chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received two doses in 2017 and never received the third booster dose. They are a category risk 3 and require a booster dose due to travel with no reported adverse event; Initial information received on 16-Jun-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2023SA187322.  This case involves a 12 years old and unknown gender patient who, received two doses Of Rabies (Hdc) Vaccine [Imovax Rabies] in 2017 and never received the third booster dose. they are a category risk 3 and require a booster dose due to travel with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date the patient received two doses of suspect Rabies (Hdc) Vaccine (lot number: not reported, Expiry date: not reported) via unknown route in unknown administration site, indication: prophylactic vaccination) in 2017 and never received the third booster dose. they are a category risk 3 and require a booster dose due to travel with no reported adverse event (inappropriate schedule of product administration).  Action taken with Rabies Vaccine was not applicable.  At time of reporting, the outcome was Unknown for the 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.
RN administered erroneous 3rd dose to patient. She neither checked their vaccine card, nor reconciled the patient's vaccine list before administration. Patient left with Mom in stable condition. MD was notified and sent patient home with ED precautions for any new or unusual symptoms.
doesn't have full use of her right hand; pain comes and goes; still has all of the pain in her arm and hand/her arm is totally not the same since she got the shot; numbing sensation in her righ arm, hand and leg, right leg gave out right under her knee; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbing sensation in her righ arm, hand and leg, right leg gave out right under her knee), HYPOKINESIA (doesn't have full use of her right hand), PAIN (pain comes and goes) and PAIN IN EXTREMITY (still has all of the pain in her arm and hand/her arm is totally not the same since she got the shot) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced HYPOAESTHESIA (numbing sensation in her righ arm, hand and leg, right leg gave out right under her knee). On an unknown date, the patient experienced HYPOKINESIA (doesn't have full use of her right hand), PAIN (pain comes and goes) and PAIN IN EXTREMITY (still has all of the pain in her arm and hand/her arm is totally not the same since she got the shot). At the time of the report, HYPOAESTHESIA (numbing sensation in her righ arm, hand and leg, right leg gave out right under her knee), HYPOKINESIA (doesn't have full use of her right hand), PAIN (pain comes and goes) and PAIN IN EXTREMITY (still has all of the pain in her arm and hand/her arm is totally not the same since she got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant details were provided No treatment details were provided. Caller confirmed information reported in previous. AE  Contact information confirmed.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant Follow up information received. NewEvents Pain and Pain in extremity was added.
A rather large lymph node in left armpit; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 50-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 05Apr2021 at 08:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. No relevant medical history. The patient did not have any allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 08Mar2021 at 08:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any medication within two weeks of vaccination. 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. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021 at 07:00 (next morning after receiving 2nd dose of vaccine), the patient had a rather large lymph node in left armpit. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the event. The clinical outcome of the event a rather large lymph node in left armpit (lymphadenopathy) was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
She got her vaccine, had no reaction.  Then two days later she had low grade fevers that do not go back to normal, upset stomach, headaches, sometimes muscle aches, fatigue, sometimes gets out of breath when she's doing something.   She is still having these symptoms every day.  She has contacted her doctor who said that there was nothing that they can do to continue taking the fever reducers and let it run it's course.  It's been 5 weeks right now, and she's not able to do things like go places or see people due to these symptoms.
9/20/12 I had a small red swollen area around injection site. 9/20/12-9/21/12 In the middle of the night (9/20) I woke up with fever/chills/leg aches and they continued till late in the evening of the 21st. 9/21/12 AM woke up with a larger red swollen area at injection site. 9/22/12 Fever/chills/aches had resolved but went to the ER around noon because red swollen area had grown again (they measured it at 13mmx13mm)- they prescribed me Keflex 500mg 1 cap q6h #20, Zyrtec 10mg 1 tab daily x15d, Lortab 5-500 1-2 tabs q6h prn pain #10 9/23/12 Arm (redness/swelling) grew overnight but only in one direction, towards my elbow. Continued meds. 9/24/12 Went in to my Family Medical Clinic for f/u. Arm grew again last night (9/23) and they measured the redness on my arm to be 19mmx15mm. They changed my treatment to D/C Keflex and begin Septra DS 1 tab bid x10d, D/C Zyrtec and begin Diphenhydramine 25mg 1 cap q6h prn itching, continue Lortab and IBU prn, and a new med Ranitidine 150mg bid x10d I follow up on 9/25/12 to see if new regimen is bringing the redness and swelling down.
Loss of smell; Loss of taste; Slightly swollen lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 60-years old female patient received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 20Mar2021 at 16:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had allergies to sulfur ingredient. 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 did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vyvanse (MANUFACTURER UNKNOWN), dosage 40mg 1xday for unknown indication, omeprazole DR (MANUFACTURER UNKNOWN), dosage 40mg for unknown indication from unknown date. On 21Mar2021 at 08:00 (as reported), patient experienced loss of smell, loss of taste and slightly swollen lymph nodes. The clinical outcome of the events  of loss of smell, loss of taste, slightly swollen lymph nodes were unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.
It was punctured on 13Jan2022 at 12:15 pm. They gave 2 doses from this vial this morning; First dose received on 06Dec2021 and second dose on 14Jan2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (It was punctured on 13Jan2022 at 12:15 pm. They gave 2 doses from this vial this morning) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 06Dec2021 and second dose on 14Jan2022) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A and 939909) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2022 at 1:04 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (It was punctured on 13Jan2022 at 12:15 pm. They gave 2 doses from this vial this morning) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 06Dec2021 and second dose on 14Jan2022). On 14-Jan-2022, EXPIRED PRODUCT ADMINISTERED (It was punctured on 13Jan2022 at 12:15 pm. They gave 2 doses from this vial this morning) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 06Dec2021 and second dose on 14Jan2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reported  No treatment medication was provided by the reporter.  Moderna vial sat out at room temperature unpunctured for greater than 12 hours and gave 2 doses from this vial on 14-JAN-2022.
seizures; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizures) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (seizures) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizures) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported. No treatment information was provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
When I woke up on Saturday morning, I noticed that there were several red bumps on the lower right side of my back.  At first I just thought that they were bug bites, but upon closer inspection realized that it was a rash.  I also had pain in my right hip and upper thigh, and it was strange - just touching the skin hurt.
I had enlarged lymph nodes around my collarbone on left side, and is still as of today.
Oxygen below 80; Couldn't breathe; Pain; diarrhea for 4 to 5 weeks; This spontaneous case was reported by a patient and describes the occurrence of OXYGEN SATURATION DECREASED (Oxygen below 80), DYSPNOEA (Couldn't breathe), PAIN (Pain) and DIARRHOEA (diarrhea for 4 to 5 weeks) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A27B, 037C21A, 032M20A and 032L620A) for COVID-19 vaccination.     Patient did not have allergies to medication, food and other products. Patient never had COVID positive test or diagnosis. No other vaccine taken by the patient within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Diabetes (No recent changes in status such as improvement or worsening.) since 2000, Blood pressure high (No recent changes in status such as improvement or worsening.) since 2000, Anxiety, Prostatic disorder, Blood cholesterol abnormal and Gastric disorder. Concomitant products included SERTRALINE for Anxiety, ATORVASTATIN for Blood cholesterol abnormal, METOPROLOL for Blood pressure high, GLIPIZIDE, GABAPENTIN and METFORMIN for Diabetes, OMEPRAZOLE for Gastric disorder, FINASTERIDE for Prostatic disorder.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OXYGEN SATURATION DECREASED (Oxygen below 80), DYSPNOEA (Couldn't breathe), PAIN (Pain) and DIARRHOEA (diarrhea for 4 to 5 weeks). At the time of the report, OXYGEN SATURATION DECREASED (Oxygen below 80) and DYSPNOEA (Couldn't breathe) had not resolved and PAIN (Pain) and DIARRHOEA (diarrhea for 4 to 5 weeks) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: Below 80.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received the vaccine in his left shoulder. The patient visited doctor for diarrhea who provided no treatment for his symptoms. The patient visited doctor for oxygen below 80 and could not breath and he was provided an Oxygen machine for breathing properly. Patient did not experience any similar events in past.   This case was linked to MOD-2022-604652, MOD-2022-604409 (Patient Link).
Dose administered after 30-day Use By Date; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication details were reported. Vaccines placed in refrigerator 13 Jan 2022 Expiration date placed on vials 12 feb 2022 Doses administered to patient 17 feb 2022
Had Vx, Got the shots and has had shingles/suspected vaccination failure; has had shingles 3 times since; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included shingles (patient's cousin had shingles 7 years ago) and nerve damage (patient's cousin left with permanent nerve damage).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had Vx, Got the shots and has had shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: has had shingles 3 times since). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient's cousin via interactive digital media. The reporter had shingles 7 years ago and was left with permanent nerve damage and had been a struggle ever since.  It was a horrible virus but he/she did not sure how much the shingles vaccine would help.  The patient got the shingles shots and had shingles three times since.  The reporter sated that so it was just a personal choice whether to get it or not. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR066981, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR066981:Same reporter
Fever chills fatigue and heart racing.  Heart rate jumping around going up into the 120s at least.  Didn't check it all night but regularly in 110s once I did.  Squeezing chest pain.
Exactly 12 hours after the second shot (Thursday morning) I started feeling flu like symptoms. Fever, chills, muscle aches, chest pain, racing heart, high blood pressure, fatigue, heart palpitations. Friday afternoon fever was reducing along with feeling less chills and fatigue. Chest pain, high bp, pulse persisted.  I went to urgent care where they took an EKG and told me to immediately go to the ER. Resting BP was around 160-170/100, pulse over 100. Chest pain.  Blood tests showed elevated D-Dimer of 354. CT scan negative for blood clots. Chest x-ray clear. Was sent home after bp and pulse had dropped.  I still after one week of the shot have chest pain racing pulse, chest pain.
Three near syncope events - very low heart rate , dropped blood pressure, cold sweat , almost threw up. Symptoms began to recede after taking Motrin and drinking some salt water.
July 2nd, 2020 - Within the hour, I had severe heart palpitations and slight chest pain which lasted about 20 minutes. An hour later, my arm was burning and felt like ants were biting me all along my arm (from the injection site to my middle finger, pointer finger, and thumb on left hand). July 3rd - I had difficult/labored breathing, while feeling like I was about to pass out (along with heart palpitations), and that continued on and off for 2 more days (July 4th and 5th). Due to this reaction, I am unsure if I will get the second dose.
Patient reports that the morning following vaccination, she awoke with chest pain and palpitations. She took a nitroglycerin and a baby aspirin, upon which the pain subsided. She was fine for the remainder of the day. The next morning she had chest pains again to a much lesser degree; they resolved in the same manner after treatment. She has been in contact with her cardiologist for a follow-up, unsure if related to vaccination or a flare up of her pre-existing condition.
Bad diziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Bad diziness) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Bad diziness). At the time of the report, DIZZINESS (Bad diziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Weak; Real tired and sleepy/exhausted; I could hardly breathe; Dizzy; This spontaneous case was reported by a patient and describes the occurrence of   in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included Asthma (Patient has a history of asthma but not had asthma or breathing problems since1987 due to keeping it under control).    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form as required.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information also mentioned an inhaler for treatment of the events.  Patient mentioned having a prior anaphylactic shock from an allergy shot much before and was cautious with this vaccine due to that.    Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Additional information added on 25JUN2021 is non significant. Patient updated email ID.
heart palpitations; felt like heart was skipping a beat almost every 3-5 minutes; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via an unspecified route of administration at the right arm on 21Dec2020 08:00 at a single dose for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination and had no known allergy. The patient had no concomitant medications. On 23Dec2020 at 11 pm, approximately 36 hours after getting vaccine, the patient had 36+ hours of heart palpitations, felt like heart was skipping a beat almost every 3-5 minutes.  Events subsided after 36-48 hours. The patient was not hospitalized for the events. There was no treatment given for the events. The events were reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.
Patient felt she may faint Monday night, felt very tired and fell asleep. She awoke on Tuesday morning and left arm was swollen, red and warm to touch. Swelling has finally decreased as of 09/07/2017.
1420 recieved vaccination. When arrived at post vaccination area, reported a very mild pins and needles sensation from L shoulder down to hand and pinky and ring finger.  1426: BP 128/90 HR 62. 1420: Reports upper arm has returned to normal feeling; senstaion of pins and needles to hand, pinky, ring finger. Reports that sensation remains at same intensity.  Over time, reports that the pins and needles sensation leaves his lower arm until at 1440 when tingling has resolved and everything feels "back to normal."  Released from post vaccination area.