chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she got COVID last year and took PAXLOVID. She added that she got COVID again; she got COVID last year and took PAXLOVID. She added that she got COVID again; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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 2022, outcome "unknown" and all described as "she got COVID last year and took PAXLOVID. She added that she got COVID again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: She mentioned that she got COVID last year and took PAXLOVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 18OCT95 & exp severe ache for 3 to 6 days;there was a reddened area @ the inj site the size of a quarter;
Developed rash and itching 10-15 minutes after shots. Brought back into room - noted urticaria on face. Given BENADRYL (po). Sxs improved after = 15 minutes. Mom called next day - no rash after 24 hours.
Severe hormonal side effects; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 (Lot number: 331308A) at the age of 31 years as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: HORMONE LEVEL ABNORMAL (non-serious) with onset Jan2022, outcome "unknown", described as "Severe hormonal side effects". Therapeutic measures were taken as a result of hormone level abnormal.  Additional information: It was stated by the reporter that she called to report an adverse reaction to the Pfizer booster. Xanax used for treatment of event. Dose: 0.5mg. Formulation: Tablet. Frequency: 3 times a day. Xanax used for treatment of event. Dose: 0.5mg. Formulation: Tablet. Frequency: 3 times a day. No other medications.  No follow-up attempts are possible. No further information is expected.
I had a fever of 103.6 degrees F (even after taking Tylenol) for 6 days.  Also, my left axillary lymph nodes swelled up to the size of a baseball and I could not fully lower my arm to my side.  My lymph nodes remained very large for over a week.  I also had extreme fatigue.    I had a fever of 103 for three days following my second dose, but I did not experience axillary lymphadenopathy.
Information has been received from a pharmacist, concerning an adult patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 11-SEP-2017 and on 03-NOV-2017, the patient was vaccinated with improperly stored doses of VARIVAX, lot number N000681 with expiration date in 06-JAN-2019 (strength, anatomical location, dose number and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (MRK) (lot number and expiration date were unknown); the pharmacist did not know if the sterile diluent (MRK) used had an excursion. The VARIVAX was stored at a temperature range of 6 degrees Fahrenheit (°F) to 14 °F for the time frame of 1.5 hours. There was no previous temperature excursion and the call was because of a data logger. No adverse symptoms were reported.
DTaP #5 was given 5/2/03. Child got up on Sat 5/3/03 with right arm swollen from where injection given to almost down to elbow with redness. Edema and redness did not go around arm. No temp and child remained playful and well seeming throughout. Mom says did not take to PCP as did not seem to bother him.
Patient with redness (3 in x 3 3/4 in), warmth, swelling, and pain at Varivax injection site - Tylenol PRN pain, Benadryl.
Had Moderna Covid 19 Vaccine Dose 2 on 2/11.  On 2/19 had itchy rashes below the neck across neck line above blouse area.  Took zyrtec, applied .1%  topical generic cortizine creme.  It has improved. But on 2/22 had rashes on the right arm and it was itching.  It has improved today.  But now I have rashes, not itchy, on the belly and left fore arm.
Patient received Fluzone Quadrivalent vaccine instead of Fluzone High-Dose Quadrivalent. Patient was notified on 9/27/22 after the error had been discovered. Patient was directed to consult with her healthcare provider to determine whether an additional vaccine would be recommended. Patient reported that she felt fine following the vaccination and didn't have any ill effects.
headache; tiredness; chill; fever; nausea; dizziness; weakness; This is spontaneous report from a contactable consumer. A 71-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: en6202), via an unspecified route of administration, administered in left arm on 06Mar2021 12:00 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No known allergies was reported. Patient did not other vaccine in four weeks. The patient experienced headache, tiredness, chill, fever, nausea, dizziness and weakness on 06Mar2021 21:00. Treatment was received by the patient. No covid prior vaccination. Patient did not covid tested post vaccination. Outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
ADVERSE EVENT NOS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. 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 prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced adverse event nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event nos was not reported. This report was non-serious.
Nurse administered 0.3mL of  Covid Vaccine to Right deltoid in error. Guardian brought pt, for booster dose to early.  Only outcome patient had was a sore arm and a headache
Pain at injection site the first day. Second day aches all over body, the whole body was very sensitive and had an on and off headache
Weak; couldn't get up; couldn't walk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Weak), DYSSTASIA (couldn't get up) and GAIT DISTURBANCE (couldn't walk) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced ASTHENIA (Weak) (seriousness criterion hospitalization), DYSSTASIA (couldn't get up) (seriousness criterion hospitalization) and GAIT DISTURBANCE (couldn't walk) (seriousness criterion hospitalization). The patient was hospitalized on 29-Mar-2021 due to ASTHENIA, DYSSTASIA and GAIT DISTURBANCE. The patient was treated with Rehabilitation therapy (Still currently resides in the rehab facility) for Asthenia; Rehabilitation therapy (Still currently resides in the rehab facility) for Dysstasia and Rehabilitation therapy (Still currently resides in the rehab facility) for Gait disturbance. At the time of the report, ASTHENIA (Weak), DYSSTASIA (couldn't get up) and GAIT DISTURBANCE (couldn't walk) had not resolved.            Patient experienced events after 1 hour of receiving the second dose of the vaccine. Patient usually walks with a walker but not this bad.  Action taken with mRNA-1273 in responsible to the event was not applicable.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-081271 (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 these events, a causal relationship cannot be excluded.
FELT LIKE HEAVINESS / WEIGHTS IN OBLIQUES; SORENESS IN ARM; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, the subject experienced soreness in arm. On 14-APR-2021, the subject experienced felt like heaviness / weights in obliques. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness in arm on 21-MAR-2021, and had not recovered from felt like heaviness / weights in obliques. This report was non-serious.
Experiencing pain that alternated from the left hip, to the left knee, to the right hip, to the right knee / return of  a previous pain in the left shoulder; Hair ceased growing / has only grown one inch since last dose received; Temporary bubble in the left eye; Low blood pressure; Dizziness; Hard lumps have formed on the top of the skin over their knuckles; Being unable to walk for approximately 1 week; Unable to chew for approximately 1 week; This case was reported by a consumer via call center representative and described the occurrence of unable to walk in a 78-year-old female patient who received HBV (Engerix B) for prophylaxis.   The patient's past medical history included shoulder pain. Previously administered products included Engerix B (1st dose received on May 2019) and Engerix B (2nd dose received on June 2019).   In November 2019, the patient received the 3rd dose of Engerix B. In January 2020, 2 months after receiving Engerix B, the patient experienced unable to walk, chewing difficulty, arthralgia multiple, hair growth decreased, eye disorder, low blood pressure, dizziness and skin nodule. On an unknown date, the outcome of the unable to walk, chewing difficulty, eye disorder, low blood pressure and dizziness were recovered/resolved and the outcome of the arthralgia multiple was recovering/resolving and the outcome of the hair growth decreased and skin nodule were not recovered/not resolved.   It was unknown if the reporter considered the unable to walk, chewing difficulty, arthralgia multiple, hair growth decreased, eye disorder, low blood pressure, dizziness and skin nodule to be related to Engerix B.  Additional details were provided as follows: The reporter was the patient. The blood tests had showed high level of B12 in the blood. The patient had received all the three doses of Engerix B. The patient had onset of symptoms as approximately 2 months after receiving last dose.  The patient was unable to walk and unable to chew for approximately 1 week. The patient was experiencing pain that alternated from the left hip, to the left knee, to the right hip, to the right knee. The patient stated that there was a return of a previous pain in the left shoulder Hair had ceased growing after receiving last dose of vaccine and had only grown one inch since the last dose. The patient reported an appearance of a temporary bubble in the left eye. The patient had also experienced low blood pressure that resulted in dizziness.  The patient also had hard lumps that had formed on the top of the skin over the knuckles. The reporter did not consent to follow-up.
Rash, hives, warm to touch, itching, swelling, ache. Took antihistamine, applied hydrocortisone. Still red,etc. on 2/23/2021
my body is swollen/ all my body is sore, it started last night in my foot and now all my arms, my hands and my face is sored, its sored, its swelling, its supper swollen; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 15Apr2021 as dose 1, single for covid-19 immunisation. The patients medical history and concomitant medications were not reported. Patient states that she was calling because yesterday (15Apr2021) she got her first dose of the Pfizer shot and that night her leg was swollen and her whole body was swollen/ body is sore. It started last night placed her foot and now all her arms, her hands and her face is sored, it was sored it was swelling, it was supper swollen. She just wanted to know if this was normal or if it was something she has to worry about. The outcome of both the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Headache, Nausea, Vomiting, Low Grade Fever, Soreness in the arm, tired
Information has been received from a physician concerning a 14 year old female with immunocompromised and a history of heart transplant who was vaccinated with a dose of GARDASIL. Concomitant therapy included varicella virus live, for the treatment of prophylaxis. Other concomitant therapy included HAVRIX. Ten days after the vaccination, the patient experienced cellulitis. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
After 2nd vaccine dose developed myalgias, fever, chills, chest pain and shortness of breath hours afterwards which persisted and continued to worsen. Initial work up so far in the hospital appears to be myocarditis and is he is being admitted to telemetry.
I had the old vaccine nine years ago. Came down with shingles two weeks ago.; This spontaneous report was received from consumer concerning to a patient with unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2013 (also reported as nine years ago), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneous injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unspecified date in August 2022 (reported as two weeks ago), the patient experienced shingles. The patient reported that had some bad headaches, shooting pains but nothing like what most people have, and very little rash (all of them were considerate as symptoms of singles). Additionally reported that had shingles right now on the  forehead and the doctors were concerned it getting in the patient's eye. The patient did not has it nearly as bad as it could and the thought it was because of the vaccine.  Causality assessment between the event and the suspect vaccine was not provided.
Diarrhea (>8 watery stools per day) for 7 days No dehydration, no weight loss Treating  with probiotic and binding foods
Received Paxlovid as the treatment of COVID-19; Received Paxlovid as the treatment of COVID-19; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 47-year-old male patient received BNT162b2 (BNT162B2), on 05Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfates" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Received Paxlovid as the treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Feels light headed and tired, felt tight in chest with breathing for 5 min, then resolved. Heart rate 78-regular rate and rhythm BP 100/68 SP02 96% RA, 98%
Patient received Tdap immunization (booster). Later that evening Pt noticed swelling, edema, hot spot on injection site. Reaction continued for several days , "about 4 days". Pt. presented 4/6/18 to pharmacist to discuss a large bruised area where injection was given. Site was decompressed with bruising in a 5cm x 7.5 cm area on the upper left arm. Pt stated it did not hurt but had some sense of increased heat remaining at injection site.
Headache that worsened over days, nausea, high blood pressure, all over joint pain, vomiting, extreme fatigue that lasted almost 30 days
got sick; Initial information received on 27-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp. This case involves an unknown age and unknown gender patient who got sick 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 produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. for prophylactic vaccination.  On an unknown date the patient developed a non-serious got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported"Since this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: Got the flu when I was in high school, got the flu shot about 8 years ago,got sick, no more shots for me".  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got sick).  At time of reporting, the outcome was Unknown for the event got sick.
Stated that she had both vaccinations and had no problems except for a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "surgery", start date: 24Feb2020 (unspecified if ongoing), notes: first surgery, reconstructed her vagina; "prolapsed vagina and colon" (unspecified if ongoing); "prolapsed vagina and colon" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Botox for to relax muscle in vagina, reaction(s): "nearly killed her"; Premarin, stop date: 2020, notes: she was out of Premarin Cream end of Mar2020 or beginning of Apr2020; 5% lidocaine pain; Gabapentin, reaction(s): "could not take a deep breath"; Valium, start date: 2020, notes: she started Valium at the end of Mar2020 or beginning of Apr2020.; Steroid for to relax muscle in vagina. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Stated that she had both vaccinations and had no problems except for a sore arm".  Additional information: She had a prolapsed vagina and colon. Stated that her first surgery was 24Feb2020. Stated that the doctor tried to give her Gabapentin and she could not take a deep breath. Stated that she recovered when it wore off. Stated that she flushed it down the commode. Stated that the Gabapentin was prescribed before the Botox. Stated that she was given one pill and never took another. Stated that she started Valium at the end of Mar2020 or beginning of Apr2020. Stated that she was out of Premarin Cream end of Mar2020 or beginning of Apr2020. Stated that she did not recover from steroid shots to relax muscle in vagina and it did not work or her doctor injected her with Botox and nearly killed her. Stated that the doctor who reconstructed her vagina injected her with Botox and nearly killed her. she had her surgery prior to Premarin Cream. Stated when doctor did first surgery got her colon too tight and she could not go to doctor to pee. Stated that he tried Valium and still could not get it to work. Stated that they were Valium suppositories. Stated that she went to another doctor and she wanted her to try steroid shots to relax muscle in vagina and it did not work. Stated that she waited 4-6 weeks and the doctor did three incisions to vagina and put Botox in there and it has been downhill from there. Stated that another place gave her 5% lidocaine pain to rub on there and she has scar tissue there. Stated that one of her incisions burst open. Stated that she cannot pay $$$ per month for Premarin Cream a month and she does not if it would do anything. Stated that she had not been pain free in two years. She was going to have a second surgery.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within hours of receiving vaccines, patient crying, weak, low grade fever (99.4 rectal), and hypotensive (65/31) with pale episode (pallor). Another child had similar sx, given same lot #.   10/5/09 ER report received, service date 9/10/09 9/11/09. Assessment: Mild Vaccine Reaction. Infant presented for evaluation of prolonged crying associated with facial pallor and decreased activity. Fussy. Overnight observation and discharged.