chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Transverse myelitis/ Acute transverse myelitis/ inflammatory transverse myelitis/ monophasic transverse myelitis; weakness and numbness in his legs; weakness and numbness in his legs; spinal cord lesion; arm pain; This case was reported by a lawyer and described the occurrence of myelitis transverse in a patient who received Herpes zoster (Shingrix) for an unknown indication.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced myelitis transverse (serious criteria GSK medically significant). On an unknown date, the outcome of the myelitis transverse was unknown.   It was unknown if the reporter considered the myelitis transverse to be related to Shingrix.  The initial information received on 10Dec2020 via medical record (The case medically confirmed). On 15 October 2020, the patient had Acute transverse myelitis. The patient had most consistent with inflammatory transverse myelitis. The patient had booster shot of Shingrix vaccine 1 month before onset of symptoms, the Shingrix vaccine caused arm pain for 4 days after the injection. The MRI showed improvement of the original spinal cord lesion. The patient had MRI T-/L-spine which shows T11-L1 FLAIR hyperintensity with enhancement, concerning for transverse myelitis. The patient had RI t-/I-spine DWI/ADC sequences were negative for spinal cord infarction. The patient had The patient diagnosed with most consistent with avaccine-associated monophasic transverse myelitis. The Shingrix vaccine link was suggested by the timing (within 30 days) and the unusual painful reaction in the arm that lasted several days. on March 020, the patient had weakness and numbness in his legs and transverse myelitis which caused hospitalization.
Upper left arm swelled a lot. Had shot Friday. Swelling starting to subside gradually. Left arm received PNEUMOVAX shot.
Pt brought to ER by son on 2/7/21 after noting increased confusion. Patient states he is going to visitor or do things that have not been around for years. Son reports onset was 24 hour prior. Pt does have some cognitive decline historically but current behaviors are a sudden change. Patient admitted observation to hospital and then discharged to local nursing home.
This is a non serious spontaneous case from a nurse of a medication error. The reporter causality was not provided to Flumist. A nurse reported a series of medication errors. The nurse misunderstood the dosing instructions for FluMist and administered a double dose of vaccine to seven pt's . Prior to the administration of the vaccine she removed the dose divider clip thereby giving 0.50ml per nostril versus the prescribed dose of 0.25 ml per nostril. On 26Oct04, at 4:00 in the afternoon, the reporter gave a double dose of FluMist to a 25 year old female pt whose medical history was not reported. The reporter stated the pt had no adverse events. No further information is available.
No adverse effect; the patients were vaccinated with improperly stored doses; Information was received from the vaccine coordinator and refers to 4 patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On an unknown date in 2019, between 16-APR-2019 and 02-MAY-2019, the patients were vaccinated with improperly stored doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) for prophylaxis, lot number R021084 with expiration date on 14-JUN-2021 (strength, dose number, anatomical location and route of administration were not reported).  No adverse effects were reported.  The temperature was of 35.2 degrees Celsius (°C) for a timeframe of 30 minutes with a previous temperature excursion of 32.7 °C for 7 hours and 30 minutes. The temperature excursion was called because a digital data logger.  This is a non-valid case due to lack of patient identifiers.  On 03-FEB-2019, a phone call was placed to the primary reporter (physician assistant). A request was made for patient identifiers, lot and vaccine received and enquired about dates. Additional information has been requested.  On 03-FEB-2019, a returned telephone call was received from the primary reporter, who requested additional information to assist him in his research on patient information. Additional information has been requested.  Follow up information was received from the vaccine coordinator referring to an approximately 1-year-old female patient on 05-FEB-2020.  On 02-MAY-2019, the patient was vaccinated with improperly stored doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB).  This case was previously considered as non- valid due to lack of patient identifiers. However, on receiving the patient's initials, date of birth and gender, this case was determined as valid.  This is one of the several reports received from the same reporter.
On June 11th I began having pain in my left calve.  June 18th I went to the doctor.  I had an ultrasound and a bloot clot was found. I have developed a blood clot in my left calve.
5AUG92 recvd 1st dose of Engerix-B & w/in 5 minutes devel pain @ inject & lost color;
terrible headache in back of her neck; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 29Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Single, (Lot # not provided)), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "terrible headache in back of her neck". Additional Information: The patient's age was reported as 76 (units unknown).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 3-4 minutes of receiving the flu shot I started to get a slightly queazy stomach, my head felt like it was filled with cotton.  I wetn and sat down and I started to get extreme muscle spasms across my middle back which came on very strong (I had to clench the chair arms).  The spasm would last about 45 seconds and slowly dissipate.  Then another spasm would happen less than a minute later.  This went on for several minutes.  I also started to break out in a sweat on my forehead and in both arms.  The pharmacist and several other employees of the store brought me water and monitored me.  After 10-15 minutes all of the symptoms were gone and I was able to leave at that time.  (My husband was with me the entire time and he tried to massage my back during the spasms which unfortunately did not help).  The pharmacist offered to call 911 but I did not feel the need.  I did not get any dizziness, shortness of breath, or heart issues.   I went home and called my doctor's office to report what occurred so they would be aware of what happened.  Once the symptoms passed I felt fine the rest of the day and had no other issues.
Full body rash started 1 week after vaccine.  Consistent with Urticaria.
Menveo vaccine given on 7/7/23 was only the diluent and did not include the powdered portion of the vaccine. Patient was revaccinated with the full dose of Menveo on 8/3/23.
Pt states she got up the next morning and had upset stomach, headache and dizziness. These symptoms continued for 6 more days and she only felt able to get up on the 7th day. After discussion, pt agrees these are some of the listed side effects of the vaccine, not adverse events, but she feels side effects should not be so severe or long lasting and asks that we report to the CDC.
Started roughly 7am with ringing in the ears Lost hearing in L ear around 1pm Onset of severe dizziness and nausea around 4:30pm Onset of vomiting, secondary to nausea around 6:30pm
6 month well child received DTaP, HIB, Prevnar at check up. Very fussy that night; had irritability, poor sleep. 2 minute generalized seizure 6 AM next day. Temp 101. ER by ambulance. Evaluated at ER.
A non-serious, spontaneous report of administration of expired product was received from a registered pharmacist concerning an adult (sex unknown) subsequent to FLUMIST. On 05-Jan-2009, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up with the reporter on 27-Jan-2009 revealed there were no delayed occurring adverse events related to expired FLUMIST administration. Follow-up with information was received on 09-Apr-2009: Product Complaint Investigation results.
Pt recvd vax & 2 days later devel a rash; MD did not feel that the rash was related to the vax but pt mom felt it was related; rash persisted for 20 days;
Large arm "rash" redness, swelling, mild chills, pain in chest along with a sharp pain with movement.  Mild headache. I rested, drank fliuds and took Motrin for a couple of days. The symptoms subsided after about 3 days. The arm rash lasted about 5 days.
numbness and tingling in fingers; tingling in fingers; chills; fever; lethargy; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history included COVID-19. Concomitant medications were not reported. It was reported the patient contracted COVID-19, 11 days after first 'jab'. Had adverse reaction after 2nd jab. Reaction lasted 16 hrs and included numbness and tingling in fingers, chills, fever and lethargy. Symptoms subsided 16 hours after onset.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021062909 same patient, same drug, different event
Severe Chills at 13-15 hours post-injection x 2 (same problem on previous dose in April 2022)
had a "negative titer for measles"; Information has been received from a physician referring to a currently 60 years old male patient. Information about medical history, concurrent condition and concomitant medication was unknown. The patient was uncertain of his vaccination history.     On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) with sterile diluent (strength, dose, frequency, route, lot# and expiration date were unspecified) as a child for prophylaxis. On an unspecified date the patient had a negative titer for measles. The patient sought medical attention from physician. On 24-APR-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). The outcome of negative titer for measles and the causality were unknown.
Patient received MODERNA on 1/14/21 in right deltoid. He said he went rock climbing immediately after getting the shot and really exerted himself that day as well as on day 2. The golf ball size swelling appears suddenly on the evening of day 2. It lasted almost 24 hours to day 3 and was completely gone on day 4. I contacted him on day 9 and he states he's without problems, no swelling, no other concerns. I reviewed his return date of February 11, advised to eat and drink that am, let us know he?s here and to avoid strenuous activity after the second vaccination.
Thrombocytopenia (diffuse petechiae, easy bruising, bleeding gums); Polychromasia; Petechiae; Easy bruising; Mild headache; Anisocytosis; A spontaneous report was received from a literature article concerning a 36, year old, female patient who experienced thrombocytopenia, headache, polychromasia, anisocytosis, petechiae and easy bruising.    The patient's medical history included thrombocytopenia and allergy to acetaminophen. Products known to have been used by the patient, within one week prior to the event, included ibuprofen and sumatriptan. A vaginal ring containing etonogestrel-ethinyl estradiol,  was place one week prior to hospitalization    Approximately one week prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on unknown date, intramuscularly in the for prophylaxis of COVID-19 infection.    The patient presented to the hospital on unknown date with diffuse petechiae, easy bruising, bleeding gums and mild headache. Vital signs were within normal limits upon arrival at hospital. Physical exam was notable for diffuse petechiae of the extremities and trunk along with oral ecchymosis of 1-2 cm: no focal neurological deficits were observed, and no hepatic or splenic enlargement was noted. Blood work was significant for white blood count of 13.1 L/uL, hemoglobin 13.6 g/dL, heamatocrit of 42.1%, and platelet count of 3000/uL.  Prothrombin time and activated partial thromboplastin time were within normal limits. SARS-CoV2 swab was negative but the SARS-CoV2 IgG antibodies were reactive. Peripheral smear showed thrombocytopenia without clumping along with polychromasia and anisocytosis appreciated with some mature neutrophils.  A CT scan of the head did not show acute infarction or hemorrhage.   Treatment for the event included, dexamethasone 40 mg intravenously daily for four days, intravenous immunoglobulin (IVIG) 1 mg/Kg for three days and was place on the Health Stroke Scale monitoring. Platelet count improved to 28000/uL within 3 days and oral lesions disappeared through some petechiae remained. The patient's contraception ring was not removed. The patient was discharged with outpatient hematology follow up.  Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event(s) was not reported.  According to the abstract, the temporal sequence of the events suggests an exacerbation of the patient's chronic thrombocytopenia related to the receipt of the mRNA-1273 Covid-19 vaccine. The abstract also stated that it is possible based on reviews of reported side effects unlikely, that the patient's headache medications and contraception were triggers for this event.    Follow up: No follow up provided.; Reporter's Comments: Very limited information regarding the events has been provided at this time.
Symptoms: Chest tightness and difficulty breathing deeply. Chest tenderness to the touch Time: started approximately 3 days after vaccination, and has persisted since (over a month)
Itching at injection site, sneezing, rhinorrhea, audible wheeze, labored breathing, given a dose of injectable Diphenhydramine 50mg/mL and a dose of injectable Epinephrine 1:1000 (1mg/mL) also given O2 at 4 liters. Ambulance was called pt transferred to medical center.
Congested; Sore throat; Tension headache; Chills; Injection site red in a big circle/round and red patch at the injection site; Soreness at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of NASAL CONGESTION (Congested), OROPHARYNGEAL PAIN (Sore throat), TENSION HEADACHE (Tension headache), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Injection site red in a big circle/round and red patch at the injection site) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol and Diabetic.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). On 23-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site red in a big circle/round and red patch at the injection site). On 25-Jan-2021, the patient experienced NASAL CONGESTION (Congested), OROPHARYNGEAL PAIN (Sore throat), TENSION HEADACHE (Tension headache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and IBUPROFEN (MOTRIN IB) for Adverse event, at a dose of UNK dosage form. In January 2021, VACCINATION SITE ERYTHEMA (Injection site red in a big circle/round and red patch at the injection site) had resolved. On 24-Jan-2021, VACCINATION SITE PAIN (Soreness at the injection site) had resolved. On 25-Jan-2021, CHILLS (Chills) had resolved. At the time of the report, NASAL CONGESTION (Congested), OROPHARYNGEAL PAIN (Sore throat) and TENSION HEADACHE (Tension headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2021: No specific follow-up information recorded.
Breakthrough case admission after 2 vaccines Pfizer 1/27/21 lot# El9261;  Pfizer 2/25/21 lot# EN6202
Patient has swelling and hardness in his right arm from the injection. The inflammation was creeping down the arm. The pain level was described as a 6 out of 10. Patient went to the ER where he was given prednisone 20 mg daily x 4 days, PEPCID 20 mg daily x 7 days, and ZYRTEC 10 mg daily x 7 days.
Unknown if patient is experiencing side effects due to current COVID-19 infection. However, patient states he is feeling "much better" the day after vaccination.
Tinnitus.  Had a headache that started that night on booster. The ringing presented the following morning.  It has been constant.
Patient began feeling ill directly after receiving the vaccine. She experienced dizziness increased heart rate and blood pressure; and was flushed for a period of 24 hrs.  On Monday, Jan 18th, she noticed a swollen lymph node in left clavicle area.  She was seen by her pcp was diagnosed with subclavicle left side  reactive lymph node as a side effect to the vaccine, and not an allergic reaction. She reports that he does recommend that she receive the second dose.  She is currently experiencing swallowing issues and ear pain. Patient is scheduled to see a surgeon on Jan 28 for consult regarding the lymph node.
Information has been received from a registered nurse (R.N.) concerning a 13 year old male who on 25-AUG-2008 was vaccinated subcutaneously with a partial second dose of VARIVAX (Merck) (lot #660405/0272X) because the patient jerked during the administration. The patient was seen at the office. At the time of this report, the outcome was unknown. Additional information has been requested.
Information has been received from a physician concerning a female (age not reported) with diabetes and allergy to "lots of medication, cholesterol and high blood pressure medications" who on approximately 26-SEP-2007 "about two weeks ago" was vaccinated subcutaneously with a 0.65 mL dose of ZOSTAVAX. Concomitant therapy included therapy unspecified (insulin "an antibiotic"). On approximately 28-SEP-2007, "2-3 days after vaccination", the patient experienced pain in her left arm that are 'similar to the pains from a heart attack" and a "heaviness" in her chest. The patient reported that "it comes and goes" and "it has been getting less severe." The patient did not seek medical attention. No laboratory diagnostic tests were performed. The patient's status was reported as recovering. There was no product quality complaint involved. Follow up information was received from a health care professional who noted that as of the time of reporting the patient had not notified them of any reaction or symptoms. No further information is available.
This spontaneous report as received from a physician via a field representative refers to a male patient of unknown age. On 16-APR-2014 the patient was vaccinated with the first dose of GARDASIL, 120 Y, lot # J006236, expiration date 25-FEB-2016 (dose and route not reported). On 16-APR-2014, the patient became "very sleepy after receiving a first dose of GARDASIL. The physician mentioned the patient had been extremely sleepy for almost an hour and mentioned the patient received MENACTRA (lot#, dose and route not reported) at this same visit. The patient sought medical attention in the office. The patient was OK for 15 minute observation, but around minute 16 or 17 the patient became very sleepy and had trouble staying awake. The patient did not lose consciousness cognitively the patient was OK. The patient became slightly hypertensive. Patient was not hypoglycemic (given candy, etc. in case that was the issue, but the candy did nothing to change patient status). The physician stated that he did not think it was pre-syncope and he did not think it was a seizure. After about 1 hour, the patient was allowed to go home, but was still not recovered. The physician followed up with patient later in the evening and the patient said they were feeling much better and were more alert and were watching TV on couch at home. Additional information has been requested.
Dizziness, tingling in right arm and right leg, redness right upper arm, HA
Quarter size area that is pink; It got worse; There is a slight itch; Still very red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Quarter size area that is pink), CONDITION AGGRAVATED (It got worse), VACCINATION SITE PRURITUS (There is a slight itch) and VACCINATION SITE ERYTHEMA (Still very red) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (Quarter size area that is pink), CONDITION AGGRAVATED (It got worse), VACCINATION SITE PRURITUS (There is a slight itch) and VACCINATION SITE ERYTHEMA (Still very red). The patient was treated with IBUPROFEN for Vaccination site pruritus, at a dose of 2 tablets and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Vaccination site pruritus, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOLOURATION (Quarter size area that is pink) and CONDITION AGGRAVATED (It got worse) outcome was unknown and VACCINATION SITE PRURITUS (There is a slight itch) and VACCINATION SITE ERYTHEMA (Still very red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient took ibuprofen two tablets, applied calamine lotion, a cold cream and washed cloth to relieve the itchiness of the rash.
Patient came in Saturday, 9/21/19 complaining of pain, redness, and swelling on her left arm. Patient says it is warm to touch and the redness started on Wed 9/18/19 and has not improved. Patient was advise to take Benadryl &  apply cool compress
Immediate redness, swelling, soreness, resolved  in 48 hours. 8 days later recurrent redness, swelling soreness, fatigue.