chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nonviable after a temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a child male patient who received HAV (Havrix) (batch number 5575N, expiry date 19th June 2022) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional case details were reported as follows: The age at vaccination was not reported. The patient was given a dose of Havrix that was deemed nonviable after a temperature excursion, which led to incorrect storage of drug.  No symptoms reported. The reporter consented to follow up. This case was 1st of 9 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021142812:same reporter US-GLAXOSMITHKLINE-US2021142813:same reporter US-GLAXOSMITHKLINE-US2021142815:same reporter US-GLAXOSMITHKLINE-US2021142816:same reporter US-GLAXOSMITHKLINE-US2021142817:same reporter US-GLAXOSMITHKLINE-US2021142818:same reporter US-GLAXOSMITHKLINE-US2021AMR151443:same reporter US-GLAXOSMITHKLINE-US2021AMR151445:same reporter US-GLAXOSMITHKLINE-US2021AMR151444:same reporter
Extremely swollen lymph nodes near left collarbone.  Noted that injection was given relatively high on arm.
Pain in entire arm of injection beginning day after and lasting 7 days. Pain and swelling in armpit/lymph nodes beginning on day 4 ending on day 7. Redness/swelling around the injection site on day 8 lasting to current day 12 after injection.
Reported by private physician that client developed hives in right arm after immunization received from Co. H.D.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 61-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number 397B5) for prophylaxis.   On 07-FEB-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
I am 23 weeks pregnant due date 2/14/2022. I had my second shot yesterday and wonk up with severe arm pain, body aches, chills, fever 100.3, headache, and sore throat.
This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. The nurse reported that, on unspecified dates, an unspecified number of patients might had received doses of improperly stored VARIVAX for prophylaxis (dose, route, anatomical location, lot/batch number and expiration date were not reported). No adverse effects reported. Temperature/Time frame: >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 46 hours 10 minutes (worst case) Previous temperature excursion:  >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 133 hours and 30 minutes (worst case) The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Swollen middle finger joints and knuckles. This inflammation was noticed upon waking the morning after the vaccine. The inflammation in this finger has not subsided despite the fact that it has been almost three months since the vaccination.
7 days after injection of DTaP/Hib, and Varivax in left outer thigh- got rash with small vesicles- about 8-10 of them.  low grade fever- felt warm, not measured at home.  no fever in office.  Seen at 9 days after immunizations given.  I told mom this was varivax reaction.  keep covered.  warm compresses.  tylenol as needed.  call if worsenes.
Patients caregiver said about 3-4 hours after vaccine, patient started vomiting uncontrollably. Also mentioned that patients blood sugar was fluctuating and the patient was barely conscious
Narrative:  82 yo male with PMH: anemia, pseudophakia, dementia, weight loss, tobacco dependence, hearing loss, COPD, osteoporosis, foot callus, onychomycosis, hematuria (2015) was found to have cardiac arrest per progress notes on 1/20/2021, 2 days after patient received COVID19 vaccine (Moderna). According to progress notes, wife found patient "slumped in a chair/likely cardiac arrest". Patient was transferred to local community hospital on 1/20/2021, the admitting diagnosis was "cardiac arrest with ROSC." Reviewed vaccine administration note from 1/18/2021. Patient denied any prior severe reaction to this vaccine or its components of a severe allergic reaction such as anaphylaxis to any vaccine or to any injectable therapy. Vaccine was administered without complication according to progress notes. Attempted to review scanned records from local hospital, none to review. Symptoms: & death, cardiac arrest Treatment:
Pt. called state health dept on 3/25/2004, reports the following symptoms: 1) sleep apnea/insomnia/extreme daytime drowsiness, onset approx. Oct 2003 2) Right elbow nodule and Left elbow "cellulitis/eczema-like appearance," onset approx. 2/15/2004 3) mouth ulcers with excessive drooling, onset approx. 3/18/2004.  Plans follow-up with infectious disease specialist and/or dermatologist
I received my Covid-19 vaccine on 10/06/2022. On the morning of 12/14/202 I woke up with a runny stuffy nose and headache. I took an at home Covid-19 test and tested positive. After testing positive I reached out to my doctor and was prescribed PAXLOVID. Symptoms lasted about 9 days.
a lot of fatigue; has a lot of heart issues; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 85 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Pfizer covid shots), for COVID-19 immunization; Bnt162b2 (Dose 2, Pfizer covid shots), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "a lot of fatigue"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "has a lot of heart issues". Therapeutic measures were taken as a result of cardiac disorder.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
sick, sick feeling, fainted & sz;CNS affected legs give out;has h/a & fatigue, can't remember;
Severe right hip pain which started 5 March and caused limping through 7 March. The pain ceased in the right hip and began in the left hip on 8 March. This caused limping through 9 March.   I used naproxen and aspirin but it didn't work very well. Pain interrupted my mobility and sleep.   Pain has finally subsided on 10 March with the occasional sharp twinges every one in a while. Walking normally again.
Pt recv vax on 12/21/98; on 12/30/98 pt exp diarrhea, chills, fever, headache until 1/2/99; nonpapular rash x 1/4/99
7-8 hours after administration of 4 vaccines, mother noticed significant swelling and redness of son's head, including ears.  No respiratory difficulty.  Red rash also noted on face and neck (only).  Treatment: Childrens Benadryl per MD.
pain in right arm/shot settled in her muscles and bones; shot settled in her muscles and bones; shot settled in her muscles and bones; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in right arm/shot settled in her muscles and bones), BONE PAIN (shot settled in her muscles and bones) and MYALGIA (shot settled in her muscles and bones) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in right arm/shot settled in her muscles and bones), BONE PAIN (shot settled in her muscles and bones) and MYALGIA (shot settled in her muscles and bones). At the time of the report, PAIN IN EXTREMITY (pain in right arm/shot settled in her muscles and bones), BONE PAIN (shot settled in her muscles and bones) and MYALGIA (shot settled in her muscles and bones) outcome was unknown.            No concomitant medication was reported. Treatment medication was not provided.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   This case was linked to MOD-2021-193869 (Patient Link).
My arm didn?t get sore for at least two weeks and it hurt all the way down my arm when you touch anywhere near the vein. it had a sharp pain/tingly feeling when bumped by anything. It also lasted for 8 days and still is sensitive when I bump the main vein where the inside elbow bends.
Hives rash swollen legs a allergic reaction. Treatment is some type of steroids.
Within one month after vaccination, developed joint pain, joint stiffness, joint swelling in bilateral finger joints. Had labs, xrays and assessment completed. New finding and diagnosis of rheumatoid arthritis
About 36 hours after getting the Pfizer covid vaccine, I woke up in the morning with a terrible pain on my right cheek bone.  It was very painful and hot feeling.  The pain lasted the full day.  It felt like it was also in my right temple area and at times would also radiate up into my right forehead.  I wanted to take pain medicine, but I remembered that I was told not to take ibuprofen for a little while after the vaccine because it could inactivate it.  So I just used an ice pack on my face.  The following day a good amount of the pain subsided but it turned into a dull headache in my right temple.  I kept hoping the headache would eventually go away. I did eventually take some ibuprofen about 5 days in which helped a bit.  On Aug 28th I got some tingling in my left toes, felt like my foot fell asleep for a minute or so.  I tried to walk it off and then it turned into a dull aching in my left calf which lasted a couple hours.  The headache continued for about 10 days before I called my dr and tried to get an appointment.  I got an appointment first with a nurse practitioner on Aug 31st  she gave me two injections (decadron and toradol) IM to try to break up the headaches. That sort of helped for a day or two. She helped me get a sooner appointment with doctor for Sept 10th.  Around 10pm on 9/5 I had an episode of blurred vision which lasted about an hour.  I saw  doctor on 9/10 (1st time seeing him to establish care) He said my face pain sounded a lot like trigeminal neuralgia. Did not give me any treatment for that visit.  The headaches mostly stopped until October 14th in the PM.  I?ve had a temple headache in my right temple for 24 hours now and decided to fill out this report. Also for the last few weeks now I?ve been having my feet and fingers fall asleep or get a tingling sensation every day.  (Also occasional leg twitching and aching.)  This never happened before I had this vaccine.  One day I grabbed my bag quickly and 3 of the fingers in my left hand went to sleep for a couple minutes.
Event occurred after 2nd dose. Patient was diagnosed with COVID Tylenol Discharged Home
Racing heart beat of 110 bpm vs normal 70 bpm.  High fever of 103 F.  Fever easily reduced by acetaminophen and ibuprofen.   Racing heart beat lasted 16 hours.
This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. No medical history was reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (lot # K023432, expiration date 18-JUN-2016) (route was not provided). No concomitant medication was reported. It was reported that 4 months after the first dose of GARDASIL, the patient was then vaccinated with a dose of GARDASIL 9 (dose and route were not provided) (lot # L007560, expiration date: 15-JUN-2017). No adverse effects were reported. It was also reported that no product quality complain was involved. Additional information has been requested.
This spontaneous report as received from a Certified Medical Assistant (CMA) (also reported as healthcare professional) refers to unspecified patients of unknown age. The healthcare reported that improperly stored GARDASIL (dose, route and lot number not reported) multidose vials were administered to an unspecified number of patients, demographics unspecified. No adverse effects were reported. It was unspecified if patients sought medical attention. This is one of several reports from the same reporter. Additional information is not expected.
With in an hour I had a severe metallic taste.  I keep wanting to drink water.  Unsure of what it was.   Then the sever chills and fever started around 10pm.  I awoke with so much pain and the headache was horrible.  The symptoms continued to worsen.  I tried to get I shower. I was weak and light headed and unable to get out of bed for 36 hours.   No where did it say I would have severs flu like symptoms.   Today 10/29. I am still with body aches and horrible head ache. Arm pain too. Mostly having flu like symptoms still.  Hot and cold sweats.   Loss of appitite
2nd Moderna vaccine given.  Aware of age <18 YO prior to administration.  CDC guidelines followed to give 2nd Moderna off label shot of series  for 16 YO.  PCP notified of off label use Moderna for 16 YO and OK for 2nd shot.  No adverse events reported from first Moderna vaccine. Well tolerated.
Patient developed motor tics mostly in lower extremities within minutes of getting the dose. She had no other signs of allergic reaction at that time. Normal mental status, no difficulty breathing, was not a seizure.She also reported feeling lightheaded/dizzy and a little nauseous. Ate 2 bags of goldfish and kept down water.  Lasted almost 12  hours afterwards despite benadryl. Also had an abnormal sensation in her lower lip which did not appear to be swollen, but she was chewing it and developed a blister there.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient started intense coughing about 10 minutes after the injection. At first pt thought it to be due to post-nasal drip which she has experienced before. She became concerned when she felt a lump in her throat and became sweaty. She was unsure if this was from coughing or a potential adverse effect from the vaccine. The patient took Benadryl 25 mg and was closely monitored for over an hour. Symptoms went away. After 4 hours called to check on patient who was feeling well, no symptoms noted.
Headache, Myalgia & Arthralgia Narrative: She noted to have joint and muscle pain as well as a headache and " spine pain"
turned into flu aches the next day.; sore arm; had aches in my bones which started like working out aches; This is a spontaneous report from a contactable consumer (patient).   A 39-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0175 expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 07May2021 12:00, as DOSE 1, SINGLE for Covid-19 immunization. Medical history included cardiomyopathy and Penicillin allergy from an unknown date and un-known if ongoing. Concomitant medications included metoprolol (METOPROLOL), valeriana officinalis root, valeriana officinalis root extract (VALERIAN ROOT EXTRACT), vitamins nos (DAILY VITA-MINS), ethinylestradiol, norgestimate (TRI-SPRINTEC) taken for an unspecified indication, start and stop date were not reported. Patient did not have other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since the vaccination. On 18Jun2021 12:00 AM, the patient had a very sore arm the 1st shot, had aches in her bones which started like working out aches and turned into flu aches the next day. The patient did not receive treatment for adverse events. The outcome of the events was reported as not resolved  Information on lot/batch number was available. Additional information has been requested.
Pt has a light rash of 12 (bumps) Some have formed pustuals this started 7/14/2008 Pt has not had any fever or no itching noted. The rash is only on back of torso and some on the side of the body.  These are the only s/s.  The VZV was administerd 7/7/08 subcue. this is the 2nd VZV the child has recieved the first dose was given 3/16/2001.
Tiredness; Ache/ little aching; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: not reported; expiration date: not reported), via an unspecified route of administration on an unspecified date in 2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced tiredness and ache/ little aching that went away the next day. Outcome of the events was reported as recovered in 2021.  The lot number for the vaccine was not provided and will be requested during follow up.
Symptoms included: Body aches Fatigue  Chills Fever Headache Nausea  Some diarrhea (mostly clear liquid) Runny nose clear Some congestion  Difficulty breathing - arrhythmia from 11pm to 4am night after vaccine administered
Sore throat, painful swallowing, headache, nasal congestion, cough, earache
pt recvd vax 6DEC92 & lab eval revealed platelet count 5000; It was felt that the pts exp was life threatening; No further details were provided; hosp w/ITP;
Hearing - started off like echoing, got worse and became constant ringing.  Lasted about 5 days; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0162) via an unspecified route of administration in the left arm on 13Apr2021(at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to lobster. Concomitant medications included amoxicillin, clavulanic acid (AMOXCLAV) 875 mg and pseudoephedrine hydrochloride (SUDAFED), all from unknown dates and for unknown indications. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in the left arm on 16Mar2021(at the age of 55-year-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 21Apr2021, the patient experienced hearing which started off like echoing which got worse and became constant ringing. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. The clinical outcome of the event hearing started off like echoing which got worse and became constant ringing lasted for about 5 days and was resolved on an unknown date in Apr 2021.   No follow-up attempts are needed. No further information is expected.
Administered after temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) (batch number ZL33B, expiry date 25th November 2024) and (batch number KP547, expiry date 29th November 2024) for prophylaxis.   On an unknown date, the patients received Boostrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Boostrix, the patients experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 17-Jan-2023 Reporter's comment: A nursing director reported that  there was a temperature excursion for several GlaxoSmithKline vaccines (Boostrix, Engerix-B, Havrix and Flulaval quadrivalent) and some of them were administered to patients.  The Boostrix (TDaps) was excursed from 23th August 2022 to 17th November 2022 and the highest temperature reached was 12.5 degree Celsius for 3 months.  The TDaps was administered to 35 or 36 patient. There were no other information available at the moment of the call regarding patient´s information. The reporter consented to follow-up via email. This 1 of 3 linked cases reported by same reporter. Additional supportive information: The patients received Boostrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023006949:Same reporter / FluLaval case US-GSK-US2023AMR007430:Same reporter / Engerix-B Havrix case
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A 60-year-old female patient received PREVNAR 13, via an unspecified route of administration on an unspecified date for immunization. Medical history included allergy. The patient's concomitant medications were not reported. The patient had some peeling after the shot but no other problems with outcome of unknown.
HSV2 Outbreak (within one week after booster) itching (worse than ever before), lesions,
After injection, there was immediate swelling at the injection site. The patient did not complain of pain or discomfort. An ice pack was applied to the inflamed area and the patient was monitored for 30 minutes. After the 30 minutes, the patient was fine, and was told to monitor the swelling and was allowed to go home.
Patient was given 0.5ml dose, instead of 0.25ml booster dose. In-service and further education has been done, before administering further vaccinations.
About four minutes after the shot was given I started getting really hot. Then my chest got really tight. My heart was racing and I was having trouble breathing. I also felt like I was going to have a bowel movement. I was shakey. It went away by itself after about 3 minutes.