chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site pain; Body aches; Feels miserable; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th May 2020, the patient received the 1st dose of Shingrix. In May 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, general body pain and feeling miserable. On an unknown date, the outcome of the injection site pain, general body pain and feeling miserable were unknown.   It was unknown if the reporter considered the injection site pain, general body pain and feeling miserable to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced injection site along with arm was very sore, body aches and feels miserable.  The reporter did not consent to follow up.
A non-serious spontaneous report of patients over 49 years of age received a dose of H1N1 LAIV was received from non healthcare professional concerning a 50-year-old female. The patient's medical history and concomitant medication were not reported. On 23-Nov-2009, the patient received Influenza A, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Headache, Myalgia, Arthralgia, chills, malaise Narrative:
HIGH FEVERS UP TO 103, INTRACTABLE VOMITING, CHILLS, COUGH, HEADACHE, WEAKNESS, SHORTNESS OF BREATH
Pt received flu vaccine in a seated position. About 3 minutes later, pt reported feeling dizzy.  Vitals were recorded, WNL.  Dizziness worsened, pt was moved to supine position with feet elevated on chair.  Pt became diaphoretic and reported feeling very sleepy.  EMS called.  Pt had trouble keeping eyes open.  BP began to elevate to 150s/90s.  EMS arrived on site and transferred pt to ED.
Initial information received from a healthcare professional on 19 September 2008. A 37 year old female patient with allergies to clindocin, doxycycline, Avalox, and latex ("other allergies are suspected but not confirmed") developed a rash after receiving ADACEL (C2966AA) on 09 September 2008 (route and site were unknown). The patient may have also received PPD and thought the results were negative. No other information was known at the time. The patient became itchy and developed a red and maculopapular rash on 09 September 2008. Over ten days the rash spread over her entire body except for her face. The patient was afebrile with no local site reaction, no asthma attack, or any other symptoms. The patient's recovery status was unknown at the time of the report. Follow up information was received on 17 October 2008 from a health care professional. The patient with a history of asthma and allergic rhinitis received an injection of Tuberculin PPD, also reported as "PPD" on 09 September 2008 (lot number, route, and site was not reported). The patient developed itching several hours after the vaccine was given. The rash began on 11 September 2008 and continued to spread. However, there wasn't a reaction at the injection site. The patient was treated with Depomedrol and oral Prednisone on 16 September 2008 at an immediate care center. The patient had a doctor's visit on 18 September 2008 and was treated with Clarinex and Xyzal. On 19 September 2008 the antihistamines were changed to Atarax. On 20 September 2008 Cardizem was discontinued and Lisinopril was prescribed by her family doctor. She returned to the allergist on 22 September 2008. The reporter did not have an update on the patient's recovery status at the time of the report. List of Documents held by Sender: None.
red area below where shot was given, red area about 3 inches wide; red and sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red area below where shot was given, red area about 3 inches wide) and VACCINATION SITE PAIN (red and sore) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-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 VACCINATION SITE ERYTHEMA (red area below where shot was given, red area about 3 inches wide) and VACCINATION SITE PAIN (red and sore). At the time of the report, VACCINATION SITE ERYTHEMA (red area below where shot was given, red area about 3 inches wide) and VACCINATION SITE PAIN (red and sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included Benadryl cream.
Patient came to our office after getting the vaccine 24 hours ago. She started w/pruritic rash on her shoulder, trunk and legs.
TINGLING IN LIPS LASTED 10 MINUTES AND FLASHING IN THE FACE, FACE IS STILL FLUSHED
This is a spontaneous report from contactable employee who reported on behalf of a consumer. This female consumer (age and race unknown) received PREVNAR13 on unknown date. Relevant medical history and concomitant medication were unknown. It was reported that on an unknown date consumer had tenderness at vaccination site. Relevant laboratory data was unknown, at the time of report. This may be a duplicate report in situations where another Marketing Authorization Holder of piperacillin has been submitted the same report to the regulatory authorities. Follow-up (12SEP2014): Follow-up attempts completed. No further information expected.
Stated neck stopped hurting but arm vaccine was given in started hurting about 2 days after receiving vaccine and still hurting.  Hurts from shoulder down to elbow.
Swelling and itching started 2 days after vaccine administration. Patient self-treated by applying topical hydrocortisone and ice. Symptoms resolved after 1 week.
Patient came to pharmacy 2 weeks after vaccination and complained of a sore arm/shoulder. He stated he had normal injection site reaction after receiving the vaccination but the pain continued.
Fever 99.3, rash at shot location starting at around 8:00 AM, treated with Tylenol at 10:30.
Intense pain at injection site but no swelling or redness Intense body and joint pain and muscle cramps. Difficulty walking. Fatigue. Chills and Fever 102.2 degrees. Brain fog and off-balance could not sleep but no headache. Nausea no appetite. Nasal congestion and mild cough.  Symptoms woke me at 2 am with chills. Took 500 mg acetominophin at 10 am. Forgot to take medication resulted in high heart rate and blood glucose. Symptoms started to decrease after 2 pm 2/28/21. Took 500 mg acetominophin around 3 pm.  Fever 100. 5 on 3/1. Fever 100 on 3.2 Felt better but cancelled morning appointment on 3/3. Went for short walk outside on 3/5/21. Did not seek medical care. Still have muscle pain fatigue and brain fog.
flu like symptoms; Sweating; my joints are killing me, lower back, knees, and buttocks; fever of 100F; severe body aches; headaches just like when I had COVID but not as severe; my joints are killing me, lower back, knees, and buttocks; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever of 100F), MYALGIA (severe body aches), HEADACHE (headaches just like when I had COVID but not as severe) and ARTHRALGIA (my joints are killing me, lower back, knees, and buttocks) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020. Concurrent medical conditions included Lupus syndrome (Lupus) and Rheumatoid arthritis.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On 11-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever of 100F), MYALGIA (severe body aches), HEADACHE (headaches just like when I had COVID but not as severe), ARTHRALGIA (my joints are killing me, lower back, knees, and buttocks), HYPERHIDROSIS (Sweating) and MUSCULOSKELETAL PAIN (my joints are killing me, lower back, knees, and buttocks). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown, PYREXIA (fever of 100F) and HYPERHIDROSIS (Sweating) had resolved and MYALGIA (severe body aches), HEADACHE (headaches just like when I had COVID but not as severe), ARTHRALGIA (my joints are killing me, lower back, knees, and buttocks) and MUSCULOSKELETAL PAIN (my joints are killing me, lower back, knees, and buttocks) had not resolved.        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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Narrative:  Per mom clinic records patient reported day after vaccine (On 1/15/22) experiencing nausea and vomiting, he also developed chills, sweats, he also had a cough and has felt short of breath at times. , He reported arm sore but no redness or warmth. He is diabetic, his blood sugars are initially on the 400s over the weekend. Did have subsequent negative COVID test on 1/18/22.
I have had vertigo most of my life.  It is not an inner ear issue and through intense testing i have vestibular migraines which causes the vertigo.  I was put on zoloft and have not had a vertigo episode in about 5 years give or take (i do not remember the dates)  about a week after taking the j and j covid vaccine, my vertigo has returned.  the first sign was around 2 in the morning when i woke to use the bathroom.  from then on every morning and throughout the day i am miserable. i have to be careful what i do, how i turn etc or it will set off a severe episode.  my quality of life as gone down hill since receiving the vaccine.  i had so many good years of waking feeling great and not having to worry about the effects of vertigo.  Now i am back to where i was years ago.  My dosage of zoloft has been increased to the maximum amount i can take but it is not helping.  I am sorry i ever got the vaccine.
The AM following the vaccine I woke up with severe tightness and stiffness in the L lower neck and upper back/shoulder muscles which lasted a full month to the day. No redness or fever.  It was like the body's whole reaction to the vaccine took place locally in these areas with no reaction at the injection site in the deltoid.  Osteopathic adjustment, oral prednisone, OTC pain meds along with heat were used for mild, not complete relief.  Symptoms didn't start to ease up until a month after the vaccine was given and then took about a week to go away completely.
Left upper arm swollen, warm and tender in area of injection.  No fever, good appetite, and active.  Treatment: atarax 10mg/5m 1/2 tsp with 8lt, motrin.  Cool compresses to area.  Return date in 3 mos.
since getting the first dose of the covid vaccine, I began having my period every two weeks. As a person who has always suffered from migraines during menstruation, this increase in my periods  doubled the number of debilitating migraines I get each month. My period comes every two weeks now and it doesnt seem to be going back to normal. I would have never taken the vaccine if I had known this could happen. I may not be able to maintain full time employment, as there is no drug that works on my migraines and i have to miss work when they occur. Thank god I am not interested in having more children bc this has done something to my reproductive/hormonal system.
next day (not quite 24 hrs) pt had a sz on lt side; t101 ax was hospitalized overnoc; poss febrile seizure or could have been a react to shot according to MD;
24 weeks pregnant; A spontaneous report was received from a consumer concerning a 31-years-old, female patient who received Moderna's COVID-19 Vaccine, and who is 24 weeks pregnant.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.    On 04 Jan 2021, the patient received the vaccine while 24 weeks pregnant and would like to enroll in the pregnancy exposure registry. Treatment information was unknown.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event 24 weeks pregnant was not reported.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy (or "patient declined further contact).
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Additional Details: high blood pressure, glucose and dizziness/vertigo
Case number PHEH2013US025315 is an initial spontaneous report received from a pharmacist on 04 DEC 2013 and a follow up report received from the pharmacist on 21 DEC 2013. This report refers to a 14-year-old female patient. She tolerated her previous vaccinations. She was vaccinated with FLUCELVAX 2013/2014 (batch number: 006031A) intramuscularly in the left deltoid on 04 DEC 2013 (at 5:00 PM). No adverse event was reported following this medication error (inappropriate age at vaccine administration).  Follow up report received from the pharmacist on 21 DEC 2013: Vaccination history added. Updated: FLUCELVAX vaccination site and time.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 31 DEC 2013. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
This spontaneous report as received from a pharmacist via a company representative refers to a female patient over the age of 65. The patient's pertinent medical history, drug allergies and concomitant medications were unknown. Approximately on 05-AUG-2016 (reported as "about a week ago"), the patient was vaccinated with ZOSTAVAX, 1 injection, (lot#, dose and route were unknown). Approximately on 06-AUG-2016 ("1 day after"), the patient developed a big red bump, the size of a silver coin on the injection site. The outcome of the event was unknown. The patient didn't seek medical attention. Additional information is not expected since no contact details was provided.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 02/10/21pfizer,Lot#EM9810 2nd dose: 03/03/21,Pfizer,Lot# EN6202 Diagnosed covid positive:07/09/2021 Exposure:unknown Symptoms:Fever, cough,fatigue,nausea,chills,runny nose,headache.
Information has been received from a doctor of pharmacy concerning a 68 year old female patient with rheumatoid arthritis and no drug reactions or allergies, who on 28-JAN-2011 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # 667610/1355Z EXP 26-OCT-2011) SQ in the left upper arm. There was no concomitant medication. The pharmacist reported that the patient experienced a flare up of rheumatoid arthritis after administration of ZOSTAVAX. There were no lab diagnosis/studies performed. The patient sought unspecified medical attention. It was reported that the patient had not received treatment for the adverse event. At the time of the report, the patient had not recovered. No further information is available.
Arm was sore and got progressively worse to the point of not being able to move in certain directions. Severe pain when moving arm. I still have pain but not as severe. I also have pain in my neck. I took ibuprofen which helped a bit but did not take away the pain. My shot was on 8/31 and I still have some pain with movement. During this time I had a sinus infection upper respiratory and swollen glands right after that I had bronchitis and an infected lymph node behind my ear. Do not know if this was related to the shot.
My sister and I and our husbands we all got the vaccine and had a little sore arm after; her teeth are chattering and the chin is moving up and down; This is a spontaneous report from a contactable consumer (reported for sister). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated that my sister and i and our husbands we all got the vaccine and had a little sore arm after and her teeth are chattering and the chin is moving up and down on an unspecified date'. Reporter wants to know if these symptoms are reported with Pfizer COVid-19 vaccine. Outcome of the events was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Shoulder has become progressively more sore; Could not lift the arm all the way up/ almost impossible to flex in some directions; Shoulder [was getting progressively the soreness and a ] weakness; Could not take a tshirt off; This is a spontaneous case initially received from the other non-health professional (consumer) on 31-Oct-2018, concerning a 63-year-old, adult male patient.  The patient's current condition included glaucoma. The patient's concomitant medication included unspecified eye drops for glaucoma.   On 11-Oct-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid (left shoulder), batch number: 02144621A and expiry date: 30-Jun-2018) for active immunization against influenza.  On 13-Oct-2018, two days after the vaccination, the patient experienced progressive soreness and weakness in shoulder. The patient neither could lift the arm up nor flex in some directions. It was reported that the patient could not take a t-shirt off (explicitly coded as activities of daily living impaired).  As of 01-Nov-2018, the patient felt better. The events had not completely subsided but was not hurting all the time. The outcome was recovering.  The reporter assessed this case as non-serious.; Reporter's Comments: A 63-year-old, female patient experienced progressive soreness and weakness in shoulder has become progressively sorer and weaker, injected limb mobility decreased and activities of daily living impaired, two days after administration of Afluria Quadrivalent. The company assessed the causality of the events (soreness and weakness in shoulder has become progressively sorer and weaker, injected limb mobility decreased) as related to the suspect vaccine due to the plausible temporal relationship between the event and suspect vaccine. The company assessed the causality of the event activities of daily living impaired as not related to the suspect vaccine as it can be alternatively explained by pain and weakness in shoulder.
Information has been received from a health professional concerning a 5-year-old female with mild asthma and eczema and no drug reactions / allergies who on 08-JUN-2002 was vaccinated SC with a 0.5 mL dose of Varivax (Lot # 639681/0963L). There was no concomitant medication. ON 22-MAY-2006, the patient developed lesions similar to lesions of chickenpox and also poison ivy. Her lesions were located all over her body. Multiple lesions were described as blister-like, and other lesions were described as maculopapular. The patient was treated empirically with acyclovir and hydroxyzine. The patient did not have systemic symptoms, and she was afebrile. Lab tests included: IgG and IgM. Both were negative. The outcome was reported as not recovered. Unspecified medical attention was sought. No further information was available. There was no product quality complaint. The reporter considered the events to be other important medical events. Additional information has been requested.
I have been dealing with a chronic cough for years because of GERD, it has gotten so much worse. In November I had gone into my pulmonologist for a regular six-month checkup that I need to do since having had my lung collapsed. My pulmonologist scheduled me to have a bronchial scope lung test, it was confirmed that I have bronchiectasis. I was prescribed albuterol nebulizer and a butterfly valve to help clear my lungs. There is not recovery for bronchiectasis, it will eventually get worse, it can be controlled.
reported having chills; muscle soreness; headache; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (solution for injection; batch/lot number and expiry date were not reported), via an unspecified route of administration on 28Jan2021, 08:30am at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, at approximately 7:30pm of 28Jan2021, the patient experienced having chills, muscle soreness and headache. The outcome of these events was unknown.  Information on the lot/batch number has been requested.
Mom states high temp starting 1 hour after administration around 101.3 degrees F.  Mom gave motrin and temp came down to normal soon after dose.  The child was fine the rest of the day and the next morning the child woke up vomiting, had cough, and temp of 103 degrees F.  Mom took child to ER, where they drew blood did chest xray and found nothing else wrong with pt and discharged home with another dose of motrin.
Poked child with an unfilled syringe. Bandd aid applied. Reviewed to watch for s/s of redness at site. Immunization supervisor notified. All questions answered.
Itching; Area turning very red; Swelling at the injection site; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), PRURITUS (Itching), RASH (Area turning very red) and VACCINATION SITE SWELLING (Swelling at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concomitant products included HCTZ for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 23-Mar-2021, the patient experienced PAIN (Soreness) and VACCINATION SITE SWELLING (Swelling at the injection site). On 26-Mar-2021, the patient experienced PRURITUS (Itching) and RASH (Area turning very red). On 24-Mar-2021, PAIN (Soreness) and VACCINATION SITE SWELLING (Swelling at the injection site) had resolved. On 28-Mar-2021, RASH (Area turning very red) had resolved. At the time of the report, PRURITUS (Itching) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Narrative: COVID infection following COVID vaccine series 04/06 Janssen dose #1 07/27 pt cc: cough, headache, myalgias, sore throat exposure: unknown 08/08 COVID swab, result: detected
Missed period.  I had terrible cramps and headaches about a week after the vaccine but never had my monthly cycle.
Developed a large bruise in upper left arm and the arm is extremely painful for the last 12 days.  Have iced etc but the pain is not subsiding.