chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up paralyzed.  I couldn't move, see or talk.  I had extreme pain in my body, particularly in my chest.  I had difficulty breathing.  I thought I was going to die.  Then, I'm guessing 20 minutes later, I was finally able to move and I made my way to the bathroom where I had a lot of diarrhea.  When I got back to bed I was having cold sweats.  I was exhausted and all I could do was get back into bed.  I realized now that my husband should have taken me to the emergency room.  But he didn't think of it and I was too exhausted to do anything other than sleep.
patient claims that she has an ashen color around the injection site that has been there since the injection but no pain or any other reactions
The first Sx was intense sharp pain below injection site. Chills and a bit of nausea, temp of almost 101 and swelling in upper arm. Next day noted redness beneath site. Redness, pain fever ajacent to injection site. No tx.
Day 4 my arm hurts a lot. My skin is constantly hot and my  arm around the injection is very hard. I keep putting ice on it, taking painkillers, but not using anything.
Swelling in arm, rash under arm, knot at injection site, dizziness, throat swelling, trouble walking, coughing, flu-like symptoms, chest and upper back pain, headaches.
Temp of 104.5 seen by PP alternate TX of Motrin and Tylenol.
Initial report received on 07 December 2009 from a health care professional in the United States. A 52 year old female patient complained of pain at the injection site immediately after she received a first time dose of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP010AA) intramuscularly in the left deltoid on 02 December 2009. The patient's right arm became heavy with decreased strength and weakness which has worsened. There is no redness or hardness at the injection site. The patient required a doctor's visit, no further information was provided. The patient had also received an influenza vaccine in September 2009, manufacturer was not reported. The patient was not recovered at the time of the report. List of Documents held by Sender: none.
Felt like something stuck in back of throat, then felt like I couldn't swallow, severe headache, severe aching in gum tissue and jaw - symptoms lasted 5 hrs.
Mild soreness of injection site, only lasted a day.; This is a spontaneous report from a non-contactable other HCP (patient herself). A 40-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9264) via an unspecified route of administration, administered in Arm Left on 29Jan2021 18:30 (at the age of 40-years-old) as 1st dose, single dose for covid-19 immunisation. The patient's had no medical history and no known allergies. The patient's concomitant medication included bupropion in two weeks 75 mg two times a day (BID) for an unspecified indication. The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination. On 30Jan2021, the patient experienced mild soreness of injection site, that only lasted a day. The patient tested for covid post vaccination, covid test type post vaccination nasal swab, a polymerase chain reaction (PCR) test done on 31Jan2021 which showed negative result. The patient did not receive treatment for the adverse event. The outcome of the event was recovered on 30Jan2021.  No follow up attempts are possible. No further information is expected.
I started feeling generally unwell around 9:00 PM. I developed chills and fever around 10:30 PM. I went to bed and fell asleep until 12:00 AM. I fell back asleep until 3:30 AM. I woke up with a racing heartbeat, chills and shortness of breath. My oxygen saturation which is usually normal was in the high 80?s. I took another dose of Motrin 800 mg and was able to break my fever and this reduced my heart rate. My oxygen saturation was still low. I fell back sleep around 4:10 AM and was able to sleep until 7:00 AM. I took another dose of Motrin around 8:00. I had a persistent headache and general malaise the day following vaccination. 2 days after vaccination I still felt very tired and weak and had a persistent headache. Day 3 was symptom free.
large area of skin erythema and induration.  Approximately 5 x 10 cm -surrounding the injection site.
ON 2/24/00, the pt presented with chickenpox that consisted of "at least 25 lesions, no fever and no other symptoms." Additional information has been requested. Follow up states the patient recovered.
Information has been received from a nurse referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant therapy were not provided. On 17-OCT-2016 and 01-NOV-2016, multiple patients were vaccinated with improperly stored RECOMBIVAX HB (lot # M029233, expiration date: 09-AUG-2018; lot # M026309, expiration date: 11-NOV-2018) (dose and route not provided). The nurse reported no adverse effects noted. The temperature for the vaccine stored was 10.1 Celsius degree with 2 hours time frame. There was no previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Bruise at the injection site; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruise at the injection site) and PYREXIA (Fever) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced PYREXIA (Fever). On 16-Jun-2021, the patient experienced VACCINATION SITE BRUISING (Bruise at the injection site). At the time of the report, VACCINATION SITE BRUISING (Bruise at the injection site) and PYREXIA (Fever) had resolved.            No concomitant medications were provided.  Patient was noticed a bruise at injection site and stated it was like  a spider web pattern, webbing out into the blood vessels.  The patient reported that he had recovered from his symptoms after a couple of days.  No treatment was reported.   This case was linked to MOD-2021-224104 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow up information received and contains significant information .outcome of the events updated from unknown to recovered/Resolved.
Patient had febrile seizure one day following vaccine administration.  Patient has had seizure in past following vaccinations (exact vaccines and time course unclear).  Patient's sister has had seizures the day following vaccinations in past times two.
suspected vaccination failure/lack of effect; Her current outbreak is in eye; Her current outbreak is located on the left side of her: scalp, mouth; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (developed shingles in February 2020 refer case US2021AMR214345).   On 12th October 2019, the patient received the 2nd dose of Shingrix. On 18th July 2018, the patient received the 1st dose of Shingrix. On an unknown date, more than a year after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingrix and Shingrix.   Additional details were reported as follows: The case was reported by the patient. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule refer case US2021AMR214345. The patient currently had shingles and her current outbreak was located on the left side of her scalp, mouth, and eye. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles were unknown. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR214345:same reporter
Severe swelling and rash at site in left arm.  Rash moved upward in arm and chest area.  Also complained of itching of nose and throat area.  Reaction occur 10-12 hr after injection.  Client treatment with IM and oral antibiotics.
extreme joint paint (whole body, spine, legs, arms, hands, feet, hips) 12+hours, extreme chills/ shivering 8 hrs,, headache 12+hours, muscle aches in shoulders/neck 8+hours.  My joints were so sore, it was extremely painful to turn over in bed or try to get out of bed.  Used a heated blanket and still had chills even though house was 71 degrees. Didn't actually sleep, just shivered and moaned in pain for 6-8 hours.  Certainly had a fever but in too much pain to go get a thermometer.
Red circle around injection site (8cm).  Red area is painful, firmer to the touch and very warm.
Immunization 05/19.  Awoke 05/21 with rash.  Noon presented to ER on 05/21/ with fleeting and cropping rash including legs, buttocks, and face.  No swelling of tongues lips or pharynx.  Treated with Pediapred and Benadryl - rash resolved in a couple of days.
Arm has been sore ever since; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 78-year-old female patient received bnt162b2 (BNT162B2), administration date 10Feb2021 (Lot number: EN9581) at the age of 78 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (Dose 1 (Lot Number: Not provided)), for COVID-19 Immunization, reaction(s): "Did not have a problem". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Feb2021, outcome "not recovered", described as "Arm has been sore ever since".  Additional Information: The patient got the second dose of the Pfizer COVID vaccine on 10Feb2021 and her arm had been sore ever since. She did not have a problem with the first dose.  No follow-up attempts are possible. No further information is expected.
Patient had 1st dose on 05/19/21. After 2nd dose of vaccine was administered, it was discovered that patient was 7 days early for the vaccine. Company of Moderna was contacted and informed us to report the incident; patient should have received vaccine on 6/16/21. at time of administration and 15 minutes post he is not reporting any adverse reactions to vaccine. Moderna representative took information. patient and his primary care provider, Dr., made aware of the situation. Patient advised to contact us if he has any problems or go to the ER.
pt developed a rash on both lower arms about 4-5 days after vaccination.  She was unsure if they were related to the immunizations or not
She was very sleepy, non-verbal, running a fever. By morning she was very limp and fever was 103.7. Took her to hospital fever was same. Was there for about 4 hours. After about a week, she was finally herself.
Large, hard, erythematous, tender area on outer aspect of deltoid.  Very warm to touch. Sent to ER for evaluation for ? need antibiotics for cellulitis.
Day after vaccination ( April 21,2021 ) developed a baseball sized lump in my armpit on the left side ( side if injection ).  For the next two weeks noticed progressive weakness in both legs until having to be admitted to Hospital with leg paralysis. And excruciating back pain.  Diagnosis was severe  discitis leading to a two week hospital stay on IV Vancomycin and another 8 weeks of at home pic line  antibiotics.
Received injection at 4:50 PM and then went to lab.  Lab called patient at 4:55 Pm to come to the lab to check on patients arm.  Red area the size of a grapefruit without itching.  Dr. notified and checked area at 5:00 PM.  No difficult breathing, no increase in redness and no further itching.
Pt received pneumovax (PVX) at Pharmacy 11/17/20.  Pt states she developed severe pain at the injection site left upper arm deltoid region, left axilla, left neck.  She took 2 aleve and 2 tylenol for this.  She states her urine was butterscotch color.  She was seen in the office 11/18/20, physical exam pt afebrile, BP 145/107  P 107, she was not in acute distress.  No erythema, fluctuance, or induration of left deltoid region, left axilla, and left neck but there was tenderness to palpation  in those regions.
Severe arm pain and erythema at site of injection. Soreness after injection into evening, then pt woke up at 4AM 2/2 severe pain at injection site which persisted. She was seen in clinic that morning.
After a week, red itchy rash over the injection site with a slight lump via swelling. No pain just feels warm to the touch and itches. Had mild soreness and tiredness the next day, but that faded quickly and had no other side effects until today with the rash. Nothing crazy, but I was told to report it anyway.
Second Dose Moderna: much more severe (than 1st dose) serious reaction with the following:  Reaction within 15-20 minutes of dose. Took benadryl on site due to previous reaction. Continued benadryl every four hours for 3 days. High fever, joint pain, chills, headache, extreme fatigue, stomach upset, high blood pressure evening of shot. Chest soreness and tightness day after. Evening of, face, chest and wrists itching.   Stomach issues with urgent forceful bm's for over a week, as of today less intence and frequency.  Approx. 45 minutes after 1st shot had numbing and tingling of mouth and tongue. Immediate soreness and pain left arm after injection. Extremely sore arm. Approx. 3 hours post injection the numbness and tingling subsided. Took benadryl as a precaution at bedtime. Following days, low grade fever, chills, fatigue.
COVID breakthrough case. I received my 2nd booster shot on 05/26/2022 and my COVID symptoms started on 05/28/2022 allergy type symptoms like headache, runny nose. 05/29/2022 headache along with other symptoms. 05/28/2022 I tested negative for COVID, and on 05/29/2022 tested positive for COVID. I did a telehealth with a doctor and they prescribed me PAXLOVID for 5 days.
Pt states after vaccination develop soreness and pain at site of injection. Notice when rotating or lifting arm is painful. Develop slight fever. Recommends cold compress to site and take apap/ motrin for pain relief.
This spontaneous report was received from a 31-year-old female pharmacist, who was reporting on herself. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 20-OCT-2017, the patient accidentally stuck herself with a needle that had properly stored ZOSTAVAX injection (lot # M040145 with expiration date on 26-DEC-2017; dose and route of administration were not reported). The patient did not seek a medical attention. No adverse reaction were reported.
Extreme headache. Extreme joint pain. Extreme fatigue. Chills. Sweats. Inability to concentrate. Headache and joint pain lasted 3 days.  On and off chills and sweats for 5 days. Fatigue and inability to concentrate continuing today (8 days)
The patient received a 3rd dose/booster at 16 years of age without an indication of being immunocompromised. His second dose of Pfizer had been 4 months prior. He is not showing signs or symptoms of an adverse effect at this time. I recommended following up with his primary care provider.
On February 26, 2021 at about 06:00 that night her neck and shoulder was stiff. Then the next day her whole body and joints was stiff. Went to see her rheumatologist because the pain wasn't going away told her she got diagnosed with LUPUS. Prescribed her with meds called Plaquenil 200ml, vitamin D 4000 units, Magnesium 500ml, Fish oil and she went to see a chiropractor because her back would not stop hurting.
Approximately 4-5 after receiving the Covid Vaccination, my heart rate dropped,  the top of my body was shaking and I passed out. The ambulance arrived and took me to the ER. My heart rate was at 40 . I was in the hospital for observation for 3+ hours.
bruising; redness; itching; rash/bumps; This case was reported by a physician via call center representative and described the occurrence of contusion in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number T7E4A, expiry date 3rd June 2020) for prophylaxis.   On 15th April 2019, the patient received Kinrix. In April 2019, less than a week after receiving Kinrix, the patient experienced contusion, erythema, pruritus and papular rash. On an unknown date, the outcome of the contusion, erythema and pruritus were unknown and the outcome of the papular rash was recovering/resolving.   It was unknown if the reporter considered the contusion, erythema, pruritus and papular rash to be related to Kinrix.  Additional details were provided as follows: The patient's rash was getting better at the time of reporting, but the physician was concerned about administering additional doses.
VARIVAX was administered to patient while it had a temperature excursion; Patient is asymptomatic/No additional AE.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot #W031813, with an expiration date on 05-OCT-2024), administered for prophylaxis (strength, and route of administration were not provided).  Nurse reported that varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient while it had a temperature excursion. The patient was asymptomatic and no adverse events were reported.  The dose of varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to a temperature excursion of 24.4 degrees Fahrenheit (°F) during a time frame of 5 hours, 51 minutes and 0 seconds.  There was no prior temperature excursions reported.
Moderate to severe pain sprea throughout upper left arm lasting 2 days. Chills the evening of vaccination. Severe headache upon waking up the morning after vaccination. Nausea upon waking up the morning after vaccination lasting until past mid day. Fatigue lasting 2 days.
I had Intergluteal cleft access on my butt crack that swelled up.  I also got an yeast infection in my butt crack.  I went to my doctor and he gave my antibiotic cream for it.
FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, 1 total, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu like symptoms. This report was non-serious.
Client reported before vaccination a history of syncopal episodes s/p vaccine administration due to a needle phobia. Client received vaccine and had a syncopal episode while in the chair. Client slumped into a person sitting next to him. Client roused after approximately 1 minute of unconsciousness, and was initially difficult to arouse. Client was moved to a cot via wheelchair and placed in reverse trendelenberg position. Initial vitals 75/43 pulse 40, sinus bradycardia rhythm, skin was pale and diaphoretic. Client had a follow up blood pressure 5 minutes after the syncopal episode of 76/44, pulse 50. Client was offered transport versus watchful waiting by EMS staff, and opted for watchful waiting. Client had gradual return to full mentation, and skin turned to pink, warm and dry. Follow up vitals 116/82, pulse 68, spO2 100% on RA. Client continued to improve and remained in observation area for 30 minutes, and was given a ride home by his wife. Client refused transport by EMS and evaluation in the emergency department.
My COVID-19 symptoms started on 03/05/2023 in the morning. I had  extreme cough, high  fever, upset stomach, headache, chills and weakness.  I did a home COVID-19 test on 03/05/2023 which was positive. I called my doctor the same day  and told her all my symptoms. I had yellow mucus  along with cough. She prescribe me Mucinex and Benzonatate. I took it for 2 weeks. I began to have heart palpation,  and erratic heart beat. I am still being evaluated. I went to the ER 2 times already. I am basically non functional now. I get systematic  and no body can find out what it is. On 02/21/2023  with Supraventricular Tachycardia. I am still under care with the doctors. On 03/31/2023 I went to an Electrophysiologist he was looking into the report I had before. I will be wearing a Holter Monitor which will be here on Sunday. My doctors are trying to find out the  cause of my irregular heart beat. I am not recovered yet. This happened before getting COVID-19 infection but it triggered more after which I am experiencing now.  I have recovered  from COVID-19 infection as of now but not from irregular heart beat.
first dose in 2019, not received 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter declined to provide patient demographics. The reporter consented to follow-up via postal.