chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got really tired; My sinuses were greatly affected; Congestion; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (My sinuses were greatly affected), NASAL CONGESTION (Congestion) and FATIGUE (Got really tired) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concomitant products included TAMSULOSIN for an unknown indication.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SINUS DISORDER (My sinuses were greatly affected), NASAL CONGESTION (Congestion) and FATIGUE (Got really tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SINUS DISORDER (My sinuses were greatly affected), NASAL CONGESTION (Congestion) and FATIGUE (Got really tired) outcome was unknown.            This case was linked to MOD-2021-080105 (Patient Link).
Tactile fever ,arm pain, headache and malaise in 24 hrs  following injection Next day generalized achiness ,retrosternal chest pain and bilateral forearm tingly  pain similar to Nov 2019 and went to  Hospital UC,CXR and EKG normal but with short PR interval on EKG ,elevated troponin 3.5 Transferred to hospital  troponin 12.1 ng/ml IVIG given  SARS IGG positive on admission PCR negative
disorientation; Flu like symtoms; Headache; chills; high fever; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (disorientation), INFLUENZA LIKE ILLNESS (Flu like symtoms), HEADACHE (Headache), CHILLS (chills) and PYREXIA (high fever) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) and ATORVASTATIN for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISORIENTATION (disorientation), INFLUENZA LIKE ILLNESS (Flu like symtoms), HEADACHE (Headache), CHILLS (chills) and PYREXIA (high fever). At the time of the report, DISORIENTATION (disorientation), INFLUENZA LIKE ILLNESS (Flu like symtoms), HEADACHE (Headache), CHILLS (chills) and PYREXIA (high fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.   Reporter did not allow further contact
Experienced variation in BP that BP was ?way down? from normal and losing breath as though he would pass out within one day, did not report to doctor, c/o hungry all of time, stated having attacks of anxiety since injection
fever 103 on 14JAN97 & 104.6 on 15JAN98;MD called;APAP was given per MD advise on 20JAN98 per phone contact mom stated pt is doing fine;
Administered both PROQUAD and VARIVAX to patient, meant to grab MMR II, not PROQUAD.
local rxn on arm;macular,erythematous area;initially began w/what appeared to be a bruise on upper arm,& since then devel a rash which is nonpruritic on the medial aspect of elbow
Left thigh erythema time 5-6 cm round area with palpable knot at injection site. Redness much improved per mom.
INFECTED MOUTH SORE, TUBULAR GUM SWELLING, STRANGE YELLOWISH PUS, INFECTION IN GUMS; MILD BODY ACHES; FEVERISH; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and anxiety, and other pre-existing medical conditions included the patient had no known drug or non-drug allergies. the patient had no previous gum/mouth condition.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included lorazepam for anxiety. On 12-MAR-2021, the subject experienced mild body aches. On 12-MAR-2021, the subject experienced feverish. On 03-APR-2021, the subject experienced infected mouth sore, tubular gum swelling, strange yellowish pus, infection in gums. On 07-APR-2021, Laboratory data included: X-ray (NR: not provided) unknown. On 08-APR-2021, treatment medications included: azithromycin. Laboratory data (dates unspecified) included: X-ray (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild body aches, and feverish on 14-MAR-2021, and was recovering from infected mouth sore, tubular gum swelling, strange yellowish pus, infection in gums. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Received vaccines 10/15/13 - Developed fever to 103 10/16/13 and upper (R) thigh redness, swelling, tender to touch warmth and limping of (R) leg 10/17/13 morning.
Fainting, pale hands, numbness on left arm, chest pain, clammy, hospitalization, elevated ALT, elevated AST,  elevated Lipase, tachycardia, palpitations.
reported to ER and latered hospitalized with chest congestion, head cold X 2 weeks after booster dose. She reported nasal congestion, cought and confusion.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient received vaccine at 1:54pm, she reported extreme dizziness at 2:06pm, Benadryl 25mg x 1 tablet was administered, at 2:13 patient reported she now had a headache but dizziness was subsiding, patient left pharmacy with boyfriend at 2:25pm and said all symptoms were resolving - also reported she had not eaten today at this time (patient was nervous to get the COVID vaccine because she got ill from a flu shot many years ago, but spoke to her MD about this and he had no concern)
Medication error-Patient received first a first dose Pfizer COVID vaccine dose on 2/4 and was accidentally administered a second dose Moderna  COVID vaccine dose on 3/10.
At first I had a severe headache and pain and swelling on the left side of my throat went to bed an awakened with the worst soar throat I've ever had pain and swelling on both sides of my throat with severe Headache that lasted for 5 days and a bad rash over the left side of my body that looked like shingles and spread slightly to the right side. I also had severe muscle pain of the left side of my body.
Dysgeusia -- first attempted to start eating around 10 AM today. Noticed that my tongue feels like I burned it on hot food (which I didn't), and my taste is altered with the foods I'm eating this morning.
What is a 5 month old received Kinrix instead of Pediarix!; What is a 5 month old received Kinrix instead of Pediarix!; This case was reported by a consumer via interactive digital media (Shingrix GSK social media) and described the occurrence of inappropriate age at vaccine administration in a 5-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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 details were provided are as follows: A 5 month old patient received Kinrix instead of Pedarix which led to inappropriate age at vaccine administration and wrong vaccine administered. No further information was reported.
Throat  tightened/swelled, unable to breath, heart racing, headache, had to be given benedryl  injection on site.  Face very red and blotchy
This is a spontaneous report from a contactable consumer (patient's parent). A female patient of an unspecified age received the second dose of PREVNAR 13 via an unspecified route of administration on an unspecified date at single dose for immunisation. Relevant medical history and concomitant medications were not reported. The patient previously took the first dose of PREVNAR 13 on an unspecified date. On an unspecified date, after the second dose of pneumococcal 13-val conj vac (dipht crm197 protein), the patient experienced fever of 102.5 Fahrenheit rectally. At the time of the report, the outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Fever Sore arm around 12 noon; chills 10pm for an hour, then fever 101-3F; relieved with tylenol
No additional adverse event; Medical assistant reporting AE improperly stored for VARIVAX.  See temperature excursion case 02193291. No additional AE information or PQC reported. Names of vaccines involved (including lot/expiration) VARIVAX: W002599 01/24/2024Temperature: 4C; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unspecified gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported  On 27-JUN-2022, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, one dose, lot #W002599, expiration date: 24-JAN-2024 (exact dose, vaccination schedule, site and route of administration were not provided) for prophylaxis, after the vaccine underwent temperature excursion in 4 Celsius degrees, in a timeframe of 108 hours. No additional adverse event was reported.
Erythematous swelling of right arm and elbow. (+) itchiness. Tx - BENADRYL. Follow-up in 2 days if worse.
Morbilliform rash started am of 1/2/2021 on abdomen and then lower chest  to back over 3 days Mild and improving in some areas as progressed to new areas by 1/4/2021 No fever, sore throat, cough, loss of taste or smell
This spontaneous report as received from a healthcare worker refers to three unspecified patients of unknown age and gender. The patients' medical histories and concomitant medications were not reported. It was reported that the unspecified doses of GARDASIL (routes of administration, lot numbers and expiry dates were not reported) that were exposed to a supported temperature excursion on 02-OCT-2014 have been administered to three unspecified patients on unspecified dates since 02-OCT-2014. No adverse effects were reported. Additional information has been requested.
localized swelling and redness for 48 hrs, chills and fever through the night after vaccination.
COVID arm, warm to the touch, rash, raised. Left arm only, still ongoing, just adding my information in case it helps
Chills, fever to 99.7,  aches, swollen arm, headaches (HA) 10 p.m. 3/15 through 9:00 p.m. 3/16.  3/17/21 11:49, woke up w sharp pain, shooting along three areas of R side of face:  forehead, cheek, lower jaw.  pain caused me to yelp.  plain cleared without meds in under a minute.  4:45 a.m., woke with mild headache, cleared spontaneously.  Frequent Headaches through 3/21/21 treated with acetaminophen and or Imitrex depending on type.  3/24/21, stabbing sensations, L hip, intestinal area.  Lasted only a couple of seconds, but felt like needle jabbing the area.  3/25/21, stabbing like instant pain R temple area.  Cleared within minutes. 3/26, HA localized to rear of skull near top, cleared in minutes.  2 hrs later headache bilateral temples, pounding.  cleared w Imitrex. 3/27/21 12:00 a.m. woke with stabbing sharp pain felt like nail being driving into R temple.  lasted only a few seconds.  10:00 mild headache, R > L. 3/31 HA most of day, had to move slowly, any jerking increased pain.  4/1:  HA most of day. Frontal.  4/2:  mild HA intermittent.  5/22/21:  stabbing sensation like bee sting behind L knee, lasted seconds.  10:30 p.m. stabbing sensation R foot, arch area, on sole of foot.  5/23/21 stabbing like bee sting L ribcage, lateral.  stabbing sensation R foot bottom. ... stabbing sensations continue through today, usually only once a day or every couple of days.  They are random, not necessarily on skin area, but sometimes feel deep internally.  They clear within seconds.
Information has been received from a pharmacist concerning a female patient with latex allergy who on 26-MAY-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # not provided). The next day, on 27-MAY-2010 the patient experienced a rash around her eyes. The patient talked to the pharmacist. At the time of this report, the patient had not recovered. No further information is available.
The patient was signed up to receive the Moderna Bivalent vaccine; however, they were administered with the Moderna Monovalent vaccine by mistake instead. No adverse event has been reported as a result of the error.
had an anxiety attack/the anxiety attack was really out of the ordinary; had a horrible panic attack/having hot fiery panic attacks; bad taste in the mouth; couldn't sleep real well/she can fall asleep, but she cant stay asleep, she recalls on the first night after getting the vaccine, on 19Feb2021 she would wake up every hour; her hands are clammy, she is sweating; her hands are clammy, she is sweating; This is a spontaneous report from a contactable consumer (patient herself). A 62-year old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route of administration in the left arm on 19Feb2021 (Batch lot number EN6200) (at the age of 62-year old) at single dose for Covid-19 immunization and alprazolam (XANAX XR) orally at 2 mg in the morning at 6 AM and 1 mg at 1 PM (3 mg daily total) for anxiety. She actually had 2 separate prescriptions: one was a Xanax Extended Release 2 mg pill, and the other was a Xanax Extended Release 1mg pill. Relevant medical history included breast cancer from 2006, high blood pressure and cholesterol abnormal. Concomitant drugs included medication for high blood pressure and cholesterol medication. The patient reported that usually her anxiety was managed by medicine, however after the shot, Friday at noon, it was weird she had a horrible panic attack. She also had the panic attack Sunday, yesterday, and a little today. Her anxiety was always controlled prior to the first dose of vaccine but after the shot, it wass not, her anxiety was out of control. She noticed her anxiety incident probably Saturday morning around 6 AM. She did have complications on Friday 19Feb2021, it was a bad taste in the mouth and she couldn't sleep real well at night. She clarified that she can fall asleep, but she cant stay asleep, she recalled on the first night after getting the vaccine, on 19Feb2021 she would wake up every hour. Anxiety was not controlled: it would say being controlled by her medicine as far as intensity of the anxiety attack. On Saturday and Sunday was the biggest anxiety attack, and it was as if she was not even on the medication that's what it felt like, she was not better, the anxiety was still there. Like during the panic attack her hands were clammy, she was sweating, its an anxiety attack, it could be hormones. This was like as if she was not even taking her Xanax XR, she was having hot fiery panic attacks. She just had a physician appointment 2 weeks before the report (and before the vaccination) and everything was fine: "perfectly fine". The outcome of bad taste was recovering, the outcome of sleep unwell was not recovered while the outcome of the other events was unknown.  No follow-up attempts are possible. No further information is expected.
significant fatigue; This is a spontaneous report from a contactable patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: EL3247), via an unspecified route of administration in the left arm on 02Mar2021 at 11:45AM (at the age of 45 years old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient not received any other vaccines within 4 weeks prior to covid vaccine and did not received any other medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient not had allergies to medications, food, or other products. On 07Mar2021, the patient had nasal swab (PCR) test the result was negative. On 11Mar2021, the patient experienced significant fatigue. The clinical outcome of significant fatigue was resolving.   No follow-up attempts are needed. No further information is expected.
has sore arm; husband has chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (has sore arm) and CHILLS (husband has chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (has sore arm) and CHILLS (husband has chills). At the time of the report, PAIN IN EXTREMITY (has sore arm) and CHILLS (husband has chills) outcome was unknown.            No concomitant medications was reported Treatment information was not provided. Patient was not for safety to follow up with doctor   This case was linked to MOD-2021-039222 (E2B Linked Report).; Sender's Comments:  MOD-2021-039222:This MOD-2021-039222 case is cross linked with this MOD-2021-040693 case.
15 minutes after the injection, I got some itching on my right shoulder near the injection site. I waited around a bit longer and the itching and heat started to grow down my arm and across my chest and back. I was asked to go to the ER as it was not resolving. At about one hour, I started to get some mild chest pain, My BP was 173/101 and around  100+ for heart rate. O2 was 100% . ER staff  did an EKG. The ER DR gave me Pepcid, Benadryl and Prednisone and 1 liter of normal saline. I was observed for about 3 hours. I went home and  was feeling much better. The next 3 days I had a moderate headache and sore arm. I took Tylenol. I had some hot flushes and mild spikes of temperatures 100-101F, through the next couple of days.
Nasal Swab covid was tested post vaccination; Nasal Swab covid was tested post vaccination; This is a spontaneous report from a contactable consumer (patient).   A 64-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 14:00 (Lot Number: EL9262) as single dose, dose 1 via an unspecified route of administration, administered in Arm Left in Jan2021 14:00 (Lot Number: GL0140) as single dose for covid-19 immunisation.Medical history included acute sinusitis. The patient did not have known allergies.The patient's concomitant medications included unspecified products within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. Nasal Swab covid test was tested post vaccination on 21Apr2021 and result was positive.It was also reported that "TESTED POSITIVE FOR COVID-19 ON 23Apr2021" and "event start date 19Apr2021 12:00 PM". The event resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The event outcome was resolving.
I had intense stomach pains, muscle pains for 4 days. Could not get out of bed. Also had a fever. I thought these were regular side effects and eventually got better.   Then, about a week later I started getting nose bleeds with blood clots coming out of my nose.  These lasted a few more days. This never happened to me before, and must have been a side effect from the vaccine.
The patient experienced fever, edema and hot in the left arm which started on 11/6/13, at night. Four days later, he woke up in the middle of the night with a panic attack that he attributed to the vaccine. He called a doctor who recommended that he take 2 tablets of hydroxyzine. The left arm recovered but the edema moved to the forearm. Then, all symptoms disappeared.
MS; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (MS) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029K20A) for COVID-19 vaccination.     The patient's past medical history included insomnia. Concurrent medical conditions included Cholesterol and Hyperthyroidism.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced MULTIPLE SCLEROSIS (MS) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 26-Apr-2021 due to MULTIPLE SCLEROSIS. The patient was treated with TERIFLUNOMIDE (AUBAGIO) ongoing since an unknown date for MS, at a dose of 1 dosage form. At the time of the report, MULTIPLE SCLEROSIS (MS) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Computerised tomogram: positive (Positive) Positive: diagnosed with MS. On 28-Apr-2021, Lumbar puncture: positive (Positive) Positive: diagnosed with MS.         Concomitant medication included medicines for cholesterol, hyperthyroidism and insomnia.  The patient reports that she was given unknown IV steroids for 7 days during her hospital stay for MS. On 13-JUN-2021 she got more of IV steroids while at ER visit. Two days later she visited MS specialist who prescribed her with IVIG and steroids for 5 days.  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. Very limited information has been reported at this time. Onset time of; 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. Very limited information has been reported at this time. Onset time of
DULL HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included low platelet count.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced dull headache. Laboratory data (dates unspecified) included: Low platelets (NR: not provided) low blood count. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dull headache was not reported. This report was non-serious.