chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 year old was given Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 29th September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 30-NOV-2022 Reporter's comment:  The reporter stated that one year old patient was given Kinrix. It was unknown to reporter which dose in the DTaP series this was.  No additional information provided on call.  The reporter consented to follow up. Additional supportive information: One year old patient was received Kinrix, which led to inappropriate age at vaccine administration.
pt recv vax & devel anaphylactic shock on 21SEP98;pt devel hives on 1OCT98;pt seen by MD treated w/DPH;
About 5 minutes after I had gotten the shot my heart rate increased pretty rapidly, my hands got pretty cold and I started sweating. I felt nauseous and had a throbbing headache. I went back to my room and was incredibly hazy and slept for about 10 hours. I woke up the next day and I was throwing up, there was a bit of blood in my throw up at the time. I had thrown up for three days. I still did not feel like my self and had waves of nausea, headaches, body aches for almost 2 weeks straight.
chills; pain where the shot was; tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm left, administration date 28Jan2021 (Batch/Lot number: unknown) at the age of 65 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 28Jan2021, outcome "unknown", described as "tiredness"; CHILLS (non-serious) with onset 29Jan2021, outcome "unknown", described as "chills"; VACCINATION SITE PAIN (non-serious) with onset 28Jan2021, outcome "unknown", described as "pain where the shot was".  Additional information: It is unknown if patient received any other vaccines within 4weeks prior to the first administration date of the suspect vaccine. It is unknown for patient medical history including illness at the time of vaccination. Patient family medical history not provided and unknown for relevant tests.  Follow-up attempts completed. No further information is expected.
Headache, achy in right arm and thigh, nausea, chest feels hollow, occasional ping of pain in chest, at the sight of injection feels bruised and sore
While waiting 15 minutes at the clinic site the sight of injection was itchy and I had dryness and bad taste in my mouth. Within first 30 minutes dizzy and lightheaded. Within first hour headache and fever of 101. Within 70 minutes nausea, tiredness, lightheaded, fever, headache, achy body.  Ongoing 6 hours later.
fatigue, lymphadenothay supraclaviular and axillary left-developed 6 days after vaccination Narrative: fatigue and lymphadenopathy 6 days after vaccination
Headache/It's starting over, even more so everywhere.; Aches/It's starting over, even more so everywhere.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache/It's starting over, even more so everywhere.) and MYALGIA (Aches/It's starting over, even more so everywhere.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included NAPROXEN SODIUM (ALEVE) and IBUPROFEN for Arthritis.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache/It's starting over, even more so everywhere.) and MYALGIA (Aches/It's starting over, even more so everywhere.). At the time of the report, HEADACHE (Headache/It's starting over, even more so everywhere.) and MYALGIA (Aches/It's starting over, even more so everywhere.) had not resolved.            No concomitant drug information provided.   This case was linked to MOD-2021-387079, MOD-2021-387075 (Patient Link).
Patient states that she was seen in clinic on Thursday afternoon for a flu vaccine. States that on Saturday she started with a scratchy throat and then developed hives yesterday morning. Hives are located in her suprapubic area, by her hips, breasts, bra line, and had 1 behind her ear. States that they range in size from about 1-6 cm.  Is unable to count how many there are because "they all run together."  They do itch. Has been using Benadryl cream and oral tablets. States that the benadryl does help with the itching.  Denies trouble breathing and swallowing.
Within approximately 1 minute after receiving the vaccine, I felt sharp abdominal pains, followed by my throat closing up, facial flushing, numbness and tingling, as well as tunnel vision and feeling like I was going to pass out.
the nurse incuring a finger stick; Flip cap did not detach all the way; Initial information received on 05-Dec-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves female patient who incuring a finger stick (limb injury), while administrating the HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, patient incured a finger stick (limb injury), while administrating the HIB (PRP/T) VACCINE [ACT-HIB] [Batch number: UJ135ABA, expiry date: 26-Nov-2020, diluent batch number: UJ135A, expiry date: 26-Feb-2021, Combo Batch number: U6477AA, expiry date: 26-Nov-2020], via unknown route at an unknown administration site.  It was also the case of syringe issue.  Details of laboratory data not reported.  Final diagnosis was limb injury.  It was not reported if the patient received a corrective treatment.  Event outcome was unknown as it not reported.
pt has hx ITP treated w/splenectomy;has exacerbation of dec platelets 9count 14);1st time post splenectomy;
This is a spontaneous report from a contactable nurse who reported 10 cases for different patients. This is the 7th of 10 cases. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient reported that the injection hurt a lot with unknown outcome. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017083713 same reporter/product, different patient.
lymph-adenopathy rt leg approx 6 days p/MMR given; swelling in rt groin;
Fainting, Convulsions, Disorientation, Brief Loss of Hearing (all lasting about a minute total).
24 hrs p/inject c/o general body aches, "felt like had the flu", t103 over the weekend; presented in office Mon AM w/upper arm redness & swelling w/tenderness; MD prescribed med;
get really sick; like having a bad flu; high fever; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: unknown), administration date: 2021, for COVID-19 Immunization, reaction(s): "It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster.", "It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster."; Bnt162b2 (DOSE 2, SINGLE, Lot number: unknown), administration date: 2021, for COVID-19 Immunization, reaction(s): "It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster.", "Inappropriate schedule of vaccine administered", "It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster."; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: unknown), administration date: Sep2021, for COVID-19 Immunization, reaction(s): "It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster.", "It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster.". The following information was reported: CHILLS (non-serious) with onset 2022, outcome "unknown"; ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "get really sick"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "high fever"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "like having a bad flu". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After the 2nd booster, the patient started to get really sick, had high fever, chills, could not be still and was in bed all the next day and described it "like having a bad flu".    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200124812 same patient different dose number/ event;
No additional AE reported.; temperautre excursion; This spontaneous report was received from a medical assistant concerning a patient of unknown age. No concurrent condition, medical history, or concomitant therapy was reported.  On 01-NOV-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength and route were unknown; 0.5 ml, recombinant Human albumin; lot # T016198 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 11-MAY-2022) and hepatitis a vaccine, inactivated(VAQTA) (strength and route were unknown; 0.5 ml; lot # T037788 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 30-APR-2022) for prophylaxis following a temperature excursion (product storage error). There was no previous temperature excursion. There was no adverse event.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2111USA009348:
Day after varicella vaccine administered site became erythematic, hardened, and warm to touch. Treatment with antibiotics and allergy medications. As of 5-20-16 redness moved further down arm and lump became bigger.
23rd April 2019 (8 hours after injection; became congested and was snoring in sleep); 26th April 2019 @0600 woke up with rash erupting around naval area, low grade fever; 26th April 2019 @12noon, rash erupting under arm pits; itchy, fever 101.3, given Tylenol; 26th April 2019@1400, rash still erupting, fever higher, taken to Hospital; 27th April 2019@2200, fever 104.5; taken to Hospital:  hands red, fever continues to return after medication wears off (giving Tylenol, or Ibuprofen every 4.5 to 6 hours).
Patient may have received an undiluted dose of Pfizer pediatric.  Fatigue reported last night and this evening 12/16/21.
devel chickenpox 10 days p/vax;no known exposure to chickenpox;
NO ADVERSE EFFECT; expired dose administered to patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent condition, medical history, drug reaction/allergies were unknown. The patient's concomitant therapy includes sterile diluent.  On 16-MAY-2019, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (M-M-R II) (frequency unknown) (lot # N014486 and expiration date:10-MAY-2019) subcutaneous in the left arm for prophylaxis (PT: Expired product administered). It was reported that both measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and sterile diluent has not had any prior temperature excursion. No adverse effect reported.
fever (up to 101.8 degrees), body aches, and chills for 24 hours after vaccine fatigue, pain at site of injection, and pain in underarm radiating through to shoulder blade for 6 days after injection muscle spasms in shoulder and chest on side of injection,  9 days after injection  called doctors office once to see if I could take pain medication for aches, and they said yes.  have not called since
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 at 12:00 as dose 1, single (Lot number: El3247), in left arm, on 11Feb2021 at 12:00 as dose 2, single (Lot number: Em9808), in right arm and on 25Sep2021 at 12:00 as dose 3 (booster), single (Lot number: Fc3184) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroidism" (unspecified if ongoing); "compete hysterectomy for uterine carcinoma" (unspecified if ongoing), notes: Other medical history: compete hysterectomy for uterine carcinoma; "compete hysterectomy for uterine carcinoma" (unspecified if ongoing), notes: Other medical history: compete hysterectomy for uterine carcinoma. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (31Jul2022) 99, notes: positive test, 99 temp on 31Jul2022; SARS-CoV-2 test: (Jul2022) Positive, notes: COVID 19 Treatment; (31Jul2022) Positive, notes: positive test, 99 temp on 31Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Paxlovid treatment for COVID-19, Treatment start date:19Jul2022, Treatment stop date:23Jul2022. The patient had no known allergies. The patient had no other medication in 2weeks.
Pain in under arm and what appears to be a knot. Assuming it is a swollen lymph gland.
Patient received employee vaccine of Hep B Vaccination at roughly about 2:30pm. He complained of symptoms at around 2:45pm that his headache got worse. Prior to receiving vaccine donor had minor headache. He complained of dizziness/feeling warm. That resolved. Temperature was 97.0 prior. Tempterature after was 97.2 at 3:00pm. He was given an icepack for his head.
4 mins of high pitched crying culminating in pallid, hypotonic & hyporeflexic episode; this occurred 3 1/2 hrs p/DTP;
redness and warmth at the site of the injection and numbness and tingling down the arm. Pain with ROM
Rash with itching on abdomen, bilateral arms, and little bit on back upon waking up on 5/6. Quickly spread to upper chest, neck/Initial rash areas increased in number and some in size; Rash with itching on abdomen, bilateral arms, and little bit on back upon waking up on 5/6. Quickly spread to upper chest, neck; Throat felt a little tight; Throat became very itchy; This is a spontaneous report from a non-contactable consumer. A 58-year-old male patient received bnt162b2, dose 1 via an unspecified route of administration, administered in the right arm on 04May2021 15:30 (Batch/Lot Number: ER8735) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included High Blood Pressure and Anaemia, both from an unknown date and unknown if ongoing. Concomitant medications included fish oil taken for an unspecified indication, start and stop date were not reported; iron taken for an unspecified indication, start and stop date were not reported; losartan taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took lisinopril and experienced allergies. The patient had rash with itching on abdomen, bilateral arms, and little bit on back upon waking up on 06May2021. It quickly spread to upper chest, neck, eventually throat felt a little tight, but throat became very itchy. Initial rash areas increased in number and some in size. Outcome of events was reported as recovering. Patient received steroid shot and Medrol Dose Pack as result of the events.  No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a contactable other health professional on behalf of physician. A 17-year-old female patient received the 2nd dose of TRUMENBA (Lot# S58877, Exp date Feb2019), intramuscular in deltoid left, on 21Mar2019 at 09:15 AM, at single dose, for immunisation. The patient's medical history was not reported. Concomitant medication included FLUZONE QUADRIVALENT (Lot# UJ005AE, Exp date Jun2019), intramuscular, in 2019 (within 4 weeks from TRUMENBA), for immunisation. The patient previously took the 1st dose of TRUMENBA (Lot# S58877, Exp date Feb2019, NDC 0005-0100-01), on 13Apr2018 (at 16 years old), for immunization and unspecified number of flu shots. The patient received expired TRUMENBA on 21Mar2019 at 09:15 AM.
weakened immune system; Hepatitis C antibody test reactive; Initial information received on 22-Feb-2023 regarding an unsolicited valid non-serious courtesy case received from Partner Pfizer.  This case involves a 64 years old female patient (165 cm and 68 kg) who experienced hepatitis c antibody test reactive, nucleic acid test is nonreactive and weakened immune system while receiving vaccines influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent] and pfizer biontech covid-19 vaccine.  The patient's past medical history included Occupational exposure to toxic agent. The patient's past vaccination(s) included INFLUENZA VACCINE on 05-NOV-2021 and PFIZER BIONTECH COVID-19 VACCINE with Dose 1- 10-Mar-2021 with Lot number lot EM6204  Dose 2- 31-Mar-2021 with Lot number lot ER8737  Dose 3- 22-oct-2021 with Lot number lot FE3590  Dose 4- 10-Jun-2022 with Lot number lot FM7553 All in the left arm. The patient's past medical treatment(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Prophylactic vaccination.  On 12-Oct-2022, the patient received a  dose of suspect influenza quadrival A-B high dose HV vaccine (lot UJ919AB, expiry date, strength, form and dose was unknown) via unknown route in unknown administration site as prophylactic vaccination. On 22-Nov-2022, the patient received a dose 5  of suspect pfizer biontech covid-19 vaccine not produced by Sanofi Pasteur (lot GJ6796, with unknown expiry date, strength, form and dose) via unknown route in the left arm as prophylactic vaccination.  On an unknown date in Jan-2023, the patient developed hepatitis c antibody test reactive, nucleic acid test is nonreactive (hepatitis c antibody positive) and on an unknown date developed weakened immune system (decreased immune responsiveness) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine and pfizer biontech covid-19 vaccine.   Relevant laboratory test results included: Hepatitis C antibody - On an unknown date: Positive Nucleic acid test - On an unknown date: Negative  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.   Hepatitis c was assessed as medically significant. Sender's Comments: Sanofi Company Comment dated 27-Feb-2023: This case involves a 64 years old female patient (165 cm and 68 kg) who experienced hepatitis c antibody test reactive, nucleic acid test is nonreactive and weakened immune system while receiving vaccines influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent] and pfizer biontech covid-19 vaccine. Based on the limited information provided, the causal role of the company suspect product cannot be excluded in occurrence of the events. However, lack of information regarding any concurrent conditions, any family history precludes the comprehensive case assessment.
Case number PHEH2014US021435 is an initial spontaneous report received from a medical assistant on 23 OCT 2014. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. This patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 14582P, expiry date: 21 MAY 2015) pre-filled syringe (PFS) on 23 OCT 2014. The medical assistant reported that when the nurse administered vaccine, the syringe malfunctioned and the patient did not receive full dose of FLUVIRIN. No adverse events were reported following the maladministration.
This vaccine was used after BUD.  Parent did not report any  adverse vaccine reaction after it was received.
This case was reported by a consumer via call center representative and described the occurrence of weakness in a 57-year-old male patient who received SHINGRIX. Concomitant products included Levothyroxine and Mometasone Topical. On 28th February 2018 14:00, the patient received the 1st dose of SHINGRIX. On 28th February 2018 20:00, 6 hrs after receiving SHINGRIX, the patient experienced weakness, chills, fuzzy head and fatigue. The patient was treated with TYLENOL. On an unknown date, the outcome of the weakness, chills, fuzzy head and fatigue were not recovered/not resolved. It was unknown if the reporter considered the weakness, chills, fuzzy head and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient never had a reaction to any vaccine previously. The patient received SHINGRIX in the left deltoid. Three hours before the time of reporting, the patient took TYLENOL and he was feeling better.
Redness, heat, tenderness and fluid/filled blister at injection site (right thigh). Blister and fever started same evening vaccine was administered. Treated with Benadryl and Tylenol, cool compress.
03/07/2023 overnight I started having chills, body aches, headache, dry heaving and fever of 102.0, sense of taste and smell was diminished. I contacted urgent care and was prescribed a course of PAXLOVID. I felt better 2-3 days later.
On the 9th day after receiving the shot., I was vaccinated on January 27, 2021, I noticed a very red, slightly raised area which was warmer to the touch where at the site of the injection. It lasted the whole of day of Friday, February 5, 2021.  It was less red the next day and less warm to the touch and today, Sunday, February 7, there is NO sign of the redness or heat at vaccine location.
Skin rash with redness, scaling, itching in multiple locations (arms, back, legs, etc.)