chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild pain at injection site. Felt very tired and weak. Slight body aches like when coming down with the flu.   Then ended up with Covid on  May 19, 2022 that was the mildest head cold I ever had. No sore throat but some swelling of soft pallet and some itching. Very mild cough occasionally, and felt very tired and a little weak. Lasting only about 4-5 days. But on May 29, 2022 I began having chest pains once or twice a day with a burning ache running down my left arm. Saw my cardiologist and he has scheduled a cardiac cath for me on June 24, 2022.
SHE WAS ADMINISTERED THE VICERELLA VACINE< YOUR SYSTEM WILL NOT LET ME ENTER VICERLLA BELOW BECAUSE THERE ARE NO MANUFACUTER OPTIONS TO SELECT.  THERE IS A FLAW IN THE WEB PAGE.       Six days after the vaccine, patient developed a high fever - 102.3 and has had that fever for over four days now.  We took her to the ER.  After examination, they couldn't find anything wrong with her and instructed us to use pedialite and motrin.  We have been doing that for four days.  Today, she developed a measle like rash.  This is nuts!  If I would have known that this caused fevers - I wouldn't have done it.  Patient had seizures as an infant and I HATE for her to get fevers.  Her seizures were GRAND MAL and there was no cause determined after a full work up at hospital.
Hives in various places from 08/27/2021 to 09/01/2021.
vertical red rash under each eye 2 days some tightening of throat muscles going on third day headache 1 day took one 10 mg dose of my husband's prednisone upon arrival at home now taking benadryl
Had flu vaccine 100303. C/O N & V after vaccine. Deceased 100703 AM cause of death not known. The autopsy report states cardiac arrhythmia and hypertensive heart disorder. Medical Record received on 10/20/2003 states gastritis.
Approximately 12 hours after the vaccination, fever and chills started with initial elevated temperature of 101.3F and reaching a maximum of 102.8F and returning to normal by approximately 12 hours from onset.  Approximately 39 hours from vaccination, recurrent vomiting (total of 5 times), abdominal pain, and wide spread, persistent, stinging body pain occurred.  I required intravenous fluids, overall 2 liters.
Rash developed at injection site 7 days after first dose was administered.  It started as small bumps which developed into a raised welt in the shape of a circle about 2-3" wide. The welt was hot to the touch and occasionally itchy.  The next morning it was larger - about 4" tall by 3" wide, and still hot to the touch and occasionally itchy.  So far I'm just trying to ignore it and not touch it.
Pt recvd vax around 6PM 13AUG91; Pt is wearing monitor @ 4AM started beeping; HR was up; Taken to ER & admitted w/t104 & HR 260min; dx w/UTI;
After injection, client stated nausea than turned pale, felt as though passing out - diaphoretic - reclining position - feet elevated, sip of coke. Never had LOC, felt sick/called mother at 4:45 - pt fine.
This spontaneous case, initially received from pharmacist on 22-Oct-2018, concerns a 72 years old elderly female patient. The patient's historical condition and concomitant medications were unknown. On 02-Nov-2018, the patient was administered FLUAD (TIV) [dose: reported as less than 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 250805 and expiry date: 30-Jun-2019]. It was reported that there was a malfunction with the needle during administration and some of the vaccine did not enter into the injection site. Patient had not received a full dose of the vaccine. The pharmacist denies any issues with the FLUAD syringe. No adverse reaction was reported after vaccination. The reporter assessed the case as non-serious. This case was considered as lost to follow up as reporter did not provide the consent for the follow up.
4 hours after vaccine I felt like I was going to pass out and my husband rushed me to ER
Swelling, redness, pain, warmth at injection site.  Patient seen at clinic and back in primary physician's office.
Pt was given Diphtheria/Tetanus Adult intradermally instead of the tuberculin Mantoux intended. The area became reddened up to 8 cm with 1 cm area dark red and hard. Pt complains of stinging and itching.
Left leg hot ,red,swollen and very painful. Baby extremely fussy. Ice pack applied for 20 minutes and 80 mg Tylenol given
PT received dose of IPV that he did not need today. No adverse reaction, none treatment needed.
The pt had varivax vaccine at 18 months. Now at 5 years old, pt has developed chicken pox.
At bedtime that night - Chills; felt like I had the flu; muscle and joint aches; muscle and joint aches; severe headache; no appetite; slight fever 99-100; This is a spontaneous report from a contactable consumer or other non hcp. A 65-year-old female patient received (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Right on 01Feb2021 10:00 am (at age of 65 years) as dose 2, single for COVID-19 immunisation. Medical history was not reported. Concomitant medications included vitamin d3 (VITAMIN D3); calcium (CALCIUM); fish oil (FISH OIL); bacopa monnieri herb, camellia sinensis leaf, curcuma longa rhizome, silybum marianum seed, with ania somnifera root (PROTANDIM) taken for an unspecified indication, start and stop date were not reported. No covid prior to vaccination and was not tested for covid post vaccination. The patient had no known allergies. The patient previously took first dose of (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE Batch/Lot number: EL1283) via an unspecified route of administration, administered in arm left on 09Jan2021 02:30 PM as single for COVID-19 immunisation. On 01Feb2021 23:00, the patient experienced at bedtime that night  chills and on the next am muscle and joint aches, severe headache, no appetite, slight fever 99- 100, felt like she had the flu which lasted all day, at 5pm she took Tylenol for headache then again at 11 pm and for the next 2 days she just had a slight headache which got a little better each day. On 01Feb2021 the patient underwent lab tests and procedures which included pyrexia:99 and 100 fahrenheit. Therapeutic measures were taken as a result of severe headache and was treated with tylenol. The outcome of events was recovered on unspecified date in 2021.
This is the first dose of Quadracel for the patient, but 4th doses of DTaP and IPV. On 7/11/19 pt received vaccinations - on 7/12/19 patient's mom called our office to report vaccination site of Quadracel on right thigh noted as red, inflamed and warm to touch. Pt fever 102.2, increased fatigue and decreased appetite. Swelling felt like fluid under the skin, not firm. Patient taken to urgent care, diagnosed with cellulitis and prescribed Cephalexin for 7 days. Pt seen again on 7/15/19 at urgent care for spreading of redness on skin near injection site; advised to continue antibiotics and monitor.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 11Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 12Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "BrCa", start date: 1995, stop date: 1997, notes: BrCa 1995-1997; "mastectomy" (unspecified if ongoing); "early melanoma", start date: 1997 (unspecified if ongoing), notes: early melanoma 1997; "mild high cholesterol" (unspecified if ongoing), notes: mild high cholesterol; "osteopenia" (unspecified if ongoing); "herpes" (unspecified if ongoing), notes: herpes; "Known allergies: dust" (unspecified if ongoing), notes: Known allergies: dust. The patient's concomitant medications were not reported. Past drug history included: Nsaids, reaction(s): "Known allergies: NSAIDS", notes: Known allergies: NSAIDS. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Aug2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Aug2022) Positive, notes: had gotten positive test 12Aug2022; (18Aug2022) Negative, notes: Tested negative 18Aug2022; (27Aug2022) Negative, notes: Tested negative 27Aug2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Other medication in 2 weeks was Yes. COVID 19 Treatment, brand: Paxlovid. Other medication in 2weeks was alendronate sodium (brand Aurobindo, lot number: UA7022020A), rosuvastatin calcium (brand: Torrent, lot number: BDN7H051) and valacyclovir (brand: Camber, lot number: VAC22004). Adverse event: COVID Rebound First COVID bout: symptoms started 13Aug2022; had gotten positive test 12Aug2022. Fatigue, very sore throat, fever, runny nose. Symptoms ended 17Aug2022. Tested negative 18Aug2022 Rebound bout: symptoms started 20Aug20222, fatigue, sore throat, fever, runny nose. Symptoms ended 26Aug2022. Tested negative 27Aug2022 AE treatment: Rest, fluids, Tylenol, antihistamine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. The consumer posted about 8 flu deaths of which, 7 had the flu shot and all 8 took THERAFLU. The consumer asked what's your take on who is to blame? It was unknown if an autopsy was performed or not. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. This case is one of the 7 cases, reported by the same reporter for same event.
This report was received from the investigator of a trial on 12 April 2010. A 29 year-old male subject with medical history significant for headaches and numbness or paralysis received ACAM2000 (lot number not reported) on 05 December 2008. The subject also received anthrax vaccine (manufacturer and lot number were not reported) that same day. Sixteen days prior, the subject received TYPHIM VI (lot # not reported) and anthrax vaccine (manufacturer and lot # not reported). Thirteen days after receipt of ACAM2000, the subject was reportedly diagnosed with encephalitis of unspecified cause. The medical record review found one code of "other causes of encephalitis" with a diagnosis date of 18 December 2008 and one code of "unspecified cause of encephalitis" on 24 December 2008. An MRI of the spinal cord on 18 December 2008 was abnormal, no other details were provided. No other information was provided. The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Peripheral Neuropathy in the feet that progressed upward over about a week until numbness encompassed about half of each calf. Following that progress, the neuropathy then receded until it was no longer noticeable in early September. The symptoms appear to be consistent with a case of Guillain Barre Syndrome.
Swollen lymph node in armpit of arm where vaccination was administered, causing moderate discomfort; Swollen lymph node in armpit of arm where vaccination was administered, causing moderate discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old male patient received BNT162b2 (BNT162B2), on 15Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "if COVID prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE. Vaccination history included: moderna coviD-19 vaccine (DOSE 1, SINGLE; lot Number: Unknown, Anatomical location: Arm Left), administration date: 18Jan2021, when the patient was 21-year-old, for COVID-19 Immunization; moderna coviD-19 vaccine (DOSE 2,  SINGLE; Lot Number: Unknown), administration date: 18Feb2021, when the patient was 21-year-old, for COVID-19 Immunization; moderna coviD-19 vaccine (DOSE 3 (BOOSTER),SINGLE;  Lot Number: Unknown), administration date: 26Oct2021, when the patient was 22-year-old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), DISCOMFORT (non-serious) all with onset 17Sep2022, outcome "unknown" and all described as "Swollen lymph node in armpit of arm where vaccination was administered, causing moderate discomfort". Therapeutic measures were not taken as a result of lymphadenopathy, discomfort.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. This report is not serious.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Female patient refers feeling agitated and itchy in the throat. Patient refers feeling unsteady and feels a lump in the throat. Vitals are BP 120/80, Sat02 97%. Paramedic and voice personnel talked with the patient, and she was given prep alcohol treated with breathing exercises for 30min. They recommended to calm down and practice breathing exercises. She was referred to primary doctor.
Patient reported localized itching, redness, & swelling at the injection site. She stayed for over 30 minutes after the injection. We gave her an ice pack. She applied it to the area for about 15 minutes. She says the itching subsided & wanted to leave. Called her doctor & he said oral or topical BENADRYL & to call him if it got worse.
itchiness; swelling; redder and redder in that area/bright red/red area getting worse; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redder and redder in that area/bright red/red area getting worse) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Depression. Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) for Depression.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced PRURITUS (itchiness), SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redder and redder in that area/bright red/red area getting worse). On 22-Apr-2021, PRURITUS (itchiness) was resolving. At the time of the report, SWELLING (swelling) outcome was unknown and VACCINATION SITE ERYTHEMA (redder and redder in that area/bright red/red area getting worse) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included anti-itch cream for pruritus.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Non-Significant follow-up (Contact Information) appended.
Sniffles/Runny nose; Cough; Get the chills and I get hot, and I get chills and I get hot and I get chills, stuff like that; Get the chills and I get hot, and I get chills and I get hot and I get chills, stuff like that; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via intramuscular on 21Jul2021 as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route on unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, patient experienced sniffles/runny nose, cough, get the chills and i get hot, and i get chills and i get hot and i get chills, stuff like that. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Arm swelled and redness below the vaccination site. Eye muscles weakened and could not hold eye opened on vaccination site side.
Weakness in upper arm that was used for vaccination.  Influenza Vaccine administered subcutaneously on 11-8-2006.  Symptoms began to occur around 12-25-2006.  Physical therapy, nerve conduction studies have been done by VA facility in Asheville NC.  5/18/07 Received medical records from VAMC which reveal patient experienced numbness of left arm w/tingling of fingers, unable to lift left arm & difficulty using left hand since 12/31/06.  Exam on 1/8/07 revealed significantly decreased ROM of left  arm.  numbness of left arm had resolved.  Dx w/left arm neuropathy.  Referred for EMG.  PMR consult on 1/12/07 revealed left shoulder girdle atrophy & limited ROM.  Left elbow flexion was limited.  There was generalized muscle weakness of the left arm.   DTRs absent at biceps & brachial radialis & there was decreased sensation.   Issued sling & referred for OT.  Neuro consult done 2/12/07 agreed w/dx.  Treated w/steroids & referred for MRI of left brachial plexus. FINAL DX: Left Brachial plexitis.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 29-JAN-2019, the patient was vaccinated with improperly stored PEDVAXHIB (1 injection, via intramuscular, lot #: R0123571, expiration date: 19-MAR-2021; strength and anatomical location were not reported) for prophylaxis. No adverse effect was reported. The PEDVAXHIB was exposed to 0 degree Celsius for 45 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA008818: US-009507513-1903USA006922: US-009507513-1903USA006923: US-009507513-1903USA006924: US-009507513-1903USA006925: US-009507513-1903USA006927: US-009507513-1903USA006928: US-009507513-1903USA006929: US-009507513-1903USA006930: US-009507513-1903USA006931: US-009507513-1903USA006932: US-009507513-1903USA006933: US-009507513-1903USA006934: US-009507513-1903USA006935: US-009507513-1903USA006936: US-009507513-1903USA006937: US-009507513-1903USA006938: US-009507513-1903USA006939: US-009507513-1903USA006940: US-009507513-1903USA006941: US-009507513-1903USA006942: US-009507513-1903USA006943: US-009507513-1903USA006944: US-009507513-1903USA006945: US-009507513-1903USA006946: US-009507513-1903USA006947: US-009507513-1903USA006948: US-009507513-1903USA006949: US-009507513-1903USA006950.
INFLAMMATION AND REDNESS ON THE LEFT ARM (DELTOID AREA AND RIGHT UNDERARM).
Event: Severe acute asthma exacerbation Treatment: Prednisone and Albuterol Outcome: Patient is still having symptoms as of today (11/18/2021
arm got  red with swelling that traveled down my arm and hot to touch, Doc put me on antibiotic for 10 days, was fine after that
Patient  called on 08/25/2023  to report side effects from administration given on 08/23/2023. Patient experienced itchiness on arm after administration and having fever of 101.F the next day, arm was tendor to the touch and  about 4.5 inches of redness.
Body aches, pains; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's comment: The case was self reported by the patient. The patient received first dose of Shingrix into right arm about 4 weeks ago and had body aches and pains. The reporter consented to follow up. The reporter did not have health care professional address. No additional details were provided by the reporter.
Client presented to the doctors office at 4pm Friday 8-06. Reported nausea, low grade fever, and approx. 10 cm of redness, swelling and warmth at the site of the varicella vaccination.
Experienced a severe pain I believe it's on the injection site which is her arm; Area where I got the shot is little bit sensitive and painful; Area where I got the shot is little bit sensitive and painful; Pain is like different, it's more like in the muscle I would say like in the internal side of the arm as opposed to external; When I stretch my arm like fully it hurt a lot of it, it feels like different then like the pain when you just got the shot; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 25 year-old female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (Lot number: EW0175) at the age of 25 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Experienced a severe pain I believe it's on the injection site which is her arm"; VACCINATION SITE REACTION (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "Area where I got the shot is little bit sensitive and painful"; MYALGIA (non-serious) with onset 06May2021, outcome "unknown", described as "Pain is like different, it's more like in the muscle I would say like in the internal side of the arm as opposed to external"; PAIN (non-serious) with onset 06May2021, outcome "unknown", described as "When I stretch my arm like fully it hurt a lot of it, it feels like different then like the pain when you just got the shot".  Additional information: The patient reported that she was not experiencing severe pain it was just some kind of discomfort she would more describe it like that. It was like very mild pain in the arm. It was also reported that she thought that was weird and the pain kind of went away and then some kind of new pain appeared after. So the patient was wondering if there were people who were experiencing this or she did not know what she would be recommended.  No follow-up attempts are possible. No further information is expected.
Pain at injection site that resolved, and "tingling' that goes down to the elbow and forearm.
Primary series staring in 6 month old and Bivalent Pfizer vaccine given instead of Monovalent