chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came to pharmacy for first moderna COVID vaccine. Patient was checked in and screened by technician. He stated he felt dizzy this morning but that is not unusual. temp was normal and no other issues stated by patient. Patient was given vaccination by pharmacist. She reported he bled through 2 bandaids. She then switched out with me due to her lunch break. I came into the room to make sure he was ok because she said it was more blood than ususal and when I entered the patient was brow was beading with a small amount of sweat. I asked the patient if they were feeling ok. He stated he felt dizzy or light headed and maybe a little nauseous. I asked if he had eaten that day. He stated he had, I asked if he had health conditions. The patient stated they had high blood pressure. I asked if they had taken their medications that day and he stated he had taken them. I asked if I could take his blood pressure and he agreed. His blood pressure was great 135/72 heart rate 74. I asked him to keep sitting in the vaccine room as he had more sweat on his forehead now and let him know he could remove his mask if he was having difficulty breathing. He said he thought he might be and removed it. He said he felt nauseous again so I put a trash can in front of him and offered some water. He said he wanted water so technician went and got him some water. I stepped out of the room for a quick consult and asked another tech to make sure to watch the patient. If he fell immediatley let me know. I finished the consult and was heading back to the room when I heard vomiting so I remained outside but could see him through the glass. He continued to vomit and was on the floor on his knees. Another consult came to the window so I stepped up to the consult as I finished I heard a sound from the vaccination room and ran to look and the patient was now on the floor on his side lying limp. I asked can you breathe can you breathe? He did not response. His eyes were open though. His lips looked a little purple/blue and I placed my hand in front of his mouth. I told him I was going to administer an epipen if he can't breathe and he did not respond. I gave the epipen and he became more responsive and was answering questions with one word or blinking.  When going to grab the epipen I told my technician to call code White and emergency and we alerted staff. EMS came and picked up patient
Patient says she developed a red band all the way around her left arm near the Shingrix injection site  1-2 days after she received Shingrix. She also mentioned the area became hard and raised 1-2 days after the Shingrix shot. The patient started developing red bumps all over her body except her face 11 days after the vaccine (10-15-19).
C/O  itching "all over".  No rash  or respiratory symptoms reported or observed. Pepcid 20mg po and Benedryl 50mg IM X 1 dose. Symptoms resolved within 15 minutes. Pt. discharged home with driver.
Little bit of pain on my shoulder; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 14May2021 at 03:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medications were not reported. The patient had no known allergies. 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 14May2021 at 04:45 the patient experienced little bit of pain on shoulder. The patient did not receive any treatment for the event. 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 little bit of pain on shoulder was unknown.   No follow-up attempts are needed. No further information is expected.
Received Hep.'B' #3 and Varicella #2 on Friday 10/28/05. Has a history of numerous environmental allergies (dust, trees, pollen etc.) Patient has complained of shortness of breath since Friday. Also Mom has observed that his eyes are red and watery. He is also complaining of cancer sores in mouth, which he has a history of since braces. 11/3/05 Saw M.D. placed on antibiotic for sinus infection. Shortness of breath decreased 11/4/05. Per M.D. patients shortness of breath was felt to be from sinus infection per M.D. at Med Express.
Patient is 16 years old and received the 0.3mg dose instead of the 0.5mg dose.
Patient was admitted to Emergency Department 36 days after receiving COVID vaccine dose #2. Patient was admitted to hospital 5 days after ED admit.
Patient developed fever with a MAXIMUM TEMPERATURE of 102 approximately 5 hours after immunization was given. Along with this he had soreness of the arm, difficulty moving the arm for 2 days, myalgias, and red rash distal to the injection site. Fever did abate 2 days after injection. He was examined in the office 3 days after the injection with ongoing presence of warmth and rash circumferentially distal to the injection site of the right arm. There were no symptoms of anaphylaxis.
Immediately after the first shot, left arm was so sore it could not be moved or touched. 36 hours after the shot, a high grade fever developed, accompanied by shaking and intense muscle aches. Acetaminophen helped reduce symptoms, however sore arm persisted.
A report was received from a health care professional on 12/17/03 concerning a 2.5 year old female vaccinee who inadvertently received Fluvirin vaccine on 12/17/03. On 12/17/03 the vaccinee was administered 0.5ml Fluvirin. The vaccinee had not exhibited any signs or symptoms of an adverse event at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Employee received annual influenza shot on 11/10/04 then subsequently also received the pneumococcal and meningococcal vaccinations from her private physician on 12/30/04.  Approximately 2-3 days following the pneumococcal injection the employee reported a swollen reddened and painful arm.  The MD treated her for localized cellulitis.  The employee continued to feel "bad" and on 1/22/05 began to complain of numbness to her lower extremities and low back pain.  The pain and numbness progressed over a five day period to the point to where the employee could not site, stand, or walk.  She was seen in the ER on 1/27/05 and was admitted for intractable back pain.  Her leg weakness and pain has continued.  The employee remains unable to stand or walk and now has a neurogenic bladder requiring catheterization.  EMG done on 2/6/05 indicative of Guillain-Barre. Diagnosis now confirmed. Patient remains hospitalized at the present time.   5/31/05 Discharge summary 1/27-2/2/2005 received. FINAL DX: Guillain Barre syndrome per neuro consult of 2/2/05; neurogenic bladder Medical records state back pain x 5 days, cardiovascular disease, nephritis, pylonephritis, disc disease, tachycardia and neurogenic bladder, vertigo, headache, urinary tract infection, vision decreased, pain and ataxia.  Pt had variable weakness & sensory loss both legs.  Neuro consult done.  Patient had flare of Meniere's disease 11/04 tx w/high dose steroids; had been exposed to shingles; developed purulent eye infection in 12/04 tx w/eye drops; developed cellulits at pneumovax site & was tx w/oral antibiotics.  Developed neurogenic bladder prior to transfer to rehab & catheter inserted.  2nd Neuro consult done & dx w/GBS.  Readmitted to hospital 2/9-2/17/2005.  LP had been done s/p IVIG tx & revealed viral meningitis which was attributed to IVIG tx.  Tx w/IV antibiotics, antivirals & steroids. Improved & re-transferred to inpt rehab.
Client states that she started having soreness in her left arm the evening of 1-25-07.  She continues to have soreness in her left arm.     She also has pain in her left shoulder, left elbow, left inner arm (near elbow), and left lower back.  Client states that she also had fluid on her knees and in her legs that started the third day after the injections.  Client states that she went to her physician on 2-22-07 for routine labs (cholesterol, etc.) but did not receive any treatment for her left arm and shoulder.  Client returned to physician on 2-28-07.  Client received a flu shot on 11-2-06.  States no other injections between 11-2-06 and 1-25-07.
Patient woke up between the hours of 3 am-430 am with a rash. Patient complained of itching on the legs, ankles, hips, and breasts. Patient used benadryl gel, tylenol, and zyrtec orally.
Nausea, vomiting, diarrhea, abdominal pain and cramping, and fever, dehydration.
Within 45 minutes, I got dizzy, then 2 hours later I got a severe splitting Headache (migraine type without the aura) , fatigue, and nausea lasting 8-10 hours. Fatigue and Headaches continue daily in the afternoons and evenings.  Then 2 days later my lips started to swell, which progressed in intensity for 3 more days until my lips and tongue split, blistered, developed more asthma and difficulty breathing but not enough to use EpiPen or go to ER, and also my tongue felt thicker.  Called Immunologist on day 6 (Monday morning).  He ordered blood work.  The symptoms started to decrease on day 10 -16 but continue to have to use Symbicort 2x/day vs 1x/day and still get very fatigued as the day progresses and daily headaches.  My lips will swell easily with allergens and an increase in asthma.
Pt reported severe skin reaction on face 9-24-21 Pt described edema,whelps, skin was hot to the touch e] use for COVID-19 under Emergency Use Authorization (EUA): pt received Moderna Lot # 046c21a
Erythema on right arm following injection. Patient had pneumonia injection and right arm on 10/3/18. Patient states that the injection site in her right arm overlying the right deltoid became erythematous following injection. Reports she was given antibiotics, KEFLEX ×10 days, 2 weeks following the injection from her PCP. Patient reports 4/10 pain currently. States that the lesion has opened twice on its own, and has drained both times. Reports a cream-colored/brown colored fluid coming from the lesion. Denies malodorous drainage. Denies ever having any reaction like this before with prior injections. Denies fever, sweats, chills. BACTRIM DS BID x 10 days ordered.
After flu shot developed autoimmune disease which kept her from eating and eventually her airway which led to her death 3-25-15.
Erythematous patches on face, ears, neck, knees, dorsal aspect of ankles   Tingling perioral area and face.  No swelling, no dyspnea, no wheezing, no fever.  No diaphoresis, no dizziness.  Mild pruritus.  Benadryl 50 mgm taken po
About five days after vaccine administration I noticed an inflammation of the area of the achilles tendon of left foot. Since I am not prone to inflammation of any sort nor did I have any strain or trauma, I took notice. I do not CHF (causing swelling of the ankles). The area of inflammation is tender, a bit red and a bit swollen. It is worrisome since I have never had anything like this in the past. I WILL NEED FOLLOW UP ON THIS. I AM UNSURE IF I SHOULD RECEIVE THE SECOND VACCINE. AND I WOULD LIKE TO KNOW IF SIMILAR INFLAMMATORY RESPONSES HAVE BEEN REPORTED, WHETHER IN ANKLE OR SOMEWHERE ELSE IN THE BODY.  I realize that this may not be a typical vaccine reaction BUT this is a brand new vaccine, has not been time-tested, is only permitted by the FDA to be administered under these emergency circumstances. SO all possible reactions must be taken seriously and recorded. We are the guinea pigs. Also. I was handed a packet of papers when I received the vaccine. To register for v-safe the only two options given for registration were smart phone browser or QR code. I do not have a cell phone. So this leaves me out of the loop, which I think is unfair and unwise. Why can computer registration not be made available, and if it can then why doesn't the instruction sheet tell of this? In rural areas not everyone has a cell phone nor is cell service available to all areas.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient. A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "stiffness"; PAIN (non-serious), outcome "unknown", described as "Body ache".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) : US-PFIZER INC-2021242765 same reporter, drug and events; different patient.
One day post vax, the pt experienced respiratory congestion, cough, fever, chills, fatigue, muscle aches, headaches. Reports being very tired, still 6 days post vax. Still not feeling well.
Pt c/o chest pain 20 min after vaccine. Pain in middle of chest, dull quality. Asked pt if she wanted to be seen by ED, and she agreed.  Pt wanted to walk, so staff assisted patient to ED.  After arrival ro ED, pt stated chest pain resolved.  pt was checked in to be further evaluated.   Pfizer dose #1.  Lot EN6198 Exp 6/30/21.
Tingling in feet and toes; Numbness in feet / Numbness in toes; Left side of mouth tingling; This spontaneous report was received from a consumer of age 25 years old, female who was participating in the mRNA-1273COVID-19 Vaccine,  Emergency Use Authorization Program and experienced multiple events of tingling in feet and toes, numbness in feet / numbness in toes and left side of mouth tingling.  The patient's medical history was not reported. No concomitant medications were reported.  On 30 Dec 2020, approximately 3 minutes earlier to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number 011J20A) intramuscularly in the deltoid muscle of the left arm for prophylaxis of COVID-19 infection.  On 30 Dec 2020, two to three minutes after the injection, the patient experienced tingling and numbness in left foot and toes. She started to walk around bit but the feeling persisted. A few minutes later the same tingling and numbness in right foot and toes developed. After ten minutes, the patient experienced tingling in her left lip. The patient was then treated with Benadryl and taken to the emergency medical technician (EMT) to be monitored. After 35 minutes and having the patient's vitals checked twice the patient was cleared to go. The patient informed that after she left the site she did not experienced any tingling or numbness.  The Action taken with mRNA-1273 Vaccine in response to the events was not reported.   The outcome for the events, tingling and numbness in left foot and toes, tingling and numbness in right foot and toes and tingling in my left lip were considered recovered/ resolved on the same date.  The reporter did not provide an assessment for the events.; Reporter's Comments: This case concerns a 25-year-old, female patient,  who experienced  non-serious unexpected events of Paraesthesia  and Hypoaesthesia extremities and Paraesthesia oral  left side . The events of Paraesthesia  and Hypoaesthesia extremities and Paraesthesia oral  left side , occurred 1 day (same day) after first dose of mRNA-1273, COVID-19 Vaccine lot # 011J20A. Treatment included Benadryl. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by a physical therapist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 66-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. It was reported that 173 doses were administered on 08-Apr-2022, 12-Apr-2022 and 13-Apr-2022 from batch 070H21A. No information was reported on date of the storage of vaccine in refrigerator. The vial did not undergo any temperature excursions. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non-significant followreceived
VIALS HAD A TEMPERATURE EXCURSION THEN ADMINISTERED TO PATIENTS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a multiple patients of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patients was previously treated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) for (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) 1 total, dose was not reported, administered on unspecified day for prophylactic vaccination (Dose number in series 1). No known events were reported after vaccination. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A and expiry: 14-DEC-2021) 1 total, dose was not reported, administered on OCT-2021 for prophylactic vaccination (Dose number in series 2).  No concomitant medications were reported.  On an unspecified day in OCT-2021, vials had a temperature excursion then administered to patients and qualified for incorrect product storage. Pharmacy assistant reported that 6 unpunctured vials of Janssen COVID-19 vaccine had multiple temperature excursions between 20-OCT-2021 until 17-NOV-2021 where the minimum temperature reached was 0.6 degree Celsius and the maximum temperature reached was 9.6 degree Celsius. The excursion happened while the vials were in the fridge and the temperature readings were recorded every 5 minutes. The pharmacy checked the temperature excursion information online and found that there was no restriction in duration for storage of unpunctured vials excursion temperature range between 0 to 1 degree Celsius and also no restriction if between 9 to 10 degree Celsius so the pharmacy administered the vaccine from these vials. They administer 5 booster shots and 1 primary shot between Oct-2021 and NOV-2021 when the vials were not expired. The pharmacy assistant was calling to confirm that the temperature excursion information found online for those temperature ranges was correct and that the vials were not adversely affected. The patients who received the vaccine from these vials did not report any adverse events to the pharmacy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vials had a temperature excursion then administered to patients and incorrect product storage was not reported. This report was non-serious.
Woke up and walked down stairs 12:30 pm Wednesday with shortness of breath, walked back upstairs 1:00 pm, slept 45 minutes, waled back down stairs, watched TV from sofa in family rm, at 4:00 pm attempted to get up to go to the bathroom and fell. Help from partner to get to bathroom and back to sofa. It was getting more difficult to shift body on sofa, no strength in arms or legs. Spent night on sofa, slept from 2:00 am until 2:00 pm Thursday. Getting up 11:00 am with help to go to bathroom. During the rest of the afternoon and evening slowly regained strength and improved breathing. Went to bed upstairs 2:00 am Friday. Woke up Friday 2:00 pm and felling much better.
Tiredness; ache in upper left arm; This case was reported by a consumer and described the occurrence of tiredness in a 65-year-old patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included chickenpox (mild case chickenpox when 12 or 13 years of age). Concurrent medical conditions included drug allergy (allergy to sulfa drugs).   On 1st September 2020, the patient received the 1st dose of Influenza vaccine Quadrivalent unspecified season. On 1st September 2020, less than a day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced tiredness and pain in arm. On an unknown date, the outcome of the tiredness and pain in arm were recovered/resolved.   It was unknown if the reporter considered the tiredness and pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The patient had no allergic reactions, only known drug allergy was to sulfa drugs. The age at vaccination was not reported but it could be 64 to 65. As the patient was aged his or her temperature ranges from 97 plus to 98.4 degree F. The patient received the Flu shot in left arm and experienced tiredness with ache in upper left arm lasted 3 days, beginning in the evening of the day of shot.  The patient received Prevnar 13 vaccine on 6th October 2020 in left arm and experienced same events. The patient received 1st dose of Shingrix on 16th November 2020 and had allergic reaction. On 19th November 2020, the patient confirmed that he or she never had shingles.  This case has been linked with US2020AMR234476 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR234476:same reporter
Half dollar red circle that is slightly raised; Itches a little bit at injection site; Slightly raised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Half dollar red circle that is slightly raised), VACCINATION SITE PRURITUS (Itches a little bit at injection site) and VACCINATION SITE SWELLING (Slightly raised) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Half dollar red circle that is slightly raised), VACCINATION SITE PRURITUS (Itches a little bit at injection site) and VACCINATION SITE SWELLING (Slightly raised). At the time of the report, VACCINATION SITE ERYTHEMA (Half dollar red circle that is slightly raised) was resolving and VACCINATION SITE PRURITUS (Itches a little bit at injection site) and VACCINATION SITE SWELLING (Slightly raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.