chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nasonegal rxn to vax; pt became pale, lips cyanotic & c/o h/a; pt rushed to Er & examined by MD:
On Saturday morning following the vaccinations (roughly 48 hours after shots) reported having blind spots Saturday and Sunday (not tunnel vision) saying she couldn't see clearly but it was not blurry, fingertips on left hand went numb for 1-2 minutes on Saturday, headache behind eyes Saturday and Sunday.   Patient stated by end of day Sunday all symptoms dissipated. patient was not vaccinated as a child so only recently in the last few years has she started receiving vaccines and this was the first time receiving either of these vaccines. she is in nursing school and getting them for college. did say she started birth control pills for the first time roughly 3 months ago.
Ongoing Heart palpitations confirmed by Zio patch (PACs, PVCs, nonsustained ventricular tachycardia, SVT)
Nausea within 4-5 hours, vomiting within 10 hours and continues now after about 22 hours. High fever (102-103)
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). Concomitant products included Atorvastatin, desloratadine, Metformin ER, Venlafaxine, glipizide and Insulin LANTUS. On 11th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 11th April 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 12th April 2018, the patient experienced cold sweat, headache, tiredness, inability to work, stiff joint, joint pain and sleep excessive. On an unknown date, the patient experienced feeling unwell. On an unknown date, the outcome of the injection site pain, tiredness and stiff joint were not recovered/not resolved and the outcome of the cold sweat and headache were recovered/resolved and the outcome of the inability to work, joint pain, sleep excessive and feeling unwell were unknown. The reporter considered the injection site pain, cold sweat, headache, tiredness, inability to work and stiff joint to be related to SHINGRIX. It was unknown if the reporter considered the joint pain, sleep excessive and feeling unwell to be related to SHINGRIX. Additional details were provided as follows; At 5:00, the patient received a dose of SHINGRIX in right deltoid. On 12th April 2018, 1 day after receiving SHINGRIX, the patient had soreness at the injection site but the patient claims that the following day she felt like a truck hit her. She described the patient's experience as cold sweats, headache, feeling tired, and joint pain. She slept a lot and missed work the next day. She was fine eating. On 17th April 2018, the patient left a message that she was still not feeling 100 percent and she still had pain at the injection site and joint stiffness.
Woke up early on 1/30 with chills, body aches, joint pain, headache. Had pain from shoulder to elbow of arm that had the injection. All symptoms mildly improved with Tylenol. Symptoms significantly improved after 24 hours.
A report has been received from a Health Professional concerning a 2 year old, male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The reporter stated that the patient had drug in only one nostril was administered which started on 02-oct-2013. The outcome of the event of only one nostril was administered is unknown. The report was considered to be non-serious.
"Developed a bump on my lip; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING ("Developed a bump on my lip) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for Diabetes.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced LIP SWELLING ("Developed a bump on my lip). At the time of the report, LIP SWELLING ("Developed a bump on my lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include High blood pressure medication and Cholesterol medication. Patient treatment information was not provided.
Positional dizziness. This is a new symptom, since the 2nd Pfizer vaccine. I have Meneiere?s disease but did not have this symptom before. It is nearly constant, and has been for months.
vaccine leakage (not administered a full dose); vaccine leakage (not administered a full dose)\syringe was not tightened and there was a leak. Pharmacist is not sure that the patient received the full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (vaccine leakage (not administered a full dose)) and UNDERDOSE (vaccine leakage (not administered a full dose)\syringe was not tightened and there was a leak. Pharmacist is not sure that the patient received the full dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002DA1C) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced DEVICE CONNECTION ISSUE (vaccine leakage (not administered a full dose)) and UNDERDOSE (vaccine leakage (not administered a full dose)\syringe was not tightened and there was a leak. Pharmacist is not sure that the patient received the full dose). On 10-Jun-2021, DEVICE CONNECTION ISSUE (vaccine leakage (not administered a full dose)) and UNDERDOSE (vaccine leakage (not administered a full dose)\syringe was not tightened and there was a leak. Pharmacist is not sure that the patient received the full dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment information not provided. The first dose of the Moderna Covid-19 vaccine to a patient on 10Jun2021 but that the syringe was not tightened and there was a leak.  Pharmacist is not sure that the patient received the full dose and asks for guidance in management
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Chills-Severe, Systemic: Fever-Severe
pt recvd vax; w/in 1 hr devel severe migraine HA; violent n & v;
Red bruise painful to touch bigger than plum with a white halo around that increased in size by Sunday Nov. 6 pain was moving up towards my shoulder the bruise started to itch as it got bigger.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 25-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R027157, expiry date 14-JUL-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000898: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000903:
This spontaneous report was received from a medical assistant referring to a patient of an unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 30-MAR-2015, the patient was vaccinated with a dose of ROTATEQ (lot # K011663) (expiration date and dose were not provided). There was a 72 hours excursion for his vaccine. No adverse events have been reported. This is one of several reports from the same reporter. Additional information has been requested.
Blurred vision, sensitivity to light and trouble focusing sight. It began a few weeks. After first dose. I have no prior vision issues.
About 5-10 minutes after vaccine, pt started saying they didn't feel right and was dizzy, heart was racing a bit, feeling anxious, sweating. 911 called and Manager on duty notified. Gave patient 4 tsp of liquid benadryl. EMS came and examined the patient. Pt signed refusal form to go to hospital and stated he thought it could have been anxiety bc he was feeling better
Neck/L lower neck swollen painful lymph node. Resolved with ice/NSAIDs.
pt recv vax & devel excruciating pain in the arm of the inj;PE was negative;pt was treated w/pred, advil & local application of ice;pt was much improved 2 days later;
Aches and pains in joints that kept me awake the Friday night that I got the vaccine. Intense fatigue, intense headache, and continued joint pain despite taking aspirin that was so bad, I had to be pushed in a wheelchair from my plane Sat morning after a 2hour flight from plane to curbside because I could not walk and pull hand luggage.  I took another aspirin and slept 2 hour ride to Dinner only to sleep for 26 more hours with feverish chills, sweats, headache, joint pain and weakness.  I slowly revived after that.  I would NOT recommend this vaccine for anyone under 70.  I thought I was being pro-active for my well-being but after reading the rate of Shingles in my 60s I can only think this is yet another Pharmaceutical marketing push to make money.  I am disappointed the CDC supports the push. It is not for the benefit of the average 60 year old.  and the effects MAY last more than 5 years???? I should have read more on it before getting the vaccine but I had never had side effects to any before, and saw that the CDC supported it,  so never imagined this. I hope they make something better when I am in my 70s. I will never take this again and am counseling all I know and like not to either. Please pull out your support or at least temper it for people in 60s and maybe healthy people in 70s.  it's awful. Try it yourself if you don't believe me!
Patient did not speak English, could not fill out their questionnaire.  Came to pharmacy looking for 2nd dose of the covid vaccine, did not state that he was looking for Moderna and was given 1st dose Pfizer instead of 2nd dose Moderna.
a little bit of coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (a little bit of coughing) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (a little bit of coughing). At the time of the report, COUGH (a little bit of coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
Upper extremity swelling; Neck swelling; Headache; General fatigue; Malaise; Menstrual irregularity including long menstruation (15 days); Menstrual irregularity including long menstruation (15 days); Hot flashes; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration on 23Jun2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included scoliosis, premenstrual syndrome (PMS) and allergy to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included fluoxetine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 23Jun2021 at 22:00, the patient experienced upper extremity swelling, neck swelling, headache, general fatigue and malaise. The patient also reported menstrual irregularity including long menstruation (15 days) and hot flashes. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 24Jul2021, the patient underwent polymerase chain reaction (PCR) test via nasal swab and the result was negative. The clinical outcome of the events upper extremity swelling, neck swelling, headache, general fatigue, malaise, menstrual irregularity including long menstruation (15 days) and hot flashes was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Really bad headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Really bad headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Really bad headaches). The patient was treated with CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) for Headache, at an unspecified dose and frequency and METRONIDAZOLE (FLAGYL [METRONIDAZOLE]) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Really bad headaches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Updated event outcome to recovered for event headache.
9 days after, swollen armpit with lump.; Significant pain in armpit area; Significant pain in armpit area and arm; Fatigue; 9 days after, swollen armpit with lump.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Apr2021 at 10:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 28Apr2021 at 00:15, 9 days after, the patient experienced swollen armpit with lump, significant pain in armpit area and arm and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of reported events. The clinical outcome of the events swollen armpit with lump, significant pain in armpit area and arm and fatigue was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Breakthrough case admission after three vaccines Pfizer 3/31/21 Lot# Er8732;  Pfizer 5/4/21 Lot# EW0179;  Pfizer 11/18/21 Lot# FH8028
Information has been received from a physician concerning a 62 year old female who on 29-MAY-2007 was vaccinated with a dose of Zostavax. Since approximately 29-MAY-2007, the patient has been experiencing mild unilateral pain across the abdomen "for about one month." The patient's pain is a 1 to 2 on a scale of 1 to 10. At the time of the report, the patient rated his pain to be about a 3 on a scale of 1 to 10. He had one or two lesions on the abdomen. Unspecified medical attention was sought and he was being treated with an unspecified anti-viral medication. At the time of the report, the patient was not recovered. A product quality complaint was not involved. Additional information has been requested.
w/in 2 minutes of receiving vax pt passed out; no sx anaphylaxis; woke up immediately & had regular rapid pulse, BP nl; sent to MD who felt was unrelated to immun;
Pt received COVID Vaccine at 1055, 1120 pt began coughing severely and could not stop, unable to speak. 1120 25mg Benadryl liquid given, Pepcid 20 mg  given PO, cough worsening.  1122 second dose of Benadryl given, called for MD.  Brought pt to Private room via wheelchair.  Upon arrival, audible stridor noted. Epinephrine 0.3 mg IM given at 1126.  IV started, placed patient on monitor and O2 via 1L NC. MD at bedside along with RT and pharmacy.  1134 Solumedrol 125 mg IV given, 1 puff of Ventolin given.  Lungs clear. 1140 Coughing stopped, pt able to speak now.  Vital signs: 1130 SPO2 99% Pulse 142 1135 99% pulse 106 BP 168/102 1140 sats 100% HR 93 BP 157/105  1145 sats 100% HR 97 BP 159/93 1200 sats 99% HR 103 155/97 114
100% OCCLUSION OF THE LAD, PARTIAL OCCLUSION OF THE RIGHT DESCENDING CORONARY ARTERY, 48 DAYS POST VACCINE; INSERTION OF SYNERGY XD EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM X3.   CARDIAC EVENT OCCURED 06/10/2021 - 06/17/2021
massive nausea; headache; low grade fever; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Jan2021 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; WELLBUTRIN. Past drug history included: Reglan, reaction(s): "Allergies". Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Previous dose lot unknown: True,, Previous dose Lot unknown reason: Unable to locate or read the details,, Prev dose number=1, Prev dose vaccine location: Left Arm,), for COVID-19 Immunization, reaction(s): "massive nausea"; Bnt162b2 (Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Previous dose lot unknown: True,, Previous dose Lot unknown reason: Unable to locate or read the details,, Prev dose number=1, Prev dose vaccine location: Left Arm,), for COVID-19 Immunization, reaction(s): "headache".  The following information was reported: NAUSEA (non-serious), outcome "not recovered", described as "massive nausea"; HEADACHE (non-serious), outcome "not recovered", described as "headache"; PYREXIA (non-serious), outcome "not recovered", described as "low grade fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, headache, pyrexia.  Additional information: Vaccine was administered at hospital. First dose, massive nausea and headache, second dose same, with low grade fever, third dose same, with nausea, vomiting and diarrhea. Have had daily headaches since first dose. AE did not result in emergency room or physician office visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a pharmacist referring to an unspecified amount of patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on unspecified dates, the patients were administered improperly stored doses of PROQUAD (Merck) injection (lot# L024124 with expiration date 30-DEC-2016; dose, frequency and route were not provided); that was stored at 39F for an unspecified amount of time. No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. Additional information has been requested.
Swelling and firmness of the left bicep and upper arm. Extreme pain, accompanied 101 degree Fever. Bad headache.
Patient received Pfizer Covid-19 >12yo  dose instead of (PEDS) pediatric (5-11yo) dose.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), 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 and concomitant medications were not reported. The patient did not have any known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 05Dec2022 to an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported COVID-19 after BNT162B2 immunization is considered drug ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Lightheadedness, nausea & weakness 3 hours after the 2nd vaccination which became worse over the next 3 days & on the 4th day, she complained of a rapid heart rate. A pulse check revealed an irregular pulse in the 70s-80s. She was encouraged to go to hospital. The next day, she made appt with her PCP & was diagnosed with atrial fibrillation & sent immediately to ER at nearby hospital. EKG showed AFib which, after 3 hours, looked like a flutter with NSR. By bedtime, she was normal sinus rhythm - spontaneously w/o intervention. She was discharged the next day. No aberrant rhythms since.