chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient began to experience, the same day of vaccine, a hot sensation on the arm where she received a vaccination, minor pain that developed into a very hot and painful sensation Vaccination site swelled around 4 inches around vaccination site. Patient iced vaccine site that night . Could not sleep that night because of the discomfort. She did not take any medication prescription/over the counter. Patient continued to ice arm even though there was no change in symptoms. The next day her arm doubled in size and became red.  No temperature but the site was hot to the touch. On 12/10/20  patient went back to Pharmacy and told the pharmacist her symptoms. He advised her to go to the ER for her reaction.  She refused to go to the ER because of her age and fear of COVID contact.12/10 she  was prescribed prednisone tablets via  virtual appointment, which she started taking right away and today 12/11. Today the swelling and redness has gone down but she is still in pain. She will continue to take the prednisone tablets 10mg 3 times a day for 5 days.
I had drawn up the vaccine and administered it. I was putting the data in the system and did not realize the vaccines expiration date was 12/15/2022.
STIFFNESS IN JOINTS, LIGAMENTS OF BOTH HANDS AND FEET; STIFFNESS IN  BONES OF BOTH HANDS AND  FEET; TINGLING IN FINGERS OF BOTH HANDS/TINGLING IN ALL TOES BOTH FEET/TINGLING IN BOTH HANDS; SHARP PAIN IN ALL FINGERS OF BOTH HANDS/SHARP PAIN IN ALL THE TOES BOTH FEET; This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 203A21A and expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-JUN-2021, the patient experienced stiffness in joints, ligaments of both hands and feet. On 19-JUN-2021, the patient experienced stiffness in bones of both hands and feet. On 19-JUN-2021, the patient experienced tingling in fingers of both hands/tingling in all toes both feet/tingling in both hands. On 19-JUN-2021, the patient experienced sharp pain in all fingers of both hands/sharp pain in all the toes both feet. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in fingers of both hands/tingling in all toes both feet/tingling in both hands, sharp pain in all fingers of both hands/sharp pain in all the toes both feet, stiffness in joints, ligaments of both hands and feet, and stiffness in bones of both hands and feet. This report was non-serious.
Skin involvement papules of head, neck, shoulders, left back wound culture= no growth, placed on antibiotics- wounds self resolving.
none as of yet, the error was found after the administration of the vaccine, pt marked that he had not had covid within the past 90 days, which was false, pt just had in September 2022
Wheezing approx 15 minutes, treated with an inhaler. Swelling and rash approximately 3 inch surface at injection site. 4/19-current.
1 dose administered 8 hours after the published expiry date/ Manufacturer date of expiry: April 7, 2022/ Date(s) of administration: April 8, 2022; Product moved to refrigeration:; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose administered 8 hours after the published expiry date/ Manufacturer date of expiry: April 7, 2022/ Date(s) of administration: April 8, 2022) and PRODUCT STORAGE ERROR (Product moved to refrigeration:) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose administered 8 hours after the published expiry date/ Manufacturer date of expiry: April 7, 2022/ Date(s) of administration: April 8, 2022) and PRODUCT STORAGE ERROR (Product moved to refrigeration:). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose administered 8 hours after the published expiry date/ Manufacturer date of expiry: April 7, 2022/ Date(s) of administration: April 8, 2022) and PRODUCT STORAGE ERROR (Product moved to refrigeration:) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Product moved to refrigeration on April 8, 2022 Treatment details was not reported by the reporter.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department (ED) three days after receiving vaccine with dry cough for 24 hours, home oxygen saturations 85-95%, and family diagnosed with COVID-19 the week prior. On exam congestion and shortness of breath noted. Vital signs within normal ranges. Discharged to home medically stable.
WEAKNESS IN LEGS (LEG GIVING OUT WHILE WALKING); SHARP PAIN IN SHOULDER JOINT (LEFT SHOULDER MESSING UP); This spontaneous report received from a patient concerned a 70 year old male. The patient's weight was 185 pounds, and height was 71 inches. The patient's concurrent conditions included pollen allergy, non smoker, and alcohol user, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced sharp pain in shoulder joint (left shoulder messing up). On JUL-2021, the subject experienced weakness in legs (leg giving out while walking). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sharp pain in shoulder joint (left shoulder messing up), and the outcome of weakness in legs (leg giving out while walking) was not reported. This report was non-serious.
Localized redness, swelling, pain, hard lump, warmth, and bruising.  Has had reaction for less than 24hrs.  Reports that it was worse when she woke up this morning (01/10/2013).  Gave her 2 25mg diphenhydramine at pharmacy.  Referred to prescribing provider location for follow-up.
couldn't swallow; Sore throat; Provisional diagnosis is infection/ metastatic infection; Provisional diagnosis is infection; Provisional diagnosis is infection; Swelling on the neck area; This case was reported by a pharmacist via call center representative and described the occurrence of infection in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number 592DX, expiry date 6th December 2021) for prophylaxis.   On 31st January 2020, the patient received the 1st dose of Shingrix. On 31st January 2020, less than a day after receiving Shingrix, the patient experienced neck swelling (serious criteria hospitalization). On 9th February 2020, the patient experienced infection (serious criteria hospitalization), bacterial infection (serious criteria hospitalization), viral infection (serious criteria hospitalization) and sore throat (serious criteria hospitalization). On 10th February 2020, the patient experienced unable to swallow (serious criteria hospitalization). The patient was treated with prednisone and antibiotics nos. On an unknown date, the outcome of the infection, bacterial infection, viral infection, sore throat and unable to swallow were unknown and the outcome of the neck swelling was recovering/resolving.   It was unknown if the reporter considered the infection, bacterial infection, viral infection, neck swelling, sore throat and unable to swallow to be related to Shingrix.  Additional information was provided as follows: The patient started experiencing swelling on the neck area on the same night of receiving vaccine which was visible to the registered pharmacist on 10th February 2020. After 9 days of receiving vaccine, the patient expereinced  a sore throat. The patient consulted urgent care on 9th February 2020 where they did a strep swab which came back negative. The patient was prescribed prednisone 20mg twice a day for 5 days but couldn't swallow it. On 10th February 2020, the patient went to the emergency room and was admitted to hospital. On 11th February 2020 the patient was hospitalized in the intensive care unit (ICU) with respiratory mechanical support.  The provisional diagnosis was infection. The patient was on vent. The reporter was not sure if it was a metastatic infection, viral infection, bacterial infection or what it was. The patient was on a short course of antibiotics at the time of reporting. The reporter consented to follow up. This case is linked with US2020024281, reported by same reporter.
Area where injection placed was swollen, hot to touch, and reddened. There was a bump 2 inches wide and 1 1/2 inches long at this site as well.
A patient tested positive a week after taking his first dose of Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (A patient tested positive a week after taking his first dose of Moderna Covid-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-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 SARS-COV-2 TEST POSITIVE (A patient tested positive a week after taking his first dose of Moderna Covid-19 vaccine). On 26-May-2021, SARS-COV-2 TEST POSITIVE (A patient tested positive a week after taking his first dose of Moderna Covid-19 vaccine) had resolved.        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.   No concomitant medications were provided. Treatment details were not provided.
Marked swelling, erythema with multiple erythematous papules, (surrounded by halos) throughout torso/limbs.
Pt experienced nausea, dizziness, lightheadedness and severe headache 2 hours after getting the shot; was taken to her primary MD and given TYLENOL but left MDs office still feeling very nauseated and dizzy *was patient's first time getting a flu shot.
So sick from the vaccinw rhat I couldn?t stand up for a couple of days.  On the forst does in April, I got my period 2 weeks early rhe day agyrer my vaccination.  On the day of the 2nd dose I was too sick to even stand up and didn?t feel back to norma for 3 weeks.  I also slipped my period until I got it on July 15th.  Today is September 8th and I have had my period for 7+ weeks, with the blood flow so strong that I?m literally gushing blood.
Patient reports developing a pruritic rash on her face, fatigue and joint pain within 2 hours of vaccine administration.  She subsequently developed painful swelling in axillary region which resolved spontaneously in about 4-5 days.  She noted a "lump" in upper chest 6 days after vaccine.  She went to ED & received IV SOLUMEDROL & VICODIN with improvement.  Now on PREDNISONE & BENADRYL.
Initial information received on 08-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2019SA040917, 2019SA040918 and 2019SA040495 same reporter. This case involves a 11 years old female patient who received vaccine IPOL lot P1A242M, expiry date- 26-Apr-2020 via intramuscular route in the left deltoid on 05-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE for Immunisation; ADACEL for Immunisation; and VARICELLA ZOSTER VACCINE for Immunisation. It was a case of actual medication error due to Incorrect product storage. It was reported that after the vaccine had a temp excursion on 04 Feb 2019 and 4 children got the IPOL on 5th Feb 2019. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Soreness throughout left arm, torso, neck, beginning 3-4 hours after the shot. Chills, fatigue,  and body aches beginning around 8 hours after the shot.
Hives on lower forearm (LT) with receiving H1N1 vaccine. Given 50mg BENADRYL IM.
Severe and acute swelling of right hand. Hand was swelled to an extent that only the top first joints of the fingers were discernible and this prevented use or any movement of fingers. Swelling began on April 19th, late afternoon. Swelling peaked on the 20th very severe, and gradually subsided over following days. Now 10 days later, hand is again usable, with very little residual swelling, though still visible different from left hand.  Took Advil for 4 nights beginning on the 20th, and everything seems fine now. Despite 30 years of rheumatoid arthritis, no such swelling event or attack had ever occurred for any reason, so we believe it was related to the vaccine, and felt we should report it. But everything seems fine now. No other reactions or side effects were noted.
On the evening of the 11th day post first vaccine, the area around the injection site became swollen, red and hot to the touch.  Over the course of the next several days, the infection spread from top of arm to elbow.  Diagnosis from PCP was cellulitis/bacterial infection and is being treated with antibiotics.
Loss of appetite, fatigue, malaise.  Next AM pretty severe pain L buttock which lasted 5 days, improving each day.
Fever averaging at 100.9 from 4/13/2021 thru 4/21/2021. Severe pain and swelling under arm, directly below arm pit. Swelling of arm minimized by 4/21/2021, but the pain under arm by armpit persists as of today 05/04/21.  Extreme lethargy form 4/13/21 thru 4/18/2021.  The extreme arm pain, fever and lethargy was significant enough to go to the hospital on 4/16/2021, but I did not have the strength to shower or get ready to be taken to the hospital. Thus, I continued sleeping till the next day 4/17/2021, where I felt well enough to get out of bed,  but continued to have extreme pain under my armpit and near my left breast.  Significant arm discomfort, impeding my ability to perform simple household tasks such as folding laundry or lifting heavy items. till present day: 5/4/21. Severe congestion since implementation of dose 1 of Pfizer Vaccine on 4/13/2021 till present day: 5/4/2021
Fever; chills; body aches; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Oct2021 (Lot number: FF8841) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248), administration date: 08Feb2021, when the patient was 27 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248), administration date: 20Jan2021, when the patient was 27 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 22Oct2021, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 22Oct2021, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 22Oct2021, outcome "recovering", described as "body aches"; HEADACHE (non-serious) with onset 22Oct2021, outcome "recovering", described as "headache". Therapeutic measures were not taken as a result of pyrexia, chills, pain, headache.  No follow-up attempts are possible. No further information is expected.
Severe headache, fever, chills, nausea, fatigue for 4 days after first dose
Day one after second shot:  morning only: nausea (Mild and only lasted an hour or so); all day: Headache, joint pain,  chills, tired, (moderate) Arm at injection site swollen, red and hot. Had to work in the afternoon other wise would have taken the day off.  Chills came and went all morning and evening. Joint pain came and when, Headache was all the time. Took Tylenol when had to go to work.  Day two after second shot: Headache (moderate), Tired/fatigue (moderate) did not go in to work. Arm/Injection site, swollen, red and hot. Day three after second shot: reported on V-Safe.
Initial reporter received from a consumer who is also the patient on 10 October 2012. A 36-year-old female patient, whose concomitant medications and medical conditions were not reported, had received FLUZONE ID vaccine (Lot number unknown, route and anatomical site of vaccination were not reported) on 09 October 2012. The patient had no known allergies. On 10 October 2012, the patient had itching, redness, hard lump about size of golf ball around injection site. Corrective treatment and laboratory investigations were not reported. The patient's outcome was not recovered. Follow-up information received from a healthcare professional on 18 January 2013. The patient received FLUZONE HD (Lot number- UT4404AA, expiry date- 3/26/2013), in left deltoid. The patient had no illness at the time of vaccination. The patient  had spontaneously recovered from the events without any prescription or treatment on an unspecified date. List of documents held by the sender: None.
CC:  Shot actionre. History of Present Illness: Shot was given approx 11 AM.  Redness and swelling started almost immediately afterwards- ie by the time she got home.  Last night had a temp up to 100.8.  Local sxs had spread when she woke up but actually a little less sore this AM and feels like temp is gone.  No antipyretic this AM.  No face or lip or throat swelling.  No SOB or wheeze.  No rash aside from arm.  Knows it was the pneumovacc she got in this arm and not her flu shot b/c she and MA talked about this ahead of time and she wanted the flu shot in her non-dominant arm. Works as cashier at babys R us so lots of lifting.  Wonders about work today.    Acute Visit History: The patient complains of musculoskeletal symptoms.  These symptoms began one day ago.  Other comments include: Pt had a pneumonia shot in her R arm yesterday and today she has a red painful and itchy reaction in the deltoid. Medications reviewed. Changes made.  Risk Factors:  Tobacco use:  current, Cigarettes:  Yes -- 3/4 pack(s) per day Passive smoke exposure:  no Drug use:  no HIV high-risk behavior:  no Caffeine use:  1-4 drinks per day Alcohol use:  no Exercise:  no Seatbelt use:  100 % Sun Exposure:  rarely  Family History Risk Factors: Family History of MI in females < 65 years old:  no, Family History of MI in males < 55 years old:  no  Mammogram History: Date of Last Mammogram:  01/31/2007  Vital Signs: Patient Profile: 65 Year Old Female Height: 67.50 inches (171.45 cm) Weight: 139 pounds BMI: 21.53 Temp: 98.4 degrees F oral Pulse rate: 88 / minute Pulse rhythm: regular Resp: 18 per minute BP sitting: 102 / 66  (left arm) Cuff size: regular  Physical Exam General: alert and in no apparent distress;  Mouth: No lip or facial swelling Skin: R uppler lateral arm with approx 10cm irreg area of soft pink swelling and erythema. Slightly warm, but not hot, tense, or fluctuant.  No other skin changes or rash.   Psych: alert, oriented and appropriate with normal affect;   Impression & Recommendations: Problem # 1:  Minor dx of OTHER SERUM REACTION NOT ELSEWHERE CLASSIFIED (ICD-999.5) Assessment: New Advised this appears to be localized reaction to immunization without sign of infection or systemic allergic rxn.  Discussed sxs to watch for as signs of those.  Would expect maybe a little more spread of sxs tomorrow and then gradual resolution.  If any systemic sxs or sig spread or recurrent fever then should seek eval.  OK to use otc prn benadryl 25 to 50 mg po q hs with caution RE sedation and loratidine 10mg po q day although advised not sure how beneficial these would be.  Also OK to try some ibuprofen if normal kidney fx and no GI SEs.   Advised ROM bid or more of shoulder gently.  She agrees.  Advised shouldnt be a contraindication to other vaccines in the future unless this became a recurrent issue.  May want to observe a little longer after next vaccine. Orders: 99213 Exp (CPT-99213)
hand flapping, hyperactivity, could not complete sentence, easily agitated & bothered by noise x 2+ weeks;
The  pharmacist  accidentally gave 1/2 dose of vaccine , but gave another  1/2 dose right after that
low grade fever; This is a spontaneous report from a contactable consumer. A 72-year-old patient of unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6205 and expiration date were not reported) intramuscularly at Left arm on 04Mar2021 at single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant includes levothyroxine for thyroid and atorvastatin for use cholesterol. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN5318), via intramuscular route of administration on the left arm on 28Jan2021 at 3 PM as a single dose for COVID-19 immunization. Patient also received Shingrix Vial (Shingrix Vial; Lot Number: EN5318, Batch/Lot :73T27) on upper left arm on 15Jan2021. On 17Feb2021, SARS-Cov2 rapid Covid-19 was Negative, F SARS CoV 2 RNA was Negative and Cepheid SARS- CoV-2 RT, PCR assay was positive. To clarify- there were no adverse events to the first shot for patient. First shot was on 28Jan2021, symptoms of Covid-19 appeared Wednesday 17Feb2021. Wife had been diagnosed with Covid-19 on 08feb2021. Case of Covid-19 for the (withheld) was mild with fever and chills, fever on and off for a total of 9 days. No other symptoms, no loss of smell or taste. Patient had second shot on 04Mar2021, one week after symptoms stopped. Reaction to second shot was mild, a few hours of low-grade fever (date not specified). The outcome of the event low-grade fever was Recovered.  No follow-up attempts are needed. No further information is expected.
Hives all over leg in which vax was given. Resolved spontaneously over some hours.