chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Pediatric Booster dose was administered instead of Booster Bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (Pediatric Booster dose was administered instead of Booster Bivalent) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus.   On 30-Oct-2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Sep-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 10-Sep-2022, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (Pediatric Booster dose was administered instead of Booster Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (Pediatric Booster dose was administered instead of Booster Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (Pediatric Booster dose was administered instead of Booster Bivalent).    No concomitant medications were reported. It was reported that pediatric booster dose was administered to  patient instead of the bivalent booster dose. Unfortunately, the Moderna Pediatric vaccine vial was mixed with the Bivalent Booster vials.  The goal was to administer the Booster Bivalent dose, but the Pediatric vial was administered instead.  There was no information primary doses. The adverse event did not cause patient to seek medical care. The patient did not experienced a similar event in the past. No treatment medications were reported.   This case was linked to MOD-2022-644030 (Patient Link).
PATIENT WAS GIVEN VACCINE PRIOR TO ROUTINE SCHEDULE DATE. PATIENT HAD NO ISSUES PRIOR TO LEAVING CLINIC.
Right leg swelling, itching at inject site, also urticaria. Given 2 tsp benadryl elixir and placed under ovservation for 30 minutes.
High fever, bad chills, bad body aches, loss of appetite, coughing up mucus infection from chest, nasal congestion and infection,  very weak and tired
I had sore throat, stiff neck (meningismus), migratory polyarthritis in right shoulder and hip, loss sense of smell, no swelling in my glands, no fever puss on my tonsils, and loss of appetite. I saw a MP and was tested for Flu A, B, Strep, no swelling in my glands, no fever COVID-19. I tested positive for COVID-19, and I had Paxlovid on hand, so I took it.
injection site pain and redness, fever, joint pain, fatigue, nausea, vomiting.  Meclizine for nausea and when tolerated 500mg acetaminophen for fever and pain.  Severe symptoms resolved within 24 hours; all symptoms resolved within 48 hours.
I felt an intense sensation of heat throughout my body, a strange sensation in my mouth and an odd taste. A lump formed in my throat with phlegm that caused me to need to cough to clear my throat. I felt very jittery. Staff at the clinic reported I felt clammy to touch and that I became pale.  I was given oral Benadryl and staff reset the clock. I experienced several of these intense body-wide heat waves while at the clinic. Staff told me I was not having an allergic reaction but that my "body was reacting to a foreign substance introduced into my body." I was told to return for the 2nd shot on 5/5/21 and staff will premedicate me with Benadryl.
Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED ----------------------------------------------------------------------------------------------------------------  HYPOTENSION 8/23/2022 OSTEOMYELITIS OF LEFT FOOT  ACUTE RESPIRATORY FAILURE 8/23/2022 OSTEOMYELITIS OF LEFT FOOT  HYPOXIA 8/4/2022 OSTEOMYELITIS OF LEFT FOOT  HYPOTENSION 8/23/2022 DM 2 W AUTONOMIC NEUROPATHY  ACUTE RESPIRATORY FAILURE 8/23/2022 DM 2 W AUTONOMIC NEUROPATHY  HYPOXIA 8/4/2022 DM 2 W AUTONOMIC NEUROPATHY  HYPOTENSION 8/23/2022 WEAKNESS  ACUTE RESPIRATORY FAILURE 8/23/2022 WEAKNESS  HYPOXIA 8/4/2022 WEAKNESS  HYPOTENSION 8/23/2022 PULMONARY EDEMA  ACUTE RESPIRATORY FAILURE 8/23/2022 PULMONARY EDEMA  HYPOXIA 8/4/2022 PULMONARY EDEMA
Information has been received from a physician concerning a female between 30 and 40 years old who on an unknown date was vaccinated with a 0.5mL dose of VARIVAX (Oka/Merck) (route and lot number not provided). Within one week of receiving VARIVAX (Oka/Merck) the patient experienced "a pretty bad case of chicken pox all over (face, arms, back, legs)". The patient was recovering from the event at the time of report. It was not specified if the patient sought medical attention. Follow-up information was received from the physician indication that she was 27 year old white female patient (previously reported as 30 to 40 year old), who in the PM of 22-FEB-2009, was vaccinated with the first dose of VARIVAX (Oka/Merck) (Lot # 660339/0487X), intramuscularly. On 20-Feb-2009, the patient developed full blown Varicella on her face, trunk, arms and back. On 28-FEB-2009, the patient sought unspecified medical attention. Additional information is not expected.
SORE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
It started a week later with a headache that would not go away. I still have it since 4/12/22. Two days later, my right eye started to swell to closure. I went to the ER and they checked for stroke but was cleared. I was referred to an Ophthalmologist who specializes in Neurology. I am experiencing double-vision.
Immediately after the shot, I got hand and finger numbness, and since the vaccine injection right sided numbness and nerve pain has been happening consistently.
low grade fever after second dose; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever after second dose) and HEADACHE (slight headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol, GERD, Anaemia and Restless leg syndrome. Concomitant products included FERROUS GLUCONATE (POLY-IRON [FERROUS GLUCONATE]) for Anaemia, OMEPRAZOLE for GERD, ATORVASTATIN for High cholesterol, CLONAZEPAM for Restless leg syndrome.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PYREXIA (low grade fever after second dose) and HEADACHE (slight headache). On 25-Feb-2021, PYREXIA (low grade fever after second dose) and HEADACHE (slight headache) had resolved.            Treatment information was not provided.   This case was linked to MOD-2021-298189 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Reporter contact info, patient demographics updated, medical  history, first dose batch no and concomitant were added,
09/28 felt ill at noon.  Went home from work. Went to bed and woke up at 730, nauseous,  dizzy, sweating. Ambulance called, to emergency room by 830pm. EKG and bloodwork.  Vomiting.  Nothing emergency room could do they said and sent me home. Very dizzy,  loss of balance,  nausea continued for next several days through weekend.  Visited my primary on Monday  10/03/22, preliminary diagnosis vertigo.  Set up PT for am 10/5/22. PT ruled out Vertigo. Primary called at 1130am request me to go to emergency room for head MRI because of stroke concern. MRI clear. PT again on Thursday diagnosed with vestibular neuritis.  Nausea gone but constantly dizzy, lack of balance,  walking and looking forward better than side to side.  Doing eye and head movements 3 sets. 3 times per day 3 separate exercises as of 10/12/22.
I am freaking out and a little concerned; I can't be that bad when I am nervous; Rash; I noticed itching in my arm; This is a spontaneous report from a contactable consumer or other non hcp.    A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot Number: EW0176) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient had experienced that rash, I noticed itching in my arm and I am freaking out and a little concerned; I can't be that bad when I am nervous. Consumer stated that on Wednesday around 2 pm, patient started to develop a rash like just within last couple of hours with lot of itching, the itching was being going on. Patient did not know a few hours, he/she did not even notice it at first might be it 6 hours, but there was like 2 days ago basically, he/she was a little bit freaking out but not completely did not worry. Consumer stated that It had been itching about several hours at least 6 hours, probably before that patient noticed he/she had itching in his/her arm. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
Patient states she had the Covid Booster on Thursday 05/12/2022. She began swelling and itching at the injection site on Friday. She applied cortisone cream. Swelling has decreased as of today but arm is still red and itching.
Vaccine for Covid-19 received Thursday 2/11/21 severe vertigo started 3am Monday 2/15/21. Lasted 4 days.  For next 3 weeks mild vertigo only at night when laying down and rolling over, or when up if bending over head down, or tilt head back.  Lasted until Tuesday March 9,2021
Pain, redness and swelling at the injection site. Mild headache and fatigue.  No treatment needed other than otc Ibu 400
WEIRD TASTE IN MOUTH, ON TONGUE AND LIPS; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number, and expiry were not reported) dose was not reported, 1 total administered on 31-MAR-2021 for prophylactic vaccination.  On an unspecified date, the patient experienced weird taste in mouth, on tongue and lips when treated with covid-19 vaccine ad26.cov2.s (dose number in series 1). 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 was not reported, 1 total administered on an unspecified date in JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in JAN-2022, within a few hours of booster vaccination, the patient experienced weird taste in mouth, on tongue and lips (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weird taste in mouth, on tongue and lips on an unspecified date in JAN-2022 (dose number in series 2). This report was non-serious. This case, involving the same patient is linked to 20220162550.
Tinnitus in left ear. I cannot state with certainty when it began. I have never experienced tinnitus before. When I had the first dose of Pfizer, I experience some temporary symptoms in the few days following including tinnitus in both ears, but it resolved itself. At some point in the weeks following the second dose, I began to notice a very high pitched ringing only in my left ear. It is intermittent, but it is still ongoing.
Patient received Pfizer for her first dose, Moderna for her 2nd dose (only 17 at time of 2nd dose)
Patient's mother phoned to report he had allergic reaction possibly to vaccines given 07/31/2003, that he broke out in hives and has joint swelling.  She took him to see the MD he prescribed Hydroxyzine 10 mg/5mL, which mother gave him and she had also given him Benadryl last pm and md stopped the Ceclor and Motrin, which she gave him Motrin on 07/31/2003.
Information here obtained from daughter: on Thursday patient had an uneventful fistulagram with angioplasty.  Patient got vaccine at end of usual Friday am dialysis treatment.  He was observed for about 30" and no untoward event noted, vitals usual.   At home on Saturday morning, seemed not quite himself by wife as reported by daughter, from whom i got his information.  He gets up late as hemodialysis starts at 515 am.   No reported problems on Friday.   On Saturday morning, he seemed not himself but sat down and ate breakfast around 9 am.  On getting up from table he got suddenly weak, his head rolled back and his eyes rolled up.  911 called and he was given resuscitation efforts of unknown duration which were unsuccessful.  He was pronounced dead at 11 am and the mortuary was called.  No premortem labs, et al.
left hand he cannot bend any of his fingers and on his right hand he can only bend his fingers half way; swelling in his hands; Body aches; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 70-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: not reported), solution for injection, via unspecified route of administration (dose: 01) on 23Feb2021 at single dose and via unspecified route of administration (dose: 02) on 16Mar2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021 (after the vaccination), the patient developed body aches, lot of swelling in his hands, cannot bend any of his fingers in his left hand and on his right hand he can only bend his fingers halfway. His doctor wrote a script for Prednisone 30mg for 5 days and that helped, but since stopping the swelling has occurred. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
It start with muscle pain on left shoulder, more every day, feel tired, feel very hot, chills, red spots on my chest and face. Pain in left ovary. Feel very hot under left arm and left ovary. 01.01.2010 start extremely heavy period, can't even walk, burning feeling in left ovary. 01.02.2010 left side of my face swollen, can't open left eye. Gassy. Sore throat all January. Feel like skin crawling. Pain all around left side of the chest, back and neck with movement. Weakness in left arm, can't hold anything, extremely tired. Can't breathe very deep. Very painful cough and sneeze. Red spots on my chest and face. High blood pressure, nauseous. Left Breast swell. Unable to sleep, nervous, numbness in left arm. Sore joints left side. Night sweats. All muscle around my left side swollen from top of my arm, the side, back, neck chest. Memory very short, confuse, and disoriented at February 2010. Can't sit and stand for long time. Spend 6 months in bed, can't walk. Large lymph nodes left armpit. Diagnoses: Large multicystic Left ovarian cyst, normal sized uterus with large pedunculated posterior fibroids. (I had exam on same day with immunization and everything was normal.) 05.29.10. Surgery: left ovary removed. My physician ignored the fact of H1N1 vaccine side effect. Didn't even put in my medical record. She told me she can't diagnose me. Other doctors I visit didn't even have this information available. Nobody can't diagnose me. Spend 6 months without right treatment for pain on my left side. Only in July start take Nortriptyline, Naproxen recommended by my second opinion doctor. Neurologist assessment: Trunk Parasthesias Quasi radicular. Improving. Temporary related to flu immunization? Hypertension. Lymphadenoaphy, axillary. Costochondritis.
Reports itching and irritation to left deltoid where Tdap was administered.  There is a bump about 3/4 inch wide on deltoid.
10/18/2018 Started feeling really bad - shaking & extremly weak around 6:00 pm & fever 102 - took 2 Acetaminophen 500mg ea - on 10/19/2018 felt really weak took 2 Acetaminophen 500mg. Took him to Pediatrics - said has a virus - Felt ok thru weekend then Monday AM shaking & fever took 2 MOTRIN 500mg then took him to Urgent Care, said not sure could be flu but didn't have all the flu symptoms, probably a virus or reaction to vaccine. Patient has been taking 2 Acetaminophen 500 mg every 6 hours & MOTRIN 500 mg every 6 hours alternating both every 3 hours the last 2 days.
Began with noticable erythema surrounding injection site approximately 3x3.5cm, then began c/o some SOB. Escorted to adjacent ED where she received IV Benadryl, Solumedrol and Pepcid and provided with predisone prescription.
Patient experienced redness, pain,itching,fever, and treated with BENADRYL cream and TYLENOL with some improvement.
12 - 18 hours after getting the second dose of the vaccine, my mother started feeling dizzy, nauseous, severe headache and full body pains. Then it moved to chest pains, reflux and heartburn, spasms in her neck and pain in her joints. Shortness of breath, hand shakes (trembling), then stomach cramps started as well with some diarrhea. it is now day 6 of these side effects, and only starting to subside now.
Had very sore arm with redness, hot and itching.  Started to get chills. Collapsed on floor unable to move felt nauseous and weak, shortness of breath. Called  EMS. They checked BP, lungs and heart. Did EKG.  Did not go to hospital. Arm soreness spread across front pectoral muscle and around back across shoulder blade. Over next 5 days on and off headache and just feeling bad all over. Started feeling better day 6 but still having headache and tenderness in arm.
"I lost 20 pounds in 3 weeks"; Reports he was vomiting every other day for 2 weeks straight after dose 1.; This spontaneous case was reported by a nurse and describes the occurrence of WEIGHT DECREASED ("I lost 20 pounds in 3 weeks") and VOMITING (Reports he was vomiting every other day for 2 weeks straight after dose 1.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Cervical spinal stenosis and Carcinoma (Carcinoma on face). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced WEIGHT DECREASED ("I lost 20 pounds in 3 weeks") and VOMITING (Reports he was vomiting every other day for 2 weeks straight after dose 1.). At the time of the report, WEIGHT DECREASED ("I lost 20 pounds in 3 weeks") and VOMITING (Reports he was vomiting every other day for 2 weeks straight after dose 1.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Computerised tomogram: pulmonary embolism (Inconclusive) Mid right lobe Pulmonary embolism.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient reported he was now on heavy thrombolytics for the rest of his life.   This case was linked to US-MODERNATX, INC.-MOD-2021-075796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075796:Case for second dose
Patient was seen at the facility for meningococcal vaccine administration. Vaccine liquid conjugate was drawn up and administered to patient. After patient left the facility, nurses noticed the vaccine has 2 parts and needed to be mixed together. Nurses informed manager of the incident. Nurse called the patient and informed her of the error. The patient returned back to the clinic to receive another dose of vaccine per CDC guideline. Vaccine was re-administered IM in left deltoid. Same lot and NDC number that is documented in the patient's immunization record. Post-immunization observation was performed. No adverse reaction noted during that period.
Case number PHEH2016US023419 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 39 year old patient whose gender was not specified. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the left arm on 24 Mar 2016. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experience any adverse events following vaccination.
On 03/05/2001 the patient presented to the doctor's office with varicella. The patient developed a scattered papulovesicular eruption on her neck, arm and back, some crusted, others vesicular. The patient had no fever. Additional information has been requested. Per F/U 6/18/02: Information has been received from an LPN concerning a 5 year old Caucasian female with no known allergies or past medical history who on 2/21/97 was vaccinated with the 1st dose of varicella (lot 2717-14-invalid), SC in the left arm. On approx. 3/5/01, the pt developed varicella and was seen in a physician's office. It was reported that "there was a rash and no fever". It was also noted that the pt had "scattered papulovesicular eruption on neck, arm, back-some crusted, others vesicular". F/U from a physician reported that there was an "erythema papulovesicular rash generalized in different stages of healing". It was reported from the physician, that the pt recovered. No further info is available.
States was very fatigued day of vaccination. Day after vaccination states bilateral feet were numb and hands felt weak. Did not seek any medical attention. Entirely resolved day of reporting this (1/18/21).
This spontaneous report has been received from a nurse concerning an unknown number of patients of unspecified age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with GARDASIL, (route, strength and dose were not provided). There was not concomitant medication reported. On an unknown date, the patients experienced dizziness, fainting or seizure like activity after receiving GARDASIL. The patients sought medical attention in the office, it was unspecified if they received treatment for the events and also if laboratories diagnostics were performed. At the reporting time, the outcome of seizure, syncope and dizziness was reported as recovered on an unspecified date. Upon internal review, the event of seizure like activity was considered to be medically significant. Additional information has been requested.