chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 16 or 17 year old female patient, with no prior medical history or notable family history. In late 2011 the patient was vaccinated with the first dose of GARDASIL (lot number, expiration date and via not reported), without incident. An a period of time later, on 08-FEB-2012 the patient was vaccinated with the second dose of GARDASIL (lot number, expiration date and via not reported). Concomitant therapies included hormonal contraceptives (unspecified). The reporter stated that subsequent to that second dose, a few days later the patient was hospitalized (also reported by the physician after additional information received as was seen in the emergency room (ER) three times for joint pain, shortness of breath, chest pain, overall fatigue and muscle aches which went away each time over a period of 3 weeks. In approximately 2012, the patient was noted to have an elevated Erythrocyte Sedimentation rate (ESR) and C-reactive Protein (CRP) and a Haemoglobin (Hb) of 8.6. The patient was treated with MEDROL pack with subsequent resolution of her symptoms. The reporter also stated that over the last 8 weeks (also reported as about six weeks), the patient developed bullous lesions on the extensor surfaces of her arms and legs, diagnosed now as bullous pemphigoid. The physician noted that this was very unusual in a young female. The outcomes of joint pain, muscle aches, overall fatigue, chest pain, shortness of breath were reported as recovered/resolved. The outcome of bullous pemphigoid, elevated Erythrocyte Sedimentation rate (ESR), C-reactive Protein (CRP) and a Haemoglobin (Hb) of 8.6 were unknown. Additional information has been requested.
A report has been received from a physician concerning a 16 year old, male subject who had been receiving FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (intranasal) started on 03-Dec-2014. The reporter stated that we accidentally gave expired doses of FLUMIST to two patients which started on 03-Dec-2014. The outcome of accidentally gave expired doses of FLUMIST to two patients is unknown. The report was considered to be non-serious.
4 months after receiving my 2nd Moderna vaccine, I experienced a stroke. The left side of my body went numb. Went to the doctor who confirmed I had a stroke. On Thursday, 10/06/2022 (16 months past 2nd injection), I was rushed by ambulance to the ICU with Thrombocytopenia. Uncontrolled rectal bleeding for 2 weeks. Hemoglobin at 4.9 (lethal level). After transfusion, removed from ICU, and more tests followed.  NO causal damage identified in either upper and lower GI tests.  Being released. Doctors literally said "We have no idea what is going on"
My 2nd Covid inj L upper arm was Wed 2/3/21 at 7:20 am. At 10pm 2/3, I began having chills. Decided to go to bed. Within 1/2 hr the chills were extreme. My L arm began to "convulse". Holding arm w/R did not slow movement. Got into bed, even colder. Hands so cold I  put them beneath my body trying to warm them. This took at least 1/2hr before falling asleep. Thursday, 2/4 medically intelligent friend advised I remain in bed and drink water which I did. Also on Friday. Awoke Sat feeling better than I could ever remember. (I was 74 at time; 75 on 2/22) A few days later L shoulder began hurting terribly. (I have a very high pain threshold.) After trying SalonPas patches and rollon, analgesics, heat and cold, I contacted MD on 2/26 convinced I needed x-ray, MRI or some means of cause of the excruciating pain. I was unable to pull clothing over my head. unable to brush my hair without putting head between knees, lift anything heavier than 1 #. There were other problems also. 5 days steroids prescribed which helped but on 8/24 pain and decreased range of movement s back, only slightly eased. Delay in seeing MD was in part due to fact I am very active with yard work - chainsaw, spreading 50# bags asphalt repair, moving, raking, pruning, etc., thinking any/all these caused the pain. I have no help. Do not believe any of these to be the cause. Return to MD 9/24 where above to be discussed. Great pain at point of injection, moves down arm. Must massage upper arm, shoulder, back prior to sleeping. Pain has awakened me multiple times. Pain has caused me to gasp. I do not wish to continue taking pain meds 1 hr before getting out of bed to ease pain allowing me to dress. I do not want to continue taking pain med to allow me to sleep. A knot has been felt in upper arm.
About 4 days after the first injection, I developed very dry mouth and dry, chapped lips.  My tongue felt like sandpaper, felt rough and a burning sensation that was quite uncomfortable.  A change in tasted occurred.  There were some small sores in my inner cheeks that lasted a short time, perhaps 24 hours.  My upper lip was red on the inside and felt burned.  These lasted about a week.  I didn't think it was a reaction to the vaccine since it happened days later. But I had a similar response after the second vaccine.  After the second, the same symptoms occurred about 3 days after the shot, were not as severe, lasted about 36 hours then disappeared.
My booster was more like a pinch/Nit a noramal vacc/It was not a poke; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION COMPLICATION (My booster was more like a pinch/Nit a noramal vacc/It was not a poke) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (My booster was more like a pinch/Nit a noramal vacc/It was not a poke). At the time of the report, VACCINATION COMPLICATION (My booster was more like a pinch/Nit a noramal vacc/It was not a poke) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were provided.
Sore at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Sep2022 at 16:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes; "Other Medical History: Environmental allergies" (unspecified if ongoing), notes: Other Medical History: Environmental allergies; "Known allergies: Allergic to raw egg" (unspecified if ongoing), notes: Known allergies: Allergic to raw egg. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 03, Booster dose), for Covid-19 immunization; Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer., Dose 2), for Covid-19 immunization; Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer., Dose 1), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Sep2022 at 20:00, outcome "recovered", described as "Sore at injection site". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: Covid tested post vaccination was not done for patient.
1500 Pt informed RN @ 1450, 5 min after injection her tongue went numb.  States her chest was tight but she was asthma as well and took her Albuterol which helped.  NO chest tightness at this time.  Numbness improving.
I was talking on the phone and all of the the sudden I couldn't feel my cheekbone and all the way up to the eye socket and my tongue felt like a sponge, and I couldn't breathe very good. So I got my friend to take to me to the ER and they gave me oxygen, and the next my tongue was still swollen and had blisters on it. They recommended scheduling a follow appointment with PCP.  They gave me a shot and three prednisone pills to take on a taper.
Wednesday afternoon "I" started coughing; To much mucus coming in to "my" mouth continuously. the mucus coming from the back of "my" nose is very salty.; "I" got the second dose vaccination Monday April 12 and "I" got sick; High fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12Apr2021 at 14:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. On 13Apr2021, after the second dose of the vaccination on 12Apr2021, the patient got sick with high fever and chills on Tuesday. Wednesday afternoon (14Apr2021 at 07:00 she started coughing and too much mucus was coming  into her mouth continuously and the mucus coming from the back of her nose was very salty. On 10May2021(on the day of this report), she was still going through the same problem. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 13Mar2021, the patient underwent Nasal Swab, SARS CoV-2 test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events got sick, high fever, chills, coughing and too much mucus coming in to mouth continuously, the mucus coming from the back of the nose was very salty were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
ZOSTAVAX vaccine caused Pain, itching, swelling and more redness than comfortable with in right arm, per pt. Pt seen PA. PA prescribed KEFLEX to fend off any infection and daily dose of ZYRTEC along with cold compresses.
COVID-19 pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criterion medically significant). At the time of the report, COVID-19 PNEUMONIA (COVID-19 pneumonia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not reported. The treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Adverse event reported was herpes zoster to left side without ocular involvement that occurred two days after second dose of the COVID 19 vaccine. Treatment with Valtrex 1g TID and gabapentin 100mg po QD.  Previous history of herpes zoster in 2015.
I got the shot and still got shingles; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 8-Jul-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient stated that he/ she got the shot and still got it. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Two areas of bruising on her arm; Inflamed lymph nodes; Headache; This is a spontaneous report from a contactable consumer.   A 67-year-old female patient (mother) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in arm left on 05Mar2021 morning (Lot number was not reported, at the age of 66-year-old) as single dose for COVID-19 immunisation (COVID protection at hospital). Patient medical history included diabetes (diagnosed over 20-year-ago) and hypertension (has had for a long time) both are still ongoing. The patient's concomitant medications were not reported. It was reported that vaccine was not administered at military facility. Patient denied for any additional vaccines administered on same date of the Pfizer suspect and also denies for prior vaccinations (within 4 weeks). On 08Mar2021, the patient experienced headache which were on and off and are not consistent. The headaches lasted for 2 days. On 12Mar2021, the patient developed two areas of bruising on her arm and had inflamed lymph nodes. None of the AE require a visit to emergency room or physician office. The outcome of event for headache was recovered on 10Mar2021 whereas for remaining events it was not recovered.  No follow-up attempts are possible. No further information is expected.
Lump at injection site few hours later same day with muscle soreness that evening into following day. Then 7 days later the lump at injection site turned red and began to itch like an allergic reaction
This spontaneous report as received from a Healthcare Worker refers to unspecified patients of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored oral, ROTATEQ which was exposed to 1 degrees centigrade for 18.5 hours (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with oral, ROTATEQ was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with ROTATEQ was unknown. No product quality issue was reproted. This is one of the many reports from the same reporter. Additional information has been requested.
Vertigo; Sinus infection and bronchitis; Sinus infection and bronchitis; Sore arm; Discoloration of abdomen; Dizziness; Headache; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), SINUSITIS (Sinus infection and bronchitis), BRONCHITIS (Sinus infection and bronchitis), PAIN IN EXTREMITY (Sore arm) and SKIN DISCOLOURATION (Discoloration of abdomen) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), SKIN DISCOLOURATION (Discoloration of abdomen), DIZZINESS (Dizziness), HEADACHE (Headache) and PYREXIA (Low grade fever). On 04-Mar-2021, the patient experienced SINUSITIS (Sinus infection and bronchitis) and BRONCHITIS (Sinus infection and bronchitis). On an unknown date, the patient experienced VERTIGO (Vertigo). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Feb-2021, SKIN DISCOLOURATION (Discoloration of abdomen) had resolved. On 16-Feb-2021, PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness), HEADACHE (Headache) and PYREXIA (Low grade fever) had resolved. At the time of the report, VERTIGO (Vertigo) had not resolved and SINUSITIS (Sinus infection and bronchitis) and BRONCHITIS (Sinus infection and bronchitis) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment details included robutussin, antibiotic.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Event added and outcome for the events was updated.
Had trouble getting out of a car or a chair; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Had trouble getting out of a car or a chair) and FATIGUE (Very tired) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced HYPOKINESIA (Had trouble getting out of a car or a chair) and FATIGUE (Very tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, HYPOKINESIA (Had trouble getting out of a car or a chair) and FATIGUE (Very tired) outcome was unknown. Unknown          Action taken with mRNA-1273 in response to the event was not applicable
Client received flu vaccine and then sat in chair while she watched her younger sister, father and mother get their flu shots. Younger sister had a syncope episode while watching mother receive her flu shot. While taking care of younger sister patient fell off chair onto floor with while having vasovagal syncope. Patient was carried to another client room and placed on a client bed. Syncope episode less than 1 minute and then client was awake and oriented. Ammonia pearl inhalant used. She continued to lie down for another 20 minutes. Client walked independently out of client with family. Pediatrician, Dr. called and informed of episode.
Expired Vaccine used; vial undergo temperature excursions; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) and PRODUCT STORAGE ERROR (vial undergo temperature excursions) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (vial undergo temperature excursions). On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 17-Oct-2021, PRODUCT STORAGE ERROR (vial undergo temperature excursions) had resolved. On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  Pharmacist stated that they discovered they administered approximately 3 doses of the Moderna vaccine after the expiration time. Wanted to know if we had guidance about how to proceed, see if patients have to be called for re-vaccination. Doses were administered today 12-14 hs after the expiration time of a vial that had already been punctured. Vial was opened on Sunday afternoon so expiration was on Sunday midnight. Date the vial was initially stored in the refrigerator: Friday morning 15-Oct-2021 from 8 AM - 11 AM. On 17-Oct-2021 at afternoon, vial was punctured. After the first puncture it was kept at room temperature. Total amount of time the vial was exposed to room temperature range (80 to 250C= 460 to 77 OF): anywhere from 24-26 hs when they were administered.
Information has been received form a nurse concerning a 79 year old male who on 16-NOV-2007 was vaccinated with a dose of ZOSTAVAX (Merck). The nurse reported that on 19-MAY-2008 the patient experienced dermatomal distribution of shingles. The patient sought medical attention "yes nurse". The patient was given VALTREX and unspecified pain medication. Lot # was not available. It was reported "our patient that got ZOSTAVAX did not really have a adverse effect, he simply got shingles after having the vaccine" " Date of ZOSTAVAX 11/07, Shingles dx 5/08" It was reported that the physician said "no follow-up is required. Patient recovered without incident" No further information is available.
This is an instance of breakthrough COVID-19 after which death occurred.  The individual was vaccinated with the Pfizer product on 02/17/2021 and 03/19/2021. They became symptomatic for COVID-19 disease on 01/30/2022 and tested positive for COVID-19 via antigen test on 01/31/2022 at the assisted living facility at which they were a resident. They were also admitted to hospital on 01/31/2022 and remained hospitalized until their death on 02/02/2022.  The individual had been on palliative care since October 2021 and was in overall poor health at the time of the adverse event.
PATIENT WAS GIVEN THE WRONG MODERNA VACCINE.  SHE SHOULD HAVE RECEIVED THE 6M-11YR 0.25ML ,BUT WAS GIVEN 12YR AND OLDER 0.5ML