chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 80-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site swelling (for tolerance to the 1st dose received on 19th May 2018, refer case US2018GSK171067). On 23rd August 2018, the patient received the 2nd dose of Shingrix (intramuscular). On 24th August 2018, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site induration and injection site erythema. On 8th September 2018, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved and the outcome of the injection site pain, injection site induration and injection site erythema were recovered/resolved. It was unknown if the reporter considered the shingles, injection site pain, rash, injection site induration and injection site erythema to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the right arm and on next day the patient experienced severe pain, severe redness and severe induration at the injection site (right arm) that lasted at least 1 week, before subsiding. Sixteen days after receiving vaccination, the patient stated that she started having prodromal symptoms (for shingles) in the middle of last week and noticed a rash on her forehead that started on Saturday, on 8th September 2018 and it got progressively worse. The patient stated that the rash was along the facial nerve on her forehead and she was officially diagnosed with shingles on the date of reporting at the physician's office.
The pt developed a round, hard, reddened areas on both thighs. Right thigh at 8 cm and left thigh at 2 cm. Rigth thigh area swollen and warm to touch. Treated with Keflex. Dx as "cellulitis."
Patient after receiving vaccine had a moment of passing out and felt dizzy and disorientated. Patient felt tingly and shaky. EMS was called and patient recovered over a period of time. EMS measured blood pressure and found patient to have normal BP and pulse. Patient was accompanied by mother and was 'normal' on departure from pharmacy
Pfizer Dose 1 3/10/21 (EN6199) Pfizer Dose 2 4/2/21 (EN6198) Pfizer Dose 3 10/20/21 (ff2593) COVID Positive 2/14/22  2/14/22: Patient patient is an 84-year-old male with past medical history significant for type 2 diabetes, COPD, hypertension, CKD stage 3, CAD s/p stent placement, pulmonary mycobacterium avium complex infection, and right upper lobe pulmonary nodule.  The patient presents to the ED via EMS from home today with complaints of weakness that has been ongoing for the last several weeks with worsening symptoms over the last week.  The patient states he has been suffering from frequent falls at home with minor injuries such as bruising and abrasions.  The patient also complains of shortness of breath, productive cough, fatigue, and body aches that has been ongoing for one week. He denies any known ill contacts.  The patient states he has been experiencing frequent falling at home especially with change in position. He states he becomes dizzy and feels as if he is going to pass out when he falls. He denies losing consciousness or hitting his head. He is not on any anticoagulation.  He is vaccinated and boosted against COVID-19 infection. He denies any alcohol abuse, illicit drug abuse or tobacco use.   Upon arrival to the ED the patient's temperature is 100.0, heart rate is 82, respirations 20, pulse ox 91% on room air, blood pressure 124/63.  Patient had an episode of desaturation to 89% and was subsequently placed on 2 liters oxygen via NC to maintain O2 saturations greater than 90%. Chest X-Ray reveals no acute cardiopulmonary process. CT chest reveals no pulmonary emboli, right lower lobe pneumonia stable when compared to prior CT, emphysema, 2 CM right upper lobe spiculated mass with hilar and mediastinal adenopathy, unchanged.  Patient's laboratory findings are significant for potassium 6.3, 5.3, glucose 152, BUN 30, creatinine 1.71, albumin 3.3, ESR 29, d-dimer 3.30, CRP 1.90.  Patient tested positive for COVID-19 infection in ED.  Blood cultures were obtained x2. Patient received 1 gm PO tylenol, duoneb x1, levaquin 750 mg IV, solu-medrol 125 mg IV, kayexelate 15 gm, and 2 liters IV normal saline in ED.  2/17/22: Pt was admited and given iv abx, iv steroids with subsequent improvement and resolution of hypoxia  He is to undergo O2 walk test prior to discharge  Echocardiogram noted HFrEF. Pt notified and will f/u with cardiologist  Pt is aware of lung mass and the importance to f/u with Dr. was stressed  Pt voiced readiness for discharge. He is discharged in stable conditions  Total time spent on d/c 45 min
some soreness after the first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (some soreness after the first vaccination) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immune disorder (NOS). Concomitant products included GENTIANA LUTEA ROOT, PRIMULA VERIS FLOWER, RUMEX CRISPUS, SAMBUCUS NIGRA FLOWER, VERBENA OFFICINALIS (SINUPRET ACUTE), VALACICLOVIR HYDROCHLORIDE (VALTREX) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 17-Jan-2021, the patient experienced PAIN IN EXTREMITY (some soreness after the first vaccination). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (some soreness after the first vaccination) had resolved.            Action taken with mRNA-123 is not applicable.   This case was linked to MOD-2021-015668, MOD-2021-015668 (Patient Link).
Tongue had numbness peaking at 1/2 hour after injection; Sensation similar to slick plastic later resolving into what a burnt tongue feels like the day after burning.; This is a spontaneous report from a non-contactable consumer, the patient. A 59-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0158) via an unspecified route of administration in the left arm on 15Apr2021 at 11:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient had allergy to nightshade family of foods (food allergies), mycin family of antibiotics (antibiotic allergies), and imaging contrast dye (contrast media allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included loratadine (CLARITIN) for unknown indication since an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Apr2021 at the patient experienced tongue numbness peaking at half hour after injection which dissipated 3 hours later, and after 24 hours it was completely gone. The patient did not lose sense of taste and experienced a sensation similar to slick plastic later resolving into what a burnt tongue feels like the day after burning. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken for the reported events. The clinical outcome of the events tongue numbness and burnt tongue was recovered on 16Apr2021.  No follow-up attempts are possible. No further information is expected.
Patient received vaccine 8/2/12. The injection site and area around became red, raised and hot to the touch. Patient reported this on 8/15/12 because hive had not changed for 2 weeks. Patient saw MD 8/16 & MD concluded local shingles outbreak. Prescribed Acyclovir 800mg.
21 yo male presented to ED Face swelling, hives, facial pruritus, throat tightness starting approx. 30-40 minutes after J&J COVID shot. In ED vitals stable, pt not in distress.  Good response w/ Epi pen and adjunct medications.
Breakthrough case admission after 2 vaccines Pfizer 3/11/21 lot# EN6207;  Pfizer 4/1/21 lot# ER8732
Had acute onset severe abdominal pain. Found to have significant elevation of liver enzymes (AST, ALT in the 900s) and INR (1.40), also had elevated high-sensitivity troponin with normal cardiac echo and EKG. Liver enzyme elevation resolved and patient did not experience any symptoms of liver failure.
Vomiting, resp distress, hives, swollen face, lips swollen, itchy. Oxygen saturation 98%, given BENADRYL, ORAPRED and epinephrine. 911 called, pt took ambulance to ER.
Information has been received from a nurse practitioner concerning a 15 month old Caucasian male pt who on 04/30/03 (also reported as 05/07/03) was vaccinated in the right thigh with a dose of varicella virus vaccine live (Lot # 644724/0074N).  There was no illness at the time of vaccination.  On 05/14/03, "about a week after the vaccine was given", the pt developed a "local cellulitis like reaction", also described as increased erythema "mild cellulitis". The nurse stated that "there were no other signs of infection or fever". Unspecified medical attention was sought.  There was no product quality complaint reported. The nurse practitioner also reported that another pt (WAES # 0305USA01592) experienced a similar reaction after receiving varicella virus vaccine live (Lot # 644724/0074N).  Additional information has been requested.
Injection site started to itch and turned red and hot the morning after vaccines received. By the second day the area of irritation had migrated down the arm toward the elbow. By the third day the reaction subsided and was only visible as a slight pink color.
A report was received from a healthcare professional on 15 October 2003 concerning a group of approximately 15 vaccinees who experienced injection site reaction, with redness, swelling and itching a few minutes after receiving Fluvirin on an unspecified date. On an unspecified date the vaccinees experienced injection site reactions with redness, swelling, and itching.  The vaccinees recovered on an unspecified date without treatment. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 22 December 2003. A follow up report was received from a healthcare professional concerning an 83 year old female vaccinee who experienced redness, swelling and moderate itching at the injection site on the same day as receiving Fluvirin on 06 October 2003. On 06 October 2003, the vaccinee experienced redness, swelling and moderate itching at the injection site after receiving Fluvirin 0.5ml.  The symptoms had resolved at the time of follow up report. No follow up pending.
Pt came in a wk or 2 after ZOSTAVAX was admin, & complained of rash from fingers to elbow. He stated it appeared the following day. Rash was on same arm that ZOSTAVAX was administered.
Very sore arm - unable to raise completely - still stiff even today. Sore side.
Received shot at approximately 1430 on 11/27/21 and by 1530 felt sluggish. Lethargic feeling continued the following day with erratic heart beat and elevated blood pressure 160/120 and chest discomfort. Went to ER at approximately 1900 on 11/29/21 and was given nitro, iv medication and fluids, other medication to lower blood pressure.
My period came early. (The last date of my menstral cycle is 7/6/2021) When I woke up this morning my menstral cycle has begun again. I also want to add on 7/24/21 I had such strong body aches that night I became rehabilitated from that night until this morning. Aches are gone but my period has now started again.
Given 2 different vaccines for dose #1 and #2.  Pfizer given as dose #1, Moderna given for Dose #2.  No reported adverse effects.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: Pt stated that her throat stated to swell up about 12 minutes after vaccination. Called 911. I also gave epipen one dose. Pt declined 911 services. she never lost consiousness. watched pt for 30 more mintues and she stated she was ok to leave.
pt recvd vax 17NOV93 & 2 days later devel nausea, redness & swelling @ the inject site;
following day around 7pm lip swelling; tongue tingling; body hives; chills; After first dose of Covid vaccine face flushing; increased HR about 45 mins. went away on its own; hours later left eye swollen; This is a spontaneous report from a contactable Nurse (patient). A 31-years-old female patient received first dose of bnt162b2 (BNT162B2, Lot number: EK9231), via an unspecified route of administration on 06Jan2021 15:00 at single dose on Left arm for covid-19 immunisation. Medical history included Known allergies: Shellfish, IV contrast dye, Penicillin. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient experienced after first dose of covid vaccine face flushing; increased hr about 45 mins. went away on its own since 06Jan2021 16:00; hours later left eye swollen on 06Jan2021; following day around 7pm lip swelling, tongue tingling, body hives, chills on 07Jan2021 19:00. The patient underwent lab tests and procedures which included heart rate: increased on Jan2021. Ae resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Ae treatment: Steroids, IV fluids, Benadryl. No COVID prior vaccination. No COVID tested post vaccinate. This report was reported non-serious. The event outcome of increased hr about 45 mins. went away on its own was recovered on 06Jan2021 16:45, outcome of other events were not recovered.; Sender's Comments: Based on the compatible time association, the serious events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pt present with irritation of right eye sp small pox vaccine x 9 days. Pt dx with conjunctivitis on 22Apr05. Pt treated with erythromycin opth oint. as a precautionary measure to ensure vaccinia was not transmitted from arm to eye. 25Apr05 eye is much improved.
during her 30 min obs period she developed a HA and R side facial numbness which she states has not resolved. Denies speech difficulty, no problems ambulating.  Pt wishes to go home at this time.
11:20 Post vaccination reports headache,  feeling anxious, tightness of throat for a few seconds; medical monitoring x 30 min, rest, po hydration provided; BP 140/80 P 105 02 sat 98%   11:43  BP 132/80 P 81; no complaints offered, feeling better, released to home from facility w/ self.
Pt came back to pharmacy about 45 min after her first Pfizer vaccine dose saying she had some chills after about 20 minutes and then starting to itch/pinprick feeling around her neck, stomach, thighs. No visible rash noted, no swelling, no trouble breathing. Pt said it was not getting worse over the time in the store. Pt had a ride so suggested some liquid Benadryl. Gave 25mg and asked her to stay around another 15 minutes. She stayed 5-10 min, but said she had to leave.
Right arm had streaks, web-like, cold to touch, numb and painful knuckles, blue and unable to move arm (sometimes). Numbness comes and goes. (Due to no insurance, ER visit denied).
Pt recv vax & 5 mins later pt came out of the examining room & passed out; pt was placed in a room & given a Pepsi; p/laying down for 10 mins pt fully recovered;
Vomiting, extreme pain (headache, joint pain) fever, chills, lethargy, sweating and loss of appetite lasted 24 hours. Extreme fatigue lasted 48 hours.
Patient reported to the pharmacy on 10/4 stating that has had facial swelling since he received the covid vaccine. I confirmed that there was facial swelling.
Felt hot, Nausea, Lightheaded.    Laid down,  Conscious, Ems with in 15 min.( 04:54 pm 8-4-2021)of administration.  Checked vitals,  ok sent home and rest.
The location of the shot is red, very itchy and the skin is at a slightly higher level where it is red then the surrounding area. The redness coveres approximately 4 square inches. The sight is very tender and painful to the touch.
Initial report received from healthcare professional on 02 December 2013. A 66-year-old female patient whose medical history and concomitant medications were not reported, received FLUZONE HD (lot number U4496AA, expiration date 05-Apr-2013) intramuscular in left deltoid on 09 October 2013. On 09 October 2013, patient experienced raised, red, itchy area at injection site. Laboratory investigation and corrective treatment were not reported. As of this report, the patient was recovered from the events. Documents held by sender: none.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 23-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 72, 47 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Patient was given the barrier bandaid but bled through the adhesive when receiving her 2nd booster of the Coivd shot from technician. She was bleeding through her shirt and asked for a new bandaid. Her arm was wiped to clean up the excess blood that was on her skin, and her barrier bandaid was replaced with a regular bandaid by pharmacist. Patient comes back a couple days after concerned that she lost some vaccine through the bleeding because her arm was not as sore as her previous doses and wanted to receive another shot. We informed her that she did receive the full dose since it was a deep IM injection and bleeding does occur from time to time. Patient was still concerned, but told her that we were unable to give her another dose. Patient understood, she states she wasn't worried about the bleeding, just worried that she didn't get the whole dose.  Patient appreciated the call back and the explanation.
Dizziness, Headache, Myalgia, NauseaVomiting, fatigue, left shoulder pain Narrative:  Other Relevant History:
Per EMS, arm turned red and was itchy - possible uricartia. 25 mg oral Benadryl given, patient monitored and reported relief felt. She declined transport, was advised to speak to her MD.  On her first vaccine dose she did not indicate she had any allergic reactions to vaccine, while at this appointment she checked that she had an allergic reaction to "another" vaccine; she was sent to the 30 minute observation lot.
severe Rash that crusted over with lace like pattern, slight fever for 5 days, high pitched cry for several hour stretches for 5 days, sight swelling, refused feedings for rest of day
pt recv vax 23MAR98 & exp a few hr later, paralysis of the lt deltoid;tx w/physiotherapy & vitamin B complex;30APR98 EMG was still pathological;
Sharp and burning  on the right buttock muscle; This is a spontaneous report received from a contactable patient. A 26-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via unspecified route of administration in left arm on an 18Mar2021 at 03:00 pm (at 26 years of age) as a single dose for COVID-19 immunisation. The patients medical history stated suspected COVID-19 and no concomitant medication was reported. No allergies to medications, food, or other products were reported. The patient did not have any symptoms associated with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On 18Mar2021 at 03:30 pm, the patient experienced severe sharp and burning on the right buttock muscle. The patient did not receive any treatment for the adverse event. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event severe sharp and burning on the right buttock muscle was not recovered at the time of the report.    Information about lot/batch number cannot be obtained. No further information is expected.
Spinal Pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (Spinal Pain) and PYREXIA (Fever) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (to Gold, Zolof, Buspirone and Electrogel). Concomitant products included OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), AMITRIPTYLINE, METOPROLOL, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and MELATONIN for an unknown indication.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced PYREXIA (Fever). On 08-May-2021, the patient experienced SPINAL PAIN (Spinal Pain). At the time of the report, SPINAL PAIN (Spinal Pain) and PYREXIA (Fever) outcome was unknown.            Treatment information included Ibuprofen and Alka Seltzer tablets.   Action taken with response to the events were not applicable.
Received vaccine 1/20/15 - developed swelling at injection site and temp to 104 degrees - still febrile at 24 hrs.