chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer communicated to a Pfizer vaccine sales representative. A 65-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date to an unspecified date at 0.5 ml for immunization.  The patient medical history and concomitant medications were not reported. The patient experienced red rash that appeared below the injection site (emphasized not at the injection site) and pain with the injection on an unspecified date with outcome of unknown.
administered on 16-MAR-2004; administered on 14-AUG-2003; administered on 22-MAY-2003; This spontaneous report was received from a health professional referring to a 5-month-old female patient.  The patient's medical history and concurrent conditions were not reported. Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP), hib vaccine, pneumococcal polysaccharide conjugate vaccine (7-valent (+) adsorbed) and polio vaccine inact (IPV).   On 23-NOV-2002, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufacturer unknown) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On 22-MAY-2003, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (inappropriate schedule of product administration). On 14-AUG-2003, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (inappropriate schedule of product administration). On 16-MAR-2004, the patient was vaccinated with the fourth dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (extra dose administered).; Sender's Comments:  US-009507513-2306USA007890:
I had a fever of 102.4 the next day at 9am and ended in the emergency room. There I was given antibiotics and was found to have cellulitis. I also had whole body arthralgia, Headache, fatigue, muscle weakness, nausea, and dizziness.
Pt states that he was standing at counter and developed severe low back pain across back - above hip line, shooting down his legs. Pt was diaphoretic - brought back to exam room - he laid on exam table - states after few min pain subsided completely - was checked out by Dr. BP 148/78 - Pulse 71 - BG level 153. Pt left after a few min pain free.
Woke up about 2 am rigoring, with terrible pain and itching at injection site and awful body aches. I took 650 mg Tylenol, fell back asleep, woke up at 330 am sweating and less achy. Awoke again at 7 am with terrible headache, nausea and upset stomach. Injection site swollen, reddened and painful to touch; took another 650 mg of Tylenol without much relief. Entire body was extremely sensitive to the slightest bit of touch or pressure. Had a hazy feeling in my head, felt mildly dizzy for hours. Around 230 pm on 1/19/21 I began sweating profusely for about 15 minutes and when that ceased  I felt almost back to normal immediately. By the following day I was feeling 100% OK other than injection site discomfort. Today, 1/23, is the first day since receiving my second dose that my arm Only slightly hurts and itches.
Started running a mild fever on 6-13-06. It spiked in the middle of the night reaching at least 104 degrees.  We took her to the ER and were told that her ears and throat looked good so they wanted to test her for a UTI.  We chose to go with the bag method since we did not want them to put a catheter in her.  The bag was not put on correctly so the urine went in her diaper instead of the bag.  We followed up with her regular doctor later that day.  Again we were told that her ears and throat looked good.  We also got a clean urine sample in the bag at this visit.  We asked the doctor if she could be having a reaction to her shots.  She stated, "No, that would have happened within one to two days".  We were told that she had a fever of unknown origin and that if she still had it after two weeks we should come back to have her tested for an infectious disease.  We were not comfortable accepting that our daughter had an unusually high fever for no reason, so we utilized other resources (health lines, internet, etc.) and found out that her symptoms could indeed be due to her immunizations.  She ran this high temp until 6-16-06.  At that time she was still running a fever but it was lower, around 100 to 101 degrees.  Her fever finally broke in the middle of that night.  Tylenol and Motrin were only cutting her fever for half of the time so we had to give her tepid baths, etc. to keep her temp down until she could have more medicine. After her fever broke on 6-17-06, she developed a rash which started on her face and head and then spread all over her torso.  The rash finally cleared up on 6-21-06.  For the past couple of days, she has had a red swollen bump on her right thigh.  We are not sure if this is from her injection site or not.
This is a serious spontaneous case, initially received from other health professional on 02-Feb-2018, concerning a male patient of an unspecified age. On 30-Sep-2017, the patient was administered with FLUCELVAX (QIV) PFS (batch number: 195210, dose, route of administration, anatomical location, expiry date: not reported). On 02-Jan-2018 (on Friday), after 3 months 4 days of vaccination, the patient was diagnosed with flu. It was reported that patient had influenza (type A). At the time of this report, the outcome of the event (flu/ influenza type A) was not reported.
chills, body aches, muscle and joint pain, headache, nausea, felt feverish but did not have fever; symptoms lasted for almost three days
pemphigus vulgaris; This case was reported in a literature article and described the occurrence of pemphigus vulgaris in a 72-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.  On an unknown date, the patient received Flu vaccine. On an unknown date, 4 weeks after receiving Flu vaccine, the patient experienced pemphigus vulgaris (serious criteria GSK medically significant). On an unknown date, the outcome of the pemphigus vulgaris was recovered/resolved.   The reporter considered the pemphigus vulgaris to be possibly related to Flu vaccine.   Additional Information: GSK receipt date: 17 May 2022 Authors comment: This case corresponds to Table-1 reported in this literature article. To better understand the potential link between vaccinations and the development of autoimmune bullous diseases (AIBDs), a systematic review was performed, which included 26 papers published between 1995 and 2021.  The patient received Influenza vaccine and had pemphigus vulgaris.  "Overall, there was currently insufficient data to suggest that vaccinations were truly or commonly related to an increased risk of AIBDs, taking into account that the available information was generally based on anecdotal, single case reports with a low level of evidence and not being confirmed in largescale, population-based studies. Consequently, there was no need to modify the present vaccination recommendations for patients with AIBD, because the benefits of vaccines outweigh the likelihood of instigating autoimmune manifestations, even though real-world data on COVID-19 vaccines in AIBD patients are currently lacking". Additional supportive information: This case is 1 of the 7 cases reported in this literature article.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022GSK081450:Same reporter
This case was reported by a pharmacist via call center representative and described the occurrence of injection site inflammation in a 67-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 22nd May 2019). On 22nd May 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 22nd May 2018, several hours after receiving SHINGRIX, the patient experienced injection site inflammation, injection site erythema, injection site swelling and intramuscular formulation administered by other route. The patient was treated with ADVIL. On an unknown date, the outcome of the injection site inflammation, injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site inflammation, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient inadvertently received SHINGRIX on left arm between 11:41 and 12 pm subcutaneously instead of intramuscular route, which led to incorrect route of drug administration. On the day of vaccination, in the evening, the patient developed inflammation, redness and swelling at the injection site (left arm). Symptoms were still present at the date of reporting. The pharmacist instructed patient to take ADVIL and pharmacist was going to follow up with patient's physician. This was the first time this pharmacist called regarding this situation. Expiration date provided might be expiration date given in pharmacy system and might not be true GSK expiration date of vaccine.
On 01/06/2023, I tested positive for COVID-19. My symptoms began on 01/04/2023. My throat was dry and scratchy and I had post-nasal drip. It felt like a cold, with nasal congestion, muscle aches and low grade fever. I called to report it to my doctor. She prescribed PAXLOVID but I did not take it.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No medical history information reported.  Concomitant products included LEVOTHYROXINE SODIUM (EUTHYROX), CHLOROTHIAZIDE and ATORVASTATIN for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Tylenol.
Information has been received from a pharmacist referring to a newborns (numbered 177). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time = 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 08-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Diagnosed with Bell's Palsy from Covid-19 injection (1st dose.)/left sided face droop; Stroke; Lower left pain under ear, sudden onset; This is a spontaneous report from two contactable consumers. A 50-year-old female patient (not pregnant) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 08:30 at single dose for COVID-19 immunisation.  Medical history included depression, anxiety, Post-traumatic stress disorder (PTSD), elevated pressure increased (BP), elevated cholesterol, spondylosis with radiculopathy. Known allergies: NSAID's and augmentin. Concomitant medications included hydrochlorothiazide, venlafaxine hydrochloride (EFFEXOR), hydroxyzine, atorvastatin and ascorbic acid;betacarotene;biotin; calcium; chloride; chromium; copper; folic acid; iodine; iron; magnesium; manganese; molybdenum; nickel; nicotinic acid; pantothenic acid; phosphorus; potassium; pyridoxine hydrochloride; riboflavin; selenium; silicon; thiamine; vanadium; vitamin B12 NOS; vitamin D NOS; vitamin E NOS; vitamin K NOS; xantofyl; zinc (CENTRUM SILVER WOMEN 50+). On 05Jan2021 at 13:00, patient experienced lower left pain under ear, sudden onset. Then, noticed symptoms of a stroke. Left sided face droop. Patient went to ER (emergency room). Patient was diagnosed with Bell's Palsy from Covid-19 injection (1st dose). Patient received treatments for the events included prednisone, acyclovir, ointment to protect eye and eye patch for covering of left eye. Lab test included Nasal Swab: negative on 07Jan2021. Outcome of the events was resolving.  Information on Lot/Batch number has been requested.
No additional AE reported; 23 year old patient was administered a dose of PROQUAD on 13-APR-2022; the patient should received MMR and Varicella separately and not the combined dose; This spontaneous report was received from a certified medical assistant and refers to a 23-year-old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient had viral titre measurement done, which showed that the patient was not fully immunized against measles, mumps, and rubella (MMR) and varicella. On 12-APR-2022, she received tuberculin PPD (purified protein derivative of tuberculin (TB-PPD)) as a part of PPD test. The patient's concomitant vaccination included unspecified hepatitis B (Hep B) adult vaccine (manufacturer reported as GlaxoSmithKline (GSK)).  On 13-APR-2022, the patient was vaccinated by a healthcare professional with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) at a dose of 0.5 ml, subcutaneously (SQ) in the left arm, lot # U026799, expiration date 26-FEB-2023 to repeat the immunization series as required by her grad school (prophylaxis). The vaccine was reconstituted with a sterile diluent (exact volume of the diluent, lot number and expiration date were not reported). The reporter stated, that according to the patient's age, she should be vaccinated with MMR and varicella vaccine separately instead of the combined dose (product administered to patient of inappropriate age, wrong vaccine administered). No adverse events were reported (described also as the patient had no response and no reactions). No prescription drug treatment was required for the reported experience.
anaphylactic-like reaction; experienced hives; tongue swelling; Advised by doctors to not get 2nd dose due to reaction to first dose which was administered 17Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic-like reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylactic-like reaction) (seriousness criterion medically significant), URTICARIA (experienced hives), SWOLLEN TONGUE (tongue swelling) and PRODUCT DOSE OMISSION ISSUE (Advised by doctors to not get 2nd dose due to reaction to first dose which was administered 17Apr2021). On 17-Apr-2021, ANAPHYLACTIC REACTION (anaphylactic-like reaction), URTICARIA (experienced hives), SWOLLEN TONGUE (tongue swelling) and PRODUCT DOSE OMISSION ISSUE (Advised by doctors to not get 2nd dose due to reaction to first dose which was administered 17Apr2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment information was not provided.  Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.
No additional adverse events reported; Nurse reporting a dose of improperly stored VARIVAX has been administered to a patient on 28JAN2022; This spontaneous report was received from a registered nurse and refers to a 12-months-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 28-JAN-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter (route of administration was not reported, lot # U020244 and expiration date 28-JUN-2023 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 6 degree fahrenheit (°f) up to 14°F (13.8°F) for 1 hour an 45 minutes, and 14°F up to 46°F (14.4°F) for 25 minutes; no previous temperature excursions were reported.  No adverse symptoms were reported.
The day after she started to have lots of pain and redness around her arm but there were no issues at the injection site. She states that she has a swollen lymph node in her shoulder now. Since she has had the shot she has been short of breath and feels like she has something on her chest.
high fever 103-104 w/red splotchy rash in inj site of IPOL;started 48hr p/shot, went on for 3 days;
administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date.) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date.).    Concomitant medications were not reported.  They stated they administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date. No adverse events were reported. The case is for the 3rd patient. Treatment medications were not reported.
Chest pain developed the next day. Saw my PCP and heart rate and blood pressure were both increased. Beta blocker was given and he consulted cardiologist. I was sent to facility and was hospitalized 8/23/2022. Tests were done. I was discharged.  Followed up with the cardiologist on 9/16/2022. Stated he thought I had possibly developed pericarditis from the vaccine. Further testing to be done  and medications were given.
Right arm swollen & red (hot to touch). Fever of 101.3 on day of administering vaccine. Took BAYER aspirin & applied ice. 28 hrs later arm still very swollen & red - fever is gone still applying ice.
Per Father-problems breathing, little response beginning @ 630PM; Per Med Record-To ER, admitted w/resp difficulty, t99.8, p163, r48, IV given admitted to Hosp Improving temp dec @ 3PM;
Hospitalization for HHS, hyperglycemia, COVID 12/26/21-1/12/22.Treated with ,zinc 50 mg daily, vitamin D3 50 mcg daily, and vitamin C 1,000  mg daily 12/27/1/12 for COVID.
This is a spontaneous case, initially received from other non-health professional (reporting on herself) on 28-Nov-2018, concerning a 77-year-old, elderly female patient. On an unspecified date, the patient was administered influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On an unspecified date, after vaccination, the patient felt bad (didn't feel good) for 1-2 days. In addition, the patient also experienced chills and was diagnosed with flu. At the time of this report, the outcome of the events was not reported. Case Comment: A 77-year-old female patient felt bad, had chills and flu, unspecified period of receipt of INN flu vaccine. Due to the lack of information important for the causality assessment, such as onset latency between the vaccination and reported events, company assessed the causality as unassessable. The company assessed the event (flu) as serious (medically significant).
This spontaneous report has been received from a pharmacist referring to a 4 month old patient unknown gender. The patient's medical history and concurrent conditions were not provided.  On an unknown date, the patient was vaccinated at the same time with a dose of VARIVAX (Merck) and PROQUAD (Merck) (doses, anatomical locations, lot numbers and expiration dates were not reported). Concomitant therapies were not provided. No adverse effects reported. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium, Additional Details: per patient she often experience hypotension, weakness, nausea after injection. She recovered within the hour
Pt states "I feel like I'm getting sick, my throat started getting congested after lunch" states he  was "wheezing" denies hx of wheezing before. PE: Bilateral scattered end expiratory wheeze. Tx: Albuterol Neb tx. Post neb lung exam = clear lung sounds all fields. States he feels better. Plani ALBUTEROL MOI 2puffs q 4 hours PRN. RTC PRN.
pt recvd vax 1045AM & lower legs solid hot pink; pt began rubbing feet together; splotchy pink areas on rt thigh; dime size splotches on abdo; noted nickle sized raised areas on abdo;
Red and raised bump at injection site on left arm Circumference of affected area is about 3-4 inches. The site is also hard and warm to the touch. Also, pain under left armpit(possibly swollen lymph nodes). Both appeared on day 3.
warm at the injection site; large red spot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm at the injection site) and INJECTION SITE ERYTHEMA (large red spot at the injection site) 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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced INJECTION SITE WARMTH (warm at the injection site) and INJECTION SITE ERYTHEMA (large red spot at the injection site). At the time of the report, INJECTION SITE WARMTH (warm at the injection site) and INJECTION SITE ERYTHEMA (large red spot at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.