chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 21Dec2020 as dose 3 (booster), single (Lot number: Ej1685) at the age of 46 years, in left 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: "Hypertension" (unspecified if ongoing); "Known allergies: Lentils" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "recovered" (2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Nov2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect products to the reported event Drug ineffective and Covid-19 cannot be completely excluded.
a one year old patient was administered a dose of PROQUAD and VARIVAX on the same day in error; a one year old patient was administered a dose of PROQUAD and VARIVAX on the same day in error; the patient was supposed to be administered a dose of MMR II and VARIVAX; This spontaneous report was received from a medical assistant and refers to a 1-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 29-JAN-2020, the patient was erroneously vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) injection, lot # R030802 with expiration date 22-APR-2020 (exact dose, route and site of administration were not reported) and with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S025610 with expiration date 18-AUG-2021 (exact dose, route and site of administration were not reported), both for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection (strength, dose, frequency, route and site of administration, lot # and expiration date were not reported) for prophylaxis. The patient was supposed to be administered a dose of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (exact dose, route and site of administration, lot # and expiration date were not reported).
below freezing temperature excursion; administrated with Havrix/ 11 month old patient; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-month-old female patient who received HAV (Havrix) (batch number yl532, expiry date 9th September 2022) for prophylaxis.   On 2nd July 2021, the patient received Havrix. On 2nd July 2021, unknown after receiving Havrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the inappropriate age at vaccine administration and incorrect storage of drug were unknown.  Additional details were provided as follows: The physician reported that a 11 months patient was administrated with Havrix after a below freezing temperature excursion, which led to inappropriate age at vaccine administration and incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case is one of 28 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164779: US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164784:
Patient began experiencing itching on side of cheek about 10 minutes after IM injection. Itching began to spread to face, then on to neck/chest area. Patient given 50 mg of benadryl PO and famotidine 20 mg PO. Symptoms have resolved within 20 minutes and will be observed for another 30 minutes. Patient counseled to inform primary care physician of itching event and to follow up with physician if any new effects arise.
This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was given on 15-Jan-2021 and 2nd dose administered on 04-Feb-2021) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025J20A) for COVID-19 vaccination. Patient had been diagnosed with and tested positive. There were none acute illness at the time of vaccination and up to one month before. Chronic or long-standing health condition were unknown. Prescriptions, over-the counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination or at the time of adverse event were unknown. The patient's past medical history included COVID-19. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was given on 15-Jan-2021 and 2nd dose administered on 04-Feb-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was given on 15-Jan-2021 and 2nd dose administered on 04-Feb-2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported. This case was linked to MOD-2022-554190 (Patient Link).
Metallic taste in mouth right after the shot; This is a spontaneous report from a contactable healthcare professional, the patient. A 50-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 03May2021 at 16:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient received other vaccine within 4 weeks prior to COVID-19 vaccination which included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 12Apr2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient previously received METOCLPRAMIDE and experienced drug allergy. On 03May2021 at 16:15 (reported as 04:15), the patient experienced metallic taste in mouth right after the shot. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event metallic taste in mouth right after the shot was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Systemic: Body Aches Generalized-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: Had nausea and diarrhea, not feeling as well as he was before the vaccine, weaker, poorer memory.
bilateral extremity itching starting on 05/11/21 for which the patient took Benadryl. The patient then started having bilateral joint pain.
I had two seizures on 3/19/21 and was admitted into the hospital. Blood tests and MRI were done.
Approx 1 day after receiving injections child developed red, scaly area of injection site. Area getting larger - swollen & warm to touch - non-tender. No other effects, mom states child otherwise acting normally. If gets worse mom will bring to doctor. (Reported to H.D. 8/16/12).
3 days after first dose I have rashes on several areas; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of RASH (3 days after first dose I have rashes on several areas) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 RASH (3 days after first dose I have rashes on several areas). At the time of the report, RASH (3 days after first dose I have rashes on several areas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not provided
"little reaction" after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION ("little reaction" after the second dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced VACCINATION COMPLICATION ("little reaction" after the second dose). At the time of the report, VACCINATION COMPLICATION ("little reaction" after the second dose) outcome was unknown.            No concomitants and treatment drugs are provided.   This case was linked to MOD-2021-381165 (Patient Link).
lymph nodes inflamed due to the vaccine and pain protruding to her left breast causing chest pain
2/6  I felt so heavy and fatigued. My body hurt all over. My eyes hurt, I had a 103 fever, chills, nausea, severe headache, shrill stabbing-like body aches like I was being stabbed with a small ice pick in my wrists, hands, hips, knees. My arm hurt so bad I could not sleep. It was red and swollen. I couldn?t get out of bed. I had stomach pains. I would sweat and break the fever and have to change clothes.  I contemplated going to the hospital.  The next day 2/7 I was still very ill but my fever stayed at 100-101.  I felt awful. The listlessness was not as severe. I hurt all over and my arm ached. The headache was still severe. 2/8 I am still ill but better than yesterday. The headache, fatigue, body aches and sore arm are still present but I can tell my symptoms are lessening.
I had a really bad reaction/week after got very sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administration date 03Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Steroids. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I had a really bad reaction/week after got very sick".  Additional information: The patient got first Pfizer vaccine on 03FEB, week after got very sick, saw hematologist and rheumatologist, still not out of problem, still on steroids. Patient was recommended not to get the shot at all or for a while.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Immediately after vaccination, patient became extremely pale (lips went white) and his arm itched "under my skin".  Six days after the vaccination, he developed a rash all over his body (face, trunk, back, genitals, legs, bottom).  He also ran a mild fever.  Gave him Benadryl for
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), TINNITUS (Tinnitus), SLEEP DISORDER (Interferes with my relaxation and sleep), FEELING ABNORMAL (Feeling was unexplainable/ it was annoying) and IMPAIRED QUALITY OF LIFE (Affecting my quality of life) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer (early stage) and Mastectomy (which was cured now) in 2021. Previously administered products included for COVID-19 vaccination: JANSSEN COVID-19 VACCINE (Batch Number JANSEN: 1805022) on 06-Mar-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concomitant products included LEVOTHYROXINE and LIOTHYRONINE SODIUM (CYTOMEL) for an unknown indication. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced TINNITUS (Tinnitus), SLEEP DISORDER (Interferes with my relaxation and sleep), FEELING ABNORMAL (Feeling was unexplainable/ it was annoying) and IMPAIRED QUALITY OF LIFE (Affecting my quality of life). On 23-Dec-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Achy), FATIGUE (Tired) and PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Tinnitus, at an unspecified dose and frequency. At the time of the report, PAIN (Achy), FATIGUE (Tired) and PAIN IN EXTREMITY (Sore arm) was resolving and TINNITUS (Tinnitus), SLEEP DISORDER (Interferes with my relaxation and sleep), FEELING ABNORMAL (Feeling was unexplainable/ it was annoying) and IMPAIRED QUALITY OF LIFE (Affecting my quality of life) had not resolved. The patient had no known allergies. The patient never tested positive for COVID-19. The patient side effects from which she was struggling. 12 hours after the booster dose the patient got the usual effects like being tired, achy and had a sore arm. She went to sleep and rested then felt better the next day. Within the week after receiving the vaccine she developed tinnitus and which was nonstop since. She read tinnitus could be something linked to a COVID-19 vaccine. She noticed tinnitus when it was quiet. Tinnitus interferes with her relaxation and sleep. Tinnitus became constant and was still ongoing. The patient had not gone to see a doctor but as an appointment coming up. The feeling was unexplainable for the patient, and it was further mentioned that if she would know about those side effects, she would never take COVID-19 Vaccination. Other treatment included unspecified anti-inflammatories, acupuncture, and ear massages but nothing worked for her.
redness @ site, warmth @ site;no problems w/mobility;samll amount hardness;pt has been itching/scratching @ site;pt also had  unexpectes movement @ time of inj;
Red, swollen upper arm below injection. Skin is hot like sunburn. Upper arm is painfull.  Symptoms were first noticed upon waking second day after vaccine.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Systemic: Unable to Sleep-Medium
Soreness at injection site; Sinus problems; Chest congestion; persistent Cough; Increased phlegm production; Raspy voice; Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 28th September 2021, 1 days after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced injection site pain, sinus disorder, lower respiratory tract congestion, persistent cough, phlegm, hoarse voice and pain in arm. On an unknown date, the outcome of the injection site pain, sinus disorder, lower respiratory tract congestion, persistent cough, phlegm, hoarse voice and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, sinus disorder, lower respiratory tract congestion, persistent cough, phlegm, hoarse voice and pain in arm to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra 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 details were provided as follows: This case was reported by the patient herself. The reporter was unsure if vaccine received was manufactured by GlaxoSmithKline, but believed it might had been Fluarix. The patient was experiencing soreness in the left arm/at injection site, sinus problems, chest congestion, a persistent cough, increased phlegm production, and a raspy voice. All symptoms began on the nest day and all symptoms were ongoing. The reporter did not consent to follow-up.
swelling and induration at the injection site with extreme itching that has been persistent for 1 week
Dizziness, fever 101.4. Rest, ice pack, water, parent picked up. Rechecked - 100.8. Student said feeling better.
2 large red blotches  - 1 about 3? and the 2nd about 4? at the injection site a week + a week post vaccination.  (I have 2 photos if needed.)
Seen in ER of 1 month WCC for 103.5 temperature had normal CBC and UA - attributed to HBV.
Pt states after receiving 4th shot, he experienced constant pain starting from injection site all the way to the end of the hand. He stated to be experiencing tingling feeling in hand and fingers.
Case number PHEH2014US000596 is an initial spontaneous report from the health care professional received on 03 Jan 2014. This report refers to a 12-year-old male patient. His medical history was not reported. On an unknown date, the patient was accidentally vaccinated with only Men A lyophilized conjugate of MENVEO (batch number: A13014) which was reconstituted in a sterile diluent instead of Men CYW-135 liquid component. It was reported that the patient did not experience any adverse event after the mal-administration. No other information was available.
A 35 year old female received TD on 1/11/00. On 1/13/00, she developed an injection site reaction characterized by a 3cm area of redness and warmth. She recovered without treatment. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of either TD adsorbed or Diphtheria and Tetanus Toxoid Adsorbed.
headache; heart pounding; her arm was really sore; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old female patient received (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection,  (Lot number and expiry date was not reported) via an unspecified route of administration on 07Feb2021 as a  dose 1 single for covid-19 immunization. Medical history included brain neoplasm from 1995 to an unknown date Stated she has brain tumour and never experienced nothing this bad. Stated that she was diagnosed with a brain tumour malignant in 1995 and has an MRI every year for growth. The patient's concomitant medications were not reported. The patient reported that she had a couple of things happen since her Pfizer Covid vaccination on 07Feb2021.She stated that 10 minutes after the vaccination on the same day, her heart pounding and she dropped the paper with the side effects on the floor and for the time it took for her husband to pick it up that it was gone. The patient reported that heart pounding was short and It happened when she was waiting at the clinic for 15 minutes. The patient reported that it did not last long. The patient reported that she did not report while she was there. The patient came home, did the floors, went to bed and her arm was really sore. On an unspecified date (at 03:00), she had a horrible headache. The patient reported that it did not last all night, but she went to sleep. The patient reported that she tossed and turned. She got up the next morning and it was fine. The patient reported that it was not a severe reaction. The patient wanted to know if she could still get the second dose on 05Mar2021. Outcome of the events was recovered on an unspecified date in 2021.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Due to concern by patient over significant side effects of a 2nd Shingrix vaccine on 9/25/23 and concern if received correct vaccine, a review and reporting were done.  Reviewed vaccine/diluent - lot, exp, NDC, shipment of corresponding lot/NDC/expiration date, spoke with MA who administered, reviewed documentation, reviewed accompanying Shingrix Prescribing Information insert.   Called GlaxoSmithKline to report suspected adverse reactions- Reported all patient signs and symptoms patient had reported since experiencing after 2nd vaccine These include - Nausea/Vomiting, Heart racing, shaking, fever, abdominal pain, diarrhea. Pt hit head during vomiting episode - thinks may have passed out -headache. Reported "hearing things, babbling nonsense" Increased liver enzymes.   Reviewed particular lot 2TL27 - GSK reporting no issues/recalls.   Advised that the following s/s are known reported SE of Shingrix - Gi issues - N/V, abd pain, diarrhea; HA; fever; shaking.  All other s/s have not been reported in clinical trials.   Conclusion: Pt's s/s  fortunately seem to be resolving per notes. Patient was given correct vaccine/diluent. No administrator errors in reconstitution or administering vaccine found.  Pt having s/s from Shingrix that are known s/s with this vaccine. Other signs/symptoms not seen in clinical trials have been reported to GSK.