chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st shot Nov 2019, 2nd not yet; left arm  hurt; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-AUG-2022 Reporter's Comments: The patient self-reported the case via interactive digital media.  She had her first Shingrix shot on an unknown date in November of 2019 in the left arm.  She did not have the lot number of the injected vaccine.  Reporter stated that her left arm hurt, like someone hit me with a brick. She stated that it lasted for about a week then resolved.  She had not yet received 2nd shot yet and it had been more than 6 months since shot 1. Did not consent to follow-up.  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
A report has been received from a Health Professional concerning a 7 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 21-Nov-2012. The patient experienced positive influenza A test which started on 02-Jan-2013. The outcome of the event of positive influenza A test is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 09-Jan-2013: patient details, adverse event start date, drug start date, lot number, exp date added.
arm swelling; Initial information received on 14-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.via other company (Pfizer) (Manufacturer Report Number: 2019257707).  This case involves an unknown age patient who experienced arm swelling, while he/she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's had no past medical history.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) for Immunisation.  On 14-Jun-2016, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5259AA via unknown route.  On an unknown date, The patient developed a non-serious arm swelling (peripheral swelling) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  No lab test was performed.  Final diagnosis was arm swelling.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for arm swelling.
Approximately 7 minutes after vaccine was administered patient developed hives in a 3" diameter around the vaccine site. The vaccine was GARDASIL 9.
Patient received his second dose of Moderna 14 days early.  Patient came in for his second dose and told us he had gotten his 1st dose at another clinic.  We were unable to find his immunization records and he initially did not have his card, however he told us he had received Moderna and was due for his second shot.  After giving him his second dose he gave us his vaccine card.  We then realized that he had gotten his second dose too early.  Patient indicated that he was traveling and needed to be fully vaccinated in order to travel so he came to our facility to be immunized early.  We checked the CDC website and noted that the patient did not need to have a repeat dose.  Patient was given his vaccine card and told to call us if he had any severe reactions.
Information has been received from a health professional concerning a school age female patient who was vaccinated with a dose of varicella virus vaccine live. In approximately March 2006 the patient developed a mild case of breakthrough varicella with less than 50 lesions. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint involved.
lip sore; lip spot; painful on her lips with indentations; lip indentation/ painful on her lips with indentations; This case was reported by a consumer via call center representative and described the occurrence of sores lip in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores.   On 20th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 21st March 2019, 1 days after receiving Shingrix, the patient experienced sores lip, lip pigmental spot, lip soreness and skin indentation. On an unknown date, the outcome of the sores lip, lip pigmental spot, lip soreness and skin indentation were not recovered/not resolved.   It was unknown if the reporter considered the sores lip, lip pigmental spot, lip soreness and skin indentation to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in the left arm. The following day she had sores on her lips. The patient stated that, these sores were different from the cold sores which she had in past. She described the area as painful on her lips with indentations. The patient had sores on the top and bottom but mostly on the bottom lip. She had a white spot on her bottom lip and then half of her bottom lip turned white. The patient had sores for two and half months and the area was still unresolved. The patient consented to follow up. Outcome of the events sores lip, lip pigmental spot and lip soreness was discrepantly reported as recovering/ resolving in source document while in database and narrative description it was reported as not recovered.
About 20 minutes after receiving the vaccine my heartbeat started beating fast, I was feeling short of breath as well as dizzy & nauseous.  I've never had a problem with vaccines before so I thought the feeling might pass but my symptoms were getting worse so I went to urgent care  next to the vaccine clinic to get evaluated. The Dr. felt that I was having an allergic reaction to the vaccine. He ran bloodwork and monitored me for the day. I went home and continued to feel terrible with my symptoms persisting, especially the rapid heartbeat and shortness of breath. A few weeks later I was diagnosed with pneumonia which exacerbated my asthma. It was difficult to breathe and I started developing issues with throat tightness and swallowing as well. I was prescribed prednisone, antibiotics and additional inhalers to help relieve the symptoms. I had a throat and swallow test done and was diagnosed with vocal chord dysphonia. I am currently doing voice therapy to help with that. I don't know if the pneumonia and other problems are a direct result of the vaccine but I do know that I didn't have these issues prior to getting the vaccine so I felt it was important to report it. Please feel free to contact me if you have any questions.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 11:35 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 11:35 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 42.81.  Concomitant products were not reported. On 28-APR-2021, Excursion time was 09 AM. temperature was 33 respectively. total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-APR-2021, vial was moved to clinic on 28-APR-2021. 3 vials were sent to clinic. Vaccine BUD date was 19-A-2021.  On 28-APR-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 40, 12 AM: 41, 1PM: 41, 2 PM: 39, 3 PM: 41 and 4 PM: 40.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Pt experienced low-grade fever (99.9 degrees F on oral temeperture) nausea, vomiting, dizziness and localized swelling @ left deltoid (site of pneumococcal vaccine administered 3/18/01) within hours of this injection Inadvertently previous vaccine given 5/22/01 was missed on chart. Review initially by the treating physician. Pt instructed to call 3/20.
ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 1/25/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
A female pt was vaccinated on 02/02/1999, 02/05/1999, and 02/10/1999 with Rabipur. No further info was given. The pt was hospitalized during the following periods. 04/05/2000,04/14/2000,10/25/2000,11/07/2000,01/09/2001 to 01/16/2001 and 09/18/2001 to 09/25/2001. A serogenetic polyneuritis (polyneuropathy NOS)and polymyalgia rheumatica were suspected and the diagnosis of a muscle hypotrophy of the pelvic girdle area was made. A muscle biopsy (11/02/2000) revealed a fibre atrophy of type II B (muscle disorder NOS).  At the time of reporting (12/19/2001) the pt had not yet recovered.
An hour after vaccines, pt started vomiting up to 12 x. Taken to ER. Put on IV antibiotics. Stayed in hospital for 1 day. Put on antibiotics due to high WBC #s.
On 5/27/23, patient had a staring event followed by perioral cyanosis then fatigue. Taken to ED, observed and sent home. Mother of patient felt uncomfortable with how she was acting, called Pediatrics. Described event. Recommended to take to Medical Center ED. A second episode happened and patient felt warm to mother. Then in ED, 3rd episode happened, witnessed by medical staff and confirmed as a third seizure. Admitted for observation and testing.  On Day 2-3 of admission while still febrile, patient had urinalysis done which showed evidence of a urinary tract infection. Given antibiotics, improved and discharged home on day 4 (day 9 after immunization).
Severe shivers unaccompanied by sweating or chills. Approximate duration: two (2) minutes.
Within 5 minutes of receiving shot I felt very nauseous and dizzy. Symptoms lasted for  five days. Very dizzy. Stomache upset. Could not leave house.
The caller is asking if that will matter because right now she's only feeling the soreness that she originally felt when she first got the Pfizer booster shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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. Vaccination history included: Covid-19 vaccine (DOSE 1), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2), for COVID-19 Immunization; Bnt162b2 (DOSE 3), for COVID-19 Immunization, reaction(s): "The caller is asking if that will matter because right now she's only feeling the soreness that she originally felt when she first got the Pfizer booster shot.". The following information was reported: PAIN (non-serious), outcome "unknown", described as "The caller is asking if that will matter because right now she's only feeling the soreness that she originally felt when she first got the Pfizer booster shot.". Additional information: The caller said she got the Pfizer booster shot, but she realized that she already got the same booster shot a year and a month ago. The caller is asking if that will matter because right now she's only feeling the soreness that she originally felt when she first got the Pfizer booster shot. The caller mentioned that she neglected to let her provider know that she already had the booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had flu shot on Tues at 3:34 p.m.  On Fri am woke up with red ear lobes and swollen rash on cheeks and neck,  some on chest.  On Fri the rash was worse.  On Sat had rash inside of both arms also and started taking benadryl..  P  The rash has been itchy especially ears and neck.  I have had many flu shots without any problems. I had not eaten or done anything leading up to this event.
8/9/23 fever 100.4 AX            faint pink blanching papular rash all over skin areas, most dense on buttock and back non urticarial Received two doses of Varicella
splitting headache; This is a spontaneous report received from a contactable consumer (reporting on herself) via Pfizer Sponsored Program. A female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiration date was not reported), via an unspecified route of administration on 23Mar2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  On 24Mar2021, she had a splitting headache since 6AM this morning. Asked if she can take Advil for a headache.  The outcome of the event was unknown.    Information on the lot/batch number has been requested
Hurts on left side (side of shot) from elbow to head/neck, swollen arm/hot, dopey feeling.
Following the vaccine I had no AEs the entire time. Not even a sore arm. On 08/13/2021, I had fever of 100 degrees, body aches much like the flu, nauseous but didn't get sick, very tired and nasal drainage. On the onset, 08/13/2021, I went to Urgent Care. I tested positive for COVID-19. The following day at 1:00 PM they gave me the infusion at the hospital, as an outpatient. 2 hours later I had horrendous chills, ice piercing cold, I literally had to put on my robe, I was shaking and I could not stop from the cold. It lasted for like 3 hours. Then I had the flu like symptoms and doing breathing treatments-albuterol 0.5/3 (2.5 mg) 4 treatments 4 x day, inhalation. Prescriptions from the pharmacy: Prednisone 10 mg 1 tablet by mouth for 5 days, azithromycin 200 mg 2 tablet on the 1st day, and then 1 tablet for 4 days, treatments for my lungs. After 2 weeks, I'm back to normal. I have totally recovered.
pt recv vax 26MAR96 & w/in 12hr post vax, devel petechiae on face & back;addtl info recv 24APR96 indicated pt recovered;
3/29, Pfizer, dose #1 04/19, Pfizer, dose #2 09/03 pt/inr 12/1 07  09/28 pt cc: headache, nausea, vomiting, fatigue exposure: unknown 10/13 COVID swab, result: detected 10/17 clinically resolved 11/08 pt/inr 11.5/1.03 11/08 COVID swab, result: detected
Patient experienced tongue swelling starting a few hours after receiving the vaccine. She presented to clinic where she was treated with benadryl, famotidine, and prednisone. Her symptoms resolved in clinic and she was discharged home a few hours later.
feeling light-headed/this morning feeling dizzy; shooting headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported) via an unknown route of administration on 01Mar2021 as 1st dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient was feeling light-headed and shooting headache. Patient reported that feeling light-headed on the short drive home, patient slept great last night then woke up this morning as feeling dizzy and every now and then a shooting headache. Outcome of the events was unknown. It was reported that patient was also on an extremely low carb diet as she doesn't eat more than 40 a day, patient means assuming grams of carbohydrates.  No follow-up attempts were possible. Information about lot/batch number cannot be obtained.
no other AEs reported; expired dose of proquad was inadvertantly; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 10-JUN-2021, the patient was inadvertently vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 1 injection lot # S038145, expiration date 25-MAY-2021 (exact dose and route of administration were nor provided) for prophylaxis. The nurse requested post-expiry viability data. No further information was provided and no other adverse events (AEs) were reported. The action taken was not applicable.
Patient was to receive an HPV vaccination. The syringe was prepared and seemed to be normal and in working order. All the air was expressed from the vaccine and there were no signs of leakage. When the needle was inserted into the patients arm and the plunger pressed down upon by the nurse, most if not all the vaccine shot out from under the hub where the needle would fit together with the syringe. The vaccine sprayed onto the nurse and the patient and some on the table. Supervisor was made aware immediately and so was the provider. I apologized to the parents for the malfunction, and they were very understanding. My supervisor informed me that I should do this report and also consult the provider on whether to do the vaccine again or wait until another appointment.
Starting 05/07/2022, I started feeling dizzy. At first I felt I had been spinning around and when I reached for something, I almost fell. So I sat down to try to not fall. Then I sat on the floor of the shower to keep myself from falling over and ended up vomiting. Then, I crawled out of the shower and knelt down in child's pose and unable to raise my head off the bathmat without feeling sick again. My husband called 911 and the EMTs came and I was laying on my side by then. They did an EKG and checked my vital signs. They told me to sit up and when I sat up I had to hold on to the bar next to the toilet to keep from falling over. Then, I started vomiting a lot. They gave me 4mg of Zofran IM then decided I needed to go to the ER. So they sat me in a wheelchair. I continued to vomit on the way to the ambulance while sitting in the wheelchair. Then, on the gurney, in the ambulance I was still slightly vomiting but at this point it was more dry heaving since my stomach was empty. They gave another 4mg of Zofran through IV and then I got to the ER and I was given Valium orally and antivert. I was feeling somewhat better but still had to keep my head still to keep from being dizzy. The ER ordered an MRI and, the results were negative. So, they sent me home with a prescription for Zofran and Antivert, and a referral for vestibular rehab therapy. I have an appointment with my PCP on wednesday afternoon (05/11/2022). I'm feeling wobbly and weak, and still experiencing some slight dizziness but no nausea since being home. I am still very tired.
8/14/13 3:00PM seen in office: Swollen, warm, tender, upper right arm. Advised children's ibuprofen and Benadryl. Go to urgent care if worsens.
blood pressure has been increasing so much and it is now at stage 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "blood pressure condition" (ongoing), notes: preexisting prior to vaccination. The patient's concomitant medications were not reported. The following information was reported: HYPERTENSION (medically significant) with onset 2021, outcome "unknown", described as "blood pressure has been increasing so much and it is now at stage 3". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (2021) increasing so much and it is now at stage 3. It was further reported that the patient has preexisting blood pressure condition prior to the vaccine but it was never like this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Diarrhea, NauseaVomiting, myalgia, chills without fever Narrative:  Developed nausea, chills (no fever), and myalgia the same day as the vaccination, which persisted for about 3 days. Also had a few episodes of diarrhea the day after the injection. No other related adverse events. Did not seek treatment or self-treat.
This spontaneous report was received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or drug reactions/allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose, route and site of administration, lot # and expiry date were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt received Tdap then HPV #2 as soon as MD finished with HPV 2, pt eyes rolled back and pt started to twitch and drool x 5 seconds. Recovered vital signs taken, water given, observed pt x 30 min. Pt states "I feel fine" and Dad feels comfortable taking pt home.
Pt developed a raised bump and soreness at injection site 3 hours after administration. Noted significant fatigue. Next day reported diffused myalgias and bone pain. Resolved symptoms the next day. Missed work x 1 days due to symptoms. No known prior COVID infection.
Patient is having flushing of the face and itching all over her body.  She has taken benadryl without any relief.