chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unbelievable pain, in her ribs, thighs, calves, and arms; Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Unbelievable pain, in her ribs, thighs, calves, and arms) and PAIN IN EXTREMITY (Sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 013L20A and FE3502) for COVID-19 vaccination.     Concurrent medical conditions included GERD and Arthritis.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, the patient experienced PAIN IN EXTREMITY (Sore arm). On 28-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Unbelievable pain, in her ribs, thighs, calves, and arms). The patient was treated with PARACETAMOL (TYLENOL) for General body pain, at an unspecified dose and frequency. At the time of the report, PAIN (Unbelievable pain, in her ribs, thighs, calves, and arms) was resolving and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were given.  With all doses of the vaccine it was a very smooth administration and patient had a little bit of sore arm.   Yesterday on 28-Apr-2022, patient started to experience unbelievable pain throughout body, in ribs, thighs, calves and arms. This was a fairly constant pain, but moved to these different body parts feeling some with more intensity than others. This has continued today on 29-Apr-2022, but was remarkably milder. Patient took Tylenol and used heat for symptoms which seemed to provide some improvement. This pain was different than past arthritis and the GERD limiting patient from taking many other medications. Patient had not taken any additional medications or treatments. Patient did not had a previous diagnosis of COVID-19.   This case was linked to MOD-2022-554727, MOD-2022-554795, MOD-2022-554797 (Patient Link).
Received phone call from patient who reports shortly after receiving vaccine she noticed swelling in her jaw and into her neck on her L side, the side where she received the injection.  She took some Benadryl and the swelling has gone down.  She is going to take Benadryl again tonight.
I got light-headed and dizzy and no energy and then I started having a very very very very bad migraine headache I still have somewhat of today and I was burning up I felt like my body was on fire I was really really really hot and I was throwing up
Stopped after first 2 days then came back on day 6;  swollen, pain, itchy rash
I had a herpes outbreak following booster on 04/18/2022. I have Genital Type 1 Herpes, I took three rounds of acyclovir. I am unsure if the outbreak began before the vaccine or right at the same time. The first three months after this began it was the worst I have ever experienced. It has been an ongoing outbreak for the last year.
pt recvd vax; pt devel small swelling which inc in size & devel inc pain & erythema; pt dx as cellulitis;
9/22/2009: Broke out in hives around site of injection and at the same time around my lower right knee, accompanied by a rash. Intense itching. That night had extreme migraine (I never get migraines) to the point I couldn't study and had to lay down. For two days later my head felt like I couldn't think. Hives went away by morning of 9/23 but they continued to come back with extreme itching in various parts of my body including my arms, legs, and side of face. The most intense itching was on my lower legs, benadryl did not relieve the symptoms. This cycle of extreme itching continued for over a weeek. On 9/29/09 evening, while still experiencing the itching in my lower legs, I noticed my legs were becoming swollen and I had lumps under the skin of my legs, I could see from looking at my leg from the side. My legs felt funny to touch, like the sensation was different, the skin was more taunt, and muscles more stiff, the skin was warmer to touch than the rest of my body. I went to see my doctor on 9/30 and he said I was having an allergic reaction that was very rare. He put me on medrol pack, allegra (changed to zyrtec because insurance didn't cover allegra) and bendryl every 4 hrs. I started the medrol Thursday Oct 1st. Oct 1st evening the swelling was still present, with weird sensation, taunt skin. My legs were sore below the knee and did feel weak toward the evening. The itching was still present in waves, but seeming to improve with the addition of zyrtec. By Friday I had noticed no improvement of my lower legs. I was waiting for the medrol to work. I worked Friday evening night shift and as the night progressed my lower legs felt tingling, even more decreased sensation to touch. It felt numb but I had no difficulty walking or moving. I became concerned with the worsening of my legs and called an on-call nurse at 4 AM Oct 3rd while I was at work. She decided that I should be re-evaluated that morning but I didn't need to go to the ER. I was able to see a doctor by 9AM, by then my legs felt incredibly decreased sensation, worse going further down the leg,to the point I couldn't feel the touch. My feet were tingling in the waiting room and felt cold. The decreased sensation was also now felt on my  lower thigh going higher. By the time I was in the exam room and took my socks off all my toenails were blue. My legs were swollen but and the doctor did say on exam with poking my leg with some plastic thing that my sensation was decreased. My lower legs didn't feel like my legs. She had me do some muscle strength tests and decided that since I'm not having any decrease strength that it wasn't guilliane barre. She told me to continue with the medrol and medications and see a doctor if I experience weakness. Since then I have noticed an improvement in the sensation, but it is still present and I haven't finished my medrol yet. I'm still taking zyrtec and benadryl so I'm not sure if the itching will come back when I go off those.
This spontaneous report was received from a Medical Assistant regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patient was vaccinated with improperly stored PROQUAD (Merck), Lot number-L008356 and expiration date-01-SEP-2016, Lot number-K02336 and expiration date-20-MAY-2016 (dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Called pt and LM 8/31/07 and 9/11/07 and sent her a letter 9/24/07 asking how her arm was and how she was feeling. Asked her to call me in answer to these questions. Have not received a response. Pt was given Daptacel on 8/9/07 instead of Adacel.
DARK RED RAISED AREA, SKIN WAS HARDENED AND HOT TO TOUCH.
Received the Second Moderna Covid-19 dose 18 days after the Moderna Covid-19 First Dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the Second Moderna Covid-19 dose 18 days after the Moderna Covid-19 First Dose) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A and 003J21/2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine (Brand: Flu Fluarix Lot #: D7AE5 Route: Intramuscular Dose: 0.5ml) on 18-Jan-2022. Past adverse reactions to the above products included No adverse event with Flu vaccine.   On 18-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the Second Moderna Covid-19 dose 18 days after the Moderna Covid-19 First Dose). On 05-Feb-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the Second Moderna Covid-19 dose 18 days after the Moderna Covid-19 First Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2022: Follow up received contains non-significant information.
Shortly after receiving the vaccine I received muscle twitches/fasciculations in my left arm & left leg. Those eventually traveled to my right arm and right leg. They have continued for 4 months in my; Shortly after receiving the vaccine I received muscle twitches/fasciculations in my left arm & left leg. Those eventually traveled to my right arm and right leg. They have continued for 4 months in my; Shortly after receiving the vaccine I received muscle twitches/fasciculations in my left arm & left leg. Those eventually traveled to my right arm and right leg. They have continued for 4 months in my; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received bnt162b2 (Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 13:00 at the age of 32-year-old as single dose for covid-19 immunization. The patient had no medical history. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient experienced shortly after receiving the vaccine, he received muscle twitches/fasciculations in his left arm and left leg, those eventually traveled to his right arm and right leg, they have continued for 4 months in his right leg. I've also experienced joint pain in his hands and feet (arch of my foot) on 07Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown result on unknown date, Covid RAPID & PCR (Nasal Swab): negative in Jul2021. Therapeutic measures were taken as a result of events. The outcome of events was not resolved. No covid prior vaccination. Not known allergies.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     Concurrent medical conditions included Palpitations (heart palpitations).    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, the patient experienced PALPITATIONS (heart palpitations). At the time of the report, PALPITATIONS (heart palpitations) outcome was unknown.            Concomitant medications were not provided Treatment medications were not provided
tired; This is a spontaneous report from a contactable consumer (patient's mother). A 42-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on Apr2021 (at the age of 42-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The  medical history included problem with the heart valve diagnosed when the patient was in his 30s, blood pressure and heart operation. The concomitant medications included blood pressure medicine low dose. On Apr2021, patient was tired after the first dose, this started a few hours after he got the vaccine and the next day. The patient rested for the day and then was fine. The outcome of the tired was recovered on Apr2021.   Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2
Notes from 6/12 phone note with pt: Started not feeling well approximately 9 pm, felt "lazy", feverish with body aches. Both arms "really hurt" couldn't raise (R) arm due to pain and at site of injection (R) arm was burning. Felt extremely weak - this has continued. Has had flu-like symptoms - body felt hot. By 6/11 she was able to raise her (R) arm up but caused pain to do so. 6/12 still feeling lightheaded and weak, no appetite. 6/13 weak, lethargic but sl. better from 6/12. Still is getting some pain in (R) arm intermittently. Declined follow up OV.
diagnosed with COVID-19; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 01Apr2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient wanted to know if he should receive the second dose of the Pfizer COVID-19 vaccine after he has been diagnosed with COVID-19. On 12Apr2021, he was diagnosed with COVID-19 and hospitalized, he improved and left the hospital yesterday (21Apr2021), his appointment for the second is today (22Apr2021). The patient was hospitalized for diagnosed with covid-19 from 12Apr2021 to 21Apr2021.  The patient underwent lab tests and procedures which included SARS-COV-2 test: positive (diagnosed with covid-19) on 12Apr2021. The outcome of the event was recovering.    Information on the lot/batch number has been requested.
Resident received 1st dose on 1/4/2021. On 1/6/2021 resident having SOB, increased weakness with O2 sats at 91% RA. On 8th resident sustained a fall, O2 sats 88-92, dizzy, weakness.  Rapid COVID test performed with negative results.  Evening of 8th resident was lethargic and diaphoretic with fever of 99.9.  Resident transferred to ER, on 5lt of oxygen.  Resident returned from the ER on 1/9/2021 with new diagnosis of Leukemia and orders for hospice.  Continued with fever, crackles and N/V and loss of appetite from the 9th and 10th of January.  Resident expired at 820am on 1/11/2021.
Brought to ER for vomiting and Nausea but not able to answer many questions. Found to have covid. Treatment includes neuro checks and gently hydration.
pt started having intense pain at the site of injection starting the day after injection. He said the pain was unbearable for 2 to 3 days, even after taking aleve. it is 20 days post-vaccination and he still says his pain at site of injection is still a 2 out of 10. He has not consulted a doctor regarding This.
I began having symptoms 12/10/2021 with pulsatile tinnitus, ear pain, headache, and symptoms lasted for 5 days. I was treated with a course of antibiotics, and the symptoms became more manageable until 01/23/2022 when the symptoms returned with extreme vertigo, dizziness, and imbalance. I was unable to work from 1/24/2022 until 02/28/2022 while under evaluation with MRI, and venogram, balance and hearing tests completed, started taking Eliquis 5mg 2x daily, headache medication, and continue to have severe headaches limiting my ability to work. I can only work 6 hours 2 days a week, and it is interfering with my studies. I am not able to perform at the level I was capable of prior to this event. I will continue to have biweekly appointments with my PCP to monitor my symptoms, assess for ability to return to normal work duties, my next MRI venogram is scheduled for 06/2022. I am also having blood clots.
Vaccines administered 4/29/08, pt called 4/30/08 states having "chills" - took hot bath 2 Tylenol -> felt better.  Check up 5/1/8 pt states had T 102.9 last night, now down to 100.1.
Some itchness on face , sudden attack of coughing and wheezing followed by chills that last all night ( about 9 hours) follwed by severe headache, sharp shooting pain and left side of head near temple,  chest tightness, burning aching feeling in muscles of chest and neck, itchy eyes, nasal congestion with servere nasal drip horseless, , pain in throat and lungs, extreme fatigue.  1 week later still having bronchial imflamation and horsenesss and nasal congestion.
just had some issues; This spontaneous report was received from a consumer (friend of patient's mother) and refers to an infant patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, orally (dose, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient experienced some unspecified issues (ill-defined disorder). It was unknown by the reporter if the patient received any treatment for the event. The outcome of the event was not provided.  The causality assessment was unknown. It was reported that they were trying to figure out if the event was due to the vaccine, but it had not been confirmed that it was the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) that caused the issues.
Had COVID-19 in July 2019. Afternoon of the second day after my first dose of Pfizer vaccine, developed minor chills/fatigue. Arm soreness persisted for several days, including swollen lymph node in my left armpit.
pt recv vax & mom mentioned that pt had recv varicella on 5APR97 & broke out w/chickenpox (only 6-7 pox on face on 20MAY97);
shortness of breath, throat pain  i dont know details of vaccine - just that it was her second covid vaccine shot
MY DAUGHTER TOLD US THE FOLLOWING MORNING THAT SHE COULDN'T SLEEP THE PRIOR NIGHT. SHE FELT HER HEART BEATING FAST ALL NIGHT. HAD ALSO CHILLS, NAUSEA, SHORTNESS OF BREATH, AND FELT VERY TIRED.  WHEN WE SPOKE TO HER IN THE MORNING (10 AM) SHE SAID SHE DID NOT FEEL AS BAD AS LAST NIGHT. HER TEMPERATURE WAS 37.7 C. GAVE HER TYLENOL 2 TABLETS.
High fever 102degrees 48 hours, Headache 72 hours, Injection site pain120 hours, Muscle aches 120 hours.  All started 7 hours after vaccine, except injection site pain started from the time of injection 10 am
Patient refers at the end of his 15 min of observation experiencing dizziness, vitals are taken in which a pressure of 140/90 is identified, once vitals are taken, the patient reports blurred vision and tachycardia. Patient reported symptom improvement at 2:25 pm after breathing exercises and refuses to be transported for medical attention.
booster; died of multiple cardiac arrest in the hospital.; felt really sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: IMMUNISATION (death, hospitalization, medically significant), outcome "fatal", described as "booster"; CARDIAC ARREST (death, hospitalization, medically significant), outcome "fatal", described as "died of multiple cardiac arrest in the hospital."; MALAISE (death, hospitalization, medically significant), outcome "fatal", described as "felt really sick". The patient date of death was unknown. The reported cause of death was cardiac arrest. It was not reported if an autopsy was performed.  Clinical course: It was reported that 2 weeks after getting the booster shot, the patient suffered for 2 weeks, felt really sick and then died of multiple cardiac arrest in the hospital.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died of multiple cardiac arrest in the hospital
After vaccine no period. Very high temperature 39.5 C first day and 38-38.5 C at second day.
Minutes after injection patient developed severe swelling at site of injection (left deltoid). Given liquid BENADRYL and ALEVE. The next day area still swollen but not as bad. 1 wk later 5-6-15 rechecked and had redness and hot below deltoid. Treated with Cephalexin.
Fever, pain/soreness at injection site. Bells palsy diagnosis 2/20/12.
May 5/8/2021 I felt a burning in leg and saw that there were 3 very large blisters and they continued to grow and was hot to touch, so I went to Urgent Care. Because I was on Prednisone, I've never had any reaction like this. I thought it was bug bites, but it wasn't. I went to Urgent Care. They concluded that it wasn't bug bites. They realized that I had received Humira shot, 2 hours after Moderna vaccine. They told me to use my Clobetasol Inhaler, finished Prednisone then they gave me a prescription for an anti-biotic and sent me home. Advised that I shouldn't Biologic vaccine near the time of the COVID vaccines.
Pt. felt like skin had creepy crawlies. Itchy and tingling. No rash or blisters. Pt. reported event today 9-10-12 said had to take Zyrtec to feel better. Being live attenuated virus shared symptom similarities with shingles.
Information has been received from a registered nurse concerning a 22 month old male with no known allergies who on an unspecified date was vaccinated with VARIVAX (Oka/Merck) (lot number, injection site and route not reported).  On 25-NOV-2008 the patient was brought to the physician's office with a 3 day history of approximately 30 erythematous papules with underlying vesicles.  Subsequently, the patient recovered from the events.  It was also reported that the patient's events were ongoing.  Additional information is not expected.
I began with what felt like a common cold consisting of coughing, sneezing, and a runny nose. That lasted for about 4 weeks before I contacted the doctor. The doctor put me on OTC DM cough medicine and Flonase. 2 weeks later the symptoms still didn't resolve so he put me on amoxicillin and an albuterol inhaler. Things have slowly gotten better. I still have problems in the evening and especially at night after taking a hot shower. I cough about 25 minutes before I end up falling asleep. The cough is always a productive cough with clear mucus and no blood. It is common that I get a cold in the winter, but It has never lasted this long before. It's a bronchial type of cough.
vaccine not shake or mix; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong technique in product usage process in a female patient who received HAB (Twinrix) for prophylaxis.   On 04-MAY-2023, the patient received Twinrix. On 04-MAY-2023, an unknown time after receiving Twinrix, the patient experienced wrong technique in product usage process (Verbatim: vaccine not shake or mix). The outcome of the wrong technique in product usage process was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-MAY-2023 The patient self-reported this case. The reporter inquired if could get hepatitis or an infection from vaccine not shaken or mixed. The patient received a Twinrix and the healthcare professional did not shake or mix the vaccine correctly.  The reporter asked that what effects would this cause. The reporter did not consent to follow-up. The patient received Twinrix dose without shaking it prior to the administration as was indicated on the prescribing information, which led to wrong technique in product usage process.