chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adacel was given to a 6 year old instead of Daptacel, No AE; Adacel vaccine was given to a 6 year old patient, No AE; Initial information received on 04-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a six-year-old female patient who was vaccinated with a 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U6706AA and expiry date: 03-Jul-2022) via unknown route in the left thigh for prophylactic vaccination on 29-Jul-2020 instead a dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.   At the time of this report, no adverse event was reported.  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.
PT RECIVED VACCINE APPROXIMATELY AT 12:00. PT CAME BACK AT 14:10 WITH A SWOLLEN LEFT ARM PAIN 10/10 RADIATING DOWN TO FINGERS, HEADACHE 10/10, LIGHTHEADEDNESS, AND BAD TASTE IN MOUTH. PT STATES ARM FEELS VERY HEAVY.  PT GIVEN REST, WATER, ICE PACK, AND TYLENOL 1000 MG. OUTCOME NOT OBSERVED AT THIS TIME.
Patient stood up and blood pressure dropped and started to faint and nursing staff was with her. Her blood pressure was 85/45 and pulse of 60. Patient got nauseated and vomited.  Nursing staff contacted MD and they decided to have her checked out at the ER.
Extreme pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Extreme pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 an unknown date, the patient experienced PAIN (Extreme pain). At the time of the report, PAIN (Extreme pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient's lab test data not reported.  Concomitant product use was not provided.  Treatment information was not provided.
The first night after the vaccine had a headache and woke up with pain near her mouth.  The 2nd night, Tuesday, 2/16/21 it got bad, woke up around the same time early morning,  had pain on the right quadrant of her upper body, from her ear, eye, throat and down to right under her throat.  When she swallows the pain is very severe with difficulty swallowing and that pain radiates to the upper part of her chest.   Then on the third night, last night, all the same pain but the headache had disappeared.   Today, 2/18/21 she is still having the same symptoms.  The hardest thing to deal with is the ear pain in the right ear, and the pain under her right throat area.  She has taken one Benadryl at 8:00 AM, and will take another at 8:00 PM.  The Benadryl triggers her tinnitus so is limited with that.  Her daughter is trying to find OTC medicine for the ear.  She has not called her doctor as they are trying to treat it with OTC medicines.    For additional information call her daughter: who takes care of all her medical information.
Patient reporting tingling sensations that radiated up towards her face following administration of both doses of the covid vaccine series. These sensations lasted "a few hours" and resolved on their own.
pt states lt arm sore the evening of vax but came down w/h/a, body aches, t99.5, arm very sore & stiff on next day 1130 in morning;
she started having pain in her leg and veins; She started having pain in her leg and veins; she can barely walk.; Vein in her leg that popped up; Barely able to move; This is a spontaneous report from a contactable consumer (patient's daughter). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0161), via an unspecified route of administration on 20May2021 at 14:00 as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that, yesterday, 4 days after her vaccination, she started having pain in her leg and veins in her thigh popped up. Today, she can barely walk. She mentioned that her mother had no health problems and had no complications before she got the vaccine. She also mentioned that she knew people that had common side effects like body aches after receiving the vaccine but her mother was different due to the vein issue. She was due for her 2nd dose on 10Jun2021 and would like to know if this has been reported with the vaccine. Reporter stated, Okay so my mom got the first shot of Pfizer vaccine. This be like you know because of vaccine because she did not have any problem before just right up she got the shot, she have that. Do you think this thing, is common for most of the people that got Pfizer. Reporter was informed about Pfizer and was provided with the number. Reporter stated, I report these to other representative couple minutes ago but right now I just need to know what we can do in this case. In this case you know for my mom. Should we go to the hospital. When informed about Pfizer . Reporter was informed to select option 3, after dialing the number and the timings as 8 AM to 8 PM from Monday to Friday and 9am to 3 pm from Saturday and Sunday as per EST. When requested for permission for further probing, reporter stated, I mean I did answer all of the questions, medical history for my mom, the age, the information of the vaccination card, I did give that all just right now, 2 minutes ago but I thought this was the medical option. Reporter was informed the timings again. Further information could not be probed as consumer was unwilling to complete the report. Hence, limited information available. Thus, product details (LOT, NDC, UPC and Expiration date) and pharmacy details could not be probed over the call. The outcome of the events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
Approximately 2 days after the vaccination, she began having joint pain in her hands. Within a week she was experiencing joint pain in her feet. Went to the doctor ~August 20th and was prescribed naproxen and blood was drawn for tests. Naproxen did not help and blood tests showed no abnormalities. Then prescribed a 9-day course of prednisone and an antibiotic on August 27th. The prednisone helped a lot but as the dose decreased, the pain returned just as bad as before. Some swelling in her knuckles is present. Referred to rheumatologist on September 7th and waiting for an appointment.
2 days after receiving a Moderna booster shot (previously received 2 shots of Pfizer) I noticed sensitivity/pain around my vagina. On the third day (Sunday) I looked closer and noticed  at least 6 small, white lesions on the inside of my inner right labia, which was also swollen. On the fourth day I got tested for herpes and started taking acyclovir. On the fifth day the herpes tests all came back negative and I stopped taking acyclovir. The lesions had already started healing and looked much less irritated. On the sixth day I got tested for syphilis, gonorrhea, clamydia, and HIV, which all came back negative. All symptoms (lesions and swelling) were gone by the following week.
Welt at injection site. Started very red about quarter size, grew to about 3 1/2 inches in diameter, quite painful. Not as red today, but noticable and sore (7/2/2019)
pt recv vax & 3 days later,pt devel & cont to have acute arthritis in the hands & feet;
SORENESS; SWEATS; CHILLS; FEVER; WORST HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced soreness, sweats, chills, fever, worst headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness, sweats, chills, fever, worst headache, and fatigue. This report was non-serious.
Arm pain; Fever; didn't feel good; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number FG2D4, expiry date 19th September 2021) for prophylaxis.   On 24th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th May 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, fever and feeling unwell. On 25th May 2019, the outcome of the pain in arm, fever and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fever and feeling unwell to be related to Shingrix.  Additional information received were as follows: The pharmacist on the line reporting after receiving 1st dose of Shingrix in the right deltoid, the patient experienced arm pain, fever and just didn't feel good the following day, which lasted about a day. The reporter consented to follow up.
Information has been received from a physician assistant concerning a 24 year old pregnant female with a history of penicillin allergy who on 12-FEB-2008 was vaccinated IM with the first 0.5 mL dose of GARDASIL (lot # 658556/1060U).  Concomitant therapy included vitamins (unspecified).  On 26-FEB-2008 the patient was examined in the doctor's office and the pregnancy was confirmed by urine pregnancy test.  The patient was referred to an obstetrician for care.  No problems were reported.  The patient's status is unknown.  Follow up information received on 13-MAR-2008.  It was reported that the patient a female with a history of depression, upper endoscopy for pill stuck in her throat in 2004, and ex-smoker was given a dose of GARDASIL (lot # 658556/1060U) and she knew she was pregnant.   The expected delivery date is 26-OCT-2008.  It was also reported that the patient was treated with ZOLOFT for depression and that she stopped therapy with ZOLOFT in August 2007.  The patient stopped smoking on 26-FEB-2008.  There were no previous pregnancies, full term deliveries, pre-term deliveries, spontaneous abortion, elective terminations or fetal defects.  Follow up information received from an outcome pregnancy questionnaire on 02-APR-2009 stated that the patient's husband had Methicillin Resistant Staphylococcus aureus (MRSA).  Concomitant medication includes prenatal vitamins started on 26-FEB-2008.  The patient had no complications during pregnancy and delivered a normal female liveborn on 04-NOV-2008 at 40 6/7 weeks from LMP, who had 7 pounds 12 oz weight and 21 inches length.  Apgar score was 4/8/9 and head circumference was 13 inches.  The patient had a C/section due to failure to progress.  The patient had a wound and an incision and drainage was performed at the physician's office.  The patient was prescribed VICODIN or TYLENOL for pain after the incision and drainage of the wound.  Laboratories studies performed include a glucose tolerance test (GTT) on 01-AUG-2008, 83 mg/dl.  Follow up information received on 03-APR-2009 from the nurse practitioner stated that the patient had delivered a baby girl who was normal with no congenital anomalies.  Upon internal review, C-section due to failure to progress was considered to be an Other Important Medical Event.  No further information is available.
After getting vaccinated;  husband's patient notify that he had to bring her to emergency room due to diarrhea, nausea, general weakness.
No adverse events; a patient was administered 1 dose of improperly stored VAQTA; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medically history provided.  On 09-SEP-2019, the patient was vaccinated with the first dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) lot number: S017739, expiration date: 29-AUG-2020 for prophylaxis (formulation, dose and route of administration were not reported).   The administrated dose of vaccine was exposed to the highest temperature above 47 degrees Fahrenheit / 9 degrees Celsius for 24 hours. There was no previous temperature excursion. The data logger was not involved. No adverse events were reported.
C/O Myalgia, headache, fever 102 which started around 7:00pm the day the shot was given.
Information has been received from a physician concerning a 5 year old male who on 15-AUG-2005 and 20-MAY-2009 was vaccinated with the first and second dose of MMR II respectively (route, site, and lot number not reported). On 06-DEC-2009 the patient experienced mumps (the date diagnosed was reported as 01-DEC-2009). The patient also experienced a fever of 103 degree F and parotitis. On 01-DEC-2009, the first blood work was done which revealed serum IgM <1:10, serum IgG 2.71 and serum amylase 422. The outcome for mumps was not reported. Follow up information has been received had indicated that 5 year old patient was vaccinated with his fist dose of MMR II on 15-AUG-2005 and with his second dose of MMR II on 20-MAY-2009. On 20-NOV-2009 (previously reported as 06-DEC-2009) the patient experienced mumps, the diagnosis was made on 24-NOV-2009. The patient's temperature was 37 C degrees, other signs and symptoms included parotitis (both sides). Diagnostic laboratory tests performed on 25-NOV-2009 included: IgM 1:40:00; IgG: 7.98 and serum amylase: 206. This is one of several reports received from the same source. No further information is available.
Patient having severe right arm pain where shot was given 4 weeks ago.  Day of vaccine, had dilated pupils, neck rash.  Next day, severe right arm pain, shoulder pain, neck pain, all on the side that vaccine was given, vomiting, weakness, swollen glands.
Low grade fever (100.5 F) began Wednesday evening (3/2/16) and continued through Sunday evening (3/6/16).  The fever temperature increased in the middle of the night, temperatures were not recorded, but mother could feel baby's head, face, neck, and hands were much hotter during the night-time than during any other time of day. Fever reduced and was gone by late Sunday night (3/6/16).  In addition to fever, during this period baby had decreased appetite and energy, increased fussiness and clinginess. After the fever had gone, a rash appeared on Monday (3/7/16).  Light reddish/pink dots and some tiny raised bumps were found along the neck and jaw of baby. Tuesday (3/8/16) the rash was no longer on neck and jaw, but covered entire back of baby. Again, in addition to the rash, baby had decreased appetite, increased fussiness and clinginess. Wednesday (3/9/16) no rash was noticeable and appetite, energy, and regular demeanor returned.
Received Sinovac vaccine and 4-5 months later was given Moderna vaccine/received 2nd dose of Moderna vaccine more than 35 days after 1st dose; Tired; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Sinovac vaccine and 4-5 months later was given Moderna vaccine/received 2nd dose of Moderna vaccine more than 35 days after 1st dose) and FATIGUE (Tired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Sep-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Sinovac vaccine and 4-5 months later was given Moderna vaccine/received 2nd dose of Moderna vaccine more than 35 days after 1st dose) and FATIGUE (Tired). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Sinovac vaccine and 4-5 months later was given Moderna vaccine/received 2nd dose of Moderna vaccine more than 35 days after 1st dose) had resolved and FATIGUE (Tired) outcome was unknown.            Concomitant medication was not provided. Treatment medication  was not provided .
He states vaccine receipt 01 APR 21 with PFizer BioNTech was unremarkable and no suggestion of IgE mediated reaction. He states on 05 or 06 APR (day #4 or 5) he experienced onset of an intermittent pinching pain to midchest with activity and mild dyspnea. He states he was very fit and now was experiencing shortness of breath even climbing a flight of stairs.
About 10 hours after vaccination, I developed very bad headache. The next day I had a fever in excess of 103 degrees, body aches, and the headache.
Stroke on the 23rd, hospilized for 10 days. Second stroke on the 12th. Died on the 18th.
Following both my second COVID vaccine in January 2021 and my booster in October 2021 I developed severe congestion, cough and shortness of breath.  It appears to have exacerbated my auto immune both times.  The first episode required a trip to the ER for shortness of breath.
Patient was vaccinated with Pfizer #1 on Monday 3/1/2021. He received a second invitation for vaccine in error, signed up, and was vaccinated a second time with Pfizer #2 on 3/2/2021. Patient could not give a reason why he thought the vaccine was due the next day. No adverse outcomes or symptoms reported. Patient was advised to check wiht his regular doctor.
pt recvd vax;27oct94,late pm, red palms,urticaria wrist,back,trunk; pruritic rash;much improved at time of report 1nov94;tx w/ dph & prednisone x 5 days; no resp distress;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive, notes: COVID 19 Treatment. The patient was treated with Paxlovid from 28Feb2023 to 04Mar2023. The information on the batch/lot number for BNT162B2, BNT162B2 OMI BA.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccine  cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Injection site became very itchy, red, hot, bruised, and painful if touched. It is still itchy, red and bruised 2 weeks later. I have been taking allergy medication and putting Benadryl cream on it regularly.
Tiredness (sleep), loss of appetite (ate Jello), fever of 101 (Tylenol),  = day after injection and next day Diarrhea/very loose bowels (Immodium) = second day after injection
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Other medical history: No. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; TYLENOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Apr2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Apr2022) Positive, notes: Adverse event: Rebound positive case. Therapeutic measures were taken as a result of covid-19.  Clinical course: other medication in 2 weeks product: Vitamin C supplement, Other medication in 2 weeks product: Tylenol. Anti-viral details: product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 20Apr2022, Treatment stop date: 25Apr2022. Known allergies: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
WHILE SITTING IN CHAIR AFTER IMMUNIZATION, SHE LOST CONSCIOUSNESS. SHE WAS NOT RESPONSIVE TO NAME OR BY TOUCH.  THIS CONTINUED FOR 5 MINUTES, AFTER WHICH SHE BECAME AWARE OF HER SURROUNDINGS.
I did not have an adverse reaction to the vaccine. I began to not feel well on 12/06/2022. I had a sore throat, dry cough, headache, no fever and tired. I tested positive for COVID-19 12/07/2022. I contacted my doctor via a telehealth visit and was offered the prescription PAXLOVID but I declined.
fever; aches; chills; headache; Tinnitus/ringing in my ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 07Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 immunization, reaction(s): "chills", "headache", "aches", "Fever"; Bnt162b2 (Second dose), for Covid-19 immunization, reaction(s): "chills", "headache", "aches", "Fever". The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "fever"; PAIN (non-serious), outcome "recovered", described as "aches"; CHILLS (non-serious), outcome "recovered", described as "chills"; HEADACHE (non-serious), outcome "recovered", described as "headache"; TINNITUS (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Tinnitus/ringing in my ears".  The lot number for bnt162b2 was not provided and will be requested during follow up.