chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle spasms in left cheek; This is a spontaneous report from a contactable consumer. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 06Mar2021 at 16:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included iodine allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 13Feb2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 07Mar2021 at 09:00, the next day following the vaccine, the patient experienced muscle spasms in her left cheek for approximately 12 hours. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event muscle spasms in left cheek was recovered on 07Mar2021.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown demographics. Patients medical history and concurrent conditions were not reported. From 20-APR-2015 to 29-APR-2015, VAQTA (lot # K005958, expiration date: 12-FEB-2017) was improperly exposed to 26F for about 216 hours. On an unknown date in 2015, unspecified number of patients might receive Hep A vaccine (dose, route of administration and anatomical location was unknown) which were improperly stored. Concomitant medications were unspecified by reporter. No known adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 11:47 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 11:47 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient ethnicity was reported. The patient received Moderna vaccine on 02-Apr-2022 11:47:06, past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. No treatment medications were provided.   This case was linked to MOD-2022-542869 (Patient Link).
"I" started feeling a little more tired than usual; Slightly sore at the vaccine site; "My" right hand started to feel extremely tingly/ Every time "I" moved it or touched anything it felt like that area was full of needles; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 06Apr2021 at 08:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and known allergies to hops (beer). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medications included vitamin d nos (VITAMIN D); for an unknown indication from an unknown date and unknown if ongoing. On 06Apr2021 at 10:00, a little over an hour after her vaccination, the patient started feeling a little more tired than usual and slightly sore at the vaccine site. After a while she took a nap, sleeping on the side where she got the vaccine. When she woke up (which was sometime between 3-4 hours after the vaccine) her right hand started to feel extremely tingly. Every time she moved it or touched anything it felt like that area was full of needles. After about 10-15 mins though this went away. A couple hours later, the patient no longer felt tired, and though her arm was a little sore over the next day or so, it was nothing significant. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events feeling a little more tired than usual, right hand started to feel extremely tingly, every time she moved it or touched anything it felt like that area was full of needles was resolved on 06Apr2021, while that of slightly sore at the vaccine site was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
After receiving Pfizer Covid vaccine booster on April 20, 2022, I experienced pain and loss of hearing in my right ear. The problem then spread to left ear. Multiple visits to ENT doctor due to hearing loss in both ears.
Bleeding from our gums, a lot of blood coming from my mouth; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL BLEEDING (Bleeding from our gums, a lot of blood coming from my mouth) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced GINGIVAL BLEEDING (Bleeding from our gums, a lot of blood coming from my mouth). At the time of the report, GINGIVAL BLEEDING (Bleeding from our gums, a lot of blood coming from my mouth) had not resolved.            No concomitant medications were reported.  No treatment information was reported. Action taken with mRNA-1273 in response to the events was not Applicable
Dermatographia developed 14 days after vaccine, itchiness across entire body including face and scalp which becomes like hives after scratching.
MULTIPLE ORGAN FAILURE; SEVERE BLOOD CLOTS; This spontaneous report received from a patient via a company representative via a social media concerned a 38 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was an former healthy woman. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 in total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date following vaccination with covid-19 vaccine ad26.cov2.s, the patient had a severe reaction such as multiple organ failure and severe blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe blood clots and multiple organ failure was not reported. This report was serious (Other Medically Important Condition). This case was a duplicate of 20221031295.  Additional information was received from patient via a company representative via a social media on 13-OCT-2022. It was determined that 20221031295 was a duplicate of this case. All relevant information regarding this case will be submitted under 20220956930. The following information was updated and incorporated into the case narrative: Case validity updated (from invalid to valid).; Sender's Comments: V2: This follow-up version updates- that It was determined that 20221031295 was a duplicate of this case. All relevant information regarding this case will be submitted under 20220956930. The following information was updated and incorporated into the case narrative: Case validity updated (from invalid to valid). This follow up information received does not alter the assessment of prior company causality of previously reported events.  : 20220956930-covid-19 vaccine ad26.cov2.s-Multiple organ failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220956930-covid-19 vaccine ad26.cov2.s-Severe blood clots. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Had a blood clot in Left lower leg DVT resulting in a Pulmonary Embolism 8 months after getting the second shot.
i) Pain in left arm and shoulder started same evening. Lasted 3-4 days ii) High fever for next 2 days. Temperature was as high as 102 iii) Dry coughing and breathlessness iv) Ongoing asthma attacks and breathlessness. Started the day after second shot. v) General feeling of tiredness and lack of focus. (Ongoing)
Recipient is a 17yo who presented for second dose of COVID-19 vaccine. She reported some anxiety related to receiving dose #2, and had some nausea after dose #1. She was alone as a driver of her own POV.  Consent was obtained from the recipient and her custodial grandparent by phone, witnessed by doctor. She initially did well after the vaccine, but after approximately 5 minutes began to complain of feeling nauseated, lightheaded, and tingling extremities (hands and feet). She was noted to be hyperventilating, and was placed in a supine position but continued to feel some lightheadedness and difficulty breathing. Breath sounds were clear without wheezing noted, HR 70s with RRR. She was noted to have ongoing anxiety, nausea and symptoms progressed and although she remained normotensive to hypertensive (initial BP 128/74), she had repeated episodes of syncope.  She was transferred to the ambulance and further vitals and EKG were obtained. She had some confusion after episodes of syncope and some seizure-like activity with syncope, with very brief episodes of LOC, with noted tachycardia with HR up to the 140s during episodes of syncope.  BP ranged 129/86 to 140/84. IV access obtained and she was given NS and started on oxygen at 2 liters, but saturations remained in the 98-99% range. She was ultimately transferred to the local ER for further evaluation and management given ongoing symptoms, evaluated at hospital.
Passed out in yard. Crawled into house . Chills and joint pain for 12 hours. Ok next morning
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On unspecified dates, an unknown number of patients were inadvertently vaccinated with VARIVAX (Merck) (dose, dose number, route, anatomical location, lot number and expiration date were unspecified), that had been improperly stored. No concomitant therapies were reported. No adverse effects reported. the outcome of the events was unknown. Additional information has been requested.
Immediate pain in left arm upon injection. Within 30min's- arm pain felt worse and persisted for 3 days.  6hrs. later fatigue, headache, shivering, fever, and nausea became unbearable.  Rendered to bed for 3 days with fever and shivering, extreme body ache, joint pain and hallucinations.  Complete loss of appetite,   Do not plan to take the 2nd dose in 2mths as recommended.
Right inguinal lymphadenopathy discovered on 2/23/2020 during routine diaper change. Lump does not appear to be painful to patient, but concerned parents who brought her in.
Moderna Vaccine , 2nd dose administered 7/22/21, on 8/2/21, hives appear,
Child was vaccinated on 4/18/16 approx. 3:45 PM.  The child went home and took a nap.  At 6:00 PM the child woke up with a 103 degree fever.  The fever continued x 3 days.  The mother contacted the provider on the 3rd day, but was unable to get in to the doctor for a few more days.  The child's fever stopped on the third day and she broke out in a rash all over her body on that same day.  The rash lasted 1 1/2 days.  By the time the child was seen by the provider, she had no symptoms.
Headache, Arthralgia, Diarrhea, NauseaVomiting, fatigue, injection site pain Narrative:  left work at noon on 12/31/20
Pt was administered the 5-11yo formulation when she had turned 12 the week before.
Covid like symptoms; fever; muscle aches; This is a spontaneous report from a contactable Nurse. A 58-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient medical history included positive for COVID in Sep2020. He was positive 98 days before receiving the vaccine. Concomitant medications were not reported.  The patient experienced covid like symptoms which include fever and muscle aches on Dec2020. Patient would like to know if receiving the vaccine after having COVID in September was causing his symptoms; if his symptoms are expected or common after the first dose; and if he should receive the second dose. Event outcome was unknown.  Information about lot/batch number has been requested.
5NOV lt shoulder pain,10NOV lt arm & lt hand weak w/tingling of 4th & 5th fingers;11NOV rt arm & rt hand weak & tingling;18NOV legs shaky & didn't feel right & lt side of face tingling;saw internist;1 or 2 2ks later saw neurologist;CTS
lump under the armpit near the breast is size of golf ball,it feels like size of softball; tenderness; is swelling underneath the left armpit, near left breast; is hard around injection site; left arm, around the injection site to across arm it is swollen,swelling- size of softball under the skin across the left arm; swelling is sore,swelling is hurting,hurts when brushing off against anything,painful, causes pain; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (lump under the armpit near the breast is size of golf ball,it feels like size of softball), TENDERNESS (tenderness), SWELLING (is swelling underneath the left armpit, near left breast), VACCINATION SITE INDURATION (is hard around injection site) and VACCINATION SITE SWELLING (left arm, around the injection site to across arm it is swollen,swelling- size of softball under the skin across the left arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 024M20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to ibuprofen), Drug allergy (Allergic to meloxicam), Psoriasis and Autoimmune disorder. Concomitant products included METHOTREXATE for Psoriasis.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced SWELLING (is swelling underneath the left armpit, near left breast), VACCINATION SITE INDURATION (is hard around injection site), VACCINATION SITE SWELLING (left arm, around the injection site to across arm it is swollen,swelling- size of softball under the skin across the left arm) and AXILLARY PAIN (swelling is sore,swelling is hurting,hurts when brushing off against anything,painful, causes pain). On an unknown date, the patient experienced AXILLARY MASS (lump under the armpit near the breast is size of golf ball,it feels like size of softball) and TENDERNESS (tenderness). The patient was treated with PARACETAMOL (TYLENOL) on 03-Oct-2021 for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, AXILLARY MASS (lump under the armpit near the breast is size of golf ball,it feels like size of softball), TENDERNESS (tenderness), SWELLING (is swelling underneath the left armpit, near left breast), VACCINATION SITE INDURATION (is hard around injection site), VACCINATION SITE SWELLING (left arm, around the injection site to across arm it is swollen,swelling- size of softball under the skin across the left arm) and AXILLARY PAIN (swelling is sore,swelling is hurting,hurts when brushing off against anything,painful, causes pain) outcome was unknown.            Patient stated that she had not taken methotrexate all this year because she is Changing PCPs.
10 days AFTER the shot, a 3-4 inch bright red circle appeared. It was HOT to the touch. It faded after 3 days.
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache every single day which worsens at night), PAIN IN EXTREMITY (sore arm) and PAIN (throbbing pain) 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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced HEADACHE (headache every single day which worsens at night) and PAIN (throbbing pain). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 19-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, HEADACHE (headache every single day which worsens at night) and PAIN (throbbing pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product used was not provided by the reporter.
Information has been received from a nurse concerning an 18 year old female with no pertinent medical history, seasonal allergies and allergies to nickel and penicillin who on 02-AUG-2007 was vaccinated intramuscularly (site not reported) with the 1st dose of the 0.5 ml Gardasil (lot#655620/0171U). The patient was concomitantly vaccinated with Varivax (MSD) and DTaP (manufacturer unknown). On 15-AUG-2007, the patient was seen in the emergency room with lowering hcg levels and some vaginal bleeding. On 16-AUG-2007 and 17-AUG-2007, the patient returned to the emergency room with continuing decreasing hcg levels and later had a spontaneous abortion (exact date not reported). On 01-OCT-2007, the patient was vaccinated intramuscularly (site not reported) with the 2nd dose of the 0.5 ml Gardasil (lot#658094/0524U) while pregnant (WAES#0801USA01237). Follow-up information was received from the nurse stating that the exact date of the spontaneous abortion and LMP after the 2nd dose of the Gardasil vaccine is unknown. Upon internal review spontaneous abortion was considered to be an other important medical events. Additional information has been requested.
Wife called to report a COVID-19 vaccine reaction. Patient received the J&J vaccine on 9/16 at Pharmacy. He did not feel well that night- achy joints, "fever skin", states skin felt as if he had the flu. He felt well after 3 days. On 9/27, Patient developed achy joints and stated he did not feel well. He died on their driveway. He was transported to Hospital and pronounced dead. Wife states she was informed he had an enlarged heart. Reports autopsy pending. States he was overweight, but had no medical history.
1/16/99 tiredness; sl fever (T not taken); 1/17 inc tiredness; T103-cool bath; 1/18 sluggish behavior; fever up & down 100-103; children's tylenol; 1/19 approx 3-4am died in sleep
Subsequent to receiving one dose of varicella virus vaccine live the pt developed a few spots on back, hands and head with no blisters and diarrhea. Six days post onset the pt recovered.
Patient states he started with fever symptoms the night after the vaccination, such as feeling very cold, shivering, and feeling low blood pressure. He said he felt like that for five minutes then it stopped without taking any medications. The next day he states he woke up with the area of the shot very red and swollen. He called the pharmacy today to follow up on symptoms, and he was counseled on using cold compresses to help with the swelling. He states he is getting better and was able to go to work normally.
By the afternoon, bump started on mid back by shoulder blades - left side. Then pain started for 10 days. Pain originated on back but could feel it on front. Little scar remains now. Did not go to the doctor bcs traveling.
Information has been received from a registered nurse concerning a 12 month old white female patient, with no medical history or allergies, who on 10-Jul-2003 at 4:30 pm was vaccinated SC into the left thigh with a first dose of MMR vaccine live (second generation) (lot #644581/1082M). Concomitant therapy on 10-Jul-2003 included a first dose of varicella virus vaccine live (lot #644569/1158M) SC into the right thigh and a third dose of Streptococcus pneumoniae vaccine (PREVNAR) (lot #492-815) IM into the right thigh. It was reported that the patient was not ill at the time of vaccination. On 10-Jul-2003 the mother called and stated that the patient's left thigh was reddened and "baseball size." The patient's mother was advised to use warm compresses, anti-pyretic and anti-inflammatory medications, and to seek medical attention if symptoms worsened and/or any respiratory or generalized symptoms occurred. It was reported that the patient vomited and was seen in the emergency room. The patient was monitored, was given ibuprofen (MOTRIN) and electrolytes (unspecified) (PEDIALYTE). It was reported that "today" the doctor examined the patient, monitored and gave fluids. During a public health nurse (PHN) home visit, it was reported that there was no redness or swelling noted and there was good strength and movement. It was reported that the patient recovered on 11-Jul-2003. Additional information is not expected.