chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle spasms; twitching in tricep of vaccination arm; Tightness in vaccination arm; burning sensation in vaccination arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Nov2021 11:30 (Lot number: FF2590) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing), notes: covid prior vaccination. Concomitant medication(s) included: DULOXETINE. The following information was reported: MUSCLE SPASMS (non-serious) with onset 01Nov2021 17:00, outcome "not recovered", described as "Muscle spasms"; MUSCLE TWITCHING (non-serious) with onset 01Nov2021 17:00, outcome "not recovered", described as "twitching in tricep of vaccination arm"; MUSCLE TIGHTNESS (non-serious) with onset 01Nov2021 17:00, outcome "not recovered", described as "Tightness in vaccination arm"; VACCINATION SITE PAIN (non-serious) with onset 01Nov2021 17:00, outcome "not recovered", described as "burning sensation in vaccination arm". The events "muscle spasms", "twitching in tricep of vaccination arm", "tightness in vaccination arm" and "burning sensation in vaccination arm" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of muscle spasms, muscle twitching, muscle tightness, vaccination site pain. Additional information: Muscle spasms/twitching in tricep of vaccination arm from the day of vaccination still continuing a week and a half later. Tightness and burning sensation in vaccination arm beginning 2 days after and still occurring a week and a half after vaccination. Comparable to having blood pressure taken. No other vaccine in four weeks. Other medications in two weeks: duloxetine. Covid was not tested post vaccination. No known allergies. No follow-up attempts are possible. No further information is expected.
LEFT DELTOID PAIN TO TOUCH AND CANNOT LIFT ARM SINCE THE TIME SHE WAS INJECTED. THE PATIENT WAS INSTRUCTED TO SEE HER PHYSICIAN
Severe pain and inflammation/heat at injection site, requiring frequent icing, lasting 36 hrs. Severe chills without remedy, lasting 24 hrs. Body aches lasting 36 hrs. Slight cough lasting 12 hrs. Severe headache lasting 36hrs. Extreme fatigue lasting 36 hrs.  All together debilitating, causing me to be bedridden and affecting all aspects of daily living.
First dose in COVID series was Moderna.  Second dose given was a Pfizer.  Because of the difference in the interval between the vaccines, we had 3 days on which the second dose of  both Pfizer and Moderna COVID vaccines were due on the same day.  We have now adjusted schedule so only 1 brand per day is given.
Patient reported Right Arm pain from shoulder joint to wrist day after vaccine administered on 11/15/16. 12/7/16 patient still experiences some shoulder joint pain, possibly in tendon.
Flushing, shortness of breath   64yo F h/o HTN c/o flushing sensation, mild blurred vision and feeling short of breath. Denies: cp, dizziness, n/v, weakness, no allergies to injectables, abdominal pain  Allergies: narcotics sob  Patient received vaccine @ 1438 - Vaccine: Pfizer Lot # EN6208  Initial: vitals- 152/86, HR 92, RR 22, o2 100% Temp: unable to take  BG: 151  1454: Repeat VS 148/86, HR 74, O2 100%  1501: BP 135/83, HR 70 RR 20 O2 98%.  - Patient reports SOB resolved. No more blurred vision or flush feeling  Exam: CTAB, RRR
This spontaneous report was received from a physician referring to a female patient of unknown age.  There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, prior to 65 years of age, the patient was vaccinated with PNEUMOVAX 23 dose 1 (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On an unspecified date, the patient experienced swelling and redness at the injection site for approximately one week after the vaccine was administered;  Patient also received a second dose of PNEUMOVAX 23 (dose, route of administration, lot number and expiration date were not reported) at 65 years of age but did not experienced any adverse effects after second dose. At the time of reporting, the patient recovered from swelling and redness at injection site. The causal relationship between the event and therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
Sore at injection site.  Muscle ache, soreness, pain.  I received the vaccination on Friday 15 Oct 2021.  My left arm as been painful since.  It hurts to touch around the injection site.  It hurts to lift my arm up in all three directions (front, back, side).
Chills, muscle aches, headache, fatigue about 14 hours after vaccination.
pt recvd last Hep B vax 9MAR93 in AUG began developing neuralgial sx; dx chronic GBS due receiving Hep B vax;
On 2/28/21 @ Co vaccination drive thru pt received 2nd dose moderna vaccine im right deltoid. approx 5min after administration pt reports rash and edema to left arm. redness and edema noted to left forearm inner aspect. localized to this area alone. pt denies other s/sx. (on assessment pt states she had non specific allergies as a child.) Benadryl was administered per dh standing orders. pt remained additional 20min and w/o further concerns.  On 3/1/21 phoned pt for f/u. pt states she is doing fine. no further problems following event. pt states she is not certain this was related to vaccine, states prior to arriving to receive vaccination she was dining outside at a restaurant and might have been bite by insect. inst pt to call if she has any further questions/concerns. pt vu.
Patient had an immediate raised welt and within minutes felt faint and sweaty. Did not complain of shortness of breath but did state that he felt like he was going to faint. The wife sat with him and kept checking his breathing. He did not have SOB but his pulse was racing and she asked me to call EMS due to history of high blood pressure and wanted to make sure he was not going to get worse.
Developed red, raised localized Rx 24 hours after shot given. At 47 hours area of (L) deltoid- Reaction worse red, raised inflamed area larger covering upper (L) deltoid. Seen and treated for cellulitis with antibiotics and topical steroids. Area improved after 24 hours of steroids.
15 minutes after vaccine administration, patient reported feeling "his heart pounding" but denied all other symptoms. Vitals were obtained (HR 72, o2 Sat was 96%, BP 176/102). Pt reported he takes lisinopril daily and normal runs in 120s/80s. Pt remained with nursing staff for additional 15 minutes and vitals rechecked which remained the same. Pt educated on being evaluated at hospital and pt denied. Pt encouraged to call primary care provider. Pt reported to staff he was going to take additional BP med when home.
Platelets- 438K, White blood cell count 12K with Immunize granulocytes, reports labs- WBC 115K Hemoglobin 11-0 HCT-35 Platelets 444k.
This spontaneous report was received from a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, approximately in 2014 (reported as 2 years ago), the patient had received two doses of GARDASIL 9 (dosing details not reported). Subsequently, on an unknown date, the patient became sick and never returned for the third dose. The outcome of the event and causality assessment was unknown. No product quality complaint (PQC) involved. Additional information is not expected as the reporter did not wish to be contacted.
Patient received the 1st COVID vaccine (Pfizer lot # EW0182 use by 5/15/2021) at 1455. The client had a history of fainting (x3) with intramuscular injections. The client reported eating lunch prior to arriving for her appointment. The client was vaccinated in the anti-gravity chair at 1455 by EMT. The client became very pale about 1 minute following the vaccination administration and she loss consciousness for 5 seconds, during this time she had 2 myoclonic contractions. RN and EMT immediately placed the patient in Fowler's position in the anti-gravity chair during the syncopal episode. The patient immediately regained consciousness and was alert and oriented to person, place, time, and situation. The patient remained in Fowler's position and vitals were taken at 1456: BP 125/95 (R arm), HR 45, RR 18, and oxygen saturation at 95%. The patient denied experiencing lightheadedness, shortness of breath, dizziness, nausea, headache, or blurry vision. The patient was given a juice box. The patient's color slowly returned. Vitals were retaken at 1505: BP 123/82 (R arm), RR 20, HR 50, oxygen saturation at 98%. The patient stated, " I usually feel really bad after I faint but this time I feel fine." Vitals at 1510 were as follows: BP 130/70, RR 18, HR 67, oxygen saturation at 100%. The patient was speaking in full sentences and laughing with her friend. Vitals taken at 1515: BP 125/ 68, RR 16, HR 68, oxygen saturation at 99%. The patient was positioned from a Fowler's position to sitting upright. The patient's color returned to her face and she denied any nausea, dizziness, blurred vision, double vision, or chest pain. Vitals were taken at 1520: BP 125/70, HR 82, RR 16, oxygen saturation at 99%. At 1524, the patient's blood pressure was 125/68 and HR was 58. The patient continued to deny any shortness of breath, dizziness, nausea, or vision changes. The patient's heart rate was taken at 1531, HR 55 and again at 1536, HR 62. The patient's mother stated her daughter was currently taking an antibiotic for acne (dosage and name unknown) and denied having any drug allergies or  chronic medical conditions. RN instructed the patient and her mother about emergency precautions and to follow up with their primary care provider. RN, also educated the patient and her mother about the importance of informing the healthcare provider about her history of fainting with injections when receiving the second COVID Pfizer vaccine.  Gave the patient's mother V-safe information and reported the occurrence in VAERS. The patient had a steady and even gait when leaving the site with her mother at 1537.
Cronic Hives. Repressed with once daily antihistamine (Allegra). Has continued since it began 12/8.
She got moderna vaccine at 9:30 AM.  She started to get itchy lips and fuzzy tongue shortly after immunization given. This is a similar reaction as when she has had carbocaine and novacaine. She is having no breathing issues. No facial swelling. She got benadryll at 10:04 AM.  She notes that has helped - the burning in her throat is better now after the benadryl. She is currently feeling like she still something in her throat, wants to clear it. Were better then throat scratchiness occurred and same throat burning and foreign body feeling returned. Epi pen given in office and patient was sent to the ER. Her vitals were stable and she had her son here who felt comfortable transporting her to the ER.
1st Pediarix-Rotarix-Hiberiix 2Dec22, 2nd 20Dec22; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 4-month-old male patient who received Hib (Hiberix) (batch number yn44n, expiry date 15th December 2023) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number n7hl3, expiry date 15th April 2024) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Rota (Rotarix lyophilized formulation) (batch number z5r33, expiry date 23rd February 2024) for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   Concomitant products included HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (HIBERIX), PEDIARIX and LIVE ATTENUATED HUMAN ROTAVIRUS G1 STRAIN (ROTARIX).   On 20th December 2022, the patient received the 2nd dose of Hiberix, the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device, Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 20th December 2022, unknown after receiving Hiberix, Pediarix, Pediarix Pre-Filled Syringe Device, Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:20-DEC-2022 Reporter's Comment: The reporter was practice manager. The reporter reported on 2nd December 2022 that, patient received the first dose of Hiberix , Pediarix and Rotarix. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Hiberix , Pediarix and Rotarix below than the recommended schedule, which led to shortening of vaccination schedule.
Left thigh area 10cmx5cm erythema with itching. Tx: Benadryl 2 tsp every 6 hours and Elocon cream AAA.
10 cm diameter dark red discoloration around injection site, slightly swollen and painful, elevated temperature, malaise, fatigue
I just felt my hair was thinning out. I did not do anything for some time. In January 2023 my scalp became itchy and noticed more hair on my hair brush. I did an appointment with a dermatologist. The doctor told me I have a rare autoimmune disorder. A biopsy was done of my scalp on 02/15/2023 and my diagnosis was LPP, Lichen Planopilaris and said it can not be cured but just treated. I was prescribed a pill finasteride and this supposed to encourage hair growth and also prescribe topical solution to relieve the itchiness clobetasol propionate solution. I have not recovered from my symptoms.
HPV# 2  4 1/2  hours after patient got the vaccine she felt light headed + dizzy and then became unresponsive, eyes deviated upwards, slight jerking for 40 seconds HPV#1 Pt had temp of 104 X 1 night after receiving HPV #1.  5/8/09 ER records received for DOS 4/17/09 with dx: Altered mental status, near syncope-etiology unclear. Pt presented after episode of altered mental mental status lasting ~ 40 secs. Onset abrupt but had resolved by arrival in ED.
Febrile seizure - tonic clonic episode lasting 5 -> 10 min with eyes rolled up.
Chills, headache and achy body follow day of  second shot. Discovered marble/golfball size lump in left armpit work days after second shot . Slight discomfort. Lasted approximately 3 days . Small lump still present . Seen primary physician at peak of lump follow up scheduled .
Initial report was received from a consumer on 14 February 2011 who is also the patient. A 45 year-old female patient who had no illness at the time of vaccination and has an allergy to thimerosal which was discovered after a "severe allergic reaction" following an Influenza vaccine 15 years ago, had received on 04 February 2011 an intramuscular left deltoid injection of DECAVAC (lot number not reported). On 08 February 2011, the patient reported she could not take a deep breath and felt like she could not catch her breath. The patient reported no chest or lung discomfort. She has not been evaluated by a physician. Treatments were not reported. The patient refused to provide names of concomitant medications. No further information was available at the time of the report. The patient's outcome was not recovered. The reporter for this case is the same as for case 2011-00629. Documents held by sender: none.
Superficial vesicle at injection site at 24 hours after IZZ. No systemic symptoms.
Patient started to complain of a moderate headache approx 15 minutes following vaccination, took 650 mg of aspirin at 5 pm, did not have any other signs or symptoms, headache began to subside at about 6 pm.
Nurse reports that patient had no problems after receiving vaccination. Patient went home and EMS was called early the next morning and team administered vaccination was contacted physician that the associate works for stating the patient had a heart attack.
Vesicular rash all over anterior thigh & nodule @ inject site; No other sx; Just getting hx; May have allergies;
Information has been received from a health professional concerning a 5 year old male who on 04/05/2001 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Subsequently in February 2004, the patient experienced breakthrough chickenpox.  It was reported that there was a total of 45 cases of breakthrough in the patient's school, including the patient, and 17 were vaccine recipients.  Unspecified medical attention was sought.  There was no product quality complaint involved.  The reporter indicated that 16 other patients (WAES0403USA00131 and 0405USA00741 through 0405USA00745) had similar experiences following exposure to varicella virus vaccine live (Oka/Merck).  Additional information has bee requested.
DAY OF SHOT, INJECTION SITE SORE COMBINED WITH WEAKNESS AND STOMACH CRAMPS. THE NEXT FOLLOWING 3 DAYS INJECTION SITE INCREASED IN SWELLING TO BASEBALL SIZE WITH DARK RED DOT WHERE INJECTION OCCURRED. IT IS ALSO WARM TO TOUCH. NO OTHER SYSTEMIC SYMPTOMS PRESENT.
trouble breathing; fever 102.5; Fatigue; Joint pain; headache; Nausea; Vomiting; muscle pain; A spontaneous report was received from a 65-years-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever 102.5/pyrexia, trouble breathing/dyspnoea, joint and muscle pain/myalgia, joint pain/arthralgia, headache, fatigue nausea and vomiting.  The patient's medical history included autoimmune disease and COVID-19 on an unknown date in Apr 2020. Concomitant medications were not provided.  On 8 Feb 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (batch number: 030M20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, after receiving mRNA-1273, patient developed fatigue, headache, fever off and on especially at night reaching as high as 102.5, joint and muscle pain, nausea, vomiting, and headache. After the vaccine she had trouble breathing and was put on a course of prednisone. She had Covid-19 in Apr 2020 and was feeling as bad as when she had it. Her HCP recommended she have a Covid-19 test and it came back negative.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, fever 102, 5, trouble breathing, joint and muscle pain, headache, nausea and vomiting was not resolved.; Reporter's Comments: This case concerns a 65 Y/O F with PMH of autoimmune disease COVID-19 had serious unexpected dyspnea and expected pyrexia, fatigue, headache, arthralgia, nausea, vomiting. Treated with prednisone. Events ongoing. after first dose mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Diarrhea, Vomiting lasting all night. 10/09/2014 Pain in shoulders and hands.
Information has been received from an MA concerning an 18 month old white male child with reactive airway disease and growth hormone deficiency, who on 12/19/01 in the PM was vaccinated with varicella virus vaccine live (route of vaccination not provided). The child had no illness at time of vaccination. It war reported that immediately following the vaccination, the child developed a half-dollar sized reaction, which was described as being like a bubble. The area was reported to be red, however it was not hot to the touch. The child's mother was instructed to dose the child with diphenhydramine (Benadryl). When the child returned to the pediatrician's office there was no sign of any reaction. No further information is expected.
Case number PHEH2014US020736, is an initial spontaneous report received from a nurse on 13 OCT 2014. This report refers to a 76 year old female patient. Her medical history and concomitant medication was not reported. Nurse stated that the person who opened the cooler stated that the gel packs were still mushy, but temperature unknown. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413201A) 0.5 ml intramuscular on 03 OCT 2014 (6 days later than supposed to get). No adverse event was reported. No further information was provided.
April 15th, 2021, about 3 weeks after getting the vaccine, I woke up nauseous and dizzy. I also had a hard time staying awake the first four days but now am able to make it through the day without extra sleeping.  I later got a headache and the ringing noise in my ears got so loud it sounded like someone screaming. I've had dizziness, with everything spinning, and tinnitus ever since. The headache comes and goes.
Adverse Event: Hypotension BP 90/59; Pulse 170; Fever 101.1+ for 24hours; Severe Nausea; Severe Dizziness; Severe Headache;  Severe muscle and joint pain; Skin rash on neck and chest; Bruising and severe pain at injection site; Mild tussis Treatment: oral fluids; rest Outcome: Majority of symptoms resolved after 24 hours; remaining symptoms after 48 hours included: skin rash; mild dizziness; mild muscle and joint pain.
Syncope,dizziness, head spinning,weakness of arms slurred speech BP 195/105 PULSE 91 Repeat BP  167/92
Patient received Trumenba and Men Quad-Fi.  Syncopal episode <1min. LOC, immediately following vaccinations. Lay flat on exam table for recovery, vitals recorded, cool cloth to forehead. Apple juice given when able to sit up. Left office ~15 mins later
PT ADVISED NOT TO HAVE 2ND DOSE OF COVID VACCINE AND TO OBTAIN ALLERGY CONSULT. At 12:05pm, pt got itching in her throat and 25mg of benadryl was given. At 12:08pm, another 25mg of benadryl was given based on weight-based dosing. Pt is drowsy and we recommended that she does not return to work b/c she was given 50mg benadryl. After 40 minutes, pt very drowsy but still has itchy throat, seems to be better. However, after the flu shot, her throat was itchy for the whole day after given 50mg benadryl. Consulted Dr who recommended we observe her for a total of 2 hours. Advised her to get an allergy consult since she has had this reaction to 2 vaccines and that she does not receive the 2nd dose of COVID vaccine unless advised by allergist. Pt verbalized understanding that she will not receive 2nd dose unless advised by allergist. Pt left at 1:35pm as she had sick child at home. Pt understands to seek medical attention if symptoms worsen. No additional reactions noted in EMR
12 y/o patient was administered Moderna COVID vaccine instead of Pfizer at mass vaccination events on or around 8/28/2021 and 9/23/2021. No adverse effects were exhibited during either time.
Really bad issues with sinuses; headache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (Really bad issues with sinuses), HEADACHE (headache), PYREXIA (Fever) and CHILLS (Chills) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUS DISORDER (Really bad issues with sinuses), HEADACHE (headache), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, SINUS DISORDER (Really bad issues with sinuses), HEADACHE (headache), PYREXIA (Fever) and CHILLS (Chills) had not resolved.            Action taken with mRNA-1273 Moderna COVID-19 Vaccination was Not applicable.  No Concomitant medication was provided.  No Treatment medication was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: TCR received on 18-june-2021 contains NNI