chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Leg cramps after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Leg cramps after the 1st dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Leg cramps after the 1st dose). At the time of the report, MUSCLE SPASMS (Leg cramps after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Developed a headache about 4 hours after injection. Face, neck, shoulder, upper arms were red in color which lasted about 8 hours. Took Benadryl and Tylenol felt better and redness went away.
Presents to RA complaining of left extremity weakness. Recent traumatic fall last autumn now post right caniotomy. Came from rehab facility. Covid19 pneumonia found incidentally. only symptom appears to be cough and congestion, has not needed supplemental O2.
Brain fog started around 1 week after vaccine, then continued with progressive worsening up through 3 weeks after. Patient was "zoning out", "staring at walls", struggling to concentrate, getting lost several times on routine drives, struggled to perform work duties and communicate, etc. Patient reported significant worsening of depression symptoms, whether direct or indirect (due to brain fog and not being "in control" of own mind): "crying multiple times a day for weeks" and increased suicidal ideation with plan.
Blood clots developed in left calf (3 of them by mid-April), prescribed Xarelto. 2 completely gone by mid-June, one small one left. Still on Xarelto in August - will go get more imaging to confirm last one is gone.
sore arm; achiness; I had  fever of 100.0 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (achiness) and PYREXIA (I had  fever of 100.0 degrees Fahrenheit) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 018B21A and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN (achiness) and PYREXIA (I had  fever of 100.0 degrees Fahrenheit). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN (achiness) and PYREXIA (I had  fever of 100.0 degrees Fahrenheit) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.0 (High) fever of 100.0 degrees Fahrenheit.         No concomitant medications provided.
Nausea; fatigue; decreased appetite; This is a spontaneous report from a contactable physician.  A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose intramuscularly, administered in Arm Right on 05Apr2021 (Lot Number: EW0150, expiration date not provided) at age of 44 years old as a single dose for covid-19 immunisation.  Medical history included neoplasm left kidney from 2007 to an unknown date. The patient's concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route on 15Mar2021 (Lot Number and expiration date not provided) at age of 44 years old as a single dose for covid-19 immunisation and experienced Nausea. The patient experienced nausea, fatigue, decreased appetite, all in 2021. Nausea, fatigue and decreased appetite which has persisted after his second Pfizer COVID-19 vaccine 05Apr2021. The outcome of the events was not recovered. The report was reported as non-serious. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for events.
1st adverse side effect was swollen right armpit with pain felt deep inside armpit starting on 7/29 immediately after waking up.  2nd adverse  side effect was both arms swelling, tingling and burning , and total muscle fatigue from shoulder down to fingers starting on  8/1 mid-morning .  1st adverse side effect has mostly gone away, but 2nd adverse side effect is still in full effect as of  8/6 with little to no improvement.  Have returned to the Urgent Care facility that vaccine was given twice on 8/1 and on  8/3  regarding the 2nd adverse effect.  On return visit on 8/1 was told we needed to give it a few days to see if any improvement.  On 2nd return visit on 8/3 after no improvement was prescribed 800 mg ibuprofen twice daily to reduce swelling and other symptoms.  800 mg ibuprofen has helped marginally at best, also using hot/cold compress  regularly with hot compress helping to alleviate symptoms most effectively, but not entirely.  During 2nd return visit on 8/3, was told by PA that symptoms may go away in a couple of days or may never go away.
PATIENT STATES ITS HARD TO BREATH WHEN HE LAYS DOWN TO SLEEP
I am having numbness in both of my arm; numbness in both of my arm like 'poor circulation' is numbness; Tingling in my arm/Tingling sensation; her arms get swollen/swelling in both of her arms; They get really cold/my arm stays cold a lot; Shortness of breath; have some issues with her left knee down/problems with left knee; This is a spontaneous report from a contactable consumer (patient herself) via medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: 3013563A and expiry date not reported),via an unspecified route of administration on 18Sep2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date on sep2021, the patient experienced I am having numbness in both of my arm, numbness in both of my arm like 'poor circulation' is numbness, Tingling in my arm/Tingling sensation, her arms get swollen/swelling in both of her arms, They get really cold/my arm stays cold a lot, Shortness of breath and have some issues with her left knee down/problems with left knee. The patient reported that regarding a reaction to the first vaccine shot of Pfizer, I am having numbness in both of my arm like 'poor circulation' is numbness, 'poor circulations' they get really cold and they are swelling, but I have my first shot on the 18th of September. The reporter stated that My side effect is numbness in both my arms and they are swelling, they swell but they go down and it's 'poor circulation' like I just can't feel it." She asked "Well I want to know what to do about it, is there anything I can do about it". There is numbness and there is tingling and shortness of breath, but I think 'it can happen to some other'. You ask me is there anything else you can help me with, my answer is there is numbness and tingling in my arm and the shortness of breath and the swelling is going on and in fact my arm stays cold a lot. The patient was informed about the role of Pfizer Drug Safety and also informed that Pfizer Medical Information is the concerned department to answer the question that consumer have and offered the number. The patient got the first dose of the Pfizer BioNTech COVID-19 vaccine on the 18Sep and she was having numbness in both of her arms, she described it as poor circulation. She had tingling sensation, her arms get swollen, they get very cold. She had tingling, numbness, coldness and swelling in both of her arms and then she says she also had shortness of breath in addition to those symptoms in her arms. She says she also have some issues with her left knee down. She said on Saturday it was hot outside she was out helping her husband cut a tree and her arms would not warmup until she put on a long sleeve shirt and a coat and she said she had to sleep with a heavy blanket on her at night. The outcome of the events her arms get swollen/swelling in both of her arms was not recovered and other events were unknown.
ADVERSE EVENT NOS; FEVER; This spontaneous report received from a patient concerned a 78 year old female. The patient's weight was 72.7 kilograms, and height was not reported. The patient's concurrent conditions included: primary pulmonary hypertension. The patient received macitentan (tablet, oral, batch number: ZE023B0301 expiry: 30-APR-2025) 10 mg, 1 time every 1 day, therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included warfarin sodium. On 11-SEP-2021, the patient experienced adverse event nos. On 11-SEP-2021, the patient experienced fever. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of macitentan was not changed. The outcome of the adverse event nos and fever was not reported. This report was non-serious.
I woke up the next day with a severe headache, body aches, chills, severe malaise, sore throat and my face had swelled at around my eye sockets close to the bridge of my nose. All these symptoms last about 5-7 days.
Pain in arm of inj. site and numb fingers & also cold fingers of same arm after injection (occurred few hrs after vaccine until 11/20/12 current).
Information has been received from a health worker concerning a 51 year old male with drug allergy to LINCOCIN who in 2001 was vaccinated IM with the first 0.5 ml dose of PNEUMOVAX 23 (lot number not reported). On approximately 17-FEB-2012 ("approximately 2 and 1/2 weeks ago") the patient was vaccinated with another dose of PNEUMOVAX 23 (671405/1420AA, exp 11-APR-2013), 0.5 ml, intramuscularly. Concomitant therapy included atenolol and ZOLOFT. On approximately 17-FEB-2012 ("the same day the patient received PNEUMOVAX 23") patient experienced injection-site erythema and swelling that spread from his deltoid to his elbow. These local reactions subsided in less than a week. While the local reactions were subsiding he started to develop body aches, dizziness, headaches, nausea and vomiting. The patient mentioned that he was taking ibuprofen (unspecified manufacturer) to treat his headaches but it caused him to have reflux so he stopped taking it. The patient sought medical attention by office visiting. NEXIUM, Swamp Mix containing MAALOX and lidocaine, PHENERGAN injection, ibuprofen and TYLENOL were given for the treatment. Lab diagnostics performed included: "H. pylori test was negative but bismuth was given that same day which may have interfered with the test results", testosterone result was in normal range and complete blood cell count (CBC) was within normal limits. At the time of reporting, the patient's dizziness, headaches and nausea persisted but no local symptoms. Follow up information has been received from the physician's assistant concerning the white "well adult" at the time of vaccination who on 03-FEB-2012, at 15:15hrs, was vaccinated in the left deltoid with the second dose of PNEUMOVAX 23 (lot # 671405/1420AA). The physician's assistant reported that on 03-FEB-2012, the patient developed erythema and edema 20x10cm at the vaccination site on the left arm for a period of 10 days. Subsequently the patient developed body aches, fever, flu like symptoms, nausea, dizziness, headache for 2-4 weeks and reflux for 5 weeks. Lab diagnostic tests were performed, H-pylori and CMP resulted negative. The physician's assistant considered erythema and edema at vaccination site, body aches, fever, flu like symptoms, nausea, dizziness, headache and reflux to be other important medical events requiring medical intervention. Additional information has been requested.
Bloating; diarrhea; I feel terrible; "I feel hard to breathing well"; 2lb weight gain; Arm pain with numbness; Arm pain with numbness; "Feels like a block of cement"; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (Bloating), DIARRHOEA (diarrhea), FEELING ABNORMAL (I feel terrible), DYSPNOEA ("I feel hard to breathing well") and WEIGHT INCREASED (2lb weight gain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 646B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced ABDOMINAL DISTENSION (Bloating), DIARRHOEA (diarrhea), FEELING ABNORMAL (I feel terrible), DYSPNOEA ("I feel hard to breathing well"), WEIGHT INCREASED (2lb weight gain), PAIN IN EXTREMITY (Arm pain with numbness), HYPOAESTHESIA (Arm pain with numbness), DYSPNOEA ("Feels like a block of cement") and HEADACHE (headaches). At the time of the report, ABDOMINAL DISTENSION (Bloating), DIARRHOEA (diarrhea), FEELING ABNORMAL (I feel terrible), DYSPNOEA ("I feel hard to breathing well"), WEIGHT INCREASED (2lb weight gain), PAIN IN EXTREMITY (Arm pain with numbness), HYPOAESTHESIA (Arm pain with numbness), DYSPNOEA ("Feels like a block of cement") and HEADACHE (headaches) outcome was unknown. Not Provided          No concomitant medications reported by investigator. Advil and Aleeve used as a Treatment Medication.   This case was linked to MOD-2021-089492 (Patient Link).
Information has been received from a physician concerning a pt who was vaccinated with MMRII (Lot # 646555/0812N). Subsequently, the pt developed bruising at injection site and bleeding through the skin. It was unknown if the pt recovered. The physician reported that "she will not use this lot # on anyone else."  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also described the events of another pt who developed a swollen thigh which was painful and caused limping after being vaccinated with MMRII (WAES # 0401USA01898). Additional information has been requested.
Began having raspiness and runny nose on  03/19/2023. Symptoms continued so I tested on 03/20/2023 testing positive. Did telehealth visit on 03/21/2023. Was prescribed Paxlovid but was unable to take it due to possible drug interaction. Began different antiviral on 03/22/2023 in the evening. Symptoms have been very mild and I have had no symptoms at all today 03/23/2023
Patient experienced sharp pain during the injection. Muscle pain/aching was severe and he woke up the next morning with weakness in his arm and limited range of motion. These effects have been ongoing.
Received H1N1 on 10/24/2009 at mass vaccination clinic held by Health Department. Complaints of soreness, pain at injection site with inability to move L arm. Started in the evening of 10/24/2009. L arm red, swollen, throbbing, can't lie on arm, difficulty getting dressed. 11/19/2009 OB GYN records, pregnant patient  EDC 1/29/2010, does not note any sx noted on VAERS per vaccine provider.
Large rash at injection site that is hot to touch, itchy, and raised. It is also somewhat hard. It causes pain when I lift my arm straight up (flexing my right deltoid).
Patient received Varivax in Left arm (subcutaneous)on 21 Feb 2007.  Received Boostrix on same day at same visit, in right arm (deltoid).  Developed fever and malaise on 2/22/07, up to about 99 degrees F; redness and swelling locally at injection site in L arm; fatigue on 2/23/07 with increasing area of redness and new central induration of a deeper hue centrally.
High temp T 104.7. Very fussy for 3 days. Refusal to bear weight. Very poor appetite, drinking OK. No local reaction/rash.
An expired Hep A vaccine was given on 03/26/19 to a patient in our clinic. The vaccine expired 03/25/19.
Tuesday 6 go the first Pfizer Covid vaccine at the race track. In the past I have had angioedema and breathing issues but never severe enough to warrant going to hospital with several injections and from over the counter meds and prescription meds. So I was wary but decided to risk a jab. Straight up got tingling tongue and lips but after 15 min was just dizzy and roughly the same feeling. I am a slow up taker and excreter though. By the time I got home, about 20 min after the 15 min wait my neck on the injection side and swelled so much I no longer had a jaw and my eyes and cheeks were pretty puffy. Then the breathing issue started. I called the gp who said Tylenol, benedryl. Usually have them made because I have problems with additives but i don?t have any right now. So I used two ea kids chewable which allow me to have a dosage that works for me as I am sensitive to larger doses which can cause pvcs. Things were better but not good enough so took Zyrtec 10 ml/24 hr. If I had not had a similar experience with other injections this would have completely freaked me out. Thank goodness my quick treatment worked well enough that I felt confident worse was unlikely to happen, though the gp and allergist both wanted me to go to the er. Yesterday I did a repeat of Tylenol and benedryl in the morning and Zyrtec in the afternoon at two pm then Tylenol and benedryl again in the evening as I still had angioedema and felt tight in breathing. Repeat benedryl and Tylenol today but no Zyrtec as felt good enough to ride stationary bike a very slow Five miles. As to fever and other typical symptoms it has been hard to tell what is reaction and what is simply the vaccine doing its job. I did not take my temperature but have felt hot no general malaise. I recognize my symptoms are unusual but felt you should have them.
Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included fever blister.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick). The outcome of the sickness was resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 25-MAR-2023 This case was reported by a patient via interactive digital media. The patient had a fever blisters he/she suffered with them all her/his life. The patient stated that don't plan to have them over half her/him body. The patient got the shots and made her/him sick for a few days but worth it. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
1st dose Apr2018, 2nd not yet; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in April 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose Apr2018, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 16-MAR-2023 The provider wondered if they should restart series or complete series with the patient.   The reporter stated that any education on the situation would be helpful. The reporter consented to follow up.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
expired dose of Daptacel was given to patient/ No AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 15 months old male patient who received expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and HIB VACCINE CONJ (TET TOX) (ACT-HIB) for Immunisation.  On 29-Oct-2019, the patient received fourth 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5307AA, expiry date-23-Oct-2019 via intramuscular route in the right vastus lateralis.  It was a case of actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.
Received immunization on November 14, 2013. By next morning, arm was swollen and painful to touch. By Nov 16, 2013, are was very red, hot, and painful. By November 2013, symptoms had resolved.
This spontaneous report as received from a 60 years old female consumer refers to herself. The patient's medical history included hormone replacement. The patient had no drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (Lot # and expire date unspecified) subcutaneous on 22-JUN-2012. No other co-suspects were reported. Concomitant medication included "LAPENACIL". On 25-JUN-2012 the patient experienced joint pain in left shoulder. She mentioned that the joint pain interrupted rest. She had problems finding comfortability while resting on her left side. Now she believed that the pain was spreading to her neck. No treatment was given. No lab diagnostics study was performed. The outcome was reported as not recovered/not resolved. The patient did not seek medical attention. Additional information has been requested.
Feeling cold and full body ache starting from 5:00 am following the day of vaccination. Did not have appetite for food, dry mouth. Took 1x200mg ibuprofen at 3:00 pm that stopped feeling cold but started sweating. The body ache gradually subsided - at of this submission there is still noticeable pain in the hand and fingers, and feet and toes.
9:00 PM woke up with shivers, 11:00 PM tried to get up and my legs did not work, 1:00 AM night sweats so bad I had to change nightgown. Fatigued for 2 days. My legs didn't work for 48 hours. Then just as suddenly as they did not work, they started to work. My thigh muscles were sore and it felt like I had done squats for the whole day. no cough, no fever,