chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shoulder operation; Left knee replacement; Limping; Left arm was numb; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4467523-00.  A 50-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) as unk (cf) (Batch/Lot number: unknown) subcutaneous for ankylosing spondylitis. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose number 1, Route of Administration: Intra-muscular), administration date: 06Oct2021, when the patient was 49-year-old, for COVID-19 immunization; BNT162b2 (Dose number 2, Route of Administration: Intra-muscular), administration date: 03Nov2021, when the patient was 50-year-old, for covid-19 immunization, reaction(s): "Left arm was numb". The following information was reported: SHOULDER OPERATION (medically significant), outcome "unknown"; KNEE ARTHROPLASTY (medically significant), outcome "unknown", described as "Left knee replacement"; GAIT DISTURBANCE (medically significant), outcome "unknown", described as "Limping"; HYPOAESTHESIA (medically significant), outcome "recovered", described as "Left arm was numb".  The reporter's assessment of the causal relationship of "shoulder operation", "left knee replacement", "limping" and "left arm was numb" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events gait disturbance and hypoesthesia with the suspect drug BNT162B2 cannot be excluded. Events shoulder operation and knee arthroplasty considered unrelated to the suspect drug BNT162B2. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
I developed acute right posterior pleuritic chest pain and shortness of breath.  Diagnosed with multiple pulmonary emboli (see below).  I was started on Eliquis initially, but then had worsening symptoms on 2/4/21 and switched to Lovenox injections.   Symptoms have been slowly improving since then.
pt recv vax 3JAN96 & 9JAN96 pt exp malaise, fatigue, pain in joints & swollen glands;no further details were provided;
Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA274204, 2018SA274203 and 2018SA274229. This case involves a female patient (age not reported) who was vaccinated with a dose of ADACEL (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (received doses of vaccines stored outside the recommended range and exceeded the 72 hour).  It was unknown whether patient experienced any adverse event following vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
One week after injection I developed Right sided facial numbness, right eye and facial drooping. Seen in ER and diagnosed with Bell's  Palsy.  Treated with Prednisone 60 mg qd for one week and Valtrex 1 Gm tid for one week. I am completing treatment today, March 10, 2021, with no improvement. Follow up visit with my provider is scheduled for March15,2021.
The patient has a history of Alzheimer's disease. She was brought to the ED by EMS on 8/10/23 for confusion and weakness. Her husband thought the patient was acting different from her baseline, more confused and weak. Her husband additionally reports that the patient has had a cold with cough, runny nose, sore throat, and congestion for the past few days. In the ED, a COVID PCR test resulted positive. Ultimately, she was admitted on 8/10/23 for acute COVID-19 infection. She was discharged 8/16/23. Of note, the patient has received the primary COVID vaccine series and three boosters.
Got very hot; sleepy; loss of appetite; she was burning up with a high fever/slight fever; chills; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (Got very hot), SOMNOLENCE (sleepy), DECREASED APPETITE (loss of appetite), PYREXIA (she was burning up with a high fever/slight fever) and CHILLS (chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 039F21A, 031L20A and 030M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Asthma, Blood pressure high and Acid reflux (esophageal) (Severe). Concomitant products included AMLODIPINE, LOSARTAN, EXEMESTANE, OMEPRAZOLE and ATORVASTATIN for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022, the patient experienced SOMNOLENCE (sleepy), DECREASED APPETITE (loss of appetite), PYREXIA (she was burning up with a high fever/slight fever) and CHILLS (chills). On 14-May-2022 at 5:00 AM, the patient experienced FEELING HOT (Got very hot). At the time of the report, FEELING HOT (Got very hot), SOMNOLENCE (sleepy), DECREASED APPETITE (loss of appetite), PYREXIA (she was burning up with a high fever/slight fever) and CHILLS (chills) outcome was unknown.            The patient had received Omeprazole DR. On 04-Nov-2021, the patient received the 1st Booster dose of Moderna COVID-19 Vaccine. On 05-May-2022, the patient received the 2nd Booster dose of Moderna COVID-19 Vaccine. Patient reported that she got very hot at 5AM on 14-May-2022. She felt like she was burning up with a high fever. a slight fever, sleepy, loss of appetite, and chills. No treatment medications were reported.   This case was linked to MOD-2022-661406 (Patient Link).
Red, hot, swollen right brachial from deltoid to elbow. Z-pak, Ibuprofen QID, moist heat.
Erythema at injection site - Patient was advised to keep close eye on area and to go to convenient care for possible treatment with antibiotic.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The reporter stated that on 26-JUN-2014 the patient was vaccinated with expired PROQUAD (Merck) (lot # H021358, expiration date: 29-MAY-2014, dose, units, anatomical location, route of administration were not reported). No adverse effect has been observed. Additional information has been requested. This is one of several reports from the same reporter.
One dose of Moderna vaccine given from a vial of Moderna vaccine expired on 10/13/2021 but kept in the refrigerator  Lot number 048c21A expired 10/13/2021 - Manufacture expiration date 11/09/2021 - removed from freezer on 09/13/2021 and kept in the refrigerator until 10/18/2021 3rd dose given
Information has been received from a physician concerning a female with a history of fainting who was vaccinated with the first dose of Gardasil and fainted. Medical attention was sought. Additional information has been requested. 10/08/2007 Information has been received from a physician concerning a female patient with a history of fainting with shots who was vaccinated with a first dose of GARDASIL. After getting the vaccination the patient fainted. Unspecified medical attention was sought. It was reported that the patient told the physician she would faint in advance of getting the vaccine. It was stated that she "always faints with shots". At the time of this report the patient recovered. No product quality complaint was involved. The reporter felt that fainted was "not an adverse event from GARDASIL". Additional information is not expected.
The day after the first shot, experienced joint swelling, pain and stiffness. Continued to get worse and move to different areas everyday
Patient came into the clinic after receiving his 1st does of MODERNA (022C21A) on 5/10. Patient was in the system with an appointment, and was given PFIZER (EW0178) before clinician noted on his paperwork that he had already received MODERNA. 1st dose. Patient was observed for 30 minutes while VAERS was completed and showed no ill effects or symptoms. Patient was counseled to consult with his personal physician re: how to proceed with any subsequent vaccines.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient called on 12/15/2021 to report arm side effects
Did not take the third and fourth dose of Vivotif; Spontaneous report received on 10FEB2020.  A pharmacist reported that a consumer "did not take the third and fourth dose of Vivotif" (PT: Product dose omission). The consumer was receiving Vivotif for immunisation. The consumer did not take their third and fourth dose of Vivotif which were due on 07FEB2020 and 09FEB2020 respectively. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer did not take the third and fourth dose of Vivotif (missed dose) on the dates when they were due. Vivotif dose should be taken every other day. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer did not take the third and fourth dose of Vivotif (missed dose) on the dates when they were due. Vivotif dose should be taken every other day. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.
Case number PHEH2014US020854 is an initial spontaneous report received from a medical assistant on 08 OCT 2014. This report refers to a 45 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413601, expiry date: Jun 2015) at a dose of 1.0 ml from a 3CC syringe on 08 OCT 2014. No adverse events reported after the maladministration (overdose).
Itching less; injection site itched like crazy; injection site swelled up; injection site is bright red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching less), VACCINATION SITE PRURITUS (injection site itched like crazy), VACCINATION SITE SWELLING (injection site swelled up) and VACCINATION SITE ERYTHEMA (injection site is bright red) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LOVASTATIN for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itched like crazy), VACCINATION SITE SWELLING (injection site swelled up) and VACCINATION SITE ERYTHEMA (injection site is bright red). On 01-May-2021, the patient experienced PRURITUS (Itching less). At the time of the report, PRURITUS (Itching less), VACCINATION SITE SWELLING (injection site swelled up) and VACCINATION SITE ERYTHEMA (injection site is bright red) outcome was unknown and VACCINATION SITE PRURITUS (injection site itched like crazy) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. Patient applied cortisone.
I have an extremely swollen axillary lymph node. I have tenderness and the standard body aches, fever, headache, congestion. Also experiencing extreme disruption to my mensural cycle.
Pt describes red, swollen, itchy, mild rash at site of injection and states is warm to the touch. Patient requested we report. Appears to be localized reaction.
she may of received an expired dose of MMR II; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, frequency, route of administration, lot #, and expiration date were not reported) for prophylaxis.         The pharmacist inquired how far past the expiration date of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), was the dose still valid and if the patient would need another vaccination.
Pt came to clinic with  c/o pain in left arm. Upon assessment noted reddened edematous area from left shoulder progressing to elbow, skin tight and very warm to touch. Recommend cool cloth, Tylenol and follow-up with MD if s/s worsen. Denies HX of fever or other complications.
First fatigue, then headache, progressing to chills with fever up to 102 lasting approximately 24 hours, body/joint aches, deep cough, felt like I couldn't get a deep breath (shallow breathing)
Within minutes when standing in front of nurse I started to feel unwell.  Nurses said I went white as a ghost.  I thought I might pass out but did not.  Slumped onto chair and  put my head down.    Within half an hour I started to feel better, still weak.  Doctor wanted to see me when I felt able to get to examining room.  He took my bp and said it was the lowest he's ever seen it with my history.   I'm sure I would have passed out had I not had such high blood pressure.
This spontaneous report was received form a pharmacist concerning a patient of unknown age and gender who on an unknown date might had received 4 times the recommended dose of PNEUMOVAX 23 (dose, route, lot number and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
Approximately 5 minutes after receiving his vaccine, pt started to feel light headed on his way to the observation area, and sat on the ground.  As Medic approached, I helped patient to his feet and walked him over to a chair and sat him down, about 10 seconds after sitting him down he stated he was going to pass out, medic immediately braced patient and held him up and pt did go unconscious for about 15 seconds.  Pt quickly regained consciousness and was alert and oriented but still feeling light headed, he was helped to a wheel chair and taken to the cot area for eval.  Pt skins pale, cool, moist, pupils perrl, lungs clear bilaterally, vitals: BP 120/84, HR 52, RR16, SPO295%, pt asked if he has a slow heart rate and he declined, HR did return to normal at 82 BPM approximately 10 minutes later. PT kept on cot for 30 minutes, and felt much better after. Pt released to his father who stated that everyone in the family always passes out when they get shots.
NO IMMEDIATE LOCAL REACTION,  NO REACTION 30MINUTES LATER. FOUND FOAMING AT THE MOUTH NEXT MORNING. PRONOUNCED DEAD AT HOSPITAL.
Patient seen again on 5/21/08 with fever and an atypical varicella rash.  Patient seen again on 5/23/2008 and diagnosed with fever and erythema multiforme minor most likely secondary to the varicella post vaccination.  She has been afebrile since 5/23/2007 and rash is slowly resolving on a tapering dose of Prednisolone and hydroxyzine for symptomatic relief.  No mucosal involvement.  Lesions have scabbed over.
The shot went in fine, it was actually the easiest shot I have had in a long time. I woke up the next morning with pain in my left shoulder and in my neck, it was a muscle pain, but it has lingered almost two weeks later. it has eased somewhat but it has also moved over to the right shoulder a little bit. I saw the doctor on April 11th she prescribed a muscle relaxer called Methocarbamol, which I took for a week. She also referred me to physical therapy which I had my first visit on yesterday, they found that my left should, and neck muscle was tight and spazzing, the gave exercises to do there and at home. I have several different times that will go to physical therapy for the month of May. It's worst in the afternoon and the evening than in the morning, it's eased up when I wake up in the morning but around supper time it is very painful again. The other things I have done for it are heat, Naproxen at least 600-800mg at a time, and also TENS.
Mental incoherency, joint problems in knees, ankles, shoulders and elbows. Pain in discomfort and slight swelling. Mental disorientation. achy, fatigue
Itchy red circular rash around injection site and painful lump under left armpit (same arm as injection). Occurred one week after receiving first Moderna shot.
Started with shoulder and armpit aches (~15 hours after receiving the shot).  Progressed into strong pain in the shoulder and armpit.  These symptoms kept me up all night.  Then progressed into large golf-ball-size swelling in the left armpit which lasted several days.  I took ibuprofen for the swelling, but didn't seem to do much.  After a few days, the swelling started to reduce.
Mother called HD on 10-8-10, stating during the night of 10-7-10 client had a temp of "105. something" stated has run a fever since getting her shots on 10-5-10. Encouraged mom to take client to MD but mother states she does not have Medicaid. Referred mother to the hospital ER.
Pain in injection site and throughout left arm for 24 hours, whole left side of body felt "heavy" and weak, headache, drowsiness, fatigue
difficulty breathing,  nausea, dizziness, BP 203/80; resolved in 1 hour; she was taken to the ED and symptoms resolved without medication
This case was reported by a pharmacist via sales rep and described the occurrence of light headedness in a 65-year-old female patient who received SHINGRIX. Concomitant products included PREVENAR 13. In March 2018, the patient received SHINGRIX (intramuscular). In March 2018, 1 day after receiving SHINGRIX, the patient experienced injection site pain. In March 2018, the patient experienced light headedness and injection site burning. In March 2018, the outcome of the light headedness was recovered/resolved. On an unknown date, the outcome of the injection site burning and injection site pain were unknown. The reporter considered the light headedness to be probably related to SHINGRIX. It was unknown if the reporter considered the injection site burning and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received PREVNAR 13 at the same visit in the other arm. Approximately 8 hours after administration of SHINGRIX, the patient became light headed. At the time of injection it burned at injection site and experienced pain at the injection site the day after administration. The reporter thought the light headedness might be related to SHINGRIX but he was not sure.
I believe my menstrual cycle has been negatively affected by the Pfizer vaccine. I had my second dose on 5/12/21 and my two periods after that have been absolutely horrendous. Spotting for many days prior, excessive HEAVY flow, foggy/light headedness, cramping, and excessive clotting. I thought I was having a miscarriage, my flow was so heavy and so clotted. My period have never been like this before. I cannot think of anything else that could have caused such a change in my cycles. If it could be at all related to the vaccine, I wanted to report it.
8SEP95 pt recvd vax & w/in 30 mins exp severe itching on upper back & felt like bugs on scalp, itching sever (ranked 10 on scale 1-10) itching lasted until 1wk ago;had bumps in area about 3mm in diameter w/o blisters, redness;no med care;
Fever, malaise and chills started about 12 hours post vaccine administration. They did not interfere with patient's activities.
I began to experience rapid heart rates to the 140s intermittently starting on the Wednesday following my first vaccination.  I also had associated neck pain and "pounding sensation" in my neck, chest, and arms. I had difficulty lying flat at night and developed a dry cough. I went to the urgent care on 4/19/21 and was diagnosed with torticollis. No one at the urgent care listened to my heart or lungs. Given that my symptoms had been diagnosed, I delayed seeking further treatment. My symptoms continued to worsen. I had difficulty walking long distances, exercising. I became short of breath easily. I ended up going to my primary care doctor on 4/26/21 for a second evaluation. He was concerned and did an EKG, it only showed sinus tachycardia. He scheduled me for an echocardiogram and put me on a beta blocker (Bystolic) 5 mg once daily. The echo showed EF 47% with global hypokinesis of the L ventricle. Doctor called me into the office as soon as he saw the results, concerned for myocarditis or pericarditis.
3x3 swelling and tenderness at injection site. Started one week after injection and present today at visit on 10-12-21
Pt received 1st Moderna Covid vaccine on 2-26-21. On 3-6-21, pt woke up with a ~2"x2" reddish, itchy rash at the site of her injection.  On 3-7-21, rash appeared more red and itching was more intense.  Pt reports treating with topical hydrocortisone cream, which provides some relief.
Skin rash on abdomen looking like shingles and very painful. Local reaction at the arm, swollen/red/pain.
This spontaneous report was received from a licensed nurse practitioner refers to an unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with unspecified number of improperly stored doses of ROTATEQ lot # L008034, expiry date 05-AUG-2016 and lot # K016263, expiry date 26-JUN-2016, (dose, frequency and route of administration were not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of two reports received from the same reporter. Additional information has been requested.