chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a patient via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. 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 experienced vasculitis after being inoculated. Laboratory data (dates unspecified) included: Blood test vasculitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vasculitis after being inoculated was not reported. This report was non-serious. This case, from the same reporter is linked to 20220732338.
Fullness and ringing in right ear. Loss of hearing. Onset about six hours after injection, lasted 24+ hours.   Left lymph node (arm pit) swelling to size of baseball
Received flu vaccine 10/7/13. Bell's palsy (L) side of face started 10/9/13. Examined at oral surgeon on 10/14/13 and primary MD on 10/15/13.
Patient experiences episodes of numbness around injection site from Sept 2020 to Dec 2020. After following up with her in Janurary, she explained the numbing sensation has gone away. Patient said it was a numb uncomfortable feeling, but not painful. She said that it would occur after using the arm for example when driving, or performing yoga and it felt as though she would loose the strength in the left arm. Thankfully she is not experiencing it any longer, but did have this feeling for about 4 months and was afraid to get the 2nd dose.
1 week after receiving shot- The area where the shot was given was itchy, red rash, swollen, hot to the touch
Skin rash over the body esp. around the legs.   Treatment: Calming body lotion
I developed severe headaches and hypertension starting on the 5th day after vaccination.  I was getting 4-5 headaches per day. I'm continuing to get 1-2 headaches per day; I developed severe headaches and hypertension starting on the 5th day after vaccination.  I was getting 4-5 headaches per day. I'm continuing to get 1-2 headaches per day; The pain starts at the back of the neck on the right side and will migrate up and over the ear towards the temple; patient took flu shot and covid vaccine pfizer on 29Sep2021; BOOSTER; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was FF2589 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 29Sep2021 at 17:30 hours (Age at vaccination was 46 years) as dose 3 (booster), single for covid-19 immunization and influenza vaccine taken for immunization from 29Sep2021 to 29Sep2021 on right arm. Medical history included hypertension from an unknown date and unknown if ongoing. The patient did not have covid prior to vaccination. The patient did not have known allergies. Concomitant medication(s) included valsartan taken for an unspecified indication, start and stop date were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EL9264 and expiration date were not reported), via an unspecified route of administration, administered in left arm, on 06Feb2021 at 09:00 hours as dose 2, single and dose 1 (lot number was EL8982 and expiration date were not reported) via an unspecified route of administration, administered in left arm, on 16Jan2021 at 09:00 hours as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. No known allergies. On 05Oct2021 at 06:00 hours patient developed severe headaches and hypertension starting on the 5th day after vaccination. He was getting 4 to 5 headaches per day and was seen in the emergency room on 09Oct2021. Patient continuing to get 1 to 2 headaches per day. The pain starts at the back of the neck on the right side and will migrate up and over the ear towards the temple. Physical will acerbate the headaches and will cause a headache to start. Adverse events resulted in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. On an unspecified date the patient underwent lab tests and procedures which included computerised tomogram with unknown result, magnetic resonance imaging with unknown result. The patient did not tested covid post vaccination. Patient took steroids, ubrevly, systolic as therapeutic measures. The outcome of events was not recovered.  Follow-Up (28Oct2021): Follow-up attempts are completed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 56-year-old female patient who received SHINGRIX. Concomitant products included Atorvastatin, Montelukast and SYMBICORT. On 11th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 11th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 12th May 2018, the patient experienced chills, pain and fever. On 13th May 2018, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site warmth. The patient was treated with TYLENOL. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema, chills, fever and injection site warmth were recovering/resolving and the outcome of the pain was recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, chills, pain and fever to be related to SHINGRIX. It was unknown if the reporter considered the injection site warmth to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient. This case was previously not reported to anyone. The patient received SHINGRIX in the left arm. In the evening of the vaccination, the patient experienced pain at the injection site such that she could not lay on that arm. One day after receiving SHINGRIX, in the afternoon, the patient experienced achiness and later in the evening the patient developed fever and chills. Two days after receiving SHINGRIX, in the morning, the patient's body temperature was recorded to be 101.5 degree F. The patient also had swollen and red area around the injection site which was 6 inches by 4 inches which was warm to the touch. On the day of reporting, in the morning, the patient's body temperature was found to be 100 degree F. The patient was treated with TYLENOL for these events.
Had change in smell; severe malaise; muscle aches with pain in injection site arm; muscle aches with pain in injection site arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable other health professional (patient) reported that a female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications was not reported. On 18Dec2020 patient received first dose of Covid-19 vaccine. 24 hrs post vaccine on 19Dec2020, had severe malaise, muscle aches with pain in injection site arm. day 18 (05Jan2021), Had change in smell that she would describe as a foul burnt smell. No loss of smell or taste. Concerned that COVID-19 on day 21 (08Jan2021), had Covid-19 PCR that was non detectable. The outcome of events was unknown.  Information about lot/batch number has been requested.
devel n/v & diarrhea the morning; took 2nd dose & same thing happened;
04/19/2022 Vaccination   05/01/2022 I had a pain in my Right arm, throbbing. When I went in the shower, I noticed  a knot in my neck around the collarbone area. A little while after I made a doctor appointment. She felt the lump and noticed enlarged and probably from vaccine. She gave me some Ibuprofen. The doctor just checked it 07/14/2022 and it is still enlarged. At night I can feel the pain in my arm. In the daytime the pain is minimal but nighttime is painful.  08/17/2022 Follow up with doctor. Going to order a ultra sound.
Information has been received from a nurse practitioner concerning a 14 month old female patient who on 04/29/97 was vaccinated with a 1st dose of MMR vaccine live. Soon after administration, the patient became lethargic and developed a high fever. She was taken to the ER where it was reported that the patient "had a possible febrile seizure." The child subsequently recovered from her experience. The possible febrile seizure was considered a significant medical event. No further information is available.
This spontaneous report as received from a Licensed Practical Nurse via a company representative refers to a 15 year old male patient. The patient's current conditions or medical history were not reported. On an unspecified date in July 2014, reported as this week, the patient was administered the first dose of GARDASIL intramuscular injection, 1 single shot, (lot number K006447 expiration date 19-JUN-2016). The patient fainted after receiving the first dose of GARDASIL. The patient sought for medical attention and did not received treatment. Outcome of fainted was unknown at the time of the report. Additional information has been requested.
Fever, joint pain and a trip to ER with TIA between 24-48 hours of vaccine
Client had one Varicella vaccine at age 1 yr and at age 12 dx'd with chicken pox.
After she received the vaccine she had injection site pain and redness. Back pain occurred a few hour later. The next day she had vertigo and diarrhea. She consulted a doctor on 7-30-18, who told her to take EXTRA STRENGTH TYLENOL. Today she still has vertigo (balance is off) and pain (left arm/shoulder and sometimes radiate to leg, she said it is still hard to sleep).
Developed severe  headache with nausea and vomiting ~ 12 hrs after vaccine . Sent to ED: w/u negative for acute process, Given IVF and antiemetics, d/c'd to home .  final dx was migraine with maxillary sinus mucous cyst.   No sequala
72 yo received her COVID19 Pfizer booster shot (lot # EW0187) in her right deltoid at 1004 9/23/21.   On 9/30/21 at 1423, the patient received her high dose flu vaccine (Fluzone lot #UJ731AB) in her left deltoid.  On 10/1, patient called back to report some redness and swelling which she was treating with a cold pack.  She also complained of a little headache.  She was advised her to monitor it at home, that it was not an unusual reaction,  take Tylenol for comfort, put a cold pack on it intermittently, move the arm around and to stay well hydrated.  On 10/27, she was seen in clinic for arm pain.  Per the provider, patient had mild myositis type reaction to the influenza vaccine. There is nothing of concern on exam
This spontaneous report was received from a medical assistant (and the mother of the patient) via a company representative and refers to a 11 your old female patient. The patient's medical history, concomitant therapies and concurrent conditions were not reported. On an unknown date, the patient received her first dose of prophylactic vaccine against human papillomavirus (HPV) reported as GARDASIL. It was not specified which vaccine was administered, therefore the suspect therapies included both: GARDASIL and GARDASIL 9 (dose, route of administration, anatomical location, lot# and expiration date were not reported). After receiving the vaccination, the patient experienced fever and general malaise. The outcome of the adverse events was reported as recovered (on an unknown date). The relatedness between the suspect therapies and the events was not reported. Additional information has been requested.
Pt recvd a total of 5 Engerix-B doses; pt reported as being a nonresponder (negative titer);
Localized redness and swelling covering at least 1/2 of posterior arm. Also, exquisite pain and tenderness.
Became extremely tired by noon. Woke up at 1:15 am 10/19/2013 with heart beating quickly and difficulty breathing, took 2 Benadryl, severe headache, weakness. Breathing and heartbeat back to normal within 30 - 45 minutes. Weakness and and tiredness continues through 10/21/2013.
Patient came to the pharmacy, accompanied by his father, to request the quadrivalent flu vaccine. He mentioned that he does not fare well with needles but wanted the vaccine anyway. After the vaccine was administered, he was given a bottle of water and asked to sit for a few minutes to see how he feels. After sitting for a few minutes, he felt weak so he laid down on the floor with his feet up on the chair for a few minutes and then sat back up on the chair for a few more minutes until he felt he was okay to leave. After he left the pharmacy and crossed the street, he felt lightheaded and fainted. He came out of it quickly, took a couple steps and fainted again. He came out of it and continue to go home. He fainted again when he reached the front entrance of his building and injured his chin as a result of his fall. His father helped him into the lobby and called down his mother for help. He laid down and rested until he felt a little better. Then they took him to the hospital to treat his injuries. His mother called today (11/26/14) to report the event and said that he is now okay.
4/16/2019:  Burning nerve pain on tops of both feet and cramping pain on bottoms of both feet.  Saw Dr. 5/9/2019.  Was examined and provided with prescription for Diclofenac Sodium.   5/21/2019:  Shooting, cramping nerve pain and numbness in both forearms and both sides of hands and fingers.  Saw Dr. on 6/13/2019. He prescribed Gabapentin and Duloxetine  for nerve pain along with continued use of Diclofenac Sodium.  Dr. referred me to neurologist.  Appointment is 8/6/2019. 6/16/2019:  Wraparound rib pain started on left side in the same area where I originally had shingles pain.  No rash present this time.
3MAY swelling, reddness (10x7 cm);tx ice, rest, elevate, APAP;
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 05-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose detail and lot number unspecified). The pharmacist stated that the patient came to the pharmacy with a prescription for Medrol dose pack to treat an unspecified diagnosis. The patient had sought unspecified medical attention. The outcome of the patient was unknown. The relatedness of the event to ZOSTAVAX was not assessed. Additional information is not expected.
11AUG93 cramps, nausea, not feeling well; low grade temp felt better 14AUG93; 19AUG93 t99;
stated there were 112 reported incidents of both the Pfizer and Moderna COVID19 vaccine bringing about shingles; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (stated there were 112 reported incidents of both the Pfizer and Moderna COVID19 vaccine bringing about shingles) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (stated there were 112 reported incidents of both the Pfizer and Moderna COVID19 vaccine bringing about shingles). At the time of the report, HERPES ZOSTER (stated there were 112 reported incidents of both the Pfizer and Moderna COVID19 vaccine bringing about shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment details were not provided.
One and 1/2 hours after shot I began to experience a mild allergic reaction.  Face is slightly red, feels flush, warm with slight burning sensation. Hands feel hot, slight burning sensation and slightly swollen. Lips feel slightly swollen.
breakout of lumps & pimple like sores on the back & chest on 17AUG; on the evening of Saturday 19AUG had a sz only lasting a few seconds & since that evening has ran a fever of 103;
Information has been received through the manufacturer pregnancy registry from a health professional concerning a 17 year old pregnant, female, with a history of 0 pregnancies and 0 live births and no known allergies, who on 9/6/2005 was vaccinated with a 0.5ml subcutaneous dose in the left deltoid of varicella virus vaccine live (lot 649741/0222R). Concomitant vaccines given on the same day included a dose of diphtheria toxoid/tetanus toxoid and a dose of hepatitis B vaccine recomb (manufacturer unknown.). Medication used during pregnancy included prenatal vitamins, daily. It was reported that the patient was at 13 1/7 weeks gestation and that her last menstrual period was 6/5/2005. There was no local reaction at the vaccination site, no varicella symptoms post vaccination, and no herpes zoster symptoms post vaccination. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a physician indicated that there were no complications during pregnancy, no infections or illnesses during pregnancy and no concurrent medical conditions. On 3/16/2006 the patient experienced the following complications during labor/delivery, dysuria although renal analysis was normal, failure to progress, which resulted in a caesarean section and chorioamnionitis, which was treated with ampicillin and Aztreonam (Azactam). On 3/13/2006 the patient delivered a male baby weighing 8 pounds and 0 ounces. There was no congential anomalies and no other complications or abnormalities. Additional information is not expected. Failure to progress was considered to be other important medical event (OMIC).
cough; coughing up yellow chuncks; This is a spontaneous report from a contactable Nurse. A non-pregnant 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, on an unspecified date (at the age of 55 years) as a single dose for COVID-19 immunization. Medical history included asthma, narcolepsy, allergy multiple. Concomitant medications were not reported. On an unspecified date, the patient experienced cough. The clinical course was as follows: The patient reported, "I have asthma, and I just received the Covid shot. I have been coughing more this last week, and coughing up yellow chuncks. I am a Dr. and I put myself on a z-pak, and I am going to do an x-ray. I will see MD next week when I see him". The prescriber was not aware. Therapeutic measures were taken as a result of cough. The clinical outcome of the cough and coughing up yellow chuncks was not recovered.   Information on the lot/batch number has been requested.
headache, myalgia, sore throat, low grade fever starting about 3 1/2 hours after the immunization
Rash, UrticariaPruritus & ERYTHEMA FAMOTIDINE 20 MG ONCE ,DIPHENHYDRAMINE 25 MG ONCE
The patient experienced hives and itching post covid vaccine. Patient-reported history of hives following first covid vaccine as well. The patient received Benedryl 25 mg by mouth which resolved the issues.
Information regarding PREVNAR was received from a healthcare professional regarding a 6-year-old male patient who experienced otitis media, pneumococcal meningitis and lack of drug effect. The patient received the fourth dose on 17-Apr-2002. The patient has a past history of bronchitis. Indication for PREVNAR was immunisation. Product was administered on 17-Apr-2002. Dose regimen was 0.5 mL 1 time per day (intramuscular). Additional suspect medication included Pneumococcal 7-valent Conj Vac (Diphtheria CRM197) (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection). Concomitant therapy included POLIO-VACCINE, VARIVAX, Hepatitis B Vaccine, M-M-R II, Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine (diphtheria/tetanus toxoid/acellular pertussis vaccine) and haemophilus b conjugate vaccine (diphtheria crm 197 protein conjugate) injection (manufacturer not specified). On 30-Apr-2007, the patient presented to the physician with otitis media, which was considered medically important. Treatment included OMNISTAFF. On 02-May-2007, the child was admitted to the hospital with pneumococcal meningitis (drug ineffective). Clinical symptoms included fever 103 degrees Fahrenheit and vomiting. The child was treated with VANCOMYCIN and ROCEPHIN. On 12-May-2007, the child was discharged from the hospital and all events resolved. On 02-May-2007 test results were: body temperature (results: 103 deg. F.); full blood count (results: "normal"); white blood cell count (results: "normal"); and lumbar puncture (results: which revealed cloudy spinal fluid). No additional information was available at the time of this report.
This spontaneous report as received from a nurse practitioner via a company representative refers to a 68 year old female patient. Patients medical history was unspecified. On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot #, expiry date, dose and route of administration unknown, reported as 'as directed by physician') after an angiogram was performed. Concomitant medication included a lot of unspecified medications. It was reported that the patient experienced redness and swelling in the arm and developed a temperature of 100F. It was reported that there was pain and discomfort in the arm (disability). The patient sought medical attention and visited physicians office. She was told to take BENADRYL, TYLENOL and use cold compress on the arm. There was no intervention to prevent pain and discomfort to the arm. The outcome of redness and swelling in the arm, developed a temperature of 100F and redness and swelling of the arm was reported as recovering. The causality of the event with suspect product was unknown. There was no product quality complaint. Additional information has been requested.
Vaccine was administered at 4:50pm and at approximately 5pm, the patient came to the pharmacy technician's station at the Drop Off Window stating she "didn't feel good." She stated she was feeling light headed and experiencing "tunnel vision and hearing."  The pharmacy technician and a customer standing behind her noticed that patient was beginning to faint and the customer grabbed her. The pharmacy technician grabbed a chair from the Waiting Area and the two helped patient to the chair. The patient was given a bottle of orange juice and stated she felt better. The pharmacist asked the patient whether she was diabetic and if she was anxious prior to the vaccine. The patient stated she wasn't diabetic but hadn't eaten that day and that she has an anxiety disorder and occasionally feels lightheaded after vaccines. Patient sat for 30 minutes before going home on her own.
approx 30 mins after became dizzy and nauseous.  Given Zofran ODT, check blood sugar, and vitals. Patient remained in office approx 1 hour after until she felt well enough to leave.  Contacted patient in am, stated that evening prior felt exhausted but this am felt fine.
3 cm erythematous raised area over vaccination site. Has soreness and stiffness to arm and shoulder joint. No meds
1- Palpetations and Aflutter which was controlled prior to second shot was exacerbated and evolved into AFIB within 1-week of second shot.  (26-March-2021)  2- Sought treatment subsequently and required cardioversion.  (3-April-2021) 3- Another cardioversion was undertaken and finally, the installation of a pacemaker was completed to avoid total heart block condition which evolved. 4- Placed on maintenance dose of Amioderone beginning 2-April. Palpetations continue
Pt said suffered from fever, pain, nausea, diarrhea, upset stomache,  dizziness and muscle aches.   Enough to go to the doctor.