chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experience with a flu shot was awful; Initial information received on 03-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves an unknown demographic patient who experienced felt awful (feeling abnormal) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious felt awful (feeling abnormal) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.
throat swelling; mouth swelling; running nose; coughs; vomiting; chills; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (throat swelling), MOUTH SWELLING (mouth swelling), RHINORRHOEA (running nose), COUGH (coughs) and VOMITING (vomiting) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PHARYNGEAL SWELLING (throat swelling), MOUTH SWELLING (mouth swelling), RHINORRHOEA (running nose), COUGH (coughs), VOMITING (vomiting) and CHILLS (chills). At the time of the report, PHARYNGEAL SWELLING (throat swelling), MOUTH SWELLING (mouth swelling), RHINORRHOEA (running nose), COUGH (coughs), VOMITING (vomiting) and CHILLS (chills) outcome was unknown.
cough, sore throat, headache, slight fever, dizziness, light headed, congestion
First dose 21Aug2021 / 2nd dose 27Sep2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 3BE39, expiry date 8th April 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 27th September 2021, the patient received the 2nd dose of Shingrix. On 27th September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional Information: GSK Receipt Date: 01-JUL-2022 Reporter's Comments: The pharmacist reported that the patient inadvertently received second dose of Shingrix early. The pharmacist reported that the patient was not immunocompromised.  The pharmacist reported that the patient did not have any side effects.  The reporter gave permission for follow up, reported that she did not have email address to provide. The reporter consented to follow up. Additional Supportive Information: The patient received the Shingrix dose earlier than the recommended interval, which led to shortening of vaccination schedule.
Painful Headache; Arm where I received the vaccine is still sore; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the second dose of BNT162B2 (COVID-19 Vaccine, lot number: EL9264), via an unspecified route of administration, administered in upper left arm on 09Feb2021 (at the age of 77-year-old) as single dose for COVID-19 immunization. Medical history was none. Concomitant medication included vitamins (unspecified). The patient called to report that with the second shot, she experienced painful headache for 6 day no its more than 6 days and everyday she woke up with a horrible headache and this never happened before so she was assuming its because of that shot. She still has it and have been up already for four hours and already took two Tylenol (treatment). Also, her arm where she received the vaccine was still sore. The events occured on 09Feb2021. The outcome of the events was not recovered.
Diffuse Right shoulder and upper arm pain starting 2 weeks and 3 days after second dose of Pfizer vaccine; in addition to Rt axillary lymphadenopathy 2in x 2in, painful, starting 2 weeks and 1 days after second dose of Pfizer vaccine, symptoms are still present, recommended OTC Tylenol as needed and follow up with primary care provider for further evaluation and treatment
Initial overdose report received from a healthcare professional on 21 March 2013. An 11-year-old patient was administered DAPTACEL vaccine instead of Tdap vaccine. No adverse event was reported. List of documents held by sender: none.
extreme chills, body aches, stabbing pain in both ears and head, muscle aches, headache. about 15 hours
Patient stated few minutes post vaccine her throat was tightening. Patient was hydrated, stayed for longer observation and felt better
Pt received first dose and stated feeling throat swelling. Monitors with vitals and called Allergy. BP WNL, Tachycardic to 106. No signs of facial edema, no difficulty breathing or swallowing, Allergy recommended to give 10mg of Zyrtec. Afterward developed tingling in mouth. Observed total of 1hr. No progression of symptoms and allowed to go home.
I suffered a Tonic Clonic grand mall seizure. My husband found me unconscious and seizing. I remained unconscious for 1.5 minutes. I came out of the seizure on my own and I scheduled a follow up appointment with my provider. I took 2 days off to recover. The provider increased the dosage of 2 of my medications used to treat Epilepsy and indicated he would monitor this. I proceeded with getting the booster and I did not experience this same symptom. I suffered from Epilepsy, but it had been 7 months and the seizures were medically controlled. I also had a Shingles vaccine and suffered a seizure following that vaccine as well. This was in October 2021. It took 4 to 5 months after the seizure to feel like I had recovered.
Tingling in my hand and feet every couple of days. In early Jan, 2009 I had an ear infection - In early Feb the tingling in the hands and feet was continuous. Around the first of March my back started burning inside the skin. I could not get comfortable in any position. I had to stand up all night, the tingling in hands and feet continued. On March 9 I walked home from a meeting and my feet felt like they had combat boots on them. My feet were very heavy. I also started losing my balance and falling. I started falling more for the next few days and we made an appointment to see a Dr. on March 13, she sent me to the emergency room. In the next week they diagnosed me with Guillain Barre Syndrome and Valley fever, I still am very weak in my legs and feel like I have rocks in my toes. The address we furnished on the form is only good until April 18, 2009 when we go to our home in another state.
Rt upper arm swollen, red and hot to touch. Rt arm was 3x larger than Lt arm.
pt recvd vax in early pregnancy, subsequently elected to undergo an abortion; No further info is expected;
Patient was pregnant and given FLUMIST vaccine. No adverse reaction. 11/13/09:  Prenatal records received for dates of service 11/3/09 to 11/10/09.  Dx: Pregnancy Assessment:  Gravida 9 Para 5, LMP 8/25/09, EDC 6/1/10 received the LAIV H1N1 vaccine on 11/9/09.
Dizziness; throat swelling; headache; Injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 01Apr2021 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included pollen allergy, allergy to molds and grass allergy. Concomitant medications included cetirizine hydrochloride (ZYRTEC), sertraline (MANUFACTURER UNKNOWN) 50mg, and drospirenone, ethinylestradiol (LORYNA) 3mg/0.2mg all taken from unknown date, for unspecified indication. The patient was allergic to various pollens, molds and grasses. 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 01Apr2021 the patient experienced dizziness for the first few minutes, throat swelling in the hour after receiving the vaccine but no loss of breathing. The  patient experienced headache for 2 days, immediate pain at injection site that increased but it went away over 48 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care The patient did not receive any treatment for the reported adverse events. The clinical outcome of the event dizziness was recovered on 01Apr2021. The clinical outcome of the event of headache was recovered 03Apr2021 after the duration of 2 days. The clinical outcome of the event injection site pain was recovered on 03Apr2021 after the duration of 48 hours. While the clinical outcome of the event of throat swelling was recovered on unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
This case was reported by a consumer and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, nausea, fatigue and injection site pain. On an unknown date, the outcome of the fever, nausea, fatigue and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever, nausea, fatigue and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The reporter had reported the case of behalf of his/her mother-in-law and four of her coworkers. The age at vaccination was not reported. The patient experienced fever, nausea, fatigue and injection site pain following their vaccination. All the symptoms listed, required the patient to take 2 days of sick leave from work. The patient full recovery after 3 to 4 days with no prolonged symptoms. This case has been linked to case US2019GSK023610, US2019GSK023609, US2019GSK023612 and US2019GSK023600, reported by same reporter.
Due date: 10/7/2020; Second  Pfizer dose on July 26th; Aug 5: prenatal check up. Good heartbeat, active. Doc said feet swelling was normal; Aug 8: began experiencing severe foot and joint pain similar to pain experienced during autoimmune flair back in 2015.  Planned to discuss at next appt. Aug 26th: prenatal appt; no heartbeat, estimated baby had been dead for some time. Aug 27: delivered baby, skin was peeling?which happens when baby dies days ago. It takes 2 weeks for second dose to fully kick in- which would be Aug 9th?around the time my symptoms appeared. 2.5 weeks before I learned my baby boy was dead. Stillborn baby boy dead within 2.5 weeks of second Pfizer vaccination. Autopsy results still not back but current results show nothing.  The only thing was the vaccine. Birth weight 4lb 15oz 17.5 inches.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 06-APR-2018 the patient was vaccinated with expired dose of ZOSTAVAX 19400 PFU (dosing details were not reported) (lot # M010472, expiry date: 01-JUN-2017) for prophylaxis that was prepared with MERCK STERILE DILUENT)(lot # R002715, expiry date: 20-FEB-2020) (expired product administered). No known adverse effects. No product quality complaint involved.
A patient, age 17, was inadvertently administered a dose of PROQUAD; This spontaneous report was received from a certified medical assistant referring to a 17 years old male patient. Information about pertinent medical history, drug reactions or allergies and concomitant medication was not provided.  On 30-NOV-2020, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Therapy Type: recombinant Human albumin) (lot # T023917 has been verified to be a valid lot number, expiration date was reported as 09-JAN-2022; strength and route of administration were not reported) 0.5 mL for prophylaxis (inappropriate age at vaccine administration). No additional adverse event or product quality complaint was reported.
ADVERSE EFFECT AND STILL HAVING PROBLEM; This spontaneous report received from a patient via social media concerned a patient of unspecified age and sex.   The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient reported that had a adverse effect and just got discharged from the hospital after 5 days of antibiotics and still having problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from adverse effect and still having problem. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- COVID-19 VACCINE AD26.COV2.s.adverse effect . This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
The day after the patient received the vaccination she had pain extending from right arm up through neck into facial area. She thought she may have an abscess so she went to the dentist who took xrays and did an examination determining it was not an abscess. The dentist was worried she may be having a heart attack so he told her to go to the emergency room. She went to her primary care provider and they also told her to go to the emergency room. At the ER they ran tests and determined it was not a heart attack, but referred her to her heart specialist. The heart specialist told her that her heart was fine and that it may have been a reaction to the SHINGRIX vaccination.
Information has been received from a 76 year old white female with osteoarthritis, osteopenia and hypothyroidism and allergic to meclofenamate who on 17-JUL-2008 was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included LEVOXYL, alendronate sodium (MSD) and ADVIL. On 21-JUL-2008, the patient experienced hot flashes, flushed feeling without a fever. The patient's hot flashes persisted. The patient did not seek medical attention. No product quality complaint was involved. Follow up information was received which reported that on 23-JUL-2008, the patient had a office visit. The patient stated she received ZOSTAVAX last week on 17-JUL-2008, she stated she tolerated the injection well. Had no pain at the injection site and had no side effects until 21-JUL-2008, four days after the injection. She stated that in the morning her face felt like it was on fire. It was warm, slightly red, lasted no more than fifteen minutes, almost a stinging sensation. She had no other bodily symptoms. No difficulty breathing. She did not feel ill. No body aches. No urinary symptoms. She stated that night about six p.m. it happened again, seemed less severe. On 22-JUL-2008, same symptoms were less severe, and on 23-JUL-2008 about noontime, which was approximately three hours ago, she had it, lasted only a few minutes and was less severe. The patient was told that this was likely a transient reaction and should go away. The patient was having no other adverse side effects. Office visit indicated that the patient was a pleasant, well-developed, well-nourished seventy-six old female, no acute distress. Vital signs: Blood pressure 138178. Heart rate 72. Weight is 152. HEENT: Normocephalic, atraumatic. Sclerae and conjunctivae are clear. Bilateral ears are clear. Oropharyngeal area without erythema or exudates. NECK: No lymphadenopathy or thyromegaly. LUNGS: Clear to auscultation and percussion throughout. Respiratory effort is unlabored. CARDIAC: S1, S without murmur, rub or gallop. ABDOMEN: Benign. Extremities: Without edema. Follow-up information also contained the following adverse event: low back pain. Additional information has been requested. Follow-up information was received from a physician which reported that the patient had not had any firther episodes for two weeks.  The physician would report any further problems.  Additonal information is not expected.
Facial and tongue edema noted on 9/22/10 about 1500. Pt brought to ED, given BENADRYL, SOLUMEDROL, epinephrine, TYLENOL and normal saline. Admitted overnight on scheduled BENADRYL every 6 hours
Extreme headache. Fever. Chills. Body ache. Slept for three days
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient had two episodes of vasovagal feeling. 911 call was placed, Paramedics came, he felt better soon enough, his vitals were stable, he went home with his mother after eating and drinking Gatorade and water. No fall, no injuries either.
This is a 67-year-old male patient that presents to the ER with a family member at the bedside complaints of cough, fever and confusion.  The current symptoms have been present for approximately 2 days.  The wife actually noticed the confusion this morning.  The patient was trying to drink his oatmeal out of a bowl this morning and then proceeded to urinate on the bathroom floor when he went to use the bathroom.  She states he as well was weaker requiring assistance to get up out of a chair and to go to the bathroom today.  The patient does have an extensive medical history including insulin-dependent diabetes, CAD, atrial fib, hypertension, hyperlipidemia as well as dementia.  The patient is alert and oriented x3 upon my presence in the room however was alert and oriented only x2 for the nurse stating that the month was August for her however answered it correctly for me.  The patient has no facial/focal weakness.  There is no headache, nausea or vomiting. Associated Symptoms: cough, fever, URI symptoms.
after a few minutes of being vaccinated, patient passed out and had a jerking movement seemed like a seizure. Only lasted for a few minutes and patient woke up okay.
This spontaneous report as received from a registered nurse (R.N.) refers to a patient of unknown age in her area (not from her office). On an unknown date patient was vaccinated with PNEUMOVAX 23 (lot # not reported). The nurse heard that the patient developed flu like symptoms, rash and cellulitis after receiving PNEUMOVAX23. It was unspecified whether the patient sought for medical attention. The nurse had no information on the patient. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Received flu shot (R) shoulder 8/30/16. Increasing pain to (R) shoulder over 2 weeks, decreased range of motion.
head pressure; Flu like symptoms; Nausea; diarrhea; low grade fever; muscle pain and aches; muscle pain and aches; tiredness; joint pain; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 26-year-old male patient received bnt162b2 (Pfizer Covid-19 mRNA vaccine, Solution for injection, Batch/Lot Number: En620s), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 12:00 PM  as SINGLE DOSE for covid-19 immunization. The patient medical history of covid prior to vaccination was reported. The concomitant medications were not reported. Patient had not taken any other vaccine in four weeks. Patient had not taken other medications in two weeks. On 05Mar2021 at 08:00 PM,  patient experienced flu like symptoms, Nausea, diarrhea, low grade fever, muscle pain and aches, tiredness, joint pain, headache, head pressure. No covid was tested post vaccination. No therapeutic measures were taken. The outcome of events is not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Due to history of vaccine reaction of hives to flu vaccine, took 25 mg benadryl 1.5 hours prior to receiving covid vaccine.  approximately 1 hours after vaccination, experienced sharp, constant retrosternal chest pain that is was non-radiating.  on 4/11 experienced fever, and developed hives to right arm that injection was given as well as nausea without vomiting or diarrhea.  Fever continued x 4 days with maximum temperature of 102.9 on 4/12.  Chest pain continues as of 4/15.  On 4/14 at approximately 2am was awoken with worsening chest pain and at that time also noticed development of a metallic taste in mouth, and since that time have been unable to taste anything but metal regardless of what is eaten or drank. Still with chest pain and metallic taste, hives resolved 4/12 evening and fever resolved on 4/14 late evening.
Newborn baby was in respitory distress a few hours after birth and required oxygen. With the weakened condition of patient, immunizations should have been postponed, however  Hepatitis B was administered the next morning after birth while patient was still requiring oxygen.  While receiving injection patient began to screem abnormally, turned red, broke out in sweat, with sweat dripping down his face.  Immediately his need for oxygen increased requiring 50% oxygen.  At that point, not able to figure out what was wrong, it was determined by Medical Center to transfer patient by ambulance to another Medical Center.  Upon arrival at MC it was determined that a left tension pneumothorax had occured.  Treatment included needle aspiration with removal of 100cc air,  3 hours later a chest tube was required. Patient required hopitalization for 9 days. 03/16/07-records received from facility for DOS7/28-8/5/2000 DC DX:Respiratory distress.  Pneumothorax-left required chest tube placement. possible sepsis term birth jaundice. Developoed respiratory distress a few hours after birth and an oxygen requirement at 12 hours of age. Started on antibiotics 7/28/00 and developed increased oxygen need. On admission HR 147 respiratory rate. 81.
On 09/23/2011 patient was shopping the day after her immunization of the flu & Pneumovax shot, stopped by the Pharmacy to show us the adverse effect the shot had to her arm. The arm she got the Pneumovax in was swollen and red from elbow to wrist. We suggested she go to the ER. On 09/26/2011 called to follow-up with her status & she said she didn't go the ER she took Benadryl & felt fine after, swelling was down.