chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 66 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Oct2021 as dose 3 (booster), single (Lot number: 039D21A), in right arm and on 03May2022 as dose 4 (booster), single (Lot number: 019L21A), in right 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: "Arterial heart stents" (unspecified if ongoing); "exercise induced asthma" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "joint replacements" (not ongoing); "back surgery" (not ongoing); "obesity" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing); "Known allergies: Cephalosporins" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Sep2022, outcome "unknown", described as "Vaccine brand other: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 25Jun203 to 29Jun2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300238421 same patient, different event/drug;
the patient stated that the first dose he received on 7/15/2022 was administered via intramuscular route; sore arm; This spontaneous report was received from a pharmacist and referred to an unknown age male patient. Pertinent medical history, concomitant medications and drug reactions/allergies were unknown.  On 15-JUL-2022, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U033046, expiration date: 21-OCT-2023, administered intramuscularly for prophylaxis (strength was not provided) (incorrect route of product administration). The patient reported having a "sore arm" following initial dose (unknown date in 2022). It was unknown if the patient sought a medical attention, received the treatment, or performed any lab diagnostics/studies. The therapy was not discontinued. On 17-AUG-2022, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) administered subcutaneously for prophylaxis (strength, dose, lot#, expire date was not provided). On 01-SEP-2022 an inbound telephone call, it was confirmed the patient received vaccine at a pharmacy. The outcome of sore arm was not reported. The causal relationship between sore arm and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.
pt recv vax 4NOV96 & father noticed hives on pt 5NOV96 when pt got out of bed that morning;father gave DPH & hives were completely gone the morning of 6NOV96;
02/13/2006 2.5 x 4.5 cm mild erythema and swelling.
there are raised bumps on the instep part of the foot below the ankle. Some are raised and some are under the skin/ it could be considered a rash; This is a spontaneous report from a contactable consumer (the patient). A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0176) via an unspecified route of administration in left upper arm on 19May2021 at age of 56-year-old at single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications (reported as no other products). The patient received the first dose of the Pfizer COVID vaccine from Pfizer. He didn't know if it was related or not. But this was the only thing that is different. He just sat down and was looking at his feet, and on his left foot there are about 12 bumps raised on the instep part of the foot, below the ankle. Some were raised and some were under the skin on 20May2021.  When he looked at the pink part of his foot on the bottom side, he could see raised bumps underneath. He just noticed this. The patient asked if this could be a reaction. He had never had anything like this before. Some of the bumps were above the skin, and some of the bumps were under the skin. He could see them protruding out of the bottom/side of foot. Most of it was on his left foot. There looked like there might be a couple on his right foot. He has a couple raised ones on his right foot, and 2-3 under the skin. Caller stated he hadn't thought of it before but it could be considered a rash. The outcome of the event was not recovered.
PATIENT STATED THAT 2 DAYS AFTER VACCINE THAT RED SPOTS STARTED ON THE RIGHT WRIST AND TRAVELED UP RIGHT ARM.  RED SPOT ALSO SHOWED UP ON THE LEFT SIDE OF HER NAVEL. THE SPOT ARE VERY ITCHY. THE SPOT ARE CONTAINED ON HER RIGHT ARM AND STOMACH AREA. BEEN TAKING BENADRYL  50MG A DAY.
Extreme pain and weakness in both shoulders and left knee, followed by arthritic feeling in both hands.  The joints affected had previously been operated on. The knee in 1983, the right shoulder in 2013 and the left shoulder in 2015.
I was having very hard chest pains. I had to keep compressions on my chest, using heat to relieve the pain. I emailed my doctor letting her know about the adverse event.
Fatigue and body aches for 48 hours, followed by rapid heart beat, dizziness/lightheadedness, tightness in the chest.
Patient received 4 year old shots and flu shot on 11/17/22.  That evening he refused to walk.  Mom gave him some ibuprofen thinking he was sore.  The following day he was unable to walk due to weakness and what mom describes as a tremor in his left leg.  Mom gave him more ibuprofen, which improved his symptoms some, although they did not resolve.  He was seen in the office on 11/18 where he was able to walk very slowly and did lift his left leg in a strange way when walking like he had a hard time moving it normally.   Symptoms gradually improved over the next few days.  Mom states that as they improved he would play and jump and act normally but sometimes his leg would give out on him without warning.  He was seen again for a follow up visit in the office on 11/23 and symptoms had completely resolved.  He never had a visible local reaction or significant tenderness at the injection site.
Site: Bruising at Injection Site-Mild, Systemic: entire deltoid region has a large bruise. it is not hot nor painful.-Mild
A spontaneous report has been received from a Health Professional concerning a patient of an unknown age and gender, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on an unknown date. In November 2014 the patient was inadvertently administered FLUMIST quadrivalent. The outcome of the event of inadvertently administered FLUMIST quadrivalent to 7 children under 2 years of age is unknown. The report was considered to be non-serious by the reporter.
My health changed after the covid vaccine. Before the vaccine I had very healthy stool (always level 4 on Bristol scale) and i haven?t had a solid stool since receiving the vaccine in March 2021. It?s level 6 or 7 on Bristol scale everyday since the vaccine. Of course I can?t know for sure what the cause is but there haven?t been any changes to my lifestyle or eating habits.
Routine home care provided by PA-C of MD 3/10/2021 11:40 am vaccinated at home since bedbound with myositis. Unclear when began to feel bad. 3/11/2021  9:07 pm EMS transported to Hospital Center ED for altered mental status following vaccination. ED physician note states "70 y/o male with pmhx of CAD, CVA, HTN, DM, myopathy and DVT on  Xarelto presents to ED with complaints of generalized weakness and change in mental status onset yesterday. Patient received his COVID vaccine yesterday and since then, patients wife is concerned he is not behaving himself and appears confused. Wife is also concerned he has a deceased appetite and decreased PO intake. Patient has no complaints at this time. Patient denies chest pain, shortness of breath, abdominal pain and back pain. HPI is limited due to patients mental status."  4/3/2021 when being scheduled for follow-up dose on 4/7/2021 his wife informed us "He had a bad reaction  to the first dose of the vaccine, had to go to the hospital, was admitted and had to stay for 3 days does not want the 2nd dose."  4/3/2021 Dr (one reporting) checked system and talked to wife to obtain this history. Agreed with her that he should not receive the second dose due to how badly he felt after the first. In addition, his prior history of COVID likely gives him sufficient protection against COVID-19.
Moderate muscular weakness which was most severe in right arm where I received a seasonal flu shot (exact version unknown). The symptoms match mild to moderate GBS and have continued to this date (11-14-2021). I have some coordination issues. I have been able to do some weight-lifting but with much lighter weights than prior to the adverse reaction.
after the second shot can you develop inching and hive that looks like bumps on legs and arms also on the nexk; after the second shot can you develop inching and hive that looks like bumps on legs and arms also on the nexk; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (after the second shot can you develop inching and hive that looks like bumps on legs and arms also on the nexk) and PRURITUS (after the second shot can you develop inching and hive that looks like bumps on legs and arms also on the nexk) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (after the second shot can you develop inching and hive that looks like bumps on legs and arms also on the nexk) and PRURITUS (after the second shot can you develop inching and hive that looks like bumps on legs and arms also on the nexk). At the time of the report, URTICARIA (after the second shot can you develop inching and hive that looks like bumps on legs and arms also on the nexk) and PRURITUS (after the second shot can you develop inching and hive that looks like bumps on legs and arms also on the nexk) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Body becoming very itchy around armpit areas, shins and thighs, ankles and feet. Itch came to a point of causing hives to appear on irritated areas. i also have a large discoloration around the vaccination area on my left arm roughly 4 inches in length and 3 inches in width. Area looks like a light bruise but does not hurt to touch.
This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On an unknown date in 2017, the patients were vaccinated with incorrectly stored doses of PNEUMOVAX 23 injection (lot# M039060, expiry date 22-MAY-2018; exact dose and route of administration were not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to the following temperatures on the following dates: on 01-FEB-2017: 33.746 degrees Fahrenheit (F) for 23 minutes; on 03-FEB-2017: 47.336 F for 6 minutes; on 06-FEB-2017: 34.988 F for 18 minutes; on 07-FEB-2017: 34.772 F for 17 minutes; on 08-FEB-2017: 6.692 F for 1 minute and 34.592 F for 90 minutes; on 09-FEB-2017: 33.89 F for 290 minutes; on 10-FEB-2017: 32.918 F for 298 minutes; on 11-FEB-2017:33.71 F for 317 minutes; on 12-FEB-2017:34.538 F for 302 minutes; on 13-FEB-2017:34.214 F for 255 minutes; on 14-FEB-2017: 34.322 F for 333 minutes; on 15-FEB-2017: 31.108 F for 464 minutes; on 16-FEB-2017: 31.874 F for 284 minutes; on 17-FEB-2017: 31.28 F for 585 minutes; on 18-FEB-2017: 31.316 F for 512 minutes; on 19-FEB-2017: 31.55 F for 517 minutes; on 20-FEB-2017: 30.866 F for 3 minutes and 31.136 F for 566 minutes; on 21-FEB-2017: 31.406 F for 245 minutes and 48.02 F for 47 minutes; on 22-FEB-2017: -4.108 F for 1 minute; on 24-FEB-2017: 34.322 F for 180 minutes; on 25-FEB-2017: 34.106 F for 240 minutes; on 26-FEB-2017: 34.214 F for 263 minutes; on 27-FEB-2017: 34.322 F for 230 minutes; and on 28-FEB-2017: 34.394 F for 289 minutes. A digital data logger was involved. The reporter stated that there were also previous excursions on unspecified dates (details not provided). No adverse experience were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA008835:
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 11-MAR-2013 at 10:00 am, the patient was vaccinated with VAQTA (lot # 0273AE and expiration date 06-DEC-2014) (dose, therapy route and anatomical location unspecified. The physician reported that VAQTA was exposed to multiple low excursions. Excursion time at -1: 126.50 hours (also reported as 17 hours, 238 hours at 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Patient vomited after getting vaccine. He stated that was very nervous about getting the shot and that he was okay.
Fever to 102, inject site slightly swollen & red, loss of appetite, & marked alteration in LOC on day following DTP/OPV immun; EEG normal. Mom reports cold doing better. Will have f/u eval & EEG 13OCT89. Pediatric DT recommended.
18 month old was administered an adult dose; 18 month old was administered an adult dose; This case was reported by a physician via call center representative and described the occurrence of adult product administered to child in a 18-month-old patient who received HAV (Havrix adult) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced adult product administered to child and accidental overdose. On an unknown date, the outcome of the adult product administered to child and accidental overdose were unknown.   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: 24-FEB-2023 Reporter's comment: The reporter consented to follow up with the clinic manager via email. Additional supportive information: 18 month old patient was inadvertently administered an adult dose of Havrix, which had led to accidental overdose and adult product administered to child.
experiencing really bad constipation; arm is sore; headache; feeling really crazy; This is a spontaneous report from a Pfizer sponsored Program. A contactable consumer (patient) reported that a 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 29Jun2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 30Jun2021, the patient experienced experiencing really bad constipation, arm is sore, headache, feeling really crazy. The patient received her first dose of the Pfizer Covid 19 Vaccine yesterday evening and states she was "experiencing really bad constipation", her arm is sore and she has a headache and stating "I'm feeling really crazy". The patient wants to know if she can take a laxative, magnesium citrate specifically. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
pt c/o dizziness after vaccine administration.  patient states history of anxiety with receiving injections.  Vital signs 138/60-73-95%O2 Sat.  Skin warm and dry.  Good cap refil.  Breath sound clear bilaterally.  VS rechecked after 15 min:  130/88-76-16-95%O2Sat.  Breath sounds clear.  skni warm and dry, good cap refil.  Pt states she is felling fine.  Patient discharged home.
t103 x 36 hrs or sl less c/o h/a; photophobia very sore arm 4x7 cm raised hard area cried a lot;
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 13-JUN-2017, the patient was vaccinated with two doses of M-M-R II injection (albumin status, dose, route and site of administration, lot number and expiration date were not reported) reconstituted with sterile diluent (manufacturer unknown) injection (dose, route and site of administration, lot number and expiration date were not reported). On the same day, the patient received two doses of PREVNAR 13 (formulation, dose, route and site of administration, lot number and expiration date were not reported). Additional information has been requested.
Subject received the vaccine on 10/29/2009, and experienced miscarriage at 19 weeks gestation on 12/21/2009. However, her physicians believe the fetus may have died at 15 weeks. The could not find any specific reasons behind the loss of pregnancy. She has had a successful full term pregnancy prior. Did not experience any adverse symptoms at the time of vaccination of immediately following vaccination. No history of miscarriage or other vaccine related adverse events; no chronic medical conditions.
Received Pfizer booster. Order of side effects- sore left arm Nov. 21 and 22nd, fatigue/tiredness and headache;Nov. 22 late morning and fever evening 101.4. Fever record: Nov.22nd 6 p.m.: 101.4                         8.p.m. :99.1 (aspirin)                         9:30 p.m.: 99.2 ( took aspirin) Nov. 23 (called off from work)                   7.a.m. : 99.1                    9 a.m.: 99.4 (asprin)                     1 p.m.:99.1                     4:15 p.m.: 99.4                     8:20 p.m. : 100.1 (aspirin)          Nov.24 : 6:15 a.m. 98.5 (feel better) no fever
About 5 hours after the injection, her heart started racing very fast; Her abdomen area started getting swollen.; Her arm was hard to touch; Her arm swelled up quite large; Immediately after receiving 1st dose, she had a sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (About 5 hours after the injection, her heart started racing very fast), ABDOMINAL DISTENSION (Her abdomen area started getting swollen.), VACCINATION SITE INDURATION (Her arm was hard to touch), VACCINATION SITE SWELLING (Her arm swelled up quite large) and VACCINATION SITE PAIN (Immediately after receiving 1st dose, she had a sore left arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Egg allergy. Concomitant products included LOSARTAN and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 20-Mar-2021, the patient experienced HEART RATE INCREASED (About 5 hours after the injection, her heart started racing very fast), ABDOMINAL DISTENSION (Her abdomen area started getting swollen.), VACCINATION SITE INDURATION (Her arm was hard to touch), VACCINATION SITE SWELLING (Her arm swelled up quite large) and VACCINATION SITE PAIN (Immediately after receiving 1st dose, she had a sore left arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Tachycardia, unspecified, at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (About 5 hours after the injection, her heart started racing very fast), ABDOMINAL DISTENSION (Her abdomen area started getting swollen.), VACCINATION SITE INDURATION (Her arm was hard to touch), VACCINATION SITE SWELLING (Her arm swelled up quite large) and VACCINATION SITE PAIN (Immediately after receiving 1st dose, she had a sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that about 5 hours after receiving the vaccine, her heart started racing very fast and had taken Benadryl. Her abdomen area started getting swollen and she stated that she has a history of severe allergies. She also had a reaction to the flu as well.
Covid-19 treatment; Covid-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Apr2023 at 14:00 as dose 5 (booster), single (Lot number: GL0446) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EP7533), in left arm, on 29Mar2021 as dose 2, single (Lot number: EP7533), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: RA5352), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FM0698), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 24May2023 to 28May2023.
Pain of arthritis severe left arm; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Pain of arthritis severe left arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037T2KUA) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Pain of arthritis severe left arm). The patient was treated with PARACETAMOL (TYLENOL) for Arthritis, at a dose of UNK, bid. At the time of the report, ARTHRITIS (Pain of arthritis severe left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Outcome of event updated as resolved.