chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of itching in a 26-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included latex allergy. On 21 October 2009 at approximately 16:00 the subject received unspecified dose of FLULAVAL (.5 cc, unknown, unknown arm). On 21 October 2009, 20 minutes after vaccination with FLULAVAL, the subject experienced itching, burning (nos), discomfort and erythema. The subject experienced itching, burning, redness and discomfort of the arms, chest and neck within 20 minutes of receiving FLULAVAL, subject took 50 mg of BENADRYL by mouth. She returned to yhe physician's office and was administered 8/10th of a cc of adrenaline. The subject was treated with BENADRYL and adrenaline. On 21 October 2009, the itching, burning, redness and discomfort of the arms, chest and neck were resolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. Follow up information was received on 23 November 2009 via the reporting healthcare professional. The healthcare professional reported that the subject received a dose of FLULAVAL in her left arm. The subject was diagnosed with a drug hypersensitivity. The healthcare professional considered the itching, burning (nos), discomfort, erythema and drug hypersensitivity were clinically significant (or requiring intervention). On 21 October 2009, the events were resolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.  12/10/2009 records from MD for 10/21/2009, patient with c/o's severe itching and burning on arms chest and neck, given benadryl and then adrenaline when sx did not subside,  given Rx for epi pens
This spontaneous report was received from a nurse refers to a 4 month old patient of unknown gender. No concurrent condition or medical history was reported. On 28-AUG-2015, the patient was inadvertently vaccinated with VAQTA (dose and route of administration not provided). No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
PATIENT CAME TO THE PHARMACY TO SHOW ME HER ARM ....SHE HAD BROWN SKIN PEELING DUE TO BLISTERING ....PATIENT REPORTED THAT THIS REACTION DID NOT HAPPEN WITH THE FIRST INJECTION AT ALL.   SHE DEVELOPED A HUGE BLISTER AT THE SITE OF INJECTION.   SHE ALSO EXPERIENCED FEVER, CHILLS, NAUSEA, AND FATIGUE.
Chronic ongoing cough everyday since 2nd dose of Pfizer. Tends to be worse in the mornings
After showering on 3/20/21 I noticed my shoulder was red and itchy. It has gotten worse since initially noticed. The rash is currently midway between my upper shoulder and muscle.
Could not get out of bed; Again could not get out of bed, legs would not work; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISORDER (Again could not get out of bed, legs would not work) and BEDRIDDEN (Could not get out of bed) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISORDER (Again could not get out of bed, legs would not work) (seriousness criteria hospitalization and medically significant) and BEDRIDDEN (Could not get out of bed) (seriousness criterion hospitalization). The patient was hospitalized from 07-Jan-2021 to 09-Jan-2021 due to MUSCULOSKELETAL DISORDER. At the time of the report, MUSCULOSKELETAL DISORDER (Again could not get out of bed, legs would not work) was resolving and BEDRIDDEN (Could not get out of bed) outcome was unknown.            Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-027194 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: Upon internal medical review on 29 Jun 2021, case was upgraded to serious.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
extreme fatigue; headache; arm ache at injection site; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 06Feb2021 14:45 as dose 1, single (at the age of 50-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient did not receive any prior COVID-19 vaccination. Patient did not test for COVID-19 post vaccination. Patient did not have any known allergies. Facility type vaccine was reported as Other. Patient did not receive any other vaccine in 4 weeks. Patient medical history included mitral valve prolapse, depression. The concomitant medications included bupropion hydrochloride (BUPROPION HCL XL) strength 300 mg, CITALOPRAM strength 30 mg. On 07Feb2021 at 09:00 patient experienced extreme fatigue, headache, arm ache at injection site. Patient did not receive any treatment for the adverse events. On an unspecified date in Feb2021, the outcome of the events was resolved.   Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received FLUARIX Quadrivalent (batch number 4GX4F, expiry date 30th June 2017. Concomitant products included PNEUMOVAX. On 17th November 2016, the patient received FLUARIX Quadrivalent. On 24th November 2016, 7 days after receiving FLUARIX Quadrivalent, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in the arm to be related to FLUARIX Quadrivalent. Additional details were provided as follows: The pharmacy student reported that one of their patients received FLUARIX Quadrivalent (unknown arm) and about a week after vaccination the patient started having pain at the injections site and pain in the arm. The patient also received PNEUMOVAX on other arm. The patient did not have any side effects on the arm where PNEUMOVAX was injected.
Extreme exhaustion, heart palpitations, dizziness/lightheadedness, congestion/cough, fluid accumulation in left ear (which persists 8 days later as I write.  Spent three days mainly sleeping, forcing myself to drink and eat.  As of today, October 8, my energy levels have returned to normal, but I hear poorly in my left ear (no pain, just feels as if there is fluid accumulation)
Received shot 10-4-07, 10-10-07 became dizzy nauseated, sweating, blood pressure dropped, ringing in the ears and sensitive to lights, 10-12-07 vomiting/ unable to walk, went to hospital. Cat Scan, MRI, IV's, bloodtest. Went to ear specialist and had hearing checked 10-19-07 broke out in red, lumpy, painful rash that was itchy later. It lasted 2 weeks. 11-16-07 I'm still dizzy but slowly getting better. On October 4, 2007 I received the Zostavax vaccine at doctor's office 10-10-07 I was shopping and I began to get real warm, sweat, and was very dizzy and nauseated. It lasted 6 hours. 10-11-07 the nausea started later in the day and lasted around 5 hours. I had a terrible ringing in my ears and lights were really hard on my eyes. My blood pressure kept dropping. The lights made more disoriented. 10-12-07 with-in 1/2 hour after getting up in the morning I was so dizzy and vomiting I could not function at all. I was taken to the emergency room. They took blood test, Cat Scan and put in IV's. The doctor ordered an MRI and had me admitted to the hospital for over night. I left the hospital on 10-13-07 even though I was still having problems. I went for a check up with the doctor on 10-15-07 and she sent me to see an ear specialist for inner ear problems. He recommended I go for therapy. Before my appointment on 10-23-07 I had more side effects. On 10-19-07 I broke out in a red, itchy, lumpy rash. It feels like a bad sun burn. It extends from ears all the way to my stomach. It is the worst on my neck and chest. I'm slowly regaining my balance and being in well lit areas isn't as bad on my eyes now. I was told I was probably contagious so I'm home bound until this clears up. This has been a very expensive side effect with all the testing, doctors, hospital and ambulance.  12/4/07 Reviewed ENT medical records which reveal patient seen 10/16/07 for continued vertigo which originally had been spinning & now was severe imbalance along w/continued tinnitus, photophobia & nausea/vomiting minimally controlled by meds.  Audiogram revealed bilat symmetric sensorineural hearing loss. FINAL DX: vestibular neuronitis; uncompensated vestibular insult; vertigo; imbalance.12/4/07 Reviewed hospital medical records which reveal patient experienced nausea & vertigo x several days.  Admitted 10/12-10/13/2007.  Tx w/antibiotics, antinausea & antivertigo meds as well as ASA. FINAL DX: vertigo, secondary to vestibulopathy; chronic small vessel ischemic changes on brain MRI; & history of HTN.
pt recv vax & devel redness & swelling @ site of inj & fatigue for about 5 days;
Felt tinging in my nose; Nose starting swelling and was tender and painful; Nose starting swelling and was tender and painful; Nose starting swelling and was tender and painful; This spontaneous case was received on 13-Oct-2021 from other non-health professional (consumer) via The Regulatory Authority (reference number: SEQW21-03865) and concerned a 59-year-old male patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 06-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (Influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical: deltoid left arm) for influenza prophylaxis. The batch number reported was 309613, expiration date: 25-Jun-2022.  On 07-Oct-2021, one day after vaccination with Flucelvax Quad, the patient felt tinging in his nose   On an unspecified date in Oct-2021, by Friday as reported, the patient's nose starting swelling and was tender and painful. He went to his doctor and he did not see anything but stated that this may be a reaction from flu vaccine. The patient was prescribed prednisone and pharmacist gave him Benadryl (diphenhydramine hydrochloride).  The outcome of the events 'nasal pain', 'tenderness' and 'localised tingling' was not reported.  At the time of this report on 13-Oct-2021, swelling was going down, the patient was recovering from te event 'nasal mucosal swelling'.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 59-year-old patient developed nasal congestion, rhinalgia, nose tenderness, and paraesthesia (reported as tinging in nose) within seven days after receiving the suspect product Flucelvax Quadrivalent. Due to plausible chronology, causality is assessed as possibly related.; Sender's Comments: A 59-year-old patient developed nasal congestion, rhinalgia, nose tenderness, and paraesthesia (reported as tinging in nose) within seven days after receiving the suspect product Flucelvax Quadrivalent. Due to plausible chronology, causality is assessed as possibly related.
Within 7 hours had chills, muscle and body aches, fever, severe headache, abdominal and kidney pain, nausea. Within 27 hours of dose got my menstrual period 2 weeks early with a very heavy flow, despite being on birth control.
C/o shoulder pain day of vaccination.  Increasing pain over two weeks.  Has seen ortho and is trying conservative treatment but is still in pain and will follow up again for more treatment.
Pt developed an urticarial, maculopapular with wheals, rash on trunk mainly, over limbs. Rash occurred 8 hrs after shot. Treated with Benadryl syrup.
On Saturday, July 22nd, customer reports seeing redness behind her ear.  Sunday she went to an urgent care because she then saw a rash behind her ear and felt pain.  She was prescribed Valtrex.   Monday she went to her PCP, she was prescribed gabapentin and lidocaine topical.  PCP told her that she had shingles.
Information has been received from a 66 year old male physician with no pertinent medical history and no drug reactions/allergies, who on 13-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported) SQ. Concomitant therapy included LIPITOR, montelukast sodium (MSD) and PRILOSEC. On 13-NOV-2010, the patient developed cellulitis 8 hours after receiving PNEUMOVAX 23. There were no lab diagnosis/studies performed. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. Additional information has been requested.
Severe headache, severe body aches, day 2 and still no energy! No appetite
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. The nurse reported that on an unknown dates, the unspecified number of patients received doses of RECOMBIVAX HB (dose, route, lot number and expiration date not reported) that were improperly stored. No adverse experiences reported. No concomitant medications were reported. No further information was provided. This is one of the several reports of the same source. Additional information has been requested.
Immunizations given at 10:30 am.  Mom reports that baby felt warm at 3pm, but she did not take his temperature until 5pm and it was 103.  Baby went to ER and had blood and urine cultures done and was given tylenol and pedialyte. No infection found and no further follow up done.
Received Tdap and Hepatitis A on 2-1-08. Right arm was sore 2-1-08 and 2-2-08. Patient removed band aid on 2-2-08 and area over right deltoid was red with speckled appearance, there was an open area that looked like broken blister. Arm stayed red, painful with open area to today when he came back to see us
tested positive for Covid; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (tested positive for Covid) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Sep-2022, the patient experienced COVID-19 (tested positive for Covid). At the time of the report, COVID-19 (tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2022, SARS-CoV-2 test: (Positive) positive.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Patient just underwent Moderna's bivalent Covid vaccination on 04-Sep-2022 and had tested positive for Covid on 14-Sep-2022. She has significant risk factors and takes immunosuppressive agents.  Caller is asking how soon can they take Paxlovid after taking the bivalent vaccine.  No treatment information was provided.
Pt received primary series pfizer as booster instead of the bivalent pfizer.  She is not reporting any side effects.
Day 1: Sore arm Day 2: Sever body aches, back pain, fever, chills Day 3: Body aches, back pain Day 4: Severe headache, fatigue, nausea   Treatment has included over the counter ibuprofen.
Client reported feeling "hot and light headed" approx 2 minutes after receiving vaccine. She was led by EMT to zero gravity chair.  12:31 V/S: HR 67, O2 99, BP 98/60. V/S  @ 12:46 BP 118/80, HR 82, O2 99, AOx3 EMT observed client's to have pallor color. V/S @ 12:56 BP 92/58, HR 72, O2 100, RR 20 and client report of "feeling much better." Client reported having hx of syncope with nose piercing. At 1312, client left site unassisted and with a steady gait.
Muscles aches; Fever up to 101.2 F; This is a spontaneous report from a contactable nurse reporting for herself. A 50-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK9231), intramuscular, on 08Jan2021 at 06:45 AM, at single dose, for COVID-19 immunisation. Medical history included mild hypertension, Hashimoto's disease, gastrooesophageal reflux disease (GERD), insomnia. Patient did not have COVID-19 prior to vaccination. Concomitant medications included hydrochlorothiazide (unknown manufacturer), gabapentin (unknown manufacturer), acetylsalicylic acid (BABY ASPIRIN), omeprazole (PRILOSEC), trazodone (unknown manufacturer), cefixime (FLEXERIL), levothyroxine (unknown manufacturer), elderberry [sambucus nigra] (unknown manufacturer), vitamin c [ascorbic acid] (unknown manufacturer), colecalciferol (VITAMIN D). Previously the patient received the 1st dose of bnt162b2 (lot# EK5730), for immunisation, on 19Dec2020 at 03:30 PM, intramuscular in right arm. The patient experienced muscles aches on 09Jan2021 at 15:30 with outcome of recovered, fever up to 101.2 F on 09Jan2021 at 15:30 with outcome of recovered. The patient underwent lab tests and procedures which included body temperature: up to 101.2 F on 09Jan2021. Therapeutic measures were taken as a result of the events and included treatment with Tylenol. Patient was not tested for COVID-19 post vaccination.
I experienced extreme headaches, body aches, chills, inflammation in my joints, and diarrhea one month after receiving the vaccine. I informed my doctors of all the symptoms that I was experiencing and they all agreed that there was not enough information to say that the vaccine was the cause of my issues. The Naturopath increased my supplement that helps with inflammation by increasing the dosage. I am still experiencing the same symptoms and the supplements are not helping. My Urocologists ordered blood work in reference to my symptoms.
On day after immunization, patient had nausea, low grade fever and redness at Adacel injection sie. Redness became bigger and painful 2 days later
30 pts failed to devel HBSAG (?HBSAB) p/ series of 3 vax.The 1st dose was Recombivax;2nd dose was Recombivax or Engerix-B;3rd dose was Engerix-B.
2 days after vaccination, a 3x5 area at site was hot, red and hard. Saw PCP who prescribed prednisone po x 5 days. Antibiotics not required - full recovery.
Pt given immunizations 4-16-08. Pt seen 4-18-08 with c/o rash on (R) thigh, where the Prevnar and Hib immunizations were given. Rash was diagnosed as urticaria, and treated with Benadryl.
pt recvd vax; devel skin redness & a swollen arm;md did not have any info regarding pt;
at approximately 5:35pm, the patient states that he felt hot and nauseous.  He vomited and was able to take Banophen 50mg.  A few minutes later, the patient stated he felt fine.
muscle atrophy; Fat necrosis; divot at the injection site; erythema; Arm swelling; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number G72ZD, expiry date 24th November 2020) for prophylaxis.   On 13th February 2019, the patient received the 2nd dose of Shingrix. On 14th February 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema and extensive swelling of vaccinated limb. On an unknown date, the patient experienced muscle atrophy, fat necrosis and injection site indentation. On an unknown date, the outcome of the injection site erythema and extensive swelling of vaccinated limb were recovered/resolved and the outcome of the muscle atrophy, fat necrosis and injection site indentation were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, extensive swelling of vaccinated limb, muscle atrophy, fat necrosis and injection site indentation to be related to Shingrix.  Additional details were provided as follows: The patient received her second dose and the next day experienced swelling from her shoulder down to her elbow on the left side that lasted a month. The reporter described it as erythema from shoulder to elbow. These events were resolved. The patient described as fat necrosis or possible muscle atrophy that has produced a divot at the injection site. The reporter had consented to follow up.
Pt developed 2-3 blister reaction within 24 hr. pain swelling. Pt was seen rx with Prednisone, Claritin. Pt was seen again drained the tense blister clear serous fluid drained.
Skin and soft tissue infection, onset 5/15/11 at site of Varicella vaccine 11 days earlier.
I first felt the usual dead arm feeling and then that quickly progressed into a full-blown hot flash/feverish feeling accompanied by a splitting headache that I had last all of last night. Now I still have a minor headache and a dead arm after taking Tylenol (Rapid Release).    I also felt very weak and fatigued all night with a dry mouth and  plugged up sinus. Felt like I was going to be knocked out for 24 hours. I can hardly do these basic task on my work laptop.
From the patient: Friday evening I came down with dizziness, chills and a severe fever. My husband and I monitored it; it seemed to come in waves but was always at a steady 102 degrees. I was incredibly weak and had small waves of nausea ? only got sick once though, and was not really hungry most of the time. I was consistently cold but was sweating buckets. The site of the vaccine was slightly swollen, hot, and feverish to the touch. It felt like a stabbing pain/ache all weekend; I could not put any weight on it or it would be a pulsating pain. Currently it is a tinge sore if I move my shoulder a certain direction, but otherwise fine. There is a bruise where the lower injection was. My fever broke early Sunday morning and since then I have been utterly exhausted (though improving) and my left arm is still a bit weak, slowly recovering strength. I took the day off work Monday to sleep/rest some more.
Patient presented at the pharmacy friday (8/25/23) with a rash covering his left arm.  He stated he received the Shingrix vaccine friday (8/18/23) at this pharmacy by another pharmacist and the next day (saturday 8/19/23) he woke up with a rash covering the left side of his trunk and left arm.  Patient also reported warmth at the injection site.   He stated that he had not taken anything to help with rash, nor had he alerted his physician.   The pharmacist on duty recommended that patient take Benadryl for a few days and to not receive the second vaccine of shingrix.  The patient was also instructed to call his physician if rash did not improve in 3 days.
Patient's arm immediately became red and site began to bruise instantly. Her arm swelled at the injection site and a lump formed. Patient was given 10ml of BENADRYL and an ice pack was applied to her arm. After several mins her arm looked and felt better.