chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from the non-clinical study program Pfizer line for healthcare professionals for a contactable consumer. This 33 year old female consumer received PREVNAR 13 on 13Feb2013 single dose. Relevant medical history included Crohn's disease since an unknown date in 2003. Relevant concomitant medication included ENTOCORT EC since an unknown duration at a dose of 6 mg daily for Crohn's disease. The consumer mentioned that she started to experience red giant painful wart (which she mentioned was on her upper right arm at the site of injection and further elaborated as a hard painful pimple which was not warm) on 13Feb2013 after PREVNAR 13 injection. Relevant laboratory data was none. The consumer mentioned that on 13Feb2013 she had washed the area with soap and applied BENADRYL (dose and frequency unknown) as therapeutic measures in response to the event. The consumer had not recovered from the event at the time of report.
Pt never had any other reaction to vaccine or seizures. After immunizations were administered, child's head leaned forward and then went backward, became stiff resembled a clonic tonic seizure, eyes rolled back and unresponsive. Picked child up and placed on exam table. Incident lasted 1 1/2 minutes. Then responsive, lips pale, able to communicate. HOB up, B/P 182/70, P 68. Instructed aunt, child needs to be evaluated by a MD. She took child to ER per father's request.
Pt came to ER with URI onset 1 week prior.  Nasal congestion, rhinorrhea, and sore throat.
This spontaneous report as received from a nurse refers to a 17 year old male patient. Medical history and concurrent conditions were none. Illness at the time of vaccination was none. On 26-AUG-2015 at 07:20 am, the patient was vaccinated with second dose of improperly stored GARDASIL (lot # K011562, expiry date: 08-APR-2017) intramuscular in the left arm. No adverse effect was reported. No concomitant therapy was reported. This is one of the six reports received from the same reporter. Additional information is not expected as all correspondence was received.
Excruciating arm pain, headache, fatigue, body aches, fever, rectal bleeding, abdominal cramping
Patient received two doses of SHINGRIX vaccine. The first dose (lot # pk9by) was given on 9/28/18 and the second dose (lot # gz29l) was given on 1/17/19. After the first dose, the patient's family reported having a fever along with chills and malaise. After the second dose, the patient's family reported numbness at the tip of his fingers and toes for a few days that was followed by malaise, nausea, muscle weakness, decreased movement and decreased speech.
Tuesday night, hot to touch area where it was given, lump, sore until Wednesday like the flu shot, 2 inch red circle around injection site, solid red circle, lump is not visible to the eye but there when touching, placed warm compress on it Wednesday and ice Wednesday afternoon, as of today it is not as sore or hot but is still warm to touch.
Patient suffered stroke 9/14/10 - transported to hosp. 9/15/10 - first noticed redness, swelling at injection site. 9/15/10 - treated with antibiotics in hosp.
Left side of eye and cheek were low. Fever of 102.6, wouldn't eat, walk or talk. Two days after the 9th, eyes started to cross. Both at times, then each eye would rotate. Went back to Dr. he told me he never heard of shots causing this. Took her to see an eye Dr. and now she is in glasses. But her eyes still cross with them.
Stuffy nose, scratchy throat - hives, abdominal cramps - itchy eyes.
Pain Meds for Vaccination Symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Pain Meds for Vaccination Symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Pain Meds for Vaccination Symptoms). At the time of the report, VACCINATION SITE PAIN (Pain Meds for Vaccination Symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants and treatment medication were reported.
I started having sinus pain and tooth pain from sinus, congestion, and it got worst and worst. On Friday, a week after, I saw a doctor and he said it was virus, I waited another week, they tested for COVID-19, and it was negative; I was breathing through my nose. I am very congested.
Follow up information received from the physician provovided a revised dose number and concomitant vaccine information. Information regarding Prevnar (pneumococcal 7-valent conjugate) was received from a pharmacist regarding a 4 month old female pt who experienced crying, screaming and a rash on right arm. At 4 months of age, the pt received the second dose on 03/29/04. The pt also received the 2nd dose of IPOL (AVENTIS) and the 2nd dose of DAPTACEL (AVENTIS), and the second dose of ACT HIB (AVENTIS) on 03/29/2004. Event details: On the evening of 03/31/2004, following receipt of her 2nd dose of Prevnar, a pharmacist reported that his daughter developed a rash on her right arm and was crying. The rash was characterized as a "red splotchy" patches. The reporter indicated "if the skin was pulled tight, there was a white mark in the center of the patches" After the child had been bathed and had slept for one hour, she woke up screaming. She had a similar "rash on her back" and the skin over the patches felt warm. According to the reporter, the " rash on her arm" did not reappear. The child remained afebrile during both events. The reporter stated that there were no adverse events at the site of injections on either thigh. The childs physician on follow up that he was unaware that this event occurred.
Pt recvd 3rd  Hep B vax 15MAY90 &  had negative antibody serum.4th dose given 06DEC90 & on 03JAN91 was HBsAB positive.
Abdominal pain; This case was reported by a consumer via interactive digital media and described the occurrence of abdominal pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced abdominal pain. On an unknown date, the outcome of the abdominal pain was not recovered/not resolved.   It was unknown if the reporter considered the abdominal pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient had shingles vaccine and the second day after suffered from extreme abdominal pain and still had them. The patient enquired about was this normal. The contact details were not reported hence follow-up not possible.
Rash Eczema flair, Tingling of lips Narrative:  Recipient had Eczema flair day after vaccine and tingling of lips day of and day after vaccine. Also reports severe itchy eyes two weeks after receiving vaccine. Has taken benadryl for 5 days for eyes. Last dose of Benadryl 2 days ago. Recipient is physician who has decided not to proceed with dose #2 at this time.
Nausea, sweaty chills, headache, site swelling and tenderness, achy arm and neck muscles, sleeplessness. Sporadic involuntary muscle contraction overnight in neck and core muscle groups.
Tinnitus in both ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus in both ears) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Bladder infection and Regurgitation. Concurrent medical conditions included High cholesterol.  On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced TINNITUS (Tinnitus in both ears). At the time of the report, TINNITUS (Tinnitus in both ears) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications reported were Medication for high cholesterol, Medication for bladder infection, Medication for stomach regurgitation.  No treatment information was provided.
Initial information received on 19-Jul-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to cases 2018SA200801 and 2018SA200797 (same reporter). This case involves a four-years old female patient who experienced lethargy, fever (98.8-100.3 temporal), shivers, vomiting and jerking (unlikely seizure), while she received vaccine QUADRACEL. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccinations were given. No other concomitant therapies were reported. On 16-Jul-2018, the patient received a first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5497AA, exp date: 17-July-2020 via intramuscular route in the right thigh. On 16-Jul-2018, same evening, the patient developed a non-serious lethargy, fever (98.8-100.3 temporal) (pyrexia), shivers (chills), vomiting and jerking (unlikely seizure) (dyskinesia). Other relevant tests included throat culture and it was negative. Final diagnosis was jerking (unlikely seizure), vomiting, shivers, fever (98.8-100.3 temporal) and lethargy. The patient was treated with Ibuprofen (Motrin) for Pyrexia. The patient outcome was unknown for all reported events. Documents held by sender: none.
She went to the Emergency department 12/20 and received a high dose of Benadryl. She reported tachycardia all day yesterday in the 130?s and was itchy all over. Subsequently she developed a rash.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: Received vaccination approximately 9:50a 6/23/21, complained of chest pain, Vitals were taken at 9:50a BP 132/93 PR 88, pt was advised to rest and water was given, BP 99/68 PR 78 at 10:05a symptom of chest pain is improving, BP 116/85 PR 73 at 10:27a and symptom of chest pain is completly gone and no other S/S complained by patient
Severe headache began, and continued for several days through today, 11/07/2010.  It was like a migraine, and similar to headaches I get when I have a reaction to medication.  I tried Excedrin to relieve it but had to end up taking Maxalt.  Had difficulty sleeping, as headache would go away and then come back when time for medication again.
Vaccine day was 1/8/2021 1pm.  employee stated that shortly after having the vaccine I felt an overall tingling in her body that started on 1/8 21 hours after the vaccine was given. on 1/9/21 she stated, " I started having a headache, body aches, and  fever of 100.4 on day 1/10/21  same signs and symptoms.  1/11/21 still has a fever now of  101.0 head ache, body aches, plus nausea that started on 1/11/21.
Received H1N1 at 11:00 AM and began to have numbness and tingling from left elbow to left neck almost immediately.
Received Pfizer vaccine on 2/5/21, 2/26/21 Tested positive for COVID-19 by PCR on 4/21/21 Symptoms of cough, dysgeusia beginning 4/18/21.
A consumer report has been received. The report concerns a 9 year old, male patient. No relevant history or concomitant medications reported. The patient was receiving nasal FLUENZ, once/single administration for influenza vaccination) started on an unknown date. The patient experienced mild fever and redness of throat. He received therapy with Tonsipret. The patient recovered from the events of mild fever and redness of throat on an unspecified date. The report was considered to be non-serious by the company physician.
PATIENT HAS INJECTION SITE SORNESS FOR GREATER THAN 1 MONTH
Within one hour of the injection I started vomiting, had pressure in my eyeballs and became unable to sit up or keep my eyes open. I went to the ER where I received the injection and I have no recollection of treatment - it is in my records at the hospital. Within a few hours my abdomen swelled and I had excrutiating pain.  I went to the ER close to my home and was given medication for pain and told to return to the original hospital for a CAT scan.   I went again to the original ER and was told I had diverticulitis.   I had no sickness or illness before the injection but had extreme abdominal inflammation and eye pressure for more than three weeks after.  I also still have uncontrollable acid reflux/vomit.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 08-DEC-2011 at 8:00, ZOSTAVAX (Lot # 671140/1266AA) was exposed to - 13 degrees C for an estimated total time out of range of 10.5 hours. On 09-JAN-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671140/1266AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Adolescent presented with localized Allergic reaction, erythema & swelling to L upper arm 4 hours after PPSV23 vaccine administration.
trying to speed up the second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (trying to speed up the second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (trying to speed up the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (trying to speed up the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Upon internal review on 21-May-2021, the age was corrected to unknown.   Reporter did not allow further contact
Received 0.3mL undiluted dose; The patient received 0.3mL undiluted for his dose; severe fatigue; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A 12-year-old male patient received BNT162b2 (BNT162B2), on 26Jul2022 as dose 3 (booster), 0.3ml single (Lot number: FL8094, Expiration Date: 05Aug2022) at the age of 12 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 (Primary immunization series complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: PRODUCT PREPARATION ERROR (non-serious) with onset 26Jul2022, outcome "unknown", described as "Received 0.3mL undiluted dose"; OVERDOSE (non-serious) with onset 26Jul2022, outcome "unknown", described as "The patient received 0.3mL undiluted for his dose"; FATIGUE (non-serious), outcome "recovered", described as "severe fatigue".  Additional information: The patient did not administer any additional vaccines on Same Date of the Pfizer Suspect. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient's relevant tests were none. The Pfizer product had a causal effect to the adverse event. Vaccination Facility Type was a Pharmacy or Drug store. No prior vaccinations (within 4 weeks). No tests for thromboembolic events with thrombocytopenia. Patient was administered 0.3ml of undiluted Pfizer vac covid-19 5-11 y injection. The Pfizer vac covid-19 5-11 y injection vial was used to draw the vaccination dose. The error was discovered where vials were inspected after the vaccination. The patient's mother was called to report of the doses discrepancy. Patient's other reported the patient was laying on the couch. On 01Sep2022, its parent were called to question any issue after the immunization father reported that the patient experienced covid vaccine syndrome. Patient experienced severe fatigue for 48hours. After 48 hours period, was back to normal without showing side effects.  Follow-Up (22Aug2022): Follow-up attempts are completed. No further information is expected.  Follow-up (13Sep2022): This is a spontaneous follow-up report received from a contactable Pharmacist . This Pharmacist reported in response to HCP letter sent which included that: Updated information included: new event Fatigue was captured. Vaccination anatomical Location (left arm) was captured.
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Error: Wrong Route (SC, IM, etc.)-
Fever; chills; SOB; pain while taking a deep breath; swelling/itchiness left arm; swollen lymph nodes on left side under arm; generalized weakness
This spontaneous report was received from a nurse, regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 19-OCT-2017, the patient was vaccinated with an expired dose of M-M-R II which had a lot # L024265 with an expiration date on 01-JUL-2017, subcutaneously (strength, dose, frequency were not mentioned) for prophylaxis. However, at the reporting time, no adverse event were reported.
Breakthrough COVID Case: The case started last Friday, the 13th of May. Symptoms: headache, sore throat, dry cough, general fatigue. That's it for that day. Treatment: Called  my primary doctor. I told her I had a positive test at home. She prescribed Paxlovid, Tessalon for the cough, Doxycycline 100mg 2xday for 10 days, Prednisone 20mg 1 tab per day for 5 days.
CHILD WAS GIVEN PFIZER COVID 19 VACCINE AT AGE OF 11.  VACCINE IS  APPROVED FOR 12 TO 17 YEARS OF AGE.  NURSE WAS TOLD VERBALLY AND IN WRITING THAT CHILD WAS 12 YEARS OLD. NO ADVERSE SYMPTOMS HAVE OCCUR TO THE CHILD.
In September of 2022 I had a mild case of COVID-19, I recovered from the virus. I was in for a routine exam with my cardiologist in October of 2022, he noticed I was in Atrial Fibrillation. I was sent for an echocardiogram, TEE, heart catheterization all tests showed that the bottom of my heart is not functioning correctly. Currently the doctor is leaning towards the virus causing the heart problem.
Information has been received from a registered nurse concerning a 11 year old female who was vaccinated with a dose of Gardasil. Concomitant therapy administered at the same time at a different anatomical site included a dose of MENACTRA. Illness at the time of vaccination included herpes simplex on the lip. On 09-JAN-2007, the patient was seen in the office and was diagnosed with herpes zoster otitis which progressed to a diagnosis of Bell's palsy and Rasmsay-Hunt Syndrome on 15-JAN-2007. At time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. 03/28/07-records received for DOS 1/16/07 DX:Bell's Palsy. Ramsay Hunt Syndrome. PH:1/9/07-Seen by PMD to treat shingles in right ear with acyclovir. TX stopped on 1/16/07 due to bells palsy. Right side facial droop difficulty eating. C/O headache thoughout with shingles. 1/16/07-stomach cramps, diarrhea. Symptoms resolved 2/8/07. Additional information is not expected.
Patient reported to pharmacy on 11/28/2013 with hematoma, large bruising on upper arm where injection was given.
Pain, swelling at site of injection on Rt. upper arm, lethargy, nausea , fever,body aches and pains, vomiting, loss of appetite,headache.
Shot was administered too high, into shoulder joint. Shot was painful itself and 1 to 2 hours later severe pain in L shoulder with marked restriction in movements. Persisting pain in L shoulder which wakes me up at night.  Unable to do my daily workouts and yoga.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Weakness-Mild
ON 06/09/2023 PATIENT'S MOTHER CAME TO THE PHARMACY AND LET ME (THE PHARMACIST) KNOW PATIENT HAS BEEN EXPERIENCING SHOOTING PAIN GOING UP HER ARM AND INTO HER NECK. I ASKED HER IF SHE IS TAKING ANYTHING FOR THE PAIN. SHE SAID HER DAUGHTER JUST TOOK SOME IBUPROFEN. I ADVISED HER TO APPLY A COLD PACK AND TO PLEASE CALL IF THE PAIN DOES NOT GO AWAY OR GETS WORSE.
Fever, stomach cramps, migraine, chills, nausea, vomitting, diarrhea, fatigue, muscle ache, arm pain/redness/numbness
Left arm increasing painful; headache; back pain; temp of 99.6; Tired; This is a spontaneous report from a contactable Consumer (patient).  A 65-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 12Feb2021 09:15 AM (Lot Number: EN6201) (at the age of 65) as single dose for covid-19 immunisation. First dose (lot#EN5318) was administered on 23Jan2021, 04:00 PM, left arm. Medical history included vitiligo, hypothyroidism, knee arthroplasty, drug hypersensitivity (sulfa and penicillin). Concomitant medications included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC ALLERGY), biotin, ergocalciferol (VIT D), collagen. The patient experienced left arm increasing painful, headache, back pain, temp of 99.6, tired all on 12Feb2021 21:30. The events outcome was not recovered.    No follow-up attempts are possible. No further information is expected
extreme hair loss, weight gain, increase in anxiety/panic attacks, worsening depression & suicidal thoughts
At first(4/27/21) it felt like the left side of my face was acting spiritic but it was really the right side of my face not really doing anything so after a week of deducing and not knowing what it was I told my mom. She called the doctors office listed and they said to send me to the ER on 5/5/21. They said I have Bells Palsy and they put me on Prednisone and eye drops. We scheduled an appointment for our primary doctor which we went to on the 5/12/21. The doctor and I + my mom talked and they said we should report this because there was nothing else that could of caused the Bells Palsy.
Patient received 2nd dose of shingrix on 9-29-23.  He felt achy and tired that evening.   He woke up on 9-30-23  around 6:30 am with redness/rash on face and arms .  Symptoms had worsened when he woke up on 10-1-23.  He decided to go to hospital since swelling was around his mouth.  Hospital gave him steroid and benadryl and he reported feeling better.
Heart palpitations, close to fainting (room appeared getting dark), swelling sensation in throat, severe headache, nausea, chills.  Symptoms began 12 minutes after receiving the COVID-19 Moderna booster. 50 cc?s of liquid  benedryl was given  as treatment as well as kept me in the urgent care to monitor my heart rhythm and oxygen level for approximately two and a half hours.  Then discharged.
Immediately I had "funny bone" pain in the opposite arm (right) of the injection. That comes and goes at night but less as time goes on. Left arm still hurts at the injection site.  Main Problems: Headaches and extreme dizziness. I thought the dizziness was a UTI problem. I took 14 pills twice to get rid of the "UTI" effect as per my GP.  The dizziness and headaches started after the vaccine and is getting worse and worse. The room is spinning when I get up at night or lay down to sleep and many times during the day. My husband cannot drive anymore and this problem is scary. I wish I did not get the vaccine.  I believe I had Covid after holidays of 2019 and into Jan. of 2020. Serious coughing and could not breath. We we