chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 03-year-old, female child patient. On 08-Oct-2018, the patient (under 4 years of age) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230 and expiry date: 31-May-2019). No adverse events were reported after administration of the vaccine. This case 201804693 was cross-linked with original case 201804691 due to the same reporter. Follow-up report received from the reporter on 12-Nov-2018: The reporter confirmed that the patient had not received partial dose of suspect vaccine. Hence, the event under-dose was deleted. The narrative was amended accordingly.
Patient reported thickening of tongue with redness and bumps. Felt like the same reaction she has to shellfish. Patient did not seek medical care as advised. Follow up phone call on 12/30/2020, patient reports feeling well.
Received a flu vaccine just prior to their admission; This spontaneous case was received on 11-Aug-2023, from a pharmacist (reference number: SEQW23-01695) and concerned a patient of an unreported age and gender.   The patient's medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, anatomical location, and indication: not reported). The batch number reported was 370269.   On an unspecified date, an unknown amount of time after receiving Fluad Quadrivalent, the patient was admitted to the hospital. It was not reported if the patient was discharged from the hospital.  The outcome of the event was unknown.  The reporter did not provide a causality assessment.   The event was considered as serious due to the seriousness criterion of hospitalization.  Company comment: A patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after vaccination, the patient was admitted to the hospital. Lack of information was provided regarding the reason for hospitalisation. It was not reported if the patient was discharged from the hospital. The patient's medical history and concomitant medications were not reported. Information regarding relevant laboratory findings and diagnostic data was not provided. Causal role of the suspect vaccine is unassessable for the event hospitalisation, due to lack of information provided.; Sender's Comments: A patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after vaccination, the patient was admitted to the hospital. Lack of information was provided regarding the reason for hospitalisation. It was not reported if the patient was discharged from the hospital. The patient's medical history and concomitant medications were not reported. Information regarding relevant laboratory findings and diagnostic data was not provided. Causal role of the suspect vaccine is unassessable for the event hospitalisation, due to lack of information provided.
Early onset of next menstrual cycle.  7 years of consistent cycle every 28 days without any hormone therapies.  Following 1st Covid-19 Pfizer vaccination, cycle occurred early, after only 21 days since beginning of previous cycle, and 14 days after vaccination.  Flow was normal volume and duration.
Pt passed out after shot - paramedics came and checked her out - pt recovered after a few minutes and was released
About 4 hours after receiving vaccine, the patient became very weak, had confusion, had loose stools and vomiting. Patient was seen at ER around 8 pm.
This spontaneous report as received from a consumer refers to a female patient of unknown age. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # not reported) on 27-JUL-2012. No other co-suspects and no concomitant medications were reported. On 28-JUL-2012 the patient experienced upper body, neck, wrist and ankle pains, headaches, and said she developed polymyalgia rheumatica after getting vaccination. It was unknown if the patient sought medical attention. No treatment information was reported. The outcome of upper body, neck, wrist and ankle pains, headaches, and polymyalgia rheumatica was reported as recovering. The relatedness for the reported events was not provided for ZOSTAVAX. Additional information has been requested.
Information has been received from an office manager concerning a 17 year old male patient who on 29-JUN-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (lot number not available). The office manager reported that after the patient was vaccinated with the three doses of RECOMBIVAX HB, all blood work (Hepatitis B surface antibody) came back negative (less than 5), "not immune", requiring a fourth dose of RECOMBIVAX HB. The patient did not develop hepatitis B. No other adverse events were reported. At the time of the report the patient had not had follow up laboratories. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow-up information received via medical records indicated that the patient was a non-smoker male. The patient's past drug therapy included first doses of IPV (unspecified), diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and Hib conj vaccine (unspecified carrier) on 21-SEP-1992. On 30-JUL-1992 the patient received a first dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown); on 21-SEP-1992 the patient received a second dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown) and on 29-APR-1993 the patient received a third dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown). On 25-JUN-2010 the patient had an anti-HBs titer (less than 5); it was reported that the patient did not have immunity to hepatitis B virus. On 29-JUN-2010, the patient was vaccinated with a fourth dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown) (lot # AHBVB789AA). On 29-JUL-2010 the patient had another anti-HBs titer which showed that the patient had immunity to hepatitis B virus (461 mIU/mL). This is one of several reports received from the same source. No further information is available.
I received the Pfizer Bivalent COVID-19 booster on 10/7/2022. On 12/22/2022, I began sneezing and having chills. On 12/23/2022, I took a home antigen test and got a positive result. I contacted my doctor, who prescribed me PAXLOVID. On 12/23/2022, I developed a sore throat and coughing. I had severe chills and couldn't get warm enough. On 12/26/2022, I felt better, because the chills were gone, and the sore throat was better. At the time of this writing, I still have a scratchy throat and little bit of chest congestion. I saw my doctor again on 1/6/2023, and I was advised to take prednisone for the scratchy throat and congestion. I am still expelling phlegm, but no signs of pneumonia or any other serious ailment were detected. I was also tested for strep, and the outcome was negative.
diarrhea; chills; headache; she had no use of the right arm; extreme pain down my arm (right), pain was like a stabbing with knife on my arm; extreme pain up my jaw (right side); extreme pain in back (right side); didn't sleep much at all; her arm was sore by 2pm and felt really weak by the )time evening came; felt really weak; arm was sore; Neck pain; A spontaneous report was received from a 72-year-old female patient, who experienced sore arm, felt weak, extreme pain in right arm, right jaw and back, and neck, did not sleep much at all, pain was like stabbing with knife on arm, no use of right arm, diarrhea, and chills.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) on 05 Feb 2021 at 10:45 AM in right arm for the prophylaxis of COVID-19 infection.  On 05 Feb 2021 at 2:00 PM, her arm was sore, felt really week by the evening, extreme pain down her arm, up my jaw, neck and back, did not sleep much. She took acetaminophen which dulled the pain.  On 06 Feb 2021, pain was like a "stabbing with knife on arm." She stated that the pain was worse at night and she had no se of the right arm.  On 07 Feb 2021, she had diarrhea, chills, and headache.  On 08 Feb 2021, she had no pain in neck and jaw, and her arm was still mildly sore, had dull headache.  Treatment included acetaminophen.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, sore arm, felt weak, extreme pain in right arm, and back was not resolved; outcome of the events, extreme pain in jaw, back, neck was resolved on 08 Feb 2021; outcome of the events, did not sleep much, pain was like a "stabbing with knife on my arm", no use of right arm, diarrhea, chills, and headache was not resolved.; Reporter's Comments: This case concerns a 72-year-old female with a serious unexpected event of LLT Paralysis arm with NS unexpected arm pain, jaw pain, neck pain, back pain, asthenia, diarrhea, difficulty sleeping and NS expected vaccination site pain, headache, chills.  The events occurred 2 days after the first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Fever up to 102.7, body aches, chills, sweats, myoclonus, and nausea
Began with nausea vomiting on 12/19/17- 12/20/17. He died of Sepsis per hospital on 12/27/17.
Hospitalization for Acute on chronic hypoxic respiratory failure and pneumonia and COVID-19 on dates 2/20/2023-3/2/2023.  Treated with dexamethasone, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Red rash upper arms bilat, back and chest, rash is macular generalized, few urticarial lesions.
Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case is linked to case 2018SA320304 (same reporter). This case involves a 3 years old (reported as 3 years and 7 months) female patient who was vaccinated with 0.5 ml once dose of FLUBLOK (Batch number: QFAA1804 and expiration date: 01-Jun-2018) in the right deltoid instead of FLUZONE QUADRIVALENT on 17-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines given. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was unknown if any adverse event occurred or not following the vaccination. 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 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. Documents held by sender: none.
Information has been received from a doctor of pharmacy concerning a 77 year old male patient with arthritis of wrist, enlarged prostate (benign), hypertension, hyperlipidaemia and arthralgia of hand who in 1997 was vaccinated with first dose of PNEUMOVAX (Lot # not reported) in left deltoid. On 16-DEC-2008 he received second dose of PNEUMOVAX (Lot # 661899/0519X) in left deltoid. There was no concomitant medication. On 16-DEC-2008 within six hours after administration vaccine he developed pain in his left arm. The pain was debilitating with swelling, redness and knot. He was unable to use his left arm, could not dress himself and wore an arm sling. He had now developed pain on his right side as well. He had been seen by several doctors beginning on 19-DEC-2008. At that visit he was prescribed VICODIN, prednisone and advised to apply ice. On 19-DEC-2008, an x-ray was unremarkable. On 30-DEC-2008 he had a left shoulder cortisone injection. A magnetic resonance imaging (MRI), computed axial tomography (CT) scan and physical therapy had been prescribed but not started yet. At the time on the report on 17-MAR-2009 the patient was not recovered. Pain debilitating in his left arm with swelling, redness, knot and pain on his right side were considered to be disabling. Additional information has been requested.
Site reaction: redness, warm to touch, painful, Hives chest area, Red rash to face- no swelling, warm to touch, burning sensation. Patient called Pharmacy 1/3/21. She was instructed to apply cool compress to left arm. Redness to arm decreased. She woke up today with hives, rash on face. She was seen in Express Care on 1/4/21. Instructed to take Benadryl 25-50 mg every 6 hours as needed, apply cool compresses to face, arm and chest, Avoid hot shower/bath. Prescription for Prednisone 40 mg daily for 5 days ordered. Unknown outcome
Pt recv vax on 10/22/97; on same day pt exp aches, fever, hot & cold feelings; 10/23 pt felt bloated.
Shingles-left shoulder blade and left breast (vaccine in left arm); began two days after vaccine with tingling on shoulder blade, then red rash, then painful blisters; stinging/stabbing pain; inability to sleep due to discomfort  Lymphadenopathy-swelling in my left breast and chest; much discomfort
Myalgia Pain, fatigue, soreness Narrative: Treated with ice, heat to arm, tylenol and motrin.  Other Relevant History:
Pt brought into COVID clinic, with HX of anaphalaxis rxn to flu vaccine, bu pt requested to con't w/ COVID vaccine.  Pt informed to wait after COVID vaccine for 30 minutes.  Approximatly 20 minutes of waiting pt started to feel like throat was swelling and she was having difficulty swallowing.  Pt taken to private area and vital signs (BP 143/106, HR 62, POX 97%RA) obtained by this RN.  Pt was given oral Benadryl 50mg and oral Pepcid 20mg.  Pt reports that she was feeling better after oral medication, but I asked her to wait till 11:00.  At 11:00 pt was still feeling better, and almost s/sx free, but I asked that she wait longer.  At about 11:10 she stated that she started feeling worse with regards to her throat, a and swallowing.  At this time 11:15 I gave her 0.3ml of Epinephrine IM in her Rt shoulder, and 911 was called to transport to ED. VS (162/103, HR 82, POX 97% RA)  At 11:20 EMS arrived and report was given to paramedics and pt transported to ED.
Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 22Mar2021 12:00 (Lot number: EN6206) at the age of 66 years as dose 2, single and intramuscular, administered in arm left, administration date 01Mar2021 12:00 (Lot number: EN6200) as dose 1, single for covid-19 immunisation. Relevant medical history included: "HTN", start date: 2000 (ongoing), notes: Patient Medical History (including any illness at time of vaccination): None, Illness/AE: HTN, Onset date: 2000, stop date: Ongoing checked, Pertinent details: take Procardia; "Hyperthyroid", start date: 06Jun2018 (ongoing), notes: Illness/AE: Hyperthyroid, Onset date: 06Jun2018, stop date: Ongoing checked, Pertinent details: take thyroxine; "High cholesterol", start date: 02Feb2019 (ongoing), notes: Illness/AE: High cholesterol, Onset Date: 02Feb2019, stop date: Ongoing checked, Pertinent details: take Crestor; "contracted covid", start date: Sep2021 (unspecified if ongoing), notes: i contracted covid back in Sep2021. Concomitant medication(s) included: PROCARDIA [NIFEDIPINE] taken for hypertension; THYROXINE taken for hyperthyroidism; CRESTOR taken for blood cholesterol increased. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 19Sep2021, outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Sep2021) negative; (13Sep2021) negative; (19Sep2021) positive, notes: Comments: Treated with Regeneron+ Steroid; (15Oct2021) negative. Therapeutic measures were taken as a result of covid-19. Clinical Information: 9Sep2021 patient had treated with Regeneron+ Steroid. Prior vaccination (within 4 weeks): None. Specific Relevant Test for thromboembolic events with thrombocytopenia: None After receiving booster on 27Nov2021, Patient ill with covid symptoms-cough, severe headache, Temp of 101 degree F. Nausea, Chills, severe pain down spine + pain to all extremities. All symptoms subsided by 29Nov2021 except for the persistent cough. Also patient had the expected sore arm at injection site.Patient did not have the covid type symptoms with mu 1st or 2nd vaccination. The reaction to the booster did feel as i did when i contracted covid back in Sep2021. If symptoms had not subsided I was going to get tested for Covid again, but luckily it resolved 2 days after booster.
Pain at injection site on left deltoid, immediately following vaccination. Febrile X 3 days and off work X 3 days following vaccination. Advil taken daily. Two weeks, post vax, developed swollen left deltoid, hot to touch with redness. Saw MD and Dx'd with cellulitis. Rx'd Zithromax, Becstra and Ultracef. Infection resolved. Pain has diminished but not resolved.
My baby woke up crying and she had a fever of 101.2 axillary. When I picked her up she started seizing for 20 seconds. Called Doctor answering service when event occurred and was advised by Dr. to monitor and give TYLENOL. The next day my baby was cranky and feverish. Also noted a dime size red bump on Right upper thigh where one of the vaccines was given. I am not sure if manufacturer, as I'm only going by the yellow immunization card that I was given.
Less than 24hrs after first shot on 03/24/2021 right ear is muffled. Feels like it clogged. Never went away Less than 24hrs after second shot on 04/14/2021 right ear is still muffled and now I have a buzzing sound in my ear.
patient received a vaccine that had Expiration date Mar 06, 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a vaccine that had Expiration date Mar 06, 2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a vaccine that had Expiration date Mar 06, 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a vaccine that had Expiration date Mar 06, 2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment information was reported.
Mild body aches; Mild upset stomach; Mild fatigue; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 01Mar2021 at 14:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (ADVIL) for unspecified indications, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the right arm on 08Feb2021 at 13:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 02Mar2021 at 13:00, the patient experienced mild body aches, mild upset stomach and mild fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild body aches, mild upset stomach and mild fatigue was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
At approximately 6:00pm on 04/23/2021 patient during 30 minute observation had a witnessed syncopal episode with loss of consciousness. Pt was assisted to stretcher during episode and assessed, presenting unresponsive initially, and then improved to AA&Ox4, airway patent, breathing normal and non-labored. Pulse bounding and thready with delayed perfusion. Pt skin pale, diaphoretic, and cool. Pt condition did not improve with oral hydration. EMS contacted via 911 for transport to the hospital. Pt administered 300ml IV Normal Saline via 18g catheter in left AC. Vitals as follows: (1800 91P, 112/58 16R, 98%)(1808 99P,90/50, 23R, 98%)(1812 109P, 94/50, 20R, 98%)
Had the first vaccine shot on 1/8/21,  never had the second one; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Had the first vaccine shot on 1/8/21,  never had the second one) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Had the first vaccine shot on 1/8/21,  never had the second one). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Had the first vaccine shot on 1/8/21,  never had the second one) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (VACCINE EXPOSURE DURING PREGNANCY) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 03-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (VACCINE EXPOSURE DURING PREGNANCY). At the time of the report, EXPOSURE DURING PREGNANCY (VACCINE EXPOSURE DURING PREGNANCY) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided Second dose is scheduled for 16Apr2021