chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had mulitple ER visits and admissions.  Pt with pulmonary embolus, muscle weakness and arthritic type pain.  10/5/09 Hospital records, discharge summary, ER visits, service dates 1/3/09 to 1/9/09. Assessment: Pulmonary embolism, generalized weakness, insomnia. Patient relates recent hx of leg pains and weakness in extremities. PCP suspected GBS and referred to ER but patient refused. Developed dry cough. Patient now presents with 1 week history of generalized weakness and 1 day of palpitations. Heart rate of 100 to 110. Right ankle swelling.  Returns to ER with fever and bilateral ear pain.  Assessment: Sinusitis, fever, elevated liver enzymes. General myalgias, nasal congestion, and mild facial discomfort.  ICD-9 Codes: 780.60 Fever unspecified, 794.8 ABN Liver Function Study, 401.9 Hypertension NOS, V12.51 HX-Ven Thrombus/Embolus, 272.4 Hyperlipidemia NEC/NOS, 427.0 Parox Atrial Tachycardia, 401.9 Pulmonary Embolism/Infarct, 780.79 Other Malaise & Fatigue, 272.0 Hypercholesterolemia, 716.95 Arthropathy NOS-Pelvis, 780.53 Insomnia Unspecified.   12/07/09 ED notes for DOS 01/19/09: DX: Fever of unknown origin, pulmonary embolism, hypertension, and transient muscle weakness. Pt presented with ho fever for 2 wks, tachycardia, tachypneic, weak and pale. At the time of ED visit, Pt's temperature was normal due to Pt taking Advil. On examination: sinus pressure, Pt looking very ill.  Tx: Vancomycin and Zosyn.   12/07/09 DC summary for DOS 01/21/09  01/28/09 Final DX: Pulmonary embolism, hypertension, fever, coagulopathy. Pt presented with fevers of unknown origin and fatigue. Pt r/o for infectious disease. Pt believed to have microcytic anemia. Tx; Coumadin, Lovenox.
Red, swollen, hot welt about 1" in diameter on the upper arm below the injection site.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of an unknown age and gender. It was reported that an unspecified number of patients have received improperly stored doses of PEDVAXHIB (lot #, expiration date, strength, dose and route of administration were not reported) on 15-OCT-2014. No symptoms reported. This is one of several reports received from the same reporter. Follow up information has been received from a medical assistant on 24-OCT-2014 concerning 4 months old patient of an unknown gender. On 26-SEP-2014, the patient received improperly stored dose of PEDVAXHIB lot # K004540, expiration date: 03-DEC-2016 (dose and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
*I have had a very hard time staying warm since the shot the  *all of Friday I was nausiouse and tiered (the day after the shot)  * when I woke the next morning my face chin area itched over the past 2 days my face has broken out it itches and is spreading I have tried dubbling my allergy pill taking Benadryl washing my face with Dawn dish soap its 1130am Sunday the 10th jan the rash is all the way up below my upper cheek bones
Daughter took the second dose again as indication from her doctor.; Daughter took the second dose again as indication from her doctor.; Fatigue; This is a spontaneous report from a contactable consumer (parent) in response to NON-HCP letter sent to consumer via telephonic follow-up activity.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunization. Medical history included lupus from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE. The reporter did not wish to be contacted any further but indicated her daughter (the patient) took the second dose again as indication from her doctor (on an unspecified date). Only adverse event fatigue (on an unspecified date). She will call back if necessary. Information sent to AER Mailbox. At the time of this report, the outcome of fatigue was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
skin hives on hands, arms, scalp, lips, torso, feet arm pit, neck, ears.  itchy hot red rashes upon scratching these areas. muscle tiredness on vaccinated arm.  minor itchy tongue. sought medical help when started having problems to breathe on 12/16/21, airway was closing, hard to swallow food.  Got prescribed methylprednisolone on 12/17/21 and started the same day due to breathing difficulties and hot skin rashes. Felt better with this medication, however, rashes are coming back.
Within 5 minutes of getting vaccine, patient developed red splotches from shoulder to elbow. Splotches went away in 30 minutes after taking oral diphenhydramine.
Morning after- fainted, low grade fever 99.8, chills, injection arm soreness.
temperature of 105.5 and stated it would fluctuate between 104-105; blurred vision; balance was off; first it was up around 163/71 and then over time it was really low 118/58; HR was high; body was jerking; arm that she got the injection in was dropping; dehydrated; urine is darker; real thirsty; extremely weak; tired and exhausted; feeling horrible; couldn't stay awake, fell asleep; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 14Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included left hip replaced on 16Nov2020 and had her right hip replaced on 29Dec2020. There were no concomitant medications. Patient reported that she got the shot at 1:30 pm and on the way home she started getting tired and exhausted on 14Jan2021. She got home and went right to bed. She felt like she couldn't stay awake, fell asleep and woke up about 6 pm then with a temperature of 105.5 and stated it would fluctuate between 104-105. She was just feeling horrible. At 7:30 pm, patient had a temperature of 103.5 and at 7:45 pm, her temperature was 104. On 14Jan2021, patient stated that she couldn't see straight, had blurred vision, having trouble walking, her balance was off and falling into walls. Her body was jerking and the arm that she got the injection in was dropping. Patient called her cardiology office, and was advised to take Tylenol 3-4 times per day and alternate it with Motrin. She was also taking coated 325 mg aspirin. She can hold her head up and was not jerking as much as she was. She was doing noticeably better. Patient had put ice bags on her groin, stomach and throat to try to cool down through the night. This brought temperature down to 103. She woke up at 12 am she was 102. Her temperature at the time of report was around 101-102. She took her blood pressure it was going crazy, first it was up around 163/71 and then over time it was really low 118/58 and heart rate was 130 for a while and went to 103. The back of her neck still felt so weak and she still feels extremely weak and exhausted. She went on to report that her HR was high and B/P was up but since then it has come down. The night of 14Jan2021, her b/p was low.On 14Jan2021, patient was also real thirsty and her urine was darker and was probably dehydrated and thought that she was real jerky muscle-wise, like she is not in control of anything last night. That she has not taken BP or heart rate on 15Jan2021, but it was not pounding today though. She was doing better today at the time of report. Patient was recovering from the events of fever, blurred vision, and balance was off; not recovered from tired, jerking, and dehydration. Outcome of remaining events was unknown.
choking in the middle of the night; I've been having problems swallowing; I have a stuffed up nose; I've had Covid twice already since I had that shot.; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING (choking in the middle of the night) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHOKING (choking in the middle of the night) (seriousness criterion medically significant), DYSPHAGIA (I've been having problems swallowing), NASAL CONGESTION (I have a stuffed up nose) and COVID-19 (I've had Covid twice already since I had that shot.). At the time of the report, CHOKING (choking in the middle of the night), DYSPHAGIA (I've been having problems swallowing), NASAL CONGESTION (I have a stuffed up nose) and COVID-19 (I've had Covid twice already since I had that shot.) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  Company Comment: This spontaneous case concerns a patient of unknown age and gender, with no medical history reported, who experienced a serious (medically Significant) unexpected event of choking unspecified days after receiving a dose of mRNA-1273.222 vaccine. Patient also complained of dysphagia and has been problems swallowing and choking in the middle of night. Patient twice had COVID since vaccination. The details of previous doses were not provided.  There was no information provided about the patient's age, gender, underlying medical conditions, concomitant medications, onset date and clinical course of the events, associated symptoms, final diagnosis, diagnostic and treatment details. The benefit-risk relationship of mRNA-1273.222 vaccine, is not affected by this report.
Left arm red and swollen past elbow.  Saw PCP, mom stated PCP said chld also had skin infection under arm not related to injection.
tenderness @ inj site;pruritus @ inj site, chills, fatigue;
First dose / in 2019 / second dose has not been administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. No identifiers were provided for the second patient. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The vaccination occurred in unknown facility. The reporter did not consent to follow up. This is1 of the 2 cases reported, by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021134479:Same reporter. Patient 1 of 2.
Pt test post needlestick was negative for Anti-HBs 9OCT90 1 1/2 yr p/vax series given;Given 5 doses 5OCT88, 2NOV88, 20APR89, 19OCT90, 19MAR91; Lot #s 1893P, 1880R, 1239S not recorded for dose 1 & 2;
Red, raised, slightly warm to the touch and itchy rash on left arm in shape of a square over the injection site. Rash measuring 4 inches. Developed 8 days after injection. Left shoulder sore
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (from 47 to 77 degrees Fahrenheit for 14 hours) doses of VARIVAX (lot # L049534, expiration date 08-DEC-2017; dose and route of administration were not reported) for prophylaxis. The vaccines were reconstituted with the properly stored sterile diluent. No adverse effect and previous excursion were reported. The call was made because of a data logger. This is one of two reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted. Sender's Comments: US-009507513-1706USA003468.
Body chills 8 hours after receiving vaccine. 2 hours after that, fever of 103 F and  severe headache. Took 1000mg of ibuprofen. The next day fever was about 100F, headache was mild, slight nausea, tired feeling.
Migraine from 12/24/21 through evening of 12/26/21. The migraine was throbbing and spread across a headband like area in front of my ears.  The location of pain was consistent across all three days. I have experienced migraines before but never lasting multiple days or occuring multiples days in a row.  During that time period nothing happen that would typically trigger a migraine (no menstruation, alcohol, or insufficient sleep). Over the counter painkillers did provide temporary relief from pain.
3 days after vaccine i got a  Horrible rash from my neck all the way down to my thighs, and its red with fire. its covers my back and arms, everywhere. Went to Patient First and was given prednisone and told to take Benadryl but not helping .
Patient presented to the emergency department for nausea, vomiting, fatigue, and weakness on 5/26/2022. Tested positive for COVID-19 via PCR that day and subsequently admitted for her symptoms. Patient was discharged on 5/27/2022. This meets criteria for vaccine breakthrough case review.
Patient bled immediately upon injection. By the time I applied the bandage, a knot the size of a marble had formed under the skin. It continued to swell and was the size of a golf ball. We applied an ice pack and had her wait about half an hour to see if she had any further reaction. The swelling did go down some by the time she left.
Lethargy, Nausea, Shortness of Breath on Exertion
Shooting pain in left shoulder around injection location. Unbearable pain in left shoulder. Restricted use of left arm i.e. can?t reach to close car door, can?t reach to put on seatbelt, can extend arm, can?t wrap arm around body.  High Blood Pressure (213/110)
55 YO patient came in for follow-up Hep A #2. Previous Hep A dose without reaction. Received Hep A #2 and SHINGRIX #1 on 5/31/18. Stated went home and laid down to sleep at 11 AM and didn't wake for 24 hours. She stated fever on/off during that time. Her arm is red, swollen, bruised, at site of injection for 3 days and was "hot to touch". She was taking acyclovir 400 mg daily. She is wondering if a 2nd dose of SHINGRIX is still recommended based on side effects after SHINGRIX. Please make recommendation.
Sore arm, tenderness, nausea, illness, fatigue, flu like s/s. 9/26/11 (Had yearly flu shots prior).
Headaches; Chills; Body aches; Extreme fatigue; lips are swollen; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lips are swollen), HEADACHE (Headaches), CHILLS (Chills), MYALGIA (Body aches) and FATIGUE (Extreme fatigue) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced LIP SWELLING (lips are swollen). On 10-Feb-2021, the patient experienced HEADACHE (Headaches), CHILLS (Chills), MYALGIA (Body aches) and FATIGUE (Extreme fatigue). On 11-Feb-2021, HEADACHE (Headaches), CHILLS (Chills), MYALGIA (Body aches) and FATIGUE (Extreme fatigue) had resolved. At the time of the report, LIP SWELLING (lips are swollen) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.
Herpes Simplex Virus rash to left armpit with enlarged lymph node in left armpit and left neck.
This spontaneous report as received from a physician via company representative and refers to a 14 year old female adolescent patient. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. On 22-JUN-2016, the patient was vaccinated with GARDASIL 9 one dose, once in the left arm for prevention of human papilloma viral infection (HPV). After receiving the first dose, patient experienced dramatic injection site redness and swelling. The patient recovered on an unspecified date. The patient was presented at the physician's office at present for a physical examination and also to find out if she should get a second dose of GARDASIL 9. The patient has not had a second dose of GARDASIL 9 at this time. No additional adverse event information was available. Sought to medical attention was yes. No lab diagnostics were performed. Patient did not receive any treatment. No product quality compliant (PQC) was involved. The reporter did not report the causal relation of event with respect to GARDASIL 9.
No adverse effects initially (only soreness for first 3 days). Exactly one week after injection, soreness, redness, swelling, heat, around injection site. Spread to cover almost all of upper arm down to elbow, and wrapped almost fully around arm.  Very alarming. No other symptoms. Took ibuprofen and tried to ice it.  3 days later it is getting better. Took Allegra today. Not as swollen but still there.
terrible headache lasting 3 days after injection; elevated temperature on day 2 of 102; sore and red arm at injection site; sore and red arm at injection site; body aches; This is a spontaneous report from a contactable Consumer.  A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number PFREL3246), via an unspecified route of administration on 09Jan2021 11:00 at single dose for covid-19 immunisation.  Medical history included COPD, Asthma, Atrial Fib, Hypertension, covid-19.  The patient previously took levaquin and underwent allergies:Levaquin. The patient experienced body aches, elevated temperature on day 2 of 102, sore and red arm at injection site, terrible headache lasting 3 days after injection. No treatment received. No Covid tested post vaccination. The outcome of the events was resolved.
The day after the shot was given she had pain an swelling in her armpit. She also reported swollen lymph nodes in the neck and could barely swallow. Also had trouble moving neck from side to side. Adverse effects resolved gradually on their own.
Pt presented to the ED on 1/23 with CC of chest pain.    Per pt CP began on wed during dialysis.  She states pain was associated with dyspnea.  No radiation of pan.  Denied any palpitations or lightheadedness.  Worsening of CP with coughing or breathing.  She reported one episode of hemoptysis.  Also reported diarrhea with 2-3 loose stools per day for the past 3 days.  Also reported fatigue.  Denied any F/C.  Admits to cocaine and marijuana and tobacco use.  She did not feel well so missed dialysis on Friday.     In ED pt with VS of temperature 98.9°, heart rate 85, respiration rate 18, blood pressure 110/67, and sats of 74% on room air.   Influenza a and B negative, RSV negative, COVID-19 PCR positive.  Urine drug screen pending collection.  Chest x-ray with cardiomegaly and central vascular congestion/fluid overload.  Mild basilar airspace disease right greater than left with possible small right pleural effusion.  She has a patchy perihilar and lower lobe infiltrates in the right middle lobe changes may be related to COVID 19.     Pt was given vitamin-C, Decadron, aspirin, remdesivir, Neurontin, Norco, and started on heparin drip.  Cardiology and nephrology were consulted.  Pt was admitted for further workup.  Cardiology started pt on heparin gtt for 24 hours and transitioned to subQ heparin.  Echo was done and LVEF of 60%.  They felt chest pain due to COVID 19 and cough.     Nephrology ran two dialysis sessions subsequent days to help with fluid overload.  Her oral intake improved.  Her breathing improved.  Pt was started on IV abx for possible superimposed bacterial infection given elevated procalcitonin.    Pt was weaned off oxygen.  Home oxygen eval done and not needing oxygen.  Pt eager to go home.  Will d/c on remaining course of abx and 5 days of prednisone.  Pt will need close follow up with PCP.   She was discharged home with covid kit and told to monitor her oxygen levels if dropping < 90% she needs to come back to ED. Pt came back to the ED on 2/8/22.   She presented with symptoms of shortness of breath, patient was saturating 84% on room air.  Patient also missed her dialysis yesterday.  In ER patient was tachypneic, hypoxic, patient was placed on BiPAP. Patient received emergent dialysis, with which her symptoms improved, potassium normalized.  Patient received dialysis consecutively for 3 days.  Patient complaining of pleuritic chest pain, troponin was elevated, trended flat trend, no concerns of acute coronary syndrome.  Her oxygenation improved, patient is back to 2 L of oxygen, patient was discharged on home oxygen post covid infection which she should be continuing at home.
soreness in her arm; This is a spontaneous report received from a contactable consumer. A contactable female consumer (patient) of an unspecified age patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. Patient medical history and concomitant medication were not reported. Patient received the first dose of the COVID-19 vaccine and developed some soreness in arm on unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
A non-serious spontaneous report of sore throat, cough, fever of 102 F and muscle aches has been received from a pharmacist concerning a 43-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received H1N1, Intranasal on unknown date. Two days after receiving H1N1, Intranasal, the patient developed sore throat, cough, fever of 102 and muscle aches. Treatment for the events was not provided. The patient's symptoms lasted for ten days.
Severe itching all over body lasting at least ten days. Rash apparent in higher-scratch areas.