chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 64-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). The patient's past medical history included blood pressure high and eye disorder. On 13th April 2018, the patient received SHINGRIX. On 14th April 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fatigue, injection site erythema, injection site pain and fever. In April 2018, the patient experienced rash, diarrhea and eye swelling. On an unknown date, the outcome of the chills, fatigue, injection site erythema, rash, diarrhea, fever and eye swelling were not recovered/not resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the chills, fatigue, injection site erythema, injection site pain, rash, diarrhea, fever and eye swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On Friday afternoon, the patient received an injection of SHINGRIX. On the next day at 4 AM, the patient began to experience chills, fever, and fatigue. The patient also reports she experienced injection site redness and pain at the injection site. Less than a week after receiving SHINGRIX, the patient experienced puffy eyes, diarrhea and mild rash. The patient did not specify when the events began other than the fever, chills, and fatigue. At time of report, the patient was still experiencing these events.
Left eye became very blurry.   Headache and pressure around eyebrow above left eye.  Visited eye doctor after my regular visit 2 months later and vision in left eye drastically changed.   Regular doctor also ran blood work and nothing was found.  Eye problem started the Sunday following first covid shot that was given in that left arm.     This is still causing balance to be off.   Another specialist tomorrow.
My arm (at the injection site) started to swell and turn red almost a week after I received the vaccine.  My arm is itching and burning. I Googled the symptoms and it is aligned with COVID arm.
He got his vaccine, started to feel a little bit weak and gradually as the week went by he could hardly walk.  Within 2 weeks he was paralyzed.  He was hospitalized at Hospital and they found some damaged disc.  They did an MRI of the brain, and saw a neurologist who told him there was nothing wrong with him and didn't check his MRI of the brain.  He has slurred speech a lot, extreme loss of balance and using a walker now, which he never had problems with balance or anything before.  He has to get a CNA, nurse, PT to come to the house to assist him with daily care.  He said that they call somebody else, and tell him to call another doctor and they don't seem to know what to do.  He had no neurological issues before the vaccine, said it's extreme.  His legs and feet are swollen, and has gone from being normal to this state over night.  He will FU with a neurologist, but does not have any appointments scheduled at this time.
Three days after ZOSTAVAX (shingle vaccine), life threatening drop in platelet count of less than 9K occurred. The only medication taken for 3 years prior to this event was simvastatin at 40mg. All data attached fully describes this episode. All this info is now sent to Merck National Svce Center, their reference SR#1-5391474323. The purpose of this writing is to confirm, assist and guide Merck team the opportunity to investigate any possible adverse reaction between ZOSTAVAX and simvastatin. It must be noted that the only medication taken for 3 years prior to the June 11, 2012 ZOSTAVAX injection was simvastatin. Three days after this injection, all the symptoms of thrombocytopenia developed (oral/lip bleeding and skin surface bruise marks) along with a life threatening drop in platelet count of less than 9K.
5 x 5 red area right of injection site, left thigh, knot in middle area.
Pink rash on chest and back; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Sep2021 at 17:00 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included hepatitis a vaccine (MANUFACTURER UNKNOWN), measles vaccine (MANUFACTURER UNKNOWN), mumps vaccine (MANUFACTURER UNKNOWN), rubella vaccine (MANUFACTURER UNKNOWN), meningococcal vaccine (MANUFACTURER UNKNOWN), varicella zoster vaccine (VARICELLA VACCINE) and bcg vaccine (MANUFACTURER UNKNOWN); all on 13Aug2021 for unknown indications. The patient received other vaccines within four weeks prior to the COVID-19 vaccine. On 11Sep2021, the patient experienced pink rash on chest and back. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included unspecified treatment. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pink rash on chest and back was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Client was in observation room with Grandmother and reported to EMTs he was feeling numbness to left arm. EMT alerted RN. RN arrived at 1631, client alert and oriented x4, sitting upright in chair. Vitals at 1635: blood pressure 146/88, pulse 80, oxygen 98%. Medical history of ADHD, no current medication and no known allergies. Per client it has been 2 years since taking ADHD medication. Client reports no history of arm injuries to left forearm in the past. RN assessed for sensory and motor of arm. Client able to move arm and reported feeling stimuli. Per client only numbness to left forearm. Vaccine administered to left Deltoid at 1609. RN gave client Capri-Sun and client drank slowly. EMT's stayed with client remaining of observation time. Vitals at 1643: blood pressure 138/76, pulse 96, oxygen 97%. Per client arm numbness improving. At 1651 client and Grandmother approached EMT table and stated he wanted to leave. EMT educated client and Grandmother member present of ER precautions and following up with medical provider. Client left facility at 1652 with steady gait.
DIZZY, ANXIOUS, BILATERAL HAND TINGLING AND NUMBNESS. B/P149/68 @10:45 B/P 128/62 PATIENT STATED SHE FEELS FINE 20MINS AFTER THE EVENT.
77 year old vaccinated male was admitted with Covid-19 pneumonia causing respiratory failure. He was treated with Remdesivir and steroids. He initially required O2. He was discharged home today in stable condition without O2.
Patient c/o chest tightness, dizziness and nausea approx. 20 minutes after receiving flu vaccine. Symptoms resolved 20 minutes later w/o treatment.
This is a spontaneous report from a contactable consumer reporting for self. This 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on 29Dec2020 around 10AM at left arm at single dose for COVID-19 immunization. Medical history included allergic to penicillin. She also had an allergy to anesthesia but was told this was irrelevant to the shot, this allergy was over 20 years ago. Ongoing acid reflux, she had a problem with acid reflux for a year (it was controlled on medication) but they made changes to her medication and started to come back. She stated it was not real bad and that this wasn't a side effect because she has been dealing with it for a year. Concomitant medications were none. No other vaccinations within 4 weeks. The patient stated she received her first dose of the vaccine and didn't have any problem with it, just that her arm was sore and ached but by the next morning it was gone. The arm soreness happened maybe 12 hours later after she took the shot. She didn't experience it immediately after getting the injection. The soreness lasted overnight and by mid morning of 30Dec2020, she recovered completely. She stated this morning (18Jan2021) she woke up with a sore throat and her ear started to throb and she asked if it is safe for someone to receive the second dose if they are not feeling their very best? She is scheduled for her next dose tomorrow.  The events did not require a visit to emergency room or physician office. Patient stated she was not sure about her weight because she lost a lot of weight dealing with the acid reflux she had had lately. Lab data included she had two COVID tests because of work previously, but these were negative. The outcome of arm soreness was recovered on 30Dec2020, outcome of other events was unknown.    Information on the LOT/Batch number has been requested.
pt recv vax & devel a gen rash;however the reporting nurse did not see it;she noted that they will try to determine hypersensitivity vs varicella-like rash d/t the vax;
pt complain of redness and swollen arm starting night of/day after shot given. still in pain 2 days after shot given. this is pt first shot.
pt received vaccine while sitting in chair became lightheaded, pale, diaphoretic. no LOC, no SOB, no N/V. brought to cot to lie down elevated feet. placed ice pack to back and chest. Left arm vac site benign. NP assessed surmised vasovagal reaction. Water given for hydration. monitored for 30 min. reassessment paleness and diaphoresis subsided. pt stated I feel much better I feel great. OK'd to exit after 30 min.
Patient mom states that was administered 6 different immunizations and had continued pain, swelling, tenderness, discoloration and area was hot to touch for three days after injection. Provider prescribed Keflex, Benadryl and ibuprofen and recommended cold compress to site, massaging area. Patient appointment was made two day after for follow up of symptoms.
-Swelling of lips within minutes - increased facial swelling of the face into the next day - She saw her PCP and stated it was an allergic reaction to vaccine.
Patient reports she awoke with numbness to her left arm (the injection site was to the left deltoid muscle). The donor reports complete resolution of the numbness within 6 hours. There is also a 3 cm hardening under the skin at the injection site today, 05/11/15. The patient reports the lump was approximately 5 cm on 05/07/15.
This spontaneous report as received from a medical assistant refers to a 5 year old female patient, started (Merck) VARIVAX, 0.5 ml once Lot number 0331AA is an invalid not number for VARIVAX (Merck) (expired date 07-MAR-2013) (site unspecified), on 08-JUL-2013 for an unknown indication. On the same date, the patient was also vaccinated with measles virus vaccine live (unspecified) and mumps virus vaccine live (site unspecified). The patient's relevant medical history was "unremarkable". She had no relevant concomitant medications: her past drug history was unknown. On 08-JUL-2013, the patient was inadvertently vaccinated with expired product. It was unknown if there was any relevant laboratory data. As of 08-JUL-2013, the patient would not continue VARIVAX (Merck). The outcome of receiving an expired product was unknown, and it was unknown if the patient has been revaccinated. Additional information has been requested.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/19/2021, 2/9/2021, and 11/16/2021. Patient presented to ED on 1/1/2022 with complaints of diarrhea that has been progressively getting worse for the past two days. Patient had been previously diagnosed with COVID and had received bamlanivimab and etesevimab on 12/24/2021. On 1/5/2022 patient decompensated and expired on 1/7/2022
1/19/08 at 3:00PM noticed soreness, redness of back of arm, induration of about 5 cm.  On 1/20/08 induration increased to about 10 cm, is very sore and hot.  On 1/23/08 still has induration of about 4 cm, with itching.
Information has been received from a physician concerning an infant less that 6 months old who was vaccinated and subsequently, the pt developed a transient rash. The pt sought unspecified medical attention. It was noted that the pt developed the rash after "multiple immunizations and the physician was not sure of which vaccines the pt received, however, he thinks it was possibly Hep-B and haemophilus B. Additional information has been requested.
this subject received influenza virus vaccine in previous years with no subsequent adverse events. On 07, December 2006 the subject received unspecified dose of Fluarix. On an unspecified date in December 2006, within one week after vaccination with Fluarix, the subject experienced injection site pain. The subject subsequently fell and "aggravated the injection site." The subject was seen at a physician's office and was prescribed ibuprofen At the time of initial reporting, 18, December 2006, the event was ongoing and the healthcare professional reported that the injection site pain, "has lasted for a week. " The healthcare professional considered the event was probably related to vaccination with Fluarix.
Acute appendicitis with perforation on  January 17, 2021 that required emergency surgery
Rash on face and torso per call on 5/16/11 at 4 pm. Tx with 1/2 tsp BENADRYL q 6hrs PRN until rash is gone.
not feeling well; shakes; felt weak; raspy voice; sore throat; chills; 2nd dose after more than 36 days; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), TREMOR (shakes), ASTHENIA (felt weak), DYSPHONIA (raspy voice) and OROPHARYNGEAL PAIN (sore throat) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after more than 36 days). On an unknown date, the patient experienced MALAISE (not feeling well), TREMOR (shakes), ASTHENIA (felt weak), DYSPHONIA (raspy voice), OROPHARYNGEAL PAIN (sore throat) and CHILLS (chills). On 08-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after more than 36 days) had resolved. At the time of the report, MALAISE (not feeling well), TREMOR (shakes), ASTHENIA (felt weak), DYSPHONIA (raspy voice), OROPHARYNGEAL PAIN (sore throat) and CHILLS (chills) outcome was unknown.            No concomitant medication was reported. The treatment information was not reported.
Pt awoke 02-18-11 with rash & itching all over body.
headaches with Tyvaso DPI increase; Oxygen saturations are dropping down to 83 to 85 percent; cold; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 75 years old male patient (65 kg) who experienced headaches with Tyvaso DPI increase, cold and oxygen saturations are dropping down to 83 to 85 percent after receiving vaccines COVID-19 VACCINE and INFLUENZA VACCINE and while treated with TREPROSTINIL SODIUM [TYVASO].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Secondary Pulmonary arterial hypertension.  Concomitant medications included NINTEDANIB ESILATE (OFEV).  On 19-Sep-2022, the patient started taking TYVASO (TREPROSTINIL SODIUM) Inhalation powder , at dose of 16 ug four times a day (QID) via  inhalational route  (lot - 000275P; expiry date: 31-Oct-2023) for Secondary pulmonary arterial hypertension. On an unknown date TYVASO (TREPROSTINIL SODIUM) (lot - 000275P; expiry date: 31-Oct-2023) , the dosage was changed to 32 ug QID. On 24-Oct-2022, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization). On 24-Oct-2022, the patient received a  dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for Covid-19 immunization.  On an unknown date in 2022,  the patient developed a non-serious event of  headaches with Tyvaso DPI (headache) (unknown latency) following the first dose intake  of TREPROSTINIL SODIUM. On the same night of 24-OCT-2022 , the patient developed a non-serious event of cold (nasopharyngitis) , (latency: same day) after the administration of INFLUENZA VACCINE , COVID-19 VACCINE and  (latency: 1 month 5 days)  following the first dose intake of TREPROSTINIL SODIUM.  On 25-Oct-2022 the patient developed a non-serious event of  oxygen saturations are dropping down to 83 to 85 percent (oxygen saturation decreased), 1 month 6 days following the first dose intake of TREPROSTINIL SODIUM and 1 day following the administration of INFLUENZA VACCINE and  COVID-19 VACCINE.  On an unknown date,headaches with Tyvaso DPI increased.  On an unknown date in Oct-2022, in the last two weeks from the date of report, the patient had missed a few doses of Tyvaso   Relevant laboratory test results included: Oxygen saturation - On 25-Oct-2022: 83-85 % [83-85%]  Action taken with TREPROSTINIL SODIUM (TYVASO) was unknown; action taken with  INFLUENZA VACCINE (INFLUENZA VACCINE) and COVID-19 VACCINE (COVID-19 VACCINE) was not applicable.  Corrective treatment: PARACETAMOL (TYLENOL) for Headache and 2 liters of OXYGEN (OXYGEN)  as needed for Oxygen saturation decreased; not reported for other event.  Outcome:  Recovered / Resolved on an unknown date in 2022 for the event headaches; unknown for other events.
Swollen joints (ankles, knees, wrists, toes, fingers), pain in joints, tingling and numbness in fingers/hands. Unable to make a fist in either hand. Limited range of motion. Fatigue, etc.
Pain at injection site (left deltoid) immediate after injection thought subsided but gradually returned and increased significantly over the next weeks. Pain immense by evening with extreme difficulty lifting raising arm to remove shirt and unbearable to sleep on left side.
Pneumococcal vaccine given 11/18/02, comes to office 11/20/02 with painful, reddened arm, possible cellulitis, given Augmentin 875mg BID x 10 days.
I started to feel fatigue, a fever, very sore throat, severe hacking cough, nausea and lack of taste and smell. I went to two urgent cares and I was tested for COVID both times and the results were negative. After going to the first urgent care, I was given a steroid shot and cough syrup. I did not feel any better. At the second urgent care, I went 7 days later, I had a chest x-ray which came back negative for pneumonia. I was given a Z-pack and that a medicine to control my cough. Both prescriptions ran out before I started to feel any better. It took 16 days for me to start feeling better. I still cannot taste anything and my sense of smell is still off, but all other symptoms have gone away.
Information has been received from a Registered Nurse concerning a 48 day old patient with a history of vomiting and "none" drug reactions or allergies who on 22-MAR-2011 was vaccinated orally with the first 2 ml dose ROTATEQ (lot # unspecified). Suspect therapy included HepB (manufacturer unknown) (dose, route and lot# unspecified). Concomitant therapy included PREVNAR and PENTACEL. The nurse reported that after receiving the first dose of ROTATEQ, the patient vomited a short time (while still in the exam room while the patient was being dressed). No treatment was given to the patient. No lab diagnostic studies were performed. At the time of the report the patient's status was not reported. The patient sought medical attention, as adverse event occurred in the physician's office. Additional information has been requested.
Pt exp one side was shaking; Ambulance called; Seen in ER noted to have a rt sided focal sz; During the night, his temp 101 developed a minimal rt otitis media;
Ache, chills, shakes, joint pain, tiredness, napped for 5 hours 7/18/2019
As reported on occurrence report by nurse in Local Health Unit:  Client received vaccines and immediately fell forward off of chair and was unresponsive.  Regained consciousness, but kept going in and out.  Layed her on the floor with feet elevated, cold cloths and cold water to drink.  Began to fall asleep, unresponsive to ammonia capsule activated and passed under her nose.  Asked to sit up after a few minutes, but kept falling asleep and had difficulty communicating.  B/P and pulse were stable.  Epinephrine 0.5ml given SQ.  Alert and communicative within 7 minutes.  Walked out on her own with mother with instructions to see her physician for further problems.
Administered MMRV (Proquad) and DTap/Polio (Kinrix) instead of MMR, VZV, Hep A, And HIB per vaccination schedule.  No adverse events reported by parent. No treatments necessary.
Very deep coughs; Have trouble sleeping at night; This is a spontaneous report from a Pfizer-sponsored patient support program COVAX US Support and a non-contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced very deep coughs and have trouble sleeping at night on an unspecified date. It was reported that caller received the vaccine 3 weeks ago and his wife a month and a half ago. They both were experiencing very deep coughs and have trouble sleeping at night. The outcome for all events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021680675 Same reporter/drug/AE, different patient
received an injection with Menactra which expired on 09-Oct-2019, no AE; Initial information received on 20-Feb-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 29 years old female patient who was vaccinated with an 0.5 mL expired first injection of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Expired product administered) (lot U6016AA, expiry date: 09-Oct-2019) via an unknown route in the left deltoid for prophylactic vaccination in 20-Feb-2020.  Medical history, medical treatment, vaccination and family history were not provided.  Patient did not take any concomitant medication.  It is a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
On morning of 10/14/15 began having episodes of eye deviation (up and to left) lasting ~ 2 seconds, occurred twice on 10/14/15, then several times per day (4-25) every day since. (mom provided video recording of the episodes of eye deviation at visit on 10/20/15). On 10/21/15 had fever 101 and 3-4 episodes of staring, lasting 5-10 secsonds each (and seemed "out of it" during the staring episodes). Seen 10/22/15 for fever and treated with amoxicillin for left acute otitis media.  MRI and EEG negative.
about 10 MiNutes after pt. received the shot, they started coMplaiNiNg about paiN iN their right arM, right leg and toNgue.