chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BLEEDING AT INJECTION SITE; COLD AIR BURNING SENSATION IN THROAT; ALLERGIC REACTION (DIFFICULTY BREATHING FOR 2 HOURS AFTER INJECTION); This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid 19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported. On MAR-2021, the subject experienced bleeding at injection site. On MAR-2021, the subject experienced cold air burning sensation in throat. On MAR-2021, the subject experienced allergic reaction (difficulty breathing for 2 hours after injection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bleeding at injection site, cold air burning sensation in throat and allergic reaction (difficulty breathing for 2 hours after injection) was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
pt recvd vax & w/in 24hrs post vax exp swelling of upper arm @ inj site;t101-103;exp hot & cold flashes, fatigue, n/d & tachycardia;numbness in lt hand, h/a, SOB, chest & lt arm pain;also tremor, collagen vascular disease, hyperthyroidism;
Headache, nausea, fever, chills, body aches, fatigue,  mild pelvic ache starting  around ovulation and lasting till period begins. This started the month after 2nd dose.
Pt stated she can't lift arm and is very painful. Patient states she first noticed symptoms approximately 2 weeks after receiving the vaccine. She states she has not sought treatment.
Case number PHEH2013US019971, is an initial spontaneous report received from a nurse on 20 SEP 2013 with a follow-up received from the nurse on 24 OCT 2013. This report refers to an 11-year-old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M12120), intramuscularly without being reconstituted with men A lyophilized conjugate vaccine component on 13 SEP 2013. No adverse event was reported following this administration error. The patient was re-called on an undetermined date and was given correctly re-constituted MENVEO vaccine. Follow-up received from the nurse on 24 OCT 2013. Updated information about re-vaccination.
The following day, I had a sore arm and was fatigue.  A few days later, I started coughing and having a running nose.  On Monday the 8th, I started running a fever.  No fever on Tuesday, but my coughing had gotten worst.  On yesterday, Nov 10th I went to urgent care.   They did a flu test and COVID-19 test.  The test came back that I have a common cold.
Child was 3years 3 months old and received the vaccine that was licensed for age 4years and older.
joint pain; moderate swelling in both hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Aug2021 16:00 (Lot number: EW0183) at the age of 37 years as dose 1,single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Note :Asthma. Concomitant medication(s) included: ADVAIR HFA; ALBUTEROL SULFATE; OXYCODONE. The following information was reported: ARTHRALGIA (disability) with onset 23Aug2021 02:30, outcome "not recovered", described as "joint pain"; PERIPHERAL SWELLING (disability) with onset 23Aug2021 02:30, outcome "not recovered", described as "moderate swelling in both hands". The events "joint pain" and "moderate swelling in both hands" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive, notes: Nasal Swab; (07Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of arthralgia, peripheral swelling.  No follow-up attempts are possible, No further information is expected.
Palpable Swollen lymph nodes in both armpits as well as palpable lump cyst in left breast, confirmed with mammogram and sonogram as complicated cyst
Information has been received form a physician's assistant student concerning an 11 year old male with no known allergies, who on 18-APR-2000 was vaccinated with a first dose of VARIVAX (Oka/Merck) (Lot # 632052/1463J) and on 23-MAY-2007 was vaccinated with a second dose of VARIVAX (Oka/Merck) (Lot # 656172/1498F). The physician's assistant student reported that the child developed an itchy, red, rash on his trunk, legs and arms on 04-SEP-2008. No other symptoms were noted. At the time of reporting the patient was recovering. The patient sought medical attention: in office. There was no product quality complaint. Additional information has been requested.
Vaccinee experienced nausea, vomiting, headache & generalized aching x 2 days post Hepatitis B vax (? w/Engerix-B). PPD was given the same day.
Scared; Scary side effects; Itching felt internal; Intense arm itching from shoulder to elbow on injection site side; High fever for 5 days; Arm pain lasted 10 days; This spontaneous case was reported by a patient and describes the occurrence of FEAR (Scared), IMMUNISATION REACTION (Scary side effects), PRURITUS (Itching felt internal), VACCINATION SITE PRURITUS (Intense arm itching from shoulder to elbow on injection site side) and PYREXIA (High fever for 5 days) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEAR (Scared), IMMUNISATION REACTION (Scary side effects), PRURITUS (Itching felt internal), VACCINATION SITE PRURITUS (Intense arm itching from shoulder to elbow on injection site side), PYREXIA (High fever for 5 days) and PAIN IN EXTREMITY (Arm pain lasted 10 days). At the time of the report, FEAR (Scared), IMMUNISATION REACTION (Scary side effects), PRURITUS (Itching felt internal) and VACCINATION SITE PRURITUS (Intense arm itching from shoulder to elbow on injection site side) outcome was unknown and PYREXIA (High fever for 5 days) and PAIN IN EXTREMITY (Arm pain lasted 10 days) had resolved.            No concomitant medications were provided. The patient had no redness or swelling. No treatment medications were reported.   This case was linked to MOD-2022-592471 (Patient Link).   Reporter did not allow further contact
a little tired the next day; Pfizer Covid-19 vaccine that was administered at least 12 hours but not greater than 24 hours from time of dilution; Pfizer Covid-19 vaccine that was administered at least 12 hours but not greater than 24 hours from time of dilution; booster dose; This is a spontaneous report from a contactable other hcp. This Other hcp reported for a 55-year-old female patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot: EW0170, Expiry date: Unknown) via an unspecified route of administration on 10Nov2021 (age at vaccination: 55years-old) as dose 3 (booster), single for covid-19 immunization. Medical history included hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included epinephrine (EPIPEN) taken for hypersensitivity, start and stop date were not reported and Just vitamins. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Historical vaccine included dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8733, Expiry date: Unknown) via an unspecified route of administration on 01Apr2021 (age at vaccination: 55years-old) as dose 1, single and dose 2 of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0170, Expiry date: Unknown) via an unspecified route of administration on 22Apr2021 (age at vaccination: 55years-old) for Covid-19 Immunization. It was reported that the patient was administered the booster dose of the Pfizer COVID-19 vaccine at least 12 hours but not more than 24 hours from time of dilution. Reporter said that it was stored in the vial and it was stored in the refrigerator before it was administered to the patient, upon follow-up 07Dec2021, onset 11Nov2021 FATIGUE (non-serious) with , outcome "unknown", described as "a little tired the next day".  Follow-up attempts are completed. No further information is expected.  Follow-up (07Dec2021): This is a spontaneous follow-up report from a contactable Other HCP. This Other HCP reported in response to the HCP letter sent and included that, Updated Information included: Event (fatigue) and clinical information was added.  Additional information: Patient age at vaccination, Route of Administration, Vaccination Facility Type was added.  Follow-up attempts are completed. No further information is expected.
Information has been received through the Merck pregnancy registry from a 26 year old female with no history of drug reactions or allergies and a history of light cramping when menstrual period starts who in November 2007 was vaccinated with the first dose of GARDASIL vaccine and in January 2008 was vaccinated with the second dose of GARDSIL vaccine. About 2 weeks ago (on approximately 12-JUN-2008), the patient experienced cramping, which is "stronger than the usual light cramping" she had before her period starts." This cramping did not fade away, but is "off and on." On 25-JUN-2008, the patient was vaccinated with the third dose of GARDASIL vaccine 0.5 mL (lot 655327/1287U). There was no concomitant medication. On 26-JUN-2008, the patient found out that she was pregnant by a pregnancy test. On 26-JUN-2008, the patient was approximately five weeks gestation. Last menstrual period was approximately 20-MAY-2008, estimated due date 24-FEB-2009. She will not get any more doses. The patient's cramping persisted. The patient sought medical attention with a telephone call. No further information is available.
Its been 30 min now and she is doing much better. Felt tingling in her arm and leg on side that vaccine was given. Felt nauseous. Also had headache. Pt has had a severe ischemic stroke in past and has an intellectual disability. Pt seems to be doing fine otherwise and is slowly improving.
Swollen gland on right side of neck under jaw and chills, feeling hot then cold and very tired. The PREVNAR 13 shot was administered into my right arm muscle. The hot/cold sensations  and chills continued every few days during the month of January.  I had 2 other swollen gland incidents during January 2017 (same right side under jaw).  Reported these negative side effects to 2 nurses @ Dr office.
patient was injected without any vaccine inside syringe. patient ended up receiving vaccine after 2nd "shot"
Lingering arm pain below injection site, in arm closer to the elbow than to the shoulder. I've taken Tylenol and Ibuprofen for the soreness.
This case was reported by a nurse and described the occurrence of injection site pain in a 57 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. There were no concurrent medications. On 28 October 2005 the subject received a dose of Fluarix in the left deltoid (lot AFLUA131BA). The nurse reported that the subject, "had been getting her flu vaccine" in previous years and "never reacted to the flu shot like she did with Fluarix." On 28 October 2005, less than one day after vaccination with Fluarix, the subject experienced injection site pain in the left arm. The nurse reported that, on 29 October 2005, "within 24 hours of injection' of Fluarix, the pain "went to her left arm, then to the neck, and subsequently to the right side of the body. The pain was so severe that the patient could not lift her left arm up." Approximately five days after injection of Fluarix, on 02 November 2005, the subject was seen at a physician's office "to treat a sinus infection." At the time of initial reporting the events were improved. The nurse considered the sinus infection to be unrelated and all the other events to probably be related to vaccination with Fluarix.
Inconsolable crying follwing 1-1 1/2 hours after shots. Brought back to office on same day-afternoon-physical exam, esseentially normal except "crying." No treatment. Stable.
pharmacy technician called the patient at home and reported that the pharmacist on duty had given the patient a Covid-19 vaccine on 07/05/2021 from a vial that was punctured on 07/03/2021 at approximately 11:30. The punctured vial was stored in the refrigerator for the entire time after puncture however it does not meet the CDC temperature storage guidelines of discarding any unused vaccine after 12 hours of puncture.
Body rash starting with bright red palms and soles of feet, then spreading over entire body; This is a spontaneous report from a contactable consumer reporting for herself. A 78-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9269/expiration date: not provided), via an unspecified route of administration, on 02Feb2021 at 11:45 as a single dose in the right arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 12Jan2021 as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. The patient has a known allergies to iodine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Feb2021 at 12:00, the patient experienced body rash starting with bright red palms and soles of feet, then spreading over entire body. The patient did not receive any treatment for these events. The outcome of the event body rash starting with bright red palms and soles of feet, then spreading over entire body was unknown. Since the vaccination, the patient had not been tested for COVID-19.
Had 1st Vaccine shot March 18   Pfizer vaccine  Within 2 days experienced Joints pain, Muscle pain , tendon pain ,  Both knees hurt like heck  My Shoulder sockets hurt I couldn?t move  Have no Lifting process from my Legs trying to rise from sitting  But walking pretty good  Whole body hurt from 7-10
8 days after vaccine, patient developed high fever (> 104) for four days as well as vomiting. he was seen in ED and recovered completely without treatment.
Pt received  Janssen vaccine on 4/5/21 and did complain of arm soreness on 4/6/21. Arm assessed small bruising noted. Pt working with therapy on 4/8/21- she was complaining of pain, nsg assessed arm and found the RUE was blue in color and hard to touch. NP made aware, ordered warm compresses as needed to arm. MD assessed pt on 4/9/21 for a poss. UTI- IV Rocephin ordered and adm.   Pt had an allergic reaction to IV Rocephin, pt sent to ER for eval and treatment. Pt was adm on 4/9/21 and returned to health on 4/15/21.  When pt arrived her entire rt arm/hand is black in blue in color. Per patient and daughter- the bruising continued to get worse day by day after she had received the vaccine
This spontaneous report was received from a register nurse refers to an unknown number of patients of an unknown age and gender. Medical history was reported. The reporter informed that on an unknown date the patients were vaccinated with VARIVAX lot number, expiration date, strength, dosage and route were not reported. Also informed that the VARIVAX was exposed to -14C for an unknown number of hours occurring intermittently over a period of 20 months. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Expired vaccine used; inappropriate schedule of vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 1808978) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered).    No concomitant medication information was provided.  No adverse reaction was reported.  No treatment medication were provided.
Sudden onset of numbness on right side - arm, torso, hip area - as of date of submission of this report, numbness still present.
covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2021 at 12:00 as dose 3 (booster), single (Lot number: P220395-0089L) at the age of 52 years, in right arm 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: "HTN" (unspecified if ongoing); (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Iv iodine, reaction(s): "Known allergies: IV Iodine".The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid (lot: 1918529A) from 15Nov2022 to 19Nov2022; and AngioCath.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Swelling; This is a spontaneous report form a contactable consumer (Patient) reported that.  This is a spontaneous report from a contactable other hcp. A 48-years-old female patient received BNT162B2 (BioNTech/Pfizer vaccine solution for injection), dose 1 via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had treated with Restylane to lips and marionette lines and noticed that she had swelling on 02Apr2021, which she thought was normal. On 04Apr2021, she saw no difference. Her before and after looks the same. The event outcome was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received on 08-AUG-2017 from a lawyer and a female patient of unknown age regarding a case in litigation. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX, (lot number and expiration not reported) subcutaneous in June of 2016 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-SEP-2016, the patient was treated by a family nurse practitioner at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
After 2 nd dose?..8 hours after receiving, slept for 24 hours straight. Awoke with a huge red warm area hard to touch and painful on my left arm. Not at the injection site ? just below and a bow the elbow. I have photos and reported to pharmacy. The unable to arouse for about 6 days.  Continues to give time to recover?yet intense head, neck, Rt shoulder pain with no sleep, nausea vomiting.    May 7 th, contacted my PCP. Referrals made?unable to see ortho until 7/14. Pain increases, lethargy,extreme fatigue, disorientation to time, dizziness with right sided weakness falling.   Systemic joint pain , SOB . Took my own driving privileges away.   Sought tx at Er on  6/27?no relief     Again, ER visit on July 6th dx of cytokine storm is a cascade of exaggerated immune responses that can cause serious problems. The immune system contains many different components that help you battle infections. It includes many different types of cells that communicate with each other via signaling molecules, known as cytokines. Might have been life saving for me.   Thank God I do not live where I would have been canceled, and piled in the back of a U Haul??how did that happen ?
25OCT91 2PM pt began to vomit & cough; Seen by MD on 25OCT91; 26OCT91 1201AM broke out in red itchy bumps,t101 went to ER given 2 injects one for vomiting & 1 for allergic reaction; also given DPH;
Shortness of breath, coughing, some deep chest soreness.  Worse when laying down in any position. Began using Albuterol this morning (approx 3 hours ago) with no change in symptoms.
General pain at injection site.  On 02/01/2010 became fever, dizziness, general malaise.  Continues on 02/02/2010.
Severe pain at injection site immediately upon administration.  Thought this was normal.  Pain and stiffness have never gone away (now 6 months later).  Unable to perform regular activities and motions with that arm without moderate to severe pain.  Range of motion severely impacted.
Received shot on Thrusday 15 Nov 2007. Sick to the stomach, nausua, and continuous headache to date.
administration error: first dose of two-dose series given 09/15/2022; second dose given today (12/09/2022), so dose too early
nauseated, chills and sweats, headache, chest hurting, hard to breath getting better but this is the third day. Treatments is just resting and doing nothing. Like I said it started oct.24,25,and now 26th.