chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 16 months old granddaughter who on 20-MAY-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot # not provided) and a dose of MMR II (Lot # not provided). The patient experienced black and blue mark at the injection site as well as fever. At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Immediately post vaccination, the pt developed erythema at the injection site. the erythema faded within 5 minutes of onset. The pt was observed for 15 minutes and was reported as being ok. It was noted that 5 weeks prior vaccination the pt had a similar reaction to varicella vaccine.
Severe chills - began at 8pm ET 3/7/21 and lasted until approximately 6am 3/8/21 Headache - began at 8pm ET 3/7/21 and lasted until 6pm 3/8/21 Nausea - began at 8pm ET 3/7/21 and lasted until approximately 6am 3/8/21
Few days after she got Covid but asymptomatic; Few days after she got Covid but asymptomatic; This is a spontaneous report received from a contactable reporter (daughter) reported that a female patient (mother) of an unspecified age (Age: 83; Unit: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on 20Jan2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated on behalf of her mother that few days after, she got Covid but asymptomatic in 2021. She went on quarantine at the facility for 2 weeks. Still remained positive in 2021 then another quarantine on their home. Took a swab test and turned negative in 2021. Reporter wanted to know the waiting time for her mother to have her 2nd dose, is it 90 days or none at all. The outcome of the event was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Chills, fever, headache, night sweats, shoulder pain, fever blister, tiredness, nausea.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. No information about medical history concurrent conditions and concomitant medications was reported. The reporter stated that after the patient was vaccinated with 1st shot of GARDASIL intramuscular, the patient developed rash which lasted for weeks. it was also reported that after the patient received the 2nd shot of GARDASIL the patient developed rash that lasted for months. The reporter mentioned that patient started the series approximately on an unknown date in 2008 (reported as about 6 years ago) and the patient never received the 3rd shot of GARDASIL. The outcome of the event reported is unknown. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
diagnosed with MS; developed photophobia; The light sensitivity turned to double vision; Initial information received on 24-Aug-2022 regarding an unsolicited valid serious case received from a patient's sister.  This case involves a 49-year-old male patient who had been diagnosed with multiple sclerosis (MS), developed photophobia, the light sensitivity turned to double vision after receiving vaccine Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA355972(Menactra).   On an unknown date in Jun or Jul of this year 2022, the patient was doubted to received suspect Menquadfi vaccine at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for immunization. Information regarding batch number requested.  On unknown date in 2022 within 24 to 48 hours of receiving the vaccine, patient developed photophobia and the light sensitivity turned to double vision (diplopia). Patient had developed other significant symptoms and after lots of testing.  On unknown date in 2022, the patient developed a serious has been diagnosed with MS (multiple sclerosis) at unknown latency. This event was assessed as medically significant.  Action taken: Not applicable.  Corrective treatment: not reported.  At time of reporting, the outcome was Unknown for the events.; Sender's Comments: Sanofi company comment 02-Sep-2022: This case involves a 49-year-old male patient who experienced has been diagnosed with multiple sclerosis (MS), developed photophobia, the light sensitivity turned to double vision after receiving MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI]. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
pt recvd vax & had inc t 103; cried for approx 45-60 min; 3cm red area on rt thigh; crusted & oozed for a while;
Swelling, redness about the size of a dime and soreness.  As of 12/15/2010  redness has spread to the size of 4 quarters with additional swelling, soreness and pain throughout arm.  Treating with Benadryl and Cortisone Cream.  Pain, weakness, soreness, swelling and redness is continuing to spread.
patient received 27 mcg of pfizer instead of 10 mcg due to incorrect vial reconstituted... patient received no adverse reaction to this occurrence
Patient up to date on COVID vaccinations who admitted to hospital with COVID complications.  Provider discharge note below:  "Per HPI, Has past medical history which includes esophageal adenocarcinoma with metastasis to bone and lung, paroxysmal atrial fibrillation, pulmonary embolism, hypertension, hyperlipidemia, coronary artery disease, peripheral neuropathy, sick sinus syndrome for which he has had pacemaker, hypothyroidism, and glucose intolerance.    Has gotten progressively more short of breath over the past month; tonight had acute exacerbation and felt short of breath even at rest.  Has been feeling very tired and like he might pass out when walking.  Has been sitting a lot.  Has been sitting in a chair to sleep for the past week. Chronically has had intermittent ""real bad ache in right upper chest and area where he has cancer in T7; gets relief with Aleve cream. Occasionally has a mild cough which is productive of clear phlegm. Urine has been bright yellow recently; unaware of any change in medications or supplement or foods he has been eating.      Last chemotherapy was 1 1/2 to 2 years ago; last radiation was summer of 2021.  Has had 2 Moderna Covid vaccine and booster. Has lost about 5 lbs in the past couple of weeks. Occasionally gets headaches for which he takes Tylenol with relief. Has chronic intermittent lower abdominal sharp gas pains for years; gets relief with omeprazole. Wears gloves 24/7 due to peripheral neuropathy. Has a sore on the back of his head which he got from a branch while mowing the last last year--it will not heal; wife reports he won't leave it alone.    Denies recent fever, chills, exposure to known sick contacts, runny nose, sore throat, nausea, vomiting, diarrhea, constipation, pain with urination.       Hospital Course:  Patient was admitted and monitored closely while being placed on heparin infusion. Patient remained hemodynamically stable without desaturation. Patient with elevated risk of VTE given underlying malignancy, possibly provoked with COVID positive status. Patient previously on Xarelto but was discontinued in 2019. Given recurrence, patient may benefit from remaining on anticoagulation indefinitely, especially with absence of absolute contraindications. "
Headache; Queasy; tired; cold; Initial information was received on 21-Nov-2020 regarding an unsolicited valid non-serious case from a non-health care professional (patient) via social media.  This case involves an adult patient with an unknown demographics who had headache, queasy (nausea), tired (fatigue) and cold (nasopharyngitis), while he/she received influenza vaccine.  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, the patient had headache, tired (fatigue), queasy (nausea) and cold (nasopharyngitis). The patient laid down and slept for about an hour, woke up and was much better (outcome: resolving for all the events).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  There will be no information available regarding batch number in this case. No further relevant information was reported.
About 10 minutes after administering the H1N1 vaccination, the patient develop perioral numbness, throat tightness and dysarthria. Epinephrine 1:1000 0.1mL was given IM, the patient was monitored and medrol dose pack was prescribed.
Client states that her hair has started to fall out since she received the Covid Vaccination. She states she has not had any medical treatment at this time.
Initial induration 8x8cm with erythema extremely from deltoid to elbow.  Pruritic. No systemic symptoms. Symptoms developed w/in 12 hours.
Patient was given the Pfizer Covid vaccine that expired 23 days prior.  Patient and physician have been notified
Information has been received from a physician concerning patients who were vaccinated with doses of VARIVAX (Merck) since 1996.  She has logged about 45 cases of breakthrough varicella in the patients.  It was reported that medical attention was sought, all cases had less than 50 lesions, none had to be treated or hospitalized and all recovered.  No product quality complaint was involved.  Additional information has been received from the physician concerning one of the patients.  It was reported that a 12 month old patient was vaccinated on 07/01/1997 with a dose of VARIVAX.  On 08/14/1997 the patient experienced varicella.  Thirty nine other cases experienced breakthrough varicella after vaccination with varicella virus vaccine live.  No additional information is expected.
Fever over 100, 3 blood clots discovered in hospital where I was sent by the Hematologist after fever started.
This spontaneous report was received from a pharmacist via a company representative, referring to a 79 year old female patient. The patient's medical history, concurrent conditions, drug and allergy history were not provided. On 25-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 on an unspecified arm (strength, dose, frequency, dose number, administration route, lot number and expiration date were not reported), to prevent pneumonia. On 26-SEP-2017, the patient received other dose of PNEUMOVAX 23 (strength, dose, frequency, dose number, administration route, lot number and expiration date were not reported). Concomitant therapies included blood pressure and anxiety medications. On 26-SEP-2017, the patient developed redness and inflammatory response on the same arm as injection site from elbow to shoulder. Lab diagnostics or studies were not performed and the patient did not seek medical attention. The outcome of injection site erythema and injection site inflammation was reported as resolving. The reporter causality assessment between the aforementioned events and PNEUMOVAX 23 was not reported.
Pt stated she received flu shot on 11/2 and that she had seizure on the next day - 11/3. Went to ER, ran tests and did EEG. They didn't find anything, but has appt with neurologist. Not able to drive yet.
Chills; body aches; fever; Tired; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 02Apr2021 at 11:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included irbesartan (MANUFACTURER UNKNOWN) and fexofenadine hydrochloride (ALLEGRA), both from unknown dates for unknown indications and unknown if ongoing. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW6215) via an unspecified route of administration in the left arm on 10Mar2021 at 11:45 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. 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 02Apr2021 at 20:30, on the evening of second vaccine, the patient was tired. On 03Apr2021 at 01:30, the patient experienced chills, body aches and fever and it lasted until the evening of 04Apr2021. On 05Apr2021 the patient was still tired and on 06Apr2021 she was better. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the events chills, body aches and fever was resolved on the evening of 04Apr2021 and the event tired was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
I had a fever (101.6 degrees), a headache, chills, and fatigue. My internal shingles got worse and my thrush got worse. My Crohn's has gotten worse. My RA also got worse. My osteoarthritis got worse. I have been really fatigued. I have had a sore throat. I have been experiencing more pain and stiffness in my joints. Every day it gets worse. I went to see my doctor on the 20th and they did blood work. They said that my CRP level was elevated. My white blood count was below normal. It dropped to a low level since about 2014. This was a normal blood level test that I have periodically. The CRP showed a response to the COVID shot. I have immune struggles, but I am still taking the impact from the vaccine. I don't feel like I have been as strong as I normally am throughout the summer.
pt fell on floor. pt remained alert and consious. pt drank gator ade. mother sat with patient until ems arrived. pt's pulse-ox was 100%. pt left store healthy.
I received the Johnson and Johnson covid vaccine on 7 April 2021.  Within 6 hours of receiving the vaccine, I experienced typical flu like symptoms.   Though the majority of the symptoms subsided within 24 hours, I continued to experience headache symptoms for several days.  On 12 April 2021, I woke up with a broken blood vessel in my left eye and  red and black eyelid.  The blood from broken blood vessel continued to get worse.  I went to the ER to have tests run because the J&J vaccine was removed from use during this time.
Initial information received on 06-Jun-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves four-year-old patient (gender not reported) who was inadvertently vaccinated with PENTACEL as 5th dose (batch number, Expiry date, dose, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to Extra dose administered. 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 holder's 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.
Day after vaccines were administered mother noted swelling, redness and tenderness of left arm. No fever, vomiting or diarrhea.
On day of receiving vax approx 10PM devel sever h/a, nausea, pain, erythema, edema @ site, pain in axilla;
They have a temperature excursion on 04Jun2022; Vial expired on 13-Jul-2022 and refrigerated on 17Jul2022 and 18Jul2022; administer expiry vaccine to 5 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expiry vaccine to 5 patients), PRODUCT TEMPERATURE EXCURSION ISSUE (They have a temperature excursion on 04Jun2022) and PRODUCT STORAGE ERROR (Vial expired on 13-Jul-2022 and refrigerated on 17Jul2022 and 18Jul2022) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Johnson & Johnson in April 2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson.   On 22-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expiry vaccine to 5 patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (They have a temperature excursion on 04Jun2022) and PRODUCT STORAGE ERROR (Vial expired on 13-Jul-2022 and refrigerated on 17Jul2022 and 18Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expiry vaccine to 5 patients), PRODUCT TEMPERATURE EXCURSION ISSUE (They have a temperature excursion on 04Jun2022) and PRODUCT STORAGE ERROR (Vial expired on 13-Jul-2022 and refrigerated on 17Jul2022 and 18Jul2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. It was reported that during time of excursion (maximum 5.8 degree F) for 15min vials were in frozen storage. 3 affected vials were stored in refrigerator on 17-Jul-2022 and 18-Jul-2022. Currently those vials were wasted and 1 vial was stored in the freezer. Vaccines did not have a change in state and were still frozen. No treatment medication was reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-611848, US-MODERNATX, INC.-MOD-2022-611864, US-MODERNATX, INC.-MOD-2022-611805, US-MODERNATX, INC.-MOD-2022-611877 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2022: Live follow-up received contains non significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-611848:Patient 2 US-MODERNATX, INC.-MOD-2022-611864:Patient 4 US-MODERNATX, INC.-MOD-2022-611805:Patient 1 US-MODERNATX, INC.-MOD-2022-611877:Patient 5
2/7/21, left lower leg pain and swelling and tenderness, began to migrate around shin and up calf. Extreme tenderness and it began to travel up my leg.  Went to vascular Dr. on 2/17, did US rules out DVT, but diagnosed with severe phlebitis.  compression socks and elevation.  Went back on 2/24/21 as continued to progress up now into thigh.  did another US, rules out DVT and phlebitis continues to be the diagnosis.
sinus drainage then moved to drainage in chest;23OCT97 fever 102.2, chills went home early wed, thurs & of Friday reported 27OCT;still feels sluggish;has had bad coughing attack had to sit up
01/27/12  Red Rashes, blisters, sharp pain on left side of face only.  Complained of left ear hurting.  Only on left side of face. 0/28/12 Continued Red Rashes, blisters, sharp pain; Went on internet and found exact picture and symptoms - shingles. 1/29/12 - Called Primary Care Physician and recommended emergency room for treatment.  Took Mother to Clinic for treatment. Attending physician prescribed antiviral medication for seven days.  Mother's caregiver staff and I must watch for pink eye and get her to eye doctor immediately.
Day 1: Arm pain, fatigue, joint stiffness, cough, chills, severe headache, nausea, vomiting. Day 2: Arm pain, fatigue, cough, mild headache. Day 3: No symptoms.
41 y/o female with c/o left arm pain and left axillary lymph node swelling, congestion, sore throat, cough X 10 days. Symptoms started 1-2 days after receiving flu vaccine. Patient states that lymph node swelling has decreased significantly and muscle pain and swelling has improved significantly. She had a similar reaction to the flu vaccine 10 yrs ago.
Sore neck muscles in back for 2 days; Sore neck muscles in back for 2 days; The initial case was the missing following minimum criteria: no adverse effect. Upon receipt of follow-up information on 08Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL8982) via an unspecified route of administration in left arm on 30Jan2021 at 12:10 (at the age of 76-years-old) as a single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. In 2021, the patient experienced sore neck muscles in back for 2 days. The patient was asked if it is possible to take the second dose to different place. The patient did not receive any treatments for the events. There was no admission to hospital involved due to the events. The outcome of the events was resolved in 2021. The patient was scheduled to get the vaccine after 4 weeks. On 26Feb2021, the patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9265), via an unspecified route of administration at single dose for Covid-19 immunization. The patient had no discomfort after second dose.  Follow-up attempts are completed. No further information is expected.
Vaccine given 11.5.07; by 11.5.07 night patient experiened shaking legs; she thinks she developed a fever; staying in bed all day Tues and Wed. Wed. night legs calmed down. There was swelling, redness and pain at injection site which showed improvement by 11.8.07 when she came in for appointment.
It was not an adverse event related to vaccine, instead it was an ADMINISTRATION ERROR.  We originally thought on 4/28/2021 at his 15 month well check that the patient had inadvertently been given varicella vaccine DILUENT only and did not receive varicella mixed with the diluent after our vaccine/inventory count was off.  I contacted the state immunization program on 5/5/2021 and informed them of suspected error. They had recommended revaccination for Varicella based on information we could conclude. Mother made aware and patient came in office on 5/6/2021 for repeat vaccination of Varicella for full dose and ensure protection.  After further investigation it was determined that the patient had inadvertently been given MMR instead of Varicella as MMR vaccine was off. This was not made evident until after we had already re-vaccinated for Varicella on 5/6/2021. Per state guidance we were to add back in the MMR as he did receive that vaccine to our EMR and the state record. This was completed and they requested VAERS report to be filled out.