chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received a PREVNAR 13 injection Monday 11/23/15. The evening of 11/24/15 she noticed some difficulty hearing. The morning of Wed 11/25/15, she had lost all hearing in her right ear, had difficulty dressing and walking (lack of balance). As Wed. 11/24/15 progressed, patient's vision and speech were off, by Wed. afternoon she was feeling nauseous and started vomiting and then into dry heaves. All together, patient's symptoms seemed stroke like. She was transported to hospital where she spent Wed. night, 11/25/15 in the emergency room and was admitted into the hospital the morning of Thursday 11/26/15.
This is a 77y.o. female who presents to the ER due to low oxygen and altered mental status.  The patient has a history of COPD and obstructive sleep apnea.  The patient herself is a poor historian and history is gathered from the chart.  She has received 2 doses of the Pfizer vaccine 3/27/2021 and 4/17/2021.  In the emergency department she was found to be hypoxic and was placed on BiPAP.  She was found to be positive for COVID-19.    She has remained on BiPAP overnight, and has maintained oxygen saturations in the lower 90s   She is on a heparin drip for elevated D-dimer and a perfusion scan is pending
Patient within minutes was confused, felt weak and became clammy to touch. She then described her vision was extremely blurry. She was confused and could not answer basic questions such as her name or where she was. Her mother stated this was abnormal and I informed my staff to call 9-1-1. I immediately obtained one  0.3mL ammonia inhalant and wafted under her nose and she became alert. I continued a few more times and she dry heaved. She slowly improved and was able to form words that she did not feel good. Within 15 minutes paramedics showed up and began taking vitals.
Friday - on and off fever and aches and sluggishness. Saturday fever gone, sluggishness and aches all over but very painful swelling in lymph node under left arm  - radiating into left breast  and chest.  Swelling was easily noticeable visually. The arm and underarm and chest was warm to the touch and very painful. By Monday pain , all other symptoms were gone and the lymph node pain was much decreased to just bothersome and always present. Swelling was still visually noticeable but to a much lesser degree. As of 9 days after vaccine booster, the underarm lymph node is now only sore if touched. Much improved and not visually noticable.
mild fever 100.3 now 100; chills; body aches; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (mild fever 100.3 now 100), CHILLS (chills), MYALGIA (body aches) and ARTHRALGIA (joint pain) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included ATENOLOL from 18-Mar-2021 to an unknown date for an unknown indication.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PYREXIA (mild fever 100.3 now 100), CHILLS (chills), MYALGIA (body aches) and ARTHRALGIA (joint pain). At the time of the report, PYREXIA (mild fever 100.3 now 100), CHILLS (chills), MYALGIA (body aches) and ARTHRALGIA (joint pain) outcome was unknown.
The day after the shot I started to notice a high pitched electrical ringing in my right ear. I noticed it the night after the shot as it made it very difficult to sleep. There is never a day without the ringing, like Tinnitus. Some days it's an 8 (1-10) and others it's a 3. I have talked to my doctor on a video visit and will be seeing him in person on 5/24/21.
no additional AEs; it was reported multiple temperature excursion 16-NOV-2022 and 09-DEC-2022 and were administered PEDVAXHIB, ROTATEQ and VAQTA; This spontaneous report was received from a medical assistant and refers to an unspecified group of patients of unknown age and gender. Their medical history, concurrent conditions and concomitant therapies were not reported.  On 16-NOV-2022 and 09-DEC-2022, the patients were vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number: U029144 and expiration date: 31-MAR-2024; with Hepatitis A Vaccine, Inactivated (VAQTA) lot number: W015191 and expiration date: 27-OCT-2023; and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number: U038854 and expiration date: 20-APR-2023. The vaccines were administered only once for prophylaxis, but dosage regimens, route of administrations and anatomical locations were not reported.  It was reported that the vaccines were administered after multiple temperature excursions (product storage error). Temperature was above 47 Fahrenheit (F) degree (50.0 F) for 0 hours 12 minutes and 0 seconds on 16-NOV-2022 and above 47 F (47.6F) for 0 hours 15 minutes and 0 seconds. Time frame was total 27 minutes. Additionally, no previous temperature excursion was reported. No other adverse event was reported (no adverse event).  Follow-up information was received from the medical assistant on 28-DEC-2022. This report refers to a 12 month old patient who was vaccinated on 29-NOV-2022 with Hepatitis A Vaccine, Inactivated (VAQTA) lot number: W015191 and expiration date: 27-OCT-2023, intramuscular (IM). The primary thermometer displayed out of range temperature for less than 15 minutes. The back-up thermometer did not display max. that was out of range. Log was ran and the temperatures were within range. The primary thermometer was re-calibrated.  Patients' identifiers were missing in the previous report but have now been provided.
muscle stiffness around injection site; redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (muscle stiffness around injection site), ERYTHEMA (redness) and SWELLING (Swelling) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (muscle stiffness around injection site), ERYTHEMA (redness) and SWELLING (Swelling). At the time of the report, MUSCULOSKELETAL STIFFNESS (muscle stiffness around injection site), ERYTHEMA (redness) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by reporter  Treatment for the events is Unknown.    Reporter did not allow further contact
Pain, redness, and swelling at the injection site, fever, headache, fatigue, and gastrointestinal symptoms.
Pt had fever of 104.2 and irritability about 3 hours post dose-lasted about 12 hours.
Hives/Uticuria developed 4 days after 2nd dose of vaccine. Treated with antihistamines but no relief then short course of prednisone and hive came back 1 week later. Still have them daily after 12 weeks and now trying hydrocortisone at 20mg but not completely gone. Allergist has suggested Xolair but have not started
(R) breast ache at site of previous biopsy that took place around 1 yr ago. Pain at site was affected by movement; also experienced transient numbness on (R) side of face. Both symptoms started day of to next day after vaccine. Improved today 6-21-10.
Received seasonal Flu vaccine at 3:00PM 10/16/09. At approxmately 9:00PM began to cough & experience chest tightness & difficulty breathing with audible wheezing. Took Benadryl 25 mgm po & wheezing relieved in 30 minutes. Self treated at home.
rash all over torso- extremely itchy.    7 days later headache, nausea, hot flashes, spikes in temperature- sweating, achy joints , no taste and injection site is reddened and swollen  approx 2 inches long.  sore to touch
On the morning of 16 March 2021 I had two red spots near the injection spot , about 3 to 4 cm in size. They were itchy and hot to the touch and sore. 17 March 2021 my mouth, tongue, throat and lungs felt dry and irritated. 18 March 2021 the two spots had faded but still noticeable, not as itchy and sore.  I started breaking out with hives on my arms, neck, and face. They break out in different places and after several hours they fade. It it now 23 March 2021 and I am only having a few break outs in various spots on my arms, neck and face.
This spontaneous report as received from a consumer refers to her unknown age daughter who is the patient and also has a twin sister. Information regarding concurrent conditions and medical history was not provided. Approximately 1 year and 2 months ago, in June 2013 the patient was vaccinated with the first dose of GARDASIL (lot#, dose and route were not provided). And at the time of the report the patient would like to receive the second dose. The consumer mentioned her daughter/patient began having unspecified "digestive system problems: after receiving the vaccine (date unspecified). The outcome of the events was not provided. This case is linked to SR#1-1206874903 (marrs# was not created yet), which has adverse information for the other twin. Additional information has been requested.
Same day of injection (within 4-6 hours) injection site pain, redness & swelling to a size over 3.5 inches, myalgia over entire body, fatigue, headache. 34 hours after injection: shivering, fever. Still experiencing adverse reaction, not resolved at this time.
Has a pain on an ulcer on the upper stomach; Sore arm; A spontaneous report was received from a consumer concerning a 76-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm/ pain in extremity and has a pain on an ulcer on the upper stomach/ gastric ulcer.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 19 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch Number: 029K20A) via unknown route for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced sore arm and a medically significant event, pain on an ulcer on the upper stomach.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, sore arm and has a pain on an ulcer on the upper stomach was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient developed big rash at the injection site and was referred to MD. She was prescribed Cephalexin.
COVID 19 BREAKTHROUGH: 65 y/o male with past medical history of  hypertension, CVA, ESRD on PD, DM I presents to the ED with the CC of SOB x2 days.  Patient admits being SOB with exertion and unable to lay down flat.  Patient admits to weakness, be, but denies fever, chills, cough, loss of sense of taste or smell, nausea, vomiting, dizziness, diarrhea, or any other symptoms at this time.  Patient verbalized that his partner tested positive for COVID-19 5 days ago but he is vaccinated against COVID-19.Patient was evaluated in the ED. EKG showed sinus rhythm no STEMI.  PT RECEIVED 4 MODERNA VACCINES. 4TH DOSE 4/22/2022.
Client presented to Covid Vaccination Site for first dose of Pfizer infant vaccine, accompanied by her mother. At approximately 1215 client was held in mother's lap ready for vaccination. Needle was introduced into the injection site (left vastus lateralis) by nurse. Client Suddenly pushed the nurses arm causing withdrawal of the needle from the injection site.  Per nurse the syringe and the needle remained intact in her hand and that there was no vaccine pushed out of the syringe. To ensure that no vaccine had been administered to the baby, the dosage in the syringe was verified by a second nurse. Per both nurses, the syringe was still filled with 0.2ml of Pfizer infant vaccine. The vaccine was wasted and recorded appropriately. The syringe and the used needle were disposed of to the appropriate sharps' container. Per nurse, the mother was consulted if she still wanted to vaccine the child and the mother gave consent to vaccinate. At approximately 1218 client was given Pfizer infant Lot#FT9142 first dose with no problems by nurse on left lateral upper outer thigh. Client and client's mother proceeded to the observation area for a 15-minute observation before departure. Lead PHN was notified about the incident after the client was already sitting down in the observation area. At approximately 1225 both lead PHNs approached the mother and the child at the observation area to check on how the baby was doing. Per mother, ?baby is tolerating the vaccine well.? The injection site was assessed by both nurses. There was no bleeding, bruising, redness, swelling, cuts, scratches observed. Per mother, the client was doing fine, and she reported that she is not bothered by the whole incident. She reported that the child made a sudden and unexpected move during vaccine administration. Lead PHN encouraged the mother to seek medical advice from the child's pediatrician if she were to notice any unusual change in child's behavior that could be related to the vaccine administration and today's incident. Nurse also educated the mother about the possible side effects and adverse effects of the vaccine and the need to seek medical advice or to call 911 for life threatening symptoms. The mother verbalized understanding. Mother denied any change in child's behavior at the time reiterating that the child was doing well. Client remained in the observation area for 15 minutes and left the facility in a steady gate accompanied by her mother. Both Lead PHNs reeducated nurse on ways to prevent same incident from happening again. Nurse was encouraged to educate parents on the need for and importance of proper stabilization of children whenever children are getting vaccination to avoid injuries that could possibly happen due to child's sudden movements during vaccine administration. Nurse  verbalized understanding.
Pt presented with 5 days of red pruritic rash, hives to arm at injection site & abdomen. C/O Ab pain & diarrhea 4-5 times/day. Treatment Loperamide/ATARAX/Hydrocortisone cream.
This spontaneous report as received from a consumer refers to her daughter a 1 years old female patient with no drug reactions or allergies and no pertinent medical history, who on 10-DEC-2012, was vaccinated with PROQUAD (dose, route and lot # not provided). Other suspect therapies included on 10-DEC-2012 varicella virus vaccine live (unspecified0 (dose, route and lot # not provided). No concomitant medications were reported. The consumer stated that a her daughter was concomitantly vaccinated with PROQUAD and varicella virus vaccine live (unspecified). The consumer reported that her daughter was perfectly fine. No adverse event to report. The patient did not sought medical attention and did not received any treatment for adverse event. Additional information has been requested.
Pt experienced swelling from his shoulder to his elbow, inability to move his left arm, redness from shoulder to elbow and heat from same area for 48 hrs following vaccination.
Swelling, redness, hardness of upper arm. Appeared following day after immunization.
10 minutes after the shot was given, I felt a release and my heart rate increased, I went to a nurse and let them know I was having a reaction, and they took me to a bed, I had brought my Benadryl with me and took 5 ml, I became very cold and began to shake, some shortness of breath, tongue became thick feeling,  I am not sure of the time schedule, but I also had my Cromolyn and took 5 ml,  I was still having problems after an hour and I took 5ml more of Benadryl and cromolyn, after about 2 hours in the covid area I felt good enough to go home
The following happened Tuesday, May 4th, 2021 around 10:00 Central time.  I started off with chest pain that I thought was a side stitch.  Tried stretching to make it go away and it only got worse.  Shortness of breath came on and I asked a co-worker to take me to a local hospital as I thought I was having a heart attack.  The hospital gave me morphine and I passed out maybe 15-20 minutes later.  After I passed out, the hospital sent me to another hospital.  At the second hospital, I had a heart cath, heart echo, an EKG, and blood drawn both nothing indicated a heart attack.
we both have a arm which is sore up; I have allergy; This is a spontaneous report from a contactable consumer. This contactable female consumer (patient) reported for herself that, a female patient of an unspecified age received first dose of BNT162B2 (solution for injection) via an unspecified route of administration on 10Apr2021 as single dose for covid-19 immunisation. Medical history included hypersensitivity, she taking tylenol, claritin, and advil. Concomitant medications was not reported. The patient reported that, after receiving the first vaccination experienced we both have a arm which is sore up. The patient husband has high blood pressure which was quietly noted. When is able to start his blood pressure medication, he did had taken it yesterday before taking the shot but he did not take it all yesterday. The patient enquired about her husband and can he take blood pressure medication today but he did not take it yesterday. The patient enquired about having Claritin, Advil, Tylenol as patient had allergy and can she take everything that normally would have taken or do we have to wait for a matter of time or do we can take anything. The only reaction patient and her husband were that they both had a arm which was sore up and and patient husband has a slight headache no reaction other than we are fine. The patient stated that they both  had sore arm but everyone has a sore arm.The patient husband had a headache because he didn't take his blood pressure medication yesterday. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Had onset of a headache about 2 hours after vaccination on Saturday, 20 March. On Tuesday 23 March, at about 11 AM began having a migraine headache (had a past medical history of migraine headaches as a teenager). About 3:10 PM on Tuesday 23 March, began to have tingling and numbness in right hand (he is right-handed). Taken to ER where he could not remember his name. He was admitted and found to have four infarcts in three lobes of his left hemisphere (parietal, frontal and temporal). CT, MRI and cardiographic exams with contrast revealed a patent foramen ovale. Discharged on 40 mg Lipitor and ASA 81 mg, and referred to UCSF Neurology for followup.
Inj on 5/27/11 (L) upper arm became red and indurated. Seen by physician on 5/28. Assessed as allergic reaction with cellulitis. Rx'd with KEFLEX & cool compress. 5/31/11 - "Arm improved - still slightly sore" (phone call to patient 2pm).
both immunizations are intramuscular injections but both were administered outside of appropriate deltoid and too low on arms.  the technician did not use.  both arms are experiencing soreness, but as the immunizations were today, no further adverse effects are apparent.  I am a nurse and was a little taken aback when the first wasn't administered directly, but didn't speak up, unfortunately, before the second shot was given in other arm.  I did speak to pharmacist briefly but didn't make an official report at the time, not realizing it would need to be reported
Described earlier on form  but,... Severe left knee and hip pain since  waking on morning after first pizer vaccine.
A consumer report via Medical Representative has been received. The report concerns a Male consumer who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. The patient experienced tested positive for influenza and tested positive for influenza B. The outcome of the event tested positive for influenza and tested positive for influenza B is unknown. The report was considered to be non-serious.
Patient 5 yrs. received 0.2mL dosage of undiluted vaccine from orange cap Pfizer vaccine. Medical Branch Coordinator (MBC) RN failed to dilute vial before a fellow RN drew the dose. Both nurses notified manager at 11:32am once it was MBC discovered the error. MBC expressed that she did not inform the other RN that it was not diluted until after it was administered. The RN that administered the vaccine expressed that she failed to recognize that the vial was not diluted, prior to drawing and administering the vaccine. Manager instructed observation RN to keep parent and patient in observation area in addition to standard 15 min observation for precaution. Parent and patient were notified before their departure from the clinic. Parent was provided information regarding monitoring for potential side effects and seeking immediate emergency care if necessary.  Patient did not have any reaction or sign of reaction during her time in observation.
FELT ACHY and TIRED; FELT ACHY and TIRED; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (FELT ACHY and TIRED) and FATIGUE (FELT ACHY and TIRED) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 16-Nov-2021, the patient experienced PAIN (FELT ACHY and TIRED) and FATIGUE (FELT ACHY and TIRED). At the time of the report, PAIN (FELT ACHY and TIRED) and FATIGUE (FELT ACHY and TIRED) outcome was unknown.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-621174 (Patient Link).
Atrial Fibrillation - rapid heartbeat, palpitations, flutter in chest.
This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored   RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action was not reported. All telephone attempts to obtain follow-up information have been unsuccessful.  Additional information was received from a registered nurse concerning a 1 day male patient. Patient's birth weight was 8 lb 13oz with 0 siblings. Patient was vaccinated with RECOMBIVAX HB the same day that he was born (02-JUN-2014) at 22:46 PM. Lot number J012520; Exp. Date: 30-JAN-2016.  The vaccine storage temp dropped to 0-1 degrees on 18 different episodes between May 14th and July 21st (unspecified year) according to min/max. All recorded temps are within 2-8 degrees. Additional information is not expected since all follow ups requested to complete the case were received.