chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient suffered three separate syncopal events within one hour on 01/11/2003.  Required ER visit to local hospital.  Complained of headache following syncopal episodes.  Was noted to have difficulty with equilibrium (failed Rhomberg test) for a few hours following syncope.  No fever or rash.  No tonic-clonic activity.  No post-ictal period.  Was seen on 1/12/2003 in clinic for follow-up.  Normal exam including Rhomberg.  Vaccine pustule had formed and "major reaction" was noted.  Given 24 hours SIQ.
About 2 min after receiving injection, I felt an intense flushing feeling all over, it felt as if my blood had turned into lava. About a minute after that I felt a "tickle" in my throat. The same sensation I felt  when I had my reaction to Gadolinium.  I tried to swallow, and it was a little difficult. I did NOT feel short of breath. I tried to calm down by doing slow concentrated breathing. I continued to take small sips of water to gauge my swallowing ability. After about 2-3 minutes, the flushing sensation subsided, and swallowing started to improve.  I had brought my Epinephrine pen with me.  About 1-2 min after the flushing sensation had subsided,, it came back and my swallowing ability got much worse, to the point I couldn't  swallow a small sip. I was breathing well, and did NOT feel short of breath, but gave myself my Epinephrine injection at that time. A Rapid Response was called at that time, my vitals signs taken, an IV inserted, 911 called. O2 sats were fine mid 90's, heart rate was mid 80's, BP was elevated,  I don't remember the exact systolic 170-180, but my diastolic was 116. It took the ambulance approximately 10-15 min to arrive. By the time the ambulance arrived, I was feeling close to my baseline and my BP was improving.  I was seen by the ER MD, and feeling fairly well, my throat still felt a tiny bit tight, but no difficulties swallowing.  The plan was to complete  treatment with IV steroids, Benadryl, and Pepcid, then be observed for a few more hours. This was approximately around 16:30. Not more than 5 min after MD left my room, I got the flushing feeling, and throat closing feeling again. While the medications were being prepared these  symptoms increased, ( I could still breath adequately and vital signs were still  OK.  It took about 10 minutes after meds were given for symptoms to begin to subside ( No epi given) I was observed until 21:30 then discharged. I am taking 50 mg daily x 3 days, 25mg Benadryl q 8hrs x 3 days, and 20mg Pepcid bid x 3 days. I feel fine , no further episodes
This spontaneous report as received from a physician assistant refers to a 63 year old female patient with hypertension. Reporter stated no drug reactions or allergies. On approximately 30-APR-2013, reported as "end of April 2013", the patient was vaccinated with ZOSTAVAX (dose, route, lot number and indication were not provided). Concomitant medications included an unspecified high blood pressure medication. Physician assistant reported that on approximately 14-MAY-2013 the patient developed "a rash noted as pinpoint erosions and little pink scabs" on both arms and across her lower back and generalized itching "about two weeks" after received ZOSTAVAX. The patient saw her physician after developing these symptoms and was prescribed prednisone (manufacturer unknown) on an unspecified date for five days. The physician assistant reports that the prednisone (manufacturer unknown) helped the patient a little bit with the itching. The patient was then started on a second course of prednisone (manufacturer unknown) "about a week or two later after the first course of prednisone" because the symptoms were still not resolved. The physician assistant reported that the patient was started on gabapentin (unspecified) "within the last week or two" on approximately 29-MAY-2013 due to developing pain in the arms that the patient described to the physician assistant as a "burning sensation when she goes out into the sun and exercise makes it worse." The physician assistant reports that the patient was informed by her physician that she probably never had chickenpox before. Physician assistant reported that the following lab diagnostics studies were performed: complete blood count (CBC), basic metabolic panel (BMP), and Thyroid-stimulating hormone (TSH) were drawn on an unspecified date after the patient developed symptoms in approximately May 2013. The physician assistant reports that the labs showed "minor abnormalities but nothing major." The outcome of the patient at the moment of the report was reported as not recovered. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 07-OCT-2013 the patient was vaccinated with ZOSTAVAX, 1 DF (Lot# and route unknown) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 14-NOV-2016, the patient was treated by a physician for a blistering outbreak which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed valacyclovir to attempt to manage and relieve her painful symptoms. 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, pain and suffering, and other damages. Additional information has been requested.
Fever to 101.4F, headache, nuchal ridigity, tachycardia low 100s, nausea, muscle aches, extremely sore arm with injection site.
My period was scheduled to come 1/14/2021, the day after my 1st dose of the Moderna vaccine.  My periods are very predictable and I am not sexually active. The evening I received the vaccine, twice  I had sharp pains in my uterus. It lasted for a few seconds and went away. It happened one more time in the middle of the night, jolting me out of sleep. My period has not come since I took the shot.  It?s been two weeks. This is very unusual.
Expired vaccine was stored in the refrigerator; Patient received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and PRODUCT STORAGE ERROR (Expired vaccine was stored in the refrigerator) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 069H21A, 017C21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and PRODUCT STORAGE ERROR (Expired vaccine was stored in the refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The patient had no side effects or adverse events with first, second and third dose of Moderna COVID-19 vaccine.  Date the vial was initially stored in the refrigerator was on 4MAY2022 and 5MAY2022.   The vial did not undergone any temperature excursions.  No treatment medications were reported.   This case was linked to MOD-2022-560259, MOD-2022-561462 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2022: Follow-up received included no new information.
Patient received a Pfizer covid vaccine dose that is 18 hours after the vaccine is prepared. Called Pfizer and they said stability is still ok 24 hours after preparation if vaccine has been stored under refrigerated temperatures, which it is. No reactions reported by patient.
Patient received Zoster immunization in her right arm. The following day she developed a raised, red area at her injection site. Diameter had increased through the course of the week - not painful or itchy.
Heart racing throughout the night; This is a spontaneous report from a contactable consumer (the patient).  A 79-year-old  male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNONW), via an unspecified route of administration, in the left arm on 29Jan2021 at 11:00 AM (at the age of 78-years) as a single dose for COVID-19 immunization. Medical history included atrial fibrillation. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), on 07-JAN-2021for COVID-19 immunization. On 31Jan2021 at 11:00 PM the patient experienced heart racing throughout the night. The patient did not receive treatment for the event. The clinical outcome of the event heart racing throughout the night was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Information requested on lot number.
morning of 28OCT pt was fussy; took pt to hosp MD said it was pneumonia gave ATB inject; pt was listless, no appetite, dec urine output, no crying, temp elevated; no better next morning; t106.3 back to hosp;
On the night of the vaccination date (March 20, 2021), I started to have a headache and body aches.  Went to bed around 11:45pm but could not sleep. Had chills all night, body aches and headache got worse.  Temperature taken around 7:30am on next day (March 21) was 100.3.  Took 2 Tylenol around 8:00 am. Severe body aches and headache, chills all day on March 21.  Temperature peaked at 100.8. Took 2 Advil midday.   Felt better but then body aches and chills returned around 7pm.  Took 2 Advil around 10pm.  Went to bed around 11:00pm.  Woke up on March 22 with headache and sore/swollen glands.  Took 2 Tylenol around 11:30am.  Headache subsided around 12:30pm.  Swelling in glands subsided around 2:30pm
2/3 pain at injection & pain across back & chest, face & neck flushed. 2/4 bruise at injection site, feel dizzy, confused, lymph pain, pain at injection causing upper body aches. 2/6-2/7 very tired. 2/9 so dizzy couldn?t get out of bed for 1hour. 2/10 more pain in lymph under injection arm, tired all day, then 10?x 4? rash/hives (for 4 days around injection site)
Moderna COVID?19 Vaccine EUA I received the Moderna vaccine on 12/23, that night I developed a fever (highest being 102), severe body aches and tiredness, chills, headache, hives, chest pain, nausea, diarrhea, numbness in the tips of my fingers, eye pressure and inability to see far away, lasting 5 days. I went to urgent care and got a COVID swab, my rapid test and PCR test were both negative. I also had a chest X-ray for chest pain on 12/29. The fever broke on 12/28 as well as all other symptoms other then chest pain which currently remains with pain under left lower ribs.
Received H1N1 vaccination about 12:30 PM at about 14:00 noted dizziness, feeling off balance, vertigo, palpitations and nausea. Was seen in the Emergency Department at 16:22, symptoms were mild-improving. Stated "had head cold 2 weeks ago", given antibiotic. Symptoms completely relieved/resolved.
According to what I have read, I have COVID ARM.  swollen, itchy, painful along with swollen lymph nodes under. my arm pit.
Information has been received from a physician concerning a patient who was vaccinated with the first and second dose of Rotateq. The physician reported that, after the first dose, the patient experienced a distended stomach and diarrhea. At 4 months of age the patient was vaccinated with a second dose of Rotateq. The patient subsequently experienced a distended stomach and diarrhea again. The patient's events subsided within 24 hours. Additional information has been requested. Follow-up information was received from a physician who indicated they were not aware of who the patient was. Additional information is not expected.
Patient stated that 30 hours after receiving the shot he started having a reaction in which his upper (mostly) and lower lips swelled towards his jaws.  He stated that he went for a run prior to experiencing the swelling so he thinks that may have exacerbated it.  He took diphenhydramine and about 24 hours after that the swelling reduced to normal.
Body ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PAIN (Body ache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 120L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced PAIN (Body ache). At the time of the report, HEADACHE (headache) had not resolved and PAIN (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: No specific follow-up information recorded. On 29-Apr-2021: Follow up information included additional event
I had rash on all my neck for two days, I had fever yesterday, it last only one day and I still have the swelling of glands starting yesterday. I haven't visit the doctor yet, but I am eating a lot of vitimine C and for my rashes, I bought the Gynecort for anti-itch.
Narrative: COVID infection following COVID vaccine series 01/14 Moderna , dose #1 02/11 Moderna ,dose #2 08/11 pt cc: headache, loss of smell or taste, myalgias, fatigue, exposure: friend 08/19 COVID swab, result: detected 08/19 SARS-COV-2 Variant Sequencing result: pending 08/20 - 08/25 pt symptoms continue 08/26 clinically resolved
The lymph node on left side in neck,under armpit felt large(golf size balls). This prompted me to contact my PCP told me this was normal side effects from vaccine.
patient received the first dose of Twinrix in May 2023 and yesterday received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose in May 2023).   On 05-NOV-2023, the patient received the 2nd dose of Twinrix. On 05-NOV-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: patient received the first dose of Twinrix in May 2023 and yesterday received the second dose). The outcome of the drug dose administration interval too long was 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: 06-NOV-2023 The HCP asked if the series needed to be re started and if not what is the recommended interval between the second and third. An health care professional (HCP) reported that a patient received the 1st dose of Twinrix in May 2023 and yesterday (day before reporting) received the 2nd dose, which led to drug dose administration interval too long. During the call permission to follow up was not requested.
3 bruises appeared 3 and 4 days following the vaccination. One on the knuckle of my left middle finger, one the size of a half dollar under my left arm pit and one large bruise about 5-6 inches in length covering my size over my ribs.
real heavy chest tightening, its not hurt me to breathe anything but my chest is really tight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 18Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 18Aug2021, outcome "unknown", described as "real heavy chest tightening, its not hurt me to breathe anything but my chest is really tight".  Additional information: Concern: consumer stated, "I just wanted to know if anybody reported about chest tightening with the Covid shot because I am experiencing that. I got my first COVID shot today." Further consumer stated, "A real heavy chest tightening like its not hurt me to breathe anything but my chest is really tight." Further probing could not be done as consumer hung up the call abruptly. Limited information was available over the call. Phone out at 8:06 AM, 2nd attempt by phone to Consumer to obtain contact information. Call answered by consumer who provided mailing address (withheld).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had a 1 degree increase in temperature around 3:00pm Felt tired and achy starting at 6:00pm Around 8:00 pm, I had moderate to severe chills and shivering  for about 1/2 hour.  I could not type on a keyboard because I was shaking too badly.  I spent the rest of the evening under blankets but was fine the next morning.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. 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. In October 2009, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Rash leading from injection site to arm pit area, painful shoulder and arm, fever, headache, general malaise, and vertigo.
10/01/08 given Pneumococcal in right arm 2 pm.  3:30 pm - red area at injection site.  10/02/08 extreme fatigue, fever of 99.2 - felt disoriented - unable to raise right arm.  10/03/08 arm not swollen - fatigue, T 99.  Symptoms lessened over next few days.  Felt 100% better on 10/07/08.
Took both doses. Still get little tiny outbreaks/ Suspected vaccination failure; Little tiny outbreaks; Painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Took both doses. Still get little tiny outbreaks/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Little tiny outbreaks) and pain (Verbatim: Painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received both doses of Shingles vaccine and still experienced little tiny outbreaks of shingles. The patient stated that the shingles are still painful. The patient reported that he or she was just grateful that the shingles are not like it used to be his or her outbreak was painful. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Narrative: 31 YOM who received second COVID vaccine on 4/20/21. Patient was admitted 6/5/21 due to pain, numbness and weakness in the abdomen, groin and bilateral lower extremities. Patient reports he had some aching of legs below the knees that lasted about 10 days when he had COVID in 12/2020. He reports he returned to normal except from some occasional, mild aching in lower extremities. Patient states after his first COVID vaccine, he experienced similar symptoms that lasted for 5 days and then resolved spontaneously. He reports that after he received his second vaccine 2 months prior to admission, the sensorimotor symptoms returned and worsened over time and were worse than prior episodes without resolution. Neurology was consulted who stated transverse myelitis was more likely given sensorimotor dysfunction that is bilateral with a clearly defined sensory level. They recommended full evaluation and a 3-5 day course of high-dose steroid. Per neurology's last assessment, it was stated that there was significant improvement following administration of steroids and recommended follow-up as outpatient with either PCP or neurology as appropriate.
her appetite never fully recovered; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported a female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient had the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) shot years ago. The patient had about every side effect (unspecified) and her appetite never fully recovered. Outcome of the event was not recovered.  No follow-up attempts are possible; information on the batch number cannot be obtained.