chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient inadvertently received 2 doses of ipol with no reported adverse event; Initial information was received on 30-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2023SA338108.  This case involves a 4 months old female patient who inadvertently received 2 doses of IPV (VERO) [IPOL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine 13v (pneumococcal 13 valent vaccine) and rotavirus vaccine (rotavirus vaccine) for prophylactic vaccination.  On 25-Oct-2023, the patient received a 0.5 ml, once dose of suspect IPV (VERO) (Suspension for injection) (lot VIB901M, expiry date: 02- Jun-2024, strength: standard) via intramuscular route in the left thigh for Immunisation and patient inadvertently received 2 doses of ipol with no reported adverse event (extra dose 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.
rash has ballooned to take up most of arm; kind of itchy; hot; hard; very red; rash; very tired; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (rash has ballooned to take up most of arm), PRURITUS (kind of itchy), FEELING HOT (hot), MASS (hard) and ERYTHEMA (very red) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced FATIGUE (very tired). On 05-Mar-2021, the patient experienced SWELLING (rash has ballooned to take up most of arm), PRURITUS (kind of itchy), FEELING HOT (hot), MASS (hard), ERYTHEMA (very red) and RASH (rash). On 25-Feb-2021, FATIGUE (very tired) had resolved. At the time of the report, SWELLING (rash has ballooned to take up most of arm), PRURITUS (kind of itchy), FEELING HOT (hot), MASS (hard), ERYTHEMA (very red) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications were  provided by Reporter No Treatment Medications were  provided by Reporter
Slight indigestion for one day, and sleeepiness for several days, January 3 - January 10, 2023 Tylenol for three days
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles and other complications. In 2014, the patient was treated at a health center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
I woke up at 3:ooam with a large amount of nasal drainage, headace,a fever of 101.00 and sneezing profusly.This continued until 4pm on 10/21/09.The symtoms seemed to just go away with some congestion. This is what makes me think it was a reaction to the vaccine. I was fine before,and fine now after 24 hours.
Weakness, body aches, was diagnosed with PMR. Was prescribed 40 mg of Prednisone for 2 weeks.
defined rash 8 hours later described her rash as mildly itchy,  red and limited to her "inner thighs, nowhere else on body; defined rash 8 hours later described her rash as mildly itchy,  red and limited to her "inner thighs, nowhere else on body; a sore arm, now it's better; wiped out; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced defined rash 8 hours post vaccination described her rash as mildly itchy, red and limited to her "inner thighs, nowhere else on body, a sore arm, now it's better, wiped out. She also said her rash is 90% gone now. She specified she didn't take anything for the rash. She added in the middle of the night, she had "a sore arm, now it's better and she also feels a "little bit wiped out" and specified it can be because she "got 5 hours of sleep". She asked was my reaction reported as a side effect of the vaccine. She added she read that the COVID-19 vaccine caused mild allergic reaction closely after the shot, in 83% of people vaccinated. What are the recommendations for someone who developed a mild rash to the vaccine, my adverse reaction be considered? should I take the second dose of the Pfizer-BioNTech COVID-19 vaccine after reacting to the first dose. Caller thanked us for our customer service and for "quickly" answering the line. There Is a medical information request. The outcome for rash red and itchy was recovering and for sore arm it was recovered and for wiped out it was unknown.  Follow-up (12Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that. Information on the batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Information has been received from a consumer concerning her daughter a female who was vaccinated, on unspecified dates, with the first two doses of GARDASIL (dose and lot number not reported) in the top of her hip. Concomitant therapy included ALLEGRA. The patient experienced pain in the injection site. On an unspecified date, the patient recovered from pain in the injection site. Patient's AE improve with unspecified therapy. The patient sought for unspecified medical attention. Additional information has been requested.
12:15 pm muscle aches , fatigue and fever up to 101.9 for 7 hours.
Patient presented to clinic 24 hours after receiving dose 1 of anthrax with swelling of the right arm. Denied pain or itching. Patient came in 48 hours after vaccine and left arm was also swollen. Patient was seen in urgent care and prescribed ZYRTEC and methylprednisolone to resolve inflammation. Will follow up with primary care manager in the next couple days to follow up.
URTICARIA- bilateral arms started 2 May. Patient received Vaccinations to Typhod, Anthrax, Small pox approx 27 Apr. Reports itching swelling, fatigue.
Had a couple of little spots on my chest and on the top of my thighs, red spots; One or two red spots on my back; There are couple on my face, little red; I have Sulfur allergy and I was a baby and I broke out in rash; This is a spontaneous report from a contactable Consumer. A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6205), via an unspecified route of administration, administered in Arm Left on 06Mar2021 as SINGLE DOSE (at the age of 73-year-old) for covid-19 immunisation; sulfur (SULFUR), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included diabetes mellitus (Verbatim: Diabetic I am diabetic and I take a number of medications, I take some heart medication (not clarified further), I take a lot of medication). Reporter stated, patient had the Pfizer COVID shot on Saturday. Yesterday, Tuesday (09Mar2021) patient noticed that, had a couple of little spots on chest and on the top of thighs, red spots. Also, one or two red spots on back and on morning there were couple on the face, little red. And patient felt fine but did not know if it was something else or that needed to do anything or whatever. Patient did not know what to do. Patient did not feel funny, not itchy, it was just there and this was her first shot. Reporter stated, In the last two weeks like on March 1st, patient had Covid test and it was negative. Reporter stated, as treatment Last night patient took a Benadryl. Reporter further stated, her big question was, patient not sure this was related to the shot but it was one of the symptoms. And in two to three weeks she have second shot coming up. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Redness, swelling, pain at injection site starting approx one week after injection, becoming progressively worse
Patient began experiencing "tunnel vision" five minutes after receiving his first dose of Pfizer COVID vaccine. Patient lost consciousness and began seizing for a few seconds. Patient regained consciousness after a couple minutes. Paramedics were called and patient was checked out. Vitals were good and parents decided to just monitor him and not send him to the hospital.
Severe left shoulder pain that is debilitating at times when arm is brought above shoulder height or goes across the body or is lifting even minor weighted objects (i.e., gallon of milk).  Noticed more pain than usual flu shot at time of vaccine, and pain has gradually increased since the vaccine was administered. Started noticing more pain in shoulder around 10 days post vaccine.
Patient reports extreme pain to right arm, shoulder, and neck. Patient reports pain is so severe she is not able to move and pain is more significant than the soreness that typically occurs after vaccination.
a patient received an extra dose of GARDASIL 9; No additional AE; This spontaneous report was received from a nurse and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with an extra dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose description, lot #, expiry date, route of administration, and indication were not provided) (extra dose administered). The nurse did not report that patient had any symptoms and did not provide any further information on when extra dose was received. No additional adverse event (no adverse event) and no product quality complaint (PQC) was involved.
Swelling, redness, itching, hot to touch at injection site with onset of roughly 8 days after shot
This spontaneous report as received from a pharmacist refers to a 51 years old female patient. The patient was vaccinated with a dose of 0.65 live ZOSTAVAX on an unspecified date. In the last month and a half, approximately in December 2012, the day after getting live ZOSTAVAX, the patient developed a 4" x4" red hot area that "kind of looked like a rash." The patient had sought medical attention. The patient was treated with BENADRYL, the AE improved a couple of days after starting BENADRYL. The outcome of the event was recovered/resolved. Additional information has been requested.
Severe headaches; Difficulty maintaining thoughts or focus/Cloudy head; Sweats; Sweats/chills; Severe sudden onset exhaustion; This is a spontaneous report from a non-contactable other healthcare professional.     A 34-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), via intramuscular, administered in arm left on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history was reported as none and concomitant medications was reported as no. The patient previously took cefixime (BIOXIN) and experienced allergies. On an unspecified date, the patient experienced severe headaches, difficulty maintaining thoughts or focus/cloudy head, and sweats/chills, severe sudden onset exhaustion. It was reported unknown if patient had COVID prior vaccination and the patient did not test for COVID post vaccination. The facility type vaccine was reported as hospital. No other vaccine in four weeks and no other medications in two weeks. There was no treatment received for the events. The patient recovered from all the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache; Chills; tension around the chest/ heart; Nausea; felt uncomfortable; Confused; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 02Jan2021 at 13:02 at single dose in left arm for covid-19 immunization.  Medical history included ongoing prostate disorder, ongoing blood pressure abnormal, ongoing cholesterol abnormal. Concomitant medication included tamsulosin 4mg tablet once a day by mouth for prostate disorder, losartan 50mg tablet once a day by mouth for blood pressure abnormal, atorvastatin 20mg tablet once a day by mouth for cholesterol abnormal; all ongoing. The patient experienced headache, chills, tension around the chest/ heart, nausea, felt uncomfortable, and confused on 02Jan2021. Event details: The patient reported that he took the vaccine a few days ago, on 02Jan2021, he felt uncomfortable and a lot of things were going on. He clarified that he experienced headaches, light chills, tension around the chest/heart, nausea and disconnect. He felt like something was going on with his brain. He felt uncomfortable with himself. He asked himself if these were his eyes and states he was confused. He put his car in reverse when he was supposed to be driving forward, stated the curb stopped him. He did not feel totally like himself. His lady said he was normally like that but he felt there was something heavy, totally different. He did take a covid test about 3 weeks prior to getting the vaccine, the result was negative. The patient underwent lab tests and procedures which included covid test: negative in Dec2020, weight: 190 to 192 pounds on an unspecified date. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Soreness with both doses at the injection site / 1st dose; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but could be 51 or 52 years. The patient received her first dose of Shingrix in left arm. The patient experienced soreness at the injection site. The reporter consented to follow up. For tolerance after 2nd dose refer case US2020AMR223832.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR223832:Same reporter
I had a breakthrough case of Covid-19 it started with a sore throat 1st test was negative I was achy then tested positive and was prescribed Molnupiravir.
Information has been received from a lawyer regarding a case in litigation concerning a 70 year old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2008, at approximately 63 years of age, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a healthcare provider. In February 2016, the patient was treated by a healthcare provider for the following injury resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to himself and economic losses. Additional information has been requested.
Weakness; Legs gave out; Joint pain, all her joints, Joints started to hurt, all her joints; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), LIMB DISCOMFORT (Legs gave out) and ARTHRALGIA (Joint pain, all her joints, Joints started to hurt, all her joints) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Diabetes and Lupus syndrome. Concomitant products included METOPROLOL, METFORMIN, PREDNISONE, HYDROXYCHLOROQUINE, PREGABALIN (LIRICA), ROSUVASTATIN and CICLOSPORIN (RESTASIS) for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ASTHENIA (Weakness), LIMB DISCOMFORT (Legs gave out) and ARTHRALGIA (Joint pain, all her joints, Joints started to hurt, all her joints). At the time of the report, ASTHENIA (Weakness), LIMB DISCOMFORT (Legs gave out) and ARTHRALGIA (Joint pain, all her joints, Joints started to hurt, all her joints) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that the patient used to take Furosemide (Lasix) but got off the medicine recently. She also took an unspecified blood thinner. Treatment taken for joint pain was over the counter medication.
Patient reported feeling "shaky" day of 2nd vaccine dose.   Patients family reports that patient wasn't feeling well the night of and called EMS to her home.  Patient passed away this morning around 5am.
Injection site is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site is red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and High cholesterol.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site is red). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication including medication for high blood pressure and cholesterol was reported.  No treatment information was specified.
Puffy red bump around injection site. Itchy and painful. Just started today first noticeable due to a stinging sensation.  It has been exactly a week since receiving the first dose.
12/03/21 presents to ED for "tachycardia and dyspnea w exertion ".  PMHx of "Covid diagnosis last month".
pt recv vax & devel h/a, fever, chills, & a rash on the arms & legs;sx resolved p/4 days;f/u info recv 14JAN97 indicated that the rash devel 2wk  post vax & resolved over 1 wk;pt remained recovered;
A consumer report has been received. The report concerns a, Female consumer, who had been receiving FLUMIST quadrivalent (intranasal), 0.2 milliliters, unknown. The patient experienced the shot causes major pain for days. FLUMIST quadrivalent was continued. The outcome of the event of the shot causes major pain for days is unknown. The report was considered to be non-serious.
This spontaneous report was received from a healthcare professional referring to a 13 months old male patient. Information about the patient's medical history and concurrent conditions was not reported. On 23-DEC-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
4 days after the covid-19 vaccine 2nd dose, I have severe pain started in the left back neck. The pain started from the neck and goes up to back left head, head above the ear and left ear. Left part of neck becomes stiff. The head pain is burning. If someone touches the pain points in the head, I don't have a pressing pain but still have a burning pain.  Initially though it was due to a sleeping position(pillow) change. But as day progressed, pain increased and saw left armpit swelled. Went to a walking clinic and Dr. said it is due to muscular pain and asked me to take over-the counter pain killer.   I took the pain killer and pain reduced but when I stopped the medication, pain reappeared.   I also found a pattern in the pain. Neck stiffness and pain starts at around 2:00 pm and it increases to 8/9 at around 3:00 to 3:30. The pain at peak is extreme pulsive burning pain and automatically reduces at around 4:30 pm to level 2/3. This happens every day. I always have pain of 2/3 during the throughout the day.  Revisited the Same walk-in clinic and other Dr. said, It might be possibly linked to the Vaccine and they have few more similar cases reported. She prescribed me the Muscle relaxer and steroid and suggested me to contact my PCP for few blood work. I didn't take any of them before contacting my PCP.  PCP ordered some blood work and CTScan. Suggested me to take muscle relaxer and not to take Steroid as It will reduce the vaccine effect.  The Blood and CTScan report came normal. She also referred me to Neurologist.  Neurologist also looked at report and said, everything looks normal.  I took muscle relaxer. Neck stiffness and  head pain is reduced but I still have pain. It repeats at the same time interval and in same manner
Started as headache within 1 hour.  Progressed to body aches within 12 hours.  No sleep due to aches.  Took 2 Aleve/Naproxen.  By morning, developed low grade fever, had numbing/tingling in left cheek and very uncomfortable.  By 8 AM, called doctors office due to numb/tingling in cheek and fever.  Went to doctor's office.  Was given Naproxen 500 mg and other meds for other medical conditions that were not an issue prior to this situation.  This situation exacerbated my other medical issues.
Patient had a positive COVID test on 2/6/22 and 2/5/22. Patient was then admitted to the hospital 3 days later and expired on 2/16/2022.