chrisvoncsefalvay/vaers-outcomes huggingface dataset:
child was administered the DTaP-IPV diluent only instead of complete Pentacel dose, no AE; Initial information received on 18-Nov-2019 and additional information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a six months old patient who was administered with the DTaP-IPV diluent only instead of complete pentacel while receiving a 0.5 ml third dose of  vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] ( DTaP [IPV lot U6524BA, expiry date: 03-Feb-2021 ,Hib lot UJ157AA, expiry date: 03-Feb-2021) via intramuscular route and in the left thigh on 8-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX); HEPATITIS B VACCINE (HEPATITIS B VACCINE); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT).  It was a case of actual medication error due to product preparation issue.  No AE was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.
Patient passed out approximately 10 minutes after receiving her first dose.  She was sitting in the waiting area with her mom and the mom said she fell out of her seat and onto the floor and tensed up for a few seconds.  The patient came to very quickly and 911 was called.  The patient remained on the floor, had good coloring but was clammy. The patient left with EMS and was taken to the hospital to get checked out.
the inside of my body feels like it is burning up, 24 hours a day, for month; I am very tired; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date in Apr2021, the patient experienced the inside of my body feels like it is burning up, 24 hours a day, for month; I am very tired. Last Name: Patient stated, you don't need my last name, I was just told that that I needed to call this number because I am having a reaction from the Pfizer vaccine and my doctors cannot figure out what is going on, so I am trying to call you guys cause everyone stops hands on me. When paraphrased that consumer has experienced side effects and wants to know about it, consumer stated, Yes and I want to know. I got my second vaccine on April, the end of April and the inside of my body feels like it is burning up, 24 hours a day, for month and I am very tired. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up attempts are completed. No further information is expected.
Chills and fever and swelling 5 inches with black center Eschar developed. Been to wound care for debriding and bandaging three times a week and still going. Wound is deep.
Patient states she had unexplained swelling in her knees and legs. She was concerned about a possible clot so she went to the orthopedic doctor to be examined. They couldn't determine cause of swelling asked if she wanted a CAT scan she declined. Also stated sever pain at injection site that doesn't go away, tender to touch, limits mobility. I suggested she return to providers office and let them know she received Janssen COVID-19 vaccine and that additional test may be warranted.
White vision; Eye sight never recovered; This spontaneous case was reported by a consumer and describes the occurrence of DYSCHROMATOPSIA (White vision) and VISUAL IMPAIRMENT (Eye sight never recovered) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSCHROMATOPSIA (White vision) and VISUAL IMPAIRMENT (Eye sight never recovered). At the time of the report, DYSCHROMATOPSIA (White vision) outcome was unknown and VISUAL IMPAIRMENT (Eye sight never recovered) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicines were reported No treatment medicines were reported   This case was linked to MOD-2021-432897.
on 8/22/21 noticed that my left 'ring' 4th finger was swollen at base and purple in color.   Was still bad the next morning so went to Dr on 8/23 who diagnosed it as a ganglion cyst.    I have never had one before.    note that I have no idea if it is associated with the vaccine or not.
Vaccine was administered approx 2pm, and pt reported feeling "dizzy" approx 5 mins after. Pt was assisted and observed for the next 15 minutes. Pt was alert and ambulated to vehicle with family at side. No other concerns reported.
Pt recvd DTP/OPV on 25SEP91 during the administration of DTP, pt exp sz; hospitalized 48 hrs for eval & observation; neurologist visit scheduled for 2OCT91;
Had chills/fever and was very, very tired all day on 10/2...unable to perform regular activities.  Headache and slight tiredness (no fever/chills) on 10/3. Redness and swelling of injection started 10/3 and continue...but redness and swelling is typical for me with most shots.  Notable that I received the flu shot on the same day, in opposite arm.
Extreme pain at time of shot, especially when needle pulled out of arm. Progressively worsening pain in shoulder and upper arm. Some tingling in fingers. No relief to date.
Telephone from the client, reporting an episode of feeling dizzy, falling and losing consciousness this AM. He reported that it took him a few minutes to "clear his head," but feels fine now. Contacted PHN 20 minutes after it occurred. Episode occurred after his morning walk. He reports eating breakfast before the walk. He denies that anything like this has ever occurred before. He wanted to know if it was related to the Flu and Td immunization that he received yesterday 10/15/03. PHN recommended that he contact his PMD, for she did not think it was related to Td and Flu immunization. He reports contacting MD who informed him that he thought it was related to the immunizations. PHN has been unable to get a hold of pt to check status.
a breast ultrasound revealed swollen lymph nodes on left side under armpit; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EK9231), via an unspecified route of administration in arm left on 01Jan2021 at 11:00 as a 1st dose, single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient had no known allergies. Age at vaccination was 56 years. The patient's concomitant medications included raloxifene hydrochloride (RALOXIFENE [RALOXIFENE HYDROCHLORIDE]), vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]), krill oil, levocetirizine dihydrochloride (XYZAL) and Multivit. It was reported that, no other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. On 20Jan2021 at 11:00 AM, the patient experienced a breast ultrasound revealed swollen lymph nodes on left side under armpit. Treatment was not received for the event. On 20Jan2021, the patient underwent lab tests and procedures which included breast ultrasound, resulted as swollen lymph nodes on left side under armpit. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL8982), via an unspecified route of administration in arm left on 01Feb2021 as a 2nd dose, single dose for COVID-19 immunization. The outcome of the event was unknown.   Follow-up attempts completed. No further information expected.
Since the evening of my vaccine I have been getting extreme dizzy spells that I feel like I'm going to pass out, along with bad headaches and nausea.; Since the evening of my vaccine I have been getting extreme dizzy spells that I feel like I'm going to pass out, along with bad headaches and nausea.; Since the evening of my vaccine I have been getting extreme dizzy spells that I feel like I'm going to pass out, along with bad headaches and nausea.; My blood pressure has been elevated; This is a spontaneous report from a contactable consumer (consumer) reporting herself. A 34-year-old female patient (non-pregnant) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8730), via an unspecified route of administration at the age of 34-year-old at arm left on 24Mar2021 17:00 at single dose for COVID-19 immunization. Medical history included ulcerative colitis, endometriosis, osteoarthritis, asthma, obesity, allergies bees. Concomitant medications included marijuana and tizanidine hydrochloride (ZANAFLEX). The patient previously allergic to cefalexin monohydrate (KEFLEX), lavender. Since the evening of her vaccine (on 24Mar2021), the patient had been getting extreme dizzy spells that she feel like she was going to pass out, along with bad headaches and nausea. Her blood pressure has been elevated since then  (in 2021) and she have since had to begin blood pressure medication to try and reduce it to a safe level. The patient did not have blood pressure issues prior to her vaccine. My doctor has advised against her getting she second dose. The adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient hasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of events was not recovered.  Follow up attempts are possible. Information about lot/batch number was provided.
itching @ inj site, devel induration & erythema-area measured 4x6 1/2cm;
Given Immunizations Thurs. PM 5/21/09, but didn't notice swelling & erythema until Saturday 5/23. Pt reports "extreme pain" Sat/Sunday but feels better today; denies being seen by physician. No treatment to arm. No fever.
Sorness at site of injection that has continued from the day of the injection until now.(It still hurts to lay on that arm at night in bed.) Never any redness,swelling, radiating pain or swollen glands or fever.
Patient experienced swelling, pain and redness on the bicep on the opposite site of the arm close to the elbow. Injection site did not show any swelling or redness. Redness appeared 24 hours after injections were given and have subsided at his writing.
Significant flare in my eczema systemically on arms, torso, legs, outside of normally experienced rash with excessive itchiness and inability to treat effectively to this time.
nurse administered FLUZONE QIV instead of FLUZONE HD with no reported adverse event; Initial information received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from Nurse.  This case involves a 65 years old male patient where nurse administered influenza quadrival a-b vaccine [Fluzone qiv] instead of fluzone hd with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Sep-2023, the patient received 0.5 ml TOTAL dose of suspect influenza quadrival a-b vaccine Suspension for injection lot UT8055NAvia intramuscular route in the left arm ( strength and expiration date: not provided) for Immunisation (wrong product administered) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
On 05NOV2010, a 50 year old male, was vaccinated with BIOTHRAX by subcutaneous route to an unknown arm. On 06Nov2010, the subject complained of swelling, pain and limited mobility of the injection site arm. It was noted that on 05NOV2010, the patient had also received a Typhoid vaccination intramuscularly on the same arm as the BIOTHRAX vaccination. At the time of report, the events had not resolved. Additional information was received on 02DEC2010 which revealed the subject recovered well, and without lasting effects.
awful headaches, fever, vomitting 4 plus times throughout the night, full body soreness, nauseous
Tested positive for COVID-19; The injection site was very sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (The injection site was very sore) and SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced INJECTION SITE PAIN (The injection site was very sore). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Pain in arm, at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (The injection site was very sore) and SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event(Vaccination site pain).a causal relationship cannot be excluded. However, The event SARS CoV-19 Positive is unlikely related to mRNA.
Developed a side effect, 8 days after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Developed a side effect, 8 days after receiving the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE REACTION (Developed a side effect, 8 days after receiving the vaccine). At the time of the report, VACCINATION SITE REACTION (Developed a side effect, 8 days after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details were not reported by the reporter.; Sender's Comments: 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.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated IM with a dose of, the patient had recovered. MMR II. Subsequently in the patient's arm that vaccine was given, the arm locked up. The arm released after 2 day to 4 weeks. As of 12-APR-2011, the patient had recovered. It was unspecified if the patient sought medical attention. Arm locking up was considered to be disabling by the reporter. This is one of several reports received from the same source. Additional information has been requested.
pt recvd flu vax & exp numbness on the rt side of body (arm & leg); pt is being evaluated for GBS;
tremors; This case was reported by a physician via sales rep and described the occurrence of tremor in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced tremor. On an unknown date, the outcome of the tremor was unknown.   It was unknown if the reporter considered the tremor to be related to Bexsero and Bexsero Pre-Filled Syringe Device. 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: 07-SEP-2022 Reporter's comment: The patient was given dose of Bexsero and had experienced tremors. The vaccine administration facility is the same as primary reporter. The reporter had consented to follow-up.
This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. There was no information about the patients' concomitant therapies, medical histories and drug reactions or allergies provided. On unknown dates, the patients were vaccinated with improperly stored multiple doses of PNEUMOVAX 23 lot# M013156, expiration date: 15-OCT-2017 (dose was not provided). There were no adverse effects reported. Administered doses of vaccines were stored in a temperature between 32 degrees Fahrenheit to 35 degrees Fahrenheit for 120 hours. Digital data logger was used to capture temperature excursion. There were no previous temperature excursions.; Sender's Comments: US-009507513-1709USA008757:
A patient called and reported an AE. The patient stated that she was supposed to receive TDap but instead received GARDASIL 9 while being pregnant. No additional AEs were reported. No further information provided; A patient called and reported an AE. The patient stated that she was supposed to receive TDap but instead received GARDASIL 9 while being pregnant. No additional AEs were reported. No further information provided; A patient called and reported an AE. The patient stated that she was supposed to receive TDap but instead received GARDASIL 9 while being pregnant. No additional AEs were reported. No further information provided; This spontaneous report has been received from the patient referring to herself a 29-year-old pregnant female patient. Information regarding the patient's historical conditions, past drugs reactions or allergies, concurrent conditions or concomitant therapies was not provided. The patient became pregnant with last menstrual period (LMP) calculated as 20-NOV-2021 (and estimated date of delivery (EDD) of 01-SEP-2022), based on a pregnancy gestation reported as 28 weeks at the time of the report.  On 03-JUN-2021, the patient was supposed to receive diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) but instead received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (formulation, strength, dose, vaccination scheme, route of administration and anatomical location, indication, lot number and expiration date were not provided) while being pregnant (wrong product administered, exposure during pregnancy). At the time of the report, the pregnancy outcome was pending, the fetal outcome was not provided, and the patient did not experience any additional adverse events.
She had a little bit of a sore arm on the first one; This is a spontaneous report received from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL8982, EL9262and Expiration date: 20May2021), via intramuscular route of administration in the Arm Left on 22Jan2021 12:30 as single dose for COVID-19 immunization. Patient medical history: Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity included: She is overweight. This past year, started in Jun2020, she lost 30 pounds, but she is still overweight. Prior Vaccinations (within 4 weeks) was none. AE following prior vaccinations was none. No previous history of immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional Vaccines Administered on Same Date of the Pfizer Suspect. Family medical history was none. The patient's concomitant medications included Thyroid and Cholesterol medication. On 22Jan2021, the patient had left arm soreness. It was reported that on 22Jan2021 17:00, the patient had a little bit of a sore arm on the first one. It was just a little bit that night and day, but not at all on the second dose. She takes Thyroid and Cholesterol medication and they don't have anything to do with it. No further details provided. She received her second dose on 12Feb2021 at 10:00 am (expiration date: 21May2021). She has had no reaction whatsoever and the site this time around was not even sore. A friend said that she read somewhere if you had no reaction it means the first shot did not give you any antigens. The patient would like to know if that was why she didn't have any reaction to the second shot. No ER or physician's office visit required. No Investigation Assessment. No relevant tests were done. The outcome of the event was recovering.
Extreme tiredness, uncontrollable shivering, mild headache and some continuing fatigue the day after vaccination.