chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red spots below the injection site area; spots were warm to touch, somewhat sore; spots were warm to touch, somewhat sore; calf pain and joint pain after receiving the vaccine; calf pain and joint pain after receiving the vaccine; fever; This spontaneous report was received from a pharmacist refers to a 68 year old female patient. Patient had no pertinent medical history and no drug allergies. Patient's current conditions included food or possibly a mold allergy. Past drugs included pneumococcal 13v conj vaccine (CRM197),,,, (PREVNAR 13) and zoster rgE vaccine (mammalian),,,,(SHINGRIX).  Concomitant medications included blood pressure medication and allergy shots. On 14-MAY-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R033342, 1 dosage form, expiry date 03-AUG-2020 (strength and batch were unknown) via intramuscular route for disease prevention (prophylaxis). Later that night, the patient got fever of 101.6 F. The patient took acetaminophen (TYLENOL) for the fever. It was reported that, on the evening of 16-MAY-2019, 3 days after onset of therapy the patient developed some "red spots" below the injection site area (vaccination site erythema), the pharmacist reported that one is 1" x 1" and below is it another red spot, 1.5" x 2" and also reported that spots were warm to the touch, some what sore, and not itchy (vaccination site warmth), vaccination site pain and also experienced calf pain and joint pain after receiving the vaccine (arthralgia and pain in extremity). Patient sought medical attention by visiting the pharmacist. The outcome of the events vaccination site erythema, vaccination site warmth, vaccination site pain, arthralgia and pain in extremity were unknown. Causality of the suspect therapy pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) with respect to event was not reported. PQC was not reported.
BLOOD CLOT; This spontaneous report received from a patient concerned a 78 year old white male of unspecified ethnic origin. The patient's weight was 194 pounds, and height was 68 inches. The patient's concurrent conditions included: alcohol user, nonsmoker, blood pressure abnormal, and cholesterol abnormal, and other pre-existing medical conditions included: The patient had no known allergies, did not have any drug abuse/illicit drug use and had taken blood pressure pills, cholesterol pills. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported , batch number: 202A2, expiry: Unknown) dose was not reported, 01 total administered to left arm on 02-MAY-2021 for prophylactic vaccination. Concomitant medications included fish oil for unknown indication.  Patient stated that about a month later, on an unspecified date in JUN-2021, he was walking to the pharmacy, and on the way home he pulled a muscle in his left leg, which continued for about a month. He then went to the emergency room and was diagnosed with a blood clot and was not admitted to the hospital. The patient had been on treatment medication (dates unspecified) Xarelto (rivaroxaban) for 3 months. Reportedly, on an unspecified date his right leg got sore and was still sore at the time of report. His primary care physician (PCP) was aware of his symptoms. He also stated that, he was first started on an unspecified another pill and then his PCP switched him to Xarelto for 3 months. Reportedly, on unspecified date patient also felt very painful to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211059076-covid-19 vaccine ad26.cov2.s-Blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pain @ site and lethargy for 1st 6 days. Developed temp, body aches, extreme lethargy days 7-14 after vaccination
Fainting and LOC resulting in head trauma and jaw trauma, 11/27/21 at 2pm
Patient reports injection itself was painful and located rather high up in the deltoid (higher than flu shot given in left arm). Almost immediately after injection, patient reports sharp pain located in one specific location of upper arm, close to shoulder. (Patient is able to physically pinpoint exact location of pain). Pain has gotten steadily worse in the 3 days since the vaccination was administered.
tested positive for COVID-19 through a Rapid test; tested positive for COVID-19 through a Rapid test; This is a spontaneous report from a contactable non-healthcare professional reported that: A 16-year-old male patient received bnt162b2 (BNT162B2) (at the age of 16-year-old), via an unspecified route of administration on 08Apr2021 (Lot Number: EP6955) as DOSE 2, SINGLE and First dose was administrated on 20Mar2021(Lot Number: EP6955) via an unspecified route as single dose, for covid-19 immunization. Patient experienced tested positive for COVID-19 through a Rapid test on 20Sep2021, the patient was currently asymptotic. Outcome of the events was unknown. Therapeutic medication was not administrated. The patient underwent lab test included SARS-CoV-2 test (rapid test) showed positive on unknown date. It was reported that the patient did not diagnose with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-Up (22Sep2021): Follow-up attempts are completed. No further information is expected.
Patient was a resident of a facility.  Patient was admitted for rehabilitation d/t lack of coordination.  Patient tested positive for Covid-19 on 02/11/2022 and was placed in isolation.  Patient expired at facility on 02/24/2022.
I had sore throat, headache, stuffing and running nose, body aches, stuffy head, and ears ringing. I tested positive for COVID-19 at home. I called my doctor on the same day and she prescribed me Paxlovid.
Breakthrough case admission after three vaccines 1/28/21 Moderna 302H20A 3/11/21 Moderna 043L20A 12/8/21 Moderna 012H21B
15min p/vax pt was standing @ front desk beside father;pt passed out, fell backward, striking back of head on floor;pt regained consciousness shortly p/smelling ammonia;pt was nauseated, h/a, pale, & hematoma on back of head;seen by MD;
The vial was initially stored in the refrigerator Lot 071B22A on 5-APR-2023, vial was expired on 12-MAR-2023 and administered to the patient on 06-APR-2023; No adverse event; Patient was administered a dose on 06-APR-2023 from the Moderna lot 071B22A which had expired on 12-MAR-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose on 06-APR-2023 from the Moderna lot 071B22A which had expired on 12-MAR-2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator Lot 071B22A on 5-APR-2023, vial was expired on 12-MAR-2023 and administered to the patient on 06-APR-2023) and NO ADVERSE EVENT (No adverse event) in a 33-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.   No Medical History information was reported.    On 06-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2023, after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose on 06-APR-2023 from the Moderna lot 071B22A which had expired on 12-MAR-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator Lot 071B22A on 5-APR-2023, vial was expired on 12-MAR-2023 and administered to the patient on 06-APR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose on 06-APR-2023 from the Moderna lot 071B22A which had expired on 12-MAR-2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator Lot 071B22A on 5-APR-2023, vial was expired on 12-MAR-2023 and administered to the patient on 06-APR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose on 06-APR-2023 from the Moderna lot 071B22A which had expired on 12-MAR-2023) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator Lot 071B22A on 5-APR-2023, vial was expired on 12-MAR-2023 and administered to the patient on 06-APR-2023).    No concomitant medications were reported.  HCP stated that when they had received the Moderna monovalent vaccine, the expiration date stated 31-Dec-2069 and they did not realize that they had to check for the manufacturer expiration date.  The vial was initially stored in the refrigerator on 5-Apr-2023.  The vial did not undergo any temperature excursions.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2023: Non Significant follow up appended contains no new information
Report A0372185A describes hepatitis C infection in a 39 year old female who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received from the vaccinee and has not been verified by a physician or other healthcare professional. The medical hisotry, concurrent conditions, and concurrent medications were not specified. The vaccinee didn't think she had any problems following receipt of the first two LYMErix injections. The vaccinee reported that she received injections of LYMErix in 1999 2000 and 2001. It was reported that six months after receiving her third LYMErix injection, possibly in 2001, she experienced liver problems. She was seen by her physician, who recently made a diagnosis of hepatitis C. According to the vaccinee, she also had other problems but said that there were too many things to explain. The vaccinee stated that the events persisted as of 6/19/02 and were probably related to LYMErix administration. Hepatitis C is considered manufacturer medically serious.
Woke up 10am July 30th with Tinnitus in left ear. First vaccine was on May 31st.  By 1pm, I lost hearing completely out of my left ear  I went to the hospital and they found no cause  Still slight tinnitus and hearing loss
Pain, redness, lump at injection site that is warm-to-touch. Patient reported these symptoms beyond 48-hours after injection. She still has some redness, pain and swelling as of 11/29/2021.
Approximatly 10min. after patient recieved her vaccine she was seen slumping over onto her mother and hyperventilating. RN was then notified and arrived to help coach patient to slow her breathing down and to take even breaths. Vitals were taken at 0950:BP-110/70,HR-90,RR-20. Skin was pale and diaphoretic. Patient then was given water and crackers and transferred to lay down in a non-stimulating environment. At about 1015 her vitals were retaken:BP-115/80,HR-100,RR-18. Skin was normal pallor and non-diaphoretic. After a few minutes in the sitting position, then standing and soon she was ready to leave. mother was advised on when to seek medical attention for signs and symptoms of anaphylaxis.
severly itchy started a couple of hours after vaccine. Taking regualr does of benadryl daily since vaccine.
This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162Bb2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on 22Mar2021 at 15:00 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, penicillin allergy, fruit allergy (peach), pine trees allergy, and dust allergy. The patient did not receive any concomitant medications. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021, the patient experienced swollen lymph nodes under the left arm, neck and groin. The patient did not receive any treatment for the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swollen lymph nodes under the left arm, neck, and groin was resolving at the time of this report. No follow-up attempts are possible. No further information is expected.
Moderna Vaccine Lot 029K20A Patient received second dose of vaccine on 2/2/21. Within 30 minutes patient had a near syncopal episode. She felt lightheaded and shortly after had episode of nonbloody vomiting. Hypotensive 81/69 and started on levophed. Alert and orientated. Lungs clear, abdomen benign on admission. Patient had no reaction when received first dose of the vaccine.  Patient developed worsening shortness of breath, tachypnea, Afib with RVR, hypotension and required intubation and multiple pressors.
Fever of 103 started at 0100 on 11/24/2021 with headache and flue like symptoms. Symptoms continued until  approx 12:00 pm on 11/24/2021. Fatigue and flue like symptoms continued throughout 11/24/2021. Other than fatigue, symptoms resolved as of 11/25/2021. All symptoms resolved as of 11/26/2021
pt recv vax 26AUG97 & the next day 27AUG97 pt exp inj site redness, swelling & warmth;pt also c/o pain of the upper extremity;
Approximately 15 hours after immunizations, presented to the emergency room with possible seizure activity. Mother states - child with rapid eye movement and shaking. Patient discharged from ER with follow up appointment in the am with pediatric clinic. On 13Sep17, patient follow up with Dr. Patient transferred to ER for further evaluation and management. After labs and CT of head, patient transferred to another Hospital for admission to PICU for ongoing monitoring and workup.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on their medical history, concurrent conditions or concomitant drugs was provided. On 26-MAY-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB which was improperly stored (dose, route of administration, lot# and expiration date not reported). No adverse effect was reported. Additional information has been requested.
NEUROPATHY IN MY FEET AFTER THE SECOND SHOT; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age and sex unknown race and ethnicity.    The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient was previously treated with covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total for prophylactic vaccination (Dose number series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. (Booster dose, Dose number series 2). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.   On an unspecified date, the patient experienced neuropathy in feet after the second shot (Dose number series 2). Patient reported that "I have it in my feet after the second shot".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of neuropathy in my feet after the second shot was not reported.  This report was serious (Other Medically Important Condition).  This case, from the same reporter is linked to 20211143298.; Sender's Comments: V0: 20211157009-covid-19 vaccine ad26.cov2.s-neuropathy in my feet after the second shot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sore arm; body aches; nausea; Dose number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 20Dec2021 14:30 (Lot number: FH8027) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hyperthyroidism" (unspecified if ongoing). Concomitant medication(s) included: METHIMAZOLE; VITAMIN D [COLECALCIFEROL]. Vaccination history included: Comirnaty (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 08Apr2021, when the patient was 45 years old, for Covid-19 immunization; Comirnaty (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 18Mar2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 14:30, outcome "unknown", described as "Dose number 3"; PAIN IN EXTREMITY (non-serious) with onset 21Dec2021 06:00, outcome "recovering", described as "Sore arm"; PAIN (non-serious) with onset 21Dec2021 06:00, outcome "recovering", described as "body aches"; NAUSEA (non-serious) with onset 21Dec2021 06:00, outcome "recovering", described as "nausea". Therapeutic measures were not taken as a result of pain in extremity, pain, nausea.  Additional information: Patient was not diagnosed with covid prior to vaccination. Patient was not tested for covid post vaccination. Patient did not receive any other vaccine in four weeks. Other medications in two weeks: FLO PMS Gummy Vitamins;Hair Skin & nails 5,000 mcg Biotin.
The patient  visited our office on 7/19/21 for Moderna vaccine. We administered Moderna 1st shot and we found that he got J&J vaccine on 4/21/21 from relations. We checked with him and he stated he needs a booster COVID vaccine shot and he got Moderna today. His father is a doctor and asked him to get a booster COVID vaccine. That's why he got Moderna today. He did not have adverse reactions during waiting 15 mins.
Injection site redness; Injection site discomfort; Menveo vaccination that was administered subcutaneously instead of intramuscularly; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA153A, expiry date 31st March 2020) for prophylaxis.   On 18th October 2019, the patient received Menveo (subcutaneous). On 18th October 2019, unknown after receiving Menveo, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The nurse administered the Menveo vaccine subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. The reporter consented to follow up.   Follow up information was received from the nurse on 19th November 2019: The patient's demographic details were updated. On 18th October 2019 received DTPa (Reduced antigen) (Boostrix) via intramuscular on the left deltoid. The patient was very anxious and the nurse was giving the shots too quickly.   Less than week after vaccination, the patient experienced injection site erythema and injection site discomfort. The event were resolved. It was unknown if the reporter considered the injection site erythema and injection site discomfort to be related to Menveo and Boostrix. This case was considred as medication error with adverse event. The VAERS details were updated.
Gait issue; involuntary lips movement; dizziness; fatigue; This is a spontaneous report received from a contactable pharmacist (who is also the patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: unknown), via an unspecified route of administration on the left arm, on 12Jan2021, at single dose, for COVID-19 immunization, at the hospital. The patient medical history was not reported. The patient has no known allergies and was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included levothyroxine and gabapentin. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown) received at age 46 years, via an unspecified route of administration on the left arm, on 24Dec2020, for COVID-19 immunization. The patient did not receive other vaccines in four weeks. On 13Jan2021, the patient experienced gait issue, involuntary lips movement, dizziness and fatigue. No treatment was given for the events. The outcome of the events was not recovered.  Information about lot/batch no. has been requested.
Nausea, very lethargic, whole body ache, dizzy,  elevated temperature, over 24 hour period
Arthralgia in both knees.  No visible swelling.  Symptoms became progressively worse.  Pain and difficulty walking peaked 5 days after administration.    On the sixth day the symptoms stopped completely.  No longer in pain.  Walking returned to normal.  I participated in the Pfizer m-RNA clinical study.  Received my second m-RNA dose in October 2021.  After the second m-RNA dose I made a VAERS report of pain in joints.  I should not have made the decision to take the booster dose.  I made this decision on my own.
pt recv vax; had fever of 105 per ear; MD felt it was due to pertussis;pt listless per mom;
Sore arm, achiness and low-grade fever the afternoon following the date of second shot. Took Advil. Felt better by evening.
Tongue irritated,  Throat irritated  Rash appearing on stomach back upper legs very itchy
3" swelling around inj site w/bruise, itchy p/5th day;
Patient has been contacted, no existing reactions were mentioned from patient herself. She was informed that the vaccine that was administered was past it's expiration date, 4-27-2021. Gardisil was given 15 days past the expiration date.
Information has been received from a registered nurse concerning a female patient who on 27-JUN-2008 was vaccinated with ZOSTAVAX vaccine (Oka/Merck) (lot # 659672/0294X), subcutaneously. The nurse reported that the patient developed zoster on her face and eye area. Her physician prescribed antivirals. The nurse stated she is interested in VZV analysis by PCR and that the physician reported to the nurse the case was reported to CDC.