redness, Swelling, and increased skin temperature occurred on left deltoid. Patient treated for with Septra Suspension antibiotic.
This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site tenderness. On an unknown date, the outcome of the injection site tenderness was recovered/resolved. It was unknown if the reporter considered the injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 63 or 64 years. In 2018, the patient received SHINGRIX and experienced some tenderness in deltoid muscle in the arm where she received the SHINGRIX which lasted approximately a week. The patient could not remember which arm it was. The patient did not consent to follow up as she never saw her doctor. For tolerance to the 2nd dose of SHINGRIX refer case US2018217458, reported for the same patient.
Site: Bruising at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: advise to see his doctor
Hives on neck/ears. Injection sites are red, splotchy and swollen. Benadryl.
This spontaneous report has been received from a physician, via immunization record from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 1804USA006650), concerning a 68-year-old male patient.  On 30-DEC-2016 (at 66 years old) and on 08-MAR-2019, the patient was vaccinated by health care providers with Hepatitis B Vaccine (Recombinant) (reported as Hep B (adult, 3-dose) or (adol. 11-15, 2-dose) (CVX=43)) (manufacturer unknown) 1 milliliter administered Intramuscularly in left and right deltoid; respectively (strengths, lot numbers, and expiration dates were not reported) as prophylaxis (inappropriate schedule of product administration).; Sender's Comments:  US-009507513-1804USA006650: US-009507513-2112USA001568:
No adverse event; HCP advised that 7 month child was given the bivalent vaccine as a primary dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP advised that 7 month child was given the bivalent vaccine as a primary dose) and NO ADVERSE EVENT (No adverse event) in a 7-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Mar-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Mar-2023, the patient experienced WRONG PRODUCT ADMINISTERED (HCP advised that 7 month child was given the bivalent vaccine as a primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP advised that 7 month child was given the bivalent vaccine as a primary dose) 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 WRONG PRODUCT ADMINISTERED (HCP advised that 7 month child was given the bivalent vaccine as a primary dose).    Concomitant medication was not reported. Patient received first dose of Moderna monovalent on 28-feb-2023.  HCP reported that, 7-month child was given the bivalent vaccine as a primary dose HCP would like to know if there are any side effect that the child may experience HCP would like to know if, and when primary dose can be administered. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Apr-2023: Live significant follow up received. Patient details, dose details and narrative was updated.
This spontaneous report was received from a health care worker via physician refers to 2 patients of unknown demographics. Approximately on 27-MAR-2014 (also reported as about 2 weeks ago) the patient was vaccinated with VARIVAX, (dose strength and dose number was not reported). No concomitant medication was reported. Approximately on 27-MAR-2014 (also reported as about 2 weeks ago) the patient experienced cellulitis. Patient sought medical attention and contacted physician. There was no product quality complaint involved. The outcome of cellulitis was reported as recovered approximately on an unknown date in 2014. Causality assessment was not provided. This case is linked to 1404USA007558 (same reporter link). Additional information has been requested.
Red area appeared at injection site on day 9,  sore to touch.   Red, sore  area larger  on day 10.  No treatment,  symptoms mild.
Two days after recieving H1N1 vaccine, pt started complaining of fatigue and achiness. Mom noticed decreased appetite and general malaise. Temperature of 99. Five days after vaccine woke up with hives on hands, went away 45 minutes later without the aid of Benadryl. General GI issues with diarrhea day four after receiving vaccine.
accidentally received Kinrix; MD mentioned it was intended for the 16 month old to get the Pentacel vaccine but accidentally received Kinrix; 4th dose of Dtap; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 16-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7DY4, expiry date 22-AUG-2025) for prophylaxis.   On 28-JUL-2023, the patient received Kinrix (right thigh). On 28-JUL-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: accidentally received Kinrix), inappropriate age at vaccine administration (Verbatim: MD mentioned it was intended for the 16 month old to get the Pentacel vaccine but accidentally received Kinrix) and inappropriate schedule of vaccine administered (Verbatim: 4th dose of Dtap).  The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were 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: 28-AUG-2023 Medical physician called to inquire  Did the dose of Dtap and IPV count with these patients and asked how to proceed with series Doctor of medicine reported they inadvertently administered Kinrix  to the patient, get the Pentacel vaccine (this was the patient's 4th dose of Dtap and IPV). The 16th month old patient received Kinrix which led to inappropriate age of vaccine administered. The inadvertently administered Kinrix instead of Pentacel, which lead to wrong vaccinbe administered. The patient received Kinrix as 4th dose, which led to inappropriate schedule of vaccine administered. The health care professional (HCP)did not consent to follow up with the safety. Call Notes:HCP declined follow-up from safety. The case is linked with US2023117325, by same reporter.; Sender's Comments:  US-GSK-US2023117325:Same reporter
Patient was given PNEUMOVAX vaccine in (R) deltoid patient called 3 days later stating (R) arm was red, swollen and hot, painful. Came into office was hypotensive sent to ER - was kept 2 days in hospital.
10 or 11 days after first vaccine I started to feel numbness and tingling in my right side of my body mostly arm, hand and foot. Then lots of inflammation. I went on to get the second vaccine and then suffered more inflammation in the rest of my body. I did also have an adverse rash not due to the vaccine however cannot tell if the numbness is due to either the vaccine or caused by complication of my rash. I went to the doctors for dermatitis and that was quickly solved. The inflammation has not gone away it?s been over a month today.
This spontaneous report was received from certificated medical assistant referring to a female patient of unknown age who on 21-NOV-2013, was vaccinated with a dose of MMR II (lot number not reported). Medical assistant reported that the patient who was believed to have been vaccinated with MMR II as a child (unspecified dates/number of doses) had titers drawn for MMR (unspecified date) which came back seronegative for an unspecified component in the vaccine, therefore the patient received a dose of MMR II on 28-MAR-2012. Medical assistant reported that the patient then had MMR titers drawn again on an unspecified date following the administration, which also exhibited seronegative results for an unspecified component in the vaccine. Medical assistant reported that the patient then received another dose of MMR II on 21-NOV-2013. The outcome of titers drawn for MMR that became seronegative for an unspecified component in the vaccine was unknown. Additional information is not expected.
pain in my shoulder; a little lightheaded; a little redness and swelling; it started itching; swelling at the injection site; excruciating pain in both lymph nodes/ pain occurs whenever he applies pressure to these areas; a little swelling; chest congestion; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in my shoulder), DIZZINESS (a little lightheaded), ERYTHEMA (a little redness and swelling), PRURITUS (it started itching) and VACCINATION SITE SWELLING (swelling at the injection site) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma. Concomitant products included SALBUTAMOL (ALBUTEROL HFA), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Asthma.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (pain in my shoulder), DIZZINESS (a little lightheaded), ERYTHEMA (a little redness and swelling), PRURITUS (it started itching), VACCINATION SITE SWELLING (swelling at the injection site), LYMPH NODE PAIN (excruciating pain in both lymph nodes/ pain occurs whenever he applies pressure to these areas), SWELLING (a little swelling) and CHEST DISCOMFORT (chest congestion). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (pain in my shoulder), DIZZINESS (a little lightheaded), ERYTHEMA (a little redness and swelling), PRURITUS (it started itching), VACCINATION SITE SWELLING (swelling at the injection site), LYMPH NODE PAIN (excruciating pain in both lymph nodes/ pain occurs whenever he applies pressure to these areas), SWELLING (a little swelling) and CHEST DISCOMFORT (chest congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Case number PHEH2015US026864, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 29-years-old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) in left deltoid on 07 Oct 2015 which was out of temperature range (34 degrees). The nurse stated that, the reason was unknown for the refrigerator to be out of temperature range. There was no any further problem since the temperature excursion problem. No further information was provided. No adverse event was reported following this administration error. Follow up report received from nurse on 26 Jan 2016: Updated reporters comments.
pain in the left arm; left shoulder pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 05May2021 as dose 2, single (Lot number: EW0182) at the age of 47 years intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE , Site: Arm left, Route of administration: Intramuscular, Batch/Lot number: Pfizer/er8731), administration date: 14Apr2021, when the patient was 47-year-old, for Covid-19 immunization, reaction(s): "I get really sick", "I could not move for two days". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "pain in the left arm"; ARTHRALGIA (non-serious), outcome "not recovered", described as "left shoulder pain". The events "pain in the left arm" and "left shoulder pain" required emergency room visit. Therapeutic measures were taken as a result of pain in extremity, arthralgia.  Additional information: After dose 2, the patient felt pain in the left arm, after a few months it got worse with left shoulder pain and he  ended up going to the urgent care and they gave him medication it help him a little bit and he still have (as reported) arm and shoulder pain. There was no relevant tests, no concomitant drugs, no prior vaccinations, no medical history. Specific Relevant Test For Thromboembolic Events with Thrombocytopenia : None; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300107482 same patient, different dose/event;
Pt. received vaccines and left exam room & became pale, lightheaded & states she saw black spots. Sat down & did not pass out.
Post vaccination x 1 week.  Sight is reddened/mod swelling/terrible intching
What I thought were 2 mosquito bites on my right elbow turned into 5 or 6 just a few hours later, all around my elbow. Very itchy. Next day I had 5 or 6 same looking  welts on my left elbow and one on my right hand knuckle. Although this one has stopped itching, it left a red callous looking mark the size of a dime. Next day after shower I had one on left hand finger knuckle and then 3 more on my left hand all on finger knuckles. All very itchy. I reported to my Dr. who said it appeared to be bug bites. I reported in again when I got them on my hands. He prescribed Atarax which I started taking on 2/8/21. The welts seem to have stopped appearing but the ones on my left elbow continue to itch and spread. I have a hard time believing that bugs would only bite me on my joints. Nothing on my legs or feet. I suggested a reaction to my Covid vaccine to the PA answering my messages and he said he did not think so.