chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer, the patient. A 51-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 left arm on 08Apr2021 at 16:30 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient known allergies included bactrim and penicillin. Concomitant medications included Tirosint on an unknown date for unknown indication and unknown if ongoing. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 18Mar2021 at 15:45 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Apr2021 at 07:00, the patient experienced horrible headache & body pain especially in thighs and upper arms. On 3 occasions, felt like the patient was being stabbed. Twice in right leg, close to knee, and once in left arm. The patient seemed to have symptoms for 1.5 days, then they went away for a day, then felt sick with a runny nose, sore throat, & oddly scalp hurt on the right side only for about 3 days. The stabbing pain was really odd and extreme for a vaccination. The scalp pain was weird too. Hope it works. Can't say if the patient does this again if this becomes a yearly deal. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department, or urgent care. The clinical outcome of the event being stabbed was recovered on 10Apr2021. The clinical outcome of the event scalp hurt on the right side was recovered on 12Apr2021. The clinical outcome of the events sick, runny nose, sore throat, horrible headache, and body pain especially in thighs and upper arms were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient had received vaccine and was in waiting area for observance. After around 10 minutes wife came to counter and said he was feeling dizzy. RPH walked out to check on patient whom had sit back down from standing up briefly. Patient seemed responsive until his head drifted down, unresponsive to voice and touch for one minute or less. Pulse on wrist was faint, but present and no signs of struggled breathing. No swelling or redness near throat present. Patient woke up shortly with pale skin, but responded well and water was given. Ambulance arrived to further assist.
Information has been received from a physician concerning a 19 year old white female who on 25-JUL-2007 was vaccinated with a first dose of GARDASIL vaccine (yeast) into the left arm (lot # 657736/0389U). Within 15 minutes of receiving the vaccine the patient fainted. She quickly recovered after lying down for 15 minutes and was able to return home. Additional information is not expected.
Once vaccinated, the patient began to complain of a sensation of bubbles in the throat and pain and itching.
The day after my first shot I developed mild tinnitus where my left ear would ring for a few seconds, a few times a day. About 3 weeks after my first shot, the tinnitus became moderate to severe, with constant ringing in the left ear.  I received my 2nd shot today. Still have the tinnitus. I did not have have any issues with tinnitus before the vaccine, however that ear was susceptible to infections throughout my life. I have not seen a doctor yet about my condition.
Chills, fever 101, Body aches, fatigue, Headache, nausea, swollen glands, SOB. started on 2/27 gradually improved and then a week later on 3/6/21 experienced body aches, chills , fever, chest tightness, headache which has resolved by 3/8/21..
pt began crying aprpox 4-5 hrs p/vax; parents unable to console or stop pt from crying;
Area of erthema & swelling & itching on arm where Varicella vaccine was administered
Was fine all day after the 10a vaccine . Woke 3am trembling and fever of 101.5F  Spouse says was moaning in my sleep and restless for about an hour prior to this. Took tylenol. Fever only reduced to 99F. Still 99F at 10a after taking second dose of tylenol.  Face red. Circles/bags under eyes and whole body aches. Arm injection site pain.
Had COVID symptoms starting Wed May 4, 2022;  Had a Positive PCR test for COVID on Fri May 6, 2022
Pt recv vax on 6/21/97; post vax pt exp LA pain w/ tingling; dx=left axillary nerve trauma; tx=NSAIDs, physical therapy, acupuncture
This infant's mother telephoned at 9 AM on 02/09/01, to report that the child was ill since last evening, vomiting, and diarrhea 2 times, severe since this AM. Had no thermometer to determine the temp, but felt hot; consulted with the doctor. The doctor advised the mother to take the child to the ER in case the child need IV fluids for dehydration, call to relate outcome. The parent did not return the call; so the writer contacted the phone # at 5:50 PM, left a message for the mother to call. No reply!
Lymph node in my right armpit was swollen; Diarrhea; Exhausted/Still tired; Headache/ My head and body still hurt; Felt sick; Broke out in hives all over my body; Extreme pain in my right arm, upper right side of my back and under my right breast; Extreme pain in my right arm, upper right side of my back and under my right breast; Extreme pain under my right breast/body still hurt; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not available), via an unspecified route of administration on 12Jan2021 13:00 at single dose in right arm for COVID-19 immunization. Medical history included the patient had known allergies to Erythromycin and pineapple. The patient had Covid-19 prior vaccination on an unspecified date. The patient had other concomitant medications. On 12Jan2021 14:00, 1 hour after vaccine the patient broke out in hives all over her body. The patient went to the ER at around 2-3pm. Later that night the patient had extreme pain in her right arm, upper right side of her back and under her right breast. The patient called ER and they told the patient to monitor it. The next morning on 13Jan2021 the patient was exhausted, had a headache and felt sick. Her right arm was painful to touch or lay on. The hives went down some. On 14Jan2021 the patient woke at 7am and her lymph node in her right armpit was swollen. It's painful to lower her arm due to the swelling. The patient was still tired and now the patient had diarrhea (on 14Jan2021). The patient's hives were less noticeable today. Her head and body still hurt. The patient had been on bed rest. No treatment was received for the events. The outcome of the events was reported as recovered with lasting effects in Jan2021.  Information on the lot/batch number has been requested.
Spoiled vaccine administered to patient after being labeled do not use/administer due to not receiving vaccine within shipping/receiving period.
Pain in deltoid muscle upon pressure at night. Hard to lay on the side of the vaccine due to pain in the arm
About 24 hrs following vaccination, mother noted redness to L deltoid area-child did not c/o pain-moves arm without difficulty. Applied warm compresses. Resolved within three days.
Report 2001004892-1 describes joint pain in a vaccinee of unspecified age and gender who received Lyme disease vaccine (Lymerix). On unspecified dates, the vaccinee received the first, second, and third doses of Lymerix. Following the third dose of Lymerix, the vaccinee experienced joint pain. As of 02/20/01, the outcome of the event was unknown. The adverse event of the "joint pain" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 06/28/00 letter.
Rash redness at site with itching all over. Complaint of Pruritus (generalized) BENEDRYL 25mg x2.
Associate stated anxious to needles at 1400 and had flu vaccine anxiety in past.  at 1403, felt sweaty and asked to lie down.  1405 had cold compress, 15 ounces apple juice, sat 40 minutes post vaccine. At 1440 ambulated to bathroom with assistance and stated she felt better at that time. Associate left to her work environment ( Lab) at hospital as she stated she was fine.
Lower Back Pain; Blurry Vision; Sides of head temple  and neck  Pain; Itchy legs and arms; Throbbing's  behind ears
now have a positive cov-19 test results; now have a positive cov-19 test results; This is a spontaneous report from a contactable nurse reporting for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) via an unspecified route of administration, on an unspecified date, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient took first round of cov-19 shot and due to take 2nd one Saturday but now have a positive cov-19 test result.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given.
pt recv vax & some time p/vax pt exp a swollen thumb;reportedly this might have happened p/1st dose;
MMR, HIB, PCV 7 gave 08/04/2003.  Mother states a rash over entire body, started yesterday and is worse today.  eating and drinking well.  no fever present.
Myalgia, Arthralgia, Fever Fatigue Narrative:  Other Relevant History:
Patient called the clinic this morning to report an allergic reaction to the Tdap that she received in clinic on Friday around 11:30 am. Around 7:30 pm on Friday evening-started having chest pain, tachycardia, pail nail beds, low grade temperature (not measured), muscle spasms and dehydration. Denies rash on swelling, no swelling or pain at injection site. Had friend give IV fluids at home. Later to ER-given IV steroids, BENADRYL and famotidine. Rx'd oral steroids-on day 3 of steroid's reports that she is doing OK. Will f/u at clinic-if any other problems occur. Discussed with patient that we will feel out VAER's and send to CDC.
Information has been received from a physician concerning a 14 year old female who on 25-JUL-2008 was vaccinated with GARDASIL, (Lot # 660553/0070X), 0.5 ml, IM.  Concomitant therapy included "Sulodine".  On 25-JUL-2008, within minutes after being vaccinated, the patient fainted and then had a seizure.  She was revived and almost immediately fainted again.  The physician states that the patient has recovered.  No other information was available.  Upon internal review, seizure was considered as other important medical event.  Additional information has been requested.
24 hours after injection, pt had redness, warmth and swelling from injection site down to elbow, but not above injection site.
08/17/2021  appendicitis - abdominal pain for 7 hours prior to going to ER.  CT Scan revealed appendicitis. 8/18/2021 - Appendectomy
after a week or so i started feeling puffy eyes and face and was concerned about it. i went to the doctor and upon consulting he asked me to get the TSH test done. when the report came back the TSH levels were through the roof. my TSH score came back above 100 while i never had any problems with the Thyroid before. no family history either.
Itching, redness, hives at injection site developed five days after injection-- resolved within approximately three hours.
Soreness at site, with red rash extending approximately 2" in diameter around the injection site.   Reddened area sensitive to touch. Chills & fever, max of 103.7 F. , from around 12 hours post vaccine, extending through the next night. Pounding headache, and uncontrollable shivering and subsequent muscle spasms.
Patient is an 11 year old boy with a birthdate of 12/28/2009 who received the Pfizer vaccine at a school clinic. He is not age appropriate to get the Pfizer vaccine, it is only authorized for children 12 years old and higher. I met his family today at Health Facility and explained that he is not able to get a second dose here as his age disqualifies him. The family will return to Health Dept/Facility after his 12th birthday in December 2021 or will contact provider for a second off label dose if their physician is willing to permit this special situation. Client and family were educated that he does not have full protection by only receiving one dose, continue to wear masks, practice social distancing, and hand wash regularly. The patient had no ill effects after the vaccine was administered at Health facility.
This patient had severe muscle and body pain all over, chills, fast heart beats, and a swollen right arm that is painful to move. Cellulitis Tetanus reaction.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 025J202A) for COVID-19 vaccination.     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-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. On 10-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved.            No concomitant product use was reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up received provided no new information.
just sweating like someone was pouring sweat on me; a little weakness; went to the bathroom but it wasn't diarrhea; a bit of nausea; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (just sweating like someone was pouring sweat on me), ASTHENIA (a little weakness), ADVERSE EVENT (went to the bathroom but it wasn't diarrhea) and NAUSEA (a bit of nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 30L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (patient reported having a long list of medication allergies(not specified)).    On 27-Jan-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021 at 11:00 AM, the patient experienced HYPERHIDROSIS (just sweating like someone was pouring sweat on me), ASTHENIA (a little weakness), ADVERSE EVENT (went to the bathroom but it wasn't diarrhea) and NAUSEA (a bit of nausea). On 28-Jan-2021, HYPERHIDROSIS (just sweating like someone was pouring sweat on me), ASTHENIA (a little weakness), ADVERSE EVENT (went to the bathroom but it wasn't diarrhea) and NAUSEA (a bit of nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported Patient did not use any medications for treatment
Patient was given 0.5mL of the Moderna Bivalent covid vaccines instead of 0.5mL of the Moderna covid vaccines (primary series)
11/3/15 - Got 2 mos immunizations. 11/10/15 - ER - cough, congestion, diarrhea, decreased PO - viral gastro. 11/11/15 clinic little better - diarrhea each feed - viral gast. 11/19/2015 - ER admit - decreased PO intake, decreased void -> TPN, rectal, NG feeds. 12/01/15 - Discharged. 12/11 - GI clinic appt. - feeding aversion, abd distention - BM only with saline rectal irrigations and stimulation. 12/11/15 - Readmit to hospital - NPO/TPN or NG feeds - still only stool with irrigations and stimulations. 12/21/15 - G-tube placed in OR. 12/22/15 - Discharged home NPO (aspiration risk with D.S.) on GT feedings, irrigations and stimulation.
Narrative:  85yo male pt with the following PROBLEM LIST: Zinc deficiency Atrial arrhythmia, HTN, HLD Sleep Apnea Anemia Abnormal liver function Benign Prostatic Hypertrophy Osteoarthritis Diet-controlled diabetes mellitus 03/27/2020 Discitis of lumbar region 03/27/2020 Osteomyelitis 03/27/2020 Weakness of right leg 03/26/2020 died on 11/25/2021 outside of facility. No info provided about place or circumstances of pt's death. Last record system note dated 3/19/21. Pt did receive covid vaccines from medical facility on 1/14/21 & 3/2/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
Diarrhea; Nausea; vomiting; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), NAUSEA (Nausea), VOMITING (vomiting) and ARTHRALGIA (Joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nausea), VOMITING (vomiting) and ARTHRALGIA (Joint pain). At the time of the report, DIARRHOEA (Diarrhea), NAUSEA (Nausea), VOMITING (vomiting) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Day after giving MMR, arm swelled up from shoulder to elbow for 3 days.
Caller had a mixture of both Pfizer and Moderna; Caller had a mixture of both Pfizer and Moderna; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "occipital neuralgia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose number unknown, single), for COVID-19 immunisation, reaction(s): "headache". The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "Caller had a mixture of both Pfizer and Moderna"; HEADACHE (non-serious), outcome "unknown". Additional information: the patient had a mixture of both Pfizer and Moderna. She had pre-existing conditions prior to getting any of the Covid vaccines and that condition is occipital neuralgia. After each dose, she gets a terrible headache. The first one lasted for a few days. Then they have gotten longer in duration. Her most recent booster, the last one, just killed her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-202201169646 same patient, different events after different doses of the vaccine;
minor injection site discomfort; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patent received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL 3246), via an unspecified route of administration n left arm on 12Jan2021 at 03:15 AM as 1st dose single for COVID-19 immunization. Medical history included HIV +, high blood pressure, shoulder replacement, hip replacement, knee replacement. Concomitant medications included dolutegravir sodium (TIVICAY), emtricitabine, tenofovir alafenamide fumarate (DESCOVY), hydrochlorothiazide, rosuvastatin. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient dd not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 03Feb2021 at 08:00 AM (after first dose), patent experienced minor injection site discomfort. No treatment was received for the adverse event. Since the vaccination, the patient had not been tested for COVID-19. Patient also received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL 82982), via an unspecified route of administration n left arm on 02Feb2021 at 03:00 PM as 2nd dose, single dose for COVID-19 immunization and experienced minor injection site discomfort, Joint pain, achy all over, weakness, little bit of fever, chills, no appetite. This lasted 1.5 days. The outcome of the event was recovered.
Injection site pain Injection site lump, bump & swelling Injection site redness Injection site itching Headache Dizziness  Fatigue for 24 hours
Dizziness, Headahce, Pt. requested fluids.  Narrative: 10 min after 2nd dose stated felt dizzy and asked to lay down 127/79, 104, 22, 100% 02sat, 20 min. later c/o not feeling well again and stated, "I can't breathe." RRT called /137/80, 108, 100% 02 sat. Pt. requested fluids. IV Normal Saline administered 500 ml through RFA 22g. Monitore until 1030. Stable. returned to clinical area. Last VS 133/82, 88, 22, 100% 02sat.
Recurrence of Covid symptoms and positive RAT test after multiple days testing negative and feeling well.; Recurrence of Covid symptoms and positive RAT test after multiple days testing negative and feeling well.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 29 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "orthostatic hypotension" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. Past drug history included: Amoxicilin, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Recurrence of Covid symptoms and positive RAT test after multiple days testing negative and feeling well.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: multiple days testing negative; Positive, notes: positive RAT test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Other medication in 2 weeks. Patient received paxlovid for COVID 19 treatment started on 06Nov2022 and stopped on 10Nov2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
She had dizziness and body aches a day after she  got shingrix and still have the symptoms up to this day.
A week after my first shot, I developed a rash. It was on my injection site, both of my upper arms, and my butt. The rash is kind of red and blotchy, and very itch. It also first looked like hives. It started to go away after a couple of days, but then came back on my arms and chest. It has been about two weeks now and the rash has not gone away.