chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous solicited report from a contactable healthcare professional and a consumer (patient) based on the information received by Pfizer (Manufactuter control number 20210339257) and via PPSPHNO02327 SP Services Theracon (no farther information specified).  A 75-year-old male patient received two single doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both on unspecified dates in 2021, for COVID-19 immunization. Co-suspect drug included macitentan (OPSUMIT; 10 mg tablet) oral, from 2017, 10 mg, 1x/day, for an unspecified indication. Medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient teste positive for COVID-19. The event required hospitalization from 04Mar2021 to 19Mar2021. The patient recovered from COVID-19 on an unspecified date in 2021. Clinical course was reported as follows. On an unspecified date, the patient experienced flu. On follow up it was reported patient was diagnosed with COVID-19, 2 days after receiving his second dose of COVID vaccine. He was admitted into the hospital on 04Mar2021. The dose of macitatan was not changed. The reporter considered the causality between Macitentan and COVID-19 not related. Company causality between macitetan and COVID-19 was not related. Additional information was received from the health care professional and patient on 11Aug2021. The following information was updated and incorporated into the case narrative: Patient demography. reporter details, event flu was updated to COVID-19, cosuspect and suspect dose details and narrative information was updated. Company Remarks (sender's comments): V2 Follow up pertained to patient demography, event of flu was updated to COVID-19), co-suspect and suspect dose details and reporter details. This report concerned an 8 decade old male patient who had COVID-19 infection while on macitentan. Considering the current COVID-19 pandemic and given the novel status of this disease and limited understanding of COVID-19 pathogenesis, the causality for the event was considered as not related to macitentan. The company will continue to monitor and the potential relationship between maitentan treatment and COVID-19 cases. Protocol relatedness was also reported unknown both for reporter and for company.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the event, a possible contribution of the drug to the event cannot be excluded.
Patient was advised to sit for 15 minutes after the vaccination. The first time around patient did not have any allergic reaction to the vaccination. The patient was aware that there was still a potential of an reaction to the vaccination  the second time. The patient sat in the same room vaccinations were being given after her vaccination. She felt a little stuffy so she asked if you could sit outside right by the door. When she went to sit outside in 2 minutes she started to cough and her airways became constricted along with her hands, face and tongue started to swell. Instantly we rushed to her with an Epi Pen but the patient had her own which she took out and used. We laid her on the floor putting a pillow beneath her head while raising her legs up in the air. The facility dialed 911 along with providing an oxygen mask. One minute after the Epi Pen the patient started to feel better then help arrived 5 minutes later to which she felt her airways constricting again. After the emergency help took her to the ER she came back in 3 hours and said she felt fine and the ER had released her.
The patient experienced swelling and pain of the left deltoid with limited range of motion of the left shoulder because of severe pain.
Arm swelling, pain. Redness, swollen red knot (hard).  Difficulty lifting arm up and over head, Redness lasted little over 4 weeks.  Pain can still be felt up until this date.  Used ice intermittently and took Tylenol.  Injection may have been done in error.
This spontaneous report as received from a pharmacist refers to a 70 year old male patient. The patient's pertinent medical history included history of seizure. The patient had no known allergies. On 08-AUG-2014, the patient was vaccinated with ZOSTAVAX 0.65ml (lot # K003597, expiration date: 12-MAR-2015) subcutaneous in the left upper arm rear. Concomitant medications included unspecified seizure medication. On an unspecified date in August 2014, the patient experienced a large scab at the injection site of left arm. The pharmacist stated that the scab was about size of quarter, itchy and painful. The pharmacist stated that there was no rash, no vesicles, no chicken pox, no shingles, just a scab at the injection site of left arm, that was looking like it was already healing. The pharmacist stated that she thought that it might have an infection at the injection site, prior to it crusting over. The pharmacist stated that client was going to follow up with his health care provider. There was no treatment given for adverse event. The outcome of the events was reported as not recovered. The relatedness between the events and the vaccination with ZOSTAVAX was unknown. The patient sought medical attention by coming into pharmacy on 20-AUG-2014. Additional information is not expected because there is no consent to further contact with the pharmacist.
Started as bad sore throat and low grade fever. 12 hours later it is a 102 fever with congestion and cough.
Following an offsite flu clinic, a patient called and complained of marked swelling of the shoulder/arm with red patchiness and numbness shooting down to her hand. Her flu shot was administered 2 hours prior to her call. Prior to administration, she talked about experiencing a similar event twice before. She was told that she experienced the reactions due to a latex allergy. We looked at the vaccine, and noted that it claims to be "free from natural rubber latex." She says she received the flu vaccine many time before; but it wasn't until those previous two incidents where she had reactions. She did not believe that she had a true latex allergy, but was willing to try the vaccine anyhow. I instructed her to ice the area and report to the emergency room if her condition worsens.
Patient called to report that she went to doctor with rash with blisters covering her arm.  She also had body aches.
Excruciating back pain from ribs to should, pain around front ribs, fever. Taking Tylenol every 8 hours. 4 days with no improvement. Remains ingoing
Scattered erythematous papules over L. thigh, improving  Fever, now resolved
Within minutes of getting 1st Pfizer vaccine he had a presyncopal episode.  Stable vitals but felt dizzy/lightheaded, no LOC.  Felt clammy and sweating on his forehead. Mom thought his color was draining from his face.  Returned to baseline after 10 minutes of lying flat with feet elevated, cold water to drink, cold rag on face, and some fruits snacks.
lt eye twitching immed p/vax-body also exhibiting twitching 1-2min;no other s/sx;
Patient had no reported side effects; an expired dose of ROTATEQ was administered; This spontaneous report was received from a nurse referring to a 4-month-old infant of unknown gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.  On 31-MAR-2021, the vaccine of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored in 46 degrees Fahrenheit for 6 hours. At 15:30, on 21-APR-2021, the patient was administered with the expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #: 1676327, expiration date: 19-APR-2021, dose: 2 milliliter (ml), strength was not reported) orally for prophylaxis. The patient had no reported side effects.
Subsequent to vax admin 5/27/99, pt devel seizures and continues to exp these as of Dec 99.
Difficult Hearing. Left ear worse than right. Similar feeling to changing elevation but with out the pressure. Never had hearing issues before. Hearing is going on and off in left ear. Not complete loss, very muffled.
Information has been received from a consumer concerning her 4 month old son who was vaccinated with a dose of HIB vaccine (manufacturer unspecified).  Two weeks later for 2 to 3 days his developmental progress stopped (the baby would not smile, roll over, be active like normal children are).  At the time of this report the patient had recovered.  Additional information is not expected.
Information was received on 11-JUL-2017 from a pharmacist regarding a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, site of administration and lot number not reported). On an unknown date, the patient came into the pharmacy on 11-JUL-2017, because she had developed "redness and a raised hard bump" at the injection site. It was not reported what date the reaction first developed. The pharmacist stated she did not have time to answer any further questions. The outcome of the events were unknown. The relationship between the events and ZOSTAVAX was not provided. No further information was provided. Additional information has been requested.
AFTER I GOT THE THIRD DOSE ON JANUARY 5, 2021, I IMMEDIATELY FELT ONLY THE DISCOMFORT OF THE PINCH. THEN THE NEXT DAY I STARTED TO FEEL PAIN IN MY LEFT ARM AND LEFT BREAST, IT WAS PAIN IN BOTH AREAS. ON FRIDAY I CONTINUED WITH THE PAIN, BOTH IN THE ARM AND LEFT BREAST, BUT AN INFLAMMATION UNDER THE LEFT ARM WAS ADDED TO THIS, WHICH CAUSES ME PAIN AND DISCOMFORT AND AN OUT-OF-NORMAL PROTUBERANCE IN MY BODY. IT IS NECESSARY TO ONLY TAKE ACETAMINOPHEN ON THURSDAY AND FRIDAY ONLY ONE DOSE EACH DAY. TODAY SATURDAY, I WOKE UP WITH THE LEFT ARM INFLAMATED, RELATIVELY MY HAND FITS IN THE BULK THAT I HAVE UNDER IT, THE PAIN IN THE LEFT ARM REDUCES, ONLY THE ANNOYANCE REMAINS ON THE SAME, ALSO DISCOMFORT.
Patient reports severe headache, vomiting  and eye sensitivity to light and eye pain that lasted approx 24 hours.  48 hours post injection Patient is complaining of significant muscle pain around her neck area.
Chills and severe body aches all night on the 26th. The next morning, the chills stopped but I had a really bad headache, the body aches continued and extreme fatigue. The body aches subsided by noon. The headache (like a migraine with light sensitivity) persisted all day along with the fatigue. I felt better by the next morning. The localized reaction (COVID arm rash) appeared 48 hours after the vaccination. All other adverse reactions have resolved but the rash is still there. If it follows the same course as the first time, it should disappear within a day or two. It doesn't appear to be getting worse.
No adverse event; The vaccine expired on 12FEB2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 12FEB2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     The patient medical history/conditions, allergy, concomitant diseases and risk factor was unknown.     On 24-Feb-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 12FEB2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 12FEB2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 12FEB2023).    The patient was around 20 years old. No concomitant medications were reported.    It was unknown if patient had receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  HCP did not knew if patient experienced any adverse events (AEs).   No treatment medications were reported.
After first dose: moderate right deltoid soreness only After second dose: fever, chills, nausea for about 36 hours from onset time listed, significant headache and fatigue for 48 hours from onset time listed
Information has been received from a pharmacist (Doctor of Pharmacy) concerning a 65 year old male who on 06-JAN-2011 was vaccinated SC with a dose of 0.65 ml ZOSTAVAX (Merck) (lot #1381Z). On 07-JAN-2011 the patient experienced shoulder pain. The pain eventually spread to all his joints. The patient was very uncomfortable and weak. The patient was not able to pick up paper. The patient's physician diagnosed him with polymyalgia rheumatica. The patient was prescribed with prednisone as treatment. Blood test was performed, result unknown. At the time of this report, the patient was recovering from polymyalgia rheumatica. The patient sought medical attention by office visit. Polymyalgia rheumatica was considered to be disabling. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a female patient with no known drug allergies or pertinent medical history who on 01-OCT-1998 was vaccinated with a first dose of RECOMBIVAX HB, 1 ml IM. Subsequently, on 10-DEC-2002 the patient was vaccinated with a second dose of RECOMBIVAX HB 1 ml IM and on 24-JUN-2004 the patient was vaccinated with a third dose of RECOMBIVAX HB 1 ml IM. The nurse reported that the patient's titers were negative. Afterwards, the patient was given another series of RECOMBIVAX HB. On 04-SEP-2009 the patient was vaccinated with a fourth dose of RECOMBIVAX HB (Lot number 662115/1263X) 1 ml IM, on 09-NOV-2009 the patient was vaccinated with a fifth dose of RECOMBIVAX HB (Lot number 662115/1263X) 1 ml IM and on 22-MAR-2010 the patient was vaccinated with a sixth dose of RECOMBIVAX HB (Lot number 0727X) 1 ml IM. The patient's titers were taken on 23-APR-2010 and they were negative. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow up information has been received from the licensed practical nurse concerning the four year old female patient with no illness at the time of vaccination. On 31-AUG-2009, a hepatitis B surface antibody test was performed to the patient, the quantity was 0.0. Afterwards, the patient was given another series of RECOMBIVAX HB. On 23-APR-2010, a hepatitis B surface antibody test was performed to the patient, the quantity was 0.0 again. On 03-MAY-2010, another hepatitis B surface antibody test was performed to the patient, the result was negative. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
pt had a 103 fever w/fussiness & irritability for over 3 hrs;
Information has been received from the VAERS database via a journalist. This spontaneous report refers to a patient of unknown age. The patient was vaccinated with lot # (657676/0619U) ZOSTAVAX on 02-OCT-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
My 2nd dose of the Pfizer vaccine was administered on February 2nd, 2021. By mid March, I began to notice bizarre depigmented patches of skin first appeared on the dorsum of my hands.  Never before in my life have I had any skin-related issues, or have I seen anything like this. I scheduled a dermatologist appointment within just a few weeks but was not able to be seen until May 6th. He confirmed the diagnosis of vitiligo. I was later seen by Dr. who also confirmed the diagnosis, and the disease is worsening and has now spread to my forearms, lower legs, and face. She commented that due to the timing of the vaccine administration just 6 weeks prior, that I should submit a VAERS report as it is extremely abnormal to be diagnosed with vitiligo this late in life, and with the timing of the vaccine it makes sense that it could be related.
Patient presented to  RN and was given 1st dose of Moderna vaccine. Upon review it was discovered that patient was 16yrs and 1 month old. Patient was observed for 15 minutes with no adverse reactions. Patient was educated and downloaded vsafe for further monitoring. Workers were notified. Patient was advised not to get 2nd dose.
Patient had/has  fever 101 degrees since injection and mucous stools, Advil 100mg/5 0.5tsp q 6 hours.
I?m experiencing leg pain such as tiredness and stiffness. It started a couple of days ago.
Developed burning in L buttock and labia on the evening of the vaccine (3/13).  This progressed to shingles with urinary retention by 3/17
17 y/o female who received 1st dose of Moderna Covid-19 vaccine in error; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 y/o female who received 1st dose of Moderna Covid-19 vaccine in error) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 19-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 y/o female who received 1st dose of Moderna Covid-19 vaccine in error). On 19-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 y/o female who received 1st dose of Moderna Covid-19 vaccine in error) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Per mom, child developed fever (103.6 deg F), injection site redness, swelling, tender to touch. She phoned PCP 1-24-18 afternoon who advised to give TYLENOL or MOTRIN PO. 1-26-18 mom took child to a quick care clinic; child was found to have an ear infection and was prescribed OMNICEF by mouth. The site of injection reddened, warm, sore to touch, appeared to have cellulitis approx. 3" wide x 4.5" long area. Mom advised to give antibiotic, which would help both ear infection and cellulitis, moist compresses, TYLENOL and MOTRIN alternating for pain/fever/ or discomfort. If condition worsened or red streak developed, to notify office. When I spoke to mom Monday 1-28-18, she stated child was running around and much improved. Site improved, not growing in size.
Severe pain and swelling. Redness, tenderness down entire arm and into chest. Fever , aches, chills.
chills and fever for 5 hours, overall aches and pains, weakness.  I was out of it for over 24 hours...could not get out of bed except to go the bathroom.  I usually have no reaction to flu vaccine.  I had mild reaction to 2nd covid dose and booser.
Starting the morning after my second dose of Moderna, I had severe chills. Then in the afternoon I had a 101.7 fever and body aches. My fever broke in the evening. The next day I had a low grade fever, brain fog, and headache. Third day headache, sore itchy red arm, red cheeks and nose (Flushed). Fourth day still have sore arm and rash at injection site.
A report has been received from a Health Professional concerning a male patient who had been receiving Nasal FLUMIST Quadrivalent (Intranasal). FLUMIST Quadrivalent (Intranasal) started on 11-Mar-2016. It was reported that patient was administered with expired FLUMIST. The outcome of the event of administered expired FLUMIST is unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationship between administered expired FLUMIST and FLUMIST Quadrivalent. The company physician considered that there was no causal relationship between administered expired FLUMIST and FLUMIST Quadrivalent.
Approx 16DEC91 pt felt numbness & dec movement in the rt side of the face; On 18DEC91 pt appeared in ER w/same sx & dec taste, dec muscle movement, dec sensitivity; dx probable Bells Palsey; ENT referral made;
Information has been received from a registered nurse concerning a 12 month old white female patient with a history of occasional Eczema who in the AM on 05/21/2004 was vaccinated in the right thigh with a first dose of varicella virus vaccine live.  Other vaccines administered in the AM on 05/21/2004 included a first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live administered in the left thigh.  The patient was not ill at the time of vaccination.  On 12 or 06/13/2004 in the afternoon the patient developed a chickenpox rash.  The pox appeared in the diaper area and down her legs.  The parent reported that the patient also had cold symptoms.  The patient also developed a diaper rash which was treated with over the counter options.  It was noted that otherwise the patient received over the counter and palliative care.  There were no laboratory or diagnostic tests performed.  It was noted that the patient and sibling had no adverse events following prior vaccinations.  The patient was reported recovered on 06/22/2004.  No product quality complaint was involved.  Unspecified medical attention was sought.  No additional information is expected.
Patient had a large reddened swollen area on the back of the right upper arm. Size 3" x 4".
Patient presented to the ED complaining of shortness of breath and cough.  Patient was admitted to the hospital with Covid and hypoxia requiring oxygen.  Patient was treated with remdesivir.
Incomplete dose of a vaccine because some dropped down his arm; A spontaneous report was received on 03 FEB 2021 from a healthcare professional concerning a patient, unknown age, unknown gender, who was administered Moderna's COVID-19 vaccine (mRNA-1273) incomplete dose because some dropped down on arm.   The patient's medical history was not provided.  No relevant concomitant medications were reported.  On an unknown date, patient received their first of two planned doses of mRNA-1273(Lot number: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  On an unknown date, patient received incomplete dose  of the vaccine because some dropped down on arm,   Action taken with the events was not reported.  The event, Moderna's COVID-19 vaccine incomplete dose administered because some dropped down on arm, was considered resolved.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of Incorrect dose administered.
Pt ran fever of "nearly 105" along with vomiting; fever broke Friday 15NOV91; MD advised that pt not receive Pertussis;
On Thursday, April 8th, a little over 24 hrs after my second dose, I noticed my  left arm felt stiff and sore. I realized the source of  pain was from my underarm , the pit felt swollen and very quickly  I could not lift my arm up nor out to the side.  I used a microwaveable heating pad both  Thursday and Friday night.  Today is Saturday and it is about 75% better although it is still sore to touch. I do suffer with fibromyalgia and if not for the armpit swell, and how quickly it all progressed, I would have thought it was ?frozen shoulder?, something I have experienced before. There did also feel like a big knot in the pit and the muscle was ver painful to touch as well as felt like a knot was in it too.