chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain on her arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on her arm) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     No medical history was reported.     On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain on her arm). At the time of the report, PAIN IN EXTREMITY (Pain on her arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.
Patient received ZOSTAVAX immunization on 7/9/15, followed up with pharmacy on 7/12 describing arm soreness, swelling, redness and warm sensation in 2 locations on same arm.
Drug ineffective; COVID-19; Disease Recurrence/tested positive for covid twice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "longstanding heart condition" (unspecified if ongoing), notes: husband has a longstanding heart condition that he takes many drugs to control. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "Disease Recurrence/tested positive for covid twice". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for covid twice. Clinical course: Reporter's husband had a longstanding heart condition that he takes many drugs to control. Had both tested positive for covid twice even though they had taken precautions and had taken shots as they become available. Both times her husband ended up with symptoms much less than her. she believe that it was possible that one or more of the heart medicines he takes may had lessened his response as compared to her.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300074310 same reporter/drug, different patient;
Patient developed chest pain 2 days after vaccination.  EKG consistent with pericarditis.  He had chest pain 2 days after vaccination and briefly on the 3rd day.
Pruritic, erythematous swelling involving anterior left thigh. Treated with cool compresses, Ibuprofen and diphenhydramine.
Left arm that was injected with Influenza Vaccine (inactivated) became very warm on the crease inside the elbow.
Headache started 4 days later. Treated with Tylenol same as after the shot. Woke up today with left-side facial paralysis. The ER diagnosed me with Bell's palsy.
Pt exp herpes on lip & lymphadenopathy on 1MAY92 following dose 1 of Engerix-B;
"Covid Toes" The toes on my left foot became red, swollen, blistered and Extremely itchy on the 5th day following my first covid vaccine which lasted for approximately 6-7 days.  This occurred again one week following my second vaccine (2nd shot 1/29), for approximately 5 days.  It has occurred three times since then, all on the Friday anniversary of my getting the shot. The symptoms for the last 3 times lasted only 2 days, and the redness has decreased, but they are still extremely itchy and have now become scaly at the site of where the most severe itching took place. They do burn occasionally at the site of the scales.
The first day she had some arm pain, nothing significant. The day after, at 4pm, she had a nosebleed. The following day, she had 3 smaller nosebleeds. She never gets nosebleeds, so I took her into the Dr. to have labs done, just to make sure her platelet count was good. All tests came back normal. We are on day 3 after her 2nd Pfizer, and she has not had a nosebleed yet today, so I'm hopeful it's resolved. In addition to the nosebleed on day 2, she was exhausted, had a headache and had a low grade fever. These I expected, but not the nosebleeds.
The  morning after the vaccine I had the chills and could not get warm. I also had a headache and extreme fatigue.  I got a hot shower to warm up, and after that was super hot and had  red flushed cheeks for hours. I felt nausea.  My temperature was 97, even though I felt like I had a fever. I felt better the next day, not 100% but better than the day after.  My arm was sore, and I had a red raised welt at the injection site. The welt on my arm got larger the next day.  I marked it on monday night, and it did not get any larger the next day. It is currently the same size, red and very itchy. It is noticeably swollen.  I am mostly concerned how I am going to respond to the second vaccine, as I have heard that it can give more symptoms after that one.
slight fatigue the next day; some left arm soreness; This is a spontaneous report from a contactable consumer (reported for himself). A 79-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EL 9261, expiry date not reported), via an unspecified route of administration on 21Jan2021 at a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure, a-fib, small stroke 5 years ago and some weakness from that (stroke). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included atenolol, amlodipine, warfarin, and lisinopril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. On 26Jan2021, patient experienced slight fatigue the next day (as reported) and some left arm soreness. No treatments received in response to the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events fatigue and left arm soreness was recovered in Jan2021.
This is a spontaneous report from a noncontactable consumer (patient). A 35-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 35, via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Mar 8, 2021, patient experienced sore arm, fatigue, headache, body ache and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of sore arm, fatigue, headache, body ache and chills: resolving (at the time of the report). No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
all over body rash with in 10min of vaccination (HIVES) Tx: Benadryl -> ED -> per ED record -> mild urticaria on L arm given additional 25mg Benadryl, observed Evaluated by Allergist 1/20/21 -> adverse reaction was allergic but not anaphylactic. Peg and polysorbate test results 1/29 Neg Underwent rapid desensitization 2/9/21
Unreported possible deep vein thrombosis day after 1st shot. 4 days of thinking I had a charley horse. Confirmed pulmonary embolism on 24Feb2021; Unreported possible deep vein thrombosis day after 1st shot. 4 days of thinking I had a charley horse. Confirmed pulmonary embolism on 24Feb2021; Unreported possible deep vein thrombosis day after 1st shot. 4 days of thinking I had a charley horse. Confirmed pulmonary embolism on 24Feb2021; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 37-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 19Jan2021 11:00 AM at single dosefor covid-19 immunization. The patient took second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 09Feb2021 at single dose for covid-19 immunisation. The patient medical history was not reported. Pas drug event included Known allergies: cinnamon. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, norethisterone acetate (JUNEL) taken for an unspecified indication, start and stop date were not reported. The patient previously took cinnamon and experienced drug hypersensitivity. The patient experienced "unreported possible deep vein thrombosis day after 1st shot. 4 days of thinking i had a charley horse. confirmed pulmonary embolism on 24Feb2021" (medically significant, life threatening) on 20Jan2021 09:00 with outcome of recovering, "unreported possible deep vein thrombosis day after 1st shot. 4 days of thinking i had a charley horse. confirmed pulmonary embolism on 24Feb2021" in Jan2021 with outcome of recovering. The patient underwent lab tests and procedures which included COVID tested post vaccination Nasal Swab, PCR (sars-cov-2 test): negative on 03Feb2021, negative on 10Feb2021, negative on 17Feb2021, negative on 10Mar2021, negative on 17Mar2021, negative on 26Mar2021, negative on 05Apr2021, negative on 07Apr2021. Therapeutic measures were taken as a result of "unreported possible deep vein thrombosis day after 1st shot. 4 days of thinking i had a charley horse. confirmed pulmonary embolism on 24Feb2021". Facility type vaccine was Hospital. No other vaccine in four weeks. AE resulted in Life threatening illness (immediate risk of death from the event). Ae treatment included treatment for Pulmonary Embolism, medications. No COVID prior vaccination.   Information on Lot/Batch number has been requested.
Information has been received from a physician concerning a 16 week old patient with no known allergies who on an unspecified date was vaccinated orally with a first dose of ROTATEQ vaccine live (human-bovine). Subsequently, within 24 hours of vaccination the patient developed diarrhea. Unspecified medical attention was sought. There were no lab studies performed. It was noted that the physician has stopped the series. At the time of the report, the patient recovered on an unspecified date. There was no product quality complaint involved. No further information is available.
woke up today with soreness at the injection site; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 51-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID -19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 08Sep2022, outcome "unknown", described as "woke up today with soreness at the injection site".  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201147439 same reporter/drug /event, different patient;
10/17/03: 48 hours later started with itching and hives lower abdomen, thighs, back. 10/18/03: legs, mid back-hives. 10/19/03: palms of hands red, back of neck and arms-hives. 10/20/03: abdomen, back-hives. Back of legs and thighs-hives. Still taking Benadryl.
I have had a history of retinal issues.  But this was different because it required immediate surgery.  I had some floaters in my right eye but it wasn't major.  On Monday May 23, 2022 I woke up and it was a blob coming from the inside corner of my right eye moving over.  I had it for a couple of weeks first thing in the morning but it would go away.  This day it got bigger and didn't go away.  I was diagnosed with detached retina in my right eye and had surgery on the May 24, 2022.  The surgery was successful and my eye healed.  Then July 5, 2022, I had the curtain coming down from the top of my right eye.  I was diagnosed with detached retina again in my right eye.  I had surgery again to repair retina on July 6, 2022.  As of today the surgery appears to be successful.
Progressive muscle aches, deep - in left arm (arm of injection), bilateral legs, and low back; fatigue; Chills; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: Unknown), via an unspecified route of administration in the left arm on 22Jan2021 10:15 at a single dose for COVID-19 immunization. The vaccine was given in a hospital. Medical history included IBS (irritable bowel syndrome) and known allergies: Sulfa. The patient was not pregnant at the time of vaccination. The patient had no COVID prior to vaccination. The patient had not been tested for COVID post vaccination. The patient has not received any vaccine in 4 weeks. Concomitant medication included macrogol 3350 (MIRALAX), Olly prenatal gummies and unspecified blood builder. On 23Jan2021 at 2pm, the patient experienced progressive muscle aches, deep - in left arm (arm of injection), bilateral legs, and low back. Also chills and fatigue. There was no treatment given for the events. The outcome of the events was recovering.   Information on the Lot/Batch number has been requested.
2 days after vaccine administered extremely sore arm, Flu like sx's, armpit and arm sore to touch. 3 days after vaccine fever, H/A small red streak - 1" away from injection site, sore throat. 4 day after vaccine all above sx's resolved except slight red streak. 5 day after vaccine red streak resolved.
Gave the wrong vaccine; A spontaneous report was received from a health professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) as a second dose when the initial dose was that of Pfizer's (wrong vaccine administered).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received a second dose of Moderna mRNA-1273 mistakenly (Lot number: not provided) for prophylaxis of COVID-19 infection.  On an unknown date, a medical student gave an employee the wrong vaccine for their second dose. They gave Moderna vaccine instead of the Pfizer vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The event gave the wrong vaccine, was considered resolved.  The reporter did not provide an assessment for the event gave the wrong vaccine.; Reporter's Comments: This report refers to a case of (Wrong Product administered) for mRNA-1273, lot # unknown  with no associated AEs.
didn't receive full dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a male patient who received Herpes zoster (Shingrix) (batch number 42cm4, expiry date 11th June 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The reporter stated that while administering Shingrix the syringe broke and some vaccine was lost and the patient did not receive full dose, which led to underdose. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.
woke up to feet numb; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 25Apr2021 at 09:15 as a single dose for COVID-19 immunisation. Medical history included lung nodules and allergies to unspecified medications. 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 medications included prednisone (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN); for an unknown indication from an unknown date and unknown if ongoing. On 29Apr2021 at 09:00, on the fourth day after first shot, the patient woke up to her feet numb. As of today, the numbness was still here. It was also reported as that the patient was due for the second dose on Sunday, 16May2021 and asking for advise if the patient should take the 2nd shot. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event woke up to feet numb was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected
Information has been received from a physician concerning a female )age not reported) who was vaccinated with the first and second dose of GARDASIL (lot # not reported). The physician reported that the patient fainted after her first dose of GARDASIL (lot # not reported). After the second dose of GARDASIL (lot # not reported), she was lightheaded and complained of being unwell. The patients complaints of not feeling well since the first vaccination. The patient's status was reported as not recovered. Additional information has been requested.
11/14/2021  Noticed I was passing clumps into the toilet. 11/15/2021 to 11/17/2021  Light vaginal bleeding; bright red. I have not had a period in over 2 years. I stopped having periods early 2019. 11/18/2021  Passed clots.
Headache, UrticariaPruritus, hives Narrative:  Developed hives associated with pruritus over entire deltoid of vaccination one week after the vaccination. This improved with Benadryl, but then recurred the following day. She went to an acupuncturist, who treated with cupping and heat. Also experienced intermittent headaches, which is atypical for her. Saw dermatologist, but hives had already resolved and she did not have a photo. No sloughing, swelling, induration, erythema or other adverse effects noted. All symptoms resolved by day 10 post vaccination.
she experienced a panic attack; This is a spontaneous report from a Pfizer sponsored program, from a contactable consumer (patient). This female patient of unspecified age reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 23Mar2021 as a single dose for COVID-19 immunization. Medical history included panic attack. Concomitant medications were not reported. On 24Mar2021, the patient experienced panic attack. The event took place after use of product (vaccine). The clinical outcome of panic attack was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Presented to Health Department on 7-25-08 complaining of soreness of both arms started few days ago. Received vaccines on 7-21-08. Received tdap in left deltoid and varicella in right arm. Had red area of left deltoid about 1 1/2 in diameter with small knot under skin. No redness or enduration noted on right arm. Client complaining of pain in both arms with pain in right elbow and stiffness of right elbow. Mother advised to observe child, give Tylenol or Motrin every 4 hours as needed for discomfort and return if any problems.
Mild itching and redness of face and neck started 12 minutes after vaccine. Was monitored by APRN and given 25mg benadryl and O2 was watched for 1 hour, left facillity took 25mg more of benadryl 4 hours later and symptoms went away within 6 hours. I have had persistent headaches since vaccine number 1 a few times per day.
Feeling tired the day of and the day after vaccination. Fever (100.4 F) 24 h post vaccinations and went away overnight.
Pt. states 2 days later noted all over both legs red pin-prickly rash with both feet swelling. Dermatologist 9/23/14 sts rxn to flu shot. Pt bought OTC CLARITIN for immune response.
Redness and mild swelling around injection site on night after injection. Fever to 102, dramatic swelling and induration, redness and increased warmth of left deltoid, shoulder, left pectoral, left scapular area on day 2 after immunization.
I got a big bold pink rash all around the injection site. I noticed when I took a shower the next day. It itched and I took a picture of it. It was probably 6 inches long by 3 inches wide all around the injection site. It had an irregular border. Weird shooting pains around the area. I was considering calling my doctor and I looked online and found COVID arm and it said nothing to worry about. I watched my symptoms and nothing became of it. Within 2 weeks, it faded out and went away.  I continue till this day to get a weird shooting pain in my left bicep, but cannot see anything there.
Almost immediately after receiving the vaccine I started feeling numbness in my left arm (injection site), dizzy, nauseous, and experienced tunnel vision. I also started profusely sweating (forehead).  I reported my symptoms to the nurse who took my temperature, BP, and heartrate. I had a low grade fever (99 degrees) and slightly elevated BP. I drank water and remained at the site for another 30 minutes and my vitals were checked again before I left.