chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: Tingling in face and legs
Frozen shoulder, sore/aching pain. Could not move arm freely for 2 months used. ALEVE for pain and physical therapy. Reported to pharmacy on 10/25/17 (inj. given 08/16/17).
Nosebleed; Upper and lower back pain; Chest pain; Knee pain; Nausea; This is a spontaneous case received from a contactable consumer (patient).   A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: Not reported), via an unspecified route of administration on 17Mar2021 at single dose for COVID-19 immunisation. The patient's medical history included COPD, insulin dependent diabetic, past drug event allergies on lisinopril, that made her coma for 3 days, coma. Concomitant medications were not reported. On an unspecified date, the patient experienced nosebleed, upper and lower back pain, chest pain, knee pain and nausea. She had experienced nosebleed for trice on an unspecified date. Patient asked if the side-effects would be worse after taking second dose. She was informed that no information about nosebleed during the clinical study of the vaccine was seen. The outcome of the events was unknown.  Information on the lot/batch number has been requested
Tingling pains in hands and arms. Days later same tingling in legs and feet. Difficulty breathing; could not talk or grab/hold on to anything. Diagnosed with Guillain Barre Syndrome.
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) (Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "heart rate is really fast and I noticed that, it got really fast like couple of days ago" (ongoing). The patient's concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "Heart rate is really fast; was like sitting down watching TV and it was like 112". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Consumer stated, just want to report some side effects that having after the first dose of the vaccine. Patient heart rate was really fast and patient noticed that, it got really fast like couple of days ago, patient was like sitting down watching TV and it was like 112. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. states immediately after receiving the 2nd Phizer 05/28/2021 started experiencing immediate muscle pain and spasm. Extreme shoulder and arm pain with limited mobility.
About 21 hours after my injection of my second dose of the Moderna Vaccine, I started having chills and uncontrollable shakes.  I left work and went home.  By about 5 pm, I was feeling weaker and felt like I was running a light fever.  I continued to have chills and uncontrollable shaking, at times.  by 6-7 pm, I felt like I had COVID all over again.  Very weak, shortness of breath, shaking, fever, aches, headache and loss of apatite.  This lasted and got worse through out the night.  The next day, I was still feeling the same.  Around noon time, I started developing a cough, like I had during my COVID experience back in August.  The doctor then told me I had a case of pneumonia with my COVID.  This felt the same.  I was incapacitated as far as doing normal activities.  I was still not eating and I could tell I was getting dehydrated.  By that evening, on the second day, I did finally start feeling better.  I got to a point were I could eat and drink, but still very tired, coughing and headaches.   The chills and fever had passed.  The third day, I was still weak, but not as bad, still having a headache and now I was a little dizzy.  I left work early on the first day and stayed home afterwards.  At the time of this writing, I am much better with a mild dull headache.  I am eating and drinking now, but still have a cough.  If the cough continues, I will seek medical care, but I hope it will clear up.
Itchy, red, sore, swollen spot at site of injection on left arm.  Spot is about 2 inches around and started 8 days after vaccine.
Was warned but for tracking purposes did want to report flu like symptoms after the vaccination. Fever of 101, chills, aches, some nausea, and feeling like my body was on fire at times. I did have to leave early from work due to Advil and Tylenol not improving symptoms. I am however feeling a little better now over 48 hours post vaccine but still have some aches in legs and joints.
pt recvd vax & devel erythema & induration @ inject site; pt was treated w/Keflex;
Hard lump popped up; Hard lump popped up- described as hard, red and painful to touch; Hard lump popped up- described as hard, red and painful to touch; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Hard lump popped up), VACCINATION SITE ERYTHEMA (Hard lump popped up- described as hard, red and painful to touch), VACCINATION SITE PAIN (Hard lump popped up- described as hard, red and painful to touch) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer BIONTECH COVID-19 vaccine (1st and 2nd doses). Past adverse reactions to the above products included No adverse reaction with Pfizer BIONTECH COVID-19 vaccine.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced VACCINATION SITE MASS (Hard lump popped up), VACCINATION SITE ERYTHEMA (Hard lump popped up- described as hard, red and painful to touch), VACCINATION SITE PAIN (Hard lump popped up- described as hard, red and painful to touch) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 05-Nov-2021, VACCINATION SITE MASS (Hard lump popped up) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Hard lump popped up- described as hard, red and painful to touch) and VACCINATION SITE PAIN (Hard lump popped up- described as hard, red and painful to touch) outcome was unknown.            On 05-Nov-2021, a hard lump popped up. It was located in the injection site and was described as hard, red and painful to touch. Patient does not take daily medication and did not take medication to treat symptoms.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a 85-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date July 2020) and (batch number DA34Z, expiry date July 2020). On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site cellulitis (serious criteria GSK medically significant), injection site rash, injection site warmth, injection site erythema, injection site swelling and allergic reaction. On an unknown date, the outcome of the injection site cellulitis, injection site rash, injection site warmth, injection site erythema and allergic reaction were not recovered/not resolved and the outcome of the injection site swelling was unknown. The reporter considered the injection site cellulitis, injection site rash, injection site warmth, injection site erythema, injection site swelling and allergic reaction to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. As per the sales data sheet the batch number changed to ZY3X4, DA34Z instead of 243XY, DA3YZ respectively. The pharmacist reported that patient received SHINGRIX vaccine about a week before the time of reporting and at the time of reporting the patient came into pharmacy with red raised warm area at the injection site. The pharmacist reported that an allergic reaction that looked like cellulitis, and when asked to describe, the pharmacist described all the adverse events. The patient reported that the area was higher above the injection site, but had moved down lower of the injection site. The pharmacist stated that was 3 to 4 inches in length by 2 to 2.5 inches in width in an oval shape. The patient was told to take CLARITIN by her physician. The pharmacist believed by discussion with the patient the physician wanted to start her on an antibiotic but the patient did not want to. No antibiotic had been ordered at time of reporting.
Within two weeks after the 2nd shot, I got "covid arm" itchy rashes in two spots an inch below the injection site. I treated the itchiness with hydrocortisone 1% cream.  It went away after about 10 days.  Shortly thereafter, the area began to tingle (pins and needles), along with the top of my forearm on the same side. This tingling has been intermittent, and my forearm has been itchy for the past 3 weeks, and hydrocortisone 1% cream doesn't make much difference. For the past two days, the itching has spread to the former "covid arm" rash area, as well as to a different area on my forearm, and also to one spot on my upper chest. I have raised welts in all three areas. The itching is maddening, and the tingling is frightening.
Joint and muscle pain in all joints.  Feels like electric shocks and then aching.   It has been 8 weeks and still have the pain.  Now it is mostly in my ankles and legs.  Before the vaccine, I never had pains in my joints.
Swelling/redness and heat distal to the injection site, from biceps to below the elbow. The injection site looks normal.
Heart rate dropped to 40, extreme pain around chest and back, sweatng, throwing up,rash
Swollen lymph node in neck; swollen right eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from a sales representative. The reporter is the patient.  A 29-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 2, Swollen lymph node in neck, Manufacturer unknown), for COVID-19 immunization, reaction(s): "Swollen lymph node in neck"; Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization.  The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph node in neck"; EYE SWELLING (non-serious), outcome "unknown", described as "swollen right eye".  Additional Information: It was reported that patient had swollen lymph node in neck occurred after dose 2 in primary series as well. This was reported as well. The event took place after use of product.   The lot number for bnt162b2 was not provided and will be requested during follow up.
She got her vaccine, she had a headache, fever, chills (soaked her bed 3-4 times), diarrhea, fatigue and not able to function for 3-4 days.  She was so tired that she stayed in bed.  She did not take anything for her symptoms.   She has now recovered from her symptoms.    She did have a similar reaction to the 4th COVID vaccine as well. but this was worse than the last one.  She did not have any reaction with the first two.
This spontaneous report as received from a nurse, refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored ROTATEQ oral liquid (strength, dose and lot number or batch number unspecified). No concomitant medications were reported. No symptoms were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient complained of difficulty breathing, sweaty, dizziness, fainting after flu shot. Gave EPIPEN immediately. Called 911 patient taken to emergency room.
STARTED AT ABOUT 8:30 PM ON 8-6-11. STATES SHE HAS RASH ON STOMACH/ENTIRE BACK = BOTH ARMS. NO REDNESS = SL. SWELLING.  NO FEVER NAUSEATED FOR ABOUT 1 HOUR.  (AT SITE RIGHT ARM) - STATES THIS AM RASH IS JUST ABOUT GONE - DENIES ANY OTHER PROBLEMS
Headache, Fever, CHILLS/FATIGUE Narrative:  Other Relevant History:
High fever. My son lost his eye contact, stop talking, since we had MMR and Hep B vaccine now he is diagnose with autism and epilepsy.
This case was reported by a lawyer and described the occurrence of hearing loss in a male subject of unspecified age who was vaccinated with Lyme disease vaccine (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject was vaccinated with Lymerix. According to a statement of injuries, at an unspecified time after vaccination with Lymerix, the subject experienced joint pain and swelling, flu like symptoms, hearing loss, tingling in extremities, headache, fatigue, possible memory loss and decreased activities of daily life. The statement further alleged that the subject suffered from rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune medicated, or other mechanism, all caused by vaccination with Lymerix, including but not limited to those set forth above. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events were was unspecified.
Patient received PNEUMOVAX 23 and FLUAD vaccination on 11/26/2018. PNEUMOVAX was in left arm, FLUAD was in right arm. Several hours after receiving vaccinations, patient's left arm began to swell. Patient's arm right arm not affected. Left arm continued to swell until 11/28/2018. Patient only reports soreness and discomfort. Patient reports taking Benadryl and Tylenol to self-treat.
A cluster of 7 patients who received ADACEL lot #C2769AA and experienced adverse events. This case is for the patient with the redness, swelling and pain of the entire vaccinated upper arm. This cluster is detailed in cases 2007-02921, 2007-02929, 2007-02995. Initial report received on 30 August 2007 from a health care professional. An unidentifiable patient received on an unspecified date a dose of ADACEL (lot #C2726AA) and experienced redness, swelling, severe pain of entire vaccinated upper arm, with impaired range of motion of his arm. The patient was seen in the office and was still recovering. No other information was provided.
On 3/14/21 @ 2304 : 77-year-old female patient presents emergency room with generalized fatigue body aches dry cough shortness of breath and subjective fevers as aggressive worsening since Friday.  Patient received a 2nd dose of the pfizer COVID-19 vaccine on Friday 3/12/21 and states her symptoms worsened since then.  Chest x-ray showed patchy bilateral infiltrates with concern for COVID pneumonia, also questionable vascular congestion as patient does have significant history of heart failure with pacemaker.  EKG revealed paced rhythm 87 beats per minute.  Emergency room patient was placed on BiPAP and responded well, patient was given vancomycin and cefepime for sepsis protocol.
No adverse event at this time.  Patient is doing fine, no symptoms, running around house acting normal. Told parent to call with any issues and will check back in on Friday.
SYMPTOMATIC, TESTED POSITIVE FOR COVID-19 5/4/2021.
Two days after receiving the vaccine, the patient came to the ER with upper left chest pain. Patient had felt fine after the second vaccine and was hiking (two 14-ers). Upon coming home he had sudden chest pain.
Severe shoulder pain, limited mobility, arm weakness still from the first day of injection (1/14) to now (1/23). Can?t adduct arm or move it side to side with out a lot of pain. If I do a wrong movement I will end up in 10/10 pain with severe aches.
pt recvd vax & 6 days later exp episode of body jerking while sleeping @ noc no other sx were reported; no fever, no vomiting; lab work revealed blood chem abn; electroencephalogram done was nl;
After a month and half after being vaccinated my periods started coming every two weeks went to see my primary care doctor and referred me to my OBGYN and have my appointment next week.
Patient fainted 5 minutes after receiving the vaccine.  Patient was helped to the floor and layed down for 5 minutes and vitals were taken. A cold pack was applied to her neck and she was given juice. patient sat in a chair for another 5 minutes and was sent home in stable condition.
Nurse prescriber reported that the patient had received MMR II on unspecified date many years ago so a titer test was done 2 weeks ago.  It came back negative for measles so a dose of MMR II was given but an expired MMR II dose was given; Nurse prescriber reported that the patient had received MMR II on unspecified date many years ago so a titer test was done 2 weeks ago.  It came back negative for measles so a dose of MMR II was given but an expired MMR II dose was given; This spontaneous report was received from a nurse prescriber referring to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date many years ago, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). So, a titer test was done 2 weeks ago on 07-JUN-2022 and it came back negative for measles, therefore on 20-JUN-2022 a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was given but this vaccine was expired (lot# T013728 with an expired date on 21-APR-2022).   At the time of reporting, the outcome of the events was not known.    The causal relationship between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
LIGHT HEADEDNESS; BAD HEADACHE; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 13-JUN-2021) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced light headedness. On 24-MAY-2021, the subject experienced bad headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from light headedness, and bad headache. This report was non-serious.
Pharmacist discovered vaccine product (Pfizer) had extra doses /solution then what he has normally come accustomed to into later part of working shift when recording/drawing  a 6th and final dose to be administered of Pfizer vaccine. Pharmacist believes there were 1-2 more doses at least left worth remaining to able to be given from product. Video footage has not been studied nor possibly will not be able to reviewed or confirm but am taking precautions in case vaccine product did not have "extra" doses and patient was inadvertently  given wrong vaccine (Moderna) as booster and or overly diluted product.
This spontaneous report as received from a Certified Medical Assistant refers to a 12-month-old patient. The patient's medical history was not reported. On 14-MAR-2016, the patient was vaccinated with a dose of PROQUAD (rHA) (lot number L046507, expiration date 17-MAY-2017) and a dose of VARIVAX (Merck) (lot number L041207, expiration date 20-OCT-2017) during the same visit due to product confusion (also considered as overdose). The reporter stated that the PROQUAD (Merck) was mistaken for M-M-R II which was the intended product.  Dose and route of administration were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
lip was swollen; Itchy Rash; rash on her arms and shoulders; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lip was swollen), RASH PRURITIC (Itchy Rash) and RASH (rash on her arms and shoulders) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced LIP SWELLING (lip was swollen), RASH PRURITIC (Itchy Rash) and RASH (rash on her arms and shoulders). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, LIP SWELLING (lip was swollen), RASH PRURITIC (Itchy Rash) and RASH (rash on her arms and shoulders) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Polymyalgia Rheumatica   PMR   muscle stiffness  disease   with pain and disable to bend over and move stiffness in neck, shoulders, back and soreness in body  Took 6 months to diagnose.   Many doctor visits, many vials of blood, 20 xrays, 2 MRIs, 1 ultrasound--Doctors--primary, pain management, rheumatologist, vascular doctor.   Had blood tests to find that CRT and SED inflammation levels were high, blood tests ruled out some diseases.   Rheumatologist diagnosed  as polymyalgia rheumatica after all the tests.  Pain meds and muscle relaxers did not help.  Stiffness got worse in night.  Could hardly navigate till late afternoon each day. Once diagnosed the Rheumatologist put me on prednisone.  That worked immediately, but now I am suffering from longterm use of prednisone. I am on it for a minimum of a year. The average length of prednisone for PMR is 3 to 5 years.  I started on a dose that helped and I try to taper down 1 mg a month.  It will take a year or more if I can actually get off prednisone.  This is a lifetime disease.  It can to in and out of remission.  I have had to change my diet and entire lifestyle.  Now I have to consider my bones and the rheumatologist wants me to take a Prolia shot.  I cannot be on Fosomax because of my acid reflux.
Dose #1 of Moderna COVID-19 6m - 5 yr given on 7/19/22 and tolerated well. Dose # 2 Moderna COVID-19 6m-5yr given on 8/9/22 (Three days earlier than grace period and 1 week prior to recommended interval date due to a scheduling error)- No adverse events reported.   Re-education provided to scheduling staff and nurses. Posted reminders to double check dosing intervals. Mother made aware of scheduling error and recommendation to revaccinate. Appointment scheduled.
5/13/21 Started stomach flu S/S: n&v, diarrhea for 2 days, then weakness began and was ongoing and still present 6/10/21 Legs started feeling heavy and hurting, no energy. Elbow and knee joint pain, terrible headaches (8-10 on pain scale). Chills but no fever 6/22/21 Chest pain off and on