chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 20 year old female with no relevant medical history who on 19-FEB-2007 was vaccinated intramuscularly with a 0.5 mL first dose of Gardasil (lot 653735/0688F). Concomitant therapy included Ortho Tri-Cyclen Lo. Subsequently, she became pregnant. Date of LMP was 04-APR-2007. The patient subsequently miscarried. The patient was seen in the emergency room on 14-MAY-2007 for the miscarriage. She was not admitted to the hospital. The patient called the office on 17-MAY-2007 to notify the physician of the miscarriage, but had not returned to the office for follow-up visits. Upon internal review, the patient's spontaneous abortion was considered an other important medical event. Additional information has been requested.
Adverse events after second dose only: Moderate arm pain radiating down to wrist, within 6hrs after vaccine and present still at 24hrs Moderate constant headaches 12hours after vaccine and still present at 24hrs.  Moderate nausea starting at 12hrs and still present at 24hrs. Shortness of breath 18 hrs after vaccine, still present at 24hrs after.  Dizziness and photosensitivity at 16hrs after and still present at 24hrs after.
Dec-9 had DTaP, IPV, Comvax and Prevnar. On 12/10, fever 103-104 and two episodes of stiffness. Seen at hospital (+) influenzae also. Discharge Summary received on 1/13/2004 states seizure. Discharge Summary received on 1/13/2004 states influenza A positive.
Information was received from certified medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates starting on or after 09-JUN-2016, the patients were administered doses of improperly stored M-M-R II injection (lot#L028273, expired on 28-JUL-2017; lot#L037356, expired on 28-SEP-2017; lot#L035674, expired on 17-SEP-2017 (dose and route unknown). The vaccines were exposed under 11.1 Celsius degree for 4 hours 25 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
101.7 fever; headache; soreness all over her body; muscles hurt; discomfort; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8727, Expiration date was not reported), dose 2 via an unspecified route of administration on 28Mar2021(age at vaccination 64 years) as dose 2, single for covid-19 immunisation. Medical history included COPD, years of smoking, skin cancer (My mother has bad COPD from years of smoking. She has also previously had skin cancer). The patient's concomitant medications were not reported. The patient previously took historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205) dose 1 for covid-19 immunization. On Mar2021 the patient experienced 101.7 fever, headache, soreness all over her body, muscles hurt, discomfort. Reporter stated, almost akin to lactic acid build up. The discomfort was much more significant. Event took place after use of product. The patient underwent lab tests and procedures which included body temperature was 101.7. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Had 2nd shot , went to bed with muscle pain that evening around 10pm. Woke up the next morning with swollen top lip. The next morning my cheeks were swollen. These sites is where I have had filler also. Allergan and Metz products have been injected in top lip and cheek areas. Also Botox.
fever 101F, sore arm, large red swollen arm near injection site and warm to touch- possible cellulitis, referred to PCP for evaluation.
Started experience weakness and balance problems in 2019, had sudden onset of unexplained double vision in January 2020, lasted for a few months. Had numbness and tingling in fingers and toes during 2020 with bad leg cramps at night, severe cramping in legs at night.  In January 2021 had a lot of neck pain and rapid heart rate, shortness of breath. In February 2021 couldn't walk at all. Ended up in the ER with extensive testing done. Spent a week in the hospital on high dose steroids, discharged to inpatient therapy, discharged one week later to out patient occupational and physicial therapy. More MRI's done and have confirmed no tumor or MS that would cause this issue. Requires walker and assistance w/daily living
Flew home on 10/6/22; didn't wear a mask, sadly. On 10/8, I had a very minor sore throat which continued on 10/9. The evening of 10/9 I also started have a bit of a runny nose. On 10/10, mid-morning, I took an iHealth Covid home test which I'd received via the post office - I tested POSITIVE. I am quarantining in-home (to protect my wife). On 10/10, I contacted my health providers and received a 5-day anti-viral course of Paxlovid.
Had the injection 7-6-09 at 5 pm.  Beginning the next day, pt had severe headache and temperature of 100 degrees, extreme fatigue, and severe pain in area of injection.  These symptoms lasted 4 days.  The severe pain in arm has NOT subsided and is not improving after 12 days.  Pt finds it very difficult to work (is a dental hygienist and uses left arm all day for tongue retraction, which often requires a lot of muscle activity); difficult if not impossible to attend her beloved aerobic dance classes, which she has faithfully attended 3 times a week for 30 years; cannot sleep on that side, which she is used to doing, cannot lift anything heavy.  Worst of all, embracing husband is impossible, and if anyone, patient, family member, or friend, touches her arm inadvertently, the pain is almost unbearable.  The pain is on the surface but is especially painful deep inside the muscle.  Anytime pt moves arm AT ALL, she experiences severe pain.
approx. two minutes after vaccines were administered, patient was sitting in the chair in the exam room waiting to be discharged, when he became dizzy, fell off the chair to the floor, hitting his head. patient was unconscious for a brief moment. the hospital rapid response team was called. Patient was evaluated on the floor and then transferred to the emergency department for evaluation.
fever chills  body aches  heavy bleeding in the uterus only a week after having period pelvic pain
The next morning couldn't move left arm without pain, had to call in to work, fever cold,  chills, body hurtshurts ¹
Pt. received PENTACEL in addition to IPV & MMR & Flu vaccines. Unable to reach pt's fm language barrier.
Patient presents to med obs 1 via wheelchair and staff member. The patient requires a medical translator.  The patient states her body feels cold and her face feels warm, patient reports it feels "like a hot flash".  The patient reports feeling "itchy" in her thighs, arms and "all over". The patient is placed in a semi fowlers position and vitals obtained. After 15 minutes the patient reports she "feels fine" and requests to leave. Patient will be driving herself home and states she feels comfortable doing so. The patient is escorted out by staff without incident.    HR- 64   Resp- 20   BP-133/74   SpO2-99%  1504 - Sitting  HR- 62   Resp- 20   BP-110/73   SpO2- 100%
Patient states that when he woke up on Wednesday 9/17/14 he had generalized body aches, sinus drainage, lack of appetite, fatigue, light headedness and a widespread red rash on his bilateral arm and legs.
Per pt the morning following Td injection the right deltoid was itchy, sore and swollen. By the PM of the same day the entire region was hot to touch, grossly swollen, blue and too painful to move. Pt further c/o becoming so sick I had to go to bed. Today is the first day I have been able to get out of the house. Pt denies seeking medical care at anytime after receiving the Td shots.
Total body itchy hives started same day as vaccine. Mild. Scattered. Persisted since that day. No prior Hx. No other assoc. symptoms. (Parent reports not relieved by OTC BENADRYL. Pending resolution: prednisolone prescribed. (This was second flu vaccine).
Information has been received from a registered nurse concerning a female patient (age not reported), (patient was not in pregnant) with none pertinent medical history and none drug reactions/allergies who on 04-MAY-2012, was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (lot # 672233/1561AA), (exp. date 28-AUG-2014). There was no concomitant medication. On 05-MAY-2012, the patient experienced an episode of syncope. On the morning of 05-MAY-2012, the patient's mother called the office and reported patient experienced syncope and hit her head and fell. After the fall, patient's mother described her daughter as "she was shaking with her arm pulled up for about 2 minutes and she was unconscious". After about 2 minutes, patient was better and shaking stopped but she did not remember what happened. After the syncope incident, patient continued to have headaches and fatigue. The patient sought medical attention via doctor office visit. No treatment was given for adverse events. No lab diagnostic studies were performed. At the time of the report the patient's status was not recovered. Follow up information has been received from registered nurse, initial reporter, concerning the 15 year old female patient with none pre-existing allergies, birth defects and medical conditions who on 04-MAY-2012 was vaccinated intramuscularly in right arm with a first dose of GARDASIL (lot # 672233/1561AA). Secondary suspect therapy included VAQTA (received intramuscularly in left arm), (dose not reported), (lot #672470/1697AA). On 05-MAY-20112 the patient experienced body shaking, patient felt tired, was standing syncope (1 minute) not rhythmic, fell, hit head on door, and for next 3 days was "very" fatigued and had headaches. The patient required doctor visit. No lab diagnostic test were performed. At the time of the report the patient's status was recovered. No further information is available.
pt recv vax & mom states pt cried 6hr inconsolable;did not take formula;mom states had given pt APAP as directed;
Pt received FLUZONE, BOOSTRIX, and ZOSTAVAX injection in right arm May 22, 2012 (Tues). Patient has suffered headaches, fever, swollen bulls eye rash, soreness, etc.
1. Redness inferior and medial to vaccination site (Pneumovax site), severe tenderness 2. N/V, diarrhea, sweats
Day 7 my arm that received the injection developed a red inflamed oval mark. The size was approximately 4in x 2in. My lymph nodes were swollen and tender. The symptoms went away after 3 days.
hot, red, silver dollar sized local react; gone in 2 days; then on 10OCT, woke w/lump 4" long by 3-4 wide; hard, size of a golf ball w/marble sized fluid sac; went to ER for tests; all neg; 22DEC93 f/u large claviclar node on lt side;
No Additional AE; The first dose was given on 30-AUG-2021 and the second dose was given on 01-DEC-2021; This spontaneous report received from a registered nurse and refers to a patient of unknown age and gender.      The information about patient's concurrent condition, medical and drug history and concomitant medications were unknown.  On 30-AUG-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) dose one (exact dose, strength, vaccination scheme, frequency, route of administration and anatomical site of vaccination, lot#U005994 and expiration date 10-SEP-2022) as prophylaxis. The patient received second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) late as the patient missed the 4 months appointment. On 01-DEC-2021, the patient was vaccinated with second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (exact dose, strength, vaccination scheme, frequency, route of administration and anatomical site of vaccination, were not reported for prophylaxis (Inappropriate schedule of product administration).No additional AE reported.
AFTER RECEIVING THE GARDASIL VACCINE MY DAUGHTER DEVELOPED ASTHMA...NO FAMILY HISTORY OF ASTHMA.
had migraine before but never like this; nauseous; felt tired; feeling dizzy / light headed; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (had migraine before but never like this), DIZZINESS (feeling dizzy / light headed), NAUSEA (nauseous) and FATIGUE (felt tired) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced DIZZINESS (feeling dizzy / light headed). On an unknown date, the patient experienced MIGRAINE (had migraine before but never like this), NAUSEA (nauseous) and FATIGUE (felt tired). At the time of the report, MIGRAINE (had migraine before but never like this), DIZZINESS (feeling dizzy / light headed), NAUSEA (nauseous) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. Treatment information was not provided.
Symptoms: left arm numbness, slight discoloration of left arm and fingers, cool to touch, decrease capillary refill greater than 2 seconds, BP 150/90 R 22 P 104 (vital signs)  verbalization of "My arm feel like it swelling up" Lungs sounds slightly diminished. S/I  controlled deep breathes and cough, Benadryl 25 mg provided per past tx history. Positioned in  semi-fowler, warm compress with covering to promote vasodilation. Observed for hour per clients request. upon leaving  BP 130/76 P- 80 R-18.Stated "feeling much better
Pelvic Pain, Green Discharge, Vaginal Infectiom - Treatment: Clindomycin Vaginal Insert Cream for 7 days as prescribed by OGYN. This is the second time that I have these symptoms and  vaginal infection a day after receiving Pfizer Covid Vaccine dose. The first time was a day after receiving second dose and the second time was after receiving the third Pfizer Covid Vaccine dose.
Overall increased issues associated with mctd; Overall increased issues associated with mctd; Major muscle spasms developed in her back along spine bur throughout; could not walk; Skin inflamed to point of peeling  and continues be inflamed and peel; Skin inflamed to point of peeling and continues be inflamed and peel; overall increased inflammation and pain; overall increased inflammation and pain; This is a spontaneous report from a contactable other hcp (patient). A 68-year-old female patient received BNT162B2 (PFZIER COVID-19 VACCINE), at the age of 68 years old, dose 2 via an unspecified route of administration in left arm on 23Apr2021 (Lot Number: ew0172) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included mixed connective tissue disease (MCTD), thyroid cancer (thyCa), hypertension, extensive back surgery, known allergies scallops. Patient had a back fusion in Jan2021 and had had 5 prior back surgeries. Patient was not diagnosed with COVID-19 prior vaccination. Patient had not been tested for COVID-19 post vaccination. Historical vaccine included BNT162B2, at the age of 68 years old, dose 1 via an unspecified route of administration in left arm on 02Apr2021 (Lot Number: ew0153) as single dose for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. Concomitant medications in two weeks included olmesartan, diltiazem, metoprolol, more. Major muscle spasms developed in her back along spine bur throughout, could not walk, general overall increased inflammation and pain. Skin inflamed to point of peeling and continued be inflamed and peel. Overall increased issues associated with MCTD. Adverse events start date was May2021. Events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. It was unknown if treatment received. Outcome of events was unknown.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This case was reported by a pharmacist (also the subject's sister) and described the occurrence of injection site redness in a 41-year-old female subject who was vaccinated with FLULAVAL, GlaxoSmithKline.  Concurrent medications included Fluoxetine.  On 27 September 2008 at 22:00 the subject received a dose of FLULAVAL at 0.5 ml in the left arm.  Several days following administration of FLULAVAL, the subject experienced injection site redness, injection site soreness, numbness at the injection site and injection site tingling.  It was also reported that the subject was experiencing arm paralysis which also began several days following FLULAVAL injection.  She has to move the affected arm with her other arm, however, she does have feeling in the affected arm.  The pharmacist considered the events were clinically significant (or requiring intervention).  The subject was treated with Ibuprofen.  At the time of reporting the events seemed to be worsening and becoming disabling.  The pharmacist considered the events were possibly related to vaccination with FLULAVAL.
Intense chills, visibly more pale than normal, maybe circulation problems, have not recovered at time of writing this, the day of injection.
Vision impairment after about 60 minutes of receiving the shot that lasted for 6 hours; Blurred vision, unable to read.; soreness; light headedness; I had the expected symptoms of headache; This is a spontaneous report received from a contactable consumer (patient). A 51-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8732), at right arm via an unspecified route of administra-tion on 27Mar2021 10:30, as SINGLE DOSE for COVID-19 immunisation. Medical history included low iron and anemia. Concomitant medications included montelukast sodium (SINGULAIR) and omepra-zole (PRILOSEC [OMEPRAZOLE]), patient received these medications within 2 weeks of vaccination. Patient was allergic to IV contrast dye and salicylates. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. After about 60minutes of receiving the shot (27Mar2021 11:30) the patient had vision impairment lasted for approximately 6 hours. Patient had blurred vision and unable to read. Patient had the expected symptoms of headache, soreness, light headedness, etc. But was not expecting vision to be decreased. Patient not received treatment for the adverse event. Patient not tested for COVID-19 after the vaccination. The outcome of the event visual impairment was recovered and for the other events its recovering.
I woke up and I had a lot of dizziness. The dizziness persisted through the evening, I was walking into walls. I went to the doctor the next day; I declined a COVID-19, influenza, and strep throat because I did not feel like I was sick or anything, just dizziness. They diagnosed me with a sinus infection and ear infection in both ears. A couple of weeks later, I had a fever and sore throat. I went to get tested and passed out in the lobby. I had a 103F fever and blood pressure of 80/50. They could only tell me I had an infection, but couldn't determine what it was. My doctor wanted to test my blood to see if I had COVID-19; the results came back with extremely high antibody count and I had had COVID-19 in the last 30 days. The doctor diagnosed me with vestibular iritis which would explain my dizziness, loss of hearing in my right ear, and other symptoms; I now have physical therapy to help balance the side differences of balance.
Information has been received from a certified medical assistant concerning a 16 year old female patient who on 21-DEC-2006 was vaccinated IM into the arm with a first 0.5ml dose of Gardasil. On 21-FEB-2007 and 21-JUN-2007 the patient was vaccinated into the arm with a second and third dose, respectively. There was no concomitant medications. On 23-MAY-2007, the patient was diagnosed with mononucleosis and a staph infection on her leg. It was reported that the patient was treated with an unnamed sulfa antibiotic and experienced an "allergic reaction." She was then treated with an unnamed steroid. Laboratory diagnostic studies performed included "unknown lab tests." Subsequently, the patient recovered from staph infection on her leg and the allergic reaction. At the time of this report, the patient was recovering from the mononucleosis. No product quality complaint was involved. Additional information has been requested.
Soreness in shoulders and lower neck. Feels almost like a strained muscle. All started after 3rd shot.
High Fever x3 days 103-104 degrees.  Lethargic. Tremors. Blank Stares. Chills. Unconsolable crying.
On May 3rd I notice a severe/itchy rash on the back of my neck, and bilateral AC's. The rash on my neck has improved but now the rash covers bilateral upper arms. I have had no changes in soap/ meds/ vitamins etc. I do not typically get rashes. It does not appear infected, it is itchy and uncomfortable.
Blistery  rash on lower portion of the arm, head aches body aches.
Right arm weakness, severe pain of right arm with internal and external rash; pain to touch triceps and deltoid muscles.
fluttering heart beat; night sweats (more common in the morning); blood pressure shot up and it took 6-7 hours to calm it back down.; since been having episodes of blood pressure changes that go up and down.; usual vaccine reactions which were slightly more severe than the first dose; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FLUTTER (fluttering heart beat), NIGHT SWEATS (night sweats (more common in the morning)), VACCINATION COMPLICATION (usual vaccine reactions which were slightly more severe than the first dose), HYPERTENSION (blood pressure shot up and it took 6-7 hours to calm it back down.) and BLOOD PRESSURE FLUCTUATION (since been having episodes of blood pressure changes that go up and down.) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION COMPLICATION (usual vaccine reactions which were slightly more severe than the first dose). On 08-Mar-2021, the patient experienced HYPERTENSION (blood pressure shot up and it took 6-7 hours to calm it back down.) and BLOOD PRESSURE FLUCTUATION (since been having episodes of blood pressure changes that go up and down.). On 12-Mar-2021, the patient experienced ATRIAL FLUTTER (fluttering heart beat) and NIGHT SWEATS (night sweats (more common in the morning)). At the time of the report, ATRIAL FLUTTER (fluttering heart beat), NIGHT SWEATS (night sweats (more common in the morning)) and BLOOD PRESSURE FLUCTUATION (since been having episodes of blood pressure changes that go up and down.) had not resolved and VACCINATION COMPLICATION (usual vaccine reactions which were slightly more severe than the first dose) and HYPERTENSION (blood pressure shot up and it took 6-7 hours to calm it back down.) outcome was unknown.            Concomitant product use was not provided.  Treatment information was not provided.  On 27-MAY-2021 patient still suffers from the fluttering heart rate, blood pressure, and night sweats occasionally.   This case was linked to MOD-2021-183202 (Patient Link).