chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician assistant to a 62 year old female patient. Pertinent medical history, drug reactions and allergies were not reported. On 01-JUL-2014 the patient was intended to receive ZOSTAVAX, but was inadvertently administered (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous (dose number and lot number were not reported). Concomitant therapies were not reported. No adverse effect reported. The outcome of inadvertently administered (Oka/Merck) VARIVAX was unknown. Additional information is not expected because the reporter refused additional contact.
Got both doses in 2018, now has shingles\ suspected Vaccination failure; Shingles, not as bad; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number Jc92p, expiry date 22nd November 2020) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (prior to the vaccine).   On 23rd August 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 24th April 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received both doses of the Shingrix vaccine and at the time of reporting had a case of shingles. The patient reports that the case of shingles they had now was not as bad as the case they had prior to the vaccine. The pharmacist was asking about giving a 3rd dose or series of the Shingrix vaccine. Referred the patient to health care professional and transferred the pharmacist to MI for further discussion. The reporter did not consent to follow-up.
About 10 minutes (moments before they told me sage to leave) I began thinking I was having a hard time breathing but associated it to anxiousness about receiving the vaccine. Ran my errands in town and kept thinking I was having problems breathing. Again, thought I was imagining. For just a minute or so it felt like my throat was tight, but soon vanished so again thought I was imagining. Just didn?t feel ?right? rest of day but assumed I was dreaming it up. That evening when I laid down to go to sleep, I quickly realized I was having shortness of breath. Could barely breath. I checked my oxygen level & it was running 91-94. However, my heart rate (usually sits between 55-65 when resting) was running in high 70?s to mid-80?s. Called ER and asked if I could take Benadryl- they said yes. Took one adult Benadryl and felt a bit better soon after. An hour later took another along with a Pepcid. Eased up enough then I could go to sleep. Didn?t take any more meds, but it was another day & 1/2 before I felt ?normal? (I have CHF so I deal with some sob always).
patient was given pfizer covid monovalent vaccine in error instead of the bivalent pfizer vaccine
Severe rash on right forearm, even more severe rash with swelling and bumps at lower left leg above Achilles heal, rash on upper right thigh and right midriff.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm started hurting after 2-3 hours/ it's hard for her to hold both arms in the air after receiving 2 doses of vaccine) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 053E71A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL, PROGESTERONE and ESTRADIOL for an unknown indication.   On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jul-2021, the patient experienced PAIN IN EXTREMITY (arm started hurting after 2-3 hours/ it's hard for her to hold both arms in the air after receiving 2 doses of vaccine). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (arm started hurting after 2-3 hours/ it's hard for her to hold both arms in the air after receiving 2 doses of vaccine) outcome was unknown.            This case was linked to MOD-2021-343679 (Patient Link).
Soreness; Fatigue; headache; This is a spontaneous report from a contactable healthcare professional (patient herself). A 48-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm on 22Jan2021 18:00 at single dose for COVID-19 immunization. Medical history included Hodgkin's disease and penicillin allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number and expiry date not reported) in the left arm on 02Jan2021 at single dose for COVID-19 immunization. On 24Jan2021, the patient experienced soreness, fatigue, and headache. Clinical outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Case number PHEH2013US015047 is an initial spontaneous report received from a nurse on 12 Jul 2013. This report refers to an 11 year old patient (gender not reported). Medical history and concomitant medications were not reported. The patient received an intramuscular dose of 0.5 ml MENVEO (batch number: 12013) on 01 Apr 2013. It was reported that the patient possibly received Men A lyophilized conjugate of MENVEO diluted with sterile water instead of being reconstituted with MenCYW-135 liquid conjugate. It was reported that a box of MENVEO was found with one full dose and one vial of powder, but without diluent. The patient would be re-vaccinated. No adverse event was reported following maladministration.
This spontaneous report was received from a medical assistant, and refers to a 28 year old male patient. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On an unspecified date in June 2016, the patient was vaccinated with the first dose of GARDASIL 9, for prophylaxis, (dose, frequency, route, lot number and expiration date were not provided. Subsequently on 10-NOV-2016, the patient was vaccinated with a dose of (dose 2 in GARDASIL series) GARDASIL. Finally, it was reported that on 19-APR-2018 (reported as "today"), the patient had presented to the reporter office to have his third dose of GARDASIL 9. No adverse effects were reported.
After approximately 5 minutes my arm was tingling  from the injection site to my fingers, I became nauseous and went to the brink of passing out. An ambulance was called and my blood pressure  had dropped to 100/60.  My blood sugar also dropped.
pt recvd vax & c/o neck pain on same side as inject given; stated felt "strange", dry mouth; w/in 5 mins dry heaving & then c/o throat closing; Epi given w/immed effect; cont to c/o neck pain;
Patient received the flu vaccine and was nearly fainting afterwards.  Mom was with the patient.  We called 911.  Patient was sitting down.  Patient did not lose consciousness entirely.  Mom kept talking to patient and patient was nearly fainting.  The paramedics came and assessed patient.  Paramedics said patient probably had a vasovagal attack.  After around 15-20 minutes, patient was better.  Paramedics said patient did not need to go to the hospital.  Paramedics left with patient and mom to escort them back to mom's vehicle.  I phoned mom to follow up after a couple of hours.  Mom said patient got home and was all well.
lower back started hurting; arm sore; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back started hurting) and MYALGIA (arm sore) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (spring allergy).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced MYALGIA (arm sore). On 11-Apr-2021, the patient experienced BACK PAIN (lower back started hurting). The patient was treated with IBUPROFEN for Back pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (lower back started hurting) and MYALGIA (arm sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
a lot of sweating.; fever; chills, shivering; slight headache; fatigue; injection site is sore; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in august 2020 for further tolerance refer case US2020221351).   On 5th November 2020, the patient received the 2nd dose of Shingrix. On 5th November 2020, less than a day after receiving Shingrix, the patient experienced fever, chills, headache and fatigue. On 6th November 2020, the patient experienced sweating increased. In November 2020, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, fever, chills, headache, fatigue and sweating increased were unknown.   It was unknown if the reporter considered the injection site pain, fever, chills, headache, fatigue and sweating increased to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix on right arm and experienced injection site soarness, fever, shivering, headache, fatigue and sweating a lot. The patient experienced fever, shivering, headache, fatigue less than day and sweating a lot 1 day after receiving shingrix. The reporter did not consented to follow up. No futher information was available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020221351:1st dose, same patient
At onset blister was flush with skin; a few hours later, blister/pustule was 1/2 CM raised clear filled.
pain has gone up back, into neck; Back Pain; Little Bug; pain has gone up back, into shoulders; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain has gone up back, into neck), BACK PAIN (Back Pain), DISCOMFORT (Little Bug) and ARTHRALGIA (pain has gone up back, into shoulders) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced NECK PAIN (pain has gone up back, into neck), BACK PAIN (Back Pain), DISCOMFORT (Little Bug) and ARTHRALGIA (pain has gone up back, into shoulders). At the time of the report, NECK PAIN (pain has gone up back, into neck), BACK PAIN (Back Pain), DISCOMFORT (Little Bug) and ARTHRALGIA (pain has gone up back, into shoulders) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
continual reduction in platelets.; This is a spontaneous report from a contactable consumer (Patient's niece). This consumer reported for a 76-Year-old-male (Patient) that.  A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: el9264), dose 1 intramuscular, administered in Arm Right on 29Jan2021 as (at the age of 76-years) DOSE 1, SINGLE, dose 2 intramuscular, administered in Arm Right on 24Feb2021 (Lot Number: en6198) as (at the age of 76-years-old) DOSE 2, SINGLE for covid-19 immunisation. Medical history included, immune thrombocytopenia from an unknown date and unknown if ongoing (verbatim: Idiopathic thombocytopenia purpura), prostatomegaly from an unknown date and unknown if ongoing (verbatim: enlarged prostate). Concomitant medication (received within 2 weeks of vaccination) included finasteride 5 MG, and plantago ovata (METAMUCIL [PLANTAGO OVATA]) all wares taken for an unspecified indication, start and stop date were not reported. The patient previously took tetracycline and experienced drug hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient did not test for COVID-19 since the vaccination. The patient experienced continual reduction in platelets on 01Apr2021. As a result of event patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care . Patient received Prednisone 60 MG as treatment for event. The patient underwent lab tests and procedures which included platelet count: decreased on 01Apr2021 Continual reduction in platelets. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
16 year old received the Moderna first dose vaccine; A spontaneous report was received from a healthcare professional, concerning a 16-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, 16-year-old received first Moderna's first dose vaccine.  The patient's medical history was not provided. Concomitant medications were not reported.  On 04-Jan-2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  The reporter stated, 16 years son received the Moderna first dose vaccine by mistake at a Vaccine center he would like to know if the patient should receive the second dose and if interested in including him in clinical trial.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event 16-year-old received first dose vaccine was considered resolved on 04-Jan-2021.  The reporter did not provide a causality assessment of the event.; Reporter's Comments: This case concerns a 16-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
On 04/01/2002 DTap and MMR given on right arm. In the evening 25 cent coin size area red and warm. On Tues afternoon, redness, swelling increased. Wed, appt for physical. right arm red, swollem warm to touch from elbow to shoulder. The occupational health placed the pt on erythemomycin.
had to stop working; vaccine affected her kidneys, her lungs and the lining of her heart; vaccine affected her kidneys, her lungs and the lining of her heart; vaccine affected her kidneys, her lungs and the lining of her heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient in her 30's received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "had to stop working"; RENAL DISORDER (non-serious), LUNG DISORDER (non-serious), CARDIAC DISORDER (non-serious), outcome "unknown" and all described as "vaccine affected her kidneys, her lungs and the lining of her heart".  Additional information: Caller stated he had a friend in her 30s and had to stop working with the police because the vaccine affected her kidneys, her lungs and the lining of her heart. Caller stated she was fine before the vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe weakness and fatigue; Severe weakness and fatigue; nausea and burning stomache; nausea and burning stomache; Migraine; excessive thirst and urination; excessive thirst and urination; chills and hot flashes; chills and hot flashes; This is a spontaneous report from a contactable consumer, the patient. A 61-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 left arm on 10Apr2021 at 13:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included degenerative disc disease, reactive airways disease (RAD) and hashimoto's. The patient previously took venlafaxine hydrochloride (EFFEXOR), nortriptyline (MANUFACTURER UNKNOWN) and metaxalone (MANUFACTURER UNKNOWN) and experienced drug allergy. Concomitant medications taken within two weeks of vaccination included naproxen (MANUFACTURER UNKNOWN), diazepam (MANUFACTURER UNKNOWN), oxycodone (MANUFACTURER UNKNOWN), galcanezumab gnlm (EMGALITY) and rizatriptan (MANUFACTURER UNKNOWN) all from unknown date for unknown indication. The patient previously took 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 25Mar2021 at 14:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. 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. On 12Apr2021 at 03:00, the patient experienced severe weakness and fatigue, nausea and burning stomache, migraine, excessive thirst and urination, chills and hot flashes. 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. The clinical outcome of the events severe weakness and fatigue, nausea and burning stomache, migraine, excessive thirst and urination, chills and hot flashes was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Case number PHEH2015US023868, is an initial spontaneous report from a pharmacy technician received on 12 Nov 2015. This report refers to a 28 years old female patient. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUVIRIN (batch number: 1515301) intradermal on 11 Nov 2015. No adverse event was reported.
c/o feeling lightheaded immediately  after 2nd dose of moderna vaccine. ? BP 191/101 pulse 95, repeat bp ?203/93 HR 143. Pt denies chest pain, sob. Pt taken to ER via wheelchair.
1) Myalgic Encephamyolitis,  2) Reactivated Lyme Disease, 3) Furry Tongue Disease, 4) Bartonella Blood Infection  5) Melanoma skin cancer  6) Muscle Twitching and Electric Shocks 7) Auto Immune Disease 8) Gut Dysbiosis
I was driving my car about ten days after the vaccine and my heart started racing. I started getting light headed as well and nauseous. I had to pull over and rest until my heart racing and light headiness passed. I had the same type of episode three or four times since then, but milder than the first episode. They're not frequent or severe, but I am still experiencing them. Probably about once a week or every two weeks.
Dizziness, Headache, NauseaVomiting, throat felt a little tight Narrative:
Patient was given her 2nd Moderna vaccine 8 days before the recommended time between the 1st and 2nd dose.
an hour or so after shot, vomiting, diarrha, then a pain in the back of my head like someone shot me, this headache has been off and on for a week and two days now, swelling in my arms and legs , chest pain, dizziness, blurred vision, disorinated, pain in my arms going from my elbows downward, numbness in the side of my face.My lips numb at times.  Pt had bad headaches for 3 weeks after the shot. Pt still have blurred vision though.
Information has been received from a health professional concerning a 37 year old female who was vaccinated with MMRII when she was a child (no records available). On 13 Jul 2006, a titer for rubella was intermediate and was negative for mumps. The patient was considered to be not recovered from her experience. Additional information has been requested.
Redness at injection site (about 2" x 2"). A little warm to touch but no real irritation or itching. Patient had iced the area.
patient reported that she couldn't move her legs. no pain reported just frozen. her bp and pulse were normal at 120/80 and 77. her o2 was 99. blood sugar was normal at 91. reported not eating prior.
red; dizziness; Chills; nausea; fever (100.2°f highest); This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red), DIZZINESS (dizziness), CHILLS (Chills), NAUSEA (nausea) and PYREXIA (fever (100.2°f highest)) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 027A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, GLIPIZIDE, LISINOPRIL, PRAVASTATIN SODIUM (PRAVACHOL) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red), DIZZINESS (dizziness), CHILLS (Chills), NAUSEA (nausea) and PYREXIA (fever (100.2°f highest)). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (red), DIZZINESS (dizziness), CHILLS (Chills), NAUSEA (nausea) and PYREXIA (fever (100.2°f highest)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included Tylenol.   This case was linked to US-MODERNATX, INC.-MOD-2021-081685 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: TCR added - address updated, event outcome; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081685:1st dose of vaccine
Nine days after receiving the vaccine, my arm became sore, at the injection site, with also a red patch that is slightly itchy.