chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pharmacist reports 63 year patient inadvertently received FLUZONE HIGH DOSE QUADRIVALENT with no adverse event; Initial information was received on 23-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist via call center.  This case involves a 63-year-old female patient who received influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent] (product administered to patient of inappropriate age).  The patient's medical history, concomitant therapy, past medical treatment(s), vaccination(s) and family history were not provided.   On 20-Oct-2020, the patient received on influenza quadrival a-b high dose hv vaccine (formulation, strength was unknown) (batch number: UJ546AA and expiration date: 30-Jun-2021) at vaccinated with 0.7 ml (once) via intramuscular route in the left deltoid for prophylactic vaccination.  On 23-Oct-2020, 3 days after starting the suspect vaccine therapy patient received patient inadvertently received influenza quadrival a-b high dose hv vaccine (product administered to patient of inappropriate age). Patient had not reported any side effects at this time.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was not applicable.  Disclaimer: 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 or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.  No further relevant information was reported.
Information has been received from a physician concerning an approximately 60 year old patient who was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently the patient developed herpes zoster less than 14 days after administration of the vaccine.  The patient was prescribed unspecified antiviral medication and at the time of this report was recovering.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.  This is one of several reports from the same source.
2 Weeks after vaccination swelling of my eyes begin, extreme itchiness and dry skin, redness began around my eye lid and upper cheek and face got worse after two days. On day 3 whole face of eye brows and upper face was swollen, went to ER where I was prescribed steroids, swelling started to subside immediately. By three days all reactions have stopped. As of now all reactions have stopped and I have since then had a booster.
Flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 21K-163-3977168-00.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (hospitalization), outcome "unknown", described as "Flu like symptoms". The patient underwent the following laboratory tests and procedures: Ultrasound kidney: Unknown results, notes: For Kidney stones.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative: COVID infection following COVID vaccine series 03/16, Pfizer, dose #1 04/07, Pfizer, dose #2 09/23 pt cc: chills, cough, fatigue, fever, loss of taste or smell, rhinorrhea, congestion exposure: Possible from student. 09/24 COVID swab, result: detected 09/24 SARS-COV-2 Variant Sequencing result: pending
Pt did not respond (no antibodies) p/receiving 1st Engerix-B booster dose plan is to revax;
The pt experienced a fever beginning immediately. Started low and peaked about 6 hours and stayed high about 6 hours. The pt also experienced aches and chills lasting 36 hours. The pt also experienced nausea and vomiting and cold sweats.
The four fingers on my left hand randomly turn white.; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 14Sep2021 at 08:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Sep2021, the patient experienced the four fingers on her left hand randomly turn white. on an unknown date in Sep2021, the patient underwent COVID-19 test and the result was unknown. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event the four fingers on her left hand randomly turn white was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Shot administered 2/24/21 Sore throat 2/25/21 Fatigue 2/26-2/28/21 Dry cough with laringitis 3/1-3/2
Fever, chills, headache, muscle aches,  fatigue, nausea, Gastro intestinal upset
Welps appearing on legs, back, chest, sides and arms that are extremely itchy.  Symptoms have continued since 1 week after vaccination.  Itching is so severe that it interferes with sleep.  I get maybe 2 hours of sleep a night.
Information has been received from a nurse practitioner concerning a patient who on 01-SEP-2009 was vaccinated with the first dose of VARIVAX (Merck) (dose, route, and lot# not reported). The nurse was reported that the patient inadvertently received VARIVAX (Merck) instead of ZOSTAVAX (Merck) (MSD) due to a human error. No adverse effect reported. Additional information has been requested.
got the flu shot one year and almost died from it; Initial information received on 15-Oct-2020 regarding an unsolicited valid non-serious case received a consumer.  This case involves a male patient of unknown age for whom it was reported that the he got the flu shot (vaccine INFLUENZA VACCINE) one year and almost died from it (Apparent life threatening event).  The medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose  suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route for prophylactic vaccination.  On an unknown date (unknown latency), following the administration of INFLUENZA VACCINE one year and reportedly almost died from it (Apparent life threatening event).  Final diagnosis was Apparent life threatening event.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  Outcome was unknown for the event at the time of reporting.  There will be no information available on the batch number for this case.
Pt and mom report that after first Covid vaccine 6-29-21, pt's ears hurt and he was sensitive to noise. That improved over days. He got 2nd vaccine 7-23-21 and has had some mild bilateral ear pain on and off since then. Normal ear exam 7-29-21
Pt went to a fast food restaurant after leaving our office.  Halfway there she got a pain in mid-sternal to epigastric region.  Then she felt very flushed, woozy, and hot.  She got out of the car & went into the restaurant still feeling a little woozy.  While ordering, she fainted & passed out.  911 was called.
Patient developed fever, grimaced when swallowing. Fever increased to 105degrees F. Taken to ER, examined. Ruled out strep throat, no antivirals or antibiotics given. Patient returned home. Tylenol and Motrin given for fever. Fever decreased to 103degrees and today 11/10/2009 stable at 100 degrees. It is important to note that patient was given Pediarix, Hib, and Prevnar on 11/05/2009. Fever developed the evening of 11/05/2009.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot #H019999 was exposed to -14C for an estimated total time out of range of 14.25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 01-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
8 days after Varivax given- pt developed fever and had 2-5 minute generalized tonic-clonic seizure. Lost verbal milestones.
She had the rash and the following day had red rash and soreness  under her armpit.  It went away and then came back Friday again 3/5/21 with rash and soreness in the armpit again.  She took Tylenol.  She still has the rash, not as red but you can still see it.  She also still has the soreness to her armpit.  Afraid to take the 2nd vaccine, told to FU with her PCP.
Patient reports  arm itching 5 inches around injection site starting 4-5pm on 9/29/23.  On 9/30/23 at 10am patient reports welts, swelling, redness and itchiness around injection site.  Patient had similar injection site reaction with previous vaccines.  No systemic reaction.  All confined to area around injection site.
Dad states that left thigh developed a "rash" the day after receiving immunizations. The site on left thigh was red and somewhat hard but not hot. Denies pain or itching or fever. The reddened area was approx. 1.5 inches in diameter. Dad states he is acting normal.
Shingles - rash, pain, discomfort on left torso... back pain 10 days after shot; rash appear around 14 days after
Patient received vaccine, then proceeded to faint and fall out of chair.  She hit her head on the floor.  Mom was with her--patient was coherent and speaking to me.  She said her head hurt--I told her I'd get an ice pack, which I did and gave to her.  Mom was really worried so I asked her if she wanted me to call 911, which I did.  2 EMTs came and checked the patient out.  Mom wanted her to go get checked out at the hospital so the patient and Mom went with the EMTs.  I called Mom around 8:00pm 5/28/2021 and she said pt was checked out.  The hospital doctor said it was a vaso-vagal reaction and released patient home with no restrictions.
3 weeks later started having trouble breathing, breathing got worse and finally went to hospital on April 19, 2021 with fluid in lungs. Echo cardiagram revealed the mitral valve failure. Heart went into afib
This case was reported by a healthcare professional and described the occurrence of inappropriate dose of drug administered in a 47-year-old male subject was vaccinated with hepatitis A vaccine inactivated (Havrix) for prophylaxis. The subject's medical history, concurrent conditions and concurrent medications were not reported. Concurrent medications included Tetanus vaccine. On 7 September 2006 the subject received 1st dose of Engerix-B at 0.5 ml and Havrix (dose number not specified) at ELISA units. At an unspecified after vaccination with Engerix-B and Havrix, the subject developed yellow fever. At the time of documenting this event, the healthcare professional noted that the lots of Engerix-B that were administered to the subject on 07 September 2006 were pediatric doses and not the adult dose. This was considered to be an inappropriate dose of drug administered as 1 ml of Engerix-B and 1440 ELISA units of Havrix are indicated for adult subjects. No additional information is available regarding this case.
sore arm; ear hurt; scratchy throat; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Feb-2021. The most recent information was received on 13-Jul-2021 and was forwarded to Moderna on 13-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), EAR PAIN (ear hurt) and OROPHARYNGEAL PAIN (scratchy throat) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 027A21A) for COVID-19 vaccination.     No medical history was reported by reporter.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), EAR PAIN (ear hurt) and OROPHARYNGEAL PAIN (scratchy throat). At the time of the report, PAIN IN EXTREMITY (sore arm), EAR PAIN (ear hurt) and OROPHARYNGEAL PAIN (scratchy throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.   This case was linked to MOD-2021-255550 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Significant follow up, lot number added
pt recvd vax 28MAR95 & c/o pain in lt leg; pt was limping & refused to let anyone touch leg; mom also reports that upper thigh is sl red also has a hard area; t103.6;
pt recv vax 6OCT95 & 16NOV96 pt exp macular, papular, & vesicular lesions (less than 20) on chest, abd, legs, scalp, palm of rt hand, & sl temp;
Intense throbbing headache during the first night and the following day. Headache disappeared after more than 24 hours after getting the shot. I took acetaminophen (2 x 500mg) every 4 hours.
An unspecified age female patient received bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number and Expiration date: Unknown), dose 1 via an unspecified route of administration on 05Feb2021 as 1st dose, single for an COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 05Feb2021, the patient had experienced arm pain. She wants to know if she can take Tylenol. The outcome of event was unknown.  Information on Lot /Batch Number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Pt recvd 3 doses of Engerix B for immunization 31Jul90, 4Sep90, & 24Jan91. 13Mar91 titer test result indicated negative, pt did not seroconvert.
She had larger areas of the patches on her neck and ears; started getting hives/hives were nowshowing up in random parts of her body; little bit of itching/itching a little bit more but it depended on the size of the patch; red patches; armpit swelling; sore arm; armpit pain; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (started getting hives/hives were nowshowing up in random parts of her body), PRURITUS (little bit of itching/itching a little bit more but it depended on the size of the patch), ERYTHEMA (red patches), SWELLING (armpit swelling) and PAIN IN EXTREMITY (sore arm) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced SWELLING (armpit swelling), PAIN IN EXTREMITY (sore arm) and AXILLARY PAIN (armpit pain). On 02-Dec-2021, the patient experienced URTICARIA (started getting hives/hives were nowshowing up in random parts of her body), PRURITUS (little bit of itching/itching a little bit more but it depended on the size of the patch) and ERYTHEMA (red patches). On 05-Dec-2021, the patient experienced RASH (She had larger areas of the patches on her neck and ears). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 04-Dec-2021 for Adverse event, at a dose of half a dose and METHYLPREDNISOLONE (METHYLPREDNISOLON [METHYLPREDNISOLONE]) on 05-Dec-2021 for Adverse event, at a dose of titrating dose. At the time of the report, URTICARIA (started getting hives/hives were nowshowing up in random parts of her body), SWELLING (armpit swelling), PAIN IN EXTREMITY (sore arm) and AXILLARY PAIN (armpit pain) outcome was unknown and PRURITUS (little bit of itching/itching a little bit more but it depended on the size of the patch), ERYTHEMA (red patches) and RASH (She had larger areas of the patches on her neck and ears) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient developed sore arm, armpit pain and swelling. On 02-Dec-2021, She started getting hives, a little bit of itching and red patches. On 03-Dec-2021, She had itching, red patches, hives. It was more involved. The hives were now showing up in random parts of her body. She was itching a little bit more, but it depended on the size of the patch. On 04-Dec-2021, patient think this day was the worst of it. She took half a dose of Benadryl. On 05-Dec-2021, She had larger areas of the patches on her neck and ears. Patient got an appointment, and she was prescribed Methylprednisone in a titrating dose. She started taking it yesterday.   This case was linked to MOD-2021-405495, MOD-2021-017910 (Patient Link).
feel tired; Flu-like symptoms; inability to lift her arms or legs; overall malaise; Weak; Shaky; lethargic; Fever; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2019, the patient received the 1st dose of Shingrix. On 22nd July 2019, 1 days after receiving Shingrix, the patient experienced tiredness, influenza-like symptoms, mobility decreased, malaise, weakness, tremor, lethargy and fever. On 24th July 2019, the outcome of the tiredness, influenza-like symptoms, mobility decreased, malaise, weakness, tremor, lethargy and fever were recovered/resolved.   It was unknown if the reporter considered the tiredness, influenza-like symptoms, mobility decreased, malaise, weakness, tremor, lethargy and fever to be related to Shingrix.  Additional case details were reported as follows: At night, the patient received Shingrix on an unknown arm and she started to feel tired.  The next day, she was in bed all day with flu-like symptoms, including the inability to lift her arms or legs, feeling tired and lethargic, weak, shaky, and overall malaise. She also felt like she had a fever but did not take her temperature.  The patient noticed she was feeling better but was not able to get out of bed until the afternoon.  All symptoms had resolved and she went in to work.  The reporter consented to follow up. This case has been linked with case US2019220473 (husband's case), reported by the same reporter.
He has had invasion local disease a blood infection that almost killed him; He has had invasion local disease a blood infection that almost killed him; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 38-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. Caller later stated on the call, patient also smoked, He also had asthma and there was a history obese. Not extremely he's got a big belly everything else was not obese but his belly's big he was also told he may have a heart issue. The patient's concomitant medications were not reported. The patient's significate other called on behalf of the patient seeking assistance with the medication pneumococcal 13-val conj vac (dipht crm197 protein). During the call, patient had invasion local disease a blood infection that almost killed him. He was afraid he's going to die if he contract another blood bourne illness from the local disease. Outcome of events were unknown.   Information on the lot/batch number has been requested.
Patient received the Johnson & Johnson / Janssen COVID-19 vaccine on April 5, 2021. Patient woke up overnight with severe headache that was different than her typical migraines headaches. Headache was "like I never had before", "it's really painful." When I asked if this was the worst headache of her life she responded "probably."  No photophonia, no phonophobia, no nausea, and no vomiting, which she gets every time she has migraines. "This is a different type of headache," she said.  "I usually throw up and my headaches get better." This headache feels like a "balloon in my head." She reported vision changes (blurred vision) 45 minutes prior to our visit which started at 8:19 a.m. on April 21, 2021. ("I was having a problem with peripheral vision, about 45 minutes ago," but not so much now. Patient denies loss of balance (dizziness), seizures, focal weakness, radicular symptoms, saddle anesthesia, sensory changes, slurred speech, numbness, chills, and fever. She was sent to the emergency department for further evaluation. She is a female patient with new, severe headache that is between 18 and 48 years of age, and has received the Ad26.COV2.S (COVID-19) vaccine within 3 weeks of headache onset.
COVID; COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4161263.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Batch/Lot number: unknown), on 03May2021 as dose 2, single (Batch/Lot number: unknown) and on 03Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: blood pressure [Blood pressure], 146/99. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 146/99. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient had COVID and had been prescribed Paxlovid.  The reporter's assessment of the causal relationship of "covid" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (DRUG INEFFECTIVE , COVID-19) and BNT162B2.