chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 36 hours after vaccine was given, slightly below vaccine site - leg became red, swollen, no pain, playful and happy.
12 hours after recieiveing the shot I had chills, body aches and headache which lasted approximately 12-15 hours. The next day I felt fine.   At approximately 6pm on 2/10/21 I went to eat something and realized that I could not taste it. I reported the symptoms to my hospital employee health and the suggested I get tested for Covid. When that was negative they made me get a second test which was also negative.  This delay caused me to miss 3 work days.
Shooting tingling sensations through arms and legs. Minor burning/heat sensation in hands and feet. Headache. Stomach pain.
pt recvd vax vax & states evening 20APR93 temp went ot 104.8 called pvt MD instructed to give double dose of APAP; also states crying but not high pitch cry & cranky;
Patient received Varivax 9/29/03, ProQuad 9/22/2004, and another Varivax 9/28/07. (I spoke with CDC on 9/28/07. May have increase local reaction, otherwise Ok).
Headache, back pain, neck pain, paint at injection site. "Feeling Down" feels sick, body aches, chills.
Sore throat; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (low grade fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PYREXIA (low grade fever). On 24-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). The patient was treated with PARACETAMOL (TYLENOL) on 23-Mar-2021 at a dose of UNK dosage form, tid. At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by the reporter.
Joint pain; Muscle pain; Tiredness; This is a Spontaneous report from a Contactable Consumer reported for himself that:  A 53-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8735), via an intramuscular route of administration, administered in Arm Left on 02Apr2021 (At the age of 53 years) as DOSE 1, SINGLE and also received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0161) via an intramuscular route of administration, administered in Arm Right on 23Apr2021 (At the age of 53 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. On an unspecified date in May2021, the patient had experienced Joint pain, muscle pain and tiredness. Therapeutic measures were taken as a result of joint pain. The patient had taken vitamins like magnesium for joint pain. At the time of reporting, the event muscle pain was recovering and events tiredness and joint pain were not recovered.  Follow-up attempts are completed. No further information is expected.
Pt. developed right lower medial leg pain on Friday. She states the pain radiated up her leg and she felt there was warmth to the area. She denies injury. She states she had the J&J covid vaccine two weeks ago and has concerns of a DVT. There is minimal swelling and ecchymosis in the area. There is no redness or warmth noted. There is no tenderness, redness or warmth noted in her calf area. She has good pedal pulse and good capillary refill of her nail beds. She has no significant PMH and denies any recent air travel, long car rides or prolonged sitting. She states she is active.
Fever (101), cold sweats, malaise, diarrhea, coryza, cough, headache.
Soreness at the site of injection for 48 hours. Mild aches for about 24 hours beginning  5 hours after injection. Treated with ibuprofen.
PT described redness, swelling and itching at inject site and forearm. Pain related to swelling. PT ibuprofen, Vicodin and applied topical homacaine?. Pain, swelling and redness treated at about 5 days post vax. Today presents 5 adverse Sx's.
Third dose of Pfizer's COVID vaccine incorrectly administered. only 2 doses required. No side effects/ symptoms observed but patient being closely monitered.
Within 36 hours, post vax, pt developed localized swelling at the injection site. No itching, soreness or induration noted.
week later still hurt like being run over by a truck; Off label use; booster; Fever; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historically the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on unspecified dates as 1st dose and 2nd dose both for covid-19 immunisation. On an unspecified date in Oct2021, the patient experienced week later still hurt like being run over by a truck. On an unspecified date in 2021, the patient experienced fever. It was reported that the patient received the booster last Monday and a week later still hurt like being run over by a truck. Her fever finally broke overnight, thankfully. It sat for days at 103 F. Her question was that with the first two shots she received messages asking how she was doing, her side effects, etc. She would like to know if Pfizer was doing this for the booster also. She would like to report on her side effects because it was one of the worst things she had ever dealt with in her lifetime. On an unspecified date in 2021, the patient underwent lab tests and procedures which included body temperature: 103 fahrenheit (It sat for days at 103 F). The outcome of the events week later still hurt like being run over by a truck was not recovered. The outcome of the event fever was recovered on an unspecified date in 2021.   The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
HAS APPROXIMATELY 15 LESIONS ON TORSO, FEW ON CHIN AND LEFT ARM.
Patient received the wrong second dose of the Covid-19 vaccine. First vaccine was Pfizer on 4/15/21 and second was Moderna at our location on 5/6/21. Patient had no adverse events and was monitored before departing from our facility.
Patient received dose of vaccine. While standing patient experienced syncope and fell to floor. Bumped head against wall while falling but was caught by father before hitting floor.  He quickly regained consciousness and had a strong pulse. He remained on the floor with feet elevated for 10 minutes.  He then sat in chair IN front of pharmacy for an additional 15 minutes.  At that point he felt fine and left the pharmacy with his father.
SLIGHTLY SORE ARM BY THE INJECTION SITE; This spontaneous report received from a patient via a company representative via social media. concerned a 9 decade old of unspecified sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. On an unspecified date, the patient was previously vaccinated with of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, for covid-19 prophylaxis. Age at time of vaccination 85 years old. The patient did not have a problem with covid-19 vaccine ad26.cov2.s (Dose number in series 1). Ten months later the patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 86 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced slightly sore arm by the injection site (Dose number in series 2).  As per the reporter, "I had my Covid shot and did not have a problem. I was going on a cruise and opted to have a 2nd J&J Covid shot as a booster 10 months later. The only reaction I had was a slightly sore arm by the injection site. I was 85 the first shot and 86 for the second shot. The reason I opted for J&J was because I worked for them when they were working on a cure for AIDS and I had first hand knowledge of how they researched and tested for a safe answer." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slightly sore arm by the injection site was not reported. This report was non-serious.
Severe menstrual bleeding over a 10 day period. Had been in menopause and not had a period for 18 months prior to receiving first dose of vaccine.
Big Blood Clot in left leg; This is a spontaneous report from a non-contactable consumer (Patient). A 80-years-old female patient (Non-pregnant) received bnt162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection), via an unspecified route of administration on 28Mar2021 11:00 as single dose for COVID-19 immunisation. The patient medical history included allergies to Demerol. The patient's concomitant medications were not reported. On 17Apr2021 21:30 patient experienced big blood clot in left leg. Patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included Nasal swab test results negative on 16Apr2021. Treatment received for the adverse event was blood thinners. The outcome of event was Not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Narrative: COVID infection following COVID vaccine series 12/30/2020, Pfizer, dose #1 01/21/2021, Pfizer, dose #2 05/27/2021 CT CHEST Impression: 1. Interval decrease in size of right upper lobe branching nodular opacity likely representing mucous plugging. Additional bilateral pulmonary nodules are stable. 2. Stable posterior right intramuscular fluid collection, possibly seroma. 07/20 pt cc: exposure: unknown 08/12 COVID swab, result: detected 08/12 SARS-COV-2 Variant Sequencing results: No results obtained. Specimen did not amplify.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. 2 years after receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation of shingles was not provided.
Vaccines administered after more than 1 temperature excursion; Vaccines administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccines administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines administered after more than 1 temperature excursion) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021 at 11:33 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021 at 11:33 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccines administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 68.39 years.  No concomitant product use was reported.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Vial was stored in cooler 1, on 03-Mar-2021, excursion temperature at 9 am 51, at 10 am 34, at 11 am 44, at 12 am 46, at 1 pm 35, at 2 pm 36, at 3 pm 36, at 4 pm 36.  On 03-Mar-2021, excursion temperature at 9 am was 51, at 10 am was 34 and at 1pm was 35, total doses given for the day was 200, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 03-Mar-2021. 20 vials were moved to clinic. Vaccine BUD date was 26-Mar-2021.  Temperature recordings were taken by using a traceable temperature monitor at every hour. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
4 x 7 inch cutaneous allergic reaction that started 9 days after the vaccine was given and is worsening with OTC therapy
COUGH; COMMON COLD; EXTREME FATIGUE/ LEG FATIGUE; FUZZY MIND (FOR COUPLE OF WEEKS); BONES HURT; HEADACHE; FELT WEAK; HEAT GLOW (FEELING LIKE HASN'T SLEPT); This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced heat glow (feeling like hasn't slept). On 14-MAY-2021, the subject experienced felt weak. On 15-MAY-2021, the subject experienced headache. On 21-MAY-2021, the subject experienced fuzzy mind (for couple of weeks). On 21-MAY-2021, the subject experienced bones hurt. On 21-MAY-2021, the subject experienced extreme fatigue/ leg fatigue. On 30-JUN-2021, the subject experienced common cold. On an unspecified date, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fuzzy mind (for couple of weeks), bones hurt, headache, felt weak, and extreme fatigue/ leg fatigue, was recovering from common cold, and heat glow (feeling like hasn't slept), and had not recovered from cough. This report was non-serious.
Patient received 1st dose of shingrix vaccine at her pharmacy on 8/22/19. Sore arm started the evening after the vaccine; redness/swelling started the day following - started out localized and has spread over time. Mild redness and swelling down arm into left armpit. Arm is sore and there is a rash. She reports fever, achiness and headaches following vaccine. Some nausea.  She reports a fever until last Saturday night - no further fevers since. No further aching, nausea or headache as of evaluation today.   No significant ongoing pain or limitation in use of arm.
Client presented with hive like rash to left upper extremity, area was warm to the touch and slightly swollen.  Client reported that area itched and that she applied topical hydrocortisone cream to area.  Client also reports that she has had flew shots before but this is the first time she has had a reaction.  Client denied any difficulty breathing.
Severe pain and stiffness in neck, shoulders, upper arms, hips and thighs. Diagnosed as POLYMYALGIA
Just a few mins after her vaccines, she began getting urticaria on both arms, left more than right.  Had 4-5 ~1cm urticaria on L upper arm and one on forearm.  Another one on RUE.  No WOB.  Not itchy.  Left arm had the MMR/V vaccine and the right had the DTaP/IPV.  Gave 7ml benadryl and monitored for 30 mins.  No progression of symptoms including breathing or GI issues.  No further lesions noted.  Sent home with mom.  They will call with any further concerns.
NAUSEA, FAINT FEELING, BLURRED VISION, HARD TIME HEARING
Pharmacy error: The Moderna vaccine with lot#003C21A that was sent out on 11/24/21 to our clinic should've the absolute expiration date of 12/17/21 and not 12/24/21
I started feeling bad on Sunday, run down, very tired, no fever. My Dad and brother and I were together over the weekend we thought we had a sinus infection because of the weather change. It feels more like a head cold, congestion, runny nose, back pain from coughing, chills. I took a home test on April 8, 2023, it came back negative. On Monday I was feeling worse, I tested again, this time it was positive, I had a telehealth visit and was prescribe PAXLOVID. I have taken the full five take course of medication. I still have congestion, raspy throat. I am not sure if it is my allergies that are bothering me or if I am not completely over COVID-19.
Temp sub-normal, 96.5 degrees then 101 degrees, then 97 degrees severe abdominal cramping and headache. Went to clinic after several days of this.
Patient vaccinated with Pfizer vaccine mixed with sterile water instead of 09% Normal Saline, preservative free. Consulted with FDA and CDC to determine next steps for patient after discovery. Re-vaccination advised and outreach team contacting impacted patient and offering to speak with a physician to discuss.
covid 19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (covid 19) in a 95-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (1st dose) in January 2021, COVID-19 VACCINE (2nd dose) in February 2021, COVID-19 VACCINE (3rd dose) in November 2021, Covid-19 vaccine (4th dose, this was an additional dose as recommended by her doctor because she is a senior citizen) in July 2022, Covid-19 vaccine on 15-Oct-2022 and bivalent (Pfizer) (6th dose - late Mar2023) in March 2023. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE, Covid-19 vaccine, Covid-19 vaccine and bivalent (Pfizer).    On 26-Sep-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 03-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced COVID-19 (covid 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 04-Oct-2023 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid 19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Oct-2023, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was reported that patient was hospitalized due to bronchitis and was in a rehab recuperating when she got the vaccine. She started having cough on 01-Oct-2023. Reporter stated that she was stable and recovering. Company Comment: This is a spontaneous case concerning a 95-year-old female patient with no reported medical history, who experienced the non-serious, unexpected event of COVID-19, which occurred approximately 7 days a after a dose of mRNA-1273.815 (Spikevax 2023-2024 PFS), received as the seventh dose of COVID-19 vaccination schedule. It was reported that patient was hospitalized due to bronchitis and was in a rehab recuperating when she got the vaccine. She started having cough on 5 days after vaccination. Reporter stated that she was stable and recovering. The benefit-risk relationship of mRNA-1273.815 (Spikevax 2023-2024 PFS) is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-744633 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744633:Son's case, Same reporter
lump in her neck area; Booster; This is a spontaneous report from contactable consumer. This 68-year-old female consumer (Patient) reported for herself. A 68-year-old female patient received third dose of BNT162B2 (COMIRNATY, formulation: solution for injection, Batch/lot number: FF8839) via unknown route of administration on 05Oct2021 (at the age of 68 years old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient did not have relevant medical history and concomitant medications were not reported. Historical vaccines included first dose of BNT162B2 (COMIRNATY, formulation: solution for injection, Batch/lot number: EM9809) via unknown route of administration on 07Feb2021 as DOSE 1, SINGLE and second dose of BNT162B2 (COMIRNATY, formulation: solution for injection, Batch/lot number: EN6203) via unknown route of administration on 28Feb2021 as DOSE 2, SINGLE for COVID-19 immunisation. It was reported that after first dose patient did not have side effects but on her 2nd dose last 28Feb2021, she developed a lump in her arm below her elbow and this summer she was diagnosed to have a Lipoma, according to caller she still had it. It had mostly stayed the same since it began and one day, this was the reason she finally got it addressed, it got firm and hard and she could feel. It was a muscular lipoma and maybe her muscle did something. She was curious as to getting the booster and wondering if that lump would get bigger. She thought it was just a coincidence with the lipoma in her arm but when this occurred with the booster she was not so sure. It might be bigger or it might not be, in her arm, but now recently she had noticed the one in her neck. On 05Oct2021 she had her booster dose, and this morning 07Oct2021 she woke up with another lump in her neck area. It is slightly different because it has a hard center and when she went to the bathroom she realized that she had a big puff all around her neck sticking out. She wanted to know if this had been reported before and was there any information on what can stop this and if this side effect that she had was not Lipoma and just swollen lymph nodes. The outcome of the event was not recovered.  Follow-up (19Oct2021): Follow-up attempts completed. No further information expected.