chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Massive migraine; Stuffy nose; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old, non-pregnant female 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 23Apr2021 at 15:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant past medical history. The patient had no allergies to medications, food, or other products. Concomitant medications included ethinylestradiol, etonogestrel (NUVARING); taken for an unknown indication on an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to vaccination. On 24Apr2021 at 11:00, the patient experienced massive migraine and stuffy nose with a sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of massive migraine, stuffy nose and sore arm were unknown 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.
Rash about 3" x 3" on right arm around site of injection.   Rash appeared approximately a week following injection, and has lasted for a little more than a week.
No adverse event; Moderna COVID-19 bivalent vaccine on 30-JUN-2023, but when HCP went to chart it, she realized that the vaccine had expired on 12-JUN-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 bivalent vaccine on 30-JUN-2023, but when HCP went to chart it, she realized that the vaccine had expired on 12-JUN-2023) and NO ADVERSE EVENT (No adverse event) in a 14-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose) and PFIZER BIONTECH COVID-19 VACCINE (2nd dose). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 30-Jun-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 bivalent vaccine on 30-JUN-2023, but when HCP went to chart it, she realized that the vaccine had expired on 12-JUN-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 bivalent vaccine on 30-JUN-2023, but when HCP went to chart it, she realized that the vaccine had expired on 12-JUN-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 bivalent vaccine on 30-JUN-2023, but when HCP went to chart it, she realized that the vaccine had expired on 12-JUN-2023).    No concomitant information was reported. The individual 2.5 ml vial was initially stored in the refrigerator on 29-JUN-2023 and did not underwent temperature excursions. The patient had not reported any adverse reactions to this dose. No treatment information was provided.
headache,body ache,chills.  PT reports HA, bodyaches, chills and nausea x 0300 received JJ vaccine yesterday. has not taken tylenol or motrin.
30 min after shot (my period which was almost over) became heavy and I bled for 39 days. I had lightheaded ness for about an hour after the shot, and now that the bleeding stopped I have chest and pelvic pains. Still in the works of going to obgyn to figure out more. Never had period issues prior to shot
large swollen whelp at vaccination site; Extreme exhaustion; Fever; Body aches; Headache; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) via an unspecified route of administration on 26Mar2021 at 16:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included ankylosing spondylitis, gastrooesophageal reflux disease (GERD), anxiety, depression and chronic diverticulitis. The patient received unspecified medication within 2 weeks of vaccination. It was reported that patient had allergies to medications, food or other products which are unspecified. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6202) via an unspecified route of administration in the right arm on 05Mar2021 at 16:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On 27Mar2021 at 04:00, the patient had extreme exhaustion within 12 hours of vaccination. The patient also had fever, body aches, headache within 24 hours. On 29Mar2021, more than 72 hours after vaccination the patient had large swollen whelp at vaccination site. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event headache was recovered on 29Mar2021.The clinical outcomes of the events extreme exhaustion, fever, body aches and large swollen whelp at vaccination site were not recovered.  No follow-up attempts are needed. No further information is expected.
Visible redness on left arm from approximately shoulder to elbow. Patient also mentioned some redness around the breast area and mild fever which had gone down. She was told to take some benadryl for the reaction and to monitor for a few days. If no resolution in a few days, she is to follow up with her primary health care provider. Patient said she did not want to take benadryl as she does not want to be drowsy, She will monitor the reaction and follow up if necessary.
LEFT SIDE STOMACH PAIN/ACHE; SWALLOWING FEELS STRANGE; CHILLS/SHIVERING; SORE LEFT SHOULDER AREA; HEADACHE; NAUSEA; FEVER; DIFFICULTY SLEEPING; THROAT SORE; SORE ARMPIT; SORE LEFT ARM; LEFT SORE NECK; THROAT SWOLLEN; SWEATING; This spontaneous report received from a patient concerned a 65 year old male. The patient's weight was 175 pounds, and height was 68 inches. The patient's concurrent conditions included Crohn's disease, nerve damage, brachial plexus injuries, muscular atrophy, penicillin allergy, recreational marijuana occasionally, non-alcoholic, non-smoker, disabled veteran, and sulfates allergy. The patient experienced drug allergy when treated with methotrexate, and methocarbamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: not reported) dose was not reported, administered on 06-APR-2021 12:40 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced left sore neck. On 06-APR-2021, the subject experienced throat swollen. On 06-APR-2021, the subject experienced sweating. On 06-APR-2021, the subject experienced difficulty sleeping. On 06-APR-2021, the subject experienced throat sore. On 06-APR-2021, the subject experienced sore armpit. On 06-APR-2021, the subject experienced sore left arm. On 06-APR-2021, the subject experienced sore left shoulder area. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced fever. Treatment medications included: paracetamol. On 06-APR-2021 21:00, the subject experienced chills/shivering. On 07-APR-2021, the subject experienced left side stomach pain/ache. On 07-APR-2021, the subject experienced swallowing feels strange. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating on 07-APR-2021, and difficulty sleeping, and nausea, was recovering from left sore neck, throat swollen, headache, and throat sore, had not recovered from left side stomach pain/ache, swallowing feels strange, and chills/shivering, and the outcome of sore left arm, sore armpit, fever and sore left shoulder area was not reported. This report was non-serious.
Moderna vial does not have an expiration date on the vial.  Nursing scans vial auto fills.In lot # field click on magnifying glass for drop down of lot numbers.  Normally when lot number is chosen expiration date auto fills. The lot number of this vaccine was not found. So lot number was manually entered and beyond use date (Beyond Use Date) that was written by pharmacy on packaging was entered in as expiration date because patient was waiting. Vaccine was administered and message sent for a lot # to be entered into Epic system. Recieved reply back that this lot was expired on 3/25/22. Imm. coordinator and NM notified and Moderna contacted for advice.
felt sleepy; soreness; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (felt sleepy), PAIN (soreness) and VACCINATION SITE PAIN (pain at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (felt sleepy), PAIN (soreness) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, SOMNOLENCE (felt sleepy), PAIN (soreness) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Tylenol. No concomitant medications were provided by reporter.
One day I was in a store while on vacation. When I looked down in my wallet, to pay for my stuff, I felt dizzy, and I couldn't focus. The room wasn't spinning, but I was super dizzy. I just held onto the counter. I could hear people talking. Then I was on the ground. I leaned down and kept going. I never passed out though. After that incident I was ok after about 10 minutes. The rest of the day I was fine, but in the middle of the night I had woke up and fell out of bed. I couldn't stand or walk. The room was spinning. I had to crawl to the bathroom. Everything was just spinning. I was vomiting. Every time I moved from one room to another or walking to the car I threw up with movement. I called my insurance, and then I went to the Medical Center. On April 14, 2022 that morning the doctors gave me some Meclizine for dizziness and Zofran for nausea. They told me that I have vertigo and gave me some exercises to do. I was not able to walk on my own for a few days. The vomiting stopped after 2 days because of the medicine I was on. Every time I lay my head down on the left side the whole room would spin. Today I am finally felling better. I don't feel like the room is spinning anymore. It went on for about 2 weeks.
On 9/30/96, the pt received a 2nd dose of varicella virus vaccine live and on 3/16/99, the pt developed chickenpox that consisted of approximately 10 papular vesicular lesions located on her left arm.
Vaccine failure. Discharge Summary received on 1/25/2005 states pt experienced fever, chills, headache, cough, SOB, loss of consciousness, hypotension, increased BUN, and increased creatinine.
This spontaneous report as received from a nurse refers to an unknown number of patients of an unknown age and gender. Medical history was not reported. On an unknown date about 68 doses of PROQUAD (Merck) 0.5 ml, subcutaneous (dosage, lot# and expiration date were not reported), were administered to unspecified patients since PROQUAD underwent a temperature excursion. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sore throat  Loss of taste  Congestion of nasal sinus  COVID-19 virus infection
Patient reports sore arm on 01/05/23 that she cannot raise above her head about 6 weeks afer vaccincation. She also reports hot to the touch, redness and itchiness and ocassional fevers.
Pt came to office 08/16/2005 with purple rash, Dx with varicella post Vaccine.
Patient reports to vaccination site for second vaccination today. Patient told vaccinator that she had complications post first vaccination. Patient stated that her blood sugar had dropped after the last vaccination and she had to receive an IV and dextrose, then patient signed off. Patient today felt faint, pain in her arms and legs. Patient also complains of weakness and a head ache. Patient was monitored and blood glucose taken. Vitals WNL and BG was 113. Patient had an unresponsive episode that lasted 3-4 minutes, witnessed by EMS. Patient was refusing further care and assistance. Patient was assisted off the cot and into chair. Patient once family got here was to weak to stand. Patient agreed to transport.  Patient moved to stretcher. Patient loaded into ambulance and care was transfered to transporting. Ambulance staff administer Dextrose via IV. Patient became more alert and acting appropriately. Patient signed off.
pt rcvd vax; pt devel local reaction, fever, malaise, wheezing & dyspnea;
Swelling of lips & eyes.  Skin rash localized to trunk/proximal extremities and face. Dx Acute Allergic Dermatitis. Patient took Benadryl 50MG 0700.  ED treatment with Epinephrine 1:10,000 0.3 SQ X1, Famotidine Inj Pepcid 20MG IV once, Methyprednisolone Inj Solu-Medrol 125 MG IV once. 12/7/2009 ED records for 11/21/2009, patient with c/o's rash on trunk and face, swelling of lips and eyes, Tx: IV solu-Medrol, Pepcid and epinephrine. sx resolved. DC Dx allergic reaction Wrong dose is lsted. Incorrectly listed as 6 dose. Correct dose should be 1 dose. Patient takes 2 types of medicine. Fosama and Nexium.
Patient given bivalent dose of Moderna over 8 weeks of receiving Moderna bivalent booster.
immediate after the injection I had tightness in my chest and wheezing relieved by Albuterol , normal pain up until day 6. In a matter of 3 hours I went to the ER because the swelling, pain and itching was  severe. Pain radiated to my shoulder and below my scaplua.  ER thought I may have a cellulitis stated on Keflex.  On day 8 went back to Walk in because the pain was still there but itching was severe. Started on Prednisone, Vistaril, and Risaquad.   I continue to have pain in my arm, shoulder and back and some itching .  the rash area is discolored brownish and very dry.
About 24 hours after the vaccine, I started experiencing severe sciatic pain from the back of my left leg and below my knees this lasted for about 4 months. I visited Urgent Care and was prescribed steroids for swelling. I also went to chiropractor which relieved the pain to a tolerable level. It has taken me roughly four months to walk without pain.
Pain in left side behind the scapula. Tylenol for discomfort lasted 2 days
Arm became numb and fingernails became cyanotic (bluish in color) for 18 hours. Used heating pad.
COVID arm; itchy; very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID arm), PRURITUS (itchy) and MYALGIA (very sore) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced VACCINATION COMPLICATION (COVID arm), PRURITUS (itchy) and MYALGIA (very sore). At the time of the report, VACCINATION COMPLICATION (COVID arm), PRURITUS (itchy) and MYALGIA (very sore) 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 product use was not provided by the reporter.   Treatment information was not provided.  Reported that events lasted about 9 days.
Peeling of the skin of both hands; This case was reported by a physician via sales rep and described the occurrence of skin peeling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of skin exfoliation (1st dose received on an unknown date, refer case US2022AMR078930).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced skin peeling. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the skin peeling was unknown.   It was unknown if the reporter considered the skin peeling to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR078930   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: The patient received dose of Shingrix vaccine and experienced peeling of the skin in both hands. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR078930:Same reporter.
PATIENT WAS IN CLINIC AND RECEIVED BEXERO AT 8:35, SHOWED NO REACTIONS. PATIENT WENT TO SCHOOL AND WHILE IN CLASS AROUND 11:17 AM TOLD HIS FRIENDS HE DID NOT FEEL WELL. WAS SHORTNESS OF BREATH, WEAK, CHILLS AND SHAKES. CALLED MOTHER AND MOTHER REACHED OUT TO ME VIA CELL PHONE. ADVISED MOTHER TO TAKE PATIENT TO THE ER. PATIENT ARRIVED AT ER 11:41 AM. PATIENT WAS TREATED WITH BENADRYL AND FAMOTIDINE AND RELEASED IN STABLE CONDITION. MOTHER CONTACTED 3/16/2022 AND ADVISED ME THAT PATIENT WAS STILL FEELING WEAK, JITTERY AND SHAKING.
The child's right thigh is swollen and red and warm to touch. The area is the size of a lemon.
Altered sense of smell; Distinctly foul taste in mouth. Altered taste (aversion) to specific foods. Example: eggs, peanut butter , pretzels, beef; Excessively dry mouth.; Altered taste (aversion) to specific foods. Example: eggs, peanut butter, pretzels, beef; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 42-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 right arm on 12Mar2021 at 12:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, anxiety and COVID-19. The patient had no known allergies to medications, food, or other products. The patient received concomitant medication (unspecified) within two weeks of vaccination on unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Feb2021 at 12:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was 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. On13Mar2021 at 12:00 the patient experienced altered sense of smell. She also experienced a distinctly foul taste in mouth. The patient had excessively dry mouth. She experienced altered taste (aversion) to specific foods. Example: eggs, peanut butter , pretzels, beef. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events altered sense of smell; a distinctly foul taste in mouth; excessively dry mouth; altered taste (aversion) to specific foods, example: eggs, peanut butter , pretzels, beef was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
patient received only the liquid DTAP-IPV portion, no AE; Initial information received on 01-Dec-2021 regarding an unsolicited valid non-serious case from a other healthcare professional and nurse via Agency (under reference number 00880090).  This case involves a 2 months old male patient who received only the liquid dtap-ipv portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation issue).  The patient's medical history, medical treatment(s) and family history were not provided.  No other vaccines/ concomitants were given to patient.   On 01-Dec-2021, the patient received a 0.5ml first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number UJ529AA and expiry date 22-Jul-2022, 30-Jun-2022, standard, once) via intramuscular route in the right leg for prophylactic vaccination.  It was an actual medication error due to inappropriate reconstitution technique (same day latency).  It was reported "Registered Nurse (RN) calling on PENTACEL. Caller states a patient received only the liquid DTAP-IPV portion of the vaccine and would like to know if that is a valid dose? Caller would also like to know if they can still administer the ACTHIB portion separately? Agent directed caller to visit pentacel.com for vaccine preparation guidance."  At time of reporting, no adverse event reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
dry cough; fever; chills; A spontaneous report was received from a consumer, a female patient, who received Moderna's COVID-19 Vaccine and experienced fever, chills, and dry cough.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 02 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 intramuscularly for COVID-19 infection prophylaxis.   On an unknown date in Jan 2021, the patient developed a fever, chills, and a dry cough. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, fever, chills, and dry cough, was considered unknown.  Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Fever & chills, whole body muscle aches, headache. Treated with tylenol. Symptoms abated after 36 hours.