chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 Pfizers, 1/24/21, 2/17/21; booster 11/11/21. Hives began 12/05/21. Saw an allergist after an ER visit on 12/25. Allergist noted increased patient volume with hives within 4-6 weeks of booster. I take a Zyrtec daily to manage the hives.  Will monitor-hope this 'hyper response to the booster' will fade with time.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (18Aug2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Aug2023) Negative; (20Aug2023) Positive, notes: rebound COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 12Aug2023 to 16Aug2023. Clinical courses: Completed taking the paxlovid on the 16th, tested negative on the 18th, and now (20Aug2023) she had tested positive for COVID again. (rebound COVID.)  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Left arm sore. Within 24 hours soreness was in arm and left chest muscle. Spent 36 hours in bed: weak, strong head cold. By third day, soreness in arm-chest stopped and could move arm with ease. 4th day doctor examined shot area: all normal. Gave Flonase for cold : cold lasted 7 days. This was my third time for this shot. Other two times, no reaction. I had not been sick for past 7 years.
sharp pain in right neck radiating down to her clavicle and upper right arm; tenderness when she touch her humerus bone; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (sharp pain in right neck radiating down to her clavicle and upper right arm), TENDERNESS (tenderness when she touch her humerus bone) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced NECK PAIN (sharp pain in right neck radiating down to her clavicle and upper right arm), TENDERNESS (tenderness when she touch her humerus bone) and CHILLS (Chills). At the time of the report, NECK PAIN (sharp pain in right neck radiating down to her clavicle and upper right arm), TENDERNESS (tenderness when she touch her humerus bone) and CHILLS (Chills) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. No concomitant medications and treatment information were reported.
Patient began feeling flush, numbing and tingling of lips, pain radiating from left elbow to shoulder.
Several hours after injection - feeling malaise, chills, nausea. Husband states face became flushed and slightly blue in color - sx mostly resolved by the time patient present to emergency room.
pt recvd 1st dose of Engerix-B on 6JUL92 & 24 hrs later devel rash & fever up to 102 which were attributed to roseola;
Through quality control check on 10/27/2021 it was identified that patient likely received concentrated dose of COVID-19 Pfizer vaccine at 1530 on 10/26/2021. This was confirmed with administering RN. Due to knowledge gap, administering RN gave concentrated dose of COVID-19 Pfizer vaccine from multi-dose vial instead of reconstituting with diluent. Administering RN voiced uncertainty of exact amount administered to patient but did confirm dose was drawn up directly from multi-dose vial.  Patient's parents were notified and counseled by Clinic Pediatrician on 10/27/2021. Parents reported that patient has not experienced any adverse events. Parents reported patient was asymptomatic. Pediatrician counseled on monitoring and provided instruction for patient to be seen in clinic or Emergency Department by a physician if any adverse effects arise.  10/27/2021 Pediatric Nursing Supervisor called and followed up with parents. Parents report only soreness of right arm for patient which is not limiting activities. Parent had no fever, body aches, chills, chest pain, or any other concerns for patient. Nursing Supervisor reiterated instruction from Pediatrician for parents should any symptoms arise. Recommended ibuprofen and warm compress for arm soreness. If any worsening of arm soreness despite interventions, parents agreed would have patient evaluated by Pediatrician.
Started experiencing rapid/elevated heart rate several hours after receiving the vaccine; I was sitting in a chair doing nothing at all and I felt my heart racing so I took my pulse via my apple watch and it indicated 123 bpm and continued to be elevated overnight.  It woke me up several times during the night and I took my pulse on my apple watch each time, 1st time around 2am was 98bpm and 2nd time around 5am was 95bpm.  Today 12/30 it has been fluctuating between 81-95.  My resting heartrate prior to injection was 70bpm.
No adverse event; Received a dosage of 0.2 ml of the bivalent vaccine dark pink cap with yellow border as their primary; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received a dosage of 0.2 ml of the bivalent vaccine dark pink cap with yellow border as their primary) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Rotavirus (Rota tec), PCV 13, ACT Hib and Pediarix. Past adverse reactions to the above products included No adverse event with Rotavirus (Rota tec), PCV 13, ACT Hib and Pediarix. Concurrent medical conditions included Lactose intolerant, Cow's milk protein allergy and Pollen allergy (Seasonal).    On 19-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 19-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Received a dosage of 0.2 ml of the bivalent vaccine dark pink cap with yellow border as their primary). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received a dosage of 0.2 ml of the bivalent vaccine dark pink cap with yellow border as their primary) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received a dosage of 0.2 ml of the bivalent vaccine dark pink cap with yellow border as their primary).    Concomitant medication was not provided.  Treatment information was not provided.  This case contains information for the 1st patient out of 4 infant patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-720525, US-MODERNATX, INC.-MOD-2023-720526, US-MODERNATX, INC.-MOD-2023-720527 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2023: Live significant follow up appended: Added patient details, vaccination details and event information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720526:Infant Patient - 3 US-MODERNATX, INC.-MOD-2023-720527:Infant Patient - 4 US-MODERNATX, INC.-MOD-2023-720525:Infant Patient - 2
redness in arm vaccine was received in, that progressed to under the arm and onto the back. Site has heat, tingling and numbness in area. Patient has ran low grade fever post vaccination (100.2). Patient contacted physician and received cephalexin for possible cellulitis.
Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: unable to regulate body temperature-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Severe, Systemic: Lymph Node Swelling-Severe, Systemic: Tachycardia-Severe
Got dizzy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Got dizzy) and HEADACHE (Headache) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced DIZZINESS (Got dizzy) and HEADACHE (Headache). At the time of the report, DIZZINESS (Got dizzy) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medications were reported.    This case was linked to MOD-2021-033901 (Patient Link).
This spontaneous report as received from a 64 years old female consumer with diabetes and allergy to CIPRIL. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# not reported). Concomitant medications included minerals (unspecified), CENTRUM SILVER, OS-CAL + D, DEXILANT, ONGLYZA, CRESTOR, ASPIRIN and enalapril maleate (manufacturer unknown). The consumer stated that she had a silver dollar shaped itchy and raised spot about six inches long after getting the vaccination (onset date was not provided). The consumer also stated that it was warm to the touch. The consumer did not seek medical attention and not treatment was given for adverse events. It was reported that in September or October 2012 the patient underwent unspecified blood work tests (results not provided). The outcome for adverse events was reported as not recovered. Additional information is not expected.
Frontal pounding headache, nausea, started 30 to 45 min /p Engerix B was given
Felt extreme pressure in L deltoid when administered injection site sore for 1 week after injection given.
Bright red skin patches, not hives. First layer of Skin is easily peeled off on Red patches from light finger touches, chest and neck are Red, eyelids are Red and peeling, small bump (pinhead size comparison) on arm and neck appeared.  Small bump on arm opened from light touching and flaked then stabbed, small bump on neck under chin is hard and has begun to open up in a similar manner.
Bilateral large (3cm) axillary LAD, persisting for > 6 weeks epitrochlear adenopathy L arm Intercostal adenopathy R chest
got the Shingle shot and still got /suspected vaccination failure; got it; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, got shingles shot and still got shingles not as bad. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Patient with 2 COVID vaccines who admited with positive COVID test and subsequently died.  Provider d/c note; "84-year-old female with a PMH of CVA in August with PEG tube placement in September who presented with sepsis in setting of likely aspiration pneumonia, UTI with recent history of candida glabrata on prior urine culture and pylonephritis, and SMA occlusion. On admission, she was tachycardic, tachypnic and appeared in acute distress. She was discovered to be in AFib with RVR in treated with IV metoprolol. The surgery team was consulted for her SMA occlusion who determined that she was not a surgical candidate due to her complex medical history. She was started on IV heparin and given 3 L of fluid.  She was given 1 dose of doxycycline in the emergency department along with 2 g of ceftriaxone. She was also prescribed micafungin for her oral thrush infection per discussion with ID. She was also found to be COVID 19+.  Due to her supplemental oxygen requirement, she was given IV remdesivir along with dexamethasone.  Her PEG tube feeds were held due to evidence of SMA occlusion.  After admission she was reassessed by the hospitalist team on multiple occasions and noted to be medically declining.  Her clinical status was discussed with family and recommended that they pursue comfort measures.  The daughter, POA declined to pursue comfort measures stating that she wished wait for extended family to be present in the morning prior to making that decision.  On final assessment she was experiencing diaphoresis, agonal breathing with profoundly increased secretions, and fluctuating blood pressures with asystolic pauses. The patient passed at 04:31 hours and was pronounced dead by doctor. "
Became faint while driving home.  Had to pull over for safety.  Pain at the injection site.  Low Grade Fever (under 102)  Night Sweats, general malaise.  Wife drove and rapid heart beat/faintness resolved within the hour.
It started about 7:30, tired, small headache, joint aches. About 10:30 or 11pm, it got real bad real fast. Chills, high fever (102, which is the highest temp I've ever had). Joints ached severely bad and headache was terrible. some short stabbing pains in lower abdomen for a few times. No nausea or vomiting . Chills were over about 5am. Fever, headache, and joint aches persisted most of the rest of the day, though not as high or as painful. By Friday, all reactions were over except tiredness.
At around 10 pm on the day of vaccination, I started to develop a sore throat, runny nose and minor headaches. The following day, April 8, I had more severe symptoms. I had a pounding headache, body aches, chills, fatigue, low grade fever, sore throat, and a runny nose. I spent the day in bed and could not go to work. Towards the end of the day, my low grade fever had subsided, and my sore throat as well. Now I had a slight cough but still had minor chills, fatigue, headache, and body aches. I was able to sleep mostly, and by the following morning, April 9, I was only suffering from body aches, a cough, and a runny nose. I was able to attend work remotely but found my desire to engage in almost any activity very minimal. By that night, most evertything was returning to normal, though a runny nose was still present.
Chest pain with being admitted to the hospital 2 times with Pericarditis, and treated once at home for Pericarditis
fatigue, sinus pressure - but most troubling was swelling of Achilles tendon in right foot. Increasingly painful at night but difficult to put pressure on throughout day.
20x14 cm are of swelling.  Area of swelling is warm with mild erythema noted more centrally.  Noted streaking, no induration or fluctuance.  No boils.  No other rash - 3 days after MENACTRA injection.  KEFLEX 500mg capsule 1 capsule oral 3 X daily.  #30 X 10 days prescribed for possible cellulitis.
2/12 vaccination 2/13 woke up with flu like symptoms; fever, body chills, muscle aches. Symptoms lasted for 24 hours. HA started sat morning and still persisting daily. I have to Excedrin daily.
Pfizer-bioNtech covid 19 vaccine eua The previous May I was hit on a bicycle by an auto.  I had a concussion.  Symptoms were dizziness on getting up, moving my head, turning my head or looking up.  Symptoms decreased and resolved after 3 months. After the vaccine, the symptoms returned but not as severe.  They continued to resolve and were gone after one month.
I'm pregnant; Itching; This is a spontaneous report from a contactable consumer(patient) via Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 10Jun2021 as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Caller received her first dose on 10Jun2021 and had itching, that started several hours after the dose. She took Benadryl. She was pregnant. She wanted to know whether she can get the second dose. Serious was reported as no. Outcome of the events was unknown.  Information on lot/batch has been requested.
I woke up the morning of 3/15/2021 experiencing severe Vertigo. I stayed in bed another hour and the symptoms eased enough to allow me to walk. The serious incident was the evening of 3/17/2021 when I completely lost hearing in my right ear. This lasted for eight hours before gradually returning to normal. I called my doctor but did not feel the need to make an appointment.
Hospitalized with  confusion, cough, extremity pain. Pneumonia related to COVID 19 treated with remdesivir, dexamethasone and O2.
10 x 7 cm area of redness, warmth and swelling at vaccine site on right upper arm (Deltoid). Tx: oral BENADRYL.
Parent here for well child visit, present with mother in exam room. Certified interpreter present via telephone. System reviewed prior to discussing vaccines with parent. No COVID vaccine noted in child's record. RN discussed vaccines due after reviewing records, including first dose of COVID vaccine, overdue 2nd dose of Hep A, and this year's dose of seasonal influenza vaccine. Mother verbalized her consent for child to receive vaccines. Agrees with this RN's understanding of vaccines child has received and not received thus far. After child received vaccines and before proceeding to waiting room for 15 minutes of observation post-vaccination, mother presented RN with COVID vaccination record card. Card indicates two previous doses of primary series Pfizer COVID vaccine.  Pfizer EW0217 given 8/5/21, Pfizer EW0181 given 8/29/21. After visit was completed, RN located two separate records- by searching for different variations of patient's  name- after vaccine administration, one record listing two previous doses of primary series Pfizer COVID vaccine.
7NOV97 pt awoke w/fever temp?;7NOV(7 8AM pt febrile 103, eyes rolled back & had jerking;took to ER was given IV & ATB;returned home;215PM pt again febrile 104 again sz like activity;MD remarks pt has sz w/fever w/in 24hr of vax;
Rash on left leg at injection site on 04/07/2006 with fever 100.3 LG area erythema with increased erythema at medial border.
Received Dose 1 on 12/18/2020 and Dose 2 on 1/8/2021  tested positive for COVID on 5/5/2021 with positive symptoms
Had a grand mal 20hr p/vax;had no sz for 6wk until now;ear infections; Convuls Grand Mal react aggrav - otitis med. This week KD straight no seizures until this vaccination. Twenty mons later. Still seen neurologist, given medication to control. Diagnosed as epilectic.
Sinus infection after first dose; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection after first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (allergies for the last 20 years that are on and off) and Pollen allergy (Sinus infections from pollen.). Concomitant products included METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for Allergy.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUSITIS (Sinus infection after first dose). The patient was treated with PREDNISONE for Sinus infection, at an unspecified dose and frequency. At the time of the report, SINUSITIS (Sinus infection after first dose) had not resolved.            Patient was advised to stop Medrol until he receive dose-2.       Reporter did not allow further contact
Pt recvd immun 17JUN91 w/o complaint; p/leaving clinic & driving approx 1 blk pt apparently fainted & had wreck; Pt admitted to Hosp for observation; MD did not believe this was due to MMR;
REDNESS AT INJECTION SITE OF HIS LEFT UPPER ARM. ITCHING, SWELLING, PAINFUL, NO FEVER,NO SHAKES, NO CHILLS. NO SHORTNESS OF BREATH."VERY SHARP LINE OF DEMARCATION. IT IS TENDER TO TOUCH. HE HAS NO AXILLARY NODES, NO CERVICAL NODES NOTED." GIVEN DECADRON 6 MG INJECTION, ATARAX SYRUP, KEFLEX PROPHYLAXIS.
My right arm is swollen and it hurts bad; My right arm is swollen and it hurts bad; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (My right arm is swollen and it hurts bad) and VACCINATION SITE PAIN (My right arm is swollen and it hurts bad) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (My right arm is swollen and it hurts bad) and VACCINATION SITE PAIN (My right arm is swollen and it hurts bad). At the time of the report, PERIPHERAL SWELLING (My right arm is swollen and it hurts bad) and VACCINATION SITE PAIN (My right arm is swollen and it hurts bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Pain in the muscle from the injection that never subsided. Left arm in constant pain with when raised or rotated. Interferes with daily living. Interrupts sleeping. Need Tylenol at all times.
Fever 102 R Friday night until Sunday noon gradually came down & no fever p/Sunday night; did not eat or drink for 48 hrs p/shot; high pitched screaming from Friday about 6PM until Sunday night for long period of time; Seen by MD;