chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 70 year old male patient with hypertension, gout, paroxysmal atrial fibrillation and no known drug allergies who on 03-AUG-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (subcutaneous injection, lot# 662856/1559X). Concomitant therapy included LOTREL and allopurinol. On 06-SEP-2009 the patient experienced shingles on the left side of face around the eye. The patient was seen by an ophthalmologist and the shingles did not extend into the eye. The patient was travelling when the symptoms began. Upon his arrival he was seen in an emergency room and was hospitalised. He was given acyclovir. The patient had been seen by his responsible physician and photographs confirmed diagnosis of shingles. The physician mentioned the patient was improving; the vesicles were gone and scabs remained along in the maxillary along the trigeminal nerve. No lab diagnostic study was performed. Additional information has been requested.
Dad reports patient had syncope that lasted only a few seconds after the vaccines that was not brought to the attention of the nurse at that visit. He was fine afterwards with no further presyncope or syncope. He was very nervous about these shots and the shots were given in the same arm right deltoid because he was not cooperative and anxious and pulling away from dad who was having trouble holding him.
hosp w/excruciating abd pain;T104;BP 58/34;rapid pulse;shallow breathing;elevated WBC;Dx: severe kidney infect;at disch bilirubin elevated 3x nl;still exp severe pain;found to have gall stones;cholecystectomy performed;pain continues w/D
My arm was very sore all night and when I woke up I had two raised, red patches on my right arm. One patch was at the injection site, one was slightly below the injection site. The injection site is also still very sore and hard.
pt cried from time inj was given @ 1030AM until around 3PM;pt was dozing in arms when brought pt in;leg had been red but redness had gone;mom had called in & was told to bring pt to be MD;hard mass @ site of inj;
Within a few hours of receiving injection, pt developed redness, swelling and pain in the same arm but not at vaccination site. Redness/swelling in bend of arm and upper arm on the inside but not at where injection was administered.
7/1/99 redness & swelling to right arm; small amt of swelling; APAP & ice
Terrible headache within 6 hours. Lasted until 14 hours after shot.  Injection site pain next day and worse on day after that (2nd day after shot).
pt hospitalized from 1/1/22 - 1/4/22 with COVID and pneumonia; back to ED via EMS on 1/5/22 with severe respiratory distress; O2 saturation 84% on 4L O2; worsening SOB; intubated; ICU; steroids, ABX, Remdesivir; pt did not make good progress; status changed to comfort care and she passed away in the hospital
pt recv vax; instructed to use ice & take advil;red lump to lt deltoid; put on ATB & Atarax;
1. Tickling sensation in nose upon immediate injection (this only happened one time and went away) 2. Goosebumps on arms twice driving home, even though I felt fine 3. Swelling/bump/soreness/warmth at site injection which didn?t go away after a few days 4. Swelling started taking a shape (1x3 inches) at day 9 post vaccination. I emailed my PCP,  to ask if this was normal. He said to monitor it and continue to have the second dose, but to wait 30 minutes after the next shot in March. 5. Swelling continued to increase (about 3x5 inches....my whole palm covers it)  and continued to remain hot still present at day 12 post vaccination  6. Occasional mild itching at injection location  7. For two days, I felt as if my antidepressants weren?t working, even though I was taking them consistently  8. One day of heart palpitations, which went away 9. One day of lightheadedness/dizziness, which went away
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 18-FEB-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius) for 1764 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
pt began with redness, warmth, and swelling to right arm when Pneumonia vaccine was admin- lasted for 4 days, slowly improved each day
pt inadvertently received 2 doses of fluogen on 27SEP93 & 14OCT93;
Patient came in next day and said she felt nauseated and the local injection site was very red and hot. We explained this is a reaction that could happen and to monitor the red area. She came in 2 days later and the "red area" had increased in size and traveled down to her arm. When I called her 4 days after her vaccine administration she explained the redness had descended to the inner elbow portion of her arm however it was no longer red but now yellow/green/blue as if it looked like a bruising had occurred. She did state she no longer had the nausea and was feeling fine aside from the arm looking bruised.
cancer sprang up on her hands shortly thereafter; Initial information received on 13-Feb-2022 regarding an unsolicited valid  serious case received from a consumer via social media.   This case involves a 97 years old female patient who experienced cancer sprang up on her hands shortly thereafter while receiving vaccine Influenza Vaccine   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect Influenza Vaccine (formulation, strength, dose, route, batch number and expiry date) in unknown administered site for immunization.  On an unknown date the patient developed a serious cancer sprang up on her hands shortly thereafter (neoplasm malignant) (unknown latency) following the administration of Influenza Vaccine.   Action taken: not applicable  It was not reported if the patient received a corrective treatment for the event (cancer sprang up on her hands shortly thereafter).  At time of reporting, the outcome was Unknown for the event cancer sprang up on her hands shortly thereafter.  seriousness- medically significant; Sender's Comments: Sanofi Company Comment dated 16-FEB-2022: This case involves a 97 years old female patient who had cancer sprang up on her hands shortly thereafter, after she was treated with ranitidine hydrochloride [Zantac]. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past and concomitant medication, therapy details, any family history of cancer and any relevant medical history of patient, any concurrent conditions and type of cancer and indication of the drug precludes comprehensive case assessment.
Information has been received on 11/28/2001 from a physician concerning a 5 year old male who approximately one year ago, November 2000, was vaccinated with one dose of varicella vaccine. There was no concomitant medication. On 11/14/2001, the pt developed varicella with about 30 lesions with mild fever and congestion. The pt did not require prescription drug treatment. The pt sought unspecified medical attention. Additional info has been requested.
Pt developed erythematous, indurated and painful area (L) thigh 48 hrs after the shots were given (DTaP #4 & HIB #4). Ran fever 24 hrs prior to large local reaction developed and with painful wt. bearing as well.
Less than 5 minutes after flu shot, patient came to counter in a panic.  Said she is having an angina attack.  Was yelling in pain while emptying her purse.  Sat down, still in pain.  We called 911.  While on the call, our tech found her nitroglycerin and gave her 1 tab.  Within about 3 minutes, patient felt it subside.  She denied having trouble breathing or like an elephant sitting on her chest.  Reported pain in her lower abdominal area.  Shortly after a policeman arrived and took over care.  Patient came back next day to report she spent the night at the hospital and they confirmed it was an angina attack.
Nerve pain at injection site, upper right arm.  Weakness and tingling extend to fingers. Continues to date, 12/9/2105.
A non-serious spontaneous report of given expired FLUMIST was received from a health professional concerning a 19-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 18-Dec-2011. On 19-Dec-2011, the patient received expired product.. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Woke up in the middle of the night from sharp chest pain in center of chest, lasted approx. 2-3 seconds, dissipated for 10-15 seconds, then another 2-3 seconds sharp pain.
Patient incorrectly given 0.5ml dose of Moderna as a booster. 1st vaccination was J&J.
Initial redness, pain and swelling at local injection site around 30 minutes after immunization.  Swelling continued  throughout the day in ?donut? shape around injection site on 10/2/2020. As of this report, redness has spread throughout area of swelling and soreness is still present.
mom reported pts t105 430AM pt had recvd vax 1JUL 815AM & was given APAP; In the evening eyes were glazed, arm is tender & reddened; jerking episode, poss sz activity or shivering; resp were grunting, protecting the arms, not wanting to use
Information has been received concerning a 7 year-old patient who on 26-Aug-1996 was vaccinated with a dose of varicella virus vaccine live (lot number 617075/1663B). The patient developed a moderate case of chickenpox. It was noted that there was an outbreak of chickenpox at a local elementary school. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint reported. It was also reported that three other patients developed a similar reaction (WAES#0305USA00312), (WAES #0304USA535) and (WAES #0305USA00536). Additional information has been requested.
14:30h - pt noticed reddened area R thigh only (non-pruritic) after removing her pants for toileting 14:32h - BP 142/92, pulse 116, RR 17, O2 sat 98%, A&Ox4 14:56 - BP 138/88, pulse 108, RR 18, O2 sat 99%, responding appropriately, observation only of mild cutaneous reaction without Stevens Johnson reaction, respiratory distress/compromise or angioedema, no interventions/treatments required, pt released to home after 30 min observation by volunteer MD
Severe projectile vomiting and dry heaving for 12 hours straight - still extremely nauseated and it?s Friday - the vomiting started Sunday early early morning. I?ve never been so violently ill.
2 MONTHS OF MUSCLE PAIN AND RED AREAS ON BOTH ANKLES AND SOULS OF FEET    .  NO PAIN OR ITCH ON RED AREAS BUT VERY RED
Patient described pain in lower neck and between shoulder blades. Did not feel sick, no fever just didn't feel great.
Patient had Pfizer COVID vaccine # 2 on 7 April, 2021.  Starting on 16 April - she developed a rash to each upper arm.  Rash was red, very itchy, and painful.  Worst symptoms were on 17 April.  Cortisone -10 cream did not make an improvement.    Exam with macular rash to each upper arm with mild warmth, redness. and tenderness (that is not cellulitis.)  Rash is consistent with "Covid Arms" delayed vaccine response.  Patient seen in Dr's office (my clinic) on 19 April.2021.  I prescribed atarax and triamcinolone cream for symptom relief.
Approximately 6-7 hours after the booster, I woke up with an achy body and with a very loud white noise in my right ear.  The white noise lasted a couple hours.  I have never had tinnitus before.  Ear is still a little tender a week later.
4APR had h/a, joint pain, sore throat;no rash, malaise;no treatment @ this time;
tested positive for Covid 19; tested positive for Covid 19; he started with sinus issues but had no fever or chills; This is a spontaneous report from a contactable consumer (spouse). A male patient of an unspecified age, received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on 31Mar2021, as a single dose for COVID-19 immunisation. 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 expiry dates were not provided) on an unknown date. Reporter stated that she and her husband both received the second shot on 31Mar2021, right before noon. Her husband didn't get much, in regards to symptoms, and was feeling fine before the shot. 2 Days later (in Apr2021), he started with sinus issues but had no fever or chills and stated that these symptoms were expected. It was reported that her husband went to the walk in clinic on 5Apr2021 because he was worried it was Covid. He tested positive for COVID-19 but, it was not even 5 days after the shot. Went to the doctor's office yesterday (06Apr2021) and got another test at the doctor's office. That test came back positive as well and got the results on 07Apr2021. The patient went to the walk in clinic on Sunday because he didn't know if he should go to work on Monday. Stated that she does not know if the antibodies from the Pfizer vaccine are showing up on the test. It has been 5 days since the second test. Outcome of the events was unknown.  Information on lot number/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Jansen COVID-19 Vaccine EUA  Since vax on Friday April 9th: - extremely lightheaded, fuzzy, dizzy and disoriented, would describe similar to vertigo  - fever on off, less frequent Sunday and Monday (today April 12) - racing heart (fri night after vax, resting heart rate over night at 70+, normal RHR 48) - anxiety
Rash at site of injection (right arm). In addition to a small rash and scab where band aid was attached to skin. Pt has allergy to adhesive but insisted on band aid use.
Per pt mother, pt has experienced episodes of right side of mouth not moving normally as it appears to pull towards the left side. This has occurred during the past couple weeks prior to vaccination, but states she has become more aware of the issue since receiving H1N1. This does resolve without specific intervention. Pt also has been complaining of severe headaches and nausea.
Received MMR, Varicella & Hep A vaccines on 4/28/08.  Developed fever on 5/6/08 which resolved on 5/7/08 and developed rash on 5/7/08 which appears to be a varicella-like rash. Otherwise the baby is doing well.
couldn't talk; Canker sores or hives came back; This spontaneous case was reported by a consumer and describes the occurrence of SPEECH DISORDER (couldn't talk) and APHTHOUS ULCER (Canker sores or hives came back) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Pacemaker insertion (cardiac) and Heart valve replacement. Concurrent medical conditions included Diabetes.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced SPEECH DISORDER (couldn't talk) and APHTHOUS ULCER (Canker sores or hives came back). On 11-Apr-2021, SPEECH DISORDER (couldn't talk) had resolved. At the time of the report, APHTHOUS ULCER (Canker sores or hives came back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications include Meds for her diabetes Treatment medications include Over the counter things for canker sores   This case was linked to US-MODERNATX, INC.-MOD-2021-083060 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083060:First dose
A report was received from a health care professional on 10/29/02, concerning a 38 year old male vaccinee who experienced an injection site reaction after receiving Fluvirin on 10/23/02. On 10/24/02, the vaccinee developed a 8"x' area of redness, swelling, tenderness and itching near the injection site. The vaccinee has not yet recovered. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/13/02:A follow up report received from a health care professional indicated that the vaccinee received Fluvirin via subcutaneous injection inferior to the deltoid muscle. Symptoms of the adverse event also included redness, induration and itching around the injection site. The vaccinee recovered after 8 days.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021 at 11:08 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:08 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 55.24 for dose administered on 15-Apr-2021.  No concomitant medications were reported.  Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 06-Apr-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Immunizations 6/24/04. Reaction left deltoid area/ red/ swollen/ hot to touch/ hard/ no symptoms this AM/ Benadryl at 10:30 pm last night/ no fever/ no pain.
Patient took second dose 22 days after the first dose; felt like everything was pushing downward on her face; face felt frozen and could not move her face; Ptosis of her left eye; Dull and severe headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (felt like everything was pushing downward on her face) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 0077M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced FACIAL PARALYSIS (felt like everything was pushing downward on her face) (seriousness criterion medically significant), HYPOAESTHESIA (face felt frozen and could not move her face), EYELID PTOSIS (Ptosis of her left eye) and HEADACHE (Dull and severe headache). On 23-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took second dose 22 days after the first dose). On 23-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took second dose 22 days after the first dose) had resolved. At the time of the report, FACIAL PARALYSIS (felt like everything was pushing downward on her face), HYPOAESTHESIA (face felt frozen and could not move her face) and HEADACHE (Dull and severe headache) outcome was unknown and EYELID PTOSIS (Ptosis of her left eye) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was reported. She consulted neurologist who prescribed apraclonidine 0.5 percent.   This case was linked to MOD-2021-066385 (Patient Link).; Sender'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. However, this is also a case of Inappropriate schedule of product administration of mRNA-1273 lot #(001A21A) with associated AE"s of facial paralysis, hypoesthesia, headache and ptosis. Further information is requested.
For the First dose:   A migraine-level headache set in about twelve hours after vaccination. It lasted for over 12 hours.  For the Second Dose: Nausea, chills, fever, vomiting all started twelve hours after vaccination. The chills and fever lasted for 18 hours total.  Mental fog started at 18 hour mark and remains 48 hours later.
Contracted associate received vaccine on 12/18/2020 at 1000.  Within 1/2 hour began to feel very hot and extremely tired.  She left and had to rest in the lobby before she could drive home.  She finally drove home and all weekend was short of breath, hot (not sure if she had a fever), fatigued.  She went to the ED this morning (12/21/20) had a Rapid COVID test that was neg and is now waiting for PCR test results.  She has been instructed to quarantine for 20 days.  She has lupus and a history of kidney transplant in 2004.
patient felt feverish, had a red, tender and inflamed area a little smaller than the size of a baseball at injection site. Patient went to urgent care 9/22/19 and was given triamcinolone cream and told to mark red area and contact primary care doctor if it enlarged and also to come tell us.