chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in back; pain in arm; difficulty sleeping; pain in head; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in back), PAIN IN EXTREMITY (pain in arm), INSOMNIA (difficulty sleeping) and HEADACHE (pain in head) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included IBUPROFEN for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced BACK PAIN (pain in back), PAIN IN EXTREMITY (pain in arm), INSOMNIA (difficulty sleeping) and HEADACHE (pain in head). At the time of the report, BACK PAIN (pain in back), PAIN IN EXTREMITY (pain in arm), INSOMNIA (difficulty sleeping) and HEADACHE (pain in head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  Other concomitant medication included anti-inflammatory medications.  Treatment information was not provided.
Vaccinated 15 Apr with SPV.  Past day or 2 noticed "pimple" like itchy rash on torso, arms, and legs.  Otherwise well, no fever, chills or chest pain.
On 9/10/18 around 3:30 in afternoon received first shingle shot of 2 part series.  By 7 or so my back hurt so bad had to go to bed.  Nothing relieved it.  Back hurt for several days and on 9/14/2018 noticed a rash and went to health clinic and confirmed I had shingles.  May be coincidence but afraid to get the 2 part shingles shots again.  Contacted manufacturer and they never tested anyone who had the live shingles shot previously.  I had live shingle shot when I was 60 years.
Immunizations given on 8/15/07, that night exp nausea, low grade temp and area surrounding DTaP became red, warm and tender
Skin is hot to the touch, there is a lump and a area of redness with a clearly defined border.
05/08/2006: 8PM-upper left arm muscle pain, starting chilling. 05/09/06 12:15AM H/A chilling, muscle pain. 1:45AM chilling temp 101.4, H/A. Upper extremity muscle pain. Sipping fluids. Taken Ibuprofen 400mg PO. Pulse 114, BP 130/80, 0230 Temp 102, H/A, chills, muscle pain. 04:30/ diaphoric (sweating), temp 100. Still have H/A, increased muscle pain. 06:10 started chilling c/o all over body, muscle joint pain. 08:00 Temp 100.8 pulse 100, BP 110/62 chilling muscle and joint pain. H/A 10:00 AM Ibuprofen 400mg PO taken. Able to take fluids in chilling, H/A, weakness, temp 101. 6. Dr's office called at 08:10. Was told to keep taking Ibuprofen and/or Tylenol, keep up with fluids. 11:10/ chilling, H/A muscle and joint pain all over body, weakness, pulse 108, BP 108/60, Temp 102.4. 1:30PM Dr's office again. Ibuprofen 600mg PO taken with fluids, BP 100/62, Pulse 110. 3:45 Diaphoric (sweating). Dr's office returning my phone call. Continue meds and fluids. 5:50PM chilling, H/A, muscle, joint pain, 7PM Temp 100.6, Ibuprofen 600 mg PO 10:00PM Temp 102.2 still having terrible muscle, joint pain. H/A 11:50: Diaphoric (sweating) temp decreased 100.4. H/A, muscle and joint pain. Taking fluids. 05/10/06 02:45 chillings, temp 100.6. Continuing to still have terrible muscle and joint pain, weakness. 03:50 Temp 101.8. Chilling 66.1. Diaphoric (sweating) temp decreased 100.6. 09:00 starting to chill again, H/A, muscle and joint pain. 11:45 Temp 101.2. Ibuprofen 600mg PO with fluids, H/A, muscle and joint pain, weak when up. 1:35 chilling, H/A, muscle and joint pain. 3:45 diaphoric (sweating). Still have H/A, muscle and joint pain. 8:00PM taking in fluids and some food, still have H/A, muscle and joint pain through out night and next morning. 5/11/06 08:30 Up but weakness, fluids, food in, H/A, muscle and joint pain through out the day.  5/12/06: still have H/A and muscle and joint pain through out day. 5/14/06 Feeling better, occ H/A, left arm slightly sore. 5/15/06 feeling fine no H/A or pain.
After receiving both initial Pfizer Covid-19 vaccines, I am having major issues with histamine intolerances; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HISTAMINE INTOLERANCE (non-serious), outcome "unknown", described as "After receiving both initial Pfizer Covid-19 vaccines, I am having major issues with histamine intolerances".  Additional information: Customer Verbatim: After receiving both initial Pfizer Covid-19 vaccines, the patient was having major issues with histamine intolerances, and had been for 12 months now. When the patient googled high histamine levels after, the search suggestions actually suggested after Covid-19vaccine and after vaccines, so it must be a popular search. Are any studies being done on this. Had any research been done on high histamine levels after the vaccines, are there any trials in progress. Possible antidote or treatments available.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt had hemotoma at injection site and saw dr. I got a call from the doctor asking why we gave them PREVNAR-13 because she had gotten it in august...we were promted to give her her PREVNAR at production when we ran a flu shot by her part B insurance, so i gave her PREVNAR and a high dose flu shot. Md asked why we gave her PREVNAR when she had just gotten it.
Tongue swelling after receiving COVID-19 vaccine.  No difficulty breathing, no rash.  Claims posterior aspect of tongue is swelling and causing her a gagging feeling.  No chest pain.
This spontaneous prospective pregnancy report as received from a Nurse Practitioner refers to a 26 year old pre-diabetic female patient with hyperthyroidism, mild asthma and no drug reactions/allergies. The patient's medical history included chickenpox as child. On 04-SEP-2013 the patient was vaccinated with a dose of VARIVAX lot # J003361, expiring 29-MAR-2015, subcutaneous (dose not reported). Concomitant therapies included Propylthiouracil. The patient was 5 weeks pregnant when received VARIVAX. No adverse event was reported. The patient's LMP was approximately of 31-JUL-2013 and EDD of 07-May-2014. No treatment was given. No lab diagnostic tests were performed. The patient sought medical attention by an office visit. Additional information has been requested.
Fever at least up to 2 days after injection. Redness of upper arm, not at injection site. Arm is sore and inflamed.
My daughter convulsed, turned grey, lips turned purple, bubbles and foam were coming out of her mouth. She was unresponsive and transported to the hospital by ambulance. She was in the hospital for four days.
I've had tinnitus since the first dose in April 2021. It starts to subside and the ramps up again with each dose or booster.
sl loss of taste; sl loss of taste; Home Ag: Positive; Home Ag: Positive; congestion; HA; cough; chills; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 28-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 16Feb2021 as dose 2, single (Lot number: EL3247) and on 12Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 06Apr2022, outcome "unknown"; HEADACHE (non-serious) with onset 07Apr2022, outcome "unknown", described as "HA"; CHILLS (non-serious) with onset 07Apr2022, outcome "unknown"; NASAL CONGESTION (non-serious) with onset 07Apr2022, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 07Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Apr2022, outcome "unknown" and all described as "Home Ag: Positive"; AGEUSIA (non-serious), SALIVARY GLAND MASS (non-serious) all with onset 09Apr2022, outcome "unknown" and all described as "sl loss of taste". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2022) Positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, fatigue, headache, cough, nasal congestion, chills, ageusia, salivary gland mass.  Clinical information: The patient was receive any other vaccines within 4 weeks prior and prior to vaccination to the COVID vaccine and patient diagnosed with COVID-19 was unknown, since the vaccination the patient has been tested for COVID-19. Reported Event: to weekend 02Apr2022 to 03Apr2022 and then fatigue 06Apr2022, HA cough congestion chills 07Apr2022 and then tested positive 08Apr with home AG then sl loss of taste over 09Apr2022 w/e.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Dizziness started about a week after my second injection.  I get dizzy with I get up too fast, turn my head from side to side or up and down.
h/a, swollen glands, stiffness in all joints & muscles since 11DEC92, papular rash all over started 15DEC92, fever up to 101, fatigue, cough;
Large red rash at injection site on upper arm.  Sore to touch and itches.
My mother had a really bad itchy sensation all over her arms and body in the middle of the night. She woke up from her sleep and used lotion to try to calm her body down.  She didn't tell me until the next day, but she couldn't sleep that night. Her left arm that received the vaccine was also very sore for her all day and it still is the next day. She doesn't feel the itchy sensation anymore though.
The patient experienced a vesiculo papular rash with 50-75 lesions eight days after the vaccination. The rash lasted 5 days. The patients fever was 102-103.5F daily 7, 8, and 9 days after immunization. Irritability was still present 16 days after immunization despite rash and fever resolution.
Temperature 35.6 F; This spontaneous report was received from a medical assistant referring to a patient of unknown age and unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 24-SEP-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1637651 with expiration date 09-JUN-2022, dose detail and route were not reported) for prophylaxis.  The vaccine was stored at 35.6 Fahrenheit degrees (F) for 3 hours and 15 minutes (product storage error). There was a previous temperature excursion and the call was because of a data logger involved.   This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA003213:
Vaccine was administered below optimal site of deltoid and caused a bruise in the patient's arm starting the administration date.
Patient arrived to Vaccine Clinic stating "I'm here for First dose" and that "she has not received a vaccine before". Pfizer vaccine was given per patient request. When entering dose into system it showed patient had received a moderna vaccine in January.  Pt had no side effects after administration of vaccine, and stayed at clinic for approximately 2 hours waiting on ride with no side effects noted.
5APR95 pt recvd shot by biojet gun & area became a big lump w/a red spot & looked lke a boil; pt had fever @ noc-t103, 102 next day; pt taken to PMD; pt put on Keflex 1tsp; boil & infect @ site;
I regularly take HUMIRA, and at the advice of my doctor, I stopped taking it the week before and after my COVID-19 vaccination, and then started taking it again. I have been on methotrexate for several years but stopped taking it about 2 weeks before my COVID-19 vaccination in September. 9/16/22 I had a blood test and my doctor called and said I had a low white blood cell count and attributed it to the vaccination. I took another one in October and the blood cells were slightly up. A few months later I returned from a business trip on 11/18. During that business trip I had been outside in the cold and wind. I had a scratchy throat the night I returned but didn't think anything of it. I took an at home rapid COVID-19 test that was very faintly positive. I called my PCP and he told me to stop taking HUMIRA and prescribed PAXLOVID. Took the tablets for 5 days. On 11/25 I tested negative. By Wednesday I still had my runny nose but felt fine. I took another test as a precaution, and I was immediately positive. I had cold like symptoms, coughing, running nose, no fever. I tested again on 12/5 and tested negative. I had some swelling in the lymph nodes on my neck and developed an outbreak of cold sores. I tested again on 12/7 and tested negative. I've also noticed that anytime I blow my nose that it has been bloody, and I have had some bloody drainage in the back of my throat, that has been since I first tested positive. I have also been getting a lot more headaches, I've been taking a lot more TYLENOL and aspirin as a result.
EE complained of generalized itching approximately 24 hours after the flu vaccine. She took Benadryl 25mg at bedtime that evening with some relief however took 50mg of Benadryl on next consecutive bedtimes with improved relief.  EE sought treatment on 10/7 she stated she had itching. No rash or excoriations on the skin and denies any change inpersonal, laundry, or environmental products and denies any changes in medications.  EE was instructed to continue Benadryl 25 mg po nightly and add Claritin 10 mg 1 po daily in the am.
Injection has turned Red about 2 -3 inch by 1-2 inch. It is severely painful to the touch.  Obviously raised.
p/1st vax pt had a knot come up on lt arm;disappeared  about a week & half p/vax;2nd & 3rd vax had no rxn;4th vax about a wk p/vax gum started bleeding, short term memory loss, sl fever, tired & diarrhea;
3 days after vaccine I had right eye pain that was very sharp knife like pain that was extremely bad. I went to see my eye doctor  that Monday where she told me my right eye optic nerve was inflamed and I needed to go to the ER. As I was waiting to be seen in the ER at local Hospital I developed a rash on the right side of my face and my eye pain got worse. I was diagnosed with shingles and put off work for 2 weeks! I ended up with a lesion on my right eye, cornea swollen and put on antiviral medication, steroids, eye drops x2 different kinds, ointment for my face, a pain pill. I still have issues after 2 weeks and still taking medicine.
Covid-19, had a fever, body aches,massive headaches on left side/The pain on left left side; unable to move their entire left side/could hardly move their left side; sharp stabbing ear pain; palpitations; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19, had a fever, body aches,massive headaches on left side/The pain on left left side), MOBILITY DECREASED (unable to move their entire left side/could hardly move their left side), EAR PAIN (sharp stabbing ear pain) and PALPITATIONS (palpitations) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included Cardiac arrhythmia.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19, had a fever, body aches,massive headaches on left side/The pain on left left side), MOBILITY DECREASED (unable to move their entire left side/could hardly move their left side), EAR PAIN (sharp stabbing ear pain) and PALPITATIONS (palpitations). At the time of the report, COVID-19 (Covid-19, had a fever, body aches,massive headaches on left side/The pain on left left side), MOBILITY DECREASED (unable to move their entire left side/could hardly move their left side), EAR PAIN (sharp stabbing ear pain) and PALPITATIONS (palpitations) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Patient experienced "a pretty bad adverse reaction", the individual had gotten Covid-19, had a fever, body aches, unable to move their entire left side, massive headaches on left side and sharp stabbing ear pain, The pain on left side was so severe that clothing touching it had them in agony, could hardly move their left side and they reported that it wasn't a paralysis but just the whole left side of their body was effected, Along with that they had increased heart rate, palpitations. Treatment medication was not reported.   This case was linked to MOD-2023-704835 (Patient Link).
SkinRash, Rash, ErythemaMultiform, 1/17 erythema rash on injection arm, warm to touch 1/21 skin rash spread distally down to forearm, swollen lymph nodes in armpits  Narrative:  1/17 went to urgent care erythema rash on injection arm, warm to  touch given zyrtec and pepcid AC. 1/21 skin rash spread distally down to forearm.  Also reports swollen lymph nodes in armpits. Reports neck pain radiating to L arm started day of vaccination. PMH of vagal response from vaccinations and  autoimmune disorder. Will be consulting neurologist and PCP. Vaccinated in health clinic.
The flublok influenza syringes were in the Fluzone influenza box. Flublok was given for the flu vaccine instead of Fluzone. No side effects noted during monitoring after event. Supervisor, management, safety officer, and pharmacy were notified. Mom was also notified of the event. Child showed no side effects or issues after receiving vaccine and was checked on again several days later.
Patient woke at about 2 am this morning (Mar 19, 2021) with severe chills, fever over 101, feeling extremely cold, joint aches, and had a severe headache.  It is about 9 am now and he feels a little better after two aspirin but is still feeling pretty sick.
allergy symptoms; This spontaneous case was reported by a nurse and describes the occurrence of HYPERSENSITIVITY (allergy symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-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 HYPERSENSITIVITY (allergy symptoms). At the time of the report, HYPERSENSITIVITY (allergy symptoms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: unknown unknown, Results Pending.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.  The patient stated that it was unknown if the Intramuscular injection was given into the Left or Right Deltoid for both the Moderna COVID-19 doses. The patient reported that she was tested for COVID-19 today out of precaution but the results were not back yet. The patient had not yet received the Moderna booster dose.   Reporter did not allow further contact
A pediatrician reported that a 3 year old female received an injection of Prevnar. A few months later, in Feb. 2002, the child developed invasive pneumococcal disease. Invasive pneumococcal disease is considered medically important. No further info was available at the date of this report. The follow up info was received from the physician on 3/14/02. The child, who had a medical history of acute lymphocytic leukemia, received her first dose of Prevnar on 9/17/02. On 2/13/02, a blood culture was collected; Strep pneumoniae was isolated. A diagnosis of pneumococcal bacteremia without focus was made; she was hospitalized that day. She was discharged from the hospital on 2/16/02.
Developed redness on 4/23/01, increasing to max on 4/25/01. Induration on 4/24/01. Less red and indurated today. Not tender and no fever. Seen on 4/26/01.
Body Aches (muscle and joint); Body Aches (muscle and joint); Body Aches (muscle and joint); headache; Fatigue; Tenderness at injection site; Fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Aug2021 17:00 (Lot number: EW0198) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: Verbatim: High Blood Pressure; "Heart Murmur" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; ERRIN [ERYTHROMYCIN]. Vaccination history included: Bnt162b2 (Dose number: 1, Administration time: 06:00 PM, Vaccine location: Right Arm, Lot number:FA6780), administration date: 27Jul2021, when the patient was 47 years old, for Covid-19 Immunization. The following information was reported: PAIN (non-serious), MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 18Aug2021 10:00, outcome "unknown" and all described as "Body Aches (muscle and joint)"; HEADACHE (non-serious) with onset 18Aug2021 10:00, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 18Aug2021 10:00, outcome "unknown", described as "Fatigue"; VACCINATION SITE PAIN (non-serious) with onset 18Aug2021 10:00, outcome "unknown", described as "Tenderness at injection site"; PYREXIA (non-serious) with onset 18Aug2021 10:00, outcome "unknown", described as "Fever". Therapeutic measures were not taken as a result of pain, myalgia, arthralgia, headache, fatigue, vaccination site pain, pyrexia.  Additional information: Patient had no known allergies. The most recent COVID-19 vaccine was administered at Public Health Clinic/Veterans Administration facility. the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.