chrisvoncsefalvay/vaers-outcomes huggingface dataset:
both of her calves are very sore; Headache; Very very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very very sore arm), MUSCLE SPASMS (both of her calves are very sore) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     NO Medical History Information was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Very very sore arm) and HEADACHE (Headache). On 05-Feb-2021, the patient experienced MUSCLE SPASMS (both of her calves are very sore). On 29-Jan-2021, PAIN IN EXTREMITY (Very very sore arm) and HEADACHE (Headache) had resolved. At the time of the report, MUSCLE SPASMS (both of her calves are very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reported relevant Concomitant medications including statins for unknown indications.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 06-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very very sore arm), MUSCLE SPASMS (both of her calves are very sore) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     NO Medical History Information was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Very very sore arm) and HEADACHE (Headache). On 05-Feb-2021, the patient experienced MUSCLE SPASMS (both of her calves are very sore). On 29-Jan-2021, PAIN IN EXTREMITY (Very very sore arm) and HEADACHE (Headache) had resolved. At the time of the report, MUSCLE SPASMS (both of her calves are very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reported relevant Concomitant medications including statins for unknown indications.   No Treatment information for the event was provided.
being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose pfizer 02/16/2021Lot#EL9266 2nd dose: Pfizer,03/09/2021 Lot#EN6206 Diagnosed covid positive: 06/17/2021 Exposure: Travel Symptoms: Cough, Runny Nose
This spontaneous report as received from a physician refers to a 58 year old female patient (wife) who was smoker. The physician stated that in the past, his wife had redness and swelling at the injection site after receiving an unspecified tetanus vaccine (manufacturer unspecified). On an unknown date in 2010(reported as 4 years ago), the patient had received PNEUMOVAX 23 vial, 0.5 milliliter (ml), intramuscular in the left arm. On 08-NOV-2014, the patient was revaccinated with PNEUMOVAX 23 in the left arm. Concomitant medications were reported as none. On an unknown date approximately in November 2014, the patient had developed injection site reaction which was described as injection site swelling and redness of her left arm at the injection site and up into the axilla area. Patient was using BENADRYL. No lab diagnostics studies performed. The outcome was reported as not recovered. Causality assessment was not reported. Product quality complaint was not reported. This is one of the 2 reports reported by same reporter. Additional information has been requested.
Patient arrived to receive her second moderna vaccine and reported that after her last Moderna vaccine she developed a shingles like rash on her right leg. She also reported a rash that developed around her anal opening. She called her physician who advised her to go to the emergency room. She was told by ER docs that they believed it was herpes and did a sexually transmitted disease work up which all came back negative. Case resolved in three or four days. Case desires and received second moderna shot on 5/17/2021.
Mine is still red all the way across my arm and hot to the touch; Underneath it had a lump; I would say it was as big as a baseball but now today it is down to about the size of a golf ball/lump as big as the size of a baseball, swelled up; This is a spontaneous report received from a contactable consumer or other non hcp. A 72-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL9265) via an unspecified route of administration in Arm Left on an unspecified date (age at vaccination 72years old) as single dose for covid-19 immunisation. Medical history included diabetes mellitus, pernicious anaemia, vitamin k deficiency, hyperparathyroidism, all from an unknown date and unknown if ongoing. The patient experienced mine is still red all the way across my arm and hot to the touch, underneath it had a lump; i would say it was as big as a baseball but now today it is down to about the size of a golf ball/lump as big as the size of a baseball, swelled up on an unspecified date. The clinical course was reported as I got my Pfizer Covid shot Thursday the 18th and I read what the possible side effects would be and one of them is possible that there could be a little bit of swelling and redness but mine is still red all the way across my arm and hot to the touch and underneath it, it had a lump, I would say it was as big as a baseball but now today it is down to about the size of a golf ball and it's been 6 days. When paraphrased the concern, Consumer stated, "It was my 2nd shot. It didn't start the very 1st day. It started the next day and it had a lump up until yesterday and it had lump as big as the size of a baseball, swelled up you could see it just by looking at it. Now today it is still red and hot but now it about the size of a golf ball. The patient received treatment for events with Tylenol. The clinical outcome of the event mine is still red all the way across my arm and hot to the touch was not recovered and other event was recovering. Therapeutic measures were taken as a result of mine is still red all the way across my arm and hot to the touch (limb discomfort), underneath it had a lump; i would say it was as big as a baseball but now today it is down to about the size of a golf ball/lump as big as the size of a baseball, swelled up (injection site mass).  No follow-up attempts are possible. No further information is expected.
Expired vaccine stored in refrigerator; Expired vaccine administered to the patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient) and PRODUCT STORAGE ERROR (Expired vaccine stored in refrigerator) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine stored in refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient) and PRODUCT STORAGE ERROR (Expired vaccine stored in refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that, the pharmacy received vaccine on 23-Feb-2022 that a pharmacy staff member looked up the expiration date and came up with an expiration date of Jun-2022 however the correct expiration date confirmed was 01-Apr-2022. The vial was initially stored in refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursion.  No treatment details were reported.
I woke up on Friday morning (shot was Wednesday afternoon) covered from head to toe in a massive rash. We are now going on day four with this rash and it isn't getting better yet at all. I'm taking prescription strength antihistimines and using topical steroid creams. It is getting redder and itchier as time goes on. I've been to urgent care twice.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster and severe complications. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. On or about 23-DEC-2013, the patient was treated for a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed FAMVIR and prednisone for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
12 days following the 1st dose, patient started having a tremor in her right hand. It is mild and intermittent, but has been consistent ever since and has not dissipated.
I tested positive with Covid on 10/08/2021, and was mandated by my employer to receive the vaccine. After this initial dose, all of my Covid symptoms I had during the active virus came back: fever, chills, insomnia, headache, body aches. These symptoms were just as severe as when I had Covid last month.
Pt registered for vaccine and was improperly screened by website and RPh intern prior to admin.
Pt felt faint and passed out a few minutes after vaccine was given.   No history of this happening prior to vaccination.
rash around the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (rash around the injection site) in a 19-year-old female patient 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 VACCINATION SITE RASH (rash around the injection site). At the time of the report, VACCINATION SITE RASH (rash around the injection site) outcome was unknown.        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.   No relevant concomitant medications were reported. No treatment information was provided.
Patient received covid 19 vaccine. She began to experience itching throat and swollen tongue. She was sent to the Emergency Department. She received IV Benadryl 50 mg, IV famotidine 20 mg and 125 mg IV solu-medrol. Around 930, patient stated that symptoms had resolved, except for tongue being slightly swollen. Patient was admitted to the observation unit of the hospital.
Two days before I tested positive, I had extreme fatigue.  The next day i had a slight runny nose and I tested at home, and it was negative. On March 27th i had a low-grade fever, a slight cough, and a mild headache. I then took another at home test, and it was positive. I called my clinic and informed them of my positive test, and they prescribed Paxlovid. It took about 5 days for me to start feeling slightly better and tested negative around April 4th. A few days later I started feeling extremely tired again to the point I couldn't get out of bed and I took another test on April 7th and tested positive again. I then again tested negative on April 15th and just now starting to feel normal.
After 10 days the shot area swelled and turned red.  The area has gotten bigger every day since then.  It is a dull ache. No throb, not hot, only hurts with a grab.  The area on January 25, 2021 is approximately 5 inches by 3 inches.
Pain on Friday night, redness and swelling noted below site on injection site red and warm to touch. Saw physician Saturday am-treated with IM Benadryl and PO antibiotic (per pt).
2 blood clots in my leg; experienced a severe lightheaded situation; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on unspecified date in 2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date in 2021 as dose 1, single for COVID-19 immunization. It was reported that patient was a male, 59 years old and he received the Pfizer COVID 19 vaccine shots this past spring (2021), he will not be getting the booster shot. A couple of weeks after getting the second shot, he experienced a severe lightheaded situation (which occurred another few times in the ensuing months). He also developed 2 blood clots in his leg 6 weeks after the shots. He realized he might be 1 in 10,000, or 1,000, or whatever, but he had been a healthy person his whole life, and the past months have been difficult.  The outcome of the events was unknown.   The lot number for the vaccine BNT162b2 was not provided and will be requested during follow-up.
this was just reported to PHN from mom pt recvd vax & mom reports 3 focal szs involving rt arm, head & eyes; no fever was reported w/immun on the day w/the focal sz; sz occurred w/in 48 hrs of vax; mom also reports high pitch cry;
On 11/21/19 patient experienced redness, pain, and hot sensation in the arm where the injection occurred. She could not sleep due to the severity of pain and came to the pharmacy for advise. We advised her it was a possible side effect after the vaccine and to try to put ice on the painful area. She continued to use ice for 3 weeks and the redness got better but she still experiences pain in the arm. On 12/19/19 she noticed the arm is now showing a bruise and she still had the pain. She describes it as a shooting pain in her am that happens all the time. The pharmacy referred her to her primary physician.
Right arm received shot on 2/27 on 3/1 had a small dot that has progressed to the size of an egg by 3/5. Area is red, swollen and painful. Did receive both in Right arm due to lymphedema of Left arm.
1.EXTREMELY PAINFUL AT THE INJECTION SITE AND SORENESS OF ARM 2.WASN'T ABLE TO LIFT UP ARM. 3.NUMBNESS/TINGLING/FATIGUE AND WEAKNESS OF INJECTED ARM AFTER VACCINE INJECTION AND SYMPTOMS HAVE NOT GONE AWAY AS OF TODAY (10/30/11). 4.NUMBNESS OF THE INJECTED SITE OF BODY AS WELL. 5.AS OF TODAY (10/30/11), STILL HAVE ABOVE SYMPTOMS ON INJECTED ARM.
Beginning about 1 hour after injection pt reported that arm became progressively more sore until she could not stand to touch it. Reported localised itching in the injection area that did not spread. Lump developed under her arm the next day. Advised pt to take BENADRYL, NSAIDS and use an ice pack on the area. Contact MD if symptoms worsened or spread. Pt reports symptoms resolving after 4 days.
Patient developed red splotchy rash on her trunk about 1 or 2 days after receiving vaccine. Patient is unsure of the exact time of onset.
Information has been received from a physician concerning a 2-year-old female, who in 2001 was vaccinated with a dose of varicella virus live (Oka/Merck). The physician reported that on 11/10/2005, the patient developed breakthrough varicella characterized by less than 20 lesions on her chest. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
pt recvd vax on 2nov94; had sz on 3nov94 in the am; no fever;
Broke out in hives/rash over my entire body within 4 hours of event start in Wednesday 12-15-21.  Severe itching and discomfort that evening.  Went to Doctor on Thursday and received Prednisone regiment to combat  my body?s reaction.  Just completed steroid series yesterday 12-28-21.  Still having intermittent rash but without itching.  Taking Zyrtec daily to combat issue.  I still get ?hot spots? where I touch, especially my face.
Per parents, high fever peaking at 104.3 degrees F in the morning after the vaccines, inconsolable crying. Treated with infant acetaminophen. Fever reduced to 102 F per parents. When in clinic the afternoon after vaccines, fever 99.9 by temporal artery scan, child inconsolable in clinic.
Moderate pain, swelling, warm to touch and an area of erythema aprox 80mm at injection site (L Deltoid).  Instructed to take Motrin and apply ice pks.
had an allergic reaction, developed hives; Initial information received on 09-Apr-2019 regarding an unsolicited valid non-serious case received from a Non-health care professional (Office staff member).  This case involves a 2 months old male patient who had an allergic reaction, developed hives, while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history and family history were not provided. At the time of the event, the patient had ongoing latex allergy.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) on 09-Apr-2019.  On 09-Apr-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ062AAA, expiry date 13-Jun-2020 via unknown route in the left thigh.  On an unknown date, the patient developed a non-serious had an allergic reaction, developed hives (urticaria) with unknown latency following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Lab data was not provided.  Final diagnosis was had an allergic reaction, developed hives.   The infant was monitored, injection site was wiped off and Benadryl 1.5 ml oral suspension was given as a corrective treatment.  The patient outcome is reported as Unknown for had an allergic reaction, developed hives.  List of documents held by sender- none.
After patient received these vaccines, she was admitted in ER and was diagnosed of Lupus and currently receive treatment at hosp.
7 days after vaccine I got a big red spot on my arm at the site of the vaccine. It itches and felt like I had a bump under my skin. The next day still itchy , bigger red spot. Less of a bump under my skin.
flushing of the leg almost immed p/DTP vax; no resp distress; condition resolved spontaneously w/in 15 mins;
Infant was born to a mother who is Hep B positive. Infant was given the HBIG injection and the Hep B vaccination in the same left thigh, instead of giving each one if a different thigh/leg. Therefore, the Hep B vaccine had to be repeated in the opposite thigh/leg.
Severe left shoulder pain unable to lift arm, C/O weakness, dyspnea and chills. See letter attached.
I couldn't move my arm for days; so painful!; This case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced mobility decreased and pain in arm. Shingles vaccine was discontinued. On an unknown date, the outcome of the mobility decreased was recovered/resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the mobility decreased and pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had 1st shot, they said it was time for the 2nd one but the patient said no thanks. The patient could not move his/her arm for several days, so painful. No contact details were available.
Sore, itchy arm. Itching lasts up to today 08/15/18 (17 days).
Got the second dose of the Pfizer covid vaccine and a 5 days later, tested positive for covid 19; Got the second dose of the Pfizer covid vaccine and a 5 days later, tested positive for covid 19; This is a spontaneous report from a contactable consumer or other non-health care professional. (patient's wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unspecified date for covid-19 immunization. The reporter stated that got the second dose of the Pfizer covid vaccine and a 5 days later, tested positive for covid 19 on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on an unspecified date. The outcome of events was reported as unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 13-SEP-2019, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010:
Information has been received from a physician concerning a 14 month old male without any known immunosuppression who on 1/23/04 was vaccinated with a dose of varicella virus vaccine live. On 1/29/04, the patient developed full blown chicken pox described as a generalized chicken pox like rash. The parents of the child reported that over the weekend, the rash was getting worse with over 200 vesicles. The physician reported that the patient was otherwise healthy with the exception of low grade cold symptoms. It was noted that the child was without any known exposure to wild type virus. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.