chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left testicular dull pain / Dull mild pain; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Dec2021 (Lot number: 33026Bb) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Mild gastritis" (unspecified if ongoing). Concomitant medication(s) included: HYOSCYAMINE; PANTOPRAZOLE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0182, Location of injection: Arm Left), administration date: 12May2021, when the patient was 41 years old, for COVID-19 immunization, reaction(s): "Left testicular dull pain"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, Location of injection: Arm Left), administration date: 21Apr2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Dec2021, outcome "unknown", described as "booster"; TESTICULAR PAIN (non-serious) with onset 05Dec2021 04:45, outcome "not recovered", described as "Left testicular dull pain / Dull mild pain". Therapeutic measures were not taken as a result of testicular pain. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that Left testicular dull pain after 2nd dose which was only experienced once after 2nd dose which lasted for few seconds and went away. And then nothing. After the 3rd booster dose it happened again. Dull mild pain that appears and goes away in few minutes. Follow-up attempts completed. No further information expected  No follow-up attempts are possible. No further information is expected.
Narrative:  CHIEF COMPLAINT: not feeling well, skin burning, Nausea, fatigue and constipation x 2.5 weeks
Pt did not respond to series of Recombivax (2 doses) & Engerix-B (1 dose);  Recv Engerix-B booster dose & lab values show titer borderline.  09Mar91 recv 2nd booster dose.
SHAKING; CHILLS; HEADACHE; FEVER; LOWER BACK HURT; NOT FEELING WELL; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight was 183 pounds, and height was 69 inches. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known allergies. patient had no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 13:30 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced not feeling well. On 09-APR-2021, the subject experienced lower back hurt. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) Low grade fever 100. On 09-APR-2021 02:00, the subject experienced shaking. On 09-APR-2021 02:00, the subject experienced chills. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, and not feeling well, and chills on 09-APR-2021, and was recovering from fever, lower back hurt, and headache. This report was non-serious.
pt said thought was having a migraine on 11/19/2019 . went to hospital experiencing  a migraine and speech difficulty
Developed "Covid rash" Rash was on my left leg below knee. I rubbed  it and it quickly began to bleed. Covered with dressing. Lasted for about a week. Did not continue to bleed once I left it alone under dressing. Also had slight rash on injection arm.  Both were very itchy.
Diarrhea; Red Arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and ERYTHEMA (Red Arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and ERYTHEMA (Red Arm). At the time of the report, DIARRHOEA (Diarrhea) and ERYTHEMA (Red Arm) outcome was unknown.            No treatment medications were provided. No concomitant medications were reported.
Injection site pain started 30 minutes after injection. Arm pain that impacted range of motion of left arm for 3 days.  Resolved 96 hours post injection
Pt. received vaccine at 10 AM. Came back in the store later to tell me that he got nauseous and did vomit after he went home within 1 hr. of vaccine.
Resident had developed a small bruises (approx. 2 cm diameter) after receiving PREVNAR injection around 3-15-16. This brownish colored bruise remains on arm. Resident also has c/o right upper arm and shoulder pain on and off since injection, which is severe at time and affects her range of motion to the arm and shoulder. At this time there is yellowish discoloration to the area with a 24.8 x 22.0 cm light reddish/purple area just below yellow area. There is also some edema.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 08-APR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Patient tested positive for COVID 4/16/21. Completed COVID vaccine series 1/10/21. Asymptomatic.
Complained of chest soreness with immunization. No shortness of breath, palpitations or dizziness Pulse 67; BP 120/76. Feeling better after drinking water. Discharged.
Sore arm, fatigue, lightheaded, headache, tingling in extremities . All mild, able to continue with daily tasks Resolved by 2 days after vaccine. Used Ibuprofen and Excedrin migraine for symptoms.
Severe ringing in both ears. I have not sought treatment.  The ringing is a constant high pitch ring and throughout the day as the ringing gets worse it will also throb to the pace of my pulse.
Patient came in with her son, daughter in law, and daughter in law's mother to get vaccine.  I processed the paper work and gave the flu shot to the daughter in law's mother first. When came to patient, because she was on the mobile chair, I bought out the vaccine stuffs to her so she does not have to come into the counseling room.  My normal route when giving vaccine is to ask for date of birth and ask or show which vaccine patient is here for.   But because of the distraction and a lot of customers is waiting, I forgot to verify with the patient and her family members which vaccine she is getting.  After the vaccine the son ask did I give back the vaccine card that when I realized, I had giving the wrong vaccine.   I reprocessed the vaccine form and gave her the booster shot of Moderna
a bad itch all over her body; allergic reaction; arm became sore; strep throat; This is a spontaneous report from a contactable consumer (patient's husband).  A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL1284) via an unspecified route of administration (arm), on 06Jan2021, single dose, for covid-19 immunisation.  The patient medical history was not reported.  Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), blood pressure medicine (unspecified) and a couple of pills (the reporter does not know what they are).  The patient had no other vaccines on the same day as the COVID vaccine. It was reported that the patient was having some kind of allergic reaction in Jan2021. The patient received the first dose on 6Jan2021 then her arm became sore for a couple of days. On 09Jan2021, the third day after the first dose of the vaccine, the patient got a real sore throat, the patient had to keep clearing her throat, and she had pus bags on the side of her throat in the back. The patient went to urgent care, and they did not check her for strep throat but they prescribed her Amoxicillin for strep throat and the patient took that. Later that same day, the patient started itching all over her body, her back especially. The doctor thought that the patient might be allergic to Amoxicillin, so they told her to quit taking that and to take Benadryl and Zyrtec however the antihistamine did help the itching. The patient never had a rash, just itching. The patient  went back to the doctor, about the sore throat, and they are sending her to an ENT doctor. Her appointment with the ENT is scheduled on the 10Jan2021, and while they are waiting for that, the patient went back and got their second COVID shots. The patient has not recently been itching because she was taking the Zyrtec and Benadryl. Outcome of the events was unknown.
vax on 10.27.20, two days later 10.29.20, on left arm became red and skin raised at site. Redness began going around upper arm. Redness wasn't hot to the touch, went away some. On 10.30.20 face and neck began looking sun burnt. Took steroids (prednisone) and it started to subside. no fever.  Not sure exactly which flu shot was given.
Rash, MD does not think rash is a result of vaccinations, but according to product insert it must be reported.
The lymph nodes under my left arm haven swollen up and become hard and painful.  It hurts to lower my arm or have any pressure there at all.  The entire area under my arm is swollen and protruding.  It is much worse than a typical swollen lymph node when getting sick.
I felt lightheaded a few hours after receiving the vaccine. Around 5-6 hours after the vaccine I was running a high temperature, felt tingling in my thighs, and having a big headache every time I stood up. Persisted for day of vaccination and next day before passing.
3 days ago I noticed my left arm feeling really sore and tired, originally I thought it was related to some chores I had done, but arm has not felt better in several days. Arm is sore and injection site feels slightly firm, and arm is tired and feels a bit weak. Pain is concentrated around injection site and hurts a lot more when touched. Other arm does not hurt at all. I'm not super concerned in that I believe it will go away but I wanted to report it.
Body aches, headache and difficulty with thermoregulation - woke up in the night feeling very hot, was very cold during the day, then started feeling very hot again.
pt recvd vax; woke up w/ fever, v 2x during day; rash at 6pm which progressed; some joint achiness;
after the second shot of covid-19 vaccine he had a stroke; This is a solicited report FACILITATED COLLECT based on the information received by Pfizer from AbbVie Inc. (MFR Control No. #21K-163-4017811-00) from a contactable consumer (patient).   A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; glecaprevir, pibrentasvir (MAVYRET), oral from Nov2020 (Batch/Lot number was not reported) to an unspecified date, at unknown dose, 3x/day for an unspecified indication.  The patient medical history was not reported.  The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date for Covid-19 Immunization. The patient had other concomitant therapy of unspecified blood pressure medication. It was reported after the second shot of covid-19 vaccine he had a stroke on an unspecified date with outcome of unknown. On an unknow date, the aptient experienced stroke, Pfizer Biontech covid-19 vaccine (Tozinameran) was also considered suspect. The patient Reported that 64 hours after the second shot of covid+19 vaccine he had a stroke. He did confirm that the stroke happened after the second dose of the Covid-19 vaccine but was not able to probe further.It was unknown if the patient was enrolled in the covid vaccine trail. On unknown, patient received 1st dose covid-19 vaccine manufactured by pfizer, lot number. The event was reported as serious as other medically important condition. The action taken for glecaprevir, pibrentasvir was Permanently Withdrawn on unknown date.  Causality for Mavyret: The reporter's casualty for the event of the stroke was not provided. Abbvie's opinion is that there is no reasonable possibilities that the event of stroke is related to the Mavyret.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal association, a causal relationship between the event stroke and bnt162b2 cannot be completely excluded. Other risk factors to be considered include the patient advanced age and history of high blood pressure. 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.
Partial third cranial nerve palsy two days after Zostavax administration.  Most likely due to history of type II diabetes, but timing so soon after vaccination warrents reporting.  2/19/08 Reviewed reporter/neuro medical records of 1/28/2008. FINAL DX: acute partial right third cranial nerve palsy, strongly suspect nerve ischemia related to diabetes. Records reveal patient experienced acute onset diplopia x 3 days followed by right ptosis.
On 12/94, 4 months or 6 months, the child had a temperature, and didn't make any eye contact for a few seconds. In 02/95, the doctor said if no changes or more symptoms and didn't continue not to worry. On 01/01/96, the child had a high fever 105 - 106 causing prolonged seizure, happened at 2 AM. Taken to the ER then the hospital until 02/06/01. Diagnosed with presumed viral encephalitis. 60 day follow up states patient is unable to walk or talk and cannot take care of herself.
Patient received the 1st COVID vaccine Pfizer lot # EW0162 and expiration date 04/16/2021 at 5:22 pm. Client reported to EMT. EMT and RN responded. Client laying in recliner chair in semi-followers position. Client reports "I felt light headed and sweaty" for about one minute following administration of Pfizer vaccine to right arm. The client reports "I saw black and white specs for a few seconds". Client reports history of similar incidents when client is near "blood and needles". No medical history, medication or allergies per client. Client denied feeling dizziness, light headedness, shortness of breath, facial or throat swelling, palpitations, chest pain or other symptoms at the time of report. Client was placed in semi-fowlers position and given water. Client is a/oX3. Vital Signs at 11:43am BP 100/70, HR: 76, RR:18. Client advised to be observed for additional 30 minutes. VS at 12:05pm BP 122/92, HR 70, RR 18 while semi-fowlers. VS at 12:18pm BP 114/86, HR 68, RR 18 while sitting-feet on floor.  VS at 12:27pm BP 122/90, HR:70, RR 18 while standing.  ER precautions given. Client informed to f/u with PCP. Recommendation given to client for transportation after vaccination incident. Client verbalized understanding. Client given instructions to bring driver for next appt and to inform vaccinator of this event. Client verbalized understanding.  Per client, symptoms resolved 1 minutes after onset of symptoms onset. Client walked out of site with a steady gate.
Pt had Flu (chills, fever, aches, malaise) x 1 week after flu shot.
On 4/16/10 pt received ADACEL, MENACTRA and GARDASIL, went home 2 Hrs later, she felt severe muscle body ache area UE, LE, trunk and chest and back. She complains of short of breath, tingling sensation of chest and back. She felt weakness of UE and LE. Not paralysis, No fever, she felt difficulty of breathing and tends to hyperventilate.
Light numbness on her right middle face; sore on arm; Little sore and hurt her right arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Light numbness on her right middle face), SKIN LESION (sore on arm) and PAIN IN EXTREMITY (Little sore and hurt her right arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02sl20a) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CABERGOLINE for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced SKIN LESION (sore on arm) and PAIN IN EXTREMITY (Little sore and hurt her right arm). On 07-Jan-2021 at 12:30 AM, the patient experienced HYPOAESTHESIA (Light numbness on her right middle face). At the time of the report, HYPOAESTHESIA (Light numbness on her right middle face) outcome was unknown and SKIN LESION (sore on arm) and PAIN IN EXTREMITY (Little sore and hurt her right arm) was resolving.        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 medications included allergy medication.  The patient started experiencing some light numbness on her right middle face, she could move her lips and nose, but it felt different, also had a little sore and hurt a little bit her right arm.  No treatment information was provided.  Company comment: This case concerns a 37-year-old female who experienced NS unexpected events of facial hypoesthesia and skin lesion and NS expected event of pain in extremity.  Event onset occurred 30 minutes after the first dose of mRNA-1273. Treatment not reported. Arm pain and skin lesion resolving, but other outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns a 37-year-old female who experienced NS unexpected events of facial hypoaesthesia and skin lesion and NS expected event of pain in extremity.  Event onset occurred 30 minutes after the first dose of mRNA-1273. Treatment not reported. Arm pain and skin lesion resolving, but other outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
had severe rheumatoid arthritis; This is a spontaneous report from a contactable Nurse who reported for her husband.    A 77-year-old male patient received second dose of bnt162b2 (COMIRNATY; Lot Number: EP7534) via an unspecified route of administration in Arm on 23Mar2021 at 11:00 (at 77 years) as single dose for covid-19 immunisation.  The patient medical history included obesity , high blood pressure. Concomitant medications were not reported. Previously patient received the first dose of bnt162b2 (COMIRNATY; lot: EN6198) in Arm on 02Mar2021 (at 77 years) as single dose for covid-19 immunisation. On an unspecified date in Mar2021, after the second dose, within a week, his wrist and hand were all deformed, he didn't have this before. He went to a Rheumatologist for blood test in 2021 and he diagnosed him with severe Rheumatoid arthritis. The doctor said he has never seen anything blow up like this. His hands were twisted, and it happened within a week. She was very surprised and called his rheumatologist immediately. The Rheumatologist was the one that asked if he had the vaccine .Patient was on an anti inflammatory. He took Enbrel (Lot number 1134801; and expiration May 2023). He took it once a week. He was a little better , but still not better. His hands were deformed and the bones were still deformed.Patient can hardly hold anything. After the doctor mentioned it, it made since that the Vaccine caused this. He was also getting a Chest CT in 2021, results unknown.Event did not required Emergency Room, but required Physician Office visit.Event Rheumatoid arthritis was serious due to Disability.The final outcome of the event was reported as recovering.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of severe Rheumatoid arthritis . The case will be reassessed once new information is available. 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
This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 42-year-old female patient who received FLUARIX QUADRIVALENT (batch number 7FF3N, expiry date 30th June 2017). This case was associated with a product complaint. Concomitant products included ZADITOR Eye Drops. On 10th October 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) 0.5 ml. On 11th October 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site swelling, injection site warmth and injection site erythema. On an unknown date, the patient experienced pharmaceutical product complaint. The patient was treated with sulphamethoxazole, BACTRIM. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site erythema and pharmaceutical product complaint were unknown. The reporter considered the injection site swelling, injection site warmth and injection site erythema to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient experienced swelling, redness, and warm to touch feeling at injection site. The patient required the emergency room visit. It was reported that the related QA was filed since health care professional felt as though events could be due to a specific lot. The patient went to doctor and was prescribed BACTRIM. The health care professional confirmed no infection was present. This case has been linked with case US2016150857 as reported by the same reporter.