chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT STARTED EXPERIENCING RASH IN HER BACK 7 DAYS AFTER HER INJECTION. ADVISE TO TAKE BENADRY AND IF RASH STILL THERE AFTER TAKING BENADRYL FOLLOW UP WITH DOCTOR. I TOLD HER TO SIGN WITH V-SAFE PROGRAMM AS WELL TO REPORT SIDE EFFECT.
Received Pfizer vaccine (1st dose) 9/30/21 about 7:40am. Experienced LUQ pain before bowel movement. Normal stool with bright red blood and small blood clots when wiping. Used the bathroom after that (urinate) wiped and still saw bright red blood.
After receiving Pfizer COVID-19 vaccine patient fell on the floor and 911 was contacted. The patient was conscious and sat on the chair until paramedics arrive. Patient experience dizziness but no other symptoms- patient did not eat anything all day prior to receiving the dose. Patient felt better and did not need paramedics to take her to hospital. she waited in waiting area for about 25 minutes until her husband came to pick her up.
Patient experienced swelling and moderate to severe pain at injection site couple days after the vaccination (11/14/17). Right arm was getting more swollen, red and tender. Patient went to see PCP and  was told to have phlebitis and infection. Patient was given Keflex 250mg four times daily for 7 days. As of today (11/25//17), arm is still a little swollen and red, but seems to get better with cold compress.
11/09/21: around 7:30 p.m is when symptoms started with flush/burning sensation in chest followed by pain and tightness this pain would come and go off and on several times for the next few hours. However at around 8:30 the pain did begin to move to my upper back area as well. I went to sleep at around 10:30 pm and was awaken at 1:00 a.m on 11/10/2021 with arm pain where injection was given and chest pain and tightness. Took ibuprofen at around 1:30 a.m to try and help with the pain, however it only helped with the arm pain from the injection. Chest pain and back pain became constant on 11/10/2021 as the morning went on so I sent my PCP an email requesting a visit to go over symptoms as these were the only symptoms I had and I was fine the day before and I have never had chest pain related issues prior to COVID vaccine. Went to see my PCP at 11:00 am on 11/10/2021 for chest pain, tightness, burning sensation and upper back pain.
COVID-19; COVID-19; still cough and congestion; still cough and congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL9264), in left arm, on 23Feb2021 as dose 2, single (Lot number: EN6203), in left arm and on 15Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: CARVEDILOL; ESTRADIOL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PROGESTERONE; HYDROCHLOROTHIAZIDE; VITAMIN D [VITAMIN D NOS]; VITAMIN B COMPLEX; VITAMIN C [ASCORBIC ACID]; FISH OIL; ALBUTEROL [SALBUTAMOL]. Past drug history included: Codeine, reaction(s): "Known allergies"; Ibuprofen, reaction(s): "Known allergies"; Naproxen, reaction(s): "Known allergies"; Quinolone antibiotics, reaction(s): "Known allergies". The following information was reported: COUGH (medically significant), NASAL CONGESTION (non-serious) all with onset 20Apr2022, outcome "not recovered" and all described as "still cough and congestion"; VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" (27Apr2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Apr2022) Negative; (21Apr2022) Positive; (27Apr2022) Negative. Therapeutic measures were taken as a result of covid-19, cough, nasal congestion.  Clinical course: Finished course 16Apr2022; well by 17Apr2022; tested negative 18Apr2022; all symptoms returned 20Apr2022; tested positive 21Apr2022; sick until 26Apr2022 then felt better (still cough and congestion but no fever); tested negative again 27Apr2022. Events were treated with Albuterol in nebulizer from 12Apr2022 to 16Apr2022 for treatment of COVID-19. Additional Information: No fever was reported.  No follow-up attempts are possible. No further information is expected.
"Woke up to body aches"; chills; "my whole body was sweating bullets"; "I threw up water and stomach acid"; "I got really cold"; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 10Apr2021 at 07:15 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression, obsessive-compulsive disorder, agoraphobia and mood disorder. Concomitant medications included 8-tetrahydrocannabinol (MANUFACTURER UNKNOWN); taken for unknown indication on an unknown date. The patient previously took Geodon, Gabapentin, Remeron and Oxcarbazepine and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 20Mar2021 at 07:00 (at the age of 25-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 11Apr2021 at 13:00, the patient slept 12 hours, that was normal. Woke up to body aches, chills, her whole body was sweating bullets and she threw up water and stomach acid, then she got really cold. The patient did not receive any treatment for the events. The clinical outcome of the events "woke up to body aches", chills, "whole body was sweating bullets", "threw up water and stomach acid" and "got really cold" was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt recvd 3 doses of Engerix-B 30OCT90, 4DEC90 & 10MAY91 & 16SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
No additional AEs; temperature excursion; Inappropriate age at vaccine administration; This spontaneous report was received from a registered nurse and refers to an 8-year-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 05-DEC-2022, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) subcutaneous injection, lot #U039549, expiration date: 14-DEC-2023, administered subcutaneously for prophylaxis (dose and strength were not provided); and influenza vaccine live reassort 3v (FLUMIST), lot #PH3533B, expiration date: 09-JAN-2023, administered nasally (dose, strength, formulation, and indication were not provided) (product storage error; product administered to patient of inappropriate age).  On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. There was no adverse event reported.  The reporter considered temperature excursion to be not related to suspect vaccines.; Sender's Comments:  US-009507513-2212USA003061: US-009507513-2212USA007838: US-009507513-2212USA007829: US-009507513-2212USA007830: US-009507513-2212USA007831: US-009507513-2212USA007832: US-009507513-2212USA007833: US-009507513-2212USA007834: US-009507513-2212USA007835: US-009507513-2212USA007836: US-009507513-2212USA007837:
Immediate pain with shot that I received in the airport.  Within an hour my arm was losing strength and I could no longer lift my bags.  Now, 2 weeks later, arm still sore and muscle soreness spreading to neck, shoulder, calves, and thighs.  Tiredness.
Information has been received from the Pregnancy Registry through a physician concerning a 16 year old female with menstruation irregular and dysmenorrhoea who on 09-AUG-2007 was vaccinated with the first dose of Gardasil and on 09-Nov-2007 the patient received the second dose. It was reported that the patient now is pregnant. Concomitant therapy included vitamins (unspecified). Follow up information has been received from the physician indicating that in December 2007, the patient experienced urinary tract infection treated with 100 mg oral dose of MACRODANTIN for 21-DEC-2007 to 31-DEC-2007. On 16-JAN-2008 the patient's pap smear revealed LGSIL. On 19-FEB-2008 the patient experienced uterine irritability treated with 0.25 mg SQ dose of TERBUTALIN on 19-FEB-2008. The patient had an ultrasound on 9-JAN-2008 and 7-FEB-2008 because of abdominal pain. Unknown medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 3/14/2008; 7/8/2008; 10/8/2008.  Initial and follow-up information has been received from a physician and a registered nurse for the Pregnancy Registry for HPV concerning a 16 year old black female patient with menstruation irregular and dysmenorrhoea and a history of BV (bacterial vaginosis) April 2007, and vasomotor syncope, who on 09-Nov-2007 the patient received the second dose.  It was reported that the patient now is pregnant.  The patient was placed on vitamins (unspecified) from December 2007 to January 2008.  Her LMP was 01-SEP-2007 with an estimated delivery date of 24-JUN-2008.  In the follow-up information the physician indicating that the patient had microcytic anemia of pregnancy (date unspecified).  In December 2007, the patient experienced urinary tract infection treated with 100 mg oral dose of MACRODANTIN from 21-DEC-2007 to 31-DEC-2007.  On 16-JAN-2008 the patient's pap smear revealed low grade squamous intraepithelial lesion (LGSIL), and in February 2008 also showed LGSIL, "HPV effect"/cervical intraepithelial neoplasia (CIN-I) was also noted.  On 19-FEB-2008 the patient experienced uterine irritability treated with 0.15 mg SQ dose of TERBUTALIN.  The patient had an ultrasound on 9-JAN-2008 and 7-FEB-2008 because of abdominal pain.  On 13-JUN-2008 the patient was treated with MACRODANTIN for urinary tract infection.  Unknown medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was involved.  In the follow-up information the nurse reported that the patient delivered a full-term male baby, who was healthy and normal, and where no complication for either the mother or the baby.  Both were doing well.  Additional information is not expected.
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) had resolved. Not Provided          Concomitant medications were not reported  Treatment details were not provided.
24 hours later unable to walk, left knee and ankle swelling needed a wheelchair. Since then having severe swelling and brusing ability to walk has improved but the more she uses it the more sore it gets.
At the site of injection, left deltoid, patient noted itching, area is red, warm to touch and the area of redness is 60mmx40mm and is firm to the touch.
15NOV p/vax devel flu like sxs achiness, fever;16NOV numbness in legs 17NOV no feeling in legs;adm to hosp;18NOV no feeling in hands or fingers;unable to walk;dx GBS;30NOV still in hosp, sl feeling in toes, still unable to walk;tired & weak
ITCHING/RED/RASH AND INFLAMMATION AT THE INJECTION SITE AND ABOUT 10 CM DOWNWARD. STARTED ABOUT A WEEK AFTER THE FIRST DOSE AND LASTED ABOUT 3 DAYS  TREATED WITH BENADRYL
Customer became diaphoretic, pale, shaky, trembling,  and shortness of breath.  Blood Glucose 129
I started experiencing ear pressure in both ears and tinnitus. My hearing acuity is also now suffering a bit. I have no history of hearing conditions/ailments.
Information has been received from a physician concerning a 13 weeks 6 days old male patient who on 14-FEB-2011 was vaccinated with his first dose of 2 ml ROTATEQ (lot # not reported). No adverse effect reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
I was having a headache starting on Christmas and it lasted until Tuesday evening. During that time frame I did end up with a fever but the highest it went was 100.6 and it responded to medication. I was also having some cold symptoms. I did a take a COVID-19 home test on Monday and that was positive. I called my doctor on Tuesday because the headache has lasted that long. By Wednesday they offered me the antiviral for my COVID-19, but I declined as I was doing better. On the same day I got my Moderna Bivalent COVID-19 vaccine I also got a flu shot but I do not have the information on that. At this point I am feeling better and only have a little postnasal drip and cold like symptoms.
headache, muscle ache, chills, neck pain 14 hours after second vaccine migraine second day after vaccine tylenol helped both days
Patient with 3 COVID vaccines who admitted with positive COVID test.  Hypoxic during stay.  Patient died on 08/01/22.  Provider d/c note:  "81 YO F with hx CAD, PAF on eliquis, TAVR, who presented with facial swelling x1 day, 1 month of increasing generalized weakness and falls, poor appetite, and 1-2 weeks of cough (diagnosed with COVID on 7/17) was found to have parotid/right tonsillar/left hilar mass in setting of symptomatic COVID with hypoxic respiratory failure. Thoracentesis performed demonstrated exudative fluid with cytology preliminary showing NSCLC. EBUS recommended; however, cancelled due to increasing oxygen requirements without overt clear etiology. Thought of latter due to post obstructive pneumonia complicated by fluid overload in setting of HFpEF.  Given suspected stage IV cancer with worsening quality of life, patient and family elected to transition to comfort measures, and patient passed at 6:41 this morning. "
Itchy shingles type rash 12 days after. Joint swelling and pain 13-14 days after. Sensitivity to light 12 days after.
This case was reported by a consumer via call center representative and described the occurrence of blindness in a 70-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced blindness (serious criteria GSK medically significant). On an unknown date, the outcome of the blindness was unknown. It was unknown if the reporter considered the blindness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's friend who wished to remain anonymous. The age at vaccination was not reported. The patient received SHINGRIX and shortly after developed complications that led to blindness. The patient's tests for stroke were negative and finally the doctor determined that the patient had a reaction to SHINGRIX. The reporter thought the event might have already been reported to GlaxoSmithKline (no duplicate case found). The reporter could not provide any other details. The patient had denied permission to contact their physician. Lab Comments: On an unknwon date, the patient's tests for stroke were negative.
Woke up at 2am (approx 14 hrs after vaccine) with bad chills/shaking/sweating, fell asleep for a few hours then woke up feverish, bad headache, major bodyaches, nauseous with throwing up throughout the day, fatigue, weakness and sore arm at injection site so I slept most of the day in general, in between sickness. 2nd day after vaccine, April 15th I woke up with still a bad headache, bodyaches, nauseous, and sore arm.  Headache subsided that night. April 16th I still was nauseous most of day and sore arm. Took extra strength tylenol a couple times on April 13th, 14th and 15th.
Chills, muscle aches, headache, sore and stiff neck with headache worsening upon change of position. This lasted for 60 hours
1/18/2010 at 4 PM-Patient was brought in by his mother. Pt has red, raised, hot to touch 2 cm bump. He has no fevers, no rash, no other symptoms.
Initial unsolicited report received from a nurse on 21-Oct-2015. This case involves a female patient (age was not reported) who was vaccinated with a dose of FLUZONE QIV (manufacturer: Sanofi Pasteur, batch number, expiry date, dose details, route and site of administration was not reported) on an unspecified date (May be two weeks before the date of reporting). The patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were unknown. On 19-Oct-2015, about two weeks after vaccination, the patient experienced rash hives, swollen tongue, shortness of breath and back pain. The patient required ER/doctor visit. When patient went to the hospital, she was diagnosed with pneumonia. It was unknown if the patient received any previous vaccination. Laboratory investigations and corrective treatment was not reported. The outcome of the events was reported as unknown. List of documents held by sender: none.
Diarrhea; Vomiting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and VOMITING (Vomiting) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea) and VOMITING (Vomiting) outcome was unknown.            No concomitant medications were reported. Treatment details were not provided.   This case was linked to MOD-2021-206890 (Patient Link).
I've always had very regular menstrual cycles. I had a regular menstrual cycle on 07/30/2021. Received my first vaccination and did not have another menstrual cycle again until 02/04/2022. Up until this point I have never missed a cycle.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 04-DEC-2014, the patient was vaccinated with an improperly store dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007288, expiration date 15-AUG-2016) dose, route and anatomical location were not provided. There was no concomitant medication provided. On an unknown date, the PNEUMOVAX had a temperature excursion for 2184 hours, the highest recorded temperature was 59.9 F (15.5 Celsius). The vaccine status was reported as "in excursion", and was storage in a Refrigerator (R). There was no product quality complaint involved and no adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Information has been received from a Registered Nurse concerning a 19 year old female patient who on unspecified dates was vaccinated with the first and second dose of GARDASIL. The nurse reported that a practice patient's daughter experienced fever, chills and abdominal pain after both the first and second dose of GARDASIL. It was reported that the mother added that the adverse symptoms were more severe after the second dose of GARDASIL. On an unspecified date, the patient recovered. The patient sought unspecified medical attention. No further information is available.
Information has been received from a physician assistant referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 22-MAR-2016 the patient was inadvertently vaccinated with an expired dose of GARDASIL (lot # J009788, expiration date 17-MAR-2016, dose and route unknown). Concomitant medication was not reported. No adverse effect was reported. Additional information has been requested.
Developed significant soreness at the injection site, then, roughly 30 hours after the injection, developed a low grade fever to 100.6 F.
From initial information received on 06/21/04 from the patient regarding an adverse event occurring in the USA, it was reported that the 57 year old female patient received a Fluzone SV '2003-'2004 vaccination, lot number U1269AA, administered intra muscularly in the left arm on 10/11/03. The patient stated that within 24 hours post vaccination, on 10/12/03, she developed muscle aches and pain in her arms, thighs and lower back. She was seen by an orthopedic physician, a chiropractor and a rheumatologist and was diagnosed with polymyalgia. Treatment included oral prednisone and cortisone injections into her left shoulder. The patient had not recovered from these events at the time of this report. From additional information received on 08/04/04 from the responsible physician, it was reported that there is no additional information at this time. It was not reported whether the patient recovered from these events.
Fully vaccianated against COVID (Moderna) plus 2 boosters (Moderna, Pfizer); COVID; COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 57-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: LISINOPRIL; LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Fully vaccianated against COVID (Moderna) plus 2 boosters (Moderna, Pfizer)". Therapeutic measures were taken as a result of drug ineffective, covid-19 which include PF-07321332, Ritonavir (Paxlovid) started on 25May2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pt was given the 1st  Pfizer Covid 19 shot and asked to sit in the lobby for 15 minutes per protocol.  After 10-15 minutes, he came to the pharmacy counter stating he felt hot and sweaty.  His eyes then rolled backwards and he collapsed on to the floor.  He was unresponsive, his head and back arched and he slightly rocked while on the ground.  I went to make sure he didn't hit his head and patient became responsive.  We tried to have pt stay on the ground, but he refused.  Therefore we moved him to a chair and elevated his legs.  911 and store medical assistance were called. After the ER services arrived and examined pt, left on his own and stated he felt fine now.