chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain and swelling in right arm and right axilla; Pain and swelling in right arm and right axilla; Pain and swelling in right arm and right axilla; Pain and swelling in right arm and right axilla; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 07Dec2021 at 16:00 (Lot number: FE3594) at the age of 48 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EP7534; Anatomical site: Right arm; Route of administration: Intramuscular), administration date: 03Apr2021, when the patient was 48 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0164; Anatomical site: Right arm; Route of administration: Intramuscular), administration date: 24Apr2021, when the patient was 48 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 at 16:00, outcome "unknown", described as "Dose received: 3"; PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious), AXILLARY PAIN (non-serious), SWELLING (non-serious) all with onset 08Dec2021 at 17:00, outcome "recovering", and all described as "Pain and swelling in right arm and right axilla". Therapeutic measures were not taken as a result of pain in extremity, peripheral swelling, axillary pain and swelling.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Headache; Fatigue; Muscle and joint pain; joint pain; Chills; heat surges; Sore throat; Not wanting to eat; Sore; Heart bothered me a little today; This is a spontaneous report from a contactable other Health Professional (Other HCP) (patient). A 35-year-old female Patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Ek9231) on 29Dec2020 10:30 AM, Intramuscularly, (vaccine location: Left arm) at single dose (first dose) for COVID-19 immunization. Medical history included Mitral valve prolapse (Mvp) and covid (patient had covid prior vaccination). Concomitant medication included naproxen a week before. Patient was allergic to Azithromycin. Patient received no other vaccine in four weeks. Patient experienced Headache, Fatigue, Muscle and joint pain, Chills and heat surges, Sore throat, Not wanting to eat, Sore, Heart bothered me a little today (29Dec2020 11:15). Patient did not receive any treatment. Patient did not have had covid tested post vaccination. The outcome of the events was unknown. This case was assessed non-serious by reporter. The events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
When client returned for his 2nd Moderna dose, on 4/26/2021, he reported to the nurse (vaccinator) that he experienced shortness of breath and difficulty with breathing, and headache after he received his first dose of Moderna vaccine on 3/29/21.  The client affirmed that these symptoms started within a 4-hour period after receiving the vaccine, but after he had left the vaccination center.  He said that the symptoms lasted about 2 hours and then resolved.  He reported that he did not seek medical care.  Vaccination with the 2nd dose of Moderna was deferred and client was directed to see one of the allergists here  for evaluation prior to getting any additional COVID19 vaccinations- he said that he could do this and he was given the names of the allergists and instructed to call them or his family doctor (he has one).
This spontaneous report was received from a nurse practitioner (also reported as a certified nurse midwife (CNM)) refers to a non-pregnant female patient of unknown age. There was no information about the patient's concurrent conditions or medical history provided. On 23-JUL-2015, the patient was vaccinated with a dose of GARDASIL lot # K014191 with an expiration date: 10-OCT-2017 (dose and route of administration were not reported). On an unspecified date, approximately in 2015, after the administration of the dose of GARDASIL, the patient experienced headache and nausea which lasted for an unspecified amount of time. On 28-SEP-2015, the patient was vaccinated with the second dose of GARDASIL lot # L010596 with an expiration date: 05-APR-2017 (dose and route of administration were not reported). The patient's concomitant therapy included multiple unspecified medications. On an unspecified date, after the administration of the second dose of GARDASIL, the patient experienced headache and nausea again. The events lasted for an unspecified amount of time. No treatment was given for the adverse events. The outcome of the headache and nausea after each vaccination with GARDASIL was not reported. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
almost caused me to go blind; This case was reported by a consumer via interactive digital media and described the occurrence of eye disorder 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 eye disorder. On an unknown date, the outcome of the eye disorder was unknown.   The reporter considered the eye disorder to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had received Shingles vaccine and it had almost caused him/her to go blind in right eye. The follow-up would not possible as no contact details were available.
Breakthrough positive COVID-19 test. Was very ill, symptomatic. Called the doctor and was prescribed Paxlovid, twice a day for five days. Severe cough.
About 8pm, fever, chills, aches, extreme fatigue-used ibuprophen 5/14/2021 about 6pm splotchy rash on torso, neck down to above knees above elbows, front and back. Not swollen, painful or itchy About 8pm fever and chills
Information has been received from a physician concerning a 78 year old male patient who on 20-JAN-2010 was vaccinated subcutaneously with a dose of VARIVAX (Merck) (Lot # 663305/1718X) inadvertently instead of ZOSTAVAX (Merck) due to a human error. No adverse affect was reported. The patient did not seek medical attention. This is one of two reports received from the same source. Additional information has been requested.
Pt recvd vax & 7 days later exp chest tightness (anterior chest) described as no wheezy-not dependent upon acitvity; no cough; no fever no cold; no treatment was given lasted for 3 wks;
Alerted by vaccination RN at 12:01 PM that the first 8 doses administered of the day had been given in insufficient amount. The RN stated she realized with the last patient of the morning (receiving dose #9) that the syringe was not the 3mL syringe she was used to using, and was in fact a 1mL insulin syringe. She noted that she had been drawing up the vaccine up to 5 (meaning 5 unit, equivalent to 0.05mL) rather than to 50u to give the full dose (0.5mL).  She stated she recognized her error with patient #9 and administered the correct amount (0.5mL) from a 3mL syringe she was used to using.  In addition to contacting KCPH's COVID-19 provider, the patient was contacted and informed of the incident and asked to reschedule to come back in to receive the full dose (per CDC guidance) as soon as possible. The patient agreed to come in for a follow-up appointment scheduled 5/19.  At the end of the day, when counting dose administered and factoring in the estimated amount of vaccine wasted due to insufficient dosages, there was just under 9 doses accounted for. The vaccinating RN was questioned again to see if there was any possibility any of the initial 8 patients received a full dose of the vaccine without her realizing it. She stated she did not believe she ever drew up the 1mL syringe to 50u nor administered a 0.5mL dose using the 3mL syringe, though she stated she couldn't say for sure. She said the container holding the syringes had each type divided in one compartment and separated from each other. The COVID-19 provider was informed of this information and additional guidance was requested.
Information has been received from an registered pharmacist concerning an adult female pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed an injection site reaction. Unspecified medical attention was sought, but treatment was not requested. A product quality complaint was not involved. Additional information has been requested.
At 1430 client reported to RN feeling "sensation of fluid running down arm". Vitals: blood pressure 148/98, pulse 86. Client reported feeling tingling sensation again within 5 minutes. Full sensation and motor present. 1445 client reported to PHN  feeling tingling, but less than last time. No other complaints. Client stayed with RN  for 30 mins. Last vitals at 1455: blood pressure 144/96, pulse 80. Per client only tingling sensation at fingers. RN  educated client to follow up with provider and gave ER precautions. Client left facility with steady gait at 1500.
Arm  swelled some but that was it; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 4 months after receiving Shingles vaccine, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the swelling arm to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter told the patient to come back 3 months after 1st shot of Shingrix. The patient received Shingrix and arm swelled some but that was it The patient heard from too many people that did have the shingles the horrible pain they were in and that made the patient mind up to get it.
On 4/10/21 I had fever and severe chills. On 4/11/21 the fever broke. I was fine but weak. On the night of 4/11/21 (9:00pm) fever returned. I took advil and went to sleep. On 4/12/21 I woke up with my arm very swollen and it was hot to touch. By the afternoon I was worse and the area was turning red so I went to the Urgent care and diagnosed with Cellulitis (which I have never had and didn't understand at first what this was about). I was treated and returned to my regular Doctor for follow up. I still have this thing and although it's better it's not gone as of this report and it is causing me distress in typing, cleaning and so on.
injection site soreness and swelling, sore are with in 1 hour, lasted 48 hours,  diarrhea started 13 hours after injection lasted 72 hours. headache started 12 hours after injection lasted 60 hours tiredness started 4 hours after injection lasted 48 hours I only took tylenol
Child given extra IPV due to confusion by "nurse" " medical assistant" over vaccine (Pediario) context.  No sequelae.
Fever; 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 PYREXIA (Fever) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided          No concomitant medication was reported . No treatment medication was reported .
On March 9, 2021 10:17am, patient returned to the COVID vaccine site to ask for an updated covid vaccination card because he received a vaccination earlier in the morning from the  site. Patient was greeted by staff, and she alerted Site Director, of the incident to check if the patient had received the Pfizer vaccine. It was discovered that the patient had scheduled a 2nd Dose of Moderna shot, was approved to enter the vaccine location upon arrival earlier this morning (greeter unknown), and was administered the vaccine by CMA and contracted employee. The patient clearly stated on his form that he had received the Istdose of Moderna on 2/10/21 but when asked by the processor at the vaccine station, if he was here for a 1st dose Pfizer vaccine he replied "yes" and never presented his vaccination card showing his 1st dose of Moderna so he received a new vaccination card with Pfizer 1st dose with today's date. When questioned by Site Director why the patient responded yes he would like the Pfizer, patient, stated he wasn't paying attention.Site Director also questioned both the processor and immunizer why neither of them noticed that the patient answered "yes" to receiving another vaccine and indicated it was "Moderna.' Both indicated that they simply weren't "paying attention because he answered yes to wanting the first dose of pfizer." Site Director consulted with CDC representative, and was advised to update the patient's card and educate the patient to enact V-Safe which is a portal that allows CDC to track patients after receiving vaccines. CDC also stated the following on their website cdc.gov: "Every effort should be made to determine which vaccine product was received as the first dose to ensure completion of the vaccine series with the same product. In exceptional situations in which the vaccine product given for the first dose cannot be determined or is no longer available,any available mRNA COVID-19 vaccine may be administered at a minimum interval of 28days between doses to complete the mRNA COVID-19 vaccination series. In situations where the same mRNA vaccine product is temporarily unavailable, it is preferable to delay the 2nddose (up to 6 weeks) to receive the same product than to receive a mixed series using a different product. If two doses of different mRNA COVID-19 vaccine products are administered in these situations (or inadvertently), no additional doses of either product are recommended at this time."
concerning; increase in her preexisting tinnitus/tinnitus almost doubled in both ears, but her right ear is worse; pressure on the right ear/and feeling like there's pressure in her right ear/feels like right ear is a little blocked or has a little pressure; slight  intermittent- dizziness with  light  headedness / had a very light sensation of lightheadedness; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiry date was not reported), dose 1 via an unspecified route of administration, administered in arm left on 22May2021 11:45 as single dose for covid-19 immunisation. Medical history included ongoing tinnitus (had pre-existing baseline tinnitus for many years prior to having the Pfizer Covid Vaccine). Patient just takes basic vitamins. The patient was taking vaccine just from peer pressure to be able to go back to work in person. The patient experienced increase in her pre-existing tinnitus which almost doubled in both ears, feeling like there was pressure on the right ear which she has never felt before and felt like right ear was a little blocked or had a little pressure causing ear discomfort but her right ear was worse leading to condition aggravated. Patient experienced almost dizziness about once a day since she was administered the Pfizer Covid Vaccine with light headedness and had a very light sensation of light headedness on an unspecified date. The tinnitus and pressure in her right ear were what's concerning her. She asked if there was anything that could be done about these events, if these were common with the vaccine; if there was information on expected duration of these events. Caller would like to know if she decides to not take the second dose of the vaccine given the side effects she experienced above, what level of protection does she have with only one dose of the vaccine? Patient contacted her doctor and had a tele-visit/video visit with the doctor on 30May2021. When patient had an appointment with her doctor on 30May2021 the doctor did not know what to tell her really; if these effects were anticipated to subside with time; patient questioned if she should go back for the second shot of Pfizer Covid Vaccine which she won't do if the events do not improve. The doctor told her it could happen again or not at all, that there was no way to know until she got the second shot of Pfizer Covid Vaccine. The outcome of the events increase in her preexisting tinnitus, pressure on the right ear, tinnitus almost doubled in both ears, but her right ear is worse was not recovered, the outcome of the other events was unknown.  Follow up attempts needed. Further information is expected.
Severe wide spread body aches; off label use; 1st and 2nd dose of moderna was taken; dose_number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 16:00 (Lot number: FJ8757) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose Number: 1, Batch/Lot No: 011L20A, Location of injection: Arm Left, Vaccine Administration Time: 2:00PM), administration date: 12Jan2021, when the patient was 47 years old, for COVID-19 immunization; Moderna (Dose Number: 2, Batch/Lot No: 032L20A, Location of injection: Arm Left, Vaccine Administration Time: 2:00PM), administration date: 09Feb2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 10Dec2021 16:00, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 10Dec2021 16:00, outcome "unknown", described as "1st and 2nd dose of moderna was taken"; IMMUNISATION (non-serious) with onset 10Dec2021 16:00, outcome "unknown", described as "dose_number=3"; PAIN (non-serious) with onset 10Dec2021 22:00, outcome "not recovered", described as "Severe wide spread body aches". Therapeutic measures were not taken as a result of pain.  Additional information The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Event resulted in None of the above, no Hospitalization Prolonged,The patient had no known allergies,The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.
Very congested, projectile vomiting, fever max 103, would not lay down in bed to sleep.
Pt recvd MMR/DTP/OPV/HIB on 12JUN92 & on 20JUN92 mom found pt on couch in midst of a generalized seizure; pt taken to local ER given 02 & was fine; pt had low grade fever in the ER; mom states blood work done in ER showed had bacterial inf
This spontaneous report as received from a physician refers to a female patient of unknown age. On 27-OCT-2016 the patient was vaccinated with GARDASIL (lot number L040054, expiration date 26-DEC-2017) dose 2 for prophylaxis. On an unknown date the patient experienced night sweats and vomiting. The outcome of night sweats and vomiting was unknown.
Red spots, bumps and rash all over body. Started on 3/17/03.
Red circular area at vaccine site about 3 inches across, very hard to the touch swollen and very itchy. continuing
Pain, swelling, redness to elbow. Bruising at site of injection (P.S. Husband had no adverse reaction - administered at same time!) (No fair!)
This spontaneous report as received from a pharmacist refers to a patient of unspecified demographics. On 28-MAR-2014, the patient was vaccinated with dose of PNEUMOVAX 23 injection, (lot # H018441 expiry date 28-FEB-2014), intramuscular, dose and frequency unspecified. Concomitant therapy was unspecified. No product quality complaint was involved. The outcome of received an expired PNEUMOVAX 23 was unknown. No known adverse effects. No further information provided. Additional information has been requested.
Patient reported that day of vaccine, she felt sick and had pain. 4 days later (day she reported it to pharmacy) she reported having a lot of pain at site, swollen, slight red lines; she also reported that day of reporting, she felt feverish, had hoarse voice, pain on shoulder that feels like "pounding".
This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. It was reported that doses of ZOSTAVAX (lot #, dose and route not reported) that were improperly stored since an unspecified date in July 2014, had been administered to patients. No adverse events were reported. This is one of several reports from the same source. Additional information is not expected (reporter refused additional contact).
The second vaccine dose was given at day 21 instead of day 28 as recommended.  First vaccination date was 10/27/2021 and second was 11/17/2021.  Both were Moderna and the same lot number: 076C21A.
Minor Sore Injection Site (After the SECOND Shot); Minor Itchy Injection Site (After the SECOND Shot); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Minor Sore Injection Site (After the SECOND Shot)) and VACCINATION SITE PRURITUS (Itchy Injection Site (After the SECOND Shot)) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE PAIN (Minor Sore Injection Site (After the SECOND Shot)). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchy Injection Site (After the SECOND Shot)). On 14-Apr-2021, VACCINATION SITE PAIN (Minor Sore Injection Site (After the SECOND Shot)) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant products were not provided. Treatment products were not provided.    This case was linked to MOD-2021-086483 (Patient Link).
Acute ITP, about 1-2 weeks prior to presentation, plt <10. Hospitalized and required prednisone which she responded to.