chrisvoncsefalvay/vaers-outcomes huggingface dataset:
liquid running down her arm from the needle to her elbow.; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (liquid running down her arm from the needle to her elbow.) in a 24-year-old female patient 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 UNDERDOSE (liquid running down her arm from the needle to her elbow.). At the time of the report, UNDERDOSE (liquid running down her arm from the needle to her elbow.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  No treatment medication was provided
onset of right eye pain  approx 4 weeks later. then given flu vaccine. symptoms continued.  progressive eye pain vision loss.  delay in diagnosis. diagnosed with right optic neuritis and hospitalized in October 2018. full workup for auto immune disorders. treated with IV steroids. vision recovered.
raised rash; nerve psi / Nerve pain; Arm weakness; Body aches; Rash turned into large red patch before fading; Rash turned into large red patch before fading; 3rd dose; 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 female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm right, administration date 21Dec2021 10:45 (Lot number: FL3197) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing); "Known allergies: Sulfur" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8735, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 20Apr2021, when the patient was 58 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 30Mar2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021 10:45, outcome "recovered", described as "3rd dose"; RASH PAPULAR (non-serious) with onset 21Dec2021 18:00, outcome "recovered", described as "raised rash"; NEURALGIA (non-serious) with onset 21Dec2021 18:00, outcome "recovered", described as "nerve psi / Nerve pain"; MUSCULAR WEAKNESS (non-serious) with onset 21Dec2021 18:00, outcome "recovered", described as "Arm weakness"; PAIN (non-serious) with onset 21Dec2021 18:00, outcome "recovered", described as "Body aches"; RASH (non-serious), ERYTHEMA (non-serious) all with onset 21Dec2021 18:00, outcome "recovered" and all described as "Rash turned into large red patch before fading". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of immunisation, rash papular, neuralgia, muscular weakness, pain, rash, erythema. Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The AE treatment was given with gabapentin.  No follow-up attempts are possible. No further information is expected.
Headache/Sharp pain across the forehead; chills; body aches; tiredness; severe migraine; This is a spontaneous report from a contactable nurse, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 04Feb2021 at 14:45 (at the age of 39-years-old) as a single dose for COVID-19 immunization. Medical history included depression-anxiety and birth control use; the patient had no known allergies. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination. Concomitant medications included vilazodone hydrochloride (VIIBRYD), drospirenone/ethinylestradiol betadex clathrate (YAZ) for birth control, clonazepam (KLONOPIN). The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 04Feb2021 at 15:00 (also reported as within 3 minutes post vaccination), the patient experienced headache as a sharp pain across the forehead. On 04Feb2021 at 15:00, the patient also experienced chills, body aches and tiredness that lasted 24 hours. The headache remained 6 days post vaccination as a severe migraine, as of an unspecified date in Feb2021, for which no medications worked. The patient iced, applied heat to the area, dark room, no sound for 2 days and finally was relieved with acupuncture. This headache was like no headache the patient had ever had and she had come very close to an emergency room visit but realized it was from the vaccine. The events "Headache/Sharp pain across the forehead" and severe migraine resulted in a healthcare professional visit and the patient was treated for these events with acupuncture. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of "Headache/Sharp pain across the forehead" and severe migraine was resolving; chills, body aches and tiredness were resolved on 05Feb2021 at 15:00.  Information on the lot/batch number has been requested.
The patient received multiple COVID-19 vaccinations. On ImmTrac2 it is evident that the patient received COVID-19, mRNA, LNP-S, PF, 30mcg/0.3mL manufactured by PFR-Pfizer-Wyeth (Lots: EN6199, and EP6955, respectively) on 3/8/21 and on 3/29/21. The patient also received the COVID-19, vector-nr, rS-Ad26, PF, 0.5mL by JSN-Janssen (Lot 1808609) on 3/24/21.  The concurrent vaccinations were not  known to the facility at the time and the patient has not reported any adverse signs or symptoms.
Swollen lymph nodes in neck, pain moved down my body every day?neck lymph nodes day 2,  shoulders day 3, rib pain day 4, stomach/hips day 5, thighs day 6, knees and calves days  7 & 8, feet day 9, toes day 10.
The vaccine was not diluted and the patient received 6 times the dose.  The patient was contacted and notified of the error. No adverse events were reported.
Moderna COVID-19 Vaccine EUA Severe chest congestion, coughed almost all day. very little actually coughed up day 2, only a very little congestion. which is normal for me.
This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a 50-year-old female patient who received SHINGRIX (batch number M77B4, expiry date August 2019) for prophylaxis. On 19th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, 4 days after receiving SHINGRIX, the patient experienced injection site rash, injection site irritation, injection site swelling and injection site warmth. On 19th August 2018, the patient experienced malaise, flu symptoms, pain and pain in arm. On 20th August 2018, the patient experienced injected limb mobility decreased. The patient was treated with ibuprofen and benadryl (nos) (Benadryl Cream). On 21st August 2018, the outcome of the malaise, flu symptoms, pain and pain in arm were recovered/resolved. On an unknown date, the outcome of the injected limb mobility decreased was recovered/resolved and the outcome of the injection site rash, injection site irritation, injection site swelling and injection site warmth were recovering/resolving. It was unknown if the reporter considered the malaise, flu symptoms, pain, pain in arm, injected limb mobility decreased, injection site rash, injection site irritation, injection site swelling and injection site warmth to be related to SHINGRIX. Additional information was reported as follows: The reporting pharmacist was the patient herself. The patient experienced flu symptoms, felt achy and also had arm pain on the same night of vaccination and the events worsened the next day following the vaccination. The next day after the vaccination, the patient could not lift her arm. The patient took ibuprofen and these symptoms resolved after 48 hours. As the arm pain resolved the patient developed a patch of rash, irritation, swelling that felt hot on her left deltoid, she applied Benadryl cream, however this events were resolving till the date of reporting.
This spontaneous report was received from a physician via a company representative and refers to a 69 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies and medical history provided. On 11-SEP-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, 0.5 ml, lot # N011305, expiry date 20-JAN-2019 (route of administration was not reported) for prevention of pneumococcal disease. On the same day, the patient developed cellulitis at the injection site on his upper right deltoid. The physician reported that the patient went to an unspecified emergency room where he received unspecified intravenous (I.V.) antibiotics for an unspecified length of time for the event. The patient was not hospitalized. The outcome of the event was reported as recovered on an unknown date in September 2017. The causality assessment was not provided by the reporter.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning an adult male patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The event had not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an adult male patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The event had not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Severe Headache; Shortness of Breath; Legs Weakness; Severe Pain in Both Shoulders; Nausea; Difficulty walking; This case was reported by a consumer via call center representative and described the occurrence of headache in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shoulder pain (had history of pain in her shoulders).   On 7th July 2020, the patient received the 1st dose of Shingrix. In July 2020, 11 hrs after receiving Shingrix, the patient experienced headache, shortness of breath, lower extremities weakness of, shoulder pain, nausea and walking difficulty. On an unknown date, the outcome of the headache, shortness of breath, lower extremities weakness of, shoulder pain, nausea and walking difficulty were not recovered/not resolved.   It was unknown if the reporter considered the headache, shortness of breath, lower extremities weakness of, shoulder pain, nausea and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and approximately at 1 to 2 am, she began having a severe headache, shortness of breath, legs were weak, difficulty walking, severe pain in both shoulders, and nausea.   She stated she had history of pain in her shoulders but that this pain was severe in both shoulders.   The reporter asked if GSK recommended she take Tylenol or ibuprofen. The reporter provided the caller with Medical Disclaimer and asked if she would like to have PI sent to her.   The reporter stated she would talk with her HCP and refused the PI to be sent because she the information from GSK website. The reporter consented to follow up. The reporter could provide no other contact information.
Approximately 15 mins post vaccine the patient began to have dyspnea and itching.
COVID vaccinated 2/10/21 & 3/3/21. Hospitalized with COVID infection 4/13/22
Injection site it red and blotchy.  Area is currently non-itchy .  Appeared 10 days after injection.  SIte it about an inch long, 1/2 in wide in one area, about 1/3 inch around below.
Severe swelling, redness, pain around the injection site. Within 24 hours, swelling increased and redness started moving up left arm. A large bubble/blister appeared over injection site. Called office to report issue and they said to contact primary doctor as it appeared to be infected and none of the information the nurses were provided with for monkeypox side effects matched the redness/swelling, blister.  Was advised by doctor to go to the hospital.  Hospital stated the injection site was infected and put me on an antibiotic for cellulitis. Doctor stated it could have been caused by the nurse not sterilizing the injection site properly, the needle being contaminated, the bandage being contaminated,  the vaccine being contaminated as they?re being used for several people, etc.
chest tightness, shortness of breath after walking short distances, on 23rd collapsed at work and died
Redness, itching, swelling, knot at site of injection. Tiredness lasting one week.
Patient was administered dose of COVID-19 Janssen vaccine. The lot number administered was expired, it expired on 9/19/21.
The day I got the vaccine around 5PM I started feeling really tired and started having symptoms from the vaccine, a really bad headache, muscle aches, temperature of 100.2F, chills, nausea and I noticed my arm hurt and then my noticed my lymph nodes under my right armpit swollen (painful - lasted about a week) all other symptoms about 2 days. I had the vaccine on a Thursday, on Friday I could not even finish my work day. The overall symptoms lasted about2 or 3 days. Consulted with PCP on the phone who suggested hot and cold compresses.
Rash and swelling of face/extremities and trunk occurred within 1 hour, post vax. Rx'd Benadryl 12.5mg/Pediapred 10mg in office then transferred to hospital ER for further care.
Redness at injection site - between size of a quarter and half dollar; generalized fatigue, stomach cramps, nausea  chills and low grade fever.   These started within 1 - 2 hours after vaccination.   Lasted  1 1/2 days . Injection site painful with extreme soreness when moving arm especially overhead.   Pain is receding and is sore to touch and minial pain on moving. Redness is approximately size of a dime now.
Severe dizziness, gradually decreasing, but I still get dizzy (10 days later).  Note:  I don't know the manufacturer, so please don't ask me to lie.
Fever; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever on an unspecified date. Outcome of the event was unknown.  The following information on the batch number has been requested.
This spontaneous report as received from a 66 year old male patient refers to himself with cholesterol, bipolar and acid reflux. His medical history included hand tremor. The patient had no drug reactions/allergies. On 10-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # unspecified) (1 injection, location and frequency unspecified) for prevention of shingles. Concomitant therapies included with LIPITOR 40mgx1, CORGARD 40mgx1, WELLBUTRIN 350x1, PREVACID 30mgx2. On 13-DEC-2013 ("3 days after the vaccine was given" as reported) the patient noticed a raised red bump about a quarter size without a rash. The patient did not seek medical attention. At the time of report, the outcome of the events was unknown. Additional information has been requested.
Received the 2nd Pfizer vaccine mid-morning. Went to bed and woke up with itchy hives on my body. It lasted 10 days.
uncomfortably hot ankles and feet; Low grade fever; soreness at injection site; tiredness; headache; muscle and joint pain; muscle and joint pain; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EL9266), via an unspecified route of administration in the right arm on 19Feb2021 at 12:00 PM (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation and penicillin allergy, both from an unknown date and unknown if ongoing. Concomitant medications included atenolol (ATENOLOL), pravastatin (PRAVASTATIN), eicosapentaenoic acid ethyl ester (VASCEPA) and multivitamin, all were taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162b2 (lot number: EL9264), via an unspecified route of administration in the left arm on 29Jan2021 at 01:15 PM (at the age of 65-years-old) for COVID-19 immunisation, prochlorperazine maleate (COMPAZINE) and experienced Compazine allergy and codeine and experienced codeine allergy. The patient did not receive any other vaccines within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced low grade fever, soreness at injection site, tiredness, headache, muscle and joint pain, including uncomfortably hot ankles and feet on 19Feb2021 at 11:00 PM. The patient did not receive treatment for the events. The outcome of events, low grade fever, soreness at injection site, tiredness, headache, muscle and joint pain, including uncomfortably hot ankles and feet was recovering.
Information has been received from a registered nurse concerning a 24 year old female who on 05/08/2000 was vaccinated with a first dose of varicella vaccine and on 07/28/2000 was vaccinated with a second dose of varicella. The nurse reported that the pt recently tested negative according to a VZVIgG antibody test. The pt had sought medical attention for her experience. Additional info has been requested.
Hives developed around R eye 8 minutes after vaccine administration. They did not spread. No other symptoms of allergy or anaphylaxis appeared.
positive COVID  sore throat, headache, congestion, fever, cough and body aches
flare up in his arthritis in his shoulders, wrists, fingers and legs; Night time pain is worse than day time pain; often wakes patient and makes sleep difficult; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 83 year-old male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "mild arthritis" (ongoing), notes: Patient had mild arthritis in his 20's which disappeared after a couple years.; "gout", start date: Dec2020 (unspecified if ongoing), notes: then in Dec2020, had issues with gout in addition to arthritis. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for COVID-19 immunization. The following information was reported: ARTHRITIS (non-serious) with onset 2021, outcome "not recovered", described as "flare up in his arthritis in his shoulders, wrists, fingers and legs"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Night time pain is worse than day time pain"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "often wakes patient and makes sleep difficult".  Additional information: Description of Event: 83-year-old male patient (withheld), my father, reported to me that he experienced a flare up in his arthritis in his shoulders, wrists, fingers and legs after the 2nd Pfizer Comirnaty vaccine in Mar2021. The arthritis flare has not yet subsided and it is now Sept 3rd. Night time pain is worse than day time pain and often wakes patient and makes sleep difficult. Patient is 5'1" and 150 lbs. Optional Information:  The arthritis worsened after the 2nd vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt vaccinated with DTP/OPV became apneic for approx 30 seconds. Became non-responsive; given 2 quick breaths w/ resultant near cry.  Fully recovered after 30 min. Was diaphoretic after episode.  Treated w/ adrenalin SQ.
Patients was tested COVID-19 positive twice > 2 weeks after being vaccinated for COVID-19.
Muscle Pain focusing in the pelvic bone; Joint Pain focusing in the pelvic bone; Tiredness, Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness, Exhaustion), MYALGIA (Muscle Pain focusing in the pelvic bone) and ARTHRALGIA (Joint Pain focusing in the pelvic bone) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical information history was reported.  Concomitant products included BIMATOPROST (LUMIGAN) and VITAMINS NOS (DAILY VITAMINS) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced FATIGUE (Tiredness, Exhaustion). On 09-Mar-2021, the patient experienced MYALGIA (Muscle Pain focusing in the pelvic bone) and ARTHRALGIA (Joint Pain focusing in the pelvic bone). At the time of the report, FATIGUE (Tiredness, Exhaustion), MYALGIA (Muscle Pain focusing in the pelvic bone) and ARTHRALGIA (Joint Pain focusing in the pelvic bone) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used unspecified home remedies to treat the events.