chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately three months after receiving my second dose, I had a Stroke. It was a pretty large Stroke. I was rushed to the hospital and they did a Thrombectomy. It was very serious, but they were able to perform emergency surgery. I had bloodwork drawn, I had CT scans and MRI's, an Echocardiogram to determine if my heart was having valve trouble and a Sonogram of my carotid. All tests show that there was not any blockage. I had a cardiac monitor inserted to monitor any abnormal activity. The doctors have told me that the results they have seen have been positive for normalcy. I am not having any problems with my motor skills.
Presented with fever, CPAP, headache, generalized weakness of many weeks duration. Completed COVID vaccine on7/6/2021, admitted to the hospital for further evaluation and treatment COVID-19 virus infection. Oxygen supplmentation, completed Remdesvir,already receiving steroids for multiple sclerosis. Discharge Condition:Stable and Improved-Home oxygen was arranged for discharge home
This spontaneous report as received from a physician via a company representative refers to a male patient of unknown demographics. No current condition or medical history has been reported. On an unknown date in March 2014, the patient was vaccinated with a dose of ZOSTAVAX vial 0.65 milliliter (ml), subcutaneous injection. No concomitant medication was reported. The physician reported that the patient was recently diagnosed at an unspecified time and date in 2014 with grovers disease which was confirmed on a biopsy by an unspecified dermatologist. There was no product quality complaint involved. The outcome of grovers disease was not reported. Causality between grovers disease and ZOSTAVAX was not reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient. The patient had no drug reactions or allergies, also she did not report any medical history. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27 - 3) virus vaccine, live (manufacturer unknown) (dose route of administration and indication were not reported). The reporter was not aware which type or tradename of the vaccine it was. Concomitant therapies were not reported. On an unknown date, the patient had titers drawn, which showed that its levels were low. The patient would need to be re-vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown). The outcome of the event was reported as not recovered/not resolved. The reporter did not assess relatedness between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown). Additional information has been requested.
Swollen, red, hot, painful injection site; Headache; Fever; Fatigue; Chills; Swollen lymph nodes under armpit; Swollen, red, hot, painful injection site; Swollen, red, hot, painful injection site; Swollen, red, hot, painful injection site; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 30Mar2021 at 10:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine and COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included topiramate (TOPAMAX), escitalopram oxalate (LEXAPRO) and cetirizine hydrochloride (ZYRTEC); all from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 02:00, the patient experienced swollen, red, hot, painful injection site 2 days post injection 6 cm, headache, fever, chills, swollen lymph nodes under armpit and fatigue. Injection site and lymph node still swollen and painful 6 days after injection. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of swollen, red, hot, painful injection site 2 days post injection 6 cm, headache, fever, chills, swollen lymph nodes under armpit and fatigue and included treatment with 50 mg diphenhydramine (BENADRYL), 800 mg ibuprofen (MANUFACTURER UNKNOWN) and ice. The clinical outcomes of swollen, red, hot, painful injection site 2 days post injection 6 cm, headache, fever, chills, swollen lymph nodes under armpit and fatigue were recovering.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a pharmacist refers to approximately 2-3 patients of unknown age and gender. On an unknown date (reported as int he past few years) those patients were vaccinated with PNEUMOVAX23 (dose, units, route of administration, anatomical location, lot number were not reported). On an unknown date (reported as in the past few years) those patients experienced unspecified injection site reactions after the administration of PNEUMOVAX23. The outcome of events was not reported. The relatedness between events and PNEUNMOVAX23 was not reported.  This is one of several reports from the same reporter. Additional information has been requested.
muscle fatigue; shaking; muscle soreness; temperature increase; chills; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE FATIGUE (muscle fatigue), TREMOR (shaking), MYALGIA (muscle soreness), PYREXIA (temperature increase) and CHILLS (chills) in a 25-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032218) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    The patient's past medical history included Coughing (Took Mucinex DM for coughing.) and COVID-19 (Once around Mar-2022 during 3 to 5 days) in March 2022. Previously administered products included for Coughing: Mucinex DM. Past adverse reactions to the above products included No adverse event with Mucinex DM.   On 04-Oct-2023, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 04-Oct-2023 at 11:30 AM, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 04-Oct-2023, the patient experienced MUSCLE FATIGUE (muscle fatigue), TREMOR (shaking), MYALGIA (muscle soreness), PYREXIA (temperature increase) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, MUSCLE FATIGUE (muscle fatigue), TREMOR (shaking), PYREXIA (temperature increase) and CHILLS (chills) was resolving and MYALGIA (muscle soreness) had not resolved.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  On 03-Jan-2021, the patient received first dose of Pfizer and the lot number was EJ1686. On 20-Jan-2021, the patient received second dose of Pfizer and the lot number was EL3248. On 20-Nov-2021, the patient received third dose of Pfizer and the lot number was FD0809. On 05-Nov-2022, the patient received fourth dose of Pfizer and the lot number was GJ6738.  The patient has received other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient had her Spikevax appointment at her work at 11:30 AM and started feeling symptoms when she was driving home approximately at 5 or 6 PM, initially felt muscle fatigue and then headedness, later on she felt temperature increase and chunk chills, she was shaking a lot, and feeling muscle soreness.  Caller took Tylenol and Excedrin. Muscle soreness was still ongoing. The patient got flu vaccine at same time than Spikevax but in a different arm.
Approx 1 hour after receiving vaccines, mom called. Reports vomiting x 2 and sweating.
Deficient humoral response to Haemophilus influenza type B meningitis in a 7 month old vaccinated child. Journal Of Allergy and Clinical Immunology 2006; 171. It was reported in a published article, title as stated above that a 7 month old male was vaccinated with 3 doses of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (manufacturer unspecified). Subsequently, the patient presented with three days of fever and bulging fontanel. Medical attention was sought and blood and cerebrospinal fluid cultures grew H influenzae type B. Within a week of developing the infraction with (Hib) meningitis, Hib Ab levels were 0.66 mg/L, with a protective index of >0.15. Three months later, while he was asymptomatic, his Hib Ab levels fell to sub-protective levels at 0.10 mg/L. It was noted that his response to pneumococcal 7 valent conjugate vaccine was adequate. The remainder of his immune workup, including total serum immunoglobulins, specific antibodies to tetanus and diphtheria, and complement studies, was normal, IVIG and prophylactic antibiotics were started for a six month course with a post-IVIG Hib titer of 5.33 mg/L. Two weeks after th IVIG was stopped, he was reimmunized with two doses of Hib conjugate vaccine with tetanus protein two months apart. After the revaccination, four months after discontinuing IVIG, his Hib Ab levels rose to protective levels of >9.0 mg/L. The reporter noted that it is likely that the patient has a specific antibody deficiency for H influenzae polysaccharide antigen. Upon internal review, meningitis was considered to be other important medical event (OMIC). Additional information is not expected. A copy of the published article is attached as further documentation of the patient's experience.
Redness; Induration; Swelling; Papules on neck and forehead and arm; Headache; Achy all over; Sore throat; Missed a day at work; Inappropriate Schedule of Vaccine; This case was reported by a physician via sales rep and described the occurrence of erythema in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced erythema, induration, swelling, papular rash, headache, general body pain, sore throat, activities of daily living impaired and drug dose administration interval too short. On an unknown date, the outcome of the erythema, induration, swelling, papular rash, headache, general body pain, sore throat, activities of daily living impaired and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the erythema, induration, swelling, papular rash, headache, general body pain, sore throat and activities of daily living impaired to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced redness, induration, swelling, papules on neck and forehead and arm, headache, achy all over, sore throat.  The patient missed a day at work. The patient received 2nd dose of Shingrix 1 month apart earlier than the recommended interval, which led to shortening of vaccination schedule.
COVID positive on 12/19/2021. Onset of symptoms  12/18/2021: Symptoms remain: fatigue, chills, fever, body aches, sore throat.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 08-MAR-2017, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Within two weeks of receiving my second shot of Pfizer vaccine, I began developing red "marks" over my body, e.g. my chest and abdomen,  my lower arms and my thighs and calves, both right and left sides. I have no way of determining if it reached my back. To my knowledge, it hasn't reached my hands, feet or face. The red marks are typically streaks of a red color that appear to be subcutaneous. There will often be a couple of streaks to several clustered together and they range from an inch or two to 5 or 6 inches long. The good news? They don't hurt or are sensitive to touch.  They appear most often in the afternoon or early evening. They are very slightly raised -- if you close your eyes, you can barely feel where they are -- but nothing severe. There is no rhyme or reason why they appear; they just come unannounced and they are generally gone by the next morning. I will get them for, say, 3 or 4 times in a week, then I won't get any for a week or so.   I did have a  dermatologist look at it and he didn't know what it was. He prescribed allergy medication for the condition, thinking that it may be some sort of hives. (I've never had hives before.) I took the allergy medication -- and it did wonders for my congestion -- but it did absolutely nothing with regard to the red marks -- no effect whatsoever although I took the entire quantity prescribed.  I cannot tell what triggers them but I didn't have them before taking the vaccine, that's for sure. It is now well over a year later and they're still with me. I have no idea what's triggering the outbreak (i.e., diet, etc.) and have no idea on how to get rid of it.
a patient received an expired doe of FLUZONE QUADRIVALENT/ No AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via agency (Reference number- 00315880) and transmitted to Sanofi on 14-Oct-2020.  This case involves female patient (age unspecified) who received an expired dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Fluzone quadrivalent) [lot number and expiry date not reported] via an unknown route at an unknown administration site on an unknown date for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   It was an actual medication error due to expired vaccine used. (Latency: at the time of vaccination)  It was reported that, reporter wanted to know how long before patient had to wait before they could administer the correct vaccine.   At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021 at 11:32 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 16-Sep-2021 at 1:27 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED had resolved. Not Provided.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment drugs were reported   This case was linked to MOD-2021-405869 (Patient Link).
When first shot was given in left arm, within a week left side of neck developed a swollen lymph which you could visibly see swelling. When 2nd COVID Vaccine was given it was given 4/26/21  in the right arm; back of neck became swollen within a couple of days stomach started hurting.  On  5/12/2021 I was admitted into the hospital due to severe abdominal pains; it was discovered to be the result of swollen lymph nodes in the stomach.   Currently taking large doses of Ibuprofen.
Developed sore throat. Fever, fatigue, and hoarseness. Pain to injection site.
FEBRILE 102*, CHILLS, MUSCLE ACHE, BONE ACHE
Pt recv vax on 8/7/98; 5 hrs later pt exp sore throat, slightly swollen tongue, &some difficulty swallowing.  On 8/8/98 pt imp.
Nervousness, c/o feeling hot, sleepy.  EMT on site-client assessed.  No sob, BP 90/50, r 18, P 70, O2Sat 99, BP 80/50. Client observed for additional 15 minutes.  Denies further c/o previous or any symptoms.  BP retaken by EMT 110/70, P 70, R 12.  Client and client's mother instructed to follow up or seek medical assistance for any further symptoms or change.
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. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 27-JUN-2015, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe varicella pneumonia. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, varicella pneumonia was determined to be medically significant. Additional information has been requested.
Syncope immediately following administration of Pfizer 5-11 vaccine. Lasted 3 seconds. Patient ok during post-vaccination wait.
Pt recvd MMR vax on 28AUG91 & w/in approx 5 hrs pt devel a fever & exp vomiting;
Fainted about 5 minutes after vaccine (patient already left vaccine room), temp taken and temp was 93.9F, patient skin was clammy to the touch. Patient declined pharmacy staff to call EMS or go to emergency room.  Patient waited extra 15-20 minutes in pharmacy waiting room. Patient's doctor was called by patient while waiting in pharmacy waiting room. Patient looked much better when she left pharmacy (skin had more color, temperature was rising when temperature checked later, skin did not feel clammy)
Redness- bright red (L) upper arm - 4" above  elbow to 2in. below shoulder. Flat, no edema. (Lateral) (Large area)            intense itching  Saw PCP Am 3/15/21.  Preseribed   .   Triamcinolone 0.1 % cream - apply topically 3 times / day. area measured by PCP
I recently tested positive for COVID-19. I would think this was a breakthrough case because I received my third dose in November of 2021 which means I was fully vaccinated.
Fever >100.6 up to 102, low temp to 97 F -Variable for 10 days.  Moderate Pain at injection site for 1 wk, itching up to 12 days. Chills/shaking 5 days. Nausea, 1 week. Vomiting, 48 hrs. Severe Fatigue 1 week, mod fatigue 5 days. Severe headache, 5 days. Muscle weakness, 5 days. Myalgia 5 days. Arthralgia, 10 days. Allodynia/skin pain 5 days.  Flushed face and chest, 5 days.  Oral mucosa ulcerations.  Swollen lymph nodes neck and groin.  Genitalia irritaiton.  Blurry vision.  Dizziness. Sore throat. Abdominal pain.  Tongue tingling and swelling 3 days.  Tachycardia.  Dyspnea.  Pallor.  Diarrhea.   TX:  Tylenol, rest/sleep, hydration.  Ice applied to injection site.
I have been missing my period and had one 40 day cycle since receiving the moderna covid 19 vaccine on february 15th. I have had no other lifestyle changes since then
Patient stated that following her vaccine, she had an intense headache which she described as though she thought she was having an aneurysm. She also experienced body aches, chills, extreme fatigue, muscle soreness & itching. Patient states that she took Norco that she had "laying around" as well as Ibuprofen, Tylenol & tramadol to decrease the intense headache she was experiencing.  Per her report, this lasted 3 days however improved slightly each day.
Mom states that started running a temp in evening p/DTp/OPV had been given in the AM; t105 called MD; states arm was also red & swollen; taken to PA; t99.2;
Arm swollen and sore at vaccine site, headache, low grade temp., and body aches.
induration where the shot was given & it turned black & has not yet gone away;the arm still is sore once in a while;like a dull ache;induration is approx 5mm in diameter;it appears the muscles atrophied around the inj site of lt deltoid;
chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced CHEST PAIN (chest pain). At the time of the report, CHEST PAIN (chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-037079 (Patient Link).
Severe pain in L. arm, up to neck and shoulder with swelling, lasting two days.