chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BILATERAL HERNIA; SORE AFTER COVID VACCINE; MINOR PLAQUE PSORIASIS FLARE UP; COUPLE OF SPOTS WITH TINY BUMPS; VACCINATION SITE PAIN; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the patient experienced bilateral hernia, sore after covid vaccine, minor plaque psoriasis flare up, couple of spots with tiny bumps, and vaccination site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from sore after covid vaccine, and vaccination site pain, and had not recovered from bilateral hernia, minor plaque psoriasis flare up, and couple of spots with tiny bumps. This report was non-serious.
Received FluMist on 11/3/06. Started breaking out in hives on 11/4/ and 11/5. Treated with Benadryl. DX: for DOS 11/16/06-urticaria, rule out strep. Possible reaction to FluMist. Strep negative. Note on 11/7/06-hives resolved. Entered note in patient chart allergy to FluMist.
Shingles worse than ever; This case was reported by a consumer and described the occurrence of shingles in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had multiple cases of reoccurring shingles). Previously administered products included Zostavax (had been previously vaccinated with Zostavax).   On 23rd July 2021, the patient received the 1st dose of Shingrix (intramuscular). In July 2021, less than 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself. The patient received Shingrix vaccine and mentioned that in July and in August 2021 he broke out with shingles all over including the lower back, hair line, and head. The stated that this episode was worse than ever. The patient inquired if it was safe for him to receive second dose of Shingrix and if it would have any benefit. The reporter consented to follow up with him and with his health care professional (pharmacist).
Day of just sore arm .  The next day I felt like I got hit by a bus . I called out of work Over the next couple weeks I felt weak ( couldn't pick up boxes at work etc I felt run down and tired.  By mid May I was having numbness and tingling in my arms and legs . Sometimes pins and needles like . Muscle twitches . Vision blurriness . Back pain .... Bladder control issues
14NOV96 pt began sx of achiness, sore throat, fever, chills, red blotchy itchy rash;also had sx of asthma (pre-existing condition);seen by MD 15NOV96 who felt this was a rxn to flu vax;
Pain in my joints and muscles started later that night after having the vaccine administered. When I woke up the next morning my whole body hurt so bad I could barely move. Over the next few days I felt better in some ways but my joints and muscles still hurt and they never have before. I am still feeling aches . I did not go see anyone as I do not have insurance.
Brain tumors damaged extreme speech problem.  Unable to speak in sentence. Had to go to the emergency room for check on.  Still covering a week later struggling for words. Burning rash on front of chest and extreme  bad back aches.
Erythema (3 x 3in), swelling, warmth at site of DTaP injection. Itchy not tender. Rx Benadryl, Tylenol
No adverse event.  Patient was under the age of FDA-authorized emergency use age limit (patient is 15 years old, Pfizer COVID-19 vaccine is authorized for 16 years and older).
Vertigo; Tired; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and FATIGUE (Tired) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo) and FATIGUE (Tired). At the time of the report, VERTIGO (Vertigo) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
raised, round, red patches on her hands and feet; raised, round, red patches on her hands and feet; This case was reported by a consumer via call center representative and described the occurrence of redness of legs in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced redness of legs. On an unknown date, the outcome of the redness of legs was unknown.   It was unknown if the reporter considered the redness of legs to be related to Shingrix.  Additional details were provided as follows: The patient experienced raised, round, red patches on her hands and feet and that they would come and go and then reappear in other locations, mostly on hands and feet and occasionally on neck.   She informed that more recently they were flat and not itchy. The reporter consented to follow up.
During her 15 minute waiting period after the injection, the patient began to experience right eye drooping; This is a spontaneous report from a non-contactable other healthcare professional. A 80-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6201, expiration date: not reported), via intramuscular route, administered in left arm on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: not reported) as dose 1 on unknown date for covid-19 immunization. On an unknown date, during her 15-minute waiting period after the injection, the patient began to experience right eye drooping. The patient denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light-headedness, dizziness, facial swelling, lip swelling and tongue swelling. Patient to follow up with PCP/new PCP if her blood pressure at home continues to be elevated greater than 140/90. Patient was stable on the day of reporting and was feeling good. Patient did well on her ambulation without stopping. The outcome of event was recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.
developed shingles on eyelid 4 days after vaccine. patient has previous history of shingles, reports that this is 9th outbreak in 2 years
pt devel rash (flat) on upper arms, chest, shoulders the evening following Hep B inj;parent denies any change in laundy or body soaps;parent called ped but was told it was not vaccine related;no other problems noted by parent;
fever, decreased taste, decreased smell, body aches, nasal congestion, runny nose.  COVID positive PCR on 7/31/21
Information has been received from a healthcare worker referring to an unspecified patient of unknown age and gender. On 24-NOV-2015 the patient was vaccinated with a dose of improperly stored ZOSTAVAX, lot # L021609, expiration date: 10-SEP-2016, (dose, dose #, route and application site were not reported). No adverse effect reported. Additional information has been requested.;
about 12 days after booster developed diffuse migratory hives.  This has persisted for 4+ weeks and continues to be present.  Hives have affected nearly all parts of my body at various times including face, hands and feet.  Initially not relieved by anything including antihistamines.  Now as things have improved, yet are still present the hives and itching seem to respond to OTC antihistamine.
Got shot on Tuesday 3/23/21 and Sat 3/27/2021 became dizzy
This report concerns the aftermath of the second of the two Moderna vaccinations that I received:  Mild point of injection pain. Fever after 48 hours 100.4 F, lasted one day. Heavy night sweat on third night after shot. After about 10 days, a light but persistent rash developed on my upper right shoulder. Approximately a week later, I experienced :"tingling" through out my right shoulder. This right shoulder has had prior rotator cuff damage (in the early 1990s). The sensations of tingling in the shoulder are identical to those from the past,. There is also an itching sensation that is best described as "inside the skin", not on the surface.   In the last two weeks, the rash has expanded to my right chest. There is little to no surface lesions or irritation, just itching and tingling as mentioned, with very slight raised bumps. None of these symptoms were present before the vaccination.  The tingling is heightened depending on arm position and when I am prone. There is no associated pain.  The itching, tingling, and rash have not gone away. Today is May 27th. I went to my family doctor today for other reasons, and mentioned the rash and post-vaccine reraction to him.
BUE achyness & weakness BUE. Very high ESR/CRP - pt being Txd with prednisone  - a polymyalgia like illness
a 4 year old patient received the product VAXELIS instead of KINRIX; This non-serious spontaneous safety report, with reference number 2022SA439239/ Inquiry# 01335763 was received by a partner on 24-OCT-2022 and forwarded on 27-OCT-2022 from another health professional.   Due to the nature of the event, the causality between the event "a 4-year-old patient received the product VAXELIS instead of KINRIXS." and Vaxelis was not applicable.  Further information is expected.
tested positive; tested positive; The initial case was missing the following minimum criteria: AE reporting - Medical Information. Upon receipt of follow-up information on (20May2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient reported as he was looking for information related to Paxlovid, and other antivirals. "I've got covid in my 3rd of symptoms". I got the Paxlovid this afternoon, should I wait until the morning to start the 5-day regimen. Patient was vaccinated for COVID-19 then tested positive yesterday, so he was prescribed Paxlovid and he wanted to know: how does a doctor determine what to give to patients in regards he prescribed him Paxlovid, and if Remdesivir was a Pfizer product. he has not taken the drug Paxlovid yet, so he doesn't know if he be of any help, since he just got it within the last half hour from the pharmacy and has been reading thru the information for it. he wanted to get some antivirals and called his doctor who doesn't take call right away so he had to wait on him and talked to his nurse and he saw Paxlovid listed on the internet as an antiviral and he knows there were other medicines. He says when he talked to him, his doctor called in Paxlovid for him without him knowing about it. He says he sees that Remdesivir was approved by the FDA as a medicine, so he would like to know. was it a Pfizer drug, and he asked the prior representative and she didn't know.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
a patient received improperly stored vaccine; This spontaneous report has been received from the administrator of a doctor's office concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.        On 16-OCT-2020,  the patient was vaccinated with an improperly stored  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 1 dosage form,  Lot # S027467, expiration date 02-MAR-2021 for prophylaxis (dosage regimen, patient route of administration and anatomical location were not reported).        The temperature was reported to had been at 17.2 °Fahrenheit (F) for 1 hour and 30 minutes.   There was digital data logger involved and a previous temperature excursion was reported to had been at 12.2 °F for 1 hour.  No other information was available.; Sender's Comments:  US-009507513-2011USA013430: US-009507513-2011USA013458:
Transverse myelitis.  Contracted covid in January 2022. Passed away on February 08, 2022 from covid.
G47.33 OBSTRUCTIVE SLEEP APNEA 12/27/2022 ACUTE PULMONARY EMBOLISM I26.99 ACUTE PULMONARY EMBOLISM 4/25/2023 ACUTE PULMONARY EMBOLISM R09.02 HYPOXIA 4/24/2023 ACUTE PULMONARY EMBOLISM
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 60 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Sep2022 at 10:00 as dose 5 (booster), single (Lot number: AS7144B), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillin" (unspecified if ongoing), notes: known allergies penicillin. There were no concomitant medications. Past drug history included: Known allergies: aspirin, reaction(s): "Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Sep2022 at 10:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received other medication in 2weeks. Other medical history: None. Anti viral details: product: COVID 19 Treatment. Brand: Paxlovid. Treatment start date: 18Jan2023 and Treatment stop date: 23Jan2023. Indication: Treatment of COVID-19.
After 2nd dose was sick for 10 days with temp as high as 104.3; extremely nauseous/So nauseous; This spontaneous case was reported by a pharmacist and describes the occurrence of NAUSEA (extremely nauseous/So nauseous) and PYREXIA (After 2nd dose was sick for 10 days with temp as high as 104.3) 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 14-Jan-2022, the patient experienced NAUSEA (extremely nauseous/So nauseous). On an unknown date, the patient experienced PYREXIA (After 2nd dose was sick for 10 days with temp as high as 104.3). At the time of the report, NAUSEA (extremely nauseous/So nauseous) outcome was unknown and PYREXIA (After 2nd dose was sick for 10 days with temp as high as 104.3) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104.3 (High) 104.3.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   Reporter did not allow further contact
Pt recvd vax & devel elevated liver enzymes & had a pos hepatitic C elevation;
Lymph nodes in her neck are severely swollen where she can barely turn her neck; Having severe lower abdominal pain; Sore throat; Headache; Overall feels horrible; Lymph nodes in her neck painful (sore); Stated that she is really tired; she could barely turn her neck; This is a spontaneous report from a contactable consumer (patient's mother). A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at age of 25-year-old at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The caller stated her daughter had the vaccine on Thursday and was having bad side effects. She stated her lymph nodes in her neck were severely/extremely swollen and painful where she could barely turn her neck and her neck was sore. She was having severe lower abdominal pain that started that evening, bad first two days and had subsided. The patient was really tired. She had a sore throat, a headache, and overall feels horrible. She stated 3 days ago there were reports of hundreds of women in her age group having these same symptoms and this information was not available to them prior to the vaccine. She stated there were woman dying in Norway from thrombosis, 20 women in their reproductive years. Woman this age were getting severe reactions and there is no available information on this. She asked, how long will these symptoms last. How to make the swelling and pain go away. Stated that she was fine before the vaccine and currently she was not fine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
p/vax pt 10 inches topical w/pain; took benadryl for itching
I received the injection to the arm and it was immediately extremely painful. I thought it was normal swelling at the site. The arm began to get progressively worse and by the 3rd day I could not move my shoulder. Its been a week and I have been using  warm and cold compresses, massage, and Ibuprofren but I still cannot move my shoulder and have a lot of pain. I cannot do simple tasks like putting on clothes and typing on the computer. This feels like something very serious, possible nerve damage. I am consulting an ortho today but based on what I have been reading online I think the injection was placed in the wrong spot and I have SIRVA (shoulder injury related to vaccine administration)
Rash over body through course of vaccine. I didn't do anything for rash except to wait it out.
Started to feel tired the next day at or around 9 AM.  At or around 1230, took temp for the first time and it was 100.2 .  Took again in two hours, the same.  Took IBUPROFEN.   At 430, took temp again, 99.6.   Then took IBUPROFEN again 4 hours after 430.   Went to sleep, slept through the night.  Woke up and took temp, it was normal and was not elevated.  No current concerns to note.
Pt stated about a week after covid vax her arm was very sore, swollen, red around the injection site and headache.  Pt states she still has a red spot but the swelling is better today.
Breakthrough covid case. Tested positive 5/23/22 with an COVID test at Hospital. Presented to ER with headache and runny nose x  day.  Positive exposure. RX given for paxlovid.  Discharged home.
Large red, painful area at deltoid, about 4x6cm at left, site of Pneumovax.  Prescribed Diprolene cream and Tylenol per mouth.
Guillain Barre syndrome.  Severe progressive motor impairment upper and lower extremities. Respiratory distress  severe widespread edema,  hypertension increase,
Information has been received from a nurse concerning a 23 year old female with no medical history or known drug allergies, who on 21-OCT-2008, was vaccinated, IM, with the first 0.5 ml dose of GARDASIL (lot # 659184/0843X). Concomitant therapy included hormonal contraceptives (unspecified). On 21-OCT-2008, the patient experienced a "fainting episode" after administration of her first dose of GARDASIL. The patient later developed a headache, which lasted 2 days (also reported as the patient had not recovered). At the time of this report, the patient was not recovered from the fainting episode. The patient visited the office for medical attention. Additional information has been requested. Follow up information received from a physician concerning a 23 year old female who on 21-OCT-2008, at 15:22 was vaccinated with the first dose of GARDASIL (lot # 659184/0843X) into the left deltoid. The patient had no illness at the time of vaccination. On 21-OCT-2008, at 15;24, the patient experienced fainting after injection and headache. Follow-up information received from a registered nurse concerning a 23 year old female with no known allergies who on 21-OCT-2008, at 15:23 was vaccinated with the first dose of GARDASIL (lot # 659184/10843X) into the deltoid. The patient had no illness at the time of vaccination. On 23-OCT-2008, at 15:23, the patient fainted after vaccination. The patient also complained of headache and felt ill all evening. The patient was recovered on 24-OCT-2008. No further information is available.
Patient reported swelling, pain, and a band of redness around arm at injection site starting 24 hours after administration.
I got a 1st shot on June 2018 but never got the 2nd shot.; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a 84-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in June 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient never got second dose of Shingrix. The patient asked should he/she get the second shot now, should he/she start the series over, or just leave well enough alone. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Patient experienced prolonged soreness and pain at injection site, fatigue, and headache which is still occurring on 10/15/21, 11 days after vaccination. Patient did have a COVID infection previously. He alerted his PCP but wanted us to report to the CDC.