chrisvoncsefalvay/vaers-outcomes huggingface dataset:
You can take water and put it in the arm and, and it's going to be sore; This is a spontaneous report received from non-contactable reporter(s) (Other HCP, Consumer or other non HCP and Physician).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "You can take water and put it in the arm and, and it's going to be sore". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT stated very sore arm that extended down to her wrist over a number of days. she stated that "her bones hurt" and that she had swelling under her arm (in lymph node area). She said that the reaction subsided over a number of weeks.
Flu like symptoms began to develop with a dull headache; left arm from shoulder to wrist had begun to ache; by morning of 05/09/2013 (5:00 AM) all joints in left side from hip to shoulder ached and felt tender, dull headache continued; by 12:00 PM on 05/09/2013 all joints right and left side ached.  By evening of 05/09/2013 and through most of 05/10/2013 the joint aches had spread to my ankles and feet. While not completely debilitating, the discomfort was distracting and I felt clumsy. My appetite was diminished; I experienced flatulence, heartburn, excessive burping. My spouse reported that I was feverish throughout the night of 05/09/2013 and 05/10/2013; I awoke both nights drenched in perspiration.  Flu like symptoms and dull headache continued until about mid-day on 05/11/2013.  The injection site remains sore (05/12/2013 at 7:00 AM, much like a bruise that is a day or so old.
he felt light headed/panic attack few minutes after getting the shot , he laid down on the floor , breathing was ok pulse was ok , called 911 , was no need for EpiPen/CPR/AED/ DIPHENHYDRAMINE
Within a few hours of getting my first shot, I developed arthralgia and myalgia, including severe low back pain, right hip/groin pain), right ankle pain/weakness, mid/upper back pain, and severe fatigue. The low back pain, groin/hip pain, and fatigue lasted. 2.5 weeks. For those 2.5 weeks, I felt weak enough that I couldn't walk more than 30 minutes, when I had been walking 30-60+ minutes daily for the last year. Also, my low back/hip/groin felt "frozen," so it made it difficult for me to walk (I was limping). Within two hours of my second shot, I developed full-body arthralgia/myalgia, including thigh pain/weakness, low back/groin/hip pain, upper back pain, shoulder and neck pain, thumb and hand pain, and ankle weakness. Over the next 12 days, my right shoulder pain progressed to the point at which I had to get a cortisone injection in my right shoulder (for bursitis) today. Prior to the second Covid vaccine shot, I had not had shoulder bursitis symptoms since November 2020, when I had a cortisone injection. I am also still experiencing excessive fatigue from the second shot. I am reporting this information so it can be included in the post-marketing study.
A physician reported that a 5 month old female received her second dose of Prevnar in May 2001. On 09-NOV-2001 at 11 months of age, the infant developed a fever and viral infection. On 16-NOV-2001, she was seen in an ER where she was diagnosed with meningitis. A lumbar puncture was positive for Streptococcus pneumoniae and the infant was admitted for hospitalization. Additional information received from the same reporter on 20-NOV-2001 indicated that the infant received her second dose of Prevnar along with DTaP, IPV and haemophilus b conjugate vaccines on 23-MAy-2001. Approximately 1 and 1/2 weeks prior to admission, the infant had been diagnosed with bronchitis and treated with an unspecified decongestant. On 16-NOV-2001, she developed a fever of 101.6 and was listless. the infant was seen by a physician who sent the infant  directly to the ER. She was treated with vanomycin abd ceftriaxone. On 18-NOV-2001, the infant was examined by a physician who noted that the infant's neck was stiff and unable to flex. Her abdomen was bulging with an enlarged liver and an additional diagnosis of hepatomegaly was made. Information regarding this event has been forwarded to the manufacturer. Follow up information received from the physician on 25-DEC-2001 indicated hat the infant received her second dose of Prevnar, Acae-Imune, Hib-titer and IPV vaccines. The pt recovered.
Reaction to covid-19; General body pain; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Reaction to covid-19), PAIN (General body pain) and PAIN IN EXTREMITY (Arm pain) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Previously administered products included for Allergy: Codeine. Past adverse reactions to the above products included Asthma with Codeine. Concurrent medical conditions included Psoriatic arthritis, Diabetic, Heart murmur, Cholesterol, Triglycerides, Insomnia, Anxiety and Clot blood. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Anxiety, MONTELUKAST SODIUM (SINGULAIR) for Asthma, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, ACETYLSALICYLIC ACID, ASCORBIC ACID (ASPIRIN COMPOUND [ACETYLSALICYLIC ACID;ASCORBIC ACID]) for Clot blood, CHLORMEZANONE (RESTORIL [CHLORMEZANONE]) for Insomnia, METHOTREXATE for Rheumatoid arthritis, OMEGA-3-ACID ETHYL ESTER (LOVAZA) for Triglycerides, TROPOLONE, FOLIC ACID, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and LISINOPRIL for an unknown indication.   In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (Reaction to covid-19), PAIN (General body pain) and PAIN IN EXTREMITY (Arm pain). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form and PARACETAMOL (PANADOL) at a dose of 1 dosage form. At the time of the report, IMMUNISATION REACTION (Reaction to covid-19), PAIN (General body pain) and PAIN IN EXTREMITY (Arm pain) had not resolved.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The Humira dose was reported as 40 mg ,1 in 15 days. The drug indication for the concomitant medication Tropolene was reported as pressure, Wellbutrin was reported as Nerves, Lisinopril was reported as heart. The therapy duration for the concomitant medications Lipitor, Lovaza, Aspirin, Restoril, Folic Acid, Methotrexate, Wellbutrin,Prilosec, Lisinopril, Singulair was reported as over three years ago.
A patient received FluMist vaccination on 28 Nov 2005 for influenza immunization.  Within 1-2 hours of receiving FluMist patient experienced dizziness and headache.  When the symptoms occurred patient called facility where they received the vaccination however was not given any specific instructions. No additional information was available at the time of this report.
Pt's wife call on 8/17/21 to inform pharmacy that her husband developed shingles approximately 3 or 4 days after receiving COVID vaccination.
1st: May20211, 2nd: late; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in May 2021 (exact date unknown)).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   GSK Receipt Date: 12-July-2022 Reporter's Comments: The patient was late for the 2nd dose. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Patient received 0.5 ml Anthrax IM in left deltoid on 10APR2012 at 0915. On 11APR2012, patient began to notice swelling and itchiness at 12 noon. The left deltoid increased in redness, swelling, itchiness, and tenderness throughout the day. Patient reported on 12APR2012 at 0845 with the prior listed signs and symptoms. Medical staff notified. Patient given heat pack, ACE Bandage, and 25 mg Benadryl PO. Patient will continue to be monitored by hospital personnel for any signs of resolution.
Blood Vessel Burst in left eye; Brain fog; Dizziness; Fatigue; Nausea; Soreness; Headache; This is a spontaneous report from a contactable consumer.  A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 33-years -old via an unspecified route of administration, administered in arm left on 05Apr2021 14:45 (Batch/Lot Number: EW0151) as single dose for covid-19 immunisation.  Medical history included polycystic ovaries from an unknown date and unknown if ongoing, gallbladder removed on an unspecified date, allergies: Sulfa from an unknown date and unknown if ongoing. Concomitant medications included calcium; colecalciferol (D3); fish oil; bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC); clarithromycin (CLARITIN); all taken for an unspecified indication, start and stop date were not reported.  The patient previously took amoxicillin and experienced allergies.  The patient experienced blood vessel burst in left eye, brain fog, dizziness, fatigue, nausea, soreness and headache on 05Apr2021 17:00. It was unknown if treatment was received for the events. The patient did not recover from the events.
Information has been received from a nurse practitioner concerning a 9 month old female with no pertinent medical history or drug allergies who was vaccinated with a dose of Rotateq.  On 27-FEB-2008 the patient experienced the symptoms of rotavirus characterized by 13 loose stools per day which had a foul odor.  The patient was seen in the physician's office for medical attention.  No labs or diagnostic studies were performed.  The patient was treated with PEDIALYTE.  The patient still had loose stools but was noted to be recovering.  There was no product quality complaint.  Additional information has been requested. 06/02/2008 Follow-up information from the reporting nurse practitioner indicated that the 9 months old female who on 03-DEC-2007 was vaccinated PO with her third dose of ROTATEQ (lot# 657659/0969U). There was no illness at the time of vaccination. On 25-FEB-2008 the patient complained of loose, watery stools with 10 occurrences in one day on 27-FEB-2008. It was also reported that rotavirus was suspected. The outcome was unknown for watery stools. Additional information has been requested.
Aches; Headache; Fever 102 degrees; This is a spontaneous report from a contactable physician, the patient.  A 59-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685), via an unspecified route of administration in the left arm on 23Dec2020 at 08:00 (at the age of 59-years-old) as a single dose for COVID-19 immunization.  Medical history included asthma and penicillin allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included naproxen sodium (ALEVE) and unspecified multivitamins (MANUFACTURER UNKNOWN).  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020 at 07:00, the patient aches, headache, and fever of 102 degrees Fahrenheit, reported as non-serious.  The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcomes of aches, headache, and fever of 102 degrees Fahrenheit were not recovered.
I woke up the following day covered in sweat, I could barely walk to the bathroom I began vomiting and I had diarrhea...About two hours later my start heart started to pound I was so scared I was gonna have a heart attack I had to lay down it took about 30 minutes from my heart rate to go down from 110 to 79
got 2 doses of Fluzone High-Dose within 10 days, no AE; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 66 years old patient who was vaccinated with doses of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ283AA via intramuscular route in the right deltoid on 25-Oct-2019 and lot number not reported via unknown route in unknown administration site on 15-Oct-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to extra dose administered.  At the time of reporting, 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.  Information on the batch number was requested.
pt recv vax & the next morning pt exp hives, rash, & itching;ER or MD visit was necessary;tx DPH & Epi;
Mother reports daughter began losing hair one week after 1st GARDASIL, accelerated after 2nd GARDASIL. Lost about 1/3 of hair. Took to PP in September 2011. Tested thyroid and for anemia, results negative. Mother reports new hair growth in last few months. Had third HPV administered at PP 1-25-12.
Within few hours I had severe chills/body aches/headache which then also lead to a fever, unable to eat & major migraine. All of which lasted for 4 days except for the migraine. The migraine reduced to a lower grade/bad headache which lasted an additional 5 days. I am still unable to eat normal meals, certain foods, etc. I instantly become nauseous, get pains in my stomach, belching and chest pains.
2/3 AM:  Started feeling sick 2/2 and run down and now feels 'horrible'  States she has aches all over, has the chills, sore arm and maybe feels like she can't breathe well. She has a history of asthma, and other autoimmune disorders.  She is a caregiver for a child with disabilities and attending school.  2/4 8:40 AM:  Husband replied that she is 'having a hard time and getting worse.  whole body hurts and head and she is coughing bad and having hard time breathing sometimes. she can barely move'. PHN responded immediately that she needs to call her doctor right away and if struggling to breathe to go in to be see immediately'.  Asked if she had seen her doctor yesterday and he said
After waiting 15 minutes I was walking to my car and felt like I was going to pass out and was blacking out . I got very hot and dizzy. I then sat down and drank water/had food and started feeling better.
Hives appeared within 90 minutes of receiving the vaccine; Horrible rash all over his body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives appeared within 90 minutes of receiving the vaccine) and RASH (Horrible rash all over his body) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced URTICARIA (Hives appeared within 90 minutes of receiving the vaccine) and RASH (Horrible rash all over his body). The patient was treated with METHYLPREDNISOLONE at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives appeared within 90 minutes of receiving the vaccine) and RASH (Horrible rash all over his body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   Treatment information mentioned stated methylprednisolone for one week.
This spontaneous report as received from a medical assistant via company representative refers to an infant male patient of unknown age. Medical history was not reported. On an unknown date the patient was vaccinated with ROTATEQ (dose 1, 1 DF, oral, strength, lot # and expiration date not reported). Concomitant medications were not reported. The reporter stated that on an unspecified date in June 2014 (also reported as within this past month), the patient tested positive for rotavirus after receiving a single dose of ROTATEQ. The patient had unspecified laboratory tests performed. The outcome of the event was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Fine rash to palms of hands and soles of feet; initial symptoms noticed by 8/17/13 approximately 2 days after vaccines Tdap and meningitis given. Fine eruptions visible and vesicles noted esp to feet with skin sloughing. Treatment provided for patient in office on 8/20/13: BENADRYL 25mg IM, SOLUMEDROL 40mg IM. Rx written KEFLEX 500mg #14 tab. Wound care provided to left great toe in office.
Injection site pain, injection site swelling and erythema, fever, body aches, tiredness, sore shoulder, rash at injection site.
Redness, swelling to (R) arm 32 x 12 cm cover from injection site with itching Atarax 1 mg qhs. Keflex 500 mg BID, Naproxen 500 mg BID Tylenol 325 mg BID
This spontaneous report as received from a registered nurse refers to a 17 year old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 02-DEC-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, (dose and route not reported) from lot # M016193 and expiry date 24-APR-2018 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received.; Sender's Comments:  US-009507513-1610USA008140: US-009507513-1610USA014706: US-009507513-1610USA014705:
Extended and heavy period: period started as expected around 4/23 (shortly after receiving the vaccine), but then was longer and heavier than usual. I have a Mirena IUD and normally have such a light period that I use at most two regular tampons and otherwise just freebleed, but last month I needed two tampons a day for several days and could not freebleed without causing a mess. My next period is starting in a few days and my cramps are much heavier than they?ve been since I received the IUD.
Pt recvd 1st & 2nd dose of Hep B vax on 10JUL91 & 12AUG91 & on 12AUG91 pt noitced a purplish discoloration on lower aspect of lt upper arm; exam on 15AUG91 revealed that arm was nl x/ for small area of ecchymosis;
Severe muscle and joint pain, generalized weakness, nausea, chill, fever, loss of appetite, headache and fatigue. All these lasted for two days with sleepless nights. I feel a bit better now but scared of the getting the next dose.
Site pain which was usual for me ever year taking a flu shot; but then headache behind the eyes and left side of the head and nausea not usual. Continued for the day of the injection then sleep. Woke in the middle of the night with higher than usual blood pressure for me: 155/79 with a 92 pulse. No fever.  Called nurse line at insurance and took Tylenol which helped.  The next day when Tylenol wore off headache returned with nausea, dry mouth some body aches. Contacted my PCP who said the symptoms may last into tomorrow and I will report back to him. I am reporting because this is the first time a vaccine has disrupted my routine at all, and not my first time taking  the over 65 dose. I hope my reporting may be helpful even though it did not cause an emergency.
c/o itchy throat, scratchy eyes. Benadryl 25 mg PO given @1439. 135/90 BP, 100% O2, 105 HR, 97.5 F Temp, 0/10 Pain, 16 RR.  Narrative:  135/90 BP, 100% O2, 105 HR, 97.5 F Temp, 0/10 Pain, 16 RR. Patient c/o itchy throat and scratchy eyes. Given Benadryl PO 25 mg @1439. Pt was taken to ED @1456 by ED RN.  Other Relevant History:
States was feeling bad that afternoon when left work with achiness, pain in arm, and chills.  States fever went to 102.4 and had two witnessed seizures.  Had vomiting also.
She has tested positive for influenza A; This spontaneous case was received on 14-Nov-2022 from physician (reference number: SEQW22-05790) with additional information received on 15-Nov-2022 (being processed together) and concerned a female patient of unreported age.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in 2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration, and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On an unspecified date in 2022, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient become sick and tested positive for influenza A.   The outcome of the event 'influenza A virus infection' was not reported.   The reporter did not provide a causality assessment.   The event of 'influenza A virus infection' was considered medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A female patient of unreported age was vaccinated with Flucelvax Quadrivalent. An unknown amount of time after vaccination, the patient become sick and tested positive for influenza A. The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine is unassessable, due to lack of information provided and unclear chronology.; Sender's Comments: A female patient of unreported age was vaccinated with Flucelvax Quadrivalent. An unknown amount of time after vaccination, the patient become sick and tested positive for influenza A. The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine is unassessable, due to lack of information provided and unclear chronology.
PT VACCINATED USING MODERNA 5/14/2021 (045B21A) + 6/11/21 (025C21A). S/O BEGAN 9/3/21, TESTED + 9/7/21