chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lab work showed not immune for Hepatitis B; This case was reported by a consumer via call center representative and described the occurrence of therapeutic response decreased in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 7S9NK, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 3NM93, expiry date unknown) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 35ZF9, expiry date unknown) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included hb vaccine (received HBV pediatric/adolescent on 21st November 2016 with batch number 9Z9LN).   On 23rd May 2017, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 21st March 2017, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 23rd January 2017, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. In July 2022, more than 2 years after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased 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: 26-Oct-2022 Reporter's comment: The patient 's mother reported that the patient had completed her series with Pediarix. In July 2022, the lab work done which showed she was not immune for Hepatitis B (low titer) and had to have a booster dose of Hepatitis B vaccine on 30th August 2022. The reporter consented to follow-up. Additional supportive information: The patient had low titer of Hepatitis B after Pediarix series, which led to therapeutic response decreased.
Pt reported to clinic with hx of recent Yellow fever vaccine (3-8-13.) She had the injection on (R) post. deltoid that area is now very swollen, red, measuring 140 mm x 110 mm. Also with axillary node involvement (R). CDC contacted, Pt sent to local ER for evaluation. Given sulfate Rx. Will follow her 3-22-13.
Pt received ZOSTAVAX vaccine Sq at clinic states right after giving the vaccine states vision problems states feeling funny took VS Temp 976 Pulse 70 Pulse Ox 98% B/P 120/80 Resp 18 Pt stayed in exam table watched Pt for 45 minutes & Pt states feeling fine will follow with eye doctor.
RECEIVED PFIZER VACCINES ON 01/08/21 & 01/29/21. 02/05/21 SAW PCP IN OFFICE REGARDING NEW RT  ARM REDNESS/PAIN. X2 DAYS. DX: CELLULITIS 02/09/21 WENT TO ER TO REPORT WORSENING ARM REDNESS R/T CELLULITIS. REFUSED INPT TREATMENT ABX AND WAS DISCHARGED ON ORAL ABX. 02/12/21 RETURNED TO ER FOR WORSENING ARM CELLULITIS DESPITE ORAL ABX. ADMITTED FOR  DX SEPSIS AND CELLULITIS.
PFIZER COVID 19 VACCINE EUA: ADMINISTRATION ERROR.  INDIVIDUAL RECEIVED VACCINE DOSE FROM VIAL STORED FOR MORE THAN 12 HOURS AFTER PUNCTURE BUT LESS THAN 24 HOURS OF PUNCTURE.  PFIZER STATED THEY HAD ADDITIONAL STABILITY INFORMATION FOR UP TO 24 HOURS AFTER PUNCTURE OF VIAL BUT NO EFFICACY DATA FOR THIS OFF LABEL USE.  RECOMMENDED MEDICAL DIRECTOR AND FNURSING FACILITY PROVIDE DISCUSS WITH INDIVIDUAL THAT THEY MAY BE REVACCINATED IF THEY CHOOSE BASED ON LACK OF EFFICACY DATA.
Redness, swelling , itching about 5inches diameter at the injection site a week after shot. Today is Feb. 7th and it is fading.
Low fever, diareahea, vomiting  chills, hyperventilation,  sore arm, nausea, exhaustion, loss of appetite.  This after both the first and second injections. It lasted one day with total exhaustion the second day.
shaking spell, elevated temp was taken to Er & evaluated & sent home w/APAP;
Within 24 hours I developed soreness in the left pectoral just under the nipple on the same side as the shot.  Four weeks after the first shot I took the second in the right arm because I didn't want to make the discomfort in the left pectoral worse.  I visited my doctor on week five and he discussed with me that it is likely a side effect of the first shot.  There is no mobility range of motion issues.  It doesn't impact my day unless I apply pressure to the site and pain is felt.  The second shot did not have any impact.  Discussed with my doctor on 10/4/21 about it persisting.  Some days almost gone and then comes back.  Doctor suggested a sonagram  and that was completed on 10/8/21 and are awaiting results.
7/21/08 received HPV injection - 8/16/08 pelvic cramp.  8/18/08 - 8/25/08 menstrual cycle with severe cramping, fatigue, nausea and vomiting x 1 day.  Menstrual cycle lasted 7 days instead of usual 3 days.  8/28/08 spotting for 1 day only.
Within  approximately 20 minutes of receiving the vaccines the patient developed coughing and urticaria. He became short of breath. On exam he was mildly tachypneic with wheezing and diffuse urticaria.  He as diagnosed as have an anaphylactic reaction.  Within 15 minutes of presentation he received diphenhydramine orally, epinephrine (0.15mg) via EpiPen Jr into the thigh and albuterol via nebulizer. He was then transferred by EMS to our local hospital emergency department where he was observed for 4 hours and sent home.
Later on that evening around 10:30pm I started having chills. Around 1am I woke up with high fever of 103 my body was very hot. By 5am the fever broke I was at normal temperature I felt better and was able to sleep. On 04/8/2021 around 6pm I went to reach out for something & I couldn't feel my arm my legs then I felt that my face was numb as well It was only left side. I felt tingling . It lasted for like 4 or 5 seconds. I went to the ER they did some lab work & a CT scan and everything came back normal. I will be scheduling an MRI as well.
About 45 minutes after the injection, I began to feel tingling in my tongue. It also looked like I had a sunburn. I was pink from head to toe.
Nonstop twitching in left arm; I also experienced a awful taste of medicine; Loss smell; Dose received: 3; This is a spontaneous report from a contactable consumer (other healthcare professional). The reporter is the patient.  A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 at 16:00 (Lot number: PD7218) at the age of 35 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EL3246; Administration time: 12:00; Anatomical location: right arm; Route of administration: unspecified), administration date: 14Jan2021, when the patient was 34 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EL9261; Administration time: 07:00; Anatomical location: right arm; Route of administration: unspecified), administration date: 05Feb2021, when the patient was 34 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 07Jan2022 at 16:00, outcome "unknown", described as "Dose received: 3"; DYSGEUSIA (non-serious) with onset 07Jan2022 at 16:15, outcome "recovered" (10Jan2022 at 16:15), described as "I also experienced a awful taste of medicine"; ANOSMIA (non-serious) with onset 07Jan2022 at 16:15, outcome "recovering", described as "Loss smell"; MUSCLE TWITCHING (non-serious) with onset 08Jan2022 at 03:00, outcome "recovering", described as "Nonstop twitching in left arm". Therapeutic measures were not taken as a result of dysgeusia, anosmia and muscle twitching.  Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Twitching began at 03:00 after the vaccine. She also experienced an awful taste of medicine and loss smell. The twitching was slowly getting better. No more taste of medicine, it lasted 3 days and she was slowly getting her smell back. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Right arm 6cm x 4 cm raised red hard area, tender to touch, localized itching.
Muscle aches; joint aches; lethargy; soreness at injection site; under the weather; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old patient of unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown), via an unspecified route of administration on 08Jan2021 at 19:30 on Arm left at single dose for COVID-19 immunization. Medical history included Hypertension. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications included Fluoxetine, Amlodipine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took venlafaxine and experienced allergy. The patient experienced Muscle aches, joint aches, lethargy, soreness at injection site, under the weather on 09Jan2021 at 19:30. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Intense body tingling, muscles tensed up, had to lay down, could not move, intense cramping in hands and fingers. This all lasted about 15 minutes max?
cold & clammy, dull eyes, stomach bloated, @ noc stomach ache cramping about every 1/2 hr extremely pale, gassy, uninterested in surroundings; 2 hrs p/shots ran temp then fell asleep; one noc started gasping; pt was weak;
Injection site swelling, erythema and pain.  Excessive itching and increasing inflammatory affect.
7/26/22 Vaccine received in 1600 hour.  2000 Emesis.  2400 Pt found w labored breathing and limp per mother of child.  Pt roused w vigorous rubbing be parent.  EMS called and assessed pt.  Pt stable and no transport to hospital determined to be necessary.   7/27/22  Mother of child reports pt improved today.  Appetite seems slightly less than normal.  Pt is breast feeding.  No hives. No wheeze. No injection site reaction.
had "more pain" on one side of her body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "cancer survivor" (unspecified if ongoing); "lupus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "had "more pain" on one side of her body".  Additional information: It was reported that patient was unaware if her reaction was due to the vaccination or if it it was an "extension" of her previous conditions, when she received the vaccine, she had "more pain" on one side of her body. She described her reaction as "livable". Upon Follow-up Agent relays that the caller is not sure if the reaction she experienced was something related to a previous illness or something from the vaccine. Agent relays the caller mentions that during the reaction one side of her body was in pain but didn't specify much about the reaction. Agent relays that she is fully vaccinated with both doses. Agent clarifies that the caller is also the patient.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tenderness in the left arm; fever of 102 degrees Fahrenheit; "threw up" five times; "really bad" severe headache; nausea; aches, pains; skin hurt; couldn't even walk; like "a Mac Truck hit her", "knocked out", "dead over here"; "wild reaction", "hit so bad"; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION ("wild reaction", "hit so bad"), VACCINATION SITE PAIN (tenderness in the left arm), PYREXIA (fever of 102 degrees Fahrenheit), VOMITING ("threw up" five times) and HEADACHE ("really bad" severe headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A and 031H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: J&J COVID-19 vaccine (Vaccine administered on  left deltoid) on 29-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J COVID-19 vaccine. Concurrent medical conditions included Penicillin allergy, Penicillin allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Latex allergy, Asthma exercise induced (Started In her late 20's.Patient is doing pretty good.) and Immunocompromised (Patient stated "immune system is not the best.). Concomitant products included SALBUTAMOL SULFATE (INHALERIN) for Exercise induced asthma.   On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 25-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-Apr-2022, the patient experienced IMMUNISATION REACTION ("wild reaction", "hit so bad"), HEADACHE ("really bad" severe headache), NAUSEA (nausea), PAIN (aches, pains), PAIN OF SKIN (skin hurt), GAIT INABILITY (couldn't even walk) and FEELING ABNORMAL (like "a Mac Truck hit her", "knocked out", "dead over here"). On 26-Apr-2022 at 1:45 AM, the patient experienced VACCINATION SITE PAIN (tenderness in the left arm), PYREXIA (fever of 102 degrees Fahrenheit) and VOMITING ("threw up" five times). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION ("wild reaction", "hit so bad") and VOMITING ("threw up" five times) had resolved and VACCINATION SITE PAIN (tenderness in the left arm), PYREXIA (fever of 102 degrees Fahrenheit), HEADACHE ("really bad" severe headache), NAUSEA (nausea), PAIN (aches, pains), PAIN OF SKIN (skin hurt), GAIT INABILITY (couldn't even walk) and FEELING ABNORMAL (like "a Mac Truck hit her", "knocked out", "dead over here") was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test positive: positive (Positive) Positive. Patient Went to Emergency Room for observation. Given IV Fluids..         This case was linked to MOD-2022-552550 (Patient Link).
ANTIBODY LEVEL DETECTED AT LOW LEVEL; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-SEP-2021, the patient experienced antibody level detected at low level. Laboratory data included: Antibody test (NR: not provided) low level. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of antibody level detected at low level was not reported. This report was non-serious.
diarrhea for 48 hours; migraines on left side for 36 hours; vomiting every hour for 24 hours; night chills; fever more 100.1 degrees Fahrenheit; uncontrollable shaking for 36 hours; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea for 48 hours), TREMOR (uncontrollable shaking for 36 hours), MIGRAINE (migraines on left side for 36 hours), CHILLS (night chills) and PYREXIA (fever more 100.1 degrees Fahrenheit) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced TREMOR (uncontrollable shaking for 36 hours), CHILLS (night chills) and PYREXIA (fever more 100.1 degrees Fahrenheit). On 09-Apr-2021, the patient experienced DIARRHOEA (diarrhea for 48 hours), MIGRAINE (migraines on left side for 36 hours) and VOMITING (vomiting every hour for 24 hours). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Apr-2021, CHILLS (night chills) had resolved. On 10-Apr-2021, TREMOR (uncontrollable shaking for 36 hours) and VOMITING (vomiting every hour for 24 hours) had resolved. On 11-Apr-2021, DIARRHOEA (diarrhea for 48 hours) and MIGRAINE (migraines on left side for 36 hours) had resolved. At the time of the report, PYREXIA (fever more 100.1 degrees Fahrenheit) outcome was unknown.            No concomitant medications were provided Action taken with mRNA-1273 in response to the events were Not Applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-075044 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075044:MOD-2021-075044
Initial health care professional report received on 27 Jan 2010: This patient was inadvertently administered with 0.5 ml of FLUVIRIN (batch number 98442P1) on 25 Jan 2010, intramuscularly instead of H1N1. No adverse events were reported on vaccination.
+ urticaria (diffuse) within 24 hours. No hx egg allergy.
emergency Room HPI This is a 90 y.o. male who presents presents in the emergency room by ambulance from local nursing home for complaint of fall with no localized pain but was said to have low blood pressure of 80/40 and low O2 sat of 77%.  PCP said to send patient to the ER for evaluation.  Patient is COVID positive but is said to have completed the vaccine on 19th of January 2021.  In the ER blood pressure is 122/71, respiration 18, pulse is 68, temperature 98.7° F and O2 sat of 95% on 4 L. Patient is confused and not answering questions which is his baseline.
Information has been received from a physician concerning a 24 year old female with no drug allergy, who on 30-APR-2010 was vaccinated intramuscularly with the first 0.5 ml dose GARDASIL (lot number not reported). Two days after receiving the vaccine, on 02-MAY-2010 the patient experienced swelling on hands and feet, so swollen that she couldn't walk. On an unknown date the therapy with GARDASIL was discontinued, no 2nd or 3rd doses given. After stopping therapy, the patient recovered from swelling on hands and feet. The patient called physician to seek medical attention. Follow up information has been received from the physician concerning the patient, a 24 year old female with a history of paroxysmal supraventricular tachycardia (PSVT). On 02-MAY-2010 at 6:00 PM the patient developed swelling in both feet, it was hard to walk with a lots of pain. The patient also had mild swelling in both hands. On 20-JUN-2010 the patient received the second dose of GARDASIL (lot # 0669Y) IM in the left deltoid (previously reported vaccine "discontinued, no 2nd or 3rd doses given"). No further information is available.
Information has been received from a Registered Nurse referring to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On unknown dates, the patients were administered wiht unknown number of doses of improperly stored GARDASIL (dose strength, route, lot # unspecified). No adverse effects reported. This is one of the several reports received from the same source. Additional information has been requested.
This report was received from the manufacturer for hepatitis A virus vaccine inactivated and was assigned manufacturer report number A0388251A.  This report concerns a patient who on 07/02/2002 was vaccinated with a dose of hepatitis A virus vaccine inactivated.  Subsequently, the patient developed arthritis with muscle pain and joint pain.  This was originally reported by a registered pharmacist.  Additional information has been requested. FOLLOW-UP information from the reporting pharmacist stated, "The incident you refer to did not involve any product manufactured by Merck." Additional information is not expected.
Diffuse chills/shaking for over an hour until Tylenol kicked in. Side effects  continued on and off through 36 hours post vaccination. Swollen lymph nodes in  right armpit (side where injection was done). Fatigue lasted ~56 hours.  Vivid/stressful dreams ni  Narrative:
had worst reaction this year to the flu shot; whole week of misery; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case received from a non-healthcare professional (consumer) via social media.  This case involved a patient of an unknown demographic who had worst reaction this year to the flu shot (Vaccination complication) and whole week of misery (Feeling abnormal), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, patient had worst reaction this year to the flu shot (Vaccination complication) and whole week of misery (Feeling abnormal) (latency: unknown) following vaccination.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was unknown for both events.  There will be no information available on the batch number for this case.
Covid symptoms  high fever chills nausea diarrhea headache congestion chill and   cystitis
Starting 02/06/2022, I started developing sinus issues. On 02/07/2022, I took the day off thinking I just needed rest to heal, but when it didn't get better I decided to go to urgent care. I went to urgent care thinking I just needed a Z-pak and it was another seasonal event. Decided to get tested for COVID and it was positive. I got the Z-pak and decided to self isolate for a few days to stay away from the wife and kids. It was a very mild case and, if I hadn't gone to urgent care, I would've never known I had it. None of the rest of the family ever tested positive.
Tiredness, muscle pain, joint pain, feeling unwell, fast heartbeat 114permin, dizziness/weakness.