chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; mild stomach cramp; sinus headache; felt weird sensation in her eyes; Achy; her right arm hurts following first shot of Moderna COVID 19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), ABDOMINAL PAIN UPPER (mild stomach cramp), SINUS HEADACHE (sinus headache), ABNORMAL SENSATION IN EYE (felt weird sensation in her eyes) and PAIN (Achy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), ABDOMINAL PAIN UPPER (mild stomach cramp), SINUS HEADACHE (sinus headache), ABNORMAL SENSATION IN EYE (felt weird sensation in her eyes), PAIN (Achy) and VACCINATION SITE PAIN (her right arm hurts following first shot of Moderna COVID 19 Vaccine). At the time of the report, FATIGUE (Fatigue), ABDOMINAL PAIN UPPER (mild stomach cramp), SINUS HEADACHE (sinus headache), ABNORMAL SENSATION IN EYE (felt weird sensation in her eyes), PAIN (Achy) and VACCINATION SITE PAIN (her right arm hurts following first shot of Moderna COVID 19 Vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Severe nausea, fever, chills, severe joint pain for 6 days now.
Lightheaded, dizzy, 1 episode clear emesis,  Semi-fowlers position, rested, nausea, subsided, refused transport, felt better
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 23-year-old male. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.
24 HOURS POST VACCINATION, INDIVIDUAL EXPERIENCING SWELLING APPROX 17CM BY 20 CM LEFT TRICEP DOWN TO ELBOW.  SITE REDDENED AND WARM TO TOUCH.
Medical staff did not dilute Pfizer vaccine properly and inadvertently gave patient larger dose. Patient has no symptoms at this time.
After the 2nd dose I experienced waves of discomfort just below my rib cage and above my belly button for 4 days; along with chills and joint pain; along with chills and joint pain; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 69-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6208 and expiration date was not reported), second dose via an unspecified route of administration, administered in Arm Left on 16Mar2021 13:00 (At the age of 69 year) single for covid-19 immunization. Medical history included high cholesterol and atrial fibrillation from an unknown date and unknown if ongoing. Patient had allergy of drug that was not reported. Concomitant medications included Lovastatin (20 MG), Metoprolol (50 MG), Aspirin (acetylsalicylic acid, 81 MG) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, it was Unknown if the patient diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The COVID-19 vaccine was administered to patient at Pharmacy or Drug Store. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6200 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 22Feb2021 10:00 (At the age of 69 year) single for covid-19 immunization leading to headache and joint pain. On 16Mar2021 22:00 the patient experienced waves of discomfort just below my rib cage and above my belly button for 4 days, along with chills and joint pain. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Patient had no Hospitalization Prolonged and Treatment Received. Case was considered as non-serious. The outcome of the events was recovered on unspecified date of 2021.
Developed itching first on back in evening of 6/14/10, then developed red itchy rash on back only (description sounded like hives) and itching progressed to chest, abdomen and arms. All symptoms resolved on own in 2 days, gone by 6/17/10. Required no treatment.
3hrs p/DT/HIB pt screamed 1 hr, t104 x 2 days-dec w/APAP 101; pt looked as if sunburned;
Transient face swelling, right eye dryness, cluster headaches  since 03/05/21. Bells palsy symptoms right side of face since 03/07/21.  Swelling is transient symptom.  Cluster headaches are transient symptoms.  Bells palsy symptoms have not resolved.  Treatment from PCP is steroid prescription started 03/20/21.
Patient presented with sore and swollen biceps - marked area and asked to watch for spreading swollen tissues. Will see a provider if it increases in area then will visit MD. Patient returned 11/12 at 9am and swelling and redness had not spread - his arm feels much better.
Woke up 10/01/15 could not raise arm above 90 degrees, upper arm swollen, next day redness of upper arm along with swelling, took about 5 days to resolve.
Developed ITP (immuno thrombocytopenic purpura), & on 3-10-12, required two doses of IVIG on 3-10 and 3-15.
Patient states she noticed the area around the injection site was swollen and red. Patient was seen in provider office on 3/19/13 and given antibiotic therapy.
I have Lichen Sclerosus all over my torso, several spots on my back and arms
Rash and hives on chest, arms and legs developed approximately 2 weeks after being vaccinated.  Treated with OTC antihistamines without success and then given a Medrol Dose Pack.  No fever ever present.
CHIEF COMPLAINT:   last had surgery 4 wks ago. now finger is infected.   HISTORY OF PRESENT ILLNESS:     Patient is an 18-year-old female with past medical history significant for Ehlers-Danlos syndrome who presents to the emergency room with complaints of an infection to her left fourth digit.  Patient reports she has had chronic issues with this finger and recently had surgery 4 weeks ago.  States she was seen by her surgeon last week on and they did a culture of the wound and it came back positive for a specific bacteria.  Due to patient's allergies as well as inability to take fluoroquinolones secondary to her Ehlers-Danlos they told her to come to the emergency room for admission, IV antibiotics, and PICC line placement.  Patient did bring a copy of susceptibility results.  Patient reports the area is mildly painful and she is having some decreased range of motion.  States that her pain is a 7 out of 10.  Denies any paresthesias or weakness.  Denies any fever, chills, chest pain, shortness of breath, nausea, vomiting, diarrhea, weakness or fatigue.  Patient also did test positive for Covid on January 15, states she has been asymptomatic the entire time.
Bilateral leg swelling 2 days after dose of vaccine, followed the next day by blotchy raised purple skin rash covering length of both legs Suspect autoimmune reaction
chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were reported. No treatment medications were reported.
pt recvd 2nd dose of vax on 4MAR92 pt devel pain & swelling of elbows, knees & joints of hands; joints were swollen & warm to the touch; lab eval was nl x/serum bilirubin 1.6, EOS 10, ANA 1:160 & a neg rheumatoid factor; 4MAR93 psoriasis;
Very high fever (104.5), nausea, vomiting, lethargy, dizziness, loss of appetite
Following administration of dose 1, the night of, chest pain and acid reflux occurred. (Pt has no history of acid reflux) Total doctor visits after due to discomfort: 3. Medications given: Prilosec and Pepsid. Symptoms did subside. Following administration of dose 2, the next morning, pain level 8 chest pain and acid reflux, epigastic pain. ER visit. Given GI cocktail.  Symptoms subsided days after for the most part...currently comes and goes.
7AUG91 mom called stating pt had been running fever 101-102 for 2 days & has 6 or 7 pimple like rash on face; 9AUG91 mom calls again states pt has rash over entire body; Encouraged to take to MD; Pt seen by MD dx poss rxn or roseala
48 hours after vaccine given in (L) deltoid, pt reported pain/aching in (L) deltoid/upper arm. Next day had radiation to elbow, forearm-still present in upper arm. On 10-11-19-seen in CLINIC w/her pain in (L) arm 6/10 with use, 4/10 @ rest. Exam: no inflammation seen, possible tingling sensation/strength.
Vaccinated with 2nd dose of Moderna COVID-19 vaccine on 7/22. Also developed a URI at that time. URI for a few days.  on 7/28 evaluated by MD for leg pain/limp and diagnosed with transient synovitis. This is likely related to URI rather than vaccine, but reporting since vaccination occurred in the past week.
1)Low grade fever on 10/2020 in evening, higher fever on 10/22. At Dr. office on 10/22. Dx Pharyngitis. Prescribed Amoxicillin. Fever gone 10/24. Had a rash on 10/24. Exposed to Roseola in daycare. Amoxicillin discontinued on 10/24 2) had staring spells, lasting several seconds, once per day starting 10/22. Also episodes of eyes looking upwards and to the side, several times a day. Does not appear tired after the episodes. Also episodes of both knees moving inwards and outwards, several times a day 3) Hospitalized 10/26/20 to 10/27/20, for 24 hours continuous digital EEG/video monitoring
Severe vertigo, nystagmus (BL), nausea, vomiting for 3 hours. No treatment, just rest the next day. My husband is a neurologist and we didn't go to the ER.
Heart Palpitations started 2 hours after the shot. Heart pounding for 48-60 hours. Unable to sleep as a result of pounding.  After heart palpitations stopped, fatigue started. Fatigue went on for 6 weeks after shot. Included occasionalll breathlessness and extreme tiredness.
Patient went to ER on 4/29/13 rash around lips and nares. Dx impetigo Rx BACTRIM. Shot administered on 4/25/13 MMR/VZV. 5/8/13 patient came to office with rash all over body. Dx varicella rash secondary VZV shot 4/25/13.
A non-serious spontaneous report of administration of expired product has been received from a Registered Nurse concerning a 6 year old female who received FLUMIST. Medical history and concomitant medications were not reported. On 16-Dec-2008, this child was administered FLUMIST which expired on 15-Dec-2008. There was no adverse event associated with this error; therefore; treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 09-Apr-2009 that included the results of an investigation of into the cause of medication error.
Patient received 4th doses of Dtap and IPV vaccine at 9 months. Nurse miscount number of Dtap and IPV vaccines patient already had. Pediatrician was informed and patient's mother was contacted to inform patient received extra dose of Dtap and IPV.
Blood thinner then before; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD DISORDER (Blood thinner then before) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029120A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced BLOOD DISORDER (Blood thinner then before). At the time of the report, BLOOD DISORDER (Blood thinner then before) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is on blood thinner. Treatment details not provided.
Immediately after vaccine patient complained of feeling hot and having hard time breathing. After 10 minutes was feeling normal. Vital signs check, BP slightly elevated which is baseline for patient. 02 sat 100% on RA.
FLU-LIKE SYMPTOMS; NERVE PAIN ON LEFT SIDE AND GOES FROM SHOULDER, ARM, CHEST, AND INTO FINGERS; CHILLS; TIREDNESS; MUSCLE ACHES; NAUSEA; FEVER; PAIN AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced flu-like symptoms. On 07-APR-2021, the subject experienced nerve pain on left side and goes from shoulder, arm, chest, and into fingers. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced muscle aches. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced pain at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, chills, muscle aches, nausea, and fever on 12-APR-2021, and had not recovered from nerve pain on left side and goes from shoulder, arm, chest, and into fingers, tiredness, and pain at the injection site. This report was non-serious.
Normal soreness the next day and then a few days later I had a sore lump in my armpit.  This lump stayed until exactly one week later and moved back into the outside of my arm near my shoulder and was sorer than the original soreness.  This went away approximately two days later.  Then, at about two more days later, I felt pins and needles throughout my whole left arm and a squeezing feeling with slight pain.  It was gone the next day.  Then, exactly three weeks after vaccine shot, on Tuesday, August 10, I had severe pressure in my left side arm, shoulder, and heart which prompted me to go the Emergency Dept thinking I was having a heart attack.  All the pressure except shoulder blade area went away and I was severly fatiqued with stomach upset and slight headache for approximately 24 hours after that.  As of today, I no longer have pressure in those areas, but still have slight headache, which most likely is from allergies.
Ptpresented to immunizations clinic for third HPV vaccination on 27 Jul 2022. Vaccine was administered 27 Jul 2022 @ 1003 am. Member waited at the clinic for 15 Minutes after the vaccination. No reactions observed at that time. Pt reports he had allergic reactions starting 29 Jul 2022. Pt has larger than a quarter size hives all over his body. Pt complaints of itchiness and redness. No know allergies at this time. Pt has had 2 HPV vaccines in the past with no allergic reactions.
Patient called the pharmacy asking about side effects regarding the flu vaccine she recieved a month ago. She says for the last month her injection arm has been sore, she's having difficulty lifting it up, and has diffiiculty doing normal daily tasks. Pharmacist spoke with her and informed the patient it could be an administration technique error where the vaccine is given either too high or too low. Pharmacist explained an event like this isn't normal and thanked her for calling. Patient is thinking about contacting her doctor.
Patient came back to clinic 4 weeks after immunizations patient had c/o of decreased appetite, fever, red spots over extremities and diaper area then spreading to back. Started light (red) and small raised bumps, then became bright red, larger and scabbed. Treatment supportive care: fluids, BENADRYL if begins scratching, lukewarm baths w/vinegar or oatmeal.
Information has been received from a physician concerning a female who in July 2007 received her second dose of Gardasil. The physician reported the patient experienced swelling in her feet, legs and abdomen which was characterized as "pitting edema." The physician reported the patient's edema was increasing weekly. The patient also experienced bloating and a decreased appetite. As of 28-SEP-2007, the patient was not recovered. Additional information has been requested.
Moderna vaccine (HDC 80777-0273-98) lot 039D21A and GTIN 00380777273983 was administered after the beyond date of 10/23/2021. Contacted manufacturer Moderna no need to repeat the dose.
Soon after receiving the shot, I had soreness in my arm but also began experiencing numbness from the area where I received the shot all the way down to my wrist.  That soreness and numbness are still there and it has been three weeks since receiving the first shot so I am concerned that this numbness is permanent.  As such I do not intend to receive the next shot for fear of my arm becoming even more numb or even losing all sensation in my left arm.
Administer expired vaccine to 450 patients after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) in a 68-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. Total of 173 doses/vials were given for LOT  070H21A.  The vial did not undergone to any temperature excursions. No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow-up received contains non significant information
Pain, tenderness, and swelling at injection site for two days. Plus joint pain, chills, fever fatigue for three days.
The vaccine was maintained at proper refrigeration temperatures, but for longer than 31 days.  7/29/21 was day 31 at refrigeration temps and vaccine was given on 8/10/21.  No adverse events have been reported by patient.  Error discovered on 8/16/21
Shingles on right back torso (size of closed hand) and spread minimally to front side of right torso.   Beginning 3/12 - present.
A little over an hour after vaccine, began having itchy rash with hives on shoulder above injection site on left arm, that quickly spread across to neck up to my chin and down to my cleavage. My husband is an icu nurse, and after consulting with the pharmacist who administered the shot, we got Benadryl (I took two) and Pepcid (I took one) to stop the reaction. Rash and hives went away after 45 minutes after taking those. Began again on my neck a few hours later, took the same dosage of Benadryl and Pepcid, has not been back.
patient got a booster dose from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got a booster dose from an expired vial) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A, 011J20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got a booster dose from an expired vial). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient got a booster dose from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter. Patient mentioned they got all doses on the left arm, does not take any medication regularly. Patient was pregnant at the time of first and second inoculation and delivery date was 28May2021. Patient  would like to participate in the pregnancy registry.
PCR test next day positive; PCR test next day positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from agency.  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Lot number: EL3247) at the age of 32 years as dose 2, single and administration date 05Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset 18Jan2022, outcome "unknown" and all described as "PCR test next day positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jan2022) positive, notes: Nasal Swab. Reporter stated that the patient received other vaccine in four weeks and covid prior vaccination was unknown. Patient had tested with covid post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure and covid-19 and BNT162B2.