chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left arm red; left arm hurt to touch; left arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (left arm red), VACCINATION SITE PAIN (left arm hurt to touch) and VACCINATION SITE SWELLING (left arm swollen) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (left arm red), VACCINATION SITE PAIN (left arm hurt to touch) and VACCINATION SITE SWELLING (left arm swollen). The patient was treated with HYDROCORTISONE (topical) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (left arm red), VACCINATION SITE PAIN (left arm hurt to touch) and VACCINATION SITE SWELLING (left arm swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Received Pfizer vaccine at 35 weeks pregnant. The estimated due date is 9/8/21. Pain and swelling in joints of hands. Feels like what I assume would be arthritis. Worse in the night and morning and gets better during the day.
Throbbing pain Bil thighs and upper arms, Tingling hands and fingers. Provider noted slight hesitation in step. Neuro intact but sent to Hospital to R/O GBS.
Hot, swollen, and red at the injection site. No other symptoms, no open sore or drainage.
Information has been received from a physician concerning a 66 year old female patient with hypertension NOS and arthritis NOS and a history of lymphoma NOS who on Dec 19, 2002 was vaccinated with pneumococcal vaccine 23 polyvalent. Concomitant therapy included glipizide (Glucotrol), metformin HCl (Glucophage), tradolapril (Mavik), nizatidine (Axid), dilitiazem hydrochloride (Tiazac), meloxicam (Mobic) and alendronate sodium (MSD). A few hours later on Dec 19, 2002, the patient experienced a red rash (6 inches in diameter) around injection site, 101 degree fever, vomiting and nausea. These symptoms persisted into Dec 21, 2002 and now have started to abate. Unspecified medical attention was sought. Additional information has been requested.
sick; chill; whole body was achy; This is spontaneous report from a contactable consumer (patient). A patient  of an unknown age and gender received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date (reported as Monday) for Covid-19 immunization. Medical history was not provided. Concomitant drug included warfarin sodium (COUMADIN). Patient had shot on "Monday" and was so sick even though "today" (14Apr2021) was chill, really chill, whole body was achy. Patient felt like did not want to take the second shot. Patient was on warfarin sodium, and inquired if that was going to affect anything. Outcome of the events was not resolved.   No Follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Patient is 63 years old and received a Fluzone Quad High Dose vaccine. According to CDC: Fluzone High-Dose Quadrivalent vaccine is approved only for people 65 years and older. Fluzone High-Dose Quadrivalent is not approved for people younger than 65 years or for people of any age with a history of severe allergic reaction to any influenza vaccine or to vaccine components other than eggs. Information about vaccine ingredients is located in the manufacturer?s package insert.
Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: pt didnt need any epinephrine . she was responsive within couple of minutes and then parametics took over and took her to hospital
Hives first developed on turso, spread to back and buttocks, inner thigh, arms and back of hands. Treated with low dose oral steroids for 6 days - during treatment hives subsided but came back after steroids finished.
Local reaction at site 5 x 7 cm redness 2 x 2 cm node in (lt) arm pit. After flu shot fever to 101.7, vomiting w/in 24 hours.
Injection site pain - Moderate; Heavy fatigue; Chills; Very Cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 14:00 (Lot number: FF3398) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "Secondary diabetes" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]; INVOKAMET XR; ATORVASTATIN. Vaccination history included: Bnt162b2 (DOSE 1, Batch/Lot No: el3302, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 19Mar2021, for Covid-19 Immunization; Bnt162b2 (DOSE 2, Batch/Lot No: fw015, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 07Apr2021, for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 30Sep2021 22:00, outcome "recovered" (03Oct2021), described as "Injection site pain - Moderate"; FATIGUE (non-serious) with onset 30Sep2021 22:00, outcome "recovered" (Oct2021), described as "Heavy fatigue"; CHILLS (non-serious) with onset 30Sep2021 22:00, outcome "recovered" (Oct2021), described as "Chills"; FEELING COLD (non-serious) with onset 30Sep2021 22:00, outcome "recovered" (Oct2021), described as "Very Cold". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, chills, feeling cold.  Additional information: The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No hospitalization. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Fatigue; headache; mild body aches; Arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the arm left on 31Mar2021 at 12:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to clindamycin. Concomitant medication included allegra (MANUFACTURER UNKNOWN) taken in two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 10Mar2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation within 4 weeks prior to vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 0000 (after 690 minutes), the patient experienced fatigue, headache, mild body aches (ache) and arm soreness (pain in arm). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the events fatigue, headache, mild body aches and arm soreness was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
expired drug used; local injection site reaction of redness; local injection site reaction of and warmth; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 1-year-old male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29-APR-2023) for prophylaxis.   On 05-MAY-2023, the patient received Infanrix (left thigh). On 05-MAY-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: expired drug used). In MAY-2023, the patient experienced injection site erythema (Verbatim: local injection site reaction of redness) and injection site warmth (Verbatim: local injection site reaction of and warmth). The outcome of the injection site erythema, injection site warmth and expired vaccine used were unknown.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Infanrix and Infanrix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site erythema and injection site warmth to be related to Infanrix and Infanrix Pre-Filled Syringe Device.   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: 09-MAY-2023. Nurse at a health department reported that two patients on 5th MAY 2023 received an expired dose of Infanrix which was already expired on 29 April 2023, which led to expired vaccine used One of the two patients had a local injection site reaction of redness and warmth on the left vastus lateralis.  The patient's mother called about the reaction the day after administration.  The reporter consented to follow up. This case has been linked to the case US2023066955 reported by the same reporter.
Had an eye reaction; This case was reported by a consumer via call center representative and described the occurrence of eye infection in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced eye infection. On an unknown date, the outcome of the eye infection was recovered/resolved.   The reporter considered the eye infection to be unrelated to Shingrix.  Additional details were provided as follows: The reporter was the patient. The reporter stated that, after vaccination with dose 1 of Shingrix, had eye reaction that lasted on and off about a month or more. For the tolerence of dose 2 refer case US2021AMR005869, reported by same reporter for same patient. Note- there was discrepancy in the reported adverse events. It is not clear after which dose patient had reported events. To be conservative, event eye reaction coded for 1st dose and other events after 2nd dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR005869:Same reporter US-GLAXOSMITHKLINE-US2021AMR005869:same reporter
Patient developed adverse reaction like fever, flu like symptoms and rashes on the first day post vaccine second dose (05/01/2021) and then she went to ER morning of 05/04/2021 at about 1 am due to chest pain and SOB
mom called to say that child had devel hives p/vax which went away p/taking DPH;mom denied any other sx or problems;
Erythema,  tenderness, edema of entire upper arm with with pruritus. With upper arm swelling to twice normal size about 48-72 hours after DTaP injection. Resolving by 6 days after injection.
Information has been received from a pharmacist concerning a 21 year old female who on 12-MAR-2007 was vaccinated with a dose of Gardasil, injection (form), 0.5 ml. Concomitant  therapy included metformin, drospirenone (+) ethinyl ethinyl estradiol (YASMIN), levofloxacin (LEVAQUIN) and naproxen. On 10-OCT-2007 after being vaccinated with her third dose of Gardasil, the patient experienced renal failure and was hospitalized. Unspecified medical attention was sought. The outcome of the event was not reported. renal failure was considered to be immediately life-threatening. Additional information has been requested.
Next day foot and ankle swelled up double size tried to ice not walk on it went to dr  2 weeks  later and they they X-ray foot  blood work showed elevated sed    Rate. Recommend to foot dr, he said I have a stress fracture of left foot. Prescribed compression and boot for 4 weeks but  still having pain and weak foot.
Pt has nonresponsive episode on 12/30/20 30 minutes after receiving his 1st injection of moderna covid vaccine.  Became responsive 3 minutes later.  Pt current patient at LTC facility hx of CVA and pseudobuldar palsy
Information has been received form a licensed practical nurse (L.P.N.) concerning a 17 year old female with no pertinent medical history or no known drug allergies who on 20-SEP-2007 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot # 657868/0523U), on 04-JAN-2008 was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot # 659439/1267U) and on 20-JUN-2008 was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL ( lot # 660393/0067X). Concomitant therapy included BENZACLIN, SUMYCIN, MENACTRA (20-JUN-2008). On 20-SEP-2007 the patient experienced syncope. The patient had also experienced intermittent vertigo and nausea since May 2008. The patient's syncope and intermittent vertigo and nausea persisted. Medical attention was sought via office visit. No product quality complaint was involved. Additional information has been requested.
The DTaP-IPV (Kinrix) that was administered to this client on 3/6/23 had expired on 3/3/23.  It was inadvertently administered past the expiration date.
Sharp like needle poking pain in feet/ sore arm; Nausea; Headache; Pain in mouth; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female 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 24Apr2021 at 08:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and unspecified birth control pill; all taken from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Apr2021 at 17:00, the patient experienced sharp like needle poking pain in feet, nausea, headache, sore arm and pain in mouth. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sharp like needle poking pain in feet/ sore arm, nausea, headache and pain in mouth were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Case number PHEH2016US027034, is an initial spontaneous report from a nurse received on 17 Oct 2016. This report refers to a 44 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX Quadrivalent (batch number: 185888) at a dose of 0.5 ml, intramuscularly on 17 Oct 2016. It was reported that, a temperature excursion occurred with FLUCELVAX Pre-filled syringe in a closed refrigerator, vaccines were cool to touch upon discovery. The patient estimates the time of excursion was 02 to 03 days and max temperature was estimated to be less than 77 degrees Fahrenheit. This was the first temperature excursion. It was stated that, vaccine has been given to 07 people this morning on 17 Oct 2016. No adverse event was reported following this medication error (incorrect product storage).
Around 12 am after the dose of my vaccine, I got a fever, chills, body aches, headache and fatigue. I knew all of these things to be normal. My arm was sore and I also knew that was expected. I could hardly move out of bed. At 0700 this morning, on 6/4, I finally got the energy to shower. That is when I noticed my lymph node in my armpit of the same arm I received my vaccine in was swollen to about the size of a tennis ball. I had a PA that I work with recommend me to go to an urgent care to be seen because she did not believe this to be normal. I received a Toradol injection and a course of antibiotics to take in case it turned out to be infected.
profound sleepiness & fussy; pt slept 12 hrs straitht (very unusual) fussy, low fever 100.5, mom noticed a strange cry during the noc;
Patient received flu shot, returned approximately 20 minutes later with Complains Of "scratchy throat and hoarse voice". Denies 5oB, itching ,or abdominal pain. Vital Signs Stable=blood pressure 149/115, P73, R16. Patient Benadryl  shot. Given 25mg  Intramusclar. Patient reports not taking home blood pressure medicine this morning, and having allergic reaction yesterday to a bee sting. Patient recovers after observation
cold sore (small and then big as a nickel); Drowsy; Feel tired; Arm was sore at the injection site; This spontaneous case was reported by a physician and describes the occurrence of ORAL HERPES (cold sore (small and then big as a nickel)), SOMNOLENCE (Drowsy), VACCINATION SITE PAIN (Arm was sore at the injection site) and FATIGUE (Feel tired) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore at the injection site). On 28-Apr-2021, the patient experienced ORAL HERPES (cold sore (small and then big as a nickel)), SOMNOLENCE (Drowsy) and FATIGUE (Feel tired). At the time of the report, ORAL HERPES (cold sore (small and then big as a nickel)), SOMNOLENCE (Drowsy), VACCINATION SITE PAIN (Arm was sore at the injection site) and FATIGUE (Feel tired) 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.   Relevant concomitant product usage were not reported by the reporter. No treatment details were added.
When I do very quick, strenuous activity (like walking quickly up stairs or up a hill) it feels like my heart is pumping out of control and feels like it is fluttering.  I was in one place when I received my vaccination and attributed this response to the high elevation to which my body was unaccustomed, however it has continued to happen in another place.  I run and go to the gym multiple times a week consistently, so I know this is an abnormal response for my body to quick, strenuous activity.
Diarrhea; body aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN (body aches) and HEADACHE (headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), PAIN (body aches) and HEADACHE (headaches). At the time of the report, DIARRHOEA (Diarrhea), PAIN (body aches) and HEADACHE (headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported Treatment information was not provided
Case number PHEH2014US002524 is an initial spontaneous report received from a pharmacist on 03 Feb 2014 with a follow up information received from a pharmacist on 27 May 2014. This case was initially reported as a multiple patient case involving 2 patients, but upon follow up information the patient identifiers were reported. This report refers to an adult female patient. Past medical history included shellfish allergy and concomitant medication were not reported. She was vaccinated with an initial dose of FLUVIRIN (batch number: 13464P) intramuscularly in the left deltoid at a dose of 0.5 ml on 05 Feb 2014. It was reported that on an unknown date after vaccination, it was hurt to lift arm and it hurt to sleep on it for 5 weeks. She experienced painful and limited movement of her arm. Arm affected was the arm she received the injection in. She did not want to go to the physician. The outcome was reported as condition improving at the end of Mar 2014. The seriousness and causality of the events were not reported. Follow up information received from a pharmacist on 27 May 2014: Patient demographics (initial, date of birth, age group and gender), medical history, vaccination date, batch number, dose and site of vaccination, description on event, stop date and outcome updated.
both IPOL and PENTACEL were administered on same day to a patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from nurse and consumer/non-health care professional via Medical Information (MI) (Reference number- 00827332) and transmitted to Sanofi on 25-Oct-2021.  This case is linked to case 2021SA357176  This case involves 6-month-old male patient administered both IPV (VERO) [IPOL] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] on same day (extra dose administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), ROTAVIRUS VACCINE and HEPATITIS B VACCINE for prophylactic vaccination.  On 25-Oct-2021, the patient received a third 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number: UJ494AAA and expiry date: 09-Jul-2022) (Frequency: once) (strength: standard) via intramuscular route in the left thigh, a third dose of suspect IPV (VERO) (lot number: T1E871M and expiry date: 10-Oct-2022) via intramuscular route in the right thigh for prophylactic vaccination respectively (extra dose administered).  It was reported "Caller would like information possible adverse effects of extra dose of IPOL so that she can inform patient's mother. Caller has (product information) PIs for IPOL and PENTACEL; caller was referred to product PIs for more information on potential adverse effects of IPOL administration and PENTACEL administration".   This case was an actual medication error due to extra dose administered (latency: same day).  At the time of reporting, no adverse event.  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Headache, Myalgia, Fever, 101.8 F, CHILLS, BODY ACHES, HA, SHIVERING, FEVER Narrative:
Rash to all extremities with itching.  Took OTC Benadryl w/o effect.  Symptoms resolved.
11/15/2011 - Injection given. 11/17/2011 - Pt called to report increase in arthritic pain & stiffness. No change in regular regimen.
My fatigue has dramatically increased since I got the second dose of the vaccine. The pattern is different from my chronic fatigue syndrome.