chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slept all day; fussy memory; severe headaches; Flu like symptoms; tired; swollen arm at vaccine site; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 78-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot Number: EL9260), via an unspecified route of administration, administered in Arm Left on 18Feb2021, at 18:00 (Age at vaccination 78-years-old), as DOSE 2, SINGLE for covid-19 immunization. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin (ATORVASTATIN), lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported. Patient did not receive other vaccine in four weeks. Patient did not have covid-19 prior to vaccination. Patient not tested for covid post vaccination. Patient did not have known allergies. The male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot Number: EL8982), via an unspecified route of administration, administered in Arm Left on 25Jan2021, at 01:00 PM, as DOSE 1, SINGLE for covid-19 immunization. On 19Feb2021, the patient experienced swollen arm at vaccine site, on 20Feb2021, the patient experienced flu like symptoms, tired, on 21Feb2021, the patient slept all day, fussy memory, severe headaches. Therapeutic measures were not taken as a result of the events except the event severe headaches and patient took tylenol to relieve headaches. Ibuprofen did not work, on sixth day patient was able to resume activities had active night dreams felt like 48 hours of regular Flu. The clinical outcome of the events was recovered on unspecified date.   No follow-up attempts are possible. No further information is expected.
3:40 pm received shot and felt soreness at injection site.  11 pm: started experiencing chills, goose bumps, headache, body aches,  3/25: all symptoms continued and also experienced sensitivity to light. Eyes hurt when moving them around All symptoms diminished 36 hours after shot. Symptoms were gone 48 hours after shot. Only soreness at injection site remained for 2 more days.
pt recvd vax on 4JUL92 w/no complications; 4AUG92 recvd 2nd dose of vax & the same day exp a h/a; pt devel urticaria & 4SEP92 exp tingling in mouth, lips & tongue; 8SEP92 seen by MD who noted puffy lip due to angioedema; tightness in throat
Narrative:  Reporting per Network guidance. Patient with 1 dose of covid vaccine. PMH h/o CAD s/p CABG (SVG to PDA 3/2008, LIMA to LAD, Radial to OM, transmyocardial revascularization of inferior wall 9/2008), multiple coronary stents, atrial fibrillation on Warfarin, DM Type II, severe COPD on home O2, and SCC of the lung s/p RUL lobectomy with newly diagnosed metastatic changes from 12/2019. Limited details of death documented.
This case was reported by a physician via sales rep and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. Previously administered products included Tetanus booster with an associated reaction of injection site pain (received on an unknown date) and ZOSTAVAX (received on an unknown date). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain and tiredness. On an unknown date, the outcome of the injection site pain and tiredness were unknown. It was unknown if the reporter considered the injection site pain and tiredness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient stated that, the SHINGRIX immunization hurt like a tetanus booster. The patient also felt tired (less than a year after vaccination), but did not had fever. The reporter did not agree to be followed up. This case was linked to case US2018GSK124675, reported by same reporter.
Patient received her first Pfizer vaccine on 4/1/21. Due to a miscommunication, patient received her second vaccine on 4/9/21 without any side effects. Notified Dr. of incident and he contacted CDC. Reported via VAERS. Notified patient of process and expected outcomes as per CDC website. Patient verbalized understanding.
Tenderness and redness around site of DTaP #3 immunization on right upper leg. Also vomiting on 05/12/05.
Mother brought pt to clinic 6/18/03 reporting pt's right deltoid injection site for Prevnar injection now reddened with added heat and never experienced such a large area of redness. Posterolateral to injection site and within reddened area is a small raised bump and next to that a very small abrasion - both appear to be a bug bite and possible site of scratching. Pt busy, not favoring arm, alert, oriented, no draining, no red lines. 48 hours after injection reddened area present. Axillary temp taken - 98 degrees. Mother used cool rag 6/17/03 on arm. 1.5"-1.75" area of redness around injection site.
Patient complained of feeling very dizzy following vaccine administration. Patient laid down, was given water and juice and reported feeling better. Patient left clinic with her sister.
Febrile episode 104.4 on 3/6/12 10:45 am. 101.1 on 3/5/12 1600 H/ 102.0 3/6/12 early am.
5-6 days p/vax devel fever 105.9 (by ear scan) vomited earlier that day approx 3-4 p/high fever-fever remained lower grade (highest 102);rash maculopapular;3-4 high fever;viral poss post MMR rash;
Very sore on my whole left side of my body. Sore and stiff muscels in my back, left arm and left side of my chest.
Arm and joint pain, tingle pins and needles for a length of time in left thumb and arm.  Hot spot and tenderness.  Very ill after second dose. Could not get up or attend work.  Body aches, severe headache and chills.
17DEC97 c/o onset of swelling & itchiness 3 days past immun;area of c/o under both eyes;status same as 17DEC97;
Information has been received from a physician, via a company representative, concerning a patient who was vaccinated with a dose of Gardasil (date not specified). On 25-OCT-2006 the patient developed "a temperature elevation of 102 degrees." Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Initial and follow up information has been received from a physician, concerning an 11 year old female patient, who on 25-OCT-2006, was vaccinated in teh afternoon (exact time not specified), in the left arm with the firs dose of GARDASIL (Lot #651650/0702F). The physician confirmed that the patient's physical exam at the visit "revealed no sign of illness." By 9:00 pm that evening, the patient had developed a temperature or 102.5F, and a swollen left arm. On 26-OCT-2006, the next day, the patient's temperature further elevated to 103 degrees, and she experienced chills. the physician reported that the patient recovered from the swollen arm, fever and chills on 28-OCT-2006, within 72 hours of the vaccination. No further information is expected.
on 01/14.21, The patient had the chills and fatigue. On 1/17/21, The patient developed severe right ear pain and right sore throat. On 1/19/21,  developed multiple painful sores on the right side of the hard palate.  On 1/20/21, the ulcers in the month got worse. Started on Valtrex. On 1/24/21, the patient felt better but the pain  and sore throat returned on the 1/26/21.
Mom states she had "blotches from head to toe", severe itching but normal temperature of 97.9F. She was given Celestone in ER and oral medicine (she thinks it was Benadryl) to take prn.
Developed a small light rash on Chest, near elbow and forearm, and above belly button. I have NOT gone to the doctor the get it checked. I have NOT develop any breathing issues just the light rash.
Patient came into pharmacy 10/15/21 stating her arm has gotten progressively more sore since receiving flu shot on 10/4/21
Injection given in left deltoid.  The whole shoulder and upper arm had swelling.  The injection sight had 3cm redness: 1cm induration.  No systemic reaction.
Client was given 3 vaccines the last Hep B in (R) delt. Client stated she felt a hot flash come over her then 30 seconds later the room was spinning. Client was checked for pulse and BP, she was told to put head between legs, 1 min client was laid on floor and was diaphoretic, BP 97/63, felt better after 5 min with cold paper towel.
He got his vaccines, had some soreness in his arms, had one vaccine in both arms, had about a 2/10.  He felt light headed that evening.  By the next morning he had the light headedness, chills and an on and off fever that came and went.  Tuesday night he had cold sweats at night.  By Wednesday he had mild fever, nausea and just lethargy.  He noticed a rash forming on Wednesday, looked like hives, but not raised, just flat, but strange pigmentation.  The rash was all over his torso, buttocks and very lightly on his upper thigh under his pant line, red dots.  Then by Thursday morning it ran down his legs to about 2/3 towards his knee where his shorts end.  Then the dots started connecting, and became a heavy rash (no itching), just pigmentation changes.  It looked like it was painful, but did not feel anything.  He took Benadryl for the reaction twice a day, and today his rash seems to be gone, very faint redness.  It started lightening up Saturday evening, and has slowly weaned until now.  It left his torso and buttocks and stayed longest on his thighs.   The other symptoms were gone by Friday afternoon/morning.    He called his doctor and informed them of it, but by the time they got back to him the situation had been resolving.
Day one after vaccine, swelling and soreness of the arm that was  vaccinated.  10 days after the vaccine:  muscle aches, hand/wrist swelling and pain, and diahrrea on day 13.  This has lasted 3 days and has started to subside with the use of ibuprofen every 4 hours.  Reported to Dr. on Day 12.
Swelling of arm (expected), swollen axilla nodes (expected), swelling onto right chest down to mid ribs with associated pain
developed diarrhea, stomach cramps, and bloating/diagnosed with lymphocytic colitis; This is spontaneous report from a contactable consume (patient). A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 12Mar2021 10:30 (Lot Number: EN6206) as dose 1, single (at age of 43-years-old) for covid-19 immunisation. No pregnant at time of vaccination. No other vaccine in four weeks. Medical history included Idiopathic hypersomnia, irritable bowel syndrome (IBS), subclinical hypothyroidism. No known allergies. No COVID prior vaccination. Concomitant medications included levothyroxine sodium; melatonin; DHEA; docosahexaenoic acid (DHA); ubidecarenone (COQ10); vitamin D NOS (VIT D); acetylcysteine (NAC). On 18Mar2021 07:00 (also reported as 6 days after the first dose of the Pfizer Covid19 vaccine), she developed diarrhea, stomach cramps, and bloating. These symptoms worsened and became chronic for 12+ weeks, at which time she finally underwent a colonoscopy. A biopsy was taken during the procedure through which she was diagnosed with lymphocytic colitis. Although she has a history of IBS, which is effectively managed with dietary restrictions, she has never had episodes of colitis prior to this time. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment (prescribed a 5 week regimen of Budesonide). The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 02Apr2021 10:30 (Lot Number: ER8733) as dose 2, single for covid-19 immunisation. The patient underwent lab tests and procedures which included biopsy: lymphocytic colitis, colonoscopy: unknown results, Saliva test by PCR - Accurate Diagnostic Labs: negative on 08Jun2021. Outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
I had running nose, cough, weakness, and chills that lasted for about 6 days. On Feb 7th, I tested positive for COVID-19.
Pain level 9 in right shoulder; radiating to the neck; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FN6197) via an unspecified route of administration in the left arm on 12Mar2021 at 09:30 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included stomach cancer and bladder cancer. The patient had no allergies to medications, food, or other products. Concomitant medications included imatinib mesilate (GLEEVEC) for cancer treatment from an unknown date. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the arm left on 19Feb2021 at 13:15 (at the age of 67-year-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 vaccination. On 09Apr2021, the patient experienced pain level 9 in the right shoulder and was radiating to the neck. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event pain level 9 in the right shoulder and radiating to the neck was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
Patient received 2 doses of Shingrix and was diagnosed with Shingles/suspected vaccination failure; Patient received 2 doses of Shingrix and was diagnosed with Shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Patient received 2 doses of Shingrix and was diagnosed with Shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Patient received 2 doses of Shingrix and was diagnosed with Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 07-NOV-2023 The reported stated patient received 2 doses of Shingrix within appropriate time frame. The patient was diagnosed with shingles after completion of Shingrix vaccine. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The reporter consented to follow up.
Patient's legs were weak, like floppy not just sore but barely moving. The next morning he was not responding to anything.  He couldn't move his arms or legs. His legs would flop to the side like frog legs. He would try to pick up his head and it would just drop.  We couldn't get him to smile like he always does or coo or interact with anything. His social skills as a 6-month old were gone and he was looking through us.  As if he didn't even see us. This went on for almost 2-hours.
I have never experienced any type of allergic reaction to Honey Bee Stings I was stung a a few times 4 weeks ago with no issues. I was stung once on my right index finger post Covid Vaccine and within 10 min of being stung broke out in a major rash, hives and swelling all over my body including  face, lips, tongue. After a large dose of Benadryl it finally stopped swelling after 15 min-30min after taking them. The rash, hives and swelling went away after 3 hours.  I have never experienced any kind of swelling or rash to beestings of any kind, especially not honeybees.
PATIENT REPORTED ON THE SECOND SHINGRIX DOSE THAT HER EYES BECAME SWOLLEN & HER SKIN WAS RED AND SPLOTCHY. THE DOCTOR HAD TO GIVE HER A STEROID INJECTION AND SUBSEQUENTLY A 5 DAY SUPPLY OF ORAL PREDNISONE. A NURSE PRACTIONER TOLD THE PT TO REPORT HER REACTION TO US. SHE DID NOT HAVE A REACTION ON THE FIRSTSHINGRIX DOSE OR ANY FLU VACCINE IN THE PAST.
Patient had one head and hand jerking as eye closing and shutting  rapidly once for 30-40 minutes after her first COVID vaccine on 8/10.   Less than 24 hours after her second vaccine on 8/31, she developed had facial muscles, head, eye, hands and arms (right more than left) and once in a while her right leg - twitching and jerking.    Was prescribed Cogentin which did nothing.  Benadryl as well as IV Lorazepam stopped them.  But only temporarily.  Oral Benadryl and Lorazepam help control her symptoms.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On 01-MAY-2018, the patient was vaccinated with a dose of ZOSTAVAX via the intramuscular route in error for prophylaxis (anatomical location, lot# and expiration date were not reported). There was no adverse effect reported. Product quality compliant was not reported.
Sleeping the entire week after; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Sleeping the entire week after) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (Sleeping the entire week after). The patient was treated with PREDNISONE at a dose of 1 dosage form. At the time of the report, HYPERSOMNIA (Sleeping the entire week after) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications  daily medicine  Patient when went for emergency care were given steroids to open up her lungs   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow Up information was received on 26-Jul-2021 Event Outcome updated.
Information has been received from a health professional, via a company representative, concerning a female patient who was vaccinated with a dose, 0.5 ml of Gardasil (date not specified). It was reported that the patient "developed auto immune disease soon after the injection." The patient sought unspecified medical attention. No further information is expected.
Severe swelling from shoulder to elbow; red, tight, hot skin; severe headache; weakness/tiredness; aches in muscles and joints; pain at injection site/upper arm.
approx 3hr p/vax pt devel pain in rt arm;had redness & swelling @ inj site;pt states pain inc to entire arm;went to ER 29MAR97;pt was told had a rxn to the inj;pt was prescribed ATB & lortabs;did not have these filled;
9.3 x 6.5 cm area of erythema with a 6.5 x 5 cm area of induration around punctures sites on R upper outer arm, mild tenderness to touch, warm to touch.
On 10/14, patient received flu shot at office at 3:20PM. Patient reports that she experienced itching all over her body, including extremities. She also felt that her "inside was itching, a lot". She used hydrocortisone on her skin, and it helped only a little bit with itching. The next day, pt experienced blisters popping up all over her skin. She went to the ER. They said it was an allergic reaction to the flu shot, and to follow up with primary if it doesn't go away. The blisters did not, and she came for follow up on 11/4/20.
Syncopal Episode with seizure episode then syncope again. EMS at vehicle. Close to refused transport to hospital. Called emergency contact after EMS checked client out.
Arm is itchy and red at site of injection (looks like Moderna or COVID arm). Lots of warmth also present at site. Reaction did not start until day 11.  Note on day 2-4, there was severe arm/shoulder soreness as well.  Also, day 1 around 4 hours after vaccine administered, my throat felt like something was stuck in it but no other signs of reaction. The feeling cleared in about 1 hour so it may not have been due to vaccine.
This case was reported by a consumer via call center representative and described the occurrence of speech disorder in a 11-week-old female patient who received KINRIX. On 18th October 2016, the patient received the 1st dose of KINRIX. On 18th October 2016, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On 19th October 2016, the patient experienced speech disorder. On an unknown date, the outcome of the speech disorder, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown. It was unknown if the reporter considered the speech disorder to be related to KINRIX. Additional details were provided as follows: This case was reported by the patient's mother. The reporter wanted her daughter to receive only DTaP, but her doctor convinced her to add poliovirus as well. As a result of this decision, KINRIX was chosen to administer the series and the patient received KINRIX at an age of 11 weeks. As a result of this decision, KINRIX was chosen to administer the series and the patient received KINRIX at an age of 11 weeks. Thus, it led to an inappropriate schedule of vaccine administered and an inappropriate age at vaccination. In morning of reporting date, the patient was not been babbling or cooing like usually does in the morning. The reporter declined to do the report.
The individual left the EH office at approximately 1400 and returned approximately at approximately 1405 saying "I can't breathe."  Her skin was cool and clammy even though she was wearing a thick hoodie.  Her eyes were rolling in her head.  She had difficulty following verbal instructions, but never lost consciousness.  HR 66.  A rapid response  was called at 1408 and EPI administered 1412.  Rapid response RN arrived 1414 and transported her to the ED in a wheelchair.
The patient had soreness at the injection site and the soreness persisted for several days, on average the pain was 3/10. She was able to move her arms, but there was some limitation due to the discomfort. She does regular intense exercise. About 20 days after the vaccination, she noted the pain to her left arm was more pronounced than the previous days about 5/10  and her left arm feeling stiff with some limits on range of motion.