chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; Patient was administered expired GARDASIL 9; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 03-MAY-2022, the patient was vaccinated with an expired dose (expired product administered) of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot #: S031287, expiration date: 08-APR-2022 (exact dose, strength, site and route of administration were not provided) for prophylaxis. There was no temperature excursions reported for the vaccine. There was no additional adverse event reported.
I RECIEVED MY SECOND DOSE OF THE MODERNA VACCINE FOR COVID-19 SHORTLY AFTER 9AM ON 2/3/21.  AT LUNCH TIME I REMEMBER FEELING MY LIPS WERE TIGHT.  BY THE TIME I WAS ABLE TO LOOK IN THE MIRROR I NOTICED THAT MY LIPS WERE SWOLLEN.  LATER THAT AFTERNOON ONCE I ARRIVED HOME FROM WORK I HAD A RASH ON MY NECK AND CHEST. MY TOUNG MOUTH AND LIPS WERE ALL SWOLLEN AND TINGLING. MY LEFT ARM AT THE INJECTION SITE WAS SWOLLEN RED.  AND BY 3PM THAT DAY I HAD A FEVER OF 101.6.  THROUGHT OUT THE NEXT FOUR DAYS MY FEVER WOULD REACH AT HIGHEST TO 103.7.  THE SWELLING IN MY LIPS CONTINUED FOR SEVERAL DAYS.
Patient received 10 mcg/0.2 mL product; should have received 25 mcg/0.25 mL product instead.
April 7 - Tachycardia confirmed by EKG lasting 72 hours. May 3 - Extreme knee/ankle and lower back pain, difficulty walking, numbness in feet and hands, extreme fatigue, swollen ankles, feet, elbows, wrists, calf muscle and foot spasms.  July 13 - numbness, fatigue and calf/foot muscle spasms continue today.
I noticed when I was taking a shower my neck was really tender swollen like a knot, couple days it got worse, then died down, never went away. I called to make an appointment with my doctor. My doctor believed it was a swollen lymph node, she said to watch it for 7 days and we would go from there if it doesn't go away she will run more test. This happened on my first vaccine, I didn't think anything of it.
Redness of left arm from vaccination site almost to my elbow.; Swelling of left arm from vaccination site almost to my elbow.; Slight fever; Tiredness; Chills; This is a spontaneous report received from a contactable consumer, the patient. An elderly patient of an unknown aged and gender, received second of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in left arm on 18Mar2021 at 12:00, as a single dose for COVID-19 immunisation. Medical history included asthma and hypothyroidism. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in left arm on 25Feb2021 at 13:00, as a single dose for COVID-19 immunisation. The patient was allergic to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced slight fever, tiredness and chills on 19Mar2021, redness and swelling of left arm from vaccination site almost to elbow on 20Mar2021. The clinical outcome of slight fever, tiredness, chills, vaccination site swelling and vaccination site erythema was unknown.   No follow-up attempts are needed. No further information is expected.
chest tightness with shortness of breath; nausea for 10 minutes. Pain radiating to jaw
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 at 10:00 as dose 1, single (Lot number: EN9581), in right arm, on 19Feb2021 at 10:00 as dose 2, single (Lot number: EL9266), in left arm and on 11Feb2022 at 10:00 as dose 3 (booster), single (Lot number: FL3209) at the age of 33 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Diabetes type 1" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid treatment was from 06Sep202 to 07Sep2022.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202201151177 Same reporter/patient, same drug/different dose, different event.;
plaintiffs allege that their child sustained unspecified injuries on an unspecified date, d/t cyanamid DPT vax which was administered contrary to instructions of the TX hlth dept & contrary to MFR recommendations
My whole body aches, it really aches; In every joint, my body seems to ache; My whole body aches, it really aches; In every joint, my body seems to ache; This is a spontaneous report from a contactable Consumer (patient). A patient of unspecified age and gender received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) , via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced whole body aches, it really aches; in every joint, body seems to ache. The outcome of events was unknown.
Pt experienced itching all over.  No shortness of breath or breathing problems were reported.  Just itching.  Pt took benadryl by mouth and got better.
ITCHING, CHOKING SENSATION, COUGHING, WHEEZING, AND DIFFICULTY BREATHING
he was brought to the hospital because he experienced vomiting, sever stomach distention, and currently, has difficulties in walking.; he was brought to the hospital because he experienced vomiting, sever stomach distention, and currently, has difficulties in walking.; he was brought to the hospital because he experienced vomiting, sever stomach distention, and currently, has difficulties in walking.; Her grandson is 9 years old and received a Pfizer Covid19 vaccine pediatric dose last 11Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 9 year-old male patient received bnt162b2 (BNT162B2), administration date 11Nov2021 (Batch/Lot number: unknown) at the age of 9 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (hospitalization), VOMITING (hospitalization), ABDOMINAL DISTENSION (hospitalization) all with onset 11Nov2021, outcome "unknown" and all described as "he was brought to the hospital because he experienced vomiting, sever stomach distention, and currently, has difficulties in walking."; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 11Nov2021, outcome "unknown", described as "Her grandson is 9 years old and received a Pfizer Covid19 vaccine pediatric dose last 11Nov2021".Her grandson is 9 years old and received a Pfizer Covid19 vaccine pediatric dose last 11Nov2021, one holiday. At the same night, he was brought to the hospital because he experienced vomiting, sever stomach distention, and currently, has difficulties in walking. She was asking if these have been reported and if there are any patients, ages 5-11 years old, who experienced the same side effects? She stated her grandson is still currently in the hospital. Caller states he had the vaccine one holiday and that night he started having symptoms.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Right upper arm, injection site: erythema, edema, heat. Local reaction to DTaP.
One day post vax, the pt awoke with pain in her left deltoid area accompanied by redness and swelling, fever, and numbness of entire left arm.
24 HOURS POST INJECTION: ERYTHEMA SURROUNDING INJECTION SITE, HOT TO TOUCH. 48 HOURS POST INJECTION: ERYTHEMA INCREASED 4X TIMES ORIGINAL SIZE SURROUNDING INJECTION SITE, HOT TO TOUCH.
On 2/4/16 patient reported after vaccine, his lips swelled and legs itched. This lasted into the next day - this was unreported at the time. Resolved without treatment.
Patient received her first dose of pfizer x 2 weeks ago Number of days post vaccine: 14 days  Initial reaction was noted on day 2 after vaccine. Redness and pain to site resolved after a 3 days. Symptoms to arm has returned with an increase in pain to the right arm of 6/10 on a pain scale. Has been taking Tylenol and use of cold compresses without any effect. Reports of an induration, area red and warm to touch. Limited range of motion; able to move arm with pain but unable to lift any object.
Not sure if connected or not but suddenly had pain in my left foot. So severe, could barely walk on it.  Only hurt when putting pressure on foot.  I received my shot in my left arm.  It is now approx. 20hrs later and it's going away.  I took Advil immediately and took more during the evening.  I didn't realize until I took a shower this morning and remove the bandaid on my left arm that the symptoms started after my flu shot.  It doesn't make sense but I did not step on anything or do anything that would make my foot so sore and now it's going away.
Daughter started throwing up, couldn't get her to respond afterwards for about 10 min, just starred into space (wasn't her normal self for another 3 days).
Severe thirst (dehydration?); Pain on injection site; Severe throbbing headache; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 28Mar2021 at 12:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient was allergic to penicillin, cherries and peaches. The patient previously took aspirin (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy on unknown dates. The patient did not receive any medication within two weeks of vaccination. Prior to 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 28Mar2021 at 16:00, the patient experienced pain on injection site, severe throbbing headache and severe thirst (Dehydration?) for 2 days following vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with ibuprofen (ADVIL) for every 5 hours. The clinical outcome of events pain on injection site, severe throbbing headache and severe thirst were resolved on 30Mar2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Very, tight chest and very difficult to take a deep breathe. Measured O2 levels and high 90's - 98.
sore arm cant sleep on it. think I inject it in to his joint. pt been taken ibuprofen and icing it
My tinnitus has worsened.   I have a louder ringing in my ears.   I do not plan on getting the 2nd dose.
Maculepap, rash all over body entire. Rash (most probably sickle effect of MMR vs. allergy to amox). D/C Amox-Benadryl 3 hydrocortisone cream
Headache; Severe chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and CHILLS (Severe chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02521A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced HEADACHE (Headache) and CHILLS (Severe chills). On 31-Mar-2021, HEADACHE (Headache) and CHILLS (Severe chills) had resolved.
The patient completed a paper flu consent form and answered "yes" to the question of whether she was pregnant or could become pregnant in the next month.  She reported that her menstrual cycle was 7 days late, so she requested the preservative-free flu vaccine out of precaution.  The RN nurse who screened her consent noted the request for preservative-free flu vaccine.  The RN vaccinator mistakenly administered Fluzone Quad instead of preservative-free Fluarix.  This was a medication error; no adverse events have occurred per our knowledge.  Another RN counseled patient post-medication error.
after 5 minutes of receiving varicella vaccine pt developed a raised welt with redness around site.
sick; Initial information regarding an unsolicited valid non-serious case received from a non-health care professional (patient's wife) via social media on 23-Nov-2020.  This case involves an unknown age male patient who was as sick (illness) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), the patient was as sick as could be with flu (illness) (non-serious event) following the administration of INFLUENZA VACCINE. He never had a shot neither before nor since then.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
A report has been received from a Health Professional concerning a 28 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 24-Oct-2013. It was reported that consumer had received FLUMIST QUADRIVALENT and suspects she might be pregnant which started on 24-Oct-2013. The outcome of the event of patient received FLUMIST QUADRIVALENT and suspects she may be pregnant is unknown. The report was considered to be non-serious. Corrected report 06-Dec-2013: Pregnancy tab was filled. Additional reporter was added as Responsible Physician.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. The reporter stated that, on 18-AUG-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB with lot # M017127, expiry date 15-SEP-2017 (dose, strength, vaccination site, route unspecified). No adverse effect were reported. Product quality complain (PQC) was not involved. No further information was provided. Additional information has been requested.
10 hours after receiving injection, spontaneously began feeling cold, shivering to rigors, rapid heart rate increased respiratory rate,  lips and nail bed dusky,  T37C.  Took to ER, Temp 101 F and experienced a grandmal seizure,  lasting approximately  1 minute of  vigrous movement.  froathing and flaying .  Temp up to 103F. tachycardia and SOB, PO2 in 90's blood pressure low 78/45 88/50 after 3 liters of fluid up to 100/50.  Chest Xray, EKG, multiple labs blood and one urine text.
I experienced a small infection in my jaw line that almost formed a clot but it did not form, I also am experiencing a blood disease.
On day 7 to 8 of administration patient developed significant right knee pain and swelling, limping gait
Patient is experiencing SIRVA (shoulder injury related to vaccine administration). She has shoulder pain that began the same day of the vaccination. It has been associated with weakness and limited range of motion. She notes some range of motion improvement overall since it began. She has been seen by her PCP with negative Xrays, given VOLTAREN gel and started with PT. She continues to do PT currently without much improvement thus far.
sore left arm next day / night sweats for 5 days after and hot flashes during the day for a week/  head aches  at back of neck/ and on the 5 day had a red, hard, hot,swollen  lump at injection site. I used Benadryl jell on arm for 3 days to get it back to normal.
Adverse event: It was reported that patient received first dose Pfizer vaccine at 08:37. He had emesis in post-observation at 08:40. Treatment: Assessed by post-observation RN. EMT called and assessed. Patient taken by EMT to private observation area with parent. His father stated he (the patient) did not eat before vaccination. Given juice. Patient also stated he was very anxious about being vaccinated. Outcome: Patient asymptomatic. Vital signs stable (per EMT). BP 104/70, HR 82, Resp 16, Temp. 96,4 F, O2 Sat 98%). EMT discharged patient with parent to home.
sudden onset severe muscle pain all over body; progressively got worse over 7 days; 4 days of loss of fine motor skills; very difficult to walk,get out of bed, etc. symptoms lasted @ 16 days
Was exposed to a COVID + person on the 12/20/2020, took a COVID test on 12/23/2020 negative results, on 12/26/2020 started feeling feverish at night, just did not feel good, felt tired, felt different.  Then the next day started developing a cough in the afternoon, no fever during the day, took my temperature and it was 99.8F and it was later on the afternoon. On the 27th I started coughing a lot more, it kinda hurt a little bit like Bronchitis, not productive at all, I coughed a lot. Did not feel bad at all but the cough was very present. On Tuesday evening it felt like I was coming down with a cold and Wednesday my taste buds started changing, I could not taste as well and then my cough got better. Just had a stuffy nose like a cold, I was feeling fine, was able to do all my normal activities as usual.  It might have lasted overall 7 days and I was completely fine.
Woke up with just a sore arm the following day. As time progressed my arm got more sore; the site was hot, with a red circle and lump under the skin. Headache, muscle and joint aches, fatigue. Treated with some Nyquil, Excedrin, and sleep. Onset was about 16 hours after the original dose.  almost 2 days later I'm still very fatigued, although the rest of the pain has largely gone away.
upper extremity 10 minute Tonic Clonic seizure suffered in parking lot after appt. transported by paramedics to hospital.
10:26h - pt reports 'can't swallow', lips tingling, feels nervous/anxious while in parked car in post-vaccination area, BP 138/72, pulse 91, O2 sat 88%, pt observed to be tachypnic but A&Ox3, responding appropriately 10:32h - BP 128/88, pulse 92, O2 sat 98%, MD arrived for further assessment, no meds given/no further interventions, close observation/monitoring only 10:38h - paramedics arrived, pt released to their care, AMA observed to be signed by pt and her partner/driver
8NOV93 hosp w/weakness; 10NOV93 transferred to med cntr on ventilator; in ICU w/dx of GBS;11NOV93 being plasmapheresed;hx of URI 1 wk prior to sx onset;
Tingling started at injection site left shoulder, then spread to left side, then whole body (still active after 6 days). Irritation of stomach lining, irritability, extreme fatigue, difficult sleeping due to tingling.
Right shoulder pain; It feels heavy and swollen, tight; It feels heavy and swollen, tight; It feels heavy and swollen, tight; This is a spontaneous report from a contactable nurse, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sulpha drugs. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient received unspecified multivitamins within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 19Apr2021, the patient experienced right shoulder pain, it felt heavy and swollen and tight. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event right shoulder pain, it felt heavy and swollen and tight was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
On night of April 25th I went to ER with a sudden and intense chest pain that brought on high heart rate, high blood pressure, head ache, dizziness, sweating and nausea.  I was admitted into ER and tested for a heart attach which I did not have.  I was released from ER in the early morning hours.  Since my first dose, I have had persistent brain fog (fuzzy thinking), trouble concentrating, and strange bouts of fatigue.  The second dose was a hard recovery with extreme fatigue lasting over 4 days but the strange bouts of fatigue are random and not just after the second dose.
within in minutes of the vaccine and while driving to the rest area almost fainted, started to black out, dizziness an hollow hearing/tinitus. Lasted for 10 mins and gradually subsided over 20 minutes
Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 05-APR-2007, the patient was inoculated by a physician with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, the patient subsequently contracted a persistent strain of herpes zoster. On or about 18-MAY-2016, the patient was treated by a physician for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles. The patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 23-SEP-2015, the patient was vaccinated with an improperly stored dose of VAQTA (dose, route, lot number and expiration date were not provided). The vaccine was exposed to temperature excursion of 34F during that month. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient presented to pharmacy where vaccines were given 2 days later to show pharmacist red, slightly swollen and warm area of arm where vaccines were administered. NO complaint of itching, pain, or rash. Only wanted to notify pharmacist.