chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe muscle spasm; generalized malaise & shoulder hurt; spasms in legs; painful clonic-tonic jerk; pain in the muscles; allergic reaction; t100.5; fever as high as 103; throat cult-beta hemolytic strep no group A;
Information has been received from a consumer concerning her approximately 3 year old son who on 05-NOV-2003 was vaccinated with a dose of MMR II. Concomitant suspect vaccinations included a dose of COMVAX (MSD) (lot #643186/0584M) on 19-AUG-2002 and another dose of COMVAX (MSD) (lot #645698/0286N) on 09-JUN-2003, and VARIVAX on 09-MAY-2003. Other concomitant vaccinations, on unspecified dates included poliovirus vaccine (manufacturer unknown), DTaP (manufacturer unknown), PREVNAR and influenza virus vaccine (unspecified) (manufacturer unknown). The mother reported that her son was diagnosed with autism spectrum disorder at age 3 (approximately 2005). He also was later diagnosed with fragile X syndrome (date unspecified). The patient also suffered several seizures, one of which required hospitalization. No further information was available. Upon internal review, the patient's autism spectrum disorder was considered to be an other important medical event, and fragile X syndrome was considered to be a congenital anomaly. Additional information is not expected.
1st shot: chills, headache, nausea, injection site pain  2nd shot: injection site pain, headache
This case was reported by a other health professional via sales rep and described the occurrence of nausea in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of nausea (vomiting and intense arm pain after 1st dose, refer case US2018GSK148194). Concomitant products included adalimumab (Humira). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced nausea, vomiting and pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the nausea, vomiting and pain in arm were unknown. It was unknown if the reporter considered the nausea, vomiting and pain in arm to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient experienced intense arm pain.
Went to ER for hives 48 hrs after vaccine.  Followed up office, still had hives, started on prednisone, ranitidine & loratadine, continue BENADRYL q 6 hrs PRN increased itching.
10 days after recieving vaccination I started getting a rash (which I now know was petichea) on my shoulders/arms that would spread all over my body in the next two days. Day 11 I woke up with black spots all over my tongue & mouth, petichea spreading on my back and chest. Day 12 I woke up with a weird, hard bruise that developed in 6 hours with a lesion on the top (it was raised weirdly and was probably an inch diameter at least) and I could also barely stand up. I went to the ER 6am on April 14th, got diagnosed with ITP (Immune thrombocytopenic) within about 24 hours. My blood platelet count was at 5,000 and I was told I was at risk for spontaneously bleeding. I took a 4-day course of dexamethasone and was monitored in the hospital. Platelet counts are currently in normal range around 350,000 last time it was checked.
Hospitalization 4/8/2021-4/16/2021 with discharge home on hospice and death 4/28/2021. Admitting diagnosis: Acute respiratory distress, COPD, acute hypercapnic hypoxic respiratory failure, Hypomagnesemia; HTN; probable UTI with concerns for Severe Sepsis; Altered mental status with concerns for metabolic encephalopathy along with dementia.
patient's mother reported she experienced a seizure on 11/14/21 at 03:00 patient has not has a seizure since 5/20/2019
Sore arm; Swelling in the arm pit; Ear pressure pain; Pressure in the neck; Fatigue; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SWELLING (Swelling in the arm pit), EAR PAIN (Ear pressure pain), MUSCULOSKELETAL DISCOMFORT (Pressure in the neck) and FATIGUE (Fatigue) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), SWELLING (Swelling in the arm pit), EAR PAIN (Ear pressure pain), MUSCULOSKELETAL DISCOMFORT (Pressure in the neck), FATIGUE (Fatigue) and MYALGIA (Body ache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), SWELLING (Swelling in the arm pit), EAR PAIN (Ear pressure pain), MUSCULOSKELETAL DISCOMFORT (Pressure in the neck), FATIGUE (Fatigue) and MYALGIA (Body ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Severe migraine starting 2 days after injection. ?Covid arm? about 10 days after, tender and hot to the touch, but not severe.
Leg weakness, numbness, loss of feeling, nerve damage, falls. Weakness began within a couple weeks of receiving 3rd dose of HPV vaccine. 1st dose given with FLUMIST.
Mom states child had seizure approximately 10-15 minutes after vaccine administered. Went pale and eyes rolled back with repeated jerking movements within the whole body x 3-4 minutes. Became diaphoretic and returned to consciousness with no recollection of what happened.
congested lungs; pain in arm; wheezing; stepped on a nail; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 20Sep2021 (at the age of 61years) as dose 2, single for Covid-19 immunization. The patient medical history was not reported. Concomitant medications included tetanus vaccine (TETANUS VACCINE) taken for an unspecified indication on 20Sep2021. Historical vaccine included first dose of Comirnaty on an unspecified date for Covid-19 immunization. On an unspecified date, the patient experienced he has congested lungs and pain in his arm where it wakes him up due to the pain. The patient added that he was also wheezing on an unspecified date. He further stated that when he got the second dose of the vaccine (20Sep2021) he stepped on a nail and he also got a tetanus shot the following day. The outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
That evening when she laid down she had some neck soreness; she woke up she saw the swollen lymph nodes.; She also experienced fatigue; arm soreness; This is a spontaneous report from a contactable consumer or other non-health care profession. A 61-years-old female patient received second dose of BNT162b2 (solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 21Apr2021 (at the age of 61-year-old) as a single dose for covid-19 immunisation. Medical history included ongoing lymphadenopathy three narrowing's in her neck and needs to get surgery on it. The patient's concomitant medications were not reported. Historical vaccine include first dose of BNT162b2, via unspecified route of administration on unspecified date (at the age of 61-year-old) at a single dose for COVID-19 immunisation. On 21Apr2021, on evening of same day of vaccination, the when the patient laid down, she had some neck soreness, and the next morning when she woke up she saw the swollen lymph nodes. She still has swollen lymph nodes now. She also experienced fatigue and arm soreness and she just put some alcohol on that and it resolved. Therapeutic measures were taken as a result of arm soreness. The patient was called to see if this is a side effect/ how long it lasts and She cannot get her neck injections or surgery until it resolves. The outcome of some neck soreness and fatigue were unknown, swollen lymph nodes was not recovered, , arm soreness was recovered.  Information on the lot/batch number has been requested.
Compensated SVT for about 4 hours, self converted during IV placement.  Ultimately did well and is on propranolol.
Patient was given Pediarix multi vaccine and an additional Hep B Engerix-B vaccine by accident in stead of HIB vaccination.  Call placed to patients mother explaining the mistake and patient mother advised patient is doing well and no adverse reaction to immunizations.  Advised mother this wont harm the patient by getting an additional dose, at her next well baby visit we can update patient on the HIB vaccination. Patients mother agreed to plan and was accepting of the information and of this nurses apology and honesty.
Pt has extreme bruising, injection site is black, very black and blue, surrounding are has erythema, very red and warm, with discomfort. Pt also had been experiencing headache since vaccination.
42 year old woman received 1st dose Moderna vaccine and then described facial flushing, numbness, tingling, warmth and nausea. Denied tongue swelling, difficulty swallowing or dyspnea. Patient was assessed by medical staff at event and 911 was called immediately. Ambulance arrived on scene and reassessed the patient with normal vital signs and stable symptoms. Patient declined transport, however was encouraged to be driven to hospital by family.
This spontaneous prospective pregnancy report was received from a physician concerning a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot number, expiry date, dose and route unspecified) early in pregnancy. The last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. The pregnancy outcome was unknown. No concomitant therapy was reported. Additional information is not expected.
This spontaneous prospective pregnancy report as received from a Licensed Practical Nurse refers to a 31 year old female patient. The patient did not have any pertinent medical history or drug reactions/allergies. On 12-JUL-2013 the pregnant patient was vaccinated with GARDASIL (lot # 1291AA, expiry date on 12-APR-2014, 0.5 ml/once, intramuscular) due to a human error. No concomitant medication was reported. The gestation was 29 weeks and 5 days. The Last Menstrual Period (LMP) was 16-DEC-2012 and expected date of delivery (EDD) was 22-SEP-2013. The pregnancy outcome was outcome pending. No adverse effect reported. No lab diagnosis studies performed. Additional information has been requested.
One day after receiving the vaccine, the patient developed a rash which was diagnosed as herpes zoster (shingles).
Information has been received from a woman in a medical office concerning a patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 643503/0541M).  Subsequently, within a day of administration, the patient developed a large hive at the injection site with a red, hot area from the injection site to the elbow and was "having symptoms" and swelling around the upper arm.  Medical attention was sought and the patient was treated with ice packs and OTC cortisone cream.  It was reported that the conditions resolved.  The reporter would like a lot number check.  On 05/08/2003 it was reported that no further information was available at this time. No product quality complaint was noted.  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.  It was also noted that two other patients were vaccinated with a dose of varicella virus vaccine live (Lot # 643503/0541M) and developed a large hive at the injection site with a red, hot area from the injection site to the elbow (WAES # 0305USA00925).  Additional information has been requested.
About 5 hours following vaccine, developed severe weakness and a fever around 100 degress F.  The fever continued for 2 days, the weakness for 5 days.  No treatment recommended by doctor.  Note: she had recurrent weakness this week coincident with a stomach flu that took her 4 days to recover from.
Immediately post injection, she developed swelling at the injection site. Within 10 hours, her arm was huge and red and she could not use it. After the reaction she developed chronic rhinitis. She was treated with unspecified prescription medicine.
lymphadenopathy, pruritis, myalgias; pustule/cellulitis near rt eye, rt groin
Headache, Myalgia, chills, sore arm, headache Narrative: Received 2nd dose 1/25/21 and is experiencing fever, body aches, chills, sore arm. Advised Employee that those are normal side effects and they should resolve in 2-3 days. Ee is taking OTC ibuprofen as needed. Advised to followup with PCP if anything becomes worse.
2 month old male developed diarrhea of 10 stools a day starting one day after receiving ROTARIX. No fever but some irritability. He also received PENTACEL and PCV13 infectious. No vomiting, no sick contacts, not dehydrated.
Information has been received from a Licensed Practical Nurse (LPN) concerning a 15 year old female patient who was vaccinated with a first dose of Gardasil.  Patient received the second dose of Gardasil on an unknown date.  The nurse reported that the patient passed out after her first vaccination of Gardasil.  An ambulance was called and the patient went to the Emergency Room (ER).  It was unknown if she was admitted to the hospital.  The patient had no incidence after her second injection.  The outcome was unknown.  Additional information has been requested.
Information has been received from a physician concerning a 14 year old female who on 24-OCT-1996 was vaccinated with the first dose of MMR II HSA (route, site, dose and lot number not reported). On 28-JUL-2000 received the second dose of MMR II HSA (route, site, dose and lot number not reported). On 03-NOV-2009 the patient developed mumps (thought the date diagnosed was reported as 3-JAN-2010). The outcome for mumps was not reported. Follow up information has been received concerning the 14 year old female patient who on 24-OCT-1996 and on 28-JUL-2000 was vaccinated with the first and second doses of MMR II HSA, (route and lot # unknown), respectively. On 13-JAN-2010, the patent experienced mumps (she was diagnosed on 15-JAN-2010) and she also had headache for two days. The patient had R parotitis. On 15-JAN-2010, a first blood work was performed IgM was <1:10, IgG was 9.61 and serum amylase tests was 56. At the time of the report the patient's outcome was unknown. No further information is available.
Patient received her first dose of the Moderna vaccine on 01/18/2021 and  second dose on 2/16/2021 at local Health. She received her booster dose of the Moderna vaccine at medical pharmacy on 12/03/2021 by unknown (pharmacy manager) Pharmacist and a technician went to Adult Day care center to do a small vaccination clinic. The social worker provided us with a photocopy of patients vaccination record which had only two doses listed (/1/18/21 and 2/16/21) She was due for her booster dose and so Pharmacist administered the vaccine per the records in front of her. Once the clinic was over, the director of Day care informed the pharmacist that patient had already received the booster dose a week ago. Patient spoke Spanish but she did not inform us that she had already received the booster a week ago.  Patient shows no side affects at the moment and will be monitored. We don't have a doctor's name on file to report the incident to.
died from the vaccine; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for 4 patients. This is one of four reports. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced died from the vaccine on an unspecified date. The reporter stated in his neighborhood 4 people died from the vaccine. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Follow-up attempts have been completed and no further information is expected. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100912595 same reporter/drug/event, different pt; Reported Cause(s) of Death: died from the vaccine
Painful swelling and hardness of nodes in left armpit (also occurred with first dose but nothing as severely), in addition to expected side effects of fever 101.6, aches, and fatigue.
lupus flare up, extreme inflammation, exhaustion, pain, aches, fatigue, headaches
Persistent pain in shoulder diagnosed as SIRVA by Primary care physician on 1/19/2021 prescribed Etodolac 400mg twice daily
HA, vomiting, Bell's Palsy, Encephalitis. Hospitalized. Serum sent to CDC for yellow fever testing. Follow-up: 06-Aug-2007 year the investigation BELL's Palsy has been resolved. Symptoms of shoulder/neck pain continues. Reminder: This case originates from FM025 which is a post marketing observation study.
Received Vaccine, 1st dose at 6 pm Jan 19, at drive-thru vaccination site; Rash appeared Jan 21,  48+ hours post-vaccination. Rash Description: Smooth, red blotchy itchy rash all over upper torso and arms. Jan 22, evening: Topical Hydrocortisone Cream 0.1% applied. No improvement to itching or redness. Jan 23, noon: Spoke with Doctor. He suggested Zyrtec.  Took 10 mg at noon.  Unknown at this point whether this will help.
10 MINS AFTER INJECTION OF ANTHRAX, SMALLPOX, AND TB, I WAS FEELING LIGHT HEADED, NAUSEOUS, AND ITCHY.  WITHIN 30 MINUTES I HAD VOMITED TWICE.  I WAS TREATED FOR RASH WITH BENADRYL AND FOR THE VOMITING I WAS GIVEN PHENERGAN.
I received the fourth dose of the Moderna Bivalent COVID-19 vaccine on 10/3/2022. Within a week or so, I developed small, itchy areas on various parts of my body. They were usually on my hands, arms, stomach, or the bottoms of my feet. The itch wasn't severe, but it was annoying. I went to my PCP on 11/18/2022, and he didn't know what was causing the itching, so he referred me to a dermatologist. On 2/14/2023, I saw the dermatologist. I explained my symptoms to her, and she thought that it was likely caused either by COVID-19 or by the COVID-19 vaccine. She prescribed triamcinolone (0.1%) cream, which I was to use as needed. I think I have only used it once. The dermatologist said that the itch should resolve on its own and that it just takes time. I have also noticed that taking oral Benadryl every once in a while has provided some relief. At the time of this writing, I haven't noticed any itching in about a month, so I think it has largely resolved itself.
I started to feel unwell soon after receiving the vaccination.  I was tired and had a sore arm the first day.  By the second day, I began having heart arrhythmia and shortness of breath, which was confirmed at my physician's office by EKG.  I was referred to a cardiologist. Today (day three), I am still feeling less energetic and have a higher than usual amount of skipped beats. I get short of breath easily.  This afternoon I have a bad headache. My cardiologist has ordered heart ultrasound and monitoring out of an abundance of caution.  He says it could be that the inflammation from the vaccine might be causing heart irritation.
1 week after receiving oral Rotateq, this 4 month old developed intussusception.  This was successfully reduced with an air contrast barium enema without further complication.  Discharged after 48 hours on regular diet.
muscle aches; nerve pain; not feeling well; pains; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from (RA). The reporter is the patient.  A 87 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Feb2021 12:00 (Lot number: EL3247) at the age of 87 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Muscle problems" (ongoing); "Nerve problems" (ongoing); "Breast cancer" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Lot No. EL8982, Administered on Right Arm.), administration date: 16Jan2021, for COVID-19 IMMUNISATION. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; NEURALGIA (non-serious), outcome "unknown", described as "nerve pain"; MALAISE (non-serious), outcome "unknown", described as "not feeling well"; PAIN (non-serious), outcome "unknown", described as "pains".  Additional Information: Patient had completed the 2 doses of the PFIZER-BIONTECH COVID-19 VACCINE 06Feb21 - A week after she experienced muscle aches and nerve pain - Patient has history of breast cancer - Wanted to know if these are reported cases in the clinical trial and asking for recommendations. The patient said that she has had ongoing muscle aches, pains, and nerve problems since her second Pfizer COVID-19 vaccine shot. She said she had some problems before that that were worse after. She said her for first dose it says Pfizer EL8982 and was given 16Jan2021, and her second dose on 06Feb2021 was LOT: EL3247.She said both doses were given in her right arm in the morning or at noon, at 12:00PM. The patient said had not had any other recent vaccinations or started any new medications prior to getting her vaccines. The patient said she was having some muscle problems and nerve problems right before and she had occupation therapy and this got better then it got worse again and hasn't subsided. The patient said she was going to have a neck nerve test done the next day for the problem, she was concerned because it was getting worse after the vaccine. She said that was why she was calling, because the facility she lives at has 300 plus people living there and several others are having nerve problems and are just not feeling well. She said she wanted to know if other people have reported having these issues.  No follow-up attempts are possible. No further information is expected.
After the second dose, the first site was activated, has itchiness on both arms; irritation on both arms; rash and bumpy of both arms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (After the second dose, the first site was activated, has itchiness on both arms), SKIN IRRITATION (irritation on both arms) and RASH (rash and bumpy of both arms) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM for Anxiety, RIVAROXABAN (XARELTO), METOPROLOL, DIGOXIN and LEVOTHYROXINE for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (After the second dose, the first site was activated, has itchiness on both arms), SKIN IRRITATION (irritation on both arms) and RASH (rash and bumpy of both arms). The patient was treated with BETAMETHASONE at a dose of 1 dosage form twice a day. At the time of the report, PRURITUS (After the second dose, the first site was activated, has itchiness on both arms), SKIN IRRITATION (irritation on both arms) and RASH (rash and bumpy of both arms) outcome was unknown.            No laboratory details was given.   This case was linked to MOD-2021-023443.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Other Possible Causes Added.No new information