chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 21 year old male who received Anthrax vaccine #1 16 Aug 04, #2 Sep 04, and #3 on 25 Sep 04. He reported no problems with these vaccinations. Between shots #2 and #3 he began to notice lower back discomfort with radiation down his right leg. He denied any history of injury and never had pain like this before. No other associated symptoms and he did not seek medical attention. He did not notice any immediate worsening of this pain with Anthrax #3. From Sep 05-Jan 06, He noticed a gradual increase in his back pain. He stated the pain was across his lower back and he noticed a decrease during the day as his movements increased. He did not seek medical attention for this pain until the spring of 05. He was told it was muscle strain and was given anti-inflammatories and muscle relaxants. He reported no relief with these measures. In Jun/Jul 05 he went to a chiropractor and he experienced only slight relief and the pain eventually returned. He went back to his provider and was given anti-inflammatories and muscle relaxants. During New Year 06 he stated his pain became so bad that he could hardly move or even walk, especially during the am. His pain continued to ease during the day. He went back to his provider and had x-rays and physical therapy. He reported that his x-rays showed something so they were repeated along with the blood work. His blood work revealed a + HLA B27 gene and he was referred to rheumatology, had an MRI and was diagnosed with Ankylosing Spondylitis (A.S.) this past spring. He was started on Enbrel and is reporting relief, however, he is noticing upper back pain. He stated that the pain was always there but that he did not notice before because of the severe lower back pain. He reported this pain to his rheumatologist who thinks that it is related to the A.S. or scoliosis. Even though he realizes he has the gene for A.S. he thinks the anthrax vaccine triggered it to become active. Pain 09/2004 low back with morning stiffness.
Extreme fatigue; Brain fog; Hot/cold flashes; Dizziness; Couldn't stand for at least 5 minutes due to the dizziness; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient 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 17Mar2021 at 10:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic fatigue syndrome/myalgia encephalomyelitis, eczema and asthma. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 12:00, after receiving dose 1, the patient experienced extreme fatigue, brain fog, hot/cold flashes, and dizziness. The same day at night, patient awoke and was so dizzy and collapsed onto the floor when patient tried walking to the bathroom. The patient could not stand for at least 5 minutes due to the dizziness and it only abated after taking medications. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events and included treatment with meclizine, XANAX 25 mg and gatorade. The clinical outcome of the events extreme fatigue, brain fog, hot/cold flashes, and dizziness and unable to stand was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 21-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J006831, expiration date: 14-SEP-2014) (dose and route were not reported). The reporter stated that ZOSTAVAX did not have any previous temperature excursions. No adverse symptoms were reported. Additional information has been requested.
There was no seriousness criteria reported in this case. Based upon appropriate medical judgement the reported event was considered serious: medical significant event (OMIC). From initial information received on 6/17/04 from a healthcare professional regarding an adverse event occurring, it was reported that a 25 year old female patient received TD ADS ADULT vaccination, lot number U1016AA, administered IM in the right deltoid, on 5/21/04. An unspecified amount of time later, the patient developed bilateral brachial plexus neuritis. She was seen by a physician, but no other information was provided. The recovery status of the patient was not reported.
Patient received typhoid and yellow fever vaccination for traveling to Kenya. Patient became pale and fainted. 911 was called BP 80/60, he was taken to the ER. Father stated this has happened before with injections.
Information has been received from a physician's assistant concerning a 55 year old female who on 10/26/05 was attending a clinic and was vaccinated IM with a 0.5ml second dose of Pneumococcal 23v polysaccharide vaccine. The pt reported that she had received the Pneumococcal 23v polysaccharide vaccine six years ago and was requesting another. The reporter noted that she had heard from another health care professional that on 10/7/05 the pt developed a cellulitis like reaction. Unspecified medical attention was sought. the pts outcome was unknown. The physicians assistant was going to call the pt to follow up with her. No product quality complaint was involved. Additional information has been requested.
Chills, Fatigue, Fever, injection site pain, redness and swelling starting 12.23.2020 I experience increase of temperature and fatigue.
5/01 Seen in ER for itchy red rash on medial upper right arm where Pneumovax was given previous day. 05/02 Recheck in ER: Patient describes chills but no fever. Pred 20mg for 5 days. Thought to be a local inflammatory reaction.
The pt experienced redness, swelling in left thigh with a fever lasting 2-3 days. Gave warm compress, Tylenol, Motrin, Keflex, and Zyrtec.
No adverse event; Vaccine was administered post expiration date 13-JUL-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     Patient did not describe any medical history or conditions.     On 21-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Jul-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022).    It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Previous doses were not reported.  No concomitant medication was reported.   The expiration date was reported as 13-JUL-2022. Caller wanted to know what the stability of the vaccine after 13-Jun-2022.  No treatment information was reported.  This case contains information for patient 2 out of 4.   This case was linked to US-MODERNATX, INC.-MOD-2023-737010 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737010:Master case, Patient 1
Dizziness began 10 minutes after injection and progressed to severe vertigo by evening.  Caused spotting/menstrual cycle in a menopausal person.
SORE ARM FOR A FEW DAYS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had received pneumonia vaccines and shingles vaccines (unspecified date). The patient have not had covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included influenza vaccine for prophylactic vaccination. On an unspecified date, the patient experienced sore arm for a few days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm for a few days. This report was non-serious. This case, from the same reporter is linked to 20221260450.
Patien got  first Moderna shot about 6 weeks ago. Turned up for second shot but a thunderstorm forced it all to shut down. APH has not contacted me to re-schedule.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patien got  first Moderna shot about 6 weeks ago. Turned up for second shot but a thunderstorm forced it all to shut down. APH has not contacted me to re-schedule.) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patien got  first Moderna shot about 6 weeks ago. Turned up for second shot but a thunderstorm forced it all to shut down. APH has not contacted me to re-schedule.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patien got  first Moderna shot about 6 weeks ago. Turned up for second shot but a thunderstorm forced it all to shut down. APH has not contacted me to re-schedule.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff)  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves (an adult) male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  It was a case of actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Pt received vaccine on Monday. Pt woke up the next day with localized swelling of the injection site. The second day after the vaccine the swelling increased in size. The third day pt stated the swelling had increased to more of his arm. Today pt presents with left upper arm swollen, erythema and warm to the touch. Pt is being treated with antibiotics.
Post first and second vax, sometime thereafter she experienced arthritic like joint pain. Treatment included Celecoxib.
Headache day after injection, lasted 2 days, hoarseness 2nd day and shoulder muscles ached for 2 days.  Fever started 3rd day 101.5 during evenings and nights and down to 96.5 during the day, night sweats 2 or 3 times during the week.  The fevers lasted.  One week after injection everything back to normal.
Inappropriate age at vaccine administration; Mumps antibody test negative; Inappropriate age at vaccine administration; Mumps antibody test negative; Measles antibody negative; Rubella antibody negative; This spontaneous report was received from a nurse, calling on behalf of herself, a female patient of unknown age. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On an unknown date, the patient received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, strength, lot #, expiry date, and route of administration were not provided) series as a child. Then, on an unknown date, the patient received an additional dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, strength, lot #, expiry date, and route of administration were not provided) in her twenties (Product administered to patient of inappropriate age).   The patient had a blood titer drawn on 19-NOV-2021 and the results were the following: Mumps- less than 9 (unit not provided) (Mumps antibody test negative), Measles- less than 13.5 (unit not provided) (Measles antibody negative), Rubella- 3.8 (unit not provided) (Rubella antibody negative). Because patient's titers came back as not immune, her university required her to get an additional dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) recombinant Human albumin (rHA) for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (lot: T007232, expiration date was not reported, but upon internal validation established as 27-FEB-2022) which she received on 30-JAN-2022 (Product administered to patient of inappropriate age). The patient then had a second blood titer drawn on 09-MAY-2023 and the results were the following: Mumps- less than 9 (unit not provided), Measles- 26.2 (unit not provided), Rubella- 9.0 (unit not provided). The most recent titer result showed that the patient was not immune to mumps (Mumps antibody test negative). No further information provided. The outcome of all events was unknown. The action taken with M-M-R II regarding all events was not applicable.   The causal relationship between events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Additional Details: Patient came in for her Pfizer Booster vaccination. Patient received the Johnson and Johnson vaccination previously. The patient vaccine screening questions were answered and no adverse reactions from vaccinations was listed in the questionaire and in her profile. Ambulance was called immediately and patient was able to walk out of the store with no issues. Patient also stated she did not eat or drink anything that day and seemed nervous about the vaccination.
Following the second dose I had some reaction consitant with what has been reported by others and consistant with side effects decribed by the CDC. Tired slept for 8 hours, slight fever, chills that started 12 hours after the shot and lasted through another 24hours, I did have a very sore arm unlike a regular flu shot that radiated to and beow my arm pit for 6-10 days befor going away. What I was not exspecting or paying much attention to sluffing it off to veriouse things was a slow but steady loss of energy the days following being vaccinated, I have always been active getting regular excercise combined with a very healthy diet, somthing was anew with me but wasn't associatieng it with anything now (cont below)
Patient stated he's pain didn't start until 2 days after administration and he's arm is still in a lot of pain today. The patient stated he can only bend his arm half way up.  He also states pain is radiating pain down his arm at certain times.
Fever/body aches and inability to sleep the first night (Wednesday into Thursday) , slight fever (99.7) with injection site pain all day on Thursday treated with Tylenol.   Severe headache Friday night (around 1:30am.).  Headache was gone by morning.   Numbness and tingling in my left hand, face and injection site throughout Saturday am. I thought I was having a stroke.   Severe Chest pains at 1:30am (Sunday early morning) with nausea  and slight fever(99.7).  I thought I was having a heart attack.  Almost went to the ER but vitals were within normal range when take at home.  Ended up taking famotidine and Tylenol and feel fairly normal today (Sunday).
Pruritus, swelling, warmth, pain. Cellulitis, Cefdinir.
Development of shingles around the right orbital socket leading dorsally to the apex of the cranium.
Fever, chills, nausea, muscle aches, injection site soreness, headache, hip pain
the arm is very swollen; About the area on arm where the vaccine was injected has swollen up; there is a little dot there; there is a little red rash; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (the arm is very swollen), VACCINATION SITE SWELLING (About the area on arm where the vaccine was injected has swollen up), VACCINATION SITE ERYTHEMA (there is a little dot there) and VACCINATION SITE RASH (there is a little red rash) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced PERIPHERAL SWELLING (the arm is very swollen), VACCINATION SITE SWELLING (About the area on arm where the vaccine was injected has swollen up), VACCINATION SITE ERYTHEMA (there is a little dot there) and VACCINATION SITE RASH (there is a little red rash). At the time of the report, PERIPHERAL SWELLING (the arm is very swollen), VACCINATION SITE SWELLING (About the area on arm where the vaccine was injected has swollen up), VACCINATION SITE ERYTHEMA (there is a little dot there) and VACCINATION SITE RASH (there is a little red rash) outcome was unknown.            Concomitant medication includes Blood thinners and Blood pressure Medication.  Treatment information was not provided.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 22-DEC-2008, a healthcare provider at a medical group administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 25-MAY-2016 and 09-JUN-2016, the patient was treated by a healthcare provider at a medical group for shingles and post-herpetic neuralgia. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. 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. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of back disorder in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included back disorder (patient had back problem at least 20 times a year). On 8th August 2018, the patient received the 2nd dose of SHINGRIX. On 8th August 2018, less than a day after receiving SHINGRIX, the patient experienced back disorder. On an unknown date, the outcome of the back disorder was unknown. It was unknown if the reporter considered the back disorder to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient mentioned that after taking the vaccine the day of reporting, as she was leaving the pharmacy, her back went out. She stated that the problem with her back was not uncommon. The patient had this problem at least 20 times a year. She said that it had nothing to do with the vaccine. The patient name was already in the system, but it was missed confirming the address. This was all of the information provided.
sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "sick".  Additional information: This PREVNAR 20 shot has no benefits for the patient because it made him sick (patient age: 68, unit unspecified).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day after treatment, fever of 100.5 degrees. Did not last long.   during the night awakened several times with rapid heart rate as well as some arrhythmias.   Was able to text my Cardiologist at 7am, who told me I was having a reaction to the vaccine.   His wife had had the same reaction.   After 72 hours, her adverse reaction was gone.