chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 02/06/2023, client presented to facility POD COVID-19 Vaccination POD to receive Pfizer Bivalent Booster. Client was accompanied by mother. At approximately 1332 client received Pfizer Bivalent booster Lot#GL0447 on left arm and Fluarix Lot#9PG4D on right arm by nurse. At approximately 1336 while sitting down in the observation area client notified nurse that he was feeling dizzy. Client was able to transfer from chair to anti-gravity chair without assistance. Nurse proceeded to take vital signs; BP: 124/71 mmHg, HR: 62, O2: 99%, RR: 16. Client denied, difficulty breathing, nausea, itchiness all over body and chest pain. Mother stated client gets scared with vaccines and that client only had an apple for breakfast. Mother reported no adverse reactions to previous Pfizer and Flu vaccines. Mother also reported no known allergies and no medical conditions. At approximately 1339 client reported dizziness had resolved. A granola bar and juice were offered to the client. Lead nurse recommended to stay 30 minutes in observation area even after dizziness had resolved to make sure that the client was okay. Client?s parents denied staying in the observation area for the 30 minutes. Lead nurse educated client?s parents on emergency precautions and to seek emergency care if symptoms worsen and to follow up with primary care doctor. Client?s parents verbalized understanding. Client denied dizziness and stated he was feeling ?fine.? At approximately 1344 client left the facility in a steady gait accompanied by parents.
Pt recvd vax on 20NOV92 & on 29NOV92 pt devel stomatitis, oral herpes, cold sores on the mouth, throat, tongue; No further details were provided;
it has been longer than six months since the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had her first dose in September of 2021.).   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 Information: GSK Receipt Date: 6 April 2022 Reporter's Comments: The pharmacist reported that the patient had been longer than six months since the first dose of Shingrix. The pharmacist indicated he would be giving the second dose to the patient. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose of shingrix which led to incomplete course of vaccination.
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 6-month-old female patient who experienced biliary atresia, possible enlarged liver, and streptococcus pneumoniae bacteremia. At 2 months of age, the patient received the first dose on 10-May-2010. At 4 months of age, the patient received the second dose on 13-Jul-2010. On 11-Sep-2010 the patient experienced streptococcus pneumoniae bacteremia and was hospitalized. In Sep-2010, while in the hospital, the patient was diagnosed with biliary atresia that was surgically treated using the Kasai procedure. In Sep-2010 the doctor was concerned about her possibly having an enlarged liver. Although her final newborn screen result was normal, she requires a liver transplant. As of 22-Sep-2010, it is unknown if she remains hospitalized. The outcome of all events was unknown. No additional information was available at the time of this report.
19 hours after vaccination she developed shortness of breath, chills and intractable vomiting which required hospitalization.
Information has been received from a physician concerning a 63 year old female patient who on 25-MAR-2009 was vaccinated with ZOSTAVAX (Merck) (Lot # 0197T). On 23-MAR-2009 the patient experienced pain, tenderness to touch, swelling and warmth at the site of injection and surrounding area on her left arm after administration of ZOSTAVAX (Merck). The patient stated that her left shoulder hurt the night prior to receiving ZOSTAVAX (Merck). On an unspecified date the patient had visited physician's office for medical attention. On 13-APR-2009 X ray of her left arm was performed. At the time of reporting the patient's pain, tenderness to touch, swelling and warmth at the site of injection and surrounding area on her left arm persisted. Additional information has been requested.
Dizziness, every few minutes chills and tingling going all the way through my body. My head felt weird like I was going to faint. About half an hour later I got a weird feeling on the left side of my face. It felt a like I had a bruise on my face but it wasn't sore to the touch. My heartbeat was also going very fast. The symptoms were gone by 9 PM that night.
Upon administration of ZOSTAVAX vaccination, patient stated an increase in pain, which is normal for a vaccination. However, plunger of syringe was difficult to push and, upon discontinuing vaccination partway through, a small white welt was noticed. CDC was contacted for further instruction on how to proceed and, due to less than half of vaccine given, CDC recommended repeat of vaccination. Patient was alright with this recommendation and was revaccinated.
PT received Pfizer vaccination.  He had stated that he had had no other vaccine series, but was found to have had Jensen prior to the clinic day.
Client fainted for a few seconds.  I held her in chair until she came to and then we got her on the exam table and let her rest for about 15 minutes.  She was fine then and left with her parents.  Client also stated she had had nothing to eat yet, shot was given at 10:45am.
Fever; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration on 15Mar2021 at 08:30 (at the age of 72-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration on 18Feb2021 (at the age of 72-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021, the patient experienced fever. The patient did not receive any treatment for the adverse events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event fever was not recovered at the time of this report.     No follow-up attempts are needed. No further information is expected.
DIZZINESS; CHILLS; MUSCLE ACHES; TIREDNESS; FEVER; This spontaneous report received from a patient concerned a 24 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included sudden drop of blood pressure, and severe pain. 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 07-APR-2021 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021 03:00, the subject experienced chills. On 08-APR-2021 03:00, the subject experienced muscle aches. On 08-APR-2021 03:00, the subject experienced tiredness. On 08-APR-2021 03:00, the subject experienced fever. On 10-APR-2021 16:00, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, muscle aches, and fever, and was recovering from tiredness, and dizziness. This report was non-serious.
This initial spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. There was no pertinent medical history, concomitant medications or drug allergies/drug reactions described. On 07-APR-2016, the patient was inadvertently vaccinated with an expired dose of M-M-R II, injection (lot # reported as K016425 with expiration date 26-MAR-2016; dose, route of administration, anatomical location and albumin status were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. A product quality complaint was not involved. Additional information has been requested.
Local rxn + maculopapular rxn of the body 2 wks later; 18MAY90 f/u: local rxn w/adenpathy; Raised border w/lump in center; swelling is decreased but remains red;
p/vax pt devel 1 hive(urticaria) 2cm in size just below varicella inj site lt deltoid area;hive lesion devel almost immed p/vax;
Date the vial was initially stored : 31-Jan-2022., Date(s) of administration of vaccine :17-MAY-2022; patients received expired Moderna COVID-19 vaccine beyond the 30 day refrigerator shelf life; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received expired Moderna COVID-19 vaccine beyond the 30 day refrigerator shelf life) and PRODUCT STORAGE ERROR (Date the vial was initially stored : 31-Jan-2022., Date(s) of administration of vaccine :17-MAY-2022) in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2022 at 5:37 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 17-May-2022 at 5:37 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received expired Moderna COVID-19 vaccine beyond the 30 day refrigerator shelf life). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored : 31-Jan-2022., Date(s) of administration of vaccine :17-MAY-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received expired Moderna COVID-19 vaccine beyond the 30 day refrigerator shelf life) and PRODUCT STORAGE ERROR (Date the vial was initially stored : 31-Jan-2022., Date(s) of administration of vaccine :17-MAY-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. The vial was initially stored on 31-Jan-2022. It was reported that vial did not undergo temperature excursion. Thaw expiration date was reported as 02-Mar-2022. It was reported that HCP did not know that vails should not be used past 30 days from thawing the vials. Total Doses given: 20 doses, 15 vials have been used. No treatment drug was reported.
Vertigo and tinnitus. Hearing loss not known yet. It started maybe 2 days after booster shot. I confused it with anxiety at first. Have a doctor's appointment tomorrow to see what I can do.
Temp 104.3 this am, emesis x 2, lethargic, at 0800 7MAR91 put in tepid water bath to cool. Pt unable to keep Tylenol down since the 0200 7MAR91 dose. Will give pedialyte & see MD.
arm is still sore at the site of injection; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient got her 1st dose of Shingrix vaccine 2 months ago and her arm was still sore at the site of injection which had not improved. The reporter did not consent to follow up.
lung nodules and am looking for my second booster; This spontaneous case was reported by an other health care professional and describes the occurrence of PULMONARY MASS (lung nodules and am looking for my second booster) in a 71-year-old patient of an unknown 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 PULMONARY MASS (lung nodules and am looking for my second booster). At the time of the report, PULMONARY MASS (lung nodules and am looking for my second booster) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications and no treatment medications were reported. Patient was looking for second booster.
The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 07-DEC-2017 and 25-APR-2018, the patient was vaccinated with improperly stored ROTATEQ (strength were unknown) (lot # N004815 and expiration date 07-OCT-2018; lot # N024295 and expiration date 24-MAR-2019) 1 dose form orally for prophylaxis. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017 and 23-JAN-2018 was 47 degree Celsius for max 15 hours. And on 07-DEC-2017 was 50 degree Celsius for max 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Fever; Headache; Chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: unknown), intramuscular on right arm on 16Dec2020 (08:45 PM) at single dose for COVID-19 immunization. The patient's medical history included diabetes mellitus, hypertension, and COVID-19. Concomitant medications were not reported. It was reported that prior vaccination, patient diagnosed with COVID-19. No known allergies. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced chills, fever, and headache on 17Dec2020 (09:00 AM). There was no treatment received for the reported adverse events. The outcome of events was recovering. This case is reported as non-serious.   Information on the lot/batch number has been requested.
Large local reaction, golf ball sized induration, red and painful area. Pt travelled right after injection given and swelling has since gone down quite dramatically.
After the patient received the vaccine, while waiting in the store, the patient fainted for few minutes. The patient looks pale but regained conciousness. Patient was having a severe panic attack at that moment.
1MAR egg sized swelling;2MAR swelling involved much larger area;3MAR swelling included armpit, lymph nodes & a red streak;MD told pt to go to ER;redness upper arm top;4MAR soreness, itchiness;blood test showed no infect-just rxn;
In August 99, there was the onset of moderate to moderate/severe joint pain and stiffness in wrists, hips, knees, and ankles. At the time of this report, there remains mild-moderate joint pain and stiffness primarily in knees. The pain makes activities involving repetative knee bending difficult.  Follow up 10/17/2000: "The administrator of the vaccine did not document the Lot #."
fatigue/joint pain dx w/lupus 4mo p/2nd inject;has been under treatment-PO meds,pred/NSAIDS/Plaquinel since dx;
Swollen lymph gland in left armpit (same side as injection) muscle/body aches, Cold sores,  headache for approximately for 1 week after injection.
Diffuse maculopapular pruritic rash with onset 30 minutes after time of injection, beginning locally at site of injection (R deltoid) then spreading all over the skin, with facial and palmar sparing. Rash persists more than 48 hours later. No anaphylaxis. No desquamation.
dime size reddness @ site of inject rt arm; reddness swelling inc to 3"x 4" on arm-duration of sx lasted until 6NOV93; no itching or pain;
Greetings: Since I had a substantial reaction to my flu shot, I thought I should notify you. I'm not complaining, but am concerned about the shot initiated this year. I've had flu shots for many years, without any negative reaction, but if I had to look forward to what happened to me this time, I wouldn't want another one. So, I'd like to explain the circumstances and ask if you can help me understand how this might have happened. On Tuesday, October 12, 2010, I had the flu shot (FLUZONE HIGH DOSE) at approximately 1:30 p.m. That afternoon I left for a trip. I felt fine when I boarded the train around 4:30 p.m., but around 6:30 p.m. I started feeling sick to my stomach. I made an attempt at dinner around 7:45 p.m., but after a few bites started throwing up. I threw up twice during the night, and developed diarrhea. Fortunately I had a sleeper. I remained in bed for the entire journey, with nausea, diarrhea, headache, weak joints, but no pain at the point of the injection. When I arrived, I went to my hotel and to bed. I remained in bed with weak joints, a feeling of exhaustion, and nausea throughout my stay - Thursday, Friday, Saturday, and Sunday, October 14-17. I got up occasionally to try a bit of food, but it didn't taste good and I continued to experience nausea throughout this time. Today, I returned by plane. For the first time, today, I was interested in eating, although I continue to feel weak and "washed out". Was it indeed the flu shot that caused the reactions mentioned above? My answer is yes, for the following reasons: 1. If it had been food poisoning, the effect would have worn off after a couple of days. 2. I rarely get sick with a cold or the flu. In fact, the last time I remember throwing up and feeling sick from it was 20 or 25 years ago. 3. I've had flu shots for many years, and have never had a reaction. I've never even felt a sore spot where the needle went in. Thus, this shot seems to have been something "special," and I'd like to find out what it is so I won't have to repeat this extremely unpleasant experience that ruined a vacation with my family. If you have any thoughts on this, or any questions about what I've said above, could you please contact me by email or phone? Thank you.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 05Dec2022 to 09Dec2022, for the treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Pain described pain w/injection at site following day came to pharmacy-2 small bumps n inch in length and swelling, redness w/rash 5 days later. Pt saw M.D who treated who w/cephalexin and BENADRYL.
Within half hour post injection had headache and fever, achy joints, end of first week had COVID Arm, Swollen Lymph Nodes.
NP was alerted by bystanders that "something was happening" in an area outside of the clinic designated for patients wait the recommended 15+ minutes after COVID vaccination. PCT on duty and provider in-training were attended to patient was sliding out of chair and was markedly pale and trembling. NP was called to the scene. He was assisted to the floor and was monitored closely. He consumed Pedialyte and reported feeling better. He said that he just "started feeling tired" while waiting after the vaccine. He was accompanied by his roommate who also had a vaccine immediately after him. After the friend had been observed along with the patient for 40+ minutes, the patient left the clinic ambulatory and was driven home by his friend.
Information has been received from a licensed practical nurse concerning a "couple" patients who were vaccinated with the Gardasil. Subsequently, the patients said that their arms hut when vaccinated with Gardasil. No additional information regarding these other patients was available. The LPN also provided information regarding another patient's experience with Gardasil (WAES#0709USA01895) and "some" patients' experience with Gardasil (WAES#0710USA00229). Additional information has been requested.
Woke up in the middle of the night with severe nausea, dizziness, stomach pain, ringing in the ears, hot and cold flashes, almost fainted.
-EXTREME muscle pain/weakness. On entire left side of body. Unable to stand or walk for 24 hours. -Intermittent stabbing 8/10 chest pain. -unable to breathe deeply without dry cough attack -migraine - vomiting  - severe brain fog.  - mensural cycle disturbances: starting and stopping randomly weeks away from regular schedule. Extremely painful cramping (NEVER HAD BEFORE IN MY LIFE)