chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness at injection site; pimples with small red dots from knees to ankles; swelling on legs; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   Concurrent medical conditions included penicillin allergy. Concomitant products included METHOTREXATE (RASUVO) and ADALIMUMAB (HUMIRA).   On 12th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th November 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, pimples and swelling of legs. On an unknown date, the outcome of the injection site erythema, pimples and swelling of legs were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, pimples and swelling of legs to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. The patient received dose of Shingrix in the phaymacy. The patient received Rasuvo and Humira as a concomitant medication. The reporter provided only partial information at the pharmacy. The reporter consented to follow up with the patient.
Sore arm / feeling is not much different from / shingles vaccine in Nov2020; When she touches it, it still hurts some / feeling is not much different from / shingles vaccine in Nov2020; Had the COVID virus back in Nov2020; Sick for 2 full weeks / with the COVID virus felt really like she does right now; Had a headache / with the COVID virus felt really like she does right now; Doesn't feel good / with the COVID virus felt really like she does right now; Tired / with the COVID virus felt really like she does right now; This case was reported by a nurse via other manufacturer and described the occurrence of pain in arm in a 53-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included breast cancer (newly diagnosed with non-metastic triple negative breast cancer prior to getting the vaccine, patient was advised by the doctor to get the vaccine as soon as possible).   In November 2020, the patient received Shingles vaccine. In November 2020, less than a month after receiving Shingles vaccine, the patient experienced pain in arm, tenderness, covid-19, sickness, headache, feeling bad and tiredness. The patient was treated with excedrin (nos) (Excedrin), paracetamol (Tylenol) and sumatriptan. On an unknown date, the outcome of the pain in arm, tenderness, covid-19, sickness, headache and feeling bad were recovered/resolved and the outcome of the tiredness was unknown.   It was unknown if the reporter considered the pain in arm, tenderness, covid-19, sickness, headache, feeling bad and tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for herself. The patient experienced sore arm and when she touch it, it was hurt. The patient had Covid virus back in November 2020, she did not feel good and was tired. The patient was sick for two full weeks with Covid and then on the third week she felt better but had a headache. On 29th January 2021, the patient received 1st dose of Pfizer Covid 19 vaccine on left deltoid with batch number EL9265 and expiration date 31st May 2021. On 30th January 2021, the patient's arm was very sore, really sore the first day after she puts a cold compresses and felt much better the next day. The patient mentioned that starting Friday she had headache on and off and felt like she was at the tail end of having the virus. The patient was not tested positive for Covid after having the first shot. The patient mentioned that, she was an active person but she had not done much since the shot. The reporter asked if was this normal and could the reaction had something to do with her already having Covid. The pharmacist told her it should only last a couple days. The consent to follow-up was granted.
I went for a regular checkup and Dr noted HR was elevated 130 which is abnormal for me. She did an EKG and noted an arrhythmia, tachycardia and then did 2nd EKG noting that it showed AFib.  Had no symptoms at all.  Was sent to ER, HR up to 160, gave me IV Diltiazem which decreased HR to 120 and they did an echocardiagram.  When laid on L side for echo, heart back into rhythm at 90.  Kept me overnight on heart monitor in observation and sent home on Lovenox then Warfarin and now taking Eliquis 5 mg bid and Oral Cartia XT 300 mg daily.
Within a few minutes started having reaction - redness, rash and then began itching all over; taken to ER. Continued same and complained of nausea and anxiety; given DECADRON, BENADRYL and PEPCID.
fever; injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and VACCINATION SITE PAIN (injection arm soreness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (fever) and VACCINATION SITE PAIN (injection arm soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Mar-2021, PYREXIA (fever) and VACCINATION SITE PAIN (injection arm soreness) had resolved. Not Provided          Concomitant Product include:cholesterol medication,diabetes medications,high blood pressure medications. Action taken with mRNA-1273 in response to the event was not applicable.
Initially, my first shot caused very little reaction.  I had a small (1 inch diameter) red spot on my arm that was itchy, but not enough that it required an anti-itch cream.  8 days after my first injection,  however, I developed a large spot on my arm.  It was approximately 4 inches in diameter, and was raised, red, and hot to the touch.   The muscle in my upper arm became quite sore, as if I had pulled or severely overworked the muscle.   After several days, the red spot became less pronounced, although a large bruise developed across the spot.  It was still visible to the pharmacist when I went in for my second shot on 3/6/2021.  The muscle pain continues, but now only hurts when I move my arm in specific ways (up to the side, or up to the back).  I received my second shot on 3/6/2021 and had almost no reaction at the injection site.  There was a small, red circle for two days that was not raised, nor itchy.  Twelve days later, a small, flat lump can be felt under the skin, but it is not painful.
I got up on the day of the vaccine, I fell and I hit my head. I don't know if it was due to the fever or what it could've been. It took about 10 days for the hives to appear. With the hives, I had a tight throat, I went to see a Dr. on November 11th they gave me Prednisone for 5-7 days and Allegra twice a day for a week or two, and then I could bring it down to only.  I'm still have the hives, they're better but I still have them.
Generalized myalgias and fatigue for 2 days. Right shoulder swelling, bruising and pain with persistent tenderness along collar bone and stiffness of shoulder. Not quite back to normal yet.
Pt. received Dtap 9-27-11. On 9-28-11 pt. developed fever, lymphadenopathy to Lt. neck and axilla, pain to left arm, shoulder and hand.
Initial unsolicited report received from a consumer on 03-Nov-2016. This case involves a patient (age and gender unknown) who was vaccinated with FLUZONE HD (lot number, expiration date, dose, route, site of administration not reported) on an unknown date. The patient's medical history and the concomitant medications were not reported. On an unknown date, after the vaccination, patient experienced chills and shakes for two hours that felt like convulsions. The patient's laboratory details and corrective treatment were not reported. The patient recovered from all events on an unknown date. Upon internal review the case was considered as serious because of important medical event: convulsions. List of the documents held by sender: none. Sender's Comments: Patient received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and reported For two hours patient had chills and shakes that felt like convulsions. Convulsions and chills is listed with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, However Time to onset was not specified. Details regarding as latency from last INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE administered, relevant medical history, patients age and gender, and diagnostic work-up- are lacking to allow adequate medical assessment.
Chronic skin irritation, itching, redness, hives upon administration of  booster shot that has persisted for 6 months. Has used allegra for treatment with no relief.
Information has been received from a certified medical assistant concerning an adult patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 18-MAY-2016, the patient was inadvertently vaccinated with a pediatric dose of RECOMBIVAX HB (lot # L048848, expiration date 09-AUG-2018; dose and route not reported). No adverse effect was reported. Additional information has been requested.
Irregular menstrual period; spotting, which has never occurred to her before. Both of her menstrual periods since time of vaccination have been irregular, preceded by and followed by spotting; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 18May2021 at 15:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 08Jun2021 at 15:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included social anxiety disorder. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included mirtazapine (REMERON) for an unknown indication from an unknown date and unknown if ongoing. On an unknown date in May2021, the patient experienced irregular menstrual period and spotting, which has never occurred to her before. Both of her menstrual periods since time of vaccination have been irregular, preceded by and followed by spotting. The events did not result in doctor or other health care 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 irregular menstrual period and spotting, which has never occurred to her before. Both of her menstrual periods since time of vaccination have been irregular, preceded by and followed by spotting was unknown at the time of this report.
Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. In 2014, the patient was vaccinated with ZOSTAVAX (strength, dose, anatomical route of vaccination, lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patient was diagnosed with shingles and / or other zoster-related injuries after and, despite being inoculated with the ZOSTAVAX (shingles and vaccination failure). Due to the patient's shingles, in 2015, the patient was treated by a healthcare provider. Furthermore, it was reported that the patient suffered serious physical, emotional and economic damages as a result. The patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering (emotional distress and pain), extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activations of latent conditions, lost wages, loss of earning capacity and other losses and damages.  At the time of report, the outcome of emotional distress and pain was reported as not recovered and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. Additionally, the reporter considered herpes zoster, condition aggravated, quality of life decreased, pain, emotional distress and vaccination failure to be related to ZOSTAVAX. The reporter considered the events to be serious due to disabling, life-threatening, hospitalization and medically significant.
She got the vaccine, did not have any reaction or that she was even given a vaccine.   Then around 7:00 PM her arm started to get a little sore but kept moving it and massaging it.  She then could not move anything by 10:00 PM, and had gone straight to bed as she felt so bad.  She was dizzy, light headed, and these symptoms continued all night and all day Thursday.  She dozed to sleep off and on all day Thursday and was in so much pain, didn't have to move to have pain.  She is still having some pain today, but feeling much better.  She still is a little bit dizzy.  Feels as if she laid down she could sleep for a long time.  She has pain in her back area, her arms, her hips.  She did not take anything for her reaction as was told not to take aspirin and does not use other medications.  She feels exhausted and if she moves her arm too much and also her legs then they start to hurt.  Getting in and out of bed is easier today, but she could not get them over the bed to get in or out on Wednesday.  Her neck also hurt to turn.  She had similar symptoms to when she had the COVID virus in November/December.  She had been hospitalized for it twice, was informed that she had a stroke after she had passed out.
I woke up very dizzy; Nausea; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 17:00 (Lot number: EW0164) at the age of 50 years as dose 1 ,single for covid-19 immunisation. Relevant medical history included: "Hashimoto" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: DIZZINESS (non-serious) with onset 20Apr2021, outcome "recovering", described as "I woke up very dizzy"; NAUSEA (non-serious) with onset 20Apr2021, outcome "recovering", described as "Nausea". Therapeutic measures were not taken as a result of dizziness, nausea.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No alergies to medications, food, or other products.  No follow-up attempts are possible. No further information is expected.
Patient called 5 days after vaccination to report a potential adverse reaction to the vaccine.   She reports as of today some swelling in her hand along with discoloration.
Subsequent to vax, this pt 'experienced a problem.' The pt was sent to the ER. Follow-up was received on 05/25 which states that one day following vax, pt developed a fever of 103.2 degrees F and an injection site reaction characterized by swelling, pain, and redness. The pt was hospitalized for 4 days and he recovered. As a result of the follow-up information, this report has been reclassified as serious, unexpected.
Fever, severe body aches, severe chills, still have symptoms this morning although less severe.
Arm got sore; Red circle 1-1/2 inches in diameter around the injection site; Swollen at the injection site; Itchy at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm got sore), VACCINATION SITE ERYTHEMA (Red circle 1-1/2 inches in diameter around the injection site), VACCINATION SITE SWELLING (Swollen at the injection site) and VACCINATION SITE PRURITUS (Itchy at the injection site) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LETROZOLE for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm got sore), VACCINATION SITE ERYTHEMA (Red circle 1-1/2 inches in diameter around the injection site), VACCINATION SITE SWELLING (Swollen at the injection site) and VACCINATION SITE PRURITUS (Itchy at the injection site). At the time of the report, PAIN IN EXTREMITY (Arm got sore), VACCINATION SITE ERYTHEMA (Red circle 1-1/2 inches in diameter around the injection site), VACCINATION SITE SWELLING (Swollen at the injection site) and VACCINATION SITE PRURITUS (Itchy at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information not provided.
a mild rash on my forearms and front of my legs; numb tongue; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Jan2021 14:30 at a single dose for covid-19 immunisation. Medical history included mild hypertension, elevated cholesterol, allergy to sulfa, allergy to gluten and celiac disease. The patient's concomitant medications were not reported. On 18Jan2021 15:30, patient experienced mild rash on his forearms and front of his legs which was treated with diphenhydramine  (BENADRYL) tablet. The patient also experienced numb tongue on 18Jan2021 15:30 with no treatment received. Outcome of event "mild rash on my forearms and front of my legs" was unknown while for the event "numb tongue" was not recovered.   Information on the Lot/Batch number has been requested.
Jittery, shaky spells several times per day for several days after HIB vaccine.  Mother reports similar symptoms after 1st dose.  Saw neurologist after first episodes, he was not terribly concerned.
Patient became short of breath, increased cough, hives on torso, stomach ache and nausea within 15 minutes after receiving MMR vaccine.  She was immediately given Epinephrine 0.3mg IM, followed with 1 albuterol neb, Zyrtec 10mg and 30mg oral prednisolone.
6/25/19: 5 cm red and tender and sl. raised around shot site left arm. Red raised tender area, 7/6/19: Pain when she pushes on it. Dark area surrounding injection site. Nodule in the center. 4.5 cm x 1.5 cm hyperpigmented mark, 2.5 cm nodule in center.
Slight rash appeared Thursday morning, it had quickly spread all over his body and brightened in color. I have him medicine for the reaction and some pain reliever. It's almost gone now.
Mother of child, states that a couple of hours, post vax, site of injection turned red. It continued to enlarge in size. Today it is approx. 6" in diameter, hot to touch and very hard. Child complaining of pain upon touch. Called for missing info on 8/17/01 and again on 8/24/01.
My son received the vaccine on 01/02/2023 and started vomiting early morning of 01/04/2023. He had 2-3 more episodes of vomiting over the next few days and then the symptoms worsened severely on 01/10/2023 with multiple episodes of vomiting. Did not have diarrhea or fever. No runny nose or cough. Needed to be hospitalized from 01/11/2023 until 01/18/2023. His vomiting was resistant to all conventional treatments: Reglan, Zofran, Phenergan. He last vomited on 01/19/2023 and since then has been better. The doctors could not conclusively determine the cause of the vomiting. They were considering gastroparesis however could not perform the gastric emptying scan as my son would not tolerate eating a meal due to vomiting. They also considered cyclic vomiting syndrome but he did not have any previous attacks to clinically confirm this diagnosis. My son also started having severe calf pain in both legs and could not walk on 01/24/2023. We had to see his pediatrician the next day. Labs were normal. He eventually started walking and symptom free on 01/30/2023.
Started out with scratchy throat coughing, joint pain and fever of 103.  Next day the fever went down to 102. Took Tylenol and went down to 101.
Pt recvd vax in FEB92 & following vax exp german measles, arthralgia, arthritis, palindromic rheumatism, fibromyalgia, blurred vision, & dry eyes; was unable to exercise because body went into tremors; lab eval MAR91 showed high WBC;
Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a other health care professional (Medical Assistant). This case involves a 48 years old female patient who experienced blister developed on her left forearm at the site, while she received vaccine ADACEL instead of TUBERSOL. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Sep-2018, the patient received concomitant vaccination with 0.5 ml dose of FLUZONE QUADRIVALENT via intramuscular route. On 10-Sep-2018, the patient received a 0.1 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot CI546CA, expiry date: 21-Nov-2020 via intradermal route in the left forearm. On an unknown date, the patient experienced a non-serious blister developed on her left forearm at the site (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was an actual medication error due to wrong vaccine administered. It was reported that ADACEL was inadvertently administered intradermally to a patient. Patient was supposed to receive TUBERSOL. Other relevant tests included no lab data. Final diagnosis was blister developed on her left forearm at the site. The patient was treated with PREDNISONE for Product used for unknown indication. On an unknown date, the patient was recovering/resolving for blister developed on her left forearm at the site. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Around early evening on Tuesday, April 20, 2021, I began feeling a bump on my forehead. Over the next few hours, it continued to become shiny and more bumps formed around it, growing to the size of slightly larger than a quarter. It was associated very mild isolated pain at the site. In the morning of April 21, it appeared more oily, but did not increase in size. No other irritation was found throughout the body. I do have a history of some type of skin rash (possibly shingles or HSV-1) which flares up once every year or two, which I believe this is the same occurrence.