chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1/18/2020 19:19 pneumonia vaccine administered R arm. 1/19/2020 16:00 pt temp was 99.5 and on 1/20/2020 16:10 was 100.3.  On 1/21/2020 during doctors rounds pt presented with complaint of pain at injection site with 3x5 inch diameter area of erythema / edema.  Warm to the touch.  Diagnosis of cellulitis. Clindamycin 300mg po QID x 21 doses. Also had tylenol & motrin available for pain / fever.  1/21/2020 per nurse practitioner note area of edema / erythema was 2.5x4inches.  Pt later discharged routinely to home with instructions to complete clindamycin.  Cold packs encouraged.
A female consumer reported that she received influenza virus vaccine, trivalent, types a & b (1998-1999 formula). The pt's concurrent illnesses include hypersensitivity and eczema with a past history of asthma and bronchitis. Following the immunization, she developed a "worse than normal skin reaction" all over her body. The reporter noted that at the time of the event, she attributed these symptoms to the winter weather and dry skin. The consumer reported 2 similar occurrences following previous immunizations with a flu vaccine. See HQ8356213NOV2001 and HQ9120205DEC2001. No additional information was available as of the date of this report.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history was not reported. On 16-JUN-2015 the patient was vaccinated with an expired dose of ZOSTAVAX (lot# 007208, exp 20-SEP-2014) via an unknown route and dose. No concomitant medication was reported. No adverse symptoms reported. Outcome, action taken and causality were not provided. No product quality issue (PQC) was involved. Additional information has been requested.
Passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Passed away) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Death occurred on September 2021 The patient died in September 2021. The cause of death was not reported. It is unknown if an autopsy was performed.            No relevant concomitant medications were reported. No treatment information was provided.  Company Comment: This case concerns an 88-year-old, female patient with unknown medical history, who experienced the unexpected event of Death. The event occurred unknown number of days after the two doses of mRNA-1273 vaccine which were administered a month apart. Cause of death has been reported as unknown, and, it's also unknown if an autopsy was performed. At the time of the report, very limited information has been provided about the patient and about the event leading to the fatal outcome. The patient's elderly age remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns an 88-year-old, female patient with unknown medical history, who experienced the unexpected event of Death. The event occurred unknown number of days after the two doses of mRNA-1273 vaccine which were administered a month apart. Cause of death has been reported as unknown, and, it's also unknown if an autopsy was performed. At the time of the report, very limited information has been provided about the patient and about the event leading to the fatal outcome. The patient's elderly age remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
has something up her heart; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "has something up her heart".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
a sore arm that lasted for only a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (a sore arm that lasted for only a couple of days) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (a sore arm that lasted for only a couple of days). At the time of the report, MYALGIA (a sore arm that lasted for only a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medications were not provided.
Pt had swelling & temp at injection site approximately 3 in in diameter 3 days after injection. Spoke to MA & Rec. use Diphenhydramine 25 mg PO q8h PRN. Spoke to Pt 7/25/12 and she says redness, itchiness & swelling have gone way done. No other adverse events reported by pt.
Initial pregnancy report received from a healthcare professional on 22 March 2013. A 30-year-old female patient, whose medical history and concomitant medications were not reported, had received intramuscular first dose of ADACEL vaccine lot number: U4612AA (Anatomical site of vaccination was not reported) on 21 March 2013. The patient was pregnant during vaccination. The patient's last menstrual period was reported as 07 July 2012 and the estimated date os delivery is 13 April 2013. As per reporter the patient did not experienced any adverse event.  Documents held by sender: None.
Anxious; Shingles; This is a spontaneous report received from a contactable consumer or other non hcp. A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158, Pfizer NTEC), via an unspecified route of administration in Arm Left on 20Apr2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After received vaccine, one week and a day later she developed shingles on 29Apr2021. She was wondering if this a reported side effect of the vaccine. She was also due to receive the second dose next week and still had shingles. She has never had shingles before. She was wondering if this has been reported. On unknown date she was anxious about the second shot next week. She did not have a prescribing doctor, offered it and she went to a clinic to get it. The shingles are still there, but she was on an antiviral medication so it has improved. It was not spreading anymore. She was on Acyclovir. The outcome of the event was reported as recovering and the event was reported as unknown.  No follow-up attempts are needed. No further information is expected.
pain at site of inj, headache, fatigue, chills, diarrhea, general feeling unwell;mild chest tightness developed overnight; rapid heart rate, feeling short of breath while walking
Redness, itchiness and swelling at site of injection. Tx: Hydroxyzine pamoate 25mg. KEFLEX 250mg.
Shortly (within the hour) after rec the DPT injection, patient began crying and kept his leg straight (unable to bend leg). He continued to cry and was unconsolable for several hours. Dr was notified and he advised patient had suffered an allergic reaction and should receive another DPT vaccination, only a DT vaccination without the pertussis.
Began with a fever, 101. Treated with Motrin, was very fussy and hot all night. Woke up on Thursday with a slight rash on her face, just small red dots. I figured it was a heat rash from the fever she'd had. The rash progressed through Thursday, into Friday where it worsened. Took her into our local hospitals pediatric unit, they said that it was a viral infection possibly from the vaccinations, possibly not. Its Saturday now and the symptoms seem to be getting worse, she is still very moody and has a bad facial rash, with small dots all over her body.
First 2 days, redness and swelling at spot of injection. Chills for 3 hours the night of injection. Redness cleared up and swelling went down. 8:00 p.m. February 5th, the redness returned the size of a quarter. It has been itchy for the past 4 days. The redness and swelling has been increasing in size. It is now about 4 inches in diameter. The injection spot looks like I had a bee sting.
Patient presented to the Emergency Department with complaints of pressure and non-radiating pain in her chest and shortness of breath. The pain sensation began 3 days after she tested positive for COVID-19. During this time, she experienced nausea with one episode of emesis, sore throat, congestion, and productive cough. On the basis of symptomatology, persistent oxygen requirements, electrocardiographic changes, and elevated troponin levels she was diagnosed with COVID-19 infection with acute hypoxemic respiratory insufficiency and non-ischemic myocardial injury. She was admitted to hospital and received one dose of dexamethasone 6mg intravenously and one dose of IV remdesivir. With symptomatic improvement, she was discharged medically stable with follow-up care plans in place.
12/27/21 Moderna booster injection. 01/8/22 burning, red rashes all over with itching symptoms. Thereafter raised skin. Took Zyrtec and topical cream/lotion or hydrocortisone application. Relief strategy helps stop burning, itching and raised skin. But, red rash continue. If relief strategy is paused, then within a day, all adverse events reappear
Swelling at the injection site that is 4 inches in diameter. Now on my third day after injection and site continues to grow.
after getting 2nd covid shot I had fever, chills, cough, dizziness, nausea, lost appetite that lasted for two weeks. I also had my booster vaccine 9/10/2021 and I am still experiencing same symptoms as the second vaccine
Morning following injection, I experienced extreme dizziness and brain discomfort. Dizziness was bad enough to make walking difficult and even created motion sickness. 5 months later the dizziness has eased but still present, flying, driving, elevators, anything seems to trigger some form of dizziness. Hights of about 10 feet give bad vertigo, I am a pilot and aircraft mechanic and this creates an issue working on jets and I do not want to possibly loose my pilots medical. Brain fog is also long lasting still and  makes mental clarity difficult which was never an issue until the day after the shot. My heart has created irregular heart rhythms, I have physical stress and tire easily and my muscles will shake and twitch after minimal effort. Biggest concern is dizziness and clarity and loss of short term memory, talking in front of large audiences for work has become difficult since my cognitive skills seem to have diminished from the lasting brain fog.
While getting my hair cut the following day I was sitting in my chair and started to feel intoxicated for about 2 minutes and then started to sweat, I then passed out and started to shake as if I were having  a seizure. This went on for about a minute I was told.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Mild, Systemic: Headache-Mild
auto-immune problems; encephalitis; fibromyalgia; This spontaneous report was received from a 37-year-old female patient via Pfizer concerning herself. The patient's concurrent conditions, medical history and concomitant therapies were not reported.   On an unspecified date in 1989, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (strength, dose, route, lot number and expiration date were not reported) for measles, mumps, and rubella immunization (prophylaxis).      On an unspecified date in 1989, 10 days after onset of therapy, the patient experienced encephalitis followed by fibromyalgia and other autoimmune problems.      The outcome of autoimmune disorder, fibromyalgia and encephalitis was reported as resolving (reported as "after 30 some odd years, she had finally gotten into a health state where she was happy").        The causality between the suspect therapy and the events was not reported.   Upon internal review, the events of encephalitis and autoimmune disorder were considered to be medically significant.
stiff neck; fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced PYREXIA (fever). On 18-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-May-2021, MUSCULOSKELETAL STIFFNESS (stiff neck) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.
Lightheaded; Shaking and very weak; Shaking and very weak; A lot of pain around the injection site and near elbow; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded), TREMOR (Shaking and very weak), ASTHENIA (Shaking and very weak) and VACCINATION SITE PAIN (A lot of pain around the injection site and near elbow) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (A lot of pain around the injection site and near elbow). On 26-Feb-2021, the patient experienced DIZZINESS (Lightheaded), TREMOR (Shaking and very weak) and ASTHENIA (Shaking and very weak). On 26-Feb-2021, DIZZINESS (Lightheaded), TREMOR (Shaking and very weak) and ASTHENIA (Shaking and very weak) had resolved. At the time of the report, VACCINATION SITE PAIN (A lot of pain around the injection site and near elbow) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided by the reporter Patient used ice packs and his arm has gotten better.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: TCR form: NNI
Ongoing diarrhea, stomach cramps, bloating. Symptoms continue for several weeks, never had it before for so long. Eye infection.
pt recv vax;onset of migrating joint effusions and arthralgias (knees,elbows,wrist,ankles,toes);no fever;started on pred;
states had back pain 2 wk prior to inj;5/28/99 c/o pain to lt buttocks, femur  & knee;saw MD 5/31/99;sent to ortho pod on 6/1/99;had MRI 6/2/99-bulging disc L3-L5, S1;
she had a major  issue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (she had a major  issue) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (she had a major  issue). At the time of the report, VACCINATION COMPLICATION (she had a major  issue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication were provided.
The second dose of the vaccine almost 8 hours after it was administered began to give me a lot of headache. After 10 hours of administration, I started vomiting throughout that night until the next morning I vomited 7 times. At 11 hours after administration I began with involuntary movements, to shake a lot. It gave me a fever of 40 degrees. The next day I couldn't get up. Body pain, I got dizzy from just walking, and I couldn't urinate, I had pain in the ovaries and pelvis area. That day that was the next, I continued vomiting and I couldn't get out of bed. I was given a saline solution for dehydration, and I took phenergan 50mg for vomiting. 36 hours later my hips and back and legs ached. At 48 hours I started diarrhea which to this day I continue with them (5 days after the vaccine). After 5 days of the vaccination I continue with diarrhea, I have controlled them with imodium and probiotics, I have a weak body, I get dizzy at times, and I continue with pain in the ovaries like menstruation that at the moment is not supposed to be because I was menstruating just 3 days before the vaccination. My body feels strange, my hips, back and head still hurt, and I continue with stomach pain, nausea and diarrhea. Medications were administered at home.
Moderate heart palpitations and premature beats. Ongoing for over 3 months at this point, but lessening in severity and frequency over that time
Exaggerated cellulitis of left arm down to elbow and up to shoulder area.  Patient also had minor outbreak of vesicles.
Swelling and discoloration started within 2 hours of injection. Reaction swelled to a size of 4" by 3" and was significantly raised ("goose egg"), hard and hot to the touch, and bright red mottled with purple and blue bruising. Site was tender but not painful. Reaction slowly decreased in height (of swelling) over a period of one week to a hard, raised, bright-red patch of the same size, 4" by 3", and stayed that way. Day 15 after the injection the color began to change from red to dark gray. Measured daily and the size has remained constant.
3cm x 2cm area of erythema/rash @ site of MMR;dad states child spent 3 days w/mom & does not really know when rash appeared;
Fever 1 day, irritable, poor appetite. Rash on his trunk, seem uncomfortable. Blanching 1 -2 min discrete red macules all over arms, trunk and legs. Viral exanthem, reaction vaccination. Fever and or pain management: Ibuprofen.
This case involves 15-year and 5-months-old and unknown gender patient is missing fourth dose of IPV (VERO) [IPOL] series (product dose omission issue). Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided. On an unknown date, the patient is missing fourth dose of suspect IPV (VERO) (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination (product dose omission issue). It was reported "Business manager states that they have a patient who is 15 years and 5 months old who came from another practice; upon reviewing her medical chart, they found that she is missing a dose in her IPV series. Business manager asks if the patient could receive QUADRACEL to make up for the missing dose in her IPV series". This case was an actual medication error due to missed dose (latency: same day). At the time of reporting, no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.
Twitching in pectoral muscle several hours after injection. Progressed to leg and calf muscle facilations over next few weeks. 8 weeks post the facilations spread to rest of body, muscle weakness in legs, extreme anxiety and nervous system issues, sleep disorders. Pain in leg muscles after walking short distances and legs twitch upon resting. All labs are normal.
After my second injection, I , the day after, had severe flu like conditions, aches, chills, feverish, extreme fatigue. The second day after my reaction, two days after I received it, I had so much fatigue that I could do nothing, but lie in bed. The third day, I felt a little better but was again fatigued and could not do anything but rest. I began to feel a little better after the third day but two weeks later I still have fatigue but can still function. The Saturday after I received the injection on Sunday I slept 11 hours.
Fatigue, joint pain,  tenderness at injection site, malaise for about  24 hours.  Treated symptoms with Tylenol  (1 dose,  650 mg at 8pm on Saturday 3/6/21).
On May 04, 2021 this 37 -year-old male patient received the second dose of Moderna Covid vaccine on his left deltoid.  On May 05, 2021 the patient complained of injection site pain, he was treated with acetaminophen 650 mg at 11:30 am and at 08:24 pm.  On May 07, 2021 I spoke with the provider who stated the patient had no longer complained of pain at the injection site.
Fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (Fever) in a 71-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2022, Body temperature: 100.4 100.4 yesterday. On 10-May-2022, SARS-CoV-2 test: negative (Negative) Took a Binex rapid test yesterday...negative. On 11-May-2022, Body temperature: 98.6 Now its just 98.6 and 99 Today 99. In May 2022, Body temperature: 101.7 101.7, 100.7 100.7 and 99.5 99.5 normal 2 days.         No concomitant medications was provided by the reporter.   Patient received 2nd booster dose Patient experienced Fever from Friday night for two and half day 101.7, 100.7, 99.5 then normal 2 days, then back up to 100.4 yesterday. on the day of reporting it was 99 and its 98.6 and No other symptoms of anything. No treatment medications was provided by the reporter.
Delayed local skin reaction. Erythema and soreness starting 3 days after vaccination and still present 11 after vaccination.
10-8-18 2:30 PM pt. got dizzy, eyes rolled back was sweating and nauseous after receiving 4 vaccines.
Joint and muscle pain; Joint and muscle pain; This is a spontaneous report from a contactable physician.  A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular on the left arm on 28Dec2020 08:45 at single dose for COVID-19 immunisation.  The patient had no medical history.  Concomitant medication included ethinylestradiol, norethisterone acetate (LOESTRIN) and naproxen sodium (ALEVE).  The patient experienced joint and muscle pain on 28Dec2020 20:00. The patient received no treatment. The outcome of the events was recovered on an unspecified date.