chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable Pharmacist (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EW0191 and Expire Date: unknown) (at the age of 44 years) via unspecified route of administration in left arm on 07Jun2021 at 19:30 as 1st dose, single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had known allergies of sulfa. Medical history was none and concomitant medications were not reported. After vaccination, on 09Jun2021 at 01:00, the patient experienced dropping blood sugar, severe exhaustion, heart palpitations. The patient underwent lab test which blood glucose measurement, result was decreased. She did not receive any treatment for the adverse events. The outcome of the events was not recovered. Information on the lot/batch was available, Additional information has been requested.
She got her vaccine, Saturday night around 5:00 she started feeling not really good . All Saturday night she had a fever of 100.1, bad headache and started throwing up.  On Sunday morning around 9:00 was when she last threw up, and laid around the rest of the day.  On Monday she laid around and then started with diarrhea that night.  She then started with pain yesterday in her right arm and her left leg.  She feels like her bone in her leg is broke, the knee and the entire part of the knee, the entire leg in the bone.  Her arm has been the same.  She was thinking she may have had a stroke.  As the day goes on and she moves more she is feeling better.  She did take Prednisone for her pain as she has it for her RA. She went to the doctor on Monday and he said that it could have been from the vaccine, she also had other vaccines 2 weeks ago, but she had to have it. The vaccine is so new that they don't know what it could be AE.  She said that she would not do this again, was told it was one and done.  She had her 6th or 7th COVID booster, got her flu shot every year. She fever and achiness with her first COVID vaccine, but none with any other ones. Her doctor told her to continue with what she was already taking.
11FEB93 3PM cough started; 12FEB93 3PM to MD poss cold started ATB; 9PM t104.5 R; given APAP & bathed pt; had sz; pt hospitalized;
Experienced flu-like symptoms and a temperature of 102 the evening after receiving the second dose of the COVID-19 vaccine; Experienced flu-like symptoms and a temperature of 102 the evening after receiving the second dose of the COVID-19 vaccine; This is a spontaneous report from a contactable consumer via Pfizer Sales Representative. A 39-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration at the age of 39 years, on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced flu-like symptoms and a temperature of 102 the evening after receiving the second dose of the COVID-19 vaccine on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 102 on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
This spontaneous report had been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccination VARIVAX dose 1, (dose, lot # and expiry date unknown). On 08-JAN-2014, the patient received improperly stored VARIVAX dose 2, from lot # H018451, expiry date 09-OCT-2014 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
event: Patient present for Covid vaccine and LPN correctly asked patient if he was getting a Moderna vaccine today and he answered, ?yes.? Mom stated to nurse ?I want him to get the Moderna.? Moderna vaccine given and when scheduling for second vaccine, it was noted that he was 17 years old and this vaccine was not indicated. The Director spoke with mom and patient, informing them of error. No adverse reaction noted. Encouraged family to call with any concerns or possible reactions. Also let them know that patient could receive second Moderna vaccine at appropriate time if they so wished. Shared that this is recommendation of CDC. Mom and patient agreed to second Moderna vaccine. Director instructed patient and mom to call with any questions or concerns.
Dizziness, Headache, Sedation, Fever & NauseaVomiting Narrative:
March 3-7: Blurred vision, spots in eyes, ringing in ears, dizziness, headaches March 7-Now: Body tremors, ataxic gait, headaches, ringing in ears, blurred vision
Headache, eye soreness, body aches, fatigue, sinus congestion from morning after injection to present (three days later).  Alka-seltzer helps some.
Wheezing, coughing, tight chest, runny nose/throat.  Lasted through the night- until 5-6am.
FLANK PAIN; INABILITY TO FALL ASLEEP; HEADACHE; NAUSEA; INABILITY TO URINATE; CONSTIPATION; This spontaneous report received from a patient concerned a 31-year-old male. The patient's height, and weight were not reported. The patient's past medical history included back pain due to car accident a year ago, and dislocated disc in lower back and neck.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, RA10630, expiry: unknown) dose was not reported, 1 total administered on 19-MAY-2021 for prophylactic vaccination to left deltoid. No concomitant medications were reported.  On 19-MAY-2021, for the first week, patient could not sleep at all and had a headache and nausea for about 3-4 days. Then it got better. As per patient, it was easier to sleep at the time of reporting, but still a little harder to fall asleep. Patient reported that he was having constipation and urinations issues since getting the vaccine. It was not painful to go to the bathroom but it took a while. Consumer woke up on 31-MAY-2021, and had excruciating pain in the back, flank area. It was hurting when he tried to move anyway to the left and if he used to touch it. He felt like he wants to scream. Consumer did consult with his PHP regarding the inability to fall asleep and problems with constipation. He was given some sleep medications and advised to take cranberry juice. HCP (health care professional) was not aware of the flank pain that consumer had that day. He was advised to call PHP or go to urgent care to determine cause of pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and nausea on MAY-2021, was recovering from inability to fall asleep, and had not recovered from constipation, flank pain, and inability to urinate. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210557948-COVID-19 VACCINE AD26.COV2.S - inability to urinate. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY
This spontaneous report as received form a 73 year old female patient regarding herself. No drug reactions were reported. On an unknown date in October 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported) one injection. Concomitant therapies included CELEXA (reproted as selexa) and estrogens (unspecified). On an unknown date in approximately in October 2013, the patient experienced shingles in spite of being vaccinated for shingles the previous year. No laboratory tests were performed. Patient sought medical attention. The outcome of the recurred shingles was unknown. The relatedness of the event shingles with ZOSTAVAX was not reported. Additional information has been requested.
2/9/21 evening: severe headache, sore throat, congested nose.  2/10/21: awoke with severe muscle/joint pain & headache, lasted thru out the day.  Increase in left cervical/UE radiculopathy pain sx in evening.  2/11/21:  skin pain thru out body, strong "sunburn" like sensation.  Clothing, warm shower painful against skin.  Neck & radicular pain continued.  2/12-13/21: continuation of 2/11 sx.  2/14/21:  "sunburn" sx in legs & lower trunk resolved; continued head, neck, upper trunk & both arms. Continued increased L arm radicular sx. 2/21/21: 2/14/21 sx continue ~ 50% intensity.  No treatment received.
Pain in my chest; Breathing a little bit heavier; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced pain in chest, breathing a little bit heavier. When probed for the concern, consumer stated, "The patient got to go and get the shot and the patient felt like patient had pain in chest, He felt like my breathing was a little bit heavier. Patient asked if that was normal." The clinical outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pain at the injection site; Sore arm; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were recovered/resolved.   It was unknown if the reporter considered the injection site pain and pain in arm to be related to Bexsero.  Additional details were provided as follows: This case was reported by the patient who herself was a physician (MD). The age at vaccination was not reported. After receiving Bexsero, the patient experienced pain at the injection site and a sore arm for 2 weeks.
Severe esophagitis, chills, body aches, headache, fatigue, lethargy and vertigo.
injection site has a round circle and is bleeding; injection site has a round circle and is bleeding; 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 INJECTION SITE HAEMORRHAGE (injection site has a round circle and is bleeding) and INJECTION SITE RASH (injection site has a round circle and is bleeding) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE HAEMORRHAGE (injection site has a round circle and is bleeding) and INJECTION SITE RASH (injection site has a round circle and is bleeding). At the time of the report, INJECTION SITE HAEMORRHAGE (injection site has a round circle and is bleeding) and INJECTION SITE RASH (injection site has a round circle and is bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
swollen lymph node; her arm is sore; Consumer reports she is 38 years of age; This non-serious case was reported by a consumer via call center representative and described the occurrence of swollen lymph nodes in a 38-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 28-SEP-2023, the patient received Shingrix and Flu vaccine. On 28-SEP-2023, an unknown time after receiving Shingrix and not applicable after receiving Flu vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: Consumer reports she is 38 years of age). On an unknown date, the patient experienced swollen lymph nodes (Verbatim: swollen lymph node) and pain in arm (Verbatim: her arm is sore).  The outcome of the swollen lymph nodes, pain in arm and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the swollen lymph nodes and pain in arm to be related to Shingrix and Flu vaccine.     It was unknown if the company considered the swollen lymph nodes and pain in arm to be related to Shingrix and Flu vaccine.   Additional Information: GSK Receipt date: 03-OCT-2023 The patient self-reported his case. The reporter reported that she had a flu vaccine (unknown manufacturer/name) and a Shingrix vaccination on same day. The patient stated that she had a swollen lymph node in one of her arms, she went to urgent care on 2nd October 2023 and the provider confirmed a swollen lymph node was present on her arm.  Patient reported that her arm was sore, especially when moved. The reporter did not consent to follow up. No further information was provided. The reporter reported that she was 38 years old at the time of reporting, which led to inappropriate age at vaccine administration.
Redness, irritation, and stinging of the skin surrounding both eyes.   Pain in the eyes when sweating.  I am 45 years old and this skin problem around my eyes only started after the first dose of the Covid vaccine and has been a recurring problem ever since.
PATIENT STATED HE NEEDED 2ND SHOT BUT FORGOT HIS CDC CARD..STARTED ON PAPERWORK AND IN PERSON HIS SHOT WAS 4/5/21 AT A PARK IN THE COUNTY. WHEN HE BROUGHT BACK CDC CARD FOR SIGNATURE, IT STATED FIRST DOSE WAS 4/14/21. WE CONFIRMED THAT DATE IN THE SHOTS
ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/18/2022 &  2/18/2023  -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient's son-in-law told us on 11/28/11 that patient was hospitalized because he developed Guillain-Barre. No more is known.
Patient complained of pain, numbness in entire arm, large raised circular reaction, hot to touch, headache, nausea and felt faint. This lasted through Friday 7:00 AM. Treated with Aleve, and benadryl.
17NOV94 stated coughing, nauseous, chest congestion, felt feverish;
About 5 minutes after vaccine was administered, patient became to appear pale and reported feeling unwell to me.  She commented that her vision was "getting black" I noted that her pupils were dilated and that her heart rate was 50 beats per minute. She was quite diaphoretic. No loss of consciousness.  She noted that she had not eaten for several hours prior to vaccine administration.  Patient was given water to drink and a bottle of fruit flavored tea.  After consuming fluids, she began to regain her usual skin tone and reported "feeling better, but not quite right".  She was observed for an additional 20 minutes and offered crackers to eat.  She called a friend to come pick her up and drive her home.  She left the clinic ambulatory accompanied by friend.
After 24 hours I experience chills without a fever my skin was sensitive to touch and I was achy that lasted about 24 hours three days later I was experiencing stomach pain with diarrhea which has lasted for six days..  On day four I had a white/clay colored stool which caused me to call the doctor and I went in for an exam and he drew blood which I haven't gotten the results back from and now I have an appointment for an ultrasound of my abdomen he doesn't think that it's my gallbladder or liver he believes it's probably from the vaccine but we're going to try to rule out Any other cause.
Information has been received from a physician concerning a 12 month old female who on 29-MAY-2008 was a dose of vaccinated with VARIVAX (Merck) (lot # 659169/1500U) on right thigh. Subsequently the patient developed vaccine related shingles. The mother brought the patient into the office on 24-JUL-2008 where the doctor diagnosed a patch of shingles near injection site on right thigh. At the time of this report, the patient was recovering. The reporter felt that vaccine related shingles was related to therapy with VARIVAX (Merck). No product quality complaint was involved. Additional information has been requested.
Pt states approx 4-5 hrs /p Td had nausea & vomiting & dizziness-had T of 103-pt c/o soreness in lt arm
Tic reaction 2hrs after vaccination - lasted approximately 24 hr - resolved. (1) eye blinking (2) jaw movements.
arm swollen; injection site red; muscle spasms; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable consumer reporting for herself. This female patient of unknown age received on 06Dec2019 a single dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) for immunization. Medical history and concomitant medications were not reported. On Saturday, on 07Dec2019, her arm swollen, the injection site red and had muscle spasms that on 13Dec2019 they have become pretty severe. Outcome was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained
She has had ongoing pain at the injection site since she received the vaccination on September 11,  2020.
6:48 pm: Upon entering room pt found unresponsive and diaphoretic sitting in a chair. Patient had been incontinent of urine. RN called for assistance. Dr. responded. Patient moved to the floor where she soon regained consciousness. Placed on oxygen (4L/min). Blood pressure 146/90, pulse thready. 6:51pm: 911 called. Pt denied chest pain and shortness of breath but complained of nausea and feeling hot. 6:55pm = Blood sugar 114 7:00pm = BP 138/74 pulse 64 O2 100% on 4L 07:05 = EMS arrived.
On 8/9/2007, Patient received DTaP and IPV at RZ S4T by nurse.  No reaction at time of injection.  On 8/17/2007 at 2pm, mother reported: "He started crying and was all red and splotchy all over."  Mother stated hives covered entire body, very itchy, and lips were slightly swollen.  Pt reported no swelling of tongue or throat; mother said pt could speak and cry normally.  No respiratory distress.  Because this had happened once before, mother immediately gave child Benadryl.  At time of phone call (5pm), pt sleeping, breathing normally, hives resolved, no distress.   The previous incident of hives also occurred one week after vaccine administration.  On 6/28/2007, pt received Pediarix (DTaP-Hep B-IPV) and Hepatitis A, also at RZ S4T.  One week later, pt reported hives and lip-swelling "exactly like what happened today."  Pt had no history of allergic reactions, so mother took pt to ER where they administered Benadryl and monitored.  ER told mother that this was an allergic reaction and to give Benadryl if it happened again.  Discussed normal timeframe for vaccine reactions with mother.  Pt next due for vaccines 2/2008.   Advised mother that I will discuss with Dr. for input and call her next week.  Reviewed signs/symptoms of allergic reaction and when to go to emergency room (swelling of lips, tongue, throat, difficulty breathing).  Will file VAERS report.
Pt. revealed pooling of blood inner bicep, soreness on deltoid, swollen area on deltoid, tender, called MD, MD asked pt. to call back if progresses, Rph recommended cold compress.
none Narrative: Patient presented to vaccine clinic seeking 2nd dose, 1st dose had been administered at other facility, after vaccine administration it was discovered her initial vaccine was Pfizer and not MOderna. patient has experienced no ADRs at this time.
Covid vaccine inadvertently given one day past use by date ( was in refridgerator for 73 days).  No ill effects.  Physician aware and notified parent.  Not redosing vaccine at present
Helt like had flu; Diarrhea; sore right shoulder; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Helt like had flu), DIARRHOEA (Diarrhea) and ARTHRALGIA (sore right shoulder) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 017E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Helt like had flu), DIARRHOEA (Diarrhea) and ARTHRALGIA (sore right shoulder). At the time of the report, INFLUENZA LIKE ILLNESS (Helt like had flu), DIARRHOEA (Diarrhea) and ARTHRALGIA (sore right shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment informations were reported.   This case was linked to MOD-2021-320087 (Patient Link).
Last Tuesday morning 11/23, I woke up and my left eye was irritated and closed. I made an appointment at the eye doctor, and he said that I had rosacea right at the base of my eyelashes. I received a prescription for eye drops, Neomycin / Polymyxin b / Dexamethasone. I am to start putting artificial tears in my eyes after my prescription is finished so it will hopefully help the infection fully go away. While taking care of my left eye, I noticed that my right eye was starting to feel/look the same way my left eye did.
Continues itching at site of innoculation; This non-serious case was reported by a consumer and described the occurrence of injection site itching in a 82-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included osteoarthritis (Osteo arthritis knees). Concomitant products included denosumab (Prolia).   On 18-SEP-2023, the patient received Arexvy. On 18-SEP-2023, less than a day after receiving Arexvy, the patient experienced injection site itching (Verbatim: Continues itching at site of innoculation).  The outcome of the injection site itching was not resolved.   It was unknown if the reporter considered the injection site itching to be related to Arexvy.     It was unknown if the company considered the injection site itching to be related to Arexvy.   Additional Information: GSK receipt date: 21-SEP-2023 The patient had continues itching at site of inoculation. The reporter did not consent to follow up.
To ED 7 hrs post vaccine with muscle aches, spasms, chills, nausea. Developed R shoulder/upper arm cellulitis (location of vaccine), "L3-4 vertebral osteomyelitis due to group B strep septicemia."