chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; feeling tired; feeling weak; sore at injection site; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th February 2020, the patient received the 2nd dose of Shingrix (intramuscular). In February 2020, less than a week after receiving Shingrix, the patient experienced fever, tiredness, feelings of weakness and injection site pain. On an unknown date, the outcome of the fever, tiredness, feelings of weakness and injection site pain were unknown.   It was unknown if the reporter considered the fever, tiredness, feelings of weakness and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received second dose of Shingrix and  experienced fever, feeling tired, feeling weak and soreness at injection site. The patient did not consent to follow up.
headache  24hrs starting the 4th day after the injection Full body aches 12 hrs Temp 99.1  12hrs.     took buffered aspirin diarrhea 1 time dizzy episodes. 6 & 7 days after vaccine.   (no medical attention needed)
Fever, shortness of breath, chest pain, body pain, dizziness,  fatigue, diarrhea, upset stomach. The patient made a visit to the physician but did not mention the treatment or  the outcome
Patient felt very warm after receiving Janssen vaccine. Patient was given an ice pack and a bottle of water. Patient quickly began to feel better. Pharmacist checked in with patient every few minutes. Patient sat in pharmacy area for a total of 30 minutes and felt totally back to normal when he left.
This spontaneous report was received from an unspecified reporter via a news concerning to over 2000 patients between school age children and adults of unknown age and gender. The patients's concurrent conditions, medical history, historical drugs and concomitant medication were not reported. On unknown dates, the patients were vaccinated  with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (dose, route, lot number and expiration date were not reported) for prophylaxis. On unknown dates since August 2016, the patients experienced mumps. It was reported that more than 90% percent affected children and 30 to 40 percent of affected adults were vaccinated but "those adult vaccination rates were typical and do not explain the outbreak" and "normally, people only received two doses of the vaccine, but they were recommending a third dose". At the time of the report, the outcome of mumps and vaccination failure was not reported. The causal relationship between the events and  Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) was not reported. This is one of the several reports from  the same reporter. Additional information is not expected as there is not contact details of the reporter.; Sender's Comments: US-009507513-1701USA006589: US-009507513-1701USA005463:
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Sep2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years for COVID-19 immunisation. The patient's relevant medical history included: "LASIK" (unspecified if ongoing); "Dry eyes" (unspecified if ongoing), notes: dry eyes due to botched LASIK and some mild GI issues, but otherwise healthy; "Mild GI issues" (unspecified if ongoing), notes: dry eyes due to botched LASIK and some mild GI issues, but otherwise healthy. The patient's concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (dose 4 (booster), single; manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (dose 3 (booster), single; manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (dose 2, single; manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (dose 1, single; manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". 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 which included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
he was hospitalized for an unrelated condition having to do with a blood problem; Drug dose administration interval too long; This case was reported by a consumer via call center representative and described the occurrence of blood disorder in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced blood disorder (serious criteria hospitalization) and drug dose administration interval too long. On an unknown date, the outcome of the blood disorder and drug dose administration interval too long were unknown.   The reporter considered the blood disorder to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient was hospitalized for an unrelated condition having to do with a blood problem. It was stated that, due to being admitted to the hospital, the patient missed the timeline for the second injection (within 6 months) which led to lengthening of vaccination schedule. The reporter stated that, the patient had a second Shingrix injection with the intention of starting the series over but not had the third injection till the time of reporting. Limited information was provided. This case was linked with case US2019194710, reported by the same reporter.
After a few minutes of receiving her third dose of HPV the patient fell onto the floor and had a brief seizure.
The day after the vaccine I began to feel headache, frequent sneezing, a lot of mucus, stuffy nose, cough, fever, and muscle pain in my neck and back. I called the line I couldn't make a report but I contacted customer service, the lady told me that maybe I got infected before with flu or another virus before. I know my body and what I feel is since the vaccine.
Arm swollen & red within an hour of injection. C/O dull headache since C/O new onset neuropathy feet since
On 11/8 I had my annual physical. I received the INFLUENZA VACCINE SPLT PRSRV FREE INC ANTIGEN IM in my left arm and the Pneumonia vaccine in my right arm. On Tuesday I only had site pain where i received the flu shot, this subsided in 48 hours. On Thursday morning the 11th I awoke with a stiff neck and a lump like a golf ball at the site of the pneumonia vaccine.  As the day progressed my neck got worse and worse until I could not move it up or to either side without extreme pain. I took advil, applied heat, and still felt pain at all times. It is now the 13th and the pain is subsiding but still present. My ability to turn my head is somewhat better but still painful. The lump on my arm is improving as well. I was unaware of any possibility of such a debilitating and painful reaction to either just the pneumonia vaccine or the combination of the 2 vaccines?  There should be a warning. It was terribly scary and I really could not safely drive.
flu like. Muscle pain. Injection site pain/swelling. Very tired. Plus a swelling under the eye on the side of injection. This happened on the first shot also.
Tested positive for COVID on 6/9/2022. Fatigue and coughing 6/8/22 through 6/20/22.
On Sunday, 04/18, I went and received my second dose of the Pfizer vaccine at 12:30 pm on my left arm. It hurt much sooner than the first, within a couple hours. It hurt worse as well. The next morning was Monday. My arm was super sore. I work from home and went by my normal routine. Oatmeal with raspberries and blueberries.  I eat this every day. I started work at 9 AM. Around 9:30 Am or so, I started having sneezing fits. Which I thought was annoying more than anything, but didn't think anything of it, until the fits developed into my hands itching, burning, turning red. I looked at my face and noticed it was red and swelling.  I've had skin allergies before, but nothing outside of hives and maybe a little skin swelling.  I have an allergy to bees. Worse that ever occurred was hives. This instance did not produce hives but a very beet red rash and swelling.  Then very quickly after, my tongue started swelling and my throat started tightening. I called my mother as I noted this was life threatening and went to the ER. I was informed I had experienced anaphylaxis.  My heart rate going in to the ER was 166. I have never experienced this in the 32 years I've lived before.  I was administered an Epi and steroids. As soon as I realized what it was, even in my panic, I was lucky to make a judgment call to save my life. The doctor said to throw out the berries just in case. The odd thing is, I eat this every day...no issues. I realize it is rare for reactions to be delayed, but was made aware it is possible.  I was not stung by anything to make this occur.
she could feel it moving down, like her arm and into my hand; she was having a reaction; I could feel it moving down, like my arm and into my hand and then I fainted; I felt like a warmth moving through my arm; my hand was punched and I was not able to like open it; This is a spontaneous report from a contactable consumer (Patient). A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0198), dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date (Age at vaccination 36 years old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 23Jul2021, patient received her first dose of vaccine few days ago, since she got it she felt like a warmth moving through her arm. They were like, she was good to go. She started walking and she did, she had fainted before from needle. So, she was like she was gonna sit down. She sat down and she could feel it moving down, like her arm and into my hand and then she fainted. Whenever she came to, they brought her an ice pack and her hand was punched and she was not able to like open it. She had used her other hand to open the one hand which was the hand that she received the shot in that arm and they were kind of concerned at first when they thought she was having a reaction. They asked all the questions, and everything seem to be okay, they said that they were going to report it but then she should check all before she get second dose. Outcome of events was unknown.    Follow-up attempts are completed. No further information is expected.
But 4 days later I got a fever 100.7 highest; Tingling fingertips; Bad recurrence of herpes; Bad recurrence of herpes; My upper arm hurt just for a day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Pancreatic cancer" (unspecified if ongoing), notes: pancreatic cancer survivor; "Herpes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "My upper arm hurt just for a day"; PYREXIA (non-serious), outcome "unknown", described as "But 4 days later I got a fever 100.7 highest"; PARAESTHESIA (non-serious), outcome "unknown", described as "Tingling fingertips"; HERPES VIRUS INFECTION (non-serious), DISEASE RECURRENCE (non-serious), outcome "unknown" and all described as "Bad recurrence of herpes". Relevant laboratory tests and procedures are available in the appropriate section. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.  Additional information: Patient reported that "I just thought I would give you the side effects I experienced after taking the Prevnar 20 vaccine. I am a 65-year-old female, pancreatic cancer survivor. My upper arm hurt just for a day but 4 days later I got a fever 100.7 highest, tingling fingertips, and bad recurrence of herpes".
On 5/15/2017, the patient has experienced redness and swelling around the injection site. There was some itching and pain that morning, but this has since gone away. The patient used ibuprofen to help with the swelling. On 05/16/2017 the redness spread farther around the injection site. The patient sought medical advice from her primary doctor and the pharmacist.  Diphenhydramine was suggested to help with the swelling and redness.
multiple unspecified patients were vaccinated with improperly stored GARDASIL 9 or RECOMBIVAX on multiple unspecified dates.; No adverse effects reported.; This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On multiple unspecified dates, the patients were vaccinated with improperly stored doses of Hepatitis B Vaccine (Recombinant) thimerosal-free (RECOMBIVAX HB) lot numbers R013540 and R007212 with expiration dates on 21-MAR-2021 and 04-NOV-2020 respectively or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot numbers N032284, R032766, and 1602284 with expiration dates on 22-SEP-2020, 31-AUG-2021, and 26-SEP-2021 respectively (dose, frequency, strength and route of administration were not reported) and all were given for prophylaxis.  Administered doses of vaccine experienced temperature excursion below 36 degrees Fahrenheit / 2 degrees Celsius (27.7degrees Fahrenheit) for 408 hours. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported.   As of 30-APR-2020, all telephone attempts trying to obtain additional information has been unsuccessful
Left arm swollen , red and hot to touch. Hurt to move arm upward position. Given Keflex.
The patient was given the 3rd dose of COVID 19 Pfizer ( 6m-4 years) and this vaccine is no longer the one that should be given due to change to 2 doses of  COVID 19 Pfizer ( 6m-4 years and 3rd dose is the Bivalent dose
Swelling of Right side of face (to include eye and cheek) starting 3 days after the injection, remainded swollen for 2 days. Hives and swelling (itching and painful) at injection site 3 days after injection and lasted for 2 days.
N/A Provided patient incorrect Undiluted Pfizer Omicron Bivalent Booster.
Fatigue, chills, body aches, headache and fever started 24 hours ago. His fever has reached as high as 103.6 and maintained fever yesterday if 102.6-8 on Tylenol and Motrin doses. This morning he vomited and woke up with 102.5 fever, chills, body aches. He is still very ill in bed. After 1 hour on Motrin (doctor prescribed higher than advised doses due to how high fever is) he is still at 102.8.
it dripped down patient's arm, not sure how much came out with no reported adverse event; Initial information received on 06-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 67 years old male patient who while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and the vaccine dripped down patient's arm, not sure how much came out with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Oct-2022, the patient received a  dose of 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength: unknown) lot number UJ928AA and expiration date: 30-Jun-2023 via intramuscular route in the left deltoid as Immunization  On an unknown date in 2022 the vaccine dripped down patient's arm, not sure how much came out with no reported adverse event (accidental exposure to product). (latency: unknown). Would like to know if they need to revaccinate or what they should do. This situation was reported as an accidental exposure.  Action taken was 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     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 set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Approx 1 hr after injection - c/o sweating - lightheaded & itching - nausea.  9/30/08 Reviewed hospital medical records of 9/11/08. FINAL DX: no d/c summary available.  Admitted for allergic reaction & elevated CK. Records reveal patient experienced recent negative antibody testing for Hep B( due to needle stick), even though had 2 complete vaccination series in the past.  Immediately after vaccination on 9/11, felt light-headed, diaphoretic, nausea, vomiting, anxiety, pruritus, facial flushing.  Seen in ER & tx w/steroids, antihistamines w/resolution of symptoms.  Observed overnight.
Information has been received from a licensed practical nurse concerning an approximately 26 year old female patient with eczema, "thyroid issues" and penicillin allergy who on 13-SEP-2010 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL. Concomitant therapy included SYNTHROID. The nurse reported that the patient had eczema prior to beginning the GARDASIL series. On an unspecified date the patient felt that the eczema got worse after beginning the series. The patient sought unspecified medical attention. No laboratory diagnostics studies were performed. The patient was currently being treated for the condition at this time with prednisone, ELIDEL cream and hydroxyzine. At the time of the report, the patient was not recovered. Additional information has been requested.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ lot # L013204, oral for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage. No adverse event was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. Additional information has been requested. Sender's Comments: US-009507513-1708USA005191.
Vaccine was given too high on the pt's arm, about 1" down from shoulder.  Pt said there was immediate pain, that did not happen after the first COVID-19 vaccine, and questioned if vaccine was given to high and would need to be repeated.   Pt was reassured that vaccine would be fine and to take Tylenol for pain.     Pt returned the next day, providing a ride to someone else receiving the COVID-19 vaccine.  I measured that injection site, which was 1" down from shoulder.  Reassured that vaccine dose was affective and would not need to be repeated.  Let patient know that I was more concerned w/an arm injury.  She said her arm felt fine, and had no more pain.   Told patient I would call the Health Department to verify that the dose did not need to be repeated and fill out a VAERS report.  Followed up a few days later, after HD response.  Let her know HD said no repeat doses was needed and asked if she was experiencing any arm pain.  She had not issues w/pain or movement of her arm.
Extremely High Fever, Vomiting, Lethargic, Would Not Eat, would not drink.
Nausea with diarrhea shortly after receiving the vaccine. Low level nausea continues to be present constantly. Periodic diarrhea (approximately 2-3 times per week) with symptoms suggestive of irritable bowel syndrome. No prior history of GI disorder or irritable bowel syndrome. OTC treatments partially effective.
Breakthrough COVID case. Fully vaccinated, COVID+ on 11/27/21. Admitted to ICU, but admitted for reasons other than COVID. COVID positive was incidental, and patient asymptomatic.
Pharmacist stated that an expired dose of Twinrix was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 20-OCT-2023, the patient received Twinrix. On 20-OCT-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Pharmacist stated that an expired dose of Twinrix was administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-Oct-2023 The vaccine administration facility was the same as primary reporter. The caller declined to provide more information. The reporter did not consent to follow-up. The patient received an expired dose of Twinrix, which led to expired vaccine used.
Left arm redness superficial to lateral humerus from mid-shaft to below elbow. PT with healing and open wound to upper humeral area 2 deg smallpox.
Within 5 minutes of receiving injection, patient became faint- Mom caught her and eased her to the floor.  When nurse arrived patient was responsive, but very pale and diaphoretic.  B/P 70/40.  Was transported to exam room and observed for 20 minutes.  Became fully alert and oriented, color pink and B/P 112/72 at discharge.  Dr examined her-felt that it was a vaso-vagal reaction.
Information has been received from a consumer referring to her son, a male patient of unknown age. The patient's pertinent medical history and drug reactions/allergies were not reported. On 19-JUN-2015 the patient was vaccinated with his first dose of GARDASIL (dose, route and lot# were not reported). The patient did not receive his second dose at the recommended two month interval, and as of the date of this report had still not received it (inappropriate schedule of drug administration). No adverse effect was reported. Additional information is not expected as there was no any contact information provided.
Patient is 9 and was given Pfizer 12+ bivalent booster instead of Pfizer 5-11 bivalent booster. Patient's mom says that patient has been lethargic and had severe arm pain following vaccination for 1 day.
No adverse effects; two patient were administered one dose of PEDVAXHIB before 2 month of age; This spontaneous report has been received from a physician concerning  an approximately 7 week old patient of unknown gender and ethnicity.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 25-MAR-2019, the patient was vaccinated with 2 doses of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB),  (frequency and anatomical location were not reported) (lot # R021083 and expiration date 13-JUN-2021) for prophylaxis.  At the vaccination time, the patient had approximately 7 weeks old (product administered to patient of inappropriate age). No adverse event reported.; Sender's Comments:  US-009507513-1905USA013730: