chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diagnosed with Covid/sinus for 2 weeks, tested positive; diagnosed with Covid/sinus for 2 weeks, tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 21-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown) and as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "diagnosed with Covid/sinus for 2 weeks, tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Sep2023) Positive. Clinical course: Caller (Patient/daughter's mother) reporting that entire family took Covid vaccine. Caller and her 2 adult daughters, started to have people around them get Covid. Jul2023, they all panicked, took the vaccines. Tuesday, this week, all of them got Covid. They live in separate households. Diagnosed with Covid: Daughters had sinus for 2 weeks, they both tested positive. This was all Tuesday, 19Sep2023. Daughters are twins, both doing all normal activities. They were isolating themselves, according to CDC. Caller and her 2 daughters took their booster in Jul2023. Does not have daughters card.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300307925 same reporter/drug/AE, different patients;
Patient returned 2 hrs after vaccination c/o shortness of breath and "tingling fingers." Hyperventilating upon arrival. VS - 1326 - BP 129/78, HR 90, 100%. 1331 - 131/68 - HR 80, 100%. 1337 - 126/71, 83, 100%. Code yellow called. Patient to ED.
Soft stool; Diarrhea; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of FAECES SOFT (Soft stool), DIARRHOEA (Diarrhea) and RHINORRHOEA (Runny nose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (Has allergies once a year with seasonal change).   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FAECES SOFT (Soft stool), DIARRHOEA (Diarrhea) and RHINORRHOEA (Runny nose). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form. At the time of the report, FAECES SOFT (Soft stool), DIARRHOEA (Diarrhea) and RHINORRHOEA (Runny nose) had resolved.            No concomitant medication were reported. Patient recently had and abdominal ultrasound to see what could be causing the gastro-intestinal issues and waiting for results. Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-239104 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Outcome of the events updated. Lab test results awaiting. On 26-Jul-2021: Follow up Contains No new information.
2 hours later after injection of covid 19 vaccine left arm was red, swollen, warm, and itching with a small rash from mid arm going around to inner left arm.
My mother mother, was diagnosed with Guillain-Barre syndrome. She was in the hospital for two weeks, and then in another hospital before she was diagnosed. She was in respiratory failure from August 10th and never recovered. She was in a third hospital for acute illness when she passed away. We had the breathing tube removed when we realized there was no hope of a recovery. The only different medicine she had had was the new vaccine for shingles. She had the first dose on April 25th, 2018 and never had the second dose. I had read that flu vaccines could cause Guillain-Barre, usually closer to the time of the vaccine. But given how Guillain-Barre is so rare and the shingle vaccine is so new, I wondered if there was a connection. The beginning symptoms of Guillain-Barre seem harder to decipher with an elderly patient that already had trouble walking and that already had neuropathy. It took many tests and many doctors, in 2 different hospitals, almost 3 weeks to confirm the diagnosis. Even with plasmapheresis, there was no significant change in her condition.
Information has been received from a health professional concerning a 19 year old female with a hypersensitivity to "sepna" who on an unspecified date was vaccinated (at another unspecified physicians office) with the first dose of Gardasil vaccine (yeast) (lot# not provided). Concomitant therapy included naproxen sodium (Aleve) and ibuprofen. Subsequently, the patient reported that she experienced itching and swelling at the injection site which spread to her body. The patient sought unspecified medical attention. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested.
Initial report received on 02 June 2009 from a health care professional. A 16 year old female patient with allergies to Augmentin and Ampicillin received ADACEL (lot number C3246B) in the right deltoid and MENACTRA (lot number U2844AA) in the left deltoid on 28 May 2009. On 29 May 2009 the patient developed a temperature of 101, neck pain, headache, nausea, and a rash on head and arms. When the patient was asked to put her chin to her chest the patient complained of severe neck and spinal pain. The patient reported that the evening after the vaccine was administered she was bumped on her back and felt severe back pain. The recovery status was unknown. List of Documents held by Sender: none.
REDNESS, SWELLING, ITCHING, WARM, PAIN TO THE BONE, HIVE.
I had my second covid vaccination on 2/3/21.  On the morning of 3/16 I woke up short of breath, chilling, chest pain, chest congestion and cough, and a fever of 101F which rose to 102.5F.  I was monitoring my pulse ox which would range from 90 to 91% but at times dropped to 84%.  I had to mentally take deep breaths to get my pulse ox to 90%.  These symptoms lasted 12 hours.  Next day, short of breath at times and tired.  Called the health department on 3/18 and was told to get a rapid test which was negative.  The NP thought I might have pneumonia or a pulmonary embolus.  I was sent to the ED and a CTa  scan was done and everything was normal including 12 lead ekg, pulse ox and vital signs.  The physician thought it was GERD.  I'm a nurse and  have GERD, this was not GERD.  The PA that took care of me agreed the symptoms were, 'weird' and I should report this incident.
vaccine had multiple temperature excursion with no reported adverse event; administering dose post temperature excursion with reported adverse event; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 14 years old female patient and reporter stated that vaccine had multiple temperature excursion with no reported adverse event and administering dose post temperature excursion with reported adverse event involving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE, MUMPS VACCINE LIVE, RUBELLA VACCINE LIVE (MEASLES MUMPS AND RUBELLA VACCINE LIVE ATTENUATED) for Immunisation.  It was reported that there were multiple excursions, the first on unopened MDV on 05-Apr-2022 a high of 8.63C for 15 minutes, reporting a dose was administered post excursion but the MDV was sealed at the time of the excursion at 8.63C for 15 minutes. The second excursion occurring on 05-Jul-2022 at a high of 11.22C out of range for 10 hours, and on 18-Jul-2022 a low of 1.17C for 45 minutes.  On 19-Jul-2022, the patient received a 0.5ml dose of suspect IPV (VERO) (strength, formulation was unknown, lot U1A452M and expiry date: 20-Feb-2023) via intramuscular route in the right deltoid for Immunization.  On 19-Jul-2022, the patient developed a non-serious event of vaccine had multiple temperature excursion with no reported adverse event (product storage error).  On 19-Jul-2022 the patient developed a non-serious event of administering dose post temperature excursion with reported adverse event (poor quality product administered) (Latency: same day) following the administration of IPV (VERO).  Further it was reported that the excursion occurring on 29-Jul-2022 at 10.93C for 12 hours, and on 06-Aug-2022 at 1.6C for 1 hour  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
FEVER; This spontaneous report received from a consumer concerned a 63 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808096, expiry: UNKNOWN) dose was not reported, administered to left arm on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, in evening, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
experienced dry pain on my knees; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (experienced dry pain on my knees) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and APIXABAN (ELIQUIS) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced ARTHRALGIA (experienced dry pain on my knees). At the time of the report, ARTHRALGIA (experienced dry pain on my knees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was unknown.   This case was linked to MOD-2021-238940.
About 1-2 minutes after patient received HPV vaccine in left deltoid, he stated that he felt like he was going to pass out. He was sitting at the time, and leaned forward slightly to hang his head between his legs. Mom and I then gently laid him back on the exam table and I pulled out the leg rest so he could lay supine; I also lowered the head of the bed as much as possible and then lifted his legs and rested them on my shoulder. He became very pale at this point and was mumbling a bit saying that he was in pain "Ow, ow" and "i'm going to pass out." About 2 minutes after the vaccine was received, as he was lying there, his eyes rolled backwards and I was only able to visualize the whites of his eyes for approx. 10 seconds. At this time he shifted over onto his right side and became quite "stiff"- he pulled his arms in towards himself and was moving them in a very mild jerking motion. I kept his legs elevated and put the pulse ox on his left index finger; it registered 97% SaO2 and 79 bpm. Mom remained very calm and stayed close to patient's face, talking to him during the episode. He was not responsive to her questioning about how he was feeling. At this point I noticed that the patient had urinated a bit while laying on the exam table. At no point can I say for certain that he "lost conciousness" - I don't recall his eyes fully closing or seeing his body fully relax / go limp - in a way he was more stiff and guarded for about a minute or so. Then slowly he regained a more normal facial expression and demeanor, and asked for a cup of water. He also stated he had to go to the bathroom. We kept him supine and gave him water, then over the course of about 10 minutes moved him from supine to seated, then from seated to standing. He was able to tolerate this well. His color did not return to normal for about 20 minutes.
Client given flu vaccine 11/10/05 @9:45 AM .  States she has previously had a skin rash from a bandaid.  A bandaid was left on her arm for approximately  five (5) minutes. At approximately 5:30 PM- 11/10/05 client noted itchy arm with rash, in general area of injection site. Client did apply cold pack to area.On 11/14/05 this CD person noted slightly reddened red raised area 13 by 10 cm & slightly warm to touch. Client reports no prior reaction to flu vaccine given annually the past 3 plus years.
2/8/08 >3 watery stools no blood.  2/9/08 10-12 watery stools heme +ve x 1.  2/11/08 ongoing watery stools.
No adverse effects; patient received a dose of MMR II that expired; This spontaneous report as received from a medical assistant refers to a patient of unknown age.and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 27-AUG-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), albumin status rHA, lot # N023153, expiration date 24-AUG-2019 (dose and route of administration were not reported) for prophylaxis, diluted in a sterile diluent. The administered expired vaccine did not have any temperature excursion. There was no adverse event reported.
Pt was admitted to Medical Center on 4/21/21 from the ED for COPD exacerbation. 11 days after receiving  the second dose of vaccine. Per guidelines, all hospitalizations are to be reported.
Tested COVID-19 positive, resulted in hospital admission. Symptoms include chest pain and fatigue.
Received KINRIX on left thigh. Mother noticed swelling, redness and itching on 3/5/17 near injection site. Erythema to left thigh noted as 13 x 14 cm during office visit.
Information was received from a lawyer regarding a case in litigation. During 2016, the patient, age and gender unspecified, was inoculated with ZOSTAVAX at a medical office (by an unspecified health care professional) as recommended for routine adult health maintenance for prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles. Later in 2016 the patient was treated (by an unspecified health care professional) at a medical office for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Leg Pain 03/03/2021 Erratic BP episode 03/11/2021 9:00am  BP 202/117, P78 After 15  minutes BP 108/65, P77 10:00am BP 172/86, P79 12:00 pm BP 138/75, P79 Dr. was called and is having us monitor her.
Breakthrough case. Confirmed covid positive on 9/6/2021 with PCR testing
The day after my second dose I was achy, tired, and weak. These were all normal to me. However, in the early afternoon I started getting stomach cramps like I did after the first dose. This time they lasted all day and throughout the night until 6am on 4/24. The cramps were located right below my rib cage on both sides although more severe on the left side. The cramps were so severe and painful that they woke me up every few hours. I had to ice my belly to get relief. The morning of 4/24 I noticed my belly was bloated, round, and hard. On top of this I experienced brain shivers or zaps. I thought this might just be me since it had been a month after stopping my anti anxiety meds, but my boyfriend also had brain shivers. He is on a steady dose of anti depressants. Brain shivers usually only occurs when a patient is decreasing these types meds. I would like someone to contact me via email in regards to all my strange side effects.
4 bouts of diarrhea from 4:00pm to 8:00pm, occurring on the second day after vaccination.  No medical treatment needed.  Hydrated with smart water (electrolytes) and slept 10 hours that night, with no further diarrhea in the night.  Ate light for the rest of Thursday and all day Friday.
Patient did not accurately complete the vaccine immunization record form prior to vaccination. Patient checked box on questionnaire incorrectly, stating that they were 18 years of age or older when in fact patient was only 17 years. Patient was given Janssen vaccine that is not approved for under 18 years.
This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Axillary lump), VACCINATION COMPLICATION (She had a bad reaction with the first dose), VACCINATION SITE PAIN (Pain at injection left arm), FATIGUE (Fatigue) and LYMPHADENOPATHY (Swollen lymph node) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection left arm) and FATIGUE (Fatigue). On 31-Mar-2021, the patient experienced AXILLARY MASS (Axillary lump) and LYMPHADENOPATHY (Swollen lymph node). On an unknown date, the patient experienced VACCINATION COMPLICATION (She had a bad reaction with the first dose). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and Bed rest for Axillary mass. On 28-Mar-2021, VACCINATION SITE PAIN (Pain at injection left arm) had resolved. On 31-Mar-2021, FATIGUE (Fatigue) had resolved. At the time of the report, AXILLARY MASS (Axillary lump), VACCINATION COMPLICATION (She had a bad reaction with the first dose) and LYMPHADENOPATHY (Swollen lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information also included heating pad.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant Follow up Appended - Reporter mail address updated and new event added and second dose information was updated.
Patient received a COVID Peds Pfizer vaccine. The vaccine vial was undiluted.
3/28/21, 9:35 a.m. received Pfizer shot.  28 mins after receiving shot in my right arm, my forehead and cheek bones started to feel numb.  Shortly after, my whole left arm (opposite arm where I had shot) all the way to my fingertips, extending to my left part of my chest, had a very strong sensation, numbing.  I told the EMT's on site and was watched.  That lasted 12 mins.  Once it subsided, we left ,thinking it was done.  Throughout the rest of the day, I felt waves of a "spacey" feeling, walked with a wide gait feeling "out of wack", and this would occur every 10-15 mins.   3/28/21 4:00 p.m.went emergency room when my left arm again, went numb.  It extended from my left elbow down and worked its way up my arm after extending to the left side of my upper back.  This occurrence was a little less intense than the first, but very worrisome.  Also, my right arm had the same reaction this time, only on a lesser intensity than my left arm.  After it resolved, both thumbs remained tingling.  Went to ER.
Developed ecchymotic areas on body 2.5 by 2.5 circle/square at the injection site and they are not fading; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 24Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION SITE BRUISING (non-serious) with onset 24Jul2022, outcome "unknown", described as "Developed ecchymotic areas on body 2.5 by 2.5 circle/square at the injection site and they are not fading".  Additional Information: The reporter was a registered nurse was calling in regards to her husband. The reporter stated that her husband received his 2nd booster dose of the Pfizer Covid 19 vaccine on 24Jul2022 and shortly after developed ecchymotic areas on his body and they are not fading. Caller asked if that affected his absorption of the booster dose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe neurological and cognitive decline.  Patient is currently unable to walk unassisted and is between a walker and a wheelchair.  His cognitive function has also been affected to the point that some days he is unable to process how to even feed himself.
100.06 fever, body aches, sore arm.  Next morning after receiving the new 2023 Moderna Spikevax.
Patient was given a dose that had been drawn up 2 days prior and stored at 5 degrees C.
pt recvd vax; pt exp'd headache, weakness, nausea, dizziness, insomnia & sleep disturbances;
Day #14 following primary smallpox vaccination, pt noted red bumps with white halos on inner thighs spreading to entire lower extremity bilaterally, and associated itching; Seen at clinic and prescribed antipruritic; Seen by me on 25Mar03 (day #20)diffuse papular, nonblanching LE rash with some intralesion color variation from violacious to dark purple; seen by Dermatology 26Mar03 and prescribed steroids, medical illustration photographs pending.
Site of vaccine administration produced a hard knot in the muscle that continues to cause patient pain. Visible knot measures 4 cm x 3 cm on (R) shoulder.
I am in pain in all my joints  bones and muscles, headache, high fever, chills, shakey,/ trimbling, can't get warm, Nauseated, Weak, arm swollen very painful, but the most concerning is I am having left inner chest palpitations of my heart, and pain like my heart muscel is knoting up, hurts through my chest to my left back under my shoulder blade...I am so weak, I can hardly walk.  I have been in bed, pain so bad I can not sleep much...I did eat cereal but made more nauseated.
No adverse effects but patient was given the correct age dose 6mo-4yrs on 12/27/22 when he was 4 years old but he was given the 5yr-11yrs dose on 1/18/23 (he turned 5 yrs old on 12/31/22).
Discription by Mother - 07/03/07 At 6:30am client was discovered having chills and difficulty breathing. Ambulance was called and client was taken to ER. Client was observed and released. Recieved medication for possible allergic reaction.