chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. Between 21-SEP-2018 and 26-SEP-2018, the patient was vaccinated with improperly stored doses of PROQUAD subcutaneously, for prophylaxis, lot number R014354, albumin status rHA and expiration date reported as 18-NOV-2019 (strength, dose and frequency were not reported), and improperly doses of VARIVAX subcutaneously, for prophylaxis, lot number reported as R008794 and expiration date reported as 20-DEC-2020 (strength, dose and frequency were not reported). The vaccines were reconstituted with a properly stored Merck sterile diluent. No adverse effects were reported. The temperature excursion was reported as from 15 degrees F to 46 degrees F (33.9 degrees F) during a time frame of 2 hours and 32 minutes. There was no previous temperature excursion. A Digital Data Logger was involved. Lot number R008794 not valid for varicella virus vaccine live (oka/merck). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA012813.
Minor pain at injection site which spread to upper arm over the course of a few days. Swelling and bruising was notice after 5 days. Swelling moved from upper arm to lower arm and fingers. Medication & follow up care provided by clients primary care provider.
Swelling Narrative:  A/P; L pectoralis swelling post pfizer vaccine 5 days ago: persistent swelling despite bactrim
Info has been received from a consumer concerning her daughter who was vaccinated with a dose of MMRII. Subsequently, she experienced a high fever. There was no product quality complaint involved. No further info was available.
NO Adverse Event: On 4-29-2022  patient came to clinic for office visit. According to his chart he was due for his First Shingles shot.  Patient agreed to have vaccinations Later that day his wife called and reported that he had his first shingles shot one at another clinic on 03-25-2022.  No reactions were reported.
Dysgeusia  This case was reported by a pharmacist and described the occurrence of taste alteration in a male subject of unspecified age who was vaccinated with hepatitis B vaccine recombinant. (Engerix-B, GlaxoSmithKline) for prophylaxis.  On an unspecified date on or before 02 March 2006, the subject received a dose of Engerix-B (dose number and lot number not provided). At an unspecified time after vaccination with Engerix-B, on an unspecified date on or before 02 March 2006, the subject experienced "an altered taste of almonds."  The outcome of the event was not reported.
Pleurisy, when I breath deeply it hurts I cannot breath deeply; Pleurisy, when I breath deeply it hurts I cannot breath deeply; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jan2022 (Batch/Lot number: unknown) at the age of 56 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Hypertension; "Epilepsy" (unspecified if ongoing), notes: little bit of epilepsy. so patient taking medication for this.; "pneumonia" (unspecified if ongoing), notes: I think I had pneumonia. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 19Jan2022, outcome "unknown", described as "Booster"; PLEURISY (non-serious), PAIN (non-serious) all with onset 21Jan2022, outcome "not recovered" and all described as "Pleurisy, when I breath deeply it hurts I cannot breath deeply". Therapeutic measures were not taken as a result of pleurisy, pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: patient was not received any treatment as it was not severe hence patient did not gone to the doctor or anything.  No follow-up attempts are possible. No further information is expected.
pt recv vax; large local rxn (swelling, redness,heat, tenderness) & achy muscles;
Product Storage Error; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a adult patient who received Herpes zoster (Shingrix) (batch number 7D9C3, expiry date 25th September 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 age group was not reported, but was selected adult as per vaccine indication. The reporter had several vials of the Shingrix product that were stored in the refrigerator and the vials froze, which led to incorrect storage of vaccine. The reporter was unable to provide any additional information.
Weakness, fever, vomit, no appetite, extreme pain in my entire body.  Soreness at injection site.
Redness and swelling at site of injection, muscle aches and headache, fever starting the night after and for about two days; took ADVIL; no additional treatment sought.
Severe muscle ache all night and unable to sleep.  Both hips were hurting so much.
Initial case was received on 14 October 2010 from a healthcare professional. A 69 year old male patient received on 05 October 2010, a left deltoid intramuscular injection of FLUZONE HIGH-DOSE (lot number U3609AA). The patient's concomitant medications included COUMADIN and a "BP Med." On an unspecified date after vaccination, hit "PT, PTT" level results were "3.9." Prior to the vaccination, "PT, PTT" levels had been "2.2" for several months. The patient had no illness at the time of the vaccination. He had no other vaccinations within 4 weeks. Pre-existing medical conditions included chronic obstructive pulmonary disease (COPD) and hypertension (HTN). No other factors, lifestyle or medication had changed. The outcome was unknown. Documents held by sender: None.
temperature excursion at low temperature of 29.0F for 45 minutes, with no adverse event; vaccine administered post temperature excursion with no adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA409526 , 2022SA409520 and 2022SA409694(CLUSTER).  This case involves Adult and unknown gender patient to whom Influenza quadrival A-B vaccine [Fluzone Quadrivalent] was administered post temperature excursion and temperature excursion at low temperature of 29.0f for 45 minutes, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was reported that Influenza quadrival A-B vaccine had temperature excursion at low temperature of 29.0f for 45 minutes, with no adverse event (product storage error) (latency: Unknown)  On 23-Sep-2022, the patient received a  dose of suspect Influenza quadrival A-B vaccine, suspension for injection (lot UT7689LA; formulation, strength, dose and expiry date  not reported) via unknown route in unknown administration site for prophylactic vaccination post temperature excursion with no adverse event (poor quality product administered) (latency; on same day)   Action taken: not applicable.  Outcome: Unknown.   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.; Sender's Comments:  SAD20220927002156:
Rash, bumps; Pain in the area between the adbomen and hip joint; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 08Apr2021 at 14:30 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included myasentia Gravis, complex regional pain syndrome  (CRPS), sinus issues and penicillin allergy. Concomitant medications included mycophenolate mofetil (CELLCEPT), pyridostigmine (MANUFACTURER UNKNOWN), celecoxib (CELEBREX) and vitamin supplement; all for unknown indication from an unknown date and unknown if ongoing. The patient previously received alendronate sodium (FOSAMAX) and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 15:30, within 24 hours, the patient got rash, bumps and pain in the area between the abdomen and hip joint. The events resulted in a visit to the doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with hydrocortisone cream. The clinical outcome of the events rash, bumps and pain in the area between the abdomen and hip joint were not recovered.   No follow-up attempts are needed. No further information is expected.
2.5 weeks after shot and first time experiencing tenderness at site of injection. No reaction to first shot or until now from second shot. Seems odd?
Began around 5:00 AM as bad shoulder/arm pain where shot was given - began running fever , very achy all over, nauseous   Treatment - Tylenol - drinking water, rest, contacted doctor's office - checking oxygen levels Seems to keep feeling worse.  Temperature runs between 99.1 to 100.2
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 4-year-old male subject who was vaccinated with KINRIX. There were no concomitant medications. Concurrent medical conditions included penicillin allergy. On 13 April 2009 at 16:30 the subject received 1st dose of KINRIX (0.5 ml, intramuscular, left arm). On 15 April 2009, 2 days after vaccination with KINRIX, the subject experienced "palm-sized" injection site redness and injection site pruritus. At the time of reporting the outcome of the events was unspecified. Follow-up received from the events was unspecified . Follow-up received from the healthcare professional 04 May 2009: Previous vaccination included 4 doses of DTAP (unknown manufacturer) administered on unspecified dates. The subject had not experienced adverse events following previous vaccinations. There were no concomitant vaccinations. The onset date of the events was change to 14 April 2009, 1 day after vaccination with KINRIX. The diagnosis was reported as localized reaction to immunization with associated signs/symptoms of injection site redness and injection site pruritus. The subject was seen in the reporters office on 15 April 2009 with "swelling / redness resolving but still evident." The healthcare professional considered it "possible but doubtful" that the events could have been associated with suspected transmission of an infectious agent via a medicinal product, and that the events were not associated with medical history, concurrent illness or erroneous administration. This case was assessed as medically serious by GSK. The subject was treated with Benadryl. On 20 April 2009, the events were resolved. The healthcare professional considered the events possibly related to vaccination with KINRIX. The healthcare professional had reported this case to the Regulatory Agency (reference number not specified).
Felt like throat was closing up and BP elevated "160s/90s" shortly after vaccine. However, has had throat sensation frequently and could never figure out why it was happening. Vaccine done at pharmacy. Next day 1/28/22 had fever, chills. body aches tmax 100.8. Sx improving except no energy. Today had feels better. No recent illness but did have sore throat 1 week before. She was negative for COVID before vaccine and r/s immunization for 1 week later
Patient came in for 2nd moderna covid 19 vaccine appointment.  I was asking him if he had experienced any issues with the first shot.  He stated he had intermittent chest pain starting a few days after the vaccine that was accompanied with mild shortness of breath which was not normal for him.  The intermittent chest pain and SOB lasted about a week and has since resolved.  Patient stated he had a physical after the vaccine.  He mentioned the symptoms and his vaccination status to the doctor.  He said the doctor listened to his heart and said he thought it was allergies.  Patient stated he does not have allergies and didn't think it was allergies.  We decided to hold off on the 2nd vaccine until we could talk to the doctor (patient came in for 2nd vaccine on a saturday when md office was closed).
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain in arm and rash. On an unknown date, the outcome of the vaccination failure, shingles, pain in arm and rash were unknown. It was unknown if the reporter considered the vaccination failure, shingles, pain in arm and rash to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the shingles on the arm after the Shingles shot. The patient's arm was sore and had rash. The follow up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
pt recv vax & exp fever of 105 & a rash; the next day pt fever 104 & the following day pt was hot; 12 days post vax pt returned to nl; tx w/APAP;
Headache, bod ache like flu. Fatigue. Swollen and painful injection site.  Overall malaise. Next morning after 24 hrs since injection, rash developed around injection site. Slowly getting bigger.
This is a spontaneous report from a contactable pharmacist communicated to a Pfizer sales representative. A patient of unspecified age, gender and race/ethnicity received PREVNAR 13 on an unknown date, in arm (unspecified), at single dose, for immunization. Medical history and concomitant medications were not provided. The patient's arm swelled for 3 days, it was abnormal swelling. The final event outcome was not provided.
TIRED; This spontaneous report received from a consumer concerned a 58 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired. This report was non-serious.
I was in the gym working on calves the following morning 12/10/2021 @ approximately 5:15am when I started experiencing severe chest pain and shortness of breath. I left my workout early and when home where I slept most of the day. The chest pain lasted approximately 3 weeks.
Started having congestion in chest and lungs. Took a home COVID-19 test, negative. Went to my doctor and was given another COVID-19 test that was negative. Still felt bad and went to the local pharmacy, where, they tested me for Influenza and COVID-19, tested positive for Influenza B. Went home and rested.
J96.00 ACUTE RESPIRATORY FAILURE 4/4/2022 PLEURAL EFFUSION R09.02 HYPOXIA 4/4/2022 PLEURAL EFFUSION
Jul2021 my legs started hurting, it progressively got red and sore and blistery, I went immediate care and got medicine, didn't work, then went to ER on18 Aug2021 and then 23Aug2021, and went to dermatologist. tomorrow vein test 10/6/2021. Diagnosed with Venous Stasis Dermatitis in Aug2021. Got flu shot 3 weeks ago
The patient developed sudden onset nausea, diaphoresis and hypotension and shaking. Symptoms improved with IV fluids and rest. She was hospitalized 2 days.
I had a very bad cough, to the point I wanted to throw up. I received and infusion on the next day of my diagnosis. After I was diagnosed and received an infusion, the evening of my infusion I had a fever. I knew right after the infusion I was getting better. I still have some long COVID in my breathing effects. In October, I knew I was having shortness of breath. Since then, I was diagnosed as being anemic, and had a procedure that found a bleeding polyp. I am under the care of a GI doctor. It could be my anemia has contributed to my breathing issues.
Pt felt dizzy, nausea, may faint had pt sit in chair the lied down on floor, was here about 20 min. watched pt. Pt left on own power *recalled pt she was better.
Pt to ED 9/2 for hypoxia and combative behavior. Pt COVID+ 9/2. 9/3 to continue decadron. 9/4 Pt A&OX2, confused, and anxious. Pt has a trach and is ventilated. 9/6 Pt alert, able to follow commands. Pt remains on vent, no resp difficulty noted. 9/8 Pt is non-verbal, he will mouth words or gesture appropriately, a/o x 3. 9/9 pt discharged.
pt was administered vax 9AM @ time of inject pt was crying & upset; p/waiting in waiting room for 10 minutes pt's mom told nurse felt sick & needed to throw up;
A report was received from a health professional on 10/30/2002, concerning a vaccinee of unknown demography, who was inadvertently administered expired Fluvirin on an unknown date in September 2002. On an unknown date in September 2002, the vaccinee was administered with 2001-2002 Fluvirin formulation. There was insufficient information to determine the reporter's causality assessment. Update 1, January 9, 2003: A follow up report was received from a healthcare professional indicating that a 74 year old female vaccinee did not experience an adverse event after inadvertent administration of expired Fluvirin on an unreported date in September 2002.
Booster; Minor flu like symptoms; Swelling in the arm; pain; Minor fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number Unknown, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovering", described as "Minor flu like symptoms"; PERIPHERAL SWELLING (non-serious), outcome "recovering", described as "Swelling in the arm"; PAIN (non-serious), outcome "recovering", described as "pain"; PYREXIA (non-serious), outcome "recovering", described as "Minor fever".  Additional information: The report was not related to a study or programme. NDC number, expiry date and investigation assessment were not provided. The patient had minor flu like symptoms, which started two days later. Ten hours later he got minor fever, swelling in the arm, and pain. After two days, 48 hours, he was like 80-90% recovered. He thought he was ok.    The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown demographics. On an unknown date, an unspecified number of patients may have received ROTATEQ 0.5 milliliters suspension, orally (lot # J012523, expiry date: not provided). The reporter reported that ROTATEQ were exposed to a lowest temperature of 32F (Farenheit) for a total of 1 hour over "four different occasions: and the improperly stored ROTATEQ were administered orally to an unspecified amount of patients. No adverse effect was reported. There was no product quality complaint involved. Outcome of medication error was unknown. The case is linked to 1405USA004024, 1405USA011937, 1405USA011938, 1405USA009508, 1405USA011939, 1406USA008955, 1406USA009970, 1406USA009971, 1406USA009972, 1406USA009973, 1406USA009974, and 1406USA009977 (same reporter link). Additional information has been requested.
Patient received his first dose of COVID 19 vaccine Moderna on 3/11/2021, and then inadvertently was given a dose of Janssen on 3-23-2021.
pt recv vax 26JAN98 & 29JAN98 pt devel urticaria & hives on arm & a red raised rash on the upper torso that seemed to follow a vein which was describe as a mild rxn;
5/19/08 awoke this AM with a rash primarily on face to a lesser extent on arms/torso.  History Rosacea with 10 min sun exposure past 2y.  Also, photophobia, conj. inj. dizziness - type 2 diabetes.
This case was received from a health professional on 03 September 2008. This case represents one in a cluster of two patients. A two-month-old female patient received the following vaccines on 26 August 2008: an intramuscularly right thigh, first injection of IPOL (lot number A0491), an intramuscular right thigh first injection of TRIPEDIA (lot number U2356CA), ACTHIB (lot number not reported), and PREVNAR (Wyeth, lot number not reported). On 27 August 2008, she developed a temperature of 102 degrees Fahrenheit, lasting 48 hours. She was seen by her physician on 31 August 2008, and at that time was noted to have local site redness. The symptoms subsequently resolved. Follow-up information received on 29 September 2008 from the original reporter wh0 is health care provider. Per the reporter, the lot number for the ACTHIB vaccine was UF493AA; and the lot number for the PREVNAR vaccine was C45721H. The patient had no concurrent illness or use of other medications at the time of the vaccinations on 26 August 2008. The birth weigh of the patient was provided as 7 pounds 7 ounces (4Kg). The patient has siblings. No relevant diagnostic tests/laboratory data were performed for the adverse events. No further information is expected. The reporter in this case also reported a similar adverse reaction in another patient; that event is captured in case number 2008-02799.
3 days after vaccination, patient developed subcutaneous tissue swelling (small subcutaneous nodules) over her left arm, right upper arm, and neck area. No overlying rash on the skin. Symptoms resolved after 3 days of Ibuprofen.
started day of vaccine 5 hours after injection had diarrhea which progressed to fever 102.8 ,chills and sever muscle and joint pain by 2400.  The fevers, chills and body aches lasted for 5 days
pt recv vax & devel chickenpox w/a significant number of lesions involved (date unk);