chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID arm; red; Hard; Swollen; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (COVID arm), ERYTHEMA (red), INDURATION (Hard) and SWELLING (Swollen) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced VACCINATION SITE REACTION (COVID arm), ERYTHEMA (red), INDURATION (Hard) and SWELLING (Swollen). At the time of the report, VACCINATION SITE REACTION (COVID arm), ERYTHEMA (red), INDURATION (Hard) and SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment information was provided by the reporter
Pt. recieved vaccine drawn up greater than 12 hours. MD notified pt. no adverse event. Pt. declined revaccination.
Itching, burning and redness at site with hives all over, No treatment per patient all symptoms self-resolved.
Patient states she noticed redness and swelling and discomfort in the left arm with a possible red streak.Left arm: Faint red streak noted extending from vaccine site and 3 cm x 4 cm area of erythema.
The night of the shot at midnight Pt had a right thigh aching  and hurting... He woke up next morning feeling very sick and was very pale in color...Then  at 11:00 A.M. That  same day day he  fainted in the shower and fell, i was unable to  wake him for at least 1 minute! That is the first time he has ever fainted!
24 hours post injections, tongue numb, r.side of face, lips tingling, up to r.ear and r.cheek.  No SOB, no swelling.  4 days later lips tingling.  7-9  days later random numbness and tingling of tongue, r. cheek, lips....comes and goes.  No rescue medication used.  No follow up pursued by patient.
Headache; Tiredness; Difficulty breathing; Dizziness; Weakness; Nauseated; blood pressure was up; Teeth chattering/chills; couldn't hardly stand up; This is a spontaneous report from a contactable consumer (patient reported herself). A 77-year-old female patient received first dose of BNT162B2 (COVID shot, Solution for injection, NDC number: Unknown) via an unspecified route of administration to her right arm on 24Feb2021 3 PM (Batch number: EN6201) as single dose for Covid-19 immunization. Vaccination Facility Type: Hospital. The patient's medical history included bladder issue (she had just been to see her doctor for bladder issues, this was prior to taking the COVID shot). Concomitant medications was reported as none. On 24Feb2021, the patient experienced blood pressure was up, teeth chattering and could not hardly stand up. On 24Feb2021 3 PM, she experienced nauseated. On 25Feb2021, she experienced headache, chills, tiredness, difficulty breathing, dizziness and weakness. Caller, reporting on the COVID shot, said that she had a reaction and had to go to the hospital. She was calling to report. It was explained that she was sick all over which she clarified as being nauseated. At first she said it started an hour to hour and a half after the shot but then clarified she got the shot at 3 PM and the event started that night. The caller was treated and released. She went to the hospital about 6 PM and was sent her home about 9 PM. She was given a steroid shot, Benadryl, her teeth were chattering and was given a pill for that. It was noted while at the hospital she could not hardly stand up. Also, her blood pressure was up and they had to get that down before she left; she was given a pill to get that down. Her blood pressure was 225 but she did not know the bottom number. She was taking the medication given and taking it easy. She was having headache, chills, tiredness, difficulty breathing, dizziness, and weakness. This all started today. The nausea was ongoing from yesterday. The caller explained that she did not think that she should take the second dose if this was what she experienced after the first dose. It was reported that the patient went to emergency room. Relevant tests were none. Outcome of the events nauseated, headache, chills, tiredness, dizziness, weakness was not recovered; blood pressure was up was recovered on 24Feb2021; and other events was unknown.  No follow-up attempts are possible; No further information is expected.
This spontaneous report was received from a physician via a company representative concerning a patient of unknown age and gender. No concurrent conditions or medical history were provided. The patient was vaccinated with ZOSTAVAX (Lot No., expiration date, dose, route and administration date were not reported). On an unknown date, post vaccination the patient developed shingles (herpes zoster). The patient sought medical attention. The outcome of herpes zoster was unknown. Additional information has been requested.
Feels like an egg; It's warm; Swollen arm; It's itchy; It's sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Feels like an egg), VACCINATION SITE WARMTH (It's warm), VACCINATION SITE SWELLING (Swollen arm), VACCINATION SITE PRURITUS (It's itchy) and VACCINATION SITE PAIN (It's sore) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS, Neuropathy and High cholesterol.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Feels like an egg), VACCINATION SITE WARMTH (It's warm), VACCINATION SITE SWELLING (Swollen arm), VACCINATION SITE PRURITUS (It's itchy) and VACCINATION SITE PAIN (It's sore). At the time of the report, VACCINATION SITE INDURATION (Feels like an egg), VACCINATION SITE WARMTH (It's warm), VACCINATION SITE SWELLING (Swollen arm), VACCINATION SITE PRURITUS (It's itchy) and VACCINATION SITE PAIN (It's sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include thyroid, neuropathy, and cholesterol medication, not otherwise specified. Treatment details not reported.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2012, the patient was inoculated with ZOSTAVAX by a physician as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On an unknown date in 2015, the patient was treated by a physician for shingles. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. Outcome of the events was unknown. Causality assessment was related.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: coughing/ wheezing-Severe, Additional Details: pt experienced side effects after 30 min from receiving 3rd dose and did not have rxns after 1st & 2nd dose. elevated BP 140/95, but pt stated that was her normal baseline. pt hx of allergic asthma, but left inhaler at home. pt given 50mg of liquid diphenhydramine as she was unable to swallow. pharmacy offered to call 911; however, pt refused and wanted to walk to urgent care. RPh instead drove her to memorial care.
After administering vaccination the guest was standing at the counter, feeling light-headed and proceeded to faint, recover a few seconds later and proceed to faint again.
Injection given 04/04/2018 2:20 PM. Typical sore arm at injection site first 24 plus hours. Approximately 27 hours after injection, (approximately 5 PM) red, raised painful rash mid-way between shoulder and elbow, outer surface, approximately 4 inches below injection. By MN, upper half of L. arm hot, inflamed, painful with marked rash. By morning, approximately 40 hours post-injection, characteristic shingles lesions. Photos available.  Saw Dr. who corroborated diagnosis at 50 hours post injection. Began treatment with Valacyclovir 1 Gm, TID X 7 days. Slight improvement of symptoms now at 76 hours post injection.  Still painful, red, raised, hot.  (I am a licensed Family Nurse Practitioner). No prior history of shingles.
PALE DIZZY SOME MOVEMENT OF ARMS AND HEAD FOR A SHORT TIME. NO RECOLLECTION OF WHAT HAPPENED.
I am a healthy and happy 51 year old male. I am active, sober for many years and in what one would consider very good health. I am 5ft 11 inches and weigh 159 pounds. I don't drink or smoke and have a VERY balanced life. On the evening of the 6th I started having thoughts that one would consider unusual.  On the 7th these thoughts turned suicidal. There wasn't a real thought of doing it but  a hundred times per day that was there "you should kill yourself".  This was coupled with a serious depression. I slept a lot, didn't get off the couch, wanted to abandon my friends and the community that I am a part of.  I was deeply concerned and was pushing away my partner in a way that was very much unlike me. This was a psychiatric episode with no valid reasoning.  On roughly Tuesday October 11th I started to feel better physically and mentally. By Friday the 14th the suicidal thoughts were gone and i would consider myself normalized again.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 79 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL8982), on 18Feb2021 as dose 2, single (Lot number: EL1283), on 21Sep2021 as dose 3 (booster), single (Lot number: FF2589) and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9893) for covid-19 immunisation. The patient's relevant medical history included: "atrial fib" (unspecified if ongoing), notes: Other medical history atrial fib; "SSS" (unspecified if ongoing), notes: Other medical history, SSS. The patient's concomitant medications were not reported. Past drug history included: Mobic, reaction(s): "Known allergies mobic", notes: Known allergies mobic; Percocet, reaction(s): "Known allergies: Percocet", notes: Known allergies: Percocet. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. It was unknown if patient received other medication in 2 weeks.
Patient stated being lightheaded. Checked vitals and and blood pressure was a little low. Took blood pressure again after 10 minutes and was back to normal. Gave orange juice and water.
Had left eye pain and skin sensitivity 20 minutes after the vaccine. Around hour 12, started with body aches and intense headache.  Between hour 12 - 36, I had fevers up to 101.1, body aches, nausea, and headaches.  All resolved by hour 36.
2 month old was due for vaccines. He needed Dtap, IPV, HIB, PCV 13 and rotavirus, a PENTACEL and an IPV and PCV 13 was given. This resulted in the child getting a double dose of the IPV vaccines. The mistake was discovered when the nurse was filling out the vaccine records and she then realized she had given the wrong vaccine. The child had no adverse effects. The mistake was reported to the local health department.
Breakthrough case of covid. On the 10th I reached out to Dr. and was prescribed Paxlovid and began course of meds that evening. Symptoms began resolving the next morning.
Pt had a missed menstral period. Previously very regular, taking Lo estergen. Did not start cycle during sugar pills. Started new pack and began spotting 10 days later.
Syncope episode after bowel movement.  BP 88/40, severe diaphoresis, dizziness, brief loss of consciousness, no pain or paresis noted. 2 nitrogen tabs administered after return to bed. No sequelae from episode.
Still don't feel back to myself; Had an Afluria shot and it was like there was a golf ball under my skin; Start itching like crazy; Fever of 102.7; This spontaneous case, reported by other non-health professional (consumer) and initially received on 09-Oct-2018, concerns a male patient of an unspecified age.  On an unspecified date (reported as few weeks ago), the patient was administered Afluria Quadrivalent (influenza vaccine, dose, route of administration, anatomical location, batch number and expiry date: not reported) for an unknown indication.  On an unspecified date, after vaccination, the patient felt it was like there was a golf ball under her skin and about 10 minutes later, it started itching like crazy. The next day the patient woke up with fever of 102.7 and she still didn't feel back to herself.   The outcome of the events was not reported.  Update received on 02-Nov-2018: Significant case correction (09-Oct-2018): The listedness of the event injection site mass was changed from unlisted to listed in the event assessment tab. No changes made in the narrative.; Reporter's Comments: A male patient of unspecified age, the patient felt like it was like there was a golf ball under his skin and experienced itching like crazy, fever of 102.7 and didn't feel back to herself, after unspecified days of vaccination. The causality of the events injection site lump, feeling abnormal, itching and pyrexia were assessed as related due to the site-specific reaction (injection site) and plausible temporal relationship between the events and the suspect vaccine.
Client reports red rash occurred 3 days after 2nd dose on left bicep and has persisted to this day. Client contacted PCP. No Rx given. Advised to alert Health Department.
Pain in arm; Swelling; Itching; Redness; Heat in arm; A spontaneous report was received from an nurse concerning a 60 years old, unspecified gender patient who experienced redness, swelling, itching, pain in the arm and heat in the arm.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  On 23 Dec 2020, prior to the onset of the symptoms, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.   The patient experienced redness, swelling, itching, pain in the arm and heat in the arm all since an unknown date.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the redness, swelling, itching, pain in the arm and heat in the arm were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-003307:
Pfizer Dose 1 1/4/21 (lot NA) Pfizer Dose 2 1/25/21 (lot NA) COVID Positive 1/16/22  1/16/22: Patient is a 71-year-old female with a past medical history significant for arthritis of bilateral knees, hypertension, bipolar disorder, morbid obesity, type 2 diabetes mellitus.  Patient is a resident a facility.  Patient was brought to a local Emergency Department to left-sided facial swelling.  When the patient arrived in the hospital he was not able to provide pertinent history for himself due to clinical picture consistent with sepsis.  Patient also has history of metabolic encephalopathy in the previous hospitalization.  All of the HPI is obtained from the ED provider and from the previous physician notes.   The emergency department note is as follows:  The patient presents with A 71 year old male with a PMx of HTN, DM and bipolar disorder presents to the ED with weakness. EMS was called by the residential facility when the patient reported left sided facial pain starting yesterday. Patient was discharged after having sepsis from a UTI 12 days ago. Patient denies fever. .  The onset was 1  days ago.  The course/duration of symptoms is worsening.  The character of symptoms is lack of strength. Risk factors consist of hypertension, diabetes mellitus, recent antibiotic use and recent hospitalization.  Prior episodes: none.  Therapy today: emergency medical services. Associated symptoms: denies fever.  1/26/22: Acute upper GI bleed, with melena, while on anticoagulation  Status post EGD-gastric ulcer with pigmented spot status post hemostasis with hemoclip Acute on chronic anemia, 2/2 blood loss - stable  Acute left parotiditis - resolving  Gastric ulcer with bleeding - status post EGD with hemostasis with hemoclip 1/25  Gastric polyps, status post biopsy  Gastritis and duodenitis  Mild hypernatremia - resolved  COVID-19 positive, asymptomatic  Acute delirium and encephalopathy - resolved  Abdominal pain  Sepsis - resolved  Leukocytosis - resolved  Type 2 DM  Chronic AFib, rate controlled  Chronic HFpEF  Chronic physical deconditioning
A rash or breakout on the face and neck; patient received BNT162B2 and influenza vaccine on the same day; patient received BNT162B2 and influenza vaccine on the same day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 5 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm left, administration date 11Nov2021 09:15 (Lot number: Fks127) at the age of 5 years as dose 1 (tris), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 11Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient had no relevant medical history. Concomitant medication(s) included: paracetamol (TYLENOL); ibuprofen (MOTRIN). The following information was reported: RASH (non-serious) with onset 12Nov2021 16:00, outcome "not recovered", described as "A rash or breakout on the face and neck"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 11Nov2021, outcome "unknown" and all described as "patient received BNT162B2 and influenza vaccine on the same day". Therapeutic measures were not taken as a result of rash.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
pt recvd vax;10 min later, began screaming,had gen giant hives & diff breathing; to er; eyes were swollen shut & hives were more profound; tx w/ dph, steroids & epinephrine;
R UPPER ARM THREE RED RAISED QUARTER SIZE RASH THAT IS ITCHING.  STARTED 10 MINUTES AFTER VACCINE INJECTION.    INSTRUCTED CLIENT TO PLACE COLD COMPRESS ON AFFECTED AREA AND TAKE BENADRLY AS PACKAGED DIRECTED.    IF SYMPTOMS GETTING WORSE, NO IMPROVEMENT, OR SHORTNESS OF BREATH, SWELLING TO SEEK EMERGENCY OR CALL EMS.
About 3-5 minutes after getting the shot, I got a headache, severe cold sweats, felt nauseas, and felt dizzy. In the middle of the night, I woke up with extremely dry lips, cold sweats, a headache, and dizziness. The dizziness started going away after hydrating. However, I did not feel entirely well until around 11AM the next morning.
Patient starting experiencing the chills, headaches,  heart palpitations, headaches and her arm and chest is hurting.
waiting for the 15 minutes after getting the shot i felt my stomach bubble around 1:30-2 when i got home i had diarrhea and then around 2-3 i had bloody diarrhea and then again around 4
Moderna lot number 038B21A expired within system on 9/25/2021, vaccine was given on 9/27/21. There is no expiration on the box  or the vials.
Reconstituted on 22Sep22/ 1.30PM, administered on 23Sep22/ 10AM; This case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in drug usage process in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2022 10:00, the patient received Shingrix. On 23rd September 2022 10:00, unknown after receiving Shingrix, the patient experienced wrong technique in drug usage process. On an unknown date, the outcome of the wrong technique in drug usage process was unknown.   Additional Information: GSK Receipt Date: 23-Sep-2022 Reporter's comment: The pharmacist reported that a dose of Shingrix reconstituted on 22nd September 2022 at 1.30 pm (local time) was administered to a patient on 23rd September 2022 at 10 am (local time). The pharmacist also reported that the Shingrix dose administered to this patient had been placed in refrigeration after reconstitution. The reporter consented to follow up. Additional Supportive Information: The Shingrix dose administered to this patient had been placed in refrigeration after reconstitution for more than recommended time, which led to wrong technique in drug usage process.
Patient presented to ER with difficulty speaking on 6/24/14 arriving at 10:53 and transferred to Neuro at 1754. No other information available after transfer.
Tues night 10/15 experienced some pain while sleeping-left arm. 10/15 AM throbbing pain in elbow, forearm, numbness in thumb, baby finger and middle finger. Called PA. PA Thurs 10/17 afternoon instructed to call Public Health. 10/18 decreased pain, my morning experience intermittent pain, throbbing, numbness. Injection site no redness, swelling or pain.
He also mentioned that he has been in the hospital for the past days due to pancreatitis.; This is a spontaneous report received from Pfizer sponsor program. A contactable male consumer (patient) of an unspecified age  received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 05Mar2021, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient has been in the hospital for the past days due to pancreatitis. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Significant lymphedema in left axilla extending down to the arm Left lower leg swelling 90%  of breast milk production reduction that did not resolve within 72 hours. Took more like a week and still not back to baseline from prior to injection