chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Syncope. Fell to ground and hit head. Had 2-3 myoclonic jerks. Awoke immediately thereafter and was alert and oriented.
arm swelling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelling) in a 65-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm swelling). At the time of the report, PERIPHERAL SWELLING (arm swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Per report, the patient received 2 doses of Moderna COVID-19 vaccine and experienced arm swelling after received doses. Treatment information was not reported.   This case was linked to MOD-2021-091442.
9/1/15 Severe arm pain, swelling, malaise. 9/2/15 Extreme fatigue, all over body aches, chest pain, chills.
Patient was stabilized in the ED and extubated. Patient transferred to the floors where he returned to baseline mentation, with Cr and Lactate normalized and LFT's improving. Source of septic shock thought to be urinary or bacterial PNA. LP clean. Grew out MSSA. Discharge on course of PO Augmentin. Patient tested positive for COVID and received Remdesivir and Decadron, but patient not hypoxic and patient's presentation more consistent with bacterial sepsis than COVID respiratory failure. Patient has panhypopituitarism. Endocrine recommended starting Levothyroxine 50mcg, and continuing on on Decadron 5mg. Endocrine follow up outpatient. Patient had lower Hgb and Platelets, likely due to dilution from IVF and inflammation. Repeat CBC in 5 days.
The patient reported feeling numbness and tingling that radiated from her right arm to the right side (cheek area) of her face. She also experienced swelling from the arm to the face. She stated that the symptoms resolved about a day later.
approx. 12 min after shot , I started to notice a sharp pain at the base of my skull bone, behind my ears. pain lasted about 20 min. around 7:00 pm that night I started having lymph node swelling under my left arm. around 7pm I started having pain in my right achilles tendon. The lymph node  swelling lasted approx. 3.5 days. The achilles tendon pain last about 24 hours.
COVID-19; COVID-19; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: unknown) via unspecified route on unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the Pfizer-BioNTech COVID-19 vaccine 2 months ago and got COVID-19 and was in a hospital. Reporter stated that she is not sure if the patient was hospitalized due to COVID-19 or due to other ailments. Reporter inquired if they should revaccinate the patient. The clinical outcome of the events was unknown.  The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up. Sender's Comments: The contributory role of the suspect product to the reported drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency.
patient had the flu once, and it was the year the patient took the shot; Initial information received on 15-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves patient of unknown demography (a sixth-grade teacher) who had the flu once, and it was the year the patient took the shot (influenza), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu once, and it was the year the patient took the shot (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE. And it was reported that teacher's immune systems build up quickly.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the event influenza.  There will be no information on the batch number for tis case.
Reported tachycardia and mild headache on Monday night. State it was so scary that she almost called 911. States she is much better today.
Patient is 16 years of age; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is 16 years of age) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is 16 years of age). On 20-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is 16 years of age) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that a 16 years old patient got 2 doses of vaccine. The patient experienced no issues with the 2 doses and the patient was not on any medications on daily basis.   This case was linked to MOD-2021-211522 (Patient Link).
Stinging and burning pain to face and head. Pain intense enough to call EMTs for transport to ER.
Combined initial reports were received from health care professional via the call center on 28 Jan 2011 and from the consumer on 31 Jan 2011: This poly-medicated patient had a medical history of fibromyalgia and rheumatoid arthritis. The patient had a vaccination history of influenza INN, tick-borne encephalitis INN and hepatitis A and B INN. All vaccinations had always been well tolerated. The patient was vaccinated with a first dose of RABIPUR (batch no. 48011A) on 15 Dec 2010, second dose on 22 Dec 2010 (batch no. 48011A) and the third dose (batch no. 48011A) on 12 Jan 2011. Approximately 1.5 hours after the first dose on 15 Dec 2010, the patient developed dizziness which was persisting including the next day and then completely recovered. Approximately 3 hours after the second dose on 22 Dec 2010, the patient developed dizziness which persisted including next day and then completely resolved. From 23 Dec 2010, the patient felt exhausted and tired. On 25 Dec 2010, the patient displayed in the evening a migraine like attack and numbness and prickle in the ring finger and index finger in both hands. The symptoms were more pronounced in the right hand. On 31 Dec 2010, the patient had completely recovered. On 05 Jan 2011 and 06 Jan 2011, the patient again displayed a migraine like attack (headache) which completely resolved. One to two hours after third vaccination on 12 Jan 2011, the patient again displayed migraine-like attack with headache and dizziness. These symptoms lasted until 24 Jan 2011. From 25 Jan 2011 to 27 Jan 2011, the patient displayed headache and exhaustedness. The final outcome of the events was reported as recovered.
Vaccine that was kept for more than 30 days in the refrigerator was administered to 4 patients; Received booster dose from a vial stored more than 30 days in refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received booster dose from a vial stored more than 30 days in refrigerator) and PRODUCT STORAGE ERROR (Vaccine that was kept for more than 30 days in the refrigerator was administered to 4 patients) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received booster dose from a vial stored more than 30 days in refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine that was kept for more than 30 days in the refrigerator was administered to 4 patients). On 29-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Received booster dose from a vial stored more than 30 days in refrigerator) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vaccine that was kept for more than 30 days in the refrigerator was administered to 4 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported No treatment medication reported No information on previous doses for patient reported Date of vial was initially stored in the refrigerator reported as 29-Dec-2021 It was reported that vial had not undergo any temperature excursions.
No additional adverse event (AE)/ product quality complaints (PQC) reported.; The vaccine was administered after the excursion; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 19-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (0.5 milliliter, lot # U017140 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 28-NOV-2022; strength and route were not reported) after temperature excursions (product storage error) with sterile diluent for prophylaxis. The administered dose experienced temperature excursions of 6 Fahrenheit (F) up to 14 F for 4 hours and 14 F up to 46 F for 4 hours 45 minutes. No previous excursion was reported. No additional adverse event was reported.  A phone call was received from the reporter on 17-MAR-2022. It was reported the reporter did not have any patient information at the reporting. It was confirmed this was one of ten reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-2203USA001850: US-009507513-2203USA001841: US-009507513-2203USA001578: US-009507513-2203USA001612: US-009507513-2203USA001617: US-009507513-2203USA001688: US-009507513-2203USA001728: US-009507513-2203USA001890: US-009507513-2203USA007379:
Pt. states that after receiving the 3rd Booster of Moderna 10/27/2021 (High-Dose Influenza 10/27/2021), started experiencing symptoms that evening of swollen/sore arm (Covid Left), headache, nausea, vomiting and fatigue. (High-Dose Influenza) arm no symptoms. No noted Primary visit/communications.
On 11/8, the mother called to report a hard, red, swollen area the size of a golfball. On 11/9, the mother called to state area now size of baseball. On 11/9, the mother also stated that an office visit was made to the pediatrician. MD states that the vaccine leaked into the subcutaneous tissue causing reaction. Treated with westcort cream and ice packs. Estimates 2-3 weeks to subside.
Starting around two weeks post-vaccination, I noticed what felt like cold sores / dry mouth around my lips. There were no visible sores, but some redness and maybe a slight swelling. I treated with some OTC items (kanka, peroxdyl) and it subsided a few days later. Then about a week ago, symptoms returned and I had a telehealth visit with my Primary Care doctor on 4/9. She prescribed Acyclovir and recommended Vitamin B12 complex, in addition to using aquaphor to assist with the dry lips. She did not indicate that it was the vaccine, but did not rule it out, so I wanted to report the reaction. While this has helped, it has still not fully improved, and I will be seeing my allergist on 4/19 for a follow up as that was her recommendation if it didn't go away.
The pt's upper arm around injection site became red and inflamed from his shoulder to 2 inches above his elbow. Reaction revolved without need for any treatment after approximately 1 week.
pt recvd vax & had fever 102; irritability; started 5 hrs after vax, persisted x 20 hrs;
Have had 5 periods since 3/11/21. Very heavy, nonstop bleeding. Bleeding for at least 10 days at a time. Currently on 5th period, day 11 and still bleeding. It doesn?t stop. Tests and ultrasounds come back normal yet the only thing  I did was get my second dose of moderna vaccine on 02/27/21. I also developed itching from head to toe about 7 days after my second dose. Itching did bot stop for 10 days .
Pt began having rash 7/28/2004. Pox broke out over entire body (>50pox). Was confirmed by PA 7/30/2004 at clinic.
Client returned to clinic 10/12/2001 complaining of pain, redness, swelling and drainage from injection site. From where the area was located on the arm, the hep B injection would have been civen there. Her mother reported client had been scratching the injection site.
The adverse events, other than a sore arm was on the third day, I had extreme dizziness for two days. Following that, which caused me to go to the DR, was that I had a foggy ear. I could not hear out of my right ear. I had pressure in my ear that has not gone away, that is still occurring and that is six months ago now. I went to an ENT DR and they did tests and found that my right hearing is lower than my right hearing and I am having ringing in  my right ear as well. I had surgery this morning on my sinuses, I was so clogged up. I have had two antibiotics to try and help and then had to have the surgery today. Now we are just waiting to see how this all works out.
I had a normal reaction of little fever and achiness for a day or two, but then in early May I started having heart palpitations like I was having intense heartbeats 3-4 times in a row and then it would go away and come back. It lasted a week or two. I went to the Doctor and they did blood work and EKG to check for other causes and it was normal and it would happen intermittently. After about 3 weeks, they sort of went away on their own of occasional episodes of 3-4 beats. My pulse felt like my heart was skipping a beat and Doctor thought it was PVC's but it's not an official diagnosis. Doctor said to come back and I would do a 24-hour monitor but they ended up going away after 3 weeks and so I haven't done that. I was cleared to run and keep running after that but to keep an eye on it.
"Reports since receiving his flu vaccination, he has experienced progressively worsening right sided facial numbness. Within the last three hours, he has begun to experience mild right sided facial droop."
After my Moderna vaccine, at about 6pm I felt my lymph nodes got swollen and my body started to ache.  I really started to feel harsher symptoms the next day on 02-20-2021;  just felt my lymph nodes more  swollen and tender to touch and I started to feel crummy. On 02-20-2021, I had an odd combo of symptoms, the pain I felt was like I was giving child birth, my uterus and ovaries were hurting really bad, had tender breasts, felt like I was lactating. I also felt like I had influenza A, where my whole body ached, these symptoms lasted a whole day. I slowly started to resume my normal activities. Since receiving the vaccine, I?ve have bad periods, pain like having childbirth.   My subsequent menstrual periods were horrible, had worse menstrual cycle.  My last menstrual cycle was not at bad at all. I called my gynecologist, reschedule for next week appt, the symptoms of menstrual period have subsided and I will be having have an appointment to see my gynecologist next week.
No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 22-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA001345: US-009507513-2207USA004690: US-009507513-2207USA004688: US-009507513-2207USA004679: US-009507513-2207USA004695: US-009507513-2207USA004697: US-009507513-2207USA004698: US-009507513-2207USA004691: US-009507513-2207USA004707: US-009507513-2207USA004709: US-009507513-2207USA004710: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715:
Patient given dose #2 of GARDASIL, seems to tolerate well. No c/o offered - fainted upon preparing to leave facility, hitting back of head hard on door frame - Loss of consciousness for approx. 1min; with posturing of head and arms, possible seizure no obvious head wound or bleeding. Patient transported to local hospital for evaluation. Had further episode of posturing after regaining consciousness.  7/13/09 Hospital ER records received DOS 5/13/09. Assessment: Vasovagal syncope. Patient present at ER after having a syncopal episode in a clinic waiting room after receiving shot of "Depo". Parents report patient was shaking and "posturing" - flexed arms and wrists. Dizziness. Mild headache.   6/19/09 ICD-9 codes received. 780.2 784.0
Patient became lighheaded,nauseous and flushed 10 min post vaccine. Moved patient to floor to prop up legs. Gave cold compresses and water. Pharmacit took BP reading and it was elevated. Pharmacist interviewed patient to find out she had not eaten today or taken BPmeds.  Patient complained of trouble breathing; RPH asked if she wanted paramedics to come and she agreed since pharmacist had taken another reading and it was 145/110. Paramedics called and took her to nearby hospital
Pt received ZOSTAVAX on 11-11-13. The next day (11-12-13) blisters appeared at the injection site. Blisters became larger and broke. Large raised area around blister and larger flush area was to the elbow.
Day of shot had extremely sore arm at the point of the shot and above and below area of the shot.  After a couple of days, joint pain in the shoulder area where the shot was administered, that has not yet gone away.
This spontaneous report was received from a consumer via Pfizer refers to a male patient of unknown age. Information on pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dosing details not provided). On an unknown date, the patient experienced unknown side effects (adverse event). The outcome of adverse event was unknown. Causality of the event was not provided.
patient received improperly stored PEDVAX HIB; No adverse effect; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, historical drugs, drug allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (strength, dose and frequency was not reported) (lot # S000352, expiration date 17-OCT-2021) for prophylaxis. On 04-NOV-2019 or 05-NOV-2019, the patient received an improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB). Exact date of administration was unknown. No adverse effects were reported. There was no previous temperature excursion reported. The call was because of data logger, with a lowest temperature below 36 degree Fahrenheit/2 degree Celsius (1.3 C) for 2 hours 18 minutes. Product quality complaint was not involved in the case.  This is one of several reports received from the same reporter.
pt recv vax about 1-2PM 11JUN96 & 3PM mom called pt appeared to have a sz-no fever;had been given APAP @ the provider-advised to take to hosp ER
pt recvd vax; screaming uncontrollably for 7 hrs, passed out fr exhaustion,has been crying since 10mar;seems in pain,not sleeping,loss of appetite;
Two swollen lymphy nodes; Joints aching; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Two swollen lymphy nodes) and ARTHRALGIA (Joints aching) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) .4 milliliter. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to .4 milliliter and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to .4 milliliter. On an unknown date, the patient experienced LYMPHADENOPATHY (Two swollen lymphy nodes) and ARTHRALGIA (Joints aching). At the time of the report, LYMPHADENOPATHY (Two swollen lymphy nodes) and ARTHRALGIA (Joints aching) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  On unknown dates patient reported two swollen lymph nodes and aching joints. Patient also reported negative reaction from last 3 Humira injections.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
In less than 12 hours I developed extreme muscular aches, heart palpitations and general anxiety.  I was nauseous, sweating, and passed out at my home early the next morning.  I was unable to get myself up due to weakness after I fell.  My husband assisted me and we went to the ER where they kept me overnight. The next day  multiple test were run due to my symptoms appearing to be heart attack and since I have a Mitral Valve Prolapse.  Those test included: ECG, Nuclear Stress Test,  MRI, Chest X Ray, Echocardiogram,  and multiple blood test throughout the 30 hours I was in the hospital.  I was released late afternoon on the 2nd day and advised to follow up with my primary doctor.
WITHIN 15 MINUTES OF RECEIVING 4 MONTH SET OF VACCINES PATIENT HAD AN URTICARIAL RASH.  HE RECEIVED 1 MG/KG OF BENADRYL WITH RESOLUTION OF RASH. HE WAS SENT HOME ON BENADRYL TWICE PER DAY FOR 5 DAYS.
Patient has subsequently been diagnosed with dilated cardiomyopathy secondary to myositis, ?vaccine-induced.  Symptoms started on 3/22/2021 and she has experienced significant progressive palpitations and dyspnea on exertion.
Booster dose given too early. Patient's pcp told the nurse to administer booster when dates verified after admin last dose of Pfizer was administed on 09/02/2021 which made the booster dose to early. No reaction to the vaccine noted.