chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021 at 10:06 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 10:06 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the fridge on 23-Mar-2021, moved to clinic on 30-Mar-2021 and proposed beyond use date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On 27-Mar-2021, at 09:00 A.M and at 10:00 A.M. the temperature recorded was 35 degree Fahrenheit that has been reached by the vial.  On 28-Mar-2021 and 29-Mar-2021, at 10:00 A.M, the temperature recorded was 35 degree Fahrenheit that has been reached by the vial.  On the date of administration, at 09:00 A.M., the temperature recorded was 33 degree Fahrenheit that has been reached by the vial.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
About 10 mins after receiving the vaccine, patient dropped phone and was slumped in chair. Nurse approached patient and patient could not hear or see her. Hands were trembling and body was distorted. Arm felt heavy and she could not hold anything.
Hives on arms and legs within 12 hours of immunization. Needed steroids from ER.
Patient received moderna vaccine on 2/4/21, 3/4/21, and 11/3/21. Presented to ER on 4/5/22 and found to be COVID positive on 4/6/22. She was found unresponsive and hypoglycemic <20 and hypothermic. Patient was admitted. Incidentally she did test positive for COVID.  She is vaccinated.  She was asymptomatic and imaging which included CT of the chest did not reveal any concerns of pneumonia.  She remained stable on room air. Discharged on 4/7/22
Dizziness; Pain in joints; Pain in muscle; Fatigue; This is a spontaneous report received from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in right arm on 17Mar2021 at 17:15 (at the age of 30-year-old), as a single dose, for COVID-19 immunisation. The patients medical history included hypothyroidism, attention deficit hyperactivity disorder (ADHD), exercise induced asthma, eczema, hay fever, allergy to grass pollen. Past drug history included allergy to pramoxine. The patients concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), CONCERTA, montleukast (MANUFACTURER UNKNOWN) and WELLBUTRIN for an unknown indication since an unspecified date. 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 4 weeks prior to the COVID vaccine. On 18Mar2021, the patient experienced pain in joints and muscle, dizziness and fatigue. The clinical outcome of events pain in joints, muscle pain, dizziness and fatigue were recovering at the time of this report.  Information about lot number cannot be obtained. No further information expected.
c/o abd pain, muscle pain, dec grade fever, feeling shaky, tachycardia, leg & muscle cramping lasted 48hr;was given pain med in ER;leg pain was relieved by med;
Hives, itchiness and swelling (occurred after the first two doses of Pfizer).
pt recv vax in rt deltoid;day following vax arm (deltoid area) became more sore & swollen;pt devel tender, palpable lymph nodes rt axilla;no fever reported;98.5 @ time of clinic visit;better on 27JAN97;
6 hours post vax, the pt woke up with nausea, dizziness, and some hives over torso and inner arms. Eyes also red and watery.
3RD DOSE, MODERNA COVID VACCINE GIVEN 11/23/21, LOT #034F21A;  pt to ED with c/o chest pain, dyspnea, fatigue; productive cough; poor po intake; has Pleurx catheter; positive for COVID; respiratory status worsened requiring Optiflow 50L at 50%; pt's condition continued to deteriorate; transitioned to hospice and passed away in the hospital
redness and itchiness at the injection site with a lump under the skin that developed 8 days after the injection. It feels like a bed bug bite but not as warm to the touch as a bed bug bite. I've read that it can last 6 to 11 days.
Fever, Headache, Nauseous, Severe Pain All Over, Extreme Tiredness, Shortness Of Breath. Swelling Of Both Feet.  Onset - 9 Days Out. Still Ongoing 12 Days Out.
Sore throat (started about 3 hours after vaccination), fatigue, body ache, generally feeling unwell.
The patient has a history of colon cancer, type II diabetes, and COPD. He was seen in the ED on 4/22/23 with dizziness that started two days prior. He additionally reported a cough with increased chest and nasal congestion as well as myalgias, generalized weakness, vomiting, and diarrhea. In the ED, a PCR COVID-19 test  resulted positive. Ultimately, the patient was admitted 4/22/23 - 4/25/23 for observation. Discharge diagnoses include unsteady gait, weakness, and COVID-19 infection related gastroenteritis. At discharge, the patient was no longer vomiting or having diarrhea.  He was not hypoxic during admission. Of note, he has received the primary COVID vaccine series and three boosters.
The patient presented for a flu shot, the flu shot was drawn up and when injected IM the vaccine drained out the back of the syringe instead of going into the muscle. The flu shot needed to be repeated due to the leakage. The syringe is also supposed to be retractable and when activated shot off the needle instead of retracting.
10/19/2012 - complaining of (L) arm hot site of injection & red & swollen. 10/20/2012 - Pt. said neck ache to head pain. Pt. feels that it's spreading.
This case was reported by a physician and described the occurrence of antigenemia in a currently 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), Hepatitis B vaccine. Concurrent vaccination included haemophilus influenzae type b vaccine (non-gsk); Merck; unknown; unknown given on 5 September 2013; live attenuated human rotavirus vaccine; GlaxoSmithKline; unknown given on 5 September 2013; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given on 5 September 2013. Concurrent medications included TRI-VI-SOL. On 5 September 2013 the subject received a dose of PEDIARIX (unknown details). On 5 July 2013 the subject received a dose of Hepatitis B vaccine (unknown details). In 2013, at an unknown time after vaccination with Hepatitis B vaccine, the subject experienced failure to thrive. On 7 September 2013, 2 days after vaccination with PEDIARIX, 64 days after vaccination with Hepatitis B vaccine, the subject experienced antigenemia. In 2013, the subject was hospitalised after administration of hepatitis B vaccine and before administration of PEDIARIX. Relevant test results included hepatitis B surface antigen test positive on 7 September 2013. At the time of reporting the outcome of the events were unknown.
SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 13 March 2008 from another manufacturer, case number not reported.  The reporter to this manufacturer had been a health care provider.  A 17-year-old male patient had received an injection of Menactra, lot number not reported, on an unspecified date.  At an unspecified time post-vaccination, the patient experienced syncope.  Recovery status was not reported.  Additional information was not provided.  The reporter in this case was the same as in case 2008-00786.
This case was reported by a nurse via call representative and described the occurrence of injection site erythema in a adult female patient who received FLUARIX (batch number D3AF5, expiry date 9th June 2016). On 21st September 2015, the patient received FLUARIX .5 ml. On an unknown date, less than a week after receiving FLUARIX season, the patient experienced injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever were unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever to be related to FLUARIX. Additional details were received as follows: Patient's age range went from around 25-55 years of age. In September 2015, less than a week after receiving FLUARIX, the patient experienced injection site redness, injection site induration, injection site tenderness, generalized itching, injection site swelling and fever. On 25th September 2015, the adverse events were noted. The date of birth and information on adverse events experienced by individual patients were unknown. Reporter just explained that the most common adverse event experienced was induration at the injection site. Also the patient experienced redness, swelling and tenderness at the injection site. Less commonly reported event was itching throughout the body. The least common reported event was fever. This case was one of the 9 cases reported by same reporter.
Immunizations given 12/24/07.  Eve of 12/24, left upper outer arm became red & warm to touch.  By 12/25 pm, area was very red, tender & temp was 100.8 and red area was size of mom's hand (fist).  By 12/26 pm red area was size of mom's outstretched hand and temp was 100.2.  She was seen by Dr. 12/26, 12/27 & 12/28.  Rx-Keflex 500 mg QID x5 days.
I started shaking, my hands were shaking so bad, my arms were shaking and my body started shaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 at 17:00 as dose number unknown, single (Lot number: HG4629) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for hypertension; LOSARTAN taken for hypertension. The following information was reported: TREMOR (non-serious) with onset 25Sep2023 at 19:00, outcome "recovered" (25Sep2023), described as "I started shaking, my hands were shaking so bad, my arms were shaking and my body started shaking". Therapeutic measures were not taken as a result of tremor. Additional information: Consumer stated, she had her Pfizer/BioNTech COVID vaccine a day before reporting (24Sep2023) at 5 o clock and when she got the vaccine, the pharmacist told her that he had just gotten his and he had some severe shaking for a while after he got the vaccine and it does not show up as a side effect of the vaccine but he just wanted to warn me of that. At 7 o clock she started shaking, her hands were shaking so bad, she could not even hold anything, her arms were shaking and her body started shaking but not her legs so she got in bed and covered up and laid in bed and was shaking for probably 40 minutes may be 45 minutes and then it finally stopped. So, she was so grateful to the pharmacist for warning me about that otherwise she would have no idea what was happening to her and then she googled side effects and this particular side effect does not show up anywhere.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300309708 same reporter/drug/event, different patient.;
This spontaneous report as received from a nurse refers to a 93-year-old female patient. The patient's medical history was not reported. In August 2015, the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml, intramuscular in the arm (lot number not reported). On an unknown date, the patient developed redness and swelling of injection-site arm after receiving PNEUMOVAX 23. the patient sought medical attention and received unspecified treatment for the events. The outcome of the events was reported as recovered/resolved (date unspecified) (also reported as recovering). The relationship between PNEUMOVAX 23 and the events was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reports that after receiving her first SHINGRIX shot, she experienced hyperactivity, increase in heart rate, and insomnia. She also experienced fever and chills.
Nerve pain and numbness of lips within 30 minutes of first shot.  Second day complete flare up of fibromyalgia.  It started to get better at day 16 so I went ahead and got 2nd shot.  By next day full flare again that continues to today, 5/27/2021.   Exhaustion, extreme muscle pain, weakness, nausea, nerve pain, blurred vision.
Received dose 4 of Moderna COVID-19 vaccine on 4/4/2022, then tested positive with a home test with positive results. Then went to a medical canter and was tested again. Was prescribed the antiviral molnupiravir 200mg capsules, took 4 tablets twice a day for 5 days. Breakthrough case.
ADMINISTRATION ERROR:   She was supposed to get the 2nd Pfizer vaccine and instead received the Bivalent booster.  She waited at least 20-30 minutes and she did not have any AE.  The doctor went in to talk to her as well and she did not have anything out of the norm and said that she felt fine.
Post vax, the pt developed muscle pain which moved up to shoulders then to neck and upper back. Pressure along spine as well.
This spontaneous report as received from a registered pharmacist refers to a male patient in his sixties years. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). The pharmacist reported to the field employee that the patient developed shingles at an unspecified time after receiving ZOSTAVAX. The patient might also have developed postherpetic neuralgia (PHN) after experiencing shingles. The patient had been prescribed VICODIN possibly related to pain associated with postherpetic neuralgia (PHN). It was unknown if the patient sought medical attention. At the time of reporting, the outcome of above events was unknown. Additional information has been requested.
Slight fever 12 hours later.  Headache the next day.  Severe headache with nausea two weeks later that lasted more than a day.  Notice a small clot in left forearm.  No pain, though.
Seizure vs vaso vagal syncope during 15 minute waiting period after vaccine administration. Fell from chair, hit head, and was unconscious for about 20 seconds.  Per onsite provider EMS was called and patient transported to ER.
Experiencing burning in rectum; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANORECTAL DISCOMFORT (non-serious), outcome "not recovered", described as "Experiencing burning in rectum".  Additional Information: The patient mentioned that she had the Pfizer Covid-19 vaccine 2 weeks ago and she wants to know about the side effects of the vaccine. She said that she was currently experiencing burning in rectum.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hives and dermatographia started 9 days after Modern booster.  I have been taking 2 types of antihistamines to control the hives and itch.  If I skip a dose, the hives immediately appear.  It has been 10 days and the hives are still appearing.
Upon wakening next day patient experienced redness, warmth, tenderness and swelling. Affected area was below shoulder to above elbow and described as "baseball". Also hard to touch. Started improving by 4th day after injection.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter (consumer) via Regulatory Authority.   A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administration date 13Apr2021 (Lot number: EP6955) as dose 2, single and (Lot number: EP6955) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) both with onset 02Jan2022, outcome "unknown" and both described as "Tested positive for Covid." The event "tested positive for Covid" was evaluated at the emergency room visit. The patient underwent the following laboratory test and procedure: COVID-19: (02Jan2022) positive. Therapeutic measures were taken as a result of Covid-19, which included an unspecified medication. The reporter and her husband (the patient) both tested positive for Covid. They were both vaccinated the same time with the batch number provided.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200010509 same reporter, product, and event; different patients
Injection site became red, swollen, sore, and warm, the next morning after getting the vaccine.  I treated the reaction with benadryl for 7 days.  I also experienced body aches, sluggishness, and a terrible headache during this time.  For the first couple of days, I also had flashes of feeling overly hot then overly cold, but never had a temperature.  The rash grew in size for the first 3 days, before it started decreasing in redness and size.
This spontaneous report was received from a Medical Assistant via a company representative referring to a 66 year old female patient. the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were unknown by reporter. The patient received a dose of PREVNAR 13. On an unknown date in 2008, the patient was vaccinated with an initial dose of PNEUMOVAX 23 for prophylaxis (strength, route, lot # and expiration date were not reported). On 15-JAN-2018, the patient recieved her second dose of PNEUMOVAX 23 lot # N025656, expiration date on 19-APR-2019, for prophylaxis (strength and route were not provided). After the second dose of  PNEUMOVAX 23, the patient returned to the office the following day, on 16-JAN-2018, with an injection site reaction that was red swollen reaction and warm to the touch. On 17-JAN-2018, the patient returned to the office again. Only the red swollen reaction had spread down her arm and was painful to touch. The office sent the patient to an unspecified hospital for the day; however, it could not be confirmed if the patient was admitted or not but in January 2018, the patient was posssibly hospitalized. At the hospital, the patient was given an unspecified antibiotic intravenously, BENADRYL, ROCEPHIN and SOLU-MEDROL. On Thursday 18-JAN-2018, the patient reported that she was recovering from the injection site erythema, injection site swelling, injection site warmth, erythema, peripheral swelling and pain in extremity. The causality assessment between the events and the vaccination with PNEUMOVAX 23 was not provided.
28 yo man who received flu vax yest woke up last night feeling out of breath.  Back was hurting, feels dizzy, very thirsty.  Walked to office tonight and felt like vision was blurry. Has an achey feeling in his shoulders and back. Usually gets flu vax every year and has never had a rxn before. Subsequently went to ED: Went to ED with chest pain. w/u was negative except Cr was 2.2. CBC, LFTs, u/a, CXR, all were unremarkable. Gradually feeling better. Still some low back pain.
A report has been received from a Pharmacist concerning a 57 year old, subject of unknown gender, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST (intranasal) started on an unknown date. The patient FLUMIST and patient was 57 year old. The outcome of the event of patient received FLUMIST and patient is 57 year old is unknown. The report was considered to be non-serious. Corrected report 22-Nov-2013: the key ingredient of the suspect drug was corrected from FLUMIST to Q/LAIV.
Pt became ill around 9pm with chills and felt like her body was on fire and was burning up. No temperature at that time. Woke up around 2p and temp orally was 102.7. Stated had trouble breathing and when walking, felt uncoordinated and legs were weak .Had to hug the wall to get to the bathroom where she vomited. Called ER and was advised to come in with shortness of breath. Stated oxygen level was ok, but was admitted for fluids and monitoring. Stated the symptoms were 10 times worse than when had COVID approximately 3 weeks ago. States CXR showed some residual pneumonia.