chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Back ache; Headache; Joint pain; Tired; This is a spontaneous report from a contactable consumer, the patient. A 52-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the arm left on 31Mar2021 at 17:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included ADD (attention deficit disorder), lichen planus and asthma. No allergies to medications, food, or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and doxycycline (MANUFACTURER UNKNOWN) both on an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the arm left on 10Mar2021 at 17:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 15:30 the patient experienced back ache, headache, joint pain and tired. No therapeutic measures were taken as a result of reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event back ache, headache, joint pain and tired was recovering.   No follow-up attempts are needed. No further information is expected.
pt recvd vax & devel rash, fever & irritability; No further details were provided;
patient received the first dose of the pfizer covid vaccine in her left arm IM. Within 30 seconds of the shot being given, patient lost consciousness for about 30 seconds, and began to convulse and slide off her chair. Her father held her up so she didn't fall, and patient regained consciousness when her father was asking what was going on.  Patient's blood pressure was checked, and it was at 84/45 with a heart rate of 55. Patient became diaphretic and extremely hot to the touch. Ice packs were given to cool the patient down. Blood pressure was taken again and her pressure went up to 165/110 with a heart rate of 103. 911 was called at this time. Patient could barely maintain consciousness, but was able to remember where she was and what happened during her shot. Patients airways remained open, and patient complained of nausea. Patient had extra salivation at this time and remained hot to the touch and continued to get hotter. Pharmacist administered .15mg of Epinepherine via epiPen at 3:53. EMS and fire arrived shortly after and transported patient to  Hospital
This spontaneous report as received from a pharmacist via company representative refers to a 50 year old female patient. On 30-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date was not reported and route was subcutaneous). On 01-MAY-2013, the patient experienced cellulitis after receiving ZOSTAVAX. On 03-MAY-2013, the patient was prescribed BACTRIM as a treatment. The outcome of cellulitis was reported as recovered. The patient sought medical attention. Additional information has been requested.
PATIENT WAS GIVEN 0.3 ML UNDILUTED VACCINE.   NO KNOWN ADVERSE EFFECTS AT THIS TIME
Vaccine was administered to twin brother. Immunization was processed under patient's twin brothers name and profile. Both brothers wanted the vaccine and both received it. It was reported incorrectly, however. No true adverse effects.
Started with chills, Dizziness. weakness, mild headache, injection site soreness & stiffness, nausea, vomiting, dry heaves,, fever 101.3. and fatigue. Was transported to Emergency Department via ambulance.  At ER given saline IV, ran chest xrays, blood test and observation.  Transported around 11:00-11:30, discharged 4:45 pm.
Patient expired.  66 y.o. male with past medical history significant for type 2 diabetes, vascular dementia, AFib on Eliquis, CHF, depression, chronic anemia, recent DVT/PE, chronic hypoxic respiratory failure who presented to emergency department with altered mental status. Upon arrival to emergency department, patient was febrile but other vitals were stable.  Baseline blood work was obtained which was remarkable for leukocytosis of 16. Lactic acid was normal.  Suprapubic catheter was changed in UA was obtained.  UA positive for acute infection.  Viral PCR negative.  CXR was obtained showing worsening bilateral infiltrates consistent with pneumonia.  CT abdomen and pelvis was obtained showing mild sigmoid colon diverticulosis without diverticulitis.  Mild to moderate large volume of stool.  Ultrasound of lower extremities was obtained which was negative acute DVT.  Blood cultures were obtained and patient was started on cefepime, vancomycin and azithromycin.  He was also given a 2 L NS bolus.  Patient was then transferred to Hospital and admitted to General Medicine for further evaluation and management.   Patient was initially confused and this had resolved after the 1st 48 hours of stay.  Neurology consulted per family's request and they agreed that this confusion is secondary to acute toxic metabolic encephalopathy related to his COVID and hypoxia.   Patient continued on oxygen support.  Patient had been requiring high-flow nasal cannula support.  Infectious Disease consulted with MRSA screen positive.  Workups showed positive COVID and the rest were negative.  Antibiotics then discontinued.  IV steroids then initiated.  Pulmonary consulted and evaluated patient. Agreed on IV steroids.  Chest CT performed and showed extensive bilateral ground-glass opacities with probable developing fibrosis as a sequelae of his previous COVID-19 pneumonia.  Patient was saturating well with his high-flow nasal cannula oxygen support.  Patient noted to have aspiration episodes that SLP consulted, performed FEES which did show significant aspirations and recommended NPO.  Patient noted to have no capacity to make decision about risks of eating and benefits of feeding tube placement and decisions on advance care planning.  Neuropsych had been consulted for this and evaluated patient.  Patient deemed to have no medical decision making capacity on this. DPOA then activated.  Initiated goals of care discussion with medical DPOA who was receptive of palliative care involvement and hospice informational meeting.  Upon seeing patient on 02/14/2022, DPOA decided on to proceed with comfort care measures.  Comfort care measures then had been initiated.  Hospice service followed and patient deemed to meet criteria for hospice on 2/15/2021.  The patient passed away and was pronounced on 2/17/2022 at 1200pm.  Cause of death is COVID-19 pneumonia and secondary bacterial pneumonia + Sepsis.
Patient reported irritation around the injection site.  She could not give a scale for the pain. She also noticed swollen around the injection site. She was advised by the pharmacist to use ice pack and take tylenol. The pharmacy will follow up with her the next morning. Also the patient was instructed that in case she has any sign of breathing problem, she should call 911.
Patient received Hep A, HPV, Meningitis and TB test. After administered he stood up and walked over to me maybe four feet and then passed out on me and before I could stand and catch completely fell to the floor. Myself and the nurse assisted him back to the chair where he started to perspire profusely and while nurse went to get a fan he started to make convulsing movements and jerk in the chair. At one point his eyes rolled. I kept yelling his name and after a few seconds he looked at me and started crying (and said Mama) he stayed in a state of confusion for maybe three to four minutes and then seemed okay. I asked the nurse to get some water and maybe some crackers and she did so. After that he started to get his color back and said he was freezing to turn off the fan. We stayed in the office for another 15 to 20 minutes and then we had him walk around to make sure he wasn't dizzy anymore. I asked the nurse if this was normal and she said the it's not unusual for patients to pass out but I think this was a little much. He did have an empty stomach as it was first thing in the morning but I was told that he needed another round 1 to 2 months and then the third round in 6 months. I would like someone to advise if this is necessary as I'm scared that this may have future affect on him. Please advise...thanks.
Patient was vaccinated with the second dose of Pfizer COVID-19 vaccine on 10/11/21 at an outside facility or pharmacy (unspecified). Patient presented to the ED on 10/22/21 with a chief complaint of tingling sensation and pins and needles "all over my body".  Reported symptom onset was the night prior, 10/21/21 at 7:00 pm. He went to an urgent care first in which they prescribed him hydroxyzine without any resolution.  He then went to another outside ED but left AMA.   He denied any recent illness, nausea, vomiting, diarrhea, URI symptoms, headache, or vision changes. He denied any similar symptoms in the past. Patient's neurological exam was normal with no measurable deficits.   Patient was discharged in stable condition with neurology follow up. Patient was called back later the same morning on 10/22/21 to return for MRI of brain, cervical, and thoracic spine after consulting with neurology. Upon return patient was unable to undergo an MRI due to inability to sit for very long despite IV sedation. Patient was encouraged to stay in the ED for continued monitoring, but patient preferred to go home. Patient was advised to return to the ED for any worsening symptoms and to follow-up with neurology as an outpatient.
Bells Palsy: prednisone PO 1 wk, acyclovir PO 10 ds started on 1-18-10. ER gave prednisone only.
large local rxn of redness, hot to touch & swollen; poss cellulitis treated w/ATB; 4MAY94 f/u cellulitis @ site of lt arm; tx Cipro
irregular hart rate, hard time to control blood pressure it spiking up to 186/110 , tingling and firing pain in legs( in particular left with sever cramps, I couldn't  walk normally for 5 days), nerve pain and tingling in lower head and shoulders with blur vision that goes away and coming back.
Fever, Chills, Nausea w/o vomiting, Muscle Aches, Headache, and elevated blood sugars.
Patient threw up 8 minutes after the vaccine was administered. Felt a little dizzy after the shot she said. No other side effect. Heart rate was normal. Sat down for 30 min in our waiting room. After 20 min mark, patient was given Gatorade.  Felt better, dizziness went away. Left after 30 min. Offered to call 911 patient refused. Possibly related to nerves
swelling of lymph nodes under arm and in shoulder/neck area, headaches, numbing in neck, shoulder/head, arm numbness off and on, dizziness, blurred vision, body aches, leg pain sometimes, swelling in arms off and on, face numbness and swelling, ear numb off and on, feels restricted when swallowing, wake up gasping for air at night, tiredness, feel off in my head like vertigo
Information has been received from a healthcare professional concerning a 62 year old female with diabetes, and allergies to sulfonamides and codeine who at the end of Sept 2005 was vaccinated IM with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine. Concomitant therapy included metformin HCL (Glucophage), Levothyroxine NA (Synthroid), venlafaxine HCL (Efferxor), atorvastatin CA (Lipitor), Benazepril HCL (Lotensin), estrogens, conjugated (Premarin) and medroxyprogesterone acetate (Provera). The healthcare professional reported that at the end of Sept 2005, one day after being vaccinated, the pt developed a fever and some swelling near injection site. Unspecified medical attention was sought, but no lab/diag test were performed. At the time of this report, the pt was recovering from her fever and injection site swelling. No further information is available.
Received Flu vac. on 10/20/10. 10/20/10 had immediate severe soreness at injection site. 10/23/10 arm still sore achiness & backache. Did not take temp. All resolved 10/24/10.
p/vax pt arm red & knotted up; no fever at present; no dr's office visit; knots are going away
Got the shot and immediately got shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Got the shot and immediately got shingles). The outcome of the shingles was not reported.   It was not reported if the reporter considered the shingles to be related to Shingles vaccine.     It was not reported if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date:28-FEB-2023 The case  was received from the patient via interactive digital media. The patient reported that his/her friends who got Shingles shot and immediately got shingles. The reporter stated that no thanks. The reporter had shingles and he/she was not risking getting it again. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR038022, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR038022:Same reporter
chills, teeth chattering, temp 101.6, sore  la (site), left hip and knee and right wrist very achy and stiff, great fatigue,  Tylenol 500 mg began about 2PM next day.  I spent 24 hours in a recliner unable to do much. The next morning was a new day--improved each hour.
L upper extremity numbness and tingling from elbow to 5th digit on ulnar side. FROM, grip strength 5/5. Cap refill less than 3 sec. Pulses 2+. All symptoms had resolved by the following day.
Global headache, malaise at 7PM                  Fever to 102F orally with chills, backache, bilateral hip pain at 11PM                       All resolved with ibuprofen, acetaminophen at home. Fever recurred at 5AM, resolved with ibuprofen. No fever on presentation.
DIzziness; A spontaneous report was received from a consumer concerning a 69 year old, female patient who received their first of two planned doses of mRNA-1273 and experienced dizziness.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 03 Feb 2021, priorto the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch number: 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 03 Feb 2021, at night the patient complained of dizziness to her daughter. On 04 Feb 2021 the patient was admitted in hospital.   Treatment for the event included Tylenol.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. Further information has been requested.
Pt was found sitting on chair in observation room after receiving her first Covid 19 test (moderna). Pt appears to be weak and pale looking and c/o loss of vision and feeling faint. Pt was t/f to wheel chair and  Pt was t/f to medical room 2 and placed on stretcher in trendelenburg position. Pt vital were taken and  bp was low at 86/54. Pt was allowed to rest and be were  taken every 5 minutes. Pt gradually felt better after 15 mins laying on stretcher in trendelenburg position. Pt felt better and skin color improved . Pt vision was back to normal and all adverse affects were diminished and patient was feeling normal. Bp was 97/66 and pt refused transport to Er and went back to observation room.
In addition to having fever, myalgias, joint pain, fatigue and arm soreness for 3 days, I also broke out in an erythematous pruritic macularpapular rash on all 4 extremities and torso which lasted about 1 week. I did not experience shortness of breath or wheezing. I am seeking guidance as to whether I should receive the 2nd dose.
Client developed a lump right after injection was administer. He denied any, SOB, resp distress. No treatment applied to injection site. Client ask to hang around for 10-20 mins.
positive Covid-19 test result; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (positive Covid-19 test result) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (positive Covid-19 test result). At the time of the report, SARS-COV-2 TEST POSITIVE (positive Covid-19 test result) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, SARS-CoV-2 test: (Positive) tested positive for Covid-19.   Action taken with mRNA-1273 in response to the events was not applicable     No concomitant medications provided No treatment medications provided
Headache on the second and third day. Today is the third day and heavier than yesterday.; My arm is till sore as well; This is a spontaneous report from a contactable consumer (patient). A 44-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6200, patient was 44-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 10Feb2021 at 04:00 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history reported as none. Concomitant medication(s) included metoprolol (METOPROLOL, 50 mg) taken within 2 weeks of vaccination. No other vaccine received in four weeks, no covid prior vaccination, not tested covid post vaccination, no Known allergies reported. On 11 Feb2021, the patient experienced headache on the second and third day. today is the third day and heavier than yesterday., my arm is still sore as well. No treatment was received for events. The outcomes of events were not recovered.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Rash, itching.  Pt states she has done nothing for it.  Called her primary care provider and left a message.
Patient received 2nd Moderna Covid vaccine 3 weeks apart instead of the recommended 4 weeks apart. No adverse events reported.
Narrative: COVID infection following COVID vaccine series 02/10, Moderna , dose #1 03/10, Moderna , dose #2 12/02 COVID swab, result: detected 11/17 pt cc: exposure: unknown
Cellulitis at injection sight that occurred 8 days after vaccine.  Was prescribed antibiotic this AM
Left arm over deltoid with erythema, faint, warm, and slightly swollen local 5th Dtap.
The next morning I woke up extremely tired with body aches . I had a  severe headache, nasal congestion, and a loss of appetite. I had a fever of 100.2. I took Aleve for my body aches, and fever which helped reduce the symptoms. The symptoms lasted almost a week and I did not go to see my Doctor.
nausea, joint pain, muscle pain, headache, chills, insomnia, tiredness, injection pain, don't feel well
Soreness at site of shot with body aches, vertigo, balance problems, motion sickness, and clicking in right ear...over two weeks later the injection site is still swollen and red and I continue to have vertigo and clicking sounds in right ear.
Patient received in monitoring area @2:11pm, slurring speech, slightly altered, flat affect, and slow to respond to questions. Patient stated she felt like she couldn't breathe and was repeatedly scratching at her neck. Patient placed in recliner and vital signs taken 160s/80s - baseline per patient. HR 90s, o2 sats greater than 98%. Patient stated she ate lunch but did not take her metformin this am. Wet cloth applied to forehead and juice given/encouraged. After approximately 20 minutes patient began to respond to questions more appropriately but still slow to respond. Vital signs with o2 sats taken every 5 minutes and remained stable throughout event. Benadryl 50mg po given for itching. Patient began reporting mild nausea. Response team arrived and encouraged patient to go to ED for continued evaluation and testing but patient refused. Daughter called to come pick patient up and patient wheeled to lobby for pickup at 3:07pm.
Moderna COVID- 19 vaccine EUA  Severe dizziness starting 15 hours after injection. Gradual improvement noted throughout morning, but still present
Patient received the J&J vaccine at 1521 and began feeling lightheaded at 1527  and lasted until 1533. Patient was placed in supine position with legs elevated and immediately stated he felt better. Vital signs were assessed and were as follows: BP 110/85, O2 98%, HR 63. Patient was given water and EMS 911 was called and arrived at 1545. Patient declined transport via EMS to the hospital and stated he was feeling "okay". Patient stayed in observation at vaccine site until 1600. Patient left AAOx4 in stable condition, gait steady.
Information has been received regarding a case in litigation concerning an approximately 12 month old male child who was vaccinated with MMR II vaccine. Concomitant therapy included vaccinations containing the emrcury-based preservative Thimerasol. It is alleged that the pt received these vaccinations in or about November 1998 through and including the year 2000 each and every time he received a multi-dose vaccine. It is further alleged that as a result of the pt's exposure to Thimerasol, he sustained severe and permanent personal injuries, including being diagnosed with autism and other neurological disorders as well as other severe and permanent health consequences as a result of exposure to high levels of mercury contained in Thimerasol. It is further alleged that as a result of exposure to Thimerasol and its highly toxic mercury component, the pt has also sustained further neurological insult from other vaccines including MMR II, which does not contain Thimerasol, but caused further neurological insult and exacerbated the pt's neurological disorder from the prior Thimerasol exposures. Upon internal review, severe autism, injuries, neurological disorders and severe/permanent health consequences were considered to be other medical events. Additional info has been requested.
Per Patient received zoster vaccine and started vomiting at 2am on 04/212021 patient was prescribed zofran and if not better in 1-2 days advice to go to ER for hydration
Immediate symptom post vaccination included soreness at the injection site and throughout arm (left). Headache, chills, body aches, extreme fatigue was experienced beginning approximately 10 hours from dose administration, lasting until 8 am the following day (27Apr2021). Patient continued to hydrate with water throughout the duration of the day on 26Apr2021, consuming approximately 1 gallon of water. Additionally, patient took 1 tablet of Motrin 200mg at 9:30am 26Apr2021 and another at 7:30 pm same day. Patient took an Aleve at 7am 27Apr2021.
Tremors, shaking in the hands, arms, head, torso (for about 40 seconds)., anxiety, nausea, no loss of consciousness.  Paramedics called and the SV and observe him.  Leave at 11:10am.
Patient was dizzy and nauseated.  Felt very tired and sat in chair with eyes closed. Symptoms continued after resting reclining for an hour. Patient reports eating a good breakfast and she drank several cups of water during this time period and declined to eat anything. Patient declined to go to her doctor,but agreed to call and consult when she got home and would got to ER if SOB occurred or symptoms worsened.  pulse: range from 94-115 BPM