chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness of arm; Pain; Flu types symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm), PAIN (Pain) and INFLUENZA LIKE ILLNESS (Flu types symptoms) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm), PAIN (Pain) and INFLUENZA LIKE ILLNESS (Flu types symptoms). At the time of the report, PAIN IN EXTREMITY (Soreness of arm), PAIN (Pain) and INFLUENZA LIKE ILLNESS (Flu types symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medications were not given.   This case was linked to MOD-2021-040914 (Patient Link).
Information has been received from a physician concerning an approximately 6-year-old female, who on 01/28/2003 was vaccinated SC with a 0.5 mL dos of varicella virus vaccine live (lot #641162/0797M). It was noted that the vaccine was stored in a refrigerator inadvertently. She was exposed to the wild type varicella in July 2005. A couple of weeks later she developed chickenpox on the face, head, and a few on the back. It was noted to be a mild case. Unspecified medical attention was sought. Subsequently, the patient recovered. A product quality complaint was not involved. Additional information has been requested. It was reported that the patient's female sibling also developed break through chickenpox after therapy with varicella virus vaccine live (WAES #0511USA01850).
2:30PM: while trying to park car, noted L arm "wasn't working right"; experienced pain over top of shoulder radiating into the rib cage. By 3:30PM, couldn't move clothing hangers on rack (shopping), fingers tingled, forearm fine motor control limited by pain;  shoulder was 'frozen' and could hardly be moved; used sling during evening; noted chills ~ 6:00 PM, fell asleep & when she woke, no longer had chills. Now has limited use of arm but improved from yesterday. Arm remains sore and cannot be lifted above shoulder height.  Is taking 800 mg ibuprofen q 6 hr, feels that symptoms (pain and limited mobility) are less today than yesterday.
This is a spontaneous report from a contactable pharmacist. This pharmacist reported for two patients with similar events. This is the first of two reports. A 81-year-old female patient started to receive PREVNAR (lot number M56442, expiration date Jun2017), intramuscular on 23Oct2015 at 1 DF, single. Medical history included coronary artery disease from an unknown date and unknown if ongoing. Concomitant medication included aspirin 81mg for cardiovascular disease prevention. The patient experienced reaction to the injection site, more red, swollen and sore/ red swollen area that extended down below the injection site on 27Oct2015 with outcome of not recovered. The action taken in response to the event for PREVNAR was not applicable. Therapeutic measures provided as cold compress. Follow-up (12Nov2015): This follow-up is submitted to amend previously reported information: reaction data coding. Follow-up (11Dec2015): Follow-up attempts completed. No further information expected.
This spontaneous report as received from a consumer refers to herself, a 72 year old female patient. Pertinent medical history, concurrent condition and concomitant medications were reported as none. On 06-MAR-2018, the patient was vaccinated with a second dose of PNEUMOVAX 23 via intramuscular route in the right arm for Pneumococcal vaccination. On 06-MAR-2018, 3 hours after receiving the vaccine, patient had an onset of allergic reactions. Patient developed a large quarter sized hive, that broke out in rash under right armpit. Patient reports that there was an area about 4 to 5 inches above waistline around rib cage and liver, very painful, but nothing visible. Pain increased, spread from original location, and persisted. On an unspecified date, the rash stopped after taking BENADRYL 50mg, orally one time (unspecified lot number and expiration date). On an unspecified date, patient called an unspecified pharmacist and physician and asked what to do about the pain. The outcome of pain was reported as not recovered/not resolved. The outcome of urticaria was reported as recovered/resolved. Causality assessment was not provided. No product quality complaint was present.
Pt. left exam room with parents after receiving vaccines. He was standing by checkout desk, he fell to floor and hit his forehead (per father). Pt was near unconsciousness. Mom stood him up, he was unable to stand. At this point a code blue was called by reception. EMT called. Staff had tended to this child and laid him down and elevated his legs. O2 was applied via FM. He was very pale, shivering. SpO2 100% with O2. VS stable. Pulses palpable but weak. EMT arrived and CT collar placed. He was still conscious but unable to speak appropriately. He was transferred to Hospital ED.
Pt had flu vaccine 9/20/2011 when he had his annual well child check up. He had URI sx at that time. MOC called 9/22 that Lt eyelid was droopy today. Seen evening of 9/22 in the office. Mild left ptosis, sl decrease nasolabial fold Lt side of face eye brows & eyelids symmetrical. NL strength U & L extremities dx ptosis ? early Bells Palsy.
Pt devel red whelps on back radiating up neck & down arm; pt given DPH 28FEB92 & recovered spontaneously; t99.7;
RASH, REDDNESS, PAIN, INFLAMMATION SKIN WAS HARD.
Shot on Thursday, by Friday I started to notice bumps & itching on my chest area, the issue continued  through today 10/3/17 and spread to the upper breast, neck and upper arms. The itching became intense over the first week and I applied itch medications daily, the bumps scabbed over and started to scar on about 10/1/17 while I continue to use itch cream on the newer bumps.  Appears remarkably similar to chicken pox, which I've had twice as a child.
I had a enlarged lymph node or sore spot in my arm. It was tender to the touch and felt like it radiated towards by breast. I gave it a week but it did not seem to resolve. I saw my doctor and she said that it was likely due to vaccine. I had a mammogram done and it was negative. I was able to palpate. It took about 12 weeks for it to resolve.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2009, the patient was inoculated with ZOSTAVAX (strength, dose, route, lot # and expiry date were not provided) by a healthcare provider as recommended for routine adult health maintenance for the prevention of shingles (prophylaxis). On an unknown date, the patient was diagnosed with shingles (herpes zoster) despite of vaccinating with ZOSTAVAX (vaccination failure). On or about 07-JUN-2014, the patient was treated for shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
On day 1 of vaccine, sore arm. over the next 48 hrs, extremely sore left arm at site of injection and feeling unwell with sore back muscles. By 72 hrs felt fine. No tenderness in arm at that point.  However, on the evening of 5/4/21 (8 days after injection)  the site of injection started itching. I noticed small (size of nickel) red splotch and more tenderness again. By this morning 5/5/21 the rash has spread 2+inches on left deltoid and is extremely itchy, swollen, with a hard lump under skin and is now very tender to the touch again.
Pt presented to the Troop Medical Clinic on 9/19/08 with c/o R eye pain and redness times two days. Reports that he also had pain the previous week for 2 days. Diagnosed with conjunctivitis and ordered Polytrim. In for follow up on 9/22/08 with worsening of sx to include vision changes and photophobia. SM vocalized concern that may be related to Smallpox vaccination as sx started after vaccination was given. SM referred to opthomology and they diagnosed iritis, possibly related to Smallpox vaccination, and reaction to polytrim. Polytrim was d/c'd and Predforte and Vigamox were ordered. Seen in follow up on 9/23/08 and 9/24/08 with improvement in sx noted.
EMPLOYEE STATES THAT SHE WAS FEELING LIGHT HEADED WITH A SLIGHT MIGRAINE, COLD, BLURRED VISION, CHILLS, DIZZINESS. TEMPERATURE WAS 98.4 F BP 152/91 PULSE 87. SYMPTOMS PERSISTED FOR ABOUT 60 MINS. LEGS WERE ELEVATED, NO BREATHING PROBLEMS NOTED, EMPLOYEE WAS IN SUPINE POSITION ON EXAM TABLE IN OFFICE. EMPLOYEE STARTED TO FEEL BETTER AFTER 60 MINS.  VITALS AT 09:45 AM WERE BP 138/64 PULSE 71 TEMPERATURE 98.6.  EMPLOYEE STATED THAT SHE STILL HAD A SLIGHT MIGRAINE BUT SHE FELT BETTER. EMPLOYEE STATED THAT SHE HAD SLIGHT MIGRAINES OCCASIONALLY OVER THE PAST FEW WEEKS. EMPLOYEE RETURNED BACK TO WORK IN PRODUCTION, STATING SHE FELT FINE. AT 10:30 AM EMPLOYEE RETURNED TO  OFFICE STATING THAT SHE IS STILL HAVING A MIGRAINE AND BEING LIGHTHEADED. 10:35 AM VITALS BP 138/87 PULSE 64, TEMPERATURE 98.4 F.  EMPLOYEE LAID IN SUPINE POSITION ON EXAM TABLE. EMPLOYEE HAD STAFF MEMBER CALL HER BOYFRIEND TO COME PICK HER UP. EMPLOYEE REMAINED IN OFFICE UNTIL BOYFRIEND PICKED HER UP AT 12:30 PM.  VITALS AT TIME OF RELEASE WAS BP 122/85 PULSE 63.
Extreme pain in left shoulder surfacing a few days after 1st injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: EM9810) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "A1C slightly elevated" (unspecified if ongoing); "thyroid cancer" (unspecified if ongoing); "gall bladder removal" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; PRILOSEC [OMEPRAZOLE]. The following information was reported: ARTHRALGIA (non-serious), outcome "recovered", described as "Extreme pain in left shoulder surfacing a few days after 1st injection". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Extreme pain in left shoulder surfacing a few days after 1st injection that gradually subsided after a few weeks. Pain occurred when lifting left arm, reaching out or above head, placing arm behind back. Also experienced extreme pain in right shoulder day after 2nd dose. Felt lethargic, extremely weak, disoriented. Took a nap for about one hour and felt a little better. Pain disrupts sleep caused from pain when moving in bed. Difficulty lifting, reaching out and to the side. Went to Orthopedist and was diagnosed with adhesive capsulitis (shoulder freeze). Physician administered cortisone and provided stretching exercises. Worked out ok for a couple weeks and then slowly began to return to the same level as before the cortisone injection. Currently working with physical therapist to loosen encapsulation with minimal improvement.
Numbness of right arm; Tingling of right arm and right side of face; Feeling dizzy or faint like; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PH8028) via an unspecified route of administration in the right arm on 20Nov2021 at 14:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. The patient did not take any concomitant medication. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Nov2021 at 14:45, the patient experienced numbness and tingling of right arm and right side of face after feeling dizzy or faint like. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events numbness and tingling of right arm and right side of face after feeling dizzy or faint like was not resolved at the time of the report.
Patient developed sore arm and leg cramps that went away the next day but starting on 1900-2000 the same day as the 1st vaccine, patient became very nauseous and vomited.  As of 3/12 patient can not eat properly. He is taking Zofran but symptoms are still persisiting. Patients stool is really runny and he can not get his blood sugar below 200.
Dizzy; This is a spontaneous report from a contactable consumer (patient's son) via Pfizer sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient got dizzy after the first dose on an unspecified date. The patient wanted to know if he has to have a second dose and where to schedule. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
NOTHING HAPPENED TO CHILD, GVE CHILD 0.1 ML OF PFIZER
pain all over her body / Laying in bed was painful; nausea; headache; pain on her skin / pain when skin was touched / hurt to have covers on. Laying in bed was painful; could not move her body due to pain when skin was touched; could barely get up the stairs due to the pain; This case was reported by a consumer and described the occurrence of general body pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than a day after receiving Shingrix, the patient experienced general body pain, nausea, headache, skin pain, mobility decreased and activities of daily living impaired. On an unknown date, the outcome of the general body pain, nausea, headache, skin pain, mobility decreased and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the general body pain, nausea, headache, skin pain, mobility decreased and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but it could be 59 or 60 years. Within 2 hours after vaccination, the patient experienced pain all over her body but was not muscle pain and pain was described as pain on her skin. The patient could not move her body due to pain when skin was touched and said that it hurt to have covers on. Laying in bed was painful for patient and she could barely get up the stairs due to the pain. The patient also had headache and nausea. All the symptoms were lasted 7 days before resolving. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR039701:same patient, same reporter 2nd dose
The pt developed cellulitis on the left upper arm from injection site down toward elbow. Treated with Keflex.
Breakthrough infection with COVID19. I woke up on 5/11 with dry hacking cough. Later that day developed fever, headache, body aches. Was prescribed Paxlovid by PCP (via telehealth visit) and started taking it that afternoon. I had injured my back on 5/6 and was prescribed (via telehealth visit on 5/9) Methylprednisolone 4Mg Dose Pack , which I started taking that day. Per PCP instructions when receiving Paxlovid prescription I stopped taking the Methylpredisolone immediately, last does was 5/10 at bedtime (about 10 PM). COVID symptoms stayed for about 3 days. I did experience some "COVID rebound" symptoms 6-8 days after starting Paxlovid, primarily recurrence of cough - primarily in the morning, about 5-15 after getting out of bed, mildly productive, prompted by some fluid/mucus in lungs. Once lungs are clear minimal coughing during the day. This has been getting better but I am still experiencing this lingering morning cough.
Pt 3 mo post repair of tetrology of fallot developed P.A.T. requiring Inderal following immunization.
Pt developed left arm cellulitis triceps fasicitis on 3/24 secondary to pneumovax injection, CT done which showed no collection. Surgery and infectious disease were consulted. Pt initially placed on dicloxacillin 500mg PO QID. Vancomycin 1gm IV and Ciprofloxacin 500 PO W 12 hr were added when erythema did not improve. By 3/26 rash began to recede per 10 records. All previous antibiotics were stopped and Ancef 2gm IV Q 12 hour was started. Pt discharged to home on 4/1 with Afadroxill 1 gram PO BID for 7 days.
HA, nausea, feels weak, vomiting, stomach ache, fever up to 100 degrees. Started after she had her GARDASIL shot yesterday 3/11/15.
NUMBNESS ON RIGHT FOOT; MILD BILATERAL LEG PAIN; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's past medical history included low platelet count, and low iron count, and concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies the patient did not have any history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 16:00 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 2017, Laboratory data included: Laboratory test (NR: not provided) Low platelet count. On SEP-2020, Laboratory data included: Laboratory test (NR: not provided) Low IRON count. On 26-APR-2021, the subject experienced mild bilateral leg pain. On an unspecified date, the subject experienced numbness on right foot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild bilateral leg pain, and numbness on right foot. This report was non-serious.
Patient reported severe increase in blood pressure from evening  following the vaccination (day1) through the day after (day 2).  Blood pressure reading about 180/110.  Upon following up with patient on day 3, patient stated blood pressure returned to relative normal reading.
16 year old female received FLUBLOK QUADRIVALENT instead of FLUZONE QUADRIVALENT/no AE; 16 year old female received FLUBLOK QUADRIVALENT /no AE; Initial information received on 24-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 16-year-old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] [injection, lot number: UJ446AA and Expiry date: 18-Mar-2021] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] 0.5 ml once dose via intramuscular route at the right arm, on 24-Sep-2020, for prophylactic vaccination (wrong product administered and product administered to patient of inappropriate age).    Medical history, medical treatment, concomitant medication and family history were not provided. No other vaccines given.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. (Latency: at the time of vaccination)  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
adverse reaction began 5 hrs post vax, t104-not controlled w/APAP; pt became listless x 2 days, anorexia, glazed eyes; seen by MD next day who ordered Ped DT for next immun;
ONE WEEK AFTER THE INJECTION, my arm swelled up all the way around from elbow to shoulder, it was red, hot, HARD, swollen and ITCHY. I wasn't even sore before that. It took about a week for this to go away completely.
Contracted COVID; Contracted COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6205), in left arm and in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation, prophylaxis. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: He also has COPD diagnosed around the same time as her 5-10 years ago. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" (2022) and all described as "Contracted COVID". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The reporter was asking her husband took Paxlovid, could he get the new booster. She had a consumer on the line regarding Pfizer COVID 19 vaccine adult formulation and unsure if purple or grey cap. Received doses 1, 2 and a booster and then contracted COVID in May2022. She did mention that her husband received the vaccine as well and then agent inadvertently disconnected before providing any additional details about husband. She stated they did not have any adverse reactions to the booster. Withheld said that people that took the Pfizer vaccines and contracted COVID afterwards was the reason she transferred her. Her husband also contracted COVID first and then she got it. He also received 3 doses of the Pfizer COVID vaccine. This report was to capture information for her husband. She said her husband took Paxlovid. His PCP (primary care physician) actually prescribed Paxlovid. He did very well with it. She did not have an address, phone or email for his primary care physician. Her husband received his first and second dose at the same time she did, but received his booster in Aug2021. She did not have his card to provide lot and expiration for any of them. He took Paxlovid and was better in 3-4 days. He did not have an ER or physician's office visit. He did not administered any other vaccine prior vaccinations (within 4 weeks).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201151180 same reporter/drug/event, different pt.
Itching all over, knots on shoulders, painful; sx began 1 day after injection and have lasted 6 days.