chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm soreness; nausea; headache; This is a spontaneous report from a contactable consumer (patient). A female of an unspecified age received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE: Lot number: unknown) via unspecified route of administration on unspecified date as a single dose for COVID-19 vaccination. After the first dose of vaccination on unspecified date patient experienced arm soreness, nausea and headache. The outcome of the events was unknown.   Follow- up attempts are completed and no further information was expected.
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. In 2015, the patient was inoculated with ZOSTAVAX for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster including, but not limited to, postherpetic neuralgia and neuropathy. Shortly after receiving ZOSTAVAX, the patient developed a rash, accompanied by pain. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from shingles, postherpetic neuralgia and neuropathy. As a direct and proximate result of these malfunctions, 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. Upon internal review neuropathy was considered medically significant event. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of injection site bruising in a female patient who received KINRIX. On an unknown date, the patient received KINRIX. On an unknown date, unknown after receiving KINRIX, the patient experienced injection site bruising, injection site induration, injection site swelling and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site bruising, injection site induration, injection site swelling and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site bruising, injection site induration and injection site swelling to be related to KINRIX. Additional details were reported as follows: The patient was 4 years old at the time of vaccination. The healthcare professional thought that the vaccine was not injected into the muscle, but instead was injected into the tendonous tissue of the thigh by mistake which led to vaccine administered at inappropriate site. The patient had a local reaction after getting KINRIX. No further information was provided.
Pt stated that shingles vaccine caused a lump, swelling, redness, and then an open wound in her arm. This wound then led her to be admitted into the hospital. However, the arm that she states received the shingle vaccine is not the arm that had the wound.
PATIENT RECEIVED PFIZER MONO VALENT INSTEAD OF PFIZER BIVALENT
Received1st  vaccination on 2/1/21 and had sore arm and slight headach. Recived 2nd vaccination on 3/1/21 at 1040 had sore arm, nausea headach on 3/2/ developed temp of 100.4 by 330pm lasting till 230am on 3/3/21. Then was fine.  On 3/9/21 developed a rash on left arm, various part of extremites and back felt hot. Skin was extreamly itcy. Red raised blotchy areas appeared down left arm then on right arm , them lower extremities legs and feet. Took benadryl and cortisone cream on  rash which seamed to help. Cleared up for a few hours then reapeared in more areas on abdomin and back.  Seems to be worse in warm room applying ice to areas helped itch.
Body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and HEADACHE (headache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced MYALGIA (Body aches) and HEADACHE (headache). At the time of the report, MYALGIA (Body aches) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.    Reporter did not allow further contact
I was visiting my son in another country, my family, my son tested positive with COVID-19. When I started coughing, they had me test. I used a home COVID-19 test that came back positive. I went to a local doctor overseas who prescribed an antihistamine, expectorant cough syrup. I quarantined the prescribed time then once I could come out I did.
Menstrual cycle was delayed. Once menstruation started, it has been ongoing and not stopped. Today is 14 days, 2 weeks of continued bleeding. I previously had issues with regualrity with menstruation but this has been remedied for a few years with the birth control I take.
COVID breakthrough; COVID breakthrough; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Lot number: ER2613), in Apr2021 as dose 2, single (Lot number: ER2613) and on 20Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 01May2022, outcome "recovered", SUSPECTED COVID-19 (medically significant) with onset 01May2022, outcome "recovered" (2022) and all described as "COVID breakthrough". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19. Clinical Course: The patient did have other vaccine in four weeks prior covid vaccine. The patient did not have covid prior vaccination.The patient tested for covid post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2/26 First dose of Pfizer Covid vaccine: Within 15 minutes -tingly and achy from injection site to wrist and fingers. Extremely sore at site. I was very, very tired by 4PM. 2/27: site is very red, round, raised. I am extremely tired and achey. This persists all day. 2/28 Severe headache and nausea. Site is extremely sensitive (cannot tolerate touch), still red and about double in size. Cannot do daily activities, but can still tolerate food and water. I feel very unwell. 3/1 Headache and nausea persist. I have to take a sick day; I cannot work. By the evening I'm feeling less nauseous. 3/2 By evening I am much improved - only slightly nauseous, but the aches return. 3/3 Runny nose emerges with significant congestion. (The app is about to time out. -- I have more to add. I also had a strong reaction to the second injection on 3/21/2021.)
Day of -  Soreness in site area  Day after Thursday -  102 fever nauseous - vomiting  dizziness lack of concentration / out of it  out of body , not feeling well but as if it wasn't my own body?  Thursday -  Insane surge of energy  Felt great but depleted by the end of the day  On and off starting Saturday through now  headaches/migraines fatigue  off , unwell
about 4 hours after injection, palms were becoming ichy. Later a red Hive was present around my wrists, legs, and torso.  I took Benadryl every 4-6 hours and the red hive did start to calm down.
Pain as lasting for a couple of weeks; redness; swelling; This case was reported by a nurse via call center representative and described the occurrence of pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. In July 2019, unknown after receiving Bexsero, the patient experienced pain, erythema and swelling. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the erythema and swelling were unknown.   It was unknown if the reporter considered the pain, erythema and swelling to be related to Bexsero.  Additional case details were reported as follows: The healthcare professional could not provide patient demographics, lot numbers, or expiration dates. The age at vaccination was not reported. The reporter reported patient experienced a variety of events following Bexsero administration.  The patient experienced redness, pain, and swelling. The healthcare professional described pain as lasting for a couple of weeks in a patient.  The healthcare professional noted these events had been takes place over the last month, no specific time frame reported. No start or end date of any of the events provided. The reporter gave permission to follow up. This case had been linked to the case US2019151259, US2019151261 and US2019151262 reported by same reporter.
Information has been received from a nurse and a physician concerning a 16 month old (previously reported as 15 month old) female patient, with no past medical history or allergies, who on 19MAR2003 was vaccinated SC into the right triceps at approximately 10:00 with a first dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation) (lot 644420/1010M). Concomitant therapy on 19MAR2003 included a dose of varicella virus vaccine live. It was reported that the patient was not ill at the time of vaccination. On 29MAR2003, about two weeks after the vaccination, the pt developed a rash all over her body. The physician reported that the patient was seen in the office on 04APR2003 with a 5-6 day history of spreading, non-pruritic red papules, initially on arms and legs and then on trunk. The physician also reported that there was no vesicles, fever or signs of illness. The pt recovered by 11APR2003. Additional information is not expected.
Fell again, breaking left leg; Breaking ankle; Breaking foot; Passed out; Stroke; Fell again; Swollen arm; Did not get second Covid shot; Joint pain; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Mar-2021. The most recent information was received on 12-May-2021 and was forwarded to Moderna on 13-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), LOSS OF CONSCIOUSNESS (Passed out), LOWER LIMB FRACTURE (Fell again, breaking left leg), ANKLE FRACTURE (Breaking ankle) and FOOT FRACTURE (Breaking foot) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced ARTHRALGIA (Joint pain). On 30-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization prolonged and medically significant), LOWER LIMB FRACTURE (Fell again, breaking left leg) (seriousness criterion hospitalization), ANKLE FRACTURE (Breaking ankle) (seriousness criterion hospitalization), FOOT FRACTURE (Breaking foot) (seriousness criterion hospitalization), FALL (Fell again), PERIPHERAL SWELLING (Swollen arm) and INCOMPLETE COURSE OF VACCINATION (Did not get second Covid shot). The patient was hospitalized for 13 days until 12-Apr-2021 due to CEREBROVASCULAR ACCIDENT, then until 12-Apr-2021 due to ANKLE FRACTURE, FOOT FRACTURE, LOSS OF CONSCIOUSNESS and LOWER LIMB FRACTURE. The patient was treated with Physical therapy for Cerebrovascular accident; Physical therapy for Lower limb fracture; Physical therapy for Ankle fracture and Physical therapy for Foot fracture. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), PERIPHERAL SWELLING (Swollen arm) and ARTHRALGIA (Joint pain) outcome was unknown, LOSS OF CONSCIOUSNESS (Passed out), FALL (Fell again) and INCOMPLETE COURSE OF VACCINATION (Did not get second Covid shot) had resolved and LOWER LIMB FRACTURE (Fell again, breaking left leg), ANKLE FRACTURE (Breaking ankle) and FOOT FRACTURE (Breaking foot) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported.  Treatment medication included Benadryl. Very limited information regarding these events has been provided at this time. This case also refers to an incomplete schedule of vaccination. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Case upgraded to serious (Hospitalization), Added Additional events experienced, Events description, and updated Treatment information.
About 5 years ago she had drug induced psychosis and has been fine since. After receiving the second shot it appears to have started the psychosis again even though there were no other drugs involved.
Heart attack; Stroke; This spontaneous case was reported by a nurse and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) and CEREBROVASCULAR ACCIDENT (Stroke) in a 52-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Vasculitis.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were provided. The patient had an underlying autoimmune condition and vasculitis as medical history. This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in. No treatment medicine were provided.  Company comment: This spontaneous case concerns a 52-year-old female patient, with concurrent medical history of vasculitis, who experienced the unexpected serious (medically significant and hospitalization) of Myocardial infarction and Cerebrovascular accident after receiving a dose of mRNA-1273 vaccine. Latency cannot be assessed as the vaccination date and onset date of events were not reported. Clinical course and treatment details were not reported. The outcome of events was unknown. Concurrent vasculitis could be considered as a risk factor for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 52-year-old female patient, with concurrent medical history of vasculitis, who experienced the unexpected serious (medically significant and hospitalization) of Myocardial infarction and Cerebrovascular accident after receiving a dose of mRNA-1273 vaccine. Latency cannot be assessed as the vaccination date and onset date of events were not reported. Clinical course and treatment details were not reported. The outcome of events was unknown. Concurrent vasculitis could be considered as a risk factor for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical.
Swelling around injection site ongoing and it?s been a week  Hardness in the tissue around injection site
Information has been received from a RN concerning a 23 yr old female who was vaccinated with a full adult dose of varicella virus vaccine live (lot 645051/0200N) several years ago. A titer was done recently, it did not show seroconversion. Medical attention was sought and according to the RN a third dose of Varivax was given this week (approx 11Oct04). No symptoms were noted. Additional information has been requested.
Patient experienced sore arm for 1-2 days after vaccine-she accidentally received the high dose vaccine instead of the regular as indicated for her age.
I felt fine that afternoon and went to bed and woke up in the middle of the night with severe headache and nausea. I believe I took headache medicine at the time (maybe Tylenol) and went back to bed and in the morning my headache was mild and in the background.
SEVERE NAUSEA; MYALGIA OF LOWER EXTREMITIES; FEVER; DROWSINESS; DIARRHEA  ALL DAY; LOSS OF APPETITE (ATE BREAKFAST AND LUNCH, THEN NOTHING ELSE); HIVES WHICH WERE SHORT-LIVED; DEAD ARM FEELING; HEADACHE; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered in left arm on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced dead arm feeling. On MAR-2021, the subject experienced diarrhea all day. On MAR-2021, the subject experienced loss of appetite (ate breakfast and lunch, then nothing else). On MAR-2021, the subject experienced hives which were short-lived. On MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 98.9 F. On 19-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 20-MAR-2021 17:00, the subject experienced drowsiness. On 20-MAR-2021 21:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 21-MAR-2021, the subject experienced severe nausea. On 21-MAR-2021, the subject experienced myalgia of lower extremities. On 21-MAR-2021 05:00, Laboratory data included: Body temperature (NR: not provided) 103.5 F. On 21-MAR-2021 16:00, treatment medications included: paracetamol. Additional treatment medications (dates unspecified) included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, was recovering from myalgia of lower extremities, and headache, and the outcome of drowsiness, severe nausea, hives which were short-lived, dead arm feeling, diarrhea all day and loss of appetite (ate breakfast and lunch, then nothing else) was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
I experienced extreme pain (spine, hip, and skin), fatigue, and fever with a huge red hard lump at the injection site. My armpits were swollen underneath that was unbearable. The symptoms finally resided after 7 to 10 days (keep me in bed the entire time). I thought that I recovered but then I experienced muscular issues (numbness, burning, fatigue, etc...also had them when I was diagnosed with COVID in 2020). I am scheduled to go in for an MRI 08/12/2021 and continue to see a Neurologist. My follow up appointment with the Neurologist is 08/12/2021.
Pt developed fever and 1 minute seizure with stiffening, eyes rolling and then limp and unresponsive about 9-10 minutes, post vax. Phoned on 6/4/01/and 6/8/01 and pt still not so responsive as before vaccine.
patient had his covid 19 vaccine. about 45 min to an hour later, at home, started to feel his throat closing. patient quickly took benadry and reported it helped. he then asked me what else he needs to do. I suggested he get checked out at the hospital and he went and got a prednisone and allegra prescriptions.
This spontaneous report as received from a physician refers to a 5 year old female patient. The patient's pertinent medical history, drug reactions/allergies were not provided. On 23-SEP-2014, a five year old patient was vaccinated with a dose of HPV (manufacturer unknown) (units not provided) lot number and expiration date not provided. No adverse effects were reported. Additional information has been requested.
On above date and approximate time, infant began with fussiness, abdominal pain and bilious vomiting and was taken to the ED.  Was later admitted to the hospital and had grossly blood stools.  Diagnosed with intussusception of colon and C. difficile colitis.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 044A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, SIMVASTATIN, CALCIUM, FISH OIL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and CICLOSPORIN (RESTASIS) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided          This case was linked to MOD-2021-051521 (Patient Link).
Patient came to pharmacy 9/18/18 and stated her arm was sore on 9/15/18 after receiving shot. She said on 9/16/18 in the afternoon her arm started bruising. She said it is not painful but going to follow up with doctor.
Case number PHHY2012US058233 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 445572) on 09 Jul 2012. This refers to a 25-year-oldl male patient. He was vaccinated with MENVEO vaccine (batch number: A10047) into his left arm on an unspecified date. Ten minutes after vaccination he was dizzy. After sitting upright and drinking he was fine and left. He was followed up few hours later and he was doing well. The final outcome was reported as complete recovery. No additional information was available.