chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 10/4/21 in the afternoon patient reported sharp pains when breathing and tightness/heaviness/burning in upper left chest area. On 10/5/21 patient went to urgent care where they informed him reaction may due to vaccine. Patient prescribed prednisone 20mg twice daily for 5 days and instructed to go to emergency room if symptoms worsened. That night patient checked into emergency room due to severe pain. Labs, X-ray and EKG performed. Patient discharged with acute chest pain and inflammation in the chest (or chest wall? patient unsure) and asked to follow-up with primary doctor.
Multiple papules on erythematous base at various stages of development.  Pruritic, low grade fever.  Recent exposure to varicella.
Unusually high pain at site of administration lasting since 10/14/13. Lump still palpable at site of injection. Pain 8-8.5/10.
expired DAPTACEL had been administered to a patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and consumer/non-health care professional via Medical Information (Reference number- 00739683).  This case involved an unknown (age and gender) patient who administered expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number was not reported and expiry date: 23-May-2021) via unknown route in unknown administration site for prophylactic vaccination (expired product administered).  It was reported,"Caller reports that they had 6 vials of DAPTACEL that expired 23MAY2021. Caller asking if this is okay or if they should re-administer. Called declined to provided information for AE (adverse event)/safety report at time of call. Caller states she would like to speak to her office manager and the provider first. Caller given case reference number and phone number to reach for Information. Caller states she will call back if she is able to provide information for AE/safety report."  This case was an actual medication error due to expired vaccine used (latency: same day)  At the time of reporting, no adverse event  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. 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.  There will be no information available on the batch number for this case.
having unusual feelings and situations in his life; He has been a little unsteady when walking; needs assistance standing for more than a minute; constipation; speech trouble.; states that it  is getting worse.; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an 61 years age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported expiry date: unknown) via an unspecified route of administration on 24Mar2021 (at the age of 61-years-old) as a Dose 2,Single for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported expiry date:Unknown) via an unspecified route of administration on an unspecified date as a Dose 1,Single for  COVID-19 immunization. The patient had second shot on 24Mar2021 and was fine but had a little bit of dizziness, unsteady walking, trouble standing up and had pretty bad constipation. He had been a little unsteady when walking, needs assistance standing for more than a minute, he had to lean on something, he developed constipation and speech trouble. These began feeling this 3 months ago and can't relate this to the vaccine and stated that it was getting worse. Reporter stated that he had been having unusual feelings and situations in his life and wondering if people have had similar reactions. Outcome of the events was unknown.  Information about the Lot/batch number has been requested.
intense pain in area of injection and spreading up shoulder and down arm,  with nausea but without vomiting.  intense pain lasted for 4 hours and now 48 hours later is still dull.  taking ibuprofen to relieve, which is slightly effective .  reduced range of motion
Received COVID vaccine on 10Apr2021 and on approx 27Apr2021 developed 2 vesicular rashes on left finger.  On 02May2021, continued to develop rashes on back of neck (left side), 2 more vesicular pimples (l finger), 2 on L wrist and red rash under L breast .  Diagnosed with shingles.  No pre-existing auto immune disease or any pre existing conditions.  Treated with valacyclovir HCL 1 gram 1 tab 3xs/day for 7 days.
Covid-19; This is a spontaneous report from a contactable Pharmacist reported for a patient that: a 68-year-old male patient received first dose bnt162b2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 (at 68 years old) (Lot Number: EN6204) at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. Reporter reported that the patient was last vaccination listed was a Tdap in 2010 for immunization.  Reporter reported that reporting for adults was not mandatory, but was done out of courtesy, so the reporter cannot say for certain that the patient did not receive prior vaccinations within 4 weeks of the Covid-19 vaccine. Reporter reported that the patient was hospitalized for Covid-19 on 09Mar2021.  Reporter reported that she assumed the patient was tested for Covid-19 on 09Mar2021 but did not know the actual date.  Reporter reported that she did not know what type of Covid-19 test was performed. Reporter reported that she would assume that the patient received a positive Covid-19 diagnosis when he was admitted to the hospital on 09Mar2021. She did not know the date of the patient was Covid-19 diagnosis, when the patient developed symptoms, or which symptoms the patient had. The patient received additional therapies for COVID-19 included: Convalescent plasma on 09Mar2021 and Remdesivir from an unknown date to 13Mar2021. Reporter reported that the patient took his last dose of Remdesivir on 13Mar2021.  Reporter reported that she did not know when the patient started Remdesivir, but she thinks that it was a 5 day treatment. Reporter reported that she did not know when the patient was discharged from the hospital. The patient was not still hospitalized. Reporter reported that the patient was not displaying clinical signs at rest indicative of severe systemic illness yesterday, 13May2021, but she die not know if he did previously. Reporter reported that the patient came into her pharmacy to get his second dose of the Covid-19 vaccine.  Reporter reported that the patient got the first dose of the Covid-19 vaccine at a different place. The patient underwent lab tests and procedures which included COVID-19 virus test: Positive on 09Mar2021. The outcome of the event was recovered in Mar2021.; Sender's Comments: Based on the information provided, A possible contributory role of the suspect product to the development of COVID-19 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
I woke up with severe headache, body ache, and chills on Wednesday morning.  I was so sick that I had to take pain killer all day long around the clock.  Luckly it went away by Thursday morning but I had lower back pain around my tail bone as a new symptom.  I still have hard time walking and changing postures freely.  I ended up going to ER.  ER doctor confirmed that it was a reaction to covid vaccine.  I was dischared witih pain killers and muscle relaxant.  Today is Jan 19, I still have same symptoms.
Woke up at 1am  very nauseous, had a fever, chills and was shaking really bad. Could barely swallow. I got up to get a drink and passed out on the floor hitting my head. When I came to went into my bed shaking and  the next day had a migraine  and my whole body was sore.
Unsure of exact time on date.  Welts/hives in a circle pattern around injection and scattered elsewhere on the body primarily torso and arms draining serosanguinous liquid.  New hives appearing 12/22/201.
Patient developed Left leg herpes zoster rash at L3 -L4 distribution two days after receiving first Shingrix vaccine at pharmacy.  Has been placed on Valacyclovir for treatment.
Not felling well; Severe body aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not felling well), MYALGIA (Severe body aches) and FATIGUE (Fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced MYALGIA (Severe body aches) and FATIGUE (Fatigue). On 07-Apr-2021, the patient experienced MALAISE (Not felling well). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, MALAISE (Not felling well), MYALGIA (Severe body aches) and FATIGUE (Fatigue) outcome was unknown.            On 06-Apr-2021, the patient received their 2nd dose of the Moderna vaccine and by midnight the patient began to experience fatigue, and severe body aches.  Reportedly, on 07-Apr-2021, the patient was not feeling well.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-069657 (Patient Link).
Got the flu; Aches/ Pains; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Got the flu), PAIN (Aches/ Pains) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Got the flu), PAIN (Aches/ Pains) and PYREXIA (Fever). At the time of the report, INFLUENZA (Got the flu), PAIN (Aches/ Pains) and PYREXIA (Fever) 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 reported.
Patient received Janssen vaccine on 04/11/2021 Patient tested positive for Covid on 10/05/2021 and was hospitalized. Per ED Note: Patient indicates over the past 3 days he has developed a nonproductive cough and difficulty breathing.  He indicates that he is not complain of any chest pain.  Does complain of some abdominal pain with nausea.  No problems with his bowel or urine.  No fevers has had chills but did not take anything for fever today.  The patient states that he has been taking Tylenol 6900 mg daily for 3 months for his Charcot foot.  Prior to that he was taking 9200 mg daily for 3 months.  About 1 week ago he stopped taking all Tylenol at the request of his physician.  He did see his physician today who took a chest x-ray and noted that he had a left upper lobe pneumonia.
Information has been received from a 27 year old female who on 2/5/02 was vaccinated with rubella virus vaccine live (second generation). The pt reported that following the vaccination, she developed boils, a rash on her face and stomach, swelling and pain around her ear, a swollen tongue and throat, a fever (temperature measurement not provided), swollen and stiff fingers and experienced dizziness and stiffness and burning of the neck. The pt was admitted to the hospital overnight and she reported that she was "yelling all night". The pt reported that her physician tested for diseases but not allergies. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
Four hours after receiving my COVID vaccine second dose I had a headache. The next morning I developed a fever up to 100.8 F. I was very nauseous and fatigued. I was unable to work because of my fever. The fever lasted two days. The headache lasted five days. The nausea continued and I found out I was pregnant that Friday. I have had severe morning sickness I?m on three medications to try to help keep it at bay. I?ve lost 13lbs. But the baby is looking healthy. I am due in September.
Narrative: COVID infection after completion of COVID vaccine series: 04/23/2021 COVID vaccine dose #1 05/14/2021 COVID vaccine dose #2 07/15/2021 Pt reported onset of HA, cough, rhinorrhea, fever and chills as well as close contact to COVID positive case 07/16/2021 COVID positive per agency nasopharyngeal swab 07/17/2021 Pt reported continued experiencing of sx 07/20/2021 Pt reported increased diarrhea and stomach pain that is not responding  to Pepto and onset of sore throat. HA and chills resolved. 07/21/2021 Pt reported  feeling same as yesterday 07/22/2021 Pt reported loss of sense of smell 07/23/2021 Pt reported continued experiencing of sx and onset of low-grade fever 07/24/2021 Pt reported continued experiencing of sx 07/25/2021 Clinical resolution of COVID infecting per guidelines
Large (approx 5 in x 12 in) swollen, red, itchy area around injection site. Pain with movement. Appears to be allergic reaction.
COVID-19 Breakthrough Case - Resulting in Hospitalization  Case is fully vaccinated with Moderna: 02/03/2021 & 03/06/2021.  Case is currently in Medical Center (as of 11/30), admitted on Friday, 11/26/2021 due to seizures. Case symptoms began on 11/26: dehydration, coughing, nasal congestion, and diarrhea. Case stated that she had Thanksgiving Dinner with her family of 10 members and has already notified them of her exposure to COVID-19. Case stated that they all tested NEGATIVE to COVID-19 via RAPID tests and are now awaiting for their PCR tests results.
Genital herpes once or twice a year during stressful time / gotten the vaccine she has had 1 to 2 episodes a month; Bruising, raised area and soreness at the sight right away; Raised area and soreness at the sight right away; discoloation; soreness; fatigue; headache; Shot was given on the backside of her left arm in the fatty part below her shoulder; she was taking just 1 a day,   but then was told by her doctor to take valacyclovir twice a da; the herpes rersolved but then returns; This case was reported by a consumer via call center representative and described the occurrence of genital herpes in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Co-suspect products included valaciclovir hydrochloride (Valacyclovir) tablet for genital herpes.  The patient's past medical history included genital herpes (once or twice a year during stressful time).   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Valacyclovir 1 g once daily (1 g daily). On an unknown date, the dose was changed to 1 g twice daily (2 g daily). On an unknown date, less than 6 months after receiving Shingrix and not applicable after starting Valacyclovir, the patient experienced genital herpes, contusion, swelling, skin discoloration, pain, fatigue, headache, vaccine administered at inappropriate site, underdose and lack of drug effect. The action taken with Valacyclovir was unknown. On an unknown date, the outcome of the genital herpes, contusion, swelling, skin discoloration, pain, fatigue, headache, vaccine administered at inappropriate site, underdose and lack of drug effect were unknown.   It was unknown if the reporter considered the genital herpes, contusion, swelling, skin discoloration, pain, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the pharmacist did not seem to be aware of where to give the shot, so it was given on the backside of her left arm in the fatty part below her shoulder, which led to inappropriate site of vaccine administration. She stated that she was told this could help with her genital herpes, which she stated was once or twice a year during stressful time. She noted she had gotten the vaccine she has had 1 to 2 episodes a month. She was being treated with Valacylovir (manufacturer unknown). She reported that she was taking just 1 a day, but then was told by her doctor to take valacyclovir twice a day, which led to underdose.  She stated that the herpes resolves, but then returns, which led to lack of drug effect. The prescribing information was reviewed for indications and dosage and administration and common adverse events seen.  She was referred to her doctor. The doctor noted she had bruising, raised area and soreness at the sight right away. She noted she also had fatigue and headache after the vaccine.   Follow up information received from physician on 23rd April 2020: The patient was under care and no longer with the practice. Called to reviewer and officer but unable to add patient discovery.
All over body hives started 3 hrs after receiving vaccine. 2 doses of prednisone, pepcid bid x 5 days, Singulair 10 MG at bedtime. Hives come back when off prednisone. Atarax for itching. Lymph nodes in armpits, elbows. Neck, behind necks all enlarged and swollen. Day # 28 still have hives, swollen lymph nodes. Per doctor has to run course. Not enough data
Patient began to slowly lose large patches of hair on his head within 4 weeks after the second dose. The hair has not grown back.
Headache, Myalgia, Fever, chills, injection site pain Narrative:  Employee reports symptoms began approximately 12 hours after receiving 2nd dose of vaccine. Reported symptoms include injection site pain/discomfort, chills, fever, headache, body aches, and numbness/tingling to left side (side which received vaccine). Reports took Tylenol and ibuprofen (no dose/frequency provided). Reports did not go to the doctor, urgent care, or ER for symptoms. Reports has since recovered from reported symptoms as of date of report.
13 year old male came in for URI, Hx of mild interm asthma well controlled. HPV 3rd dose was given few minutes later he said he felt dizzy and left arm where HPV was given felt pain and numbness, radiates fr. (L) forearm to arm. He also say his legs feels weak. We check BS = 71, he has not taken any meal that day, then he ate a chocolate, then his BS = 85. He still feels pain and numbness on (L) arm and (L) forearm, stable V/S, negative fever, nl HR and RR and BP and pulse ox.
I have terrible colitis now. Around day 6 I started with diarrhea, I have been eating bananas and rice for about 3 days. Today the 23rd I have moved to broth, jello and coconut water.
PUFFY UPPER LIPS, SWOLLEN FACE, SORE ARM AND FEVER.
Pt describing headache, numbness to face and weakness to extremities. Was taken directly to ER by parent and evaluated at Hosp. dx with migrain, CT scan of head done and sent home. Spoke with our office 9/28/12 with continuing s/s and was referred back to ER. Seen at another hospital then transferred to final hospital for admission.
I did have the shot, and still got the flu; Initial information received on 06-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves a patient of unknown age and gender who reported i did have the shot, and still got the flu after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s), concomitants and family history were not provided.   On an unknown date, the patient had received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, route, formulation, batch number and expiry date: unknown) in unknown administration site for flu (influenza).  On an unknown date, the patient reported i did have the shot, and still got the flu (influenza) (latency: unknown) following the administration of influenza vaccine.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.   At time of reporting, the outcome was Unknown for the event.
Vaccines given 3/20/14, parents reported immediate change in child and showed signs of staring spells and stopped talking. Parents state son has not been the same since vaccines that day. They wonder if 2 of same vaccine given since twin was given shots too in same room.
Systemic: Diarrhea-Medium, Additional Details: pt has not been to the doctor or discussed with him, takes electrolytes
Post menopausal hemorrhage that started next morning and continues for 1.5 years. It reversed my menopause and restarted endometriosis and PCOS, resulting in asthma, cardiovascular symptoms. I?ve been to ER three (3) times in the past year as a result, and now my only option is to remove uterus, ovaries, and Fallopian tubes because of the damage they accumulated due to pathological blood supply to tissues. I can?t even get the hysterectomy in the state of Utah, as there is a backlog of post menopausal bleeding women waiting for a hysterectomy. Who is helping us when every doctor I have seen both is helpless in the face of vaccine ?being new and understudied? and REFUSE to put on our records that symptoms have started immediately after receiving the vaccine? There is massive manipulation  of public health record regarding vaccine related health issues and Department of Health is ignoring the issue. Pfizer covid-19 mRNA vaccine has reversed my menopause and that has lead to pulmonary, cardiovascular, and gynecological problems every healthcare provider is ignoring being related to the COVID-19 vaccination. Pfizer assumed no responsibility upon contact and refused to help.
Pt cried all night; would not settle down in crib but did settle briefly in parent's arms.
COVID vaccine breakthrough case. Pfizer 3/17/21 ER2613, 4/7/21 EW0158 and boosted 11/17/21 JT1620
myocarditis- I am 32 years old. Have never had any issues. 5 days after receiving the Moderna shot, I experienced chest pain. A rapid heart beat, shortness of breath and a sharp stabbing pain in my back and chest
bilateral neck pain, low back pain, Left arm pain. Pt reports he "passed out" at ER. Pt states he went to the ER at 6:00 due to symptoms- Pt reported all testing  in ER came back normal