chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In June 2016, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2017, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of her injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Form re-accomplished. Original form thought to be filed in 2000. No record found. 1999-2000 pt c/o loss of sleep, noticed excessive bruising, CDTS, injuries took excessive time to heal. Pt reports sx have resolved since that time. Last shot given May 2000. First dose 11/7/98.
A very sore arm - right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (A very sore arm - right arm) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (A very sore arm - right arm). At the time of the report, VACCINATION SITE PAIN (A very sore arm - right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Instant headache after vaccine then malaise. Next day mild upper respiratory symptoms, fatigue and malaise. Fatigue and headache for 4 days. Slept most of the next 3 days. I took tylenol with little effect
Starting about noon the next day I was walking outside and completely passed out cold, hit head on the way down. When I came to everyone was standing around me and told me not to move. I was unconscious about 10 sec. Everything went white. An ambulance was called, it took them a while to show up, evaluated inside ambulance, everything was normal. EMT advised that they didn't think I needed to go to the ER.
The patient had burning of the throat and had trouble breathing, I had to call emergency number at patient request and was evaluated by paramedics.  The patient had two vaccines administered at one time, the covid and a tetanus shot.
A nurse reported that an adult patient did not respond to the hepatitis B recombinant immunization series. On 5/20/03, the patient received the third injection of Engerix B, which was injected into the right leg, rather than the recommended deltoid. An unspecified titer performed on 6/19/03 revealed that the patient did not obtain adequate titer levels.
This spontaneous report as received from a consumer on behalf of her sister, a 61 year old female patient. The patient had shingles twice before receiving ZOSTAVAX however the cases of shingles had resolved before receiving the ZOSTAVAX. Patient had no drug reactions/allergies. On 19-SEP-2013 the patient was vaccinated with ZOSTAVAX in the left upper arm, lot #, dose, route, frequency and indication unspecified. On 24-SEP-2013, the patient experienced nerve and muscular pain. She self-diagnosed that she had Shingles again however no rash has developed. No treatment had been given for the events, and no lab diagnostics studies performed. The patient did not seek medical attention. The outcome of the events was reported as not recovered/not resolved. Additional information is not expected.
Developed pain and cellulitis to right upper arm shoulder area and fever up to 104. She received both the flu and pneumococcal vaccine in same arm on 10/4.
Individual with nausea, vasovagal response s/p vaccine administration. Monitored and recovered s/p PO fluid intake and fresh air.
No adverse reaction. Patient was given rotateq PO on 3/29/22 and it expired 3/28/22. Mother notified during visit. Called CDC and department of health both stated it would be invalid and to repeat in 4 weeks. Mother notified and voiced understanding.
Pt with severe hematoma 1 day after administration. hematoma and pain presisted 3 days after. One month since vaccine and pt with decreased ROM and muscle decrease in right arm with severe pain to the shoulder.
Huge lump the size of a softball (and growing)  tender, hot and very tight. Feels like a tremendous boil that could burst.
13 Days after receiving booster Vaccine developed hives that come and go.  Hive are on different parts of the body that last approximately 24 hours.  Applies hydrocortisone cream which helps with hive.  Hives continue to present to different areas.  Has been evaluated by dermatologist.  Referred to allergist.
No adverse event...Expired vaccine was inadvertently administered to patient. Manufacturer (Merck) confirmed that the Lot is still effective.
Patient described it as muscle aches starting in opposite arm (left arm) as injection arm (right arm) and all over muscle aches. Vaccine was given in 11/2015 and she still has problem with left arm. Can't raise it all the way.
three doses were administered to three patients after manufacturer date of expiry; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (three doses were administered to three patients after manufacturer date of expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (three doses were administered to three patients after manufacturer date of expiry). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (three doses were administered to three patients after manufacturer date of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug was not reported. Treatment medication was not reported.  On 08-Sep-2021, The vial was initially stored in the refrigerator and the vial did not undergo any temperature excursions.  Three patients were administered expired Moderna covid-19 vaccine (Manufacturer Expiration Date: 18-Sep-2021)
Moderna Booster administered. Patient had checked no on all pre-screening questions per staff. Patient assisted to common area to monitored by staff. Patient became unresponsive. Staff assessed patient and reported bradycardia and hypotension. Patient made comfortable and stable, staff remained at patients side and call for medical response to scene. Staff later reported patient has been trying to get her A-fib under control and is currently taking a beta blocker. Staff report that they may need to adjust her dosage and that this is the second time recently that this patient has had a hypotensive spell.
pt recv vax 24AUG94 & exp irritability, low grade fever noted x 48 hr; sx worsened-MD visit 3 days p/vax; had bulging fontanelle; spinal tap revealed elevated wBC; dx viral meningitis; rx as outpatient-recovered; no sequelae
I got my vaccine around 11:40 am. Within 5 minutes of the vaccine, I could feel that my face was hot and had tingling sensation under the skin around my cheek. I was sent behind the curtain with a Emergency doctor. At the time, the symptom did not get worse, so I was discharged. When I got back to my place and was in my meeting around 1:45 pm, something felt weird around my lips and my tongue. I could feel that my tongue was swelling, so as my lips  I got scared so I took another dose of Xyzal. I could still feel that swelling was progressing. My colleagues told me that I was talking as if I couldn't feel my tongue and my tongue wasn't moving as I was talking. I remembered the doctor at the vaccine site told me to call 911 if the symptoms got worse. So I called 911, paramedics came. Epipen wasn't necessary, but I took another dose of Xyzal. Other than my blood pressure being shot up, my vitals were okay. They did confirm the allergic reaction but told me that they cannot confirm that it is from the vaccine. However, I have never had such a reaction in my life, I highly believe that it was from the vaccine. The swelling did not go away for 7 days. And during the time, I was taking at least 15 mg of Xyzal per day to keep the itchiness and swelling down.  I reached out to my PCP and he advised not to get the second dose.
Vaccine administered beyond Expiration date. However, per Moderna- all vaccines met viability requirements.  Completing VAERS per state requirements.
Patient was monitored and at 30 minutes, patient stated feeling itchy with slight rash/redness developing on neck/chest area. Patient stated feeling increased heartrate, however heart rate and sp02 were check twice and at normal levels. Administration of benadryl 50 mg was given. Patient did not have any signs of anaphylaxis , after 1 hour patient still had itchy feeling/rash but no other issues. Patient was recommended to seek medical attention. Contacted later and patient was doing ok with no other symptoms besides tiredness/fatigue from vaccine.
CHANGE IN SMELL, ALL THINGS SMELL SIMILARLY BAD.   CHANGE IN STOOL COLOR.    BLOOD TESTS SHOW NOTHING ABNORMAL.  ALL WITHIN NORMAL RANGES.
33 y/o male, no past medical history, who presents with left ear and left upper and lower extremity numbness. Negative Stroke Scale.  Vaccination site was the left deltoid. NP and Paramedics at patients side. Patient vitals within normal limits. Patient placed in Trendelenburg position. Patient asked to lay on his right side to see if the feeling would travel to his right side. Patient states that numbness was getting better and he thinks that it was going to the right side. Patient denied headache, no facial droop noted, no facial asymmetry present. Patient symptoms persisted for over 40 mins so Fire Rescue was called. Patient was transported to hospital. -------------------END.
Area of injection became reddened and it change on 10/14/2001. On 10/15/2001 and 10/16/2001 with redness and itching. Improved by 10/17/2001.
feeling like a muscle injury; decline in range of motion; This is a spontaneous report from a contactable consumer or other non Health care professional (patient, self-reporting) via Pfizer Spontaneous Program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration in arm on an unspecified date as single dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration in arm on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced feeling like a muscle injury and decline in range of motion on an unspecified date. She reported that had her first and second dose of the COVID-19 vaccine, reporter stated that injections were both in the same arm, complaints of feeling like a muscle injury and decline in range of motion. The outcome of the events was unknown.  No follow up attempts are possible. Information about lot/ batch number cannot be obtained.
This adolescent recieved the incorrect formulation of the Pfizer Bivalent Booster. He recieved the 30mcg dose of bivalent instead of the 10mcg orange cap dose. Family reported no reaction or development of any side effects that day or since that day.
Information has been received from a medical assistant referring to an 11 week old male patient. No relevant medical history or concurrent conditions were reported. On 29-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a 41 year old female who was postpartum with no known drug allergies and no significant medical history and on 27 MAY 1996 was vaccinated with MMR. Therewas no concomitant medication. In 1999 the patient experienced weak feeling, fever, facial twitching and chills. Additional information has been requested.
Just a lot of soreness. After 2 hours I began to have a lot of pain; I was even having trouble raising my arm up because of the pain/soreness; I was even having trouble raising my arm up because of the pain/soreness; This is a spontaneous report from a contactable healthcare professional (patient). A 22-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL8982), intramuscular on 21Jan2021 10:00 at single dose (left arm) for covid-19 immunization. The patient medical history was not reported. The patient had no allergies to medications, food or other products and patient was not pregnant. There were no concomitant medications. On 21Jan2021, 12:00, the patient experienced a lot of soreness. After 2 hours, she began to have a lot of pain for the rest of the day. That same night, she was even having trouble raising her arm up because of the pain/soreness, but by the next day the soreness went a lot more down. There was no therapy for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had no other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included Sars covid test (Nasal Swab/Rapid Antigen) was negative on 22Jan2021. Outcome of events was recovered on an unspecified date.
Patient came here for 2nd dose. After giving the vaccine, it was discovered the 1st dose was given 1/7/2022. 2nd dose was given 10 days early.
mom states t103 on day of visit w/swelling to elbow, & redness; mom giving APAP q 4 hrs; day 2 swelling & redness inc fever better; day #3 swelling & redness inc, c/o itching @ site; day #4 fever gone redness better but swelling spread;
Moth of child brought pt back in within 15 minutes c/o rxn. Redness/rash developed on left and right thigh where MRR and Varicella vaccines where respectively administered.  PCP made aware. Took verbal order to give 12.5 mg of Benadryl. PCP assessed pt's cardiac/respiratory system. Pt monitored for 30 minutes.  Symptoms subsided. Cleared by PCP. PCP prescribed Benadryl as needed with directions of when to seek help. VAERS to be completed.
DOSE 1: hours post vaccination.  14th hour: low fever 100F with chills. 30 -hours: high fever 104.2F for continued for 6-8 hrs. reduced after intense cold water sponging. Full recovery post 60hrs  DOSE 2:   1PM Thursday: got me second shot 12.45AM Friday: onset of high temperature 105.3F for  3hrs (reduced after intense ice water sponging), vomited twice. 3.30AM Friday: chills and excessive sweating Friday morning to Saturday all day low fever with chills, mild headache, tiredness and body pains. Sunday-Monday: mild headache, loss of taste, onset of cough. Tuesday-till date: mild loss of taste
suspected COVID-19; suspected COVID-19; This is a spontaneous report from a non-contactable consumer (patient's daughter). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on 24Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that the patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine on 24Jan2021 and had contracted COVID-19. The reporter stated that the patient was supposed to receive the second dose "today"; however, since the patient contracted COVID-19 she was unable to get her second dose. The reporter wanted to know if the vaccine would still be effective if the patient waited until after she had recovered before receiving the second dose. The reporter wanted to know exactly how many days after the patient recovered from COVID-19 should she receive the second dose of the vaccine. The patient also stated that her sister suggested that their mother receive an antibody infusion and wanted to know if this would affect the Pfizer-BioNTech Covid-19 Vaccine. The clinical outcome of the event "suspected COVID-19" was unknown.    No follow-up attempts are possible. No further information is expected.
progressively gotten worse; tingling in the same arm; throbbing, painful feeling, it's interrupted by pain, it's a dull pain; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in the same arm), PAIN (throbbing, painful feeling, it's interrupted by pain, it's a dull pain) and CONDITION AGGRAVATED (progressively gotten worse) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for HIV disease, ATORVASTATIN for an unknown indication.    On 20-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced PARAESTHESIA (tingling in the same arm) and PAIN (throbbing, painful feeling, it's interrupted by pain, it's a dull pain). On an unknown date, the patient experienced CONDITION AGGRAVATED (progressively gotten worse). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (tingling in the same arm), PAIN (throbbing, painful feeling, it's interrupted by pain, it's a dull pain) and CONDITION AGGRAVATED (progressively gotten worse) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient said that pain had progressively gotten worse. The last week or two he could not find a comfortable position to sleep due to the pain he has been experiencing. His sleep has been getting interrupted by the pain. He says that he is normally a healthy person and he does not participate in any activities that would cause a throbbing pain like this.  He says that not having been able to sleep the last couple of weeks is most distressing. The patient was qualified to take third dose of Moderna vaccine. The patient could only point towards the Moderna vaccine for causing this.   This case was linked to MOD-2021-335659 (Patient Link).
A rash developed around the injection site about 8 days following injection.  The area was also hot to the touch and itchy.  Lasted about 5days.  Applied some hydrocortisone cream after 4 days.
There were no patient adverse reactions to the injection site or health of the patient. Noted and reported due to the administration of expired vaccine.
By 10:50 am, my tongue was numb, I couldn't hold a pencil, my right hand and arm had pins and needles, and I was confused.
Within a few minutes after vaccination, while parked, she had onset of a severe pain on the right side of her face with numbness as if she just had dental work. She has history of severe migraines in past of similar severity, but usually on her head, not her face. The pain spread to her forehead. She denied weakness, shortness of breath, difficulty swallowing, face nor throat swelling. Her blood pressure was checked and was normal. Her face stayed symmetric. She had normal movement of all extremities. She took her migraine medication rizatriptan around 125pm. She repeated her dose 45min later. She was still in severe pain, but better enough where she could move and talk again. Her husband who was present, slowly helped her to the passenger seat and drove her home. I checked in 2 hours later and he reported that she was improving and resting.  I advised multiple times to call us or 911 if having any new weakness. If she developed right face weakness, only we would likely start prednisone for bells palsy. Husband expressed understanding of plan.  On 3/6 at 3pm, on follow-up call, pain has resolved. Still with numbness "as if I've been injected with novocaine", and tingling on her right side of face to touch. No weakness, no facial asymmetry.
No adverse reaction has been reported however Pediarix is only approved for use in those from 6 weeks to 6 years old.  Patient was in need of Polio vaccination but should have received IPOL, not this product.
Patient had swelling on the right arm the day after his vaccines that ended up in an urgent care visit and treatment for cellulitis. Mother called me over the weekend reporting swelling of the extremity where the vaccine had been given. Told her to apply ice 10 minutes on and the rest of the hour off as much as she could, to outline the erythema, and to give ibuprofen. Told her to FU with our office or urgent care if it became worse. Notes from urgent care were sent to our office today stating they placed the child on cephalexin and told to FU with our office. Patient has not FU with us yet.
patient reports severe flu symptoms (fever, sweating, chills, and headache) that developed Friday night after the vaccine (11/1/2019), lasted throughout Saturday (11/2/19) and subsided Sunday (11/3/19)
Patient developed a rash at the site of vaccination a few days after receiving the second dose of vaccine. Patient stated that the rash was improving. Advised the patient to monitor the rash, if it got worse or became painful at any point to seek medical attention. Patient understood, and replied that the rash was not bothersome, but wanted to make sure it was okay to have.