chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, Myalgia, limited range of motion, pain in left arm Narrative:
This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 58-year-old male patient who received SHINGRIX (batch number 3S354, expiry date 4th July 2020). On 22nd May 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). In May 2018, 12 hrs after receiving SHINGRIX, the patient experienced injection site erythema. On 22nd May 2018, the patient experienced intramuscular formulation administered to other route. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX dose subcutaneously instead of intramuscular, which led to incorrect route of drug administration. The patient had a red area about 4 cm at the injection site.
I woke up this morning with a headache so bad that I can barely see out of my eyes. It feels like my eyes are going to pop out of their sockets, the headache is that bad.
Guillain Barré Syndrome. Persisting numbness in feet- Tires easily.
Mother first reported daughter complained of problems with immunizations given on 8-16-16.  However, mother declined to elaborate regarding problems. On 9-20-16 mother requested lot numbers for vaccines administered to her daughter. Mother also stated that her daughter was still complaining of a left sore arm and left foot, including some mild numbness to left toe. Mother also denied any seizures, fevers, or fainting after immunizations were administered.
Information has been received from a physician concerning a 11 month old male who on 20-FEB-2008 and 19-NOV-2008 when the patient was 11 months of age was vaccinated with the first and third dose of ROTATEQ (lot number not reported) oral respectively.  No adverse symptoms reported.  Additional information has been requested.
The day of the shots he got a fever of 101.5 within an hour. A few days later he could not breath so the doctors gave him steroids orally and through shots also through breathing treatments. The treatments were not helping for very long. He was admitted into the hospital. He seemed a little better, then before we left the hospital he got a weird rash and a fever. I continued medicine at home. A few weeks later he got diarrhea and was vomiting for weeks. Before this he had a check up and was perfect. He never even had a runny nose. This has been going on for over a month. He is still vomiting. 3/21/06-Reviewed 11-page d/c summary. Final diagnosis was croup (LARYNGITIS). Symptoms were noted as purulent drainage from nares, cough with stridor, and runny nose. No respiratory distress was noted.  Chronic cough, runny nose, rashes, sore throats, ear infection, hyper.  All these things started the day he got the shots.  I am taking him to a specialist in June.
Pt received Pfizer x3.  Pt tested COVID + on 9/24/21 and admitted to hospital for COVID on 9/24/2021. Pt received remdesivir and dexamethasone.
the patient experienced left shoulder pain; the patient experienced left shoulder warmth; The patient experienced limited range of motion in the left shoulder; This spontaneous report was received from a registered nurse referring to a 81-year-old female patient. The patient's pertinent concurrent conditions included hypertension, hypothyroidism, elevated cholesterol (blood cholesterol increased) and gastrooesophageal reflux disease. Her concomitant medications included levothyroxine sodium, metoprolol (reported as metopropol), mirtazapine (manufacturer unknown), omeprazole and hydrochlorothiazide (+) triamterene(DYAZIDE). The patient had a previous drug reaction to penicillin, nabumetone and tobramycin.      On 25-AUG-2003, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, intramuscular as prophylaxis (concentration, vaccination scheme frequency, number of dose administered, lot number and expiration date were not provided), then on 27-MAY-2020, the patient was vaccinated with another dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, intramuscular in the left arm as prophylaxis (concentration, vaccination scheme frequency, number of dose administer were not reported, reported lot number S034299 and expiration date  01-JUL-2021)   On 28-MAY-2020, the patient experienced left shoulder pain (musculoskeletal pain), left shoulder warmth (joint warmth) and limited range of motion in the left shoulder (joint range of motion decreased). On the same date, the patient returned to the physician office for an evaluation of the left shoulder, therefore, the patient was advised to take acetaminophen (TYLENOL) or naproxen sodium (ALEVE) for the left shoulder pain and the patient should begin physical therapy to increased her left shoulder mobility. No laboratory diagnostic or studies were performed.  At the time of this report, the outcome of musculoskeletal pain, joint range of motion decreased and joint warmth was unknown by the reporter.     The causality assessment between therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the aforementioned events was not reported.  This is one of two reports from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S034299; expirationdate: 01-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2006USA001705:
Pt. states that after receiving the 3rd Booster of Moderna 10/28/2021, started experiencing symptoms of shoulder pain throughout the arm, low back pain, swollen finger joints with itchiness (Right), chills, and feverish. No noted Primary visit/communications. Still continuing to experience symptoms.
Tightness and pain in center of chest.  At times waxed and waned, but lasted approximately three hours in duration and started waning through the night.
Was drawn up shots for a patient and was distracted by provider double check my imms before administering and still only to realize that I had given MMRV and Varicella, Spoke with patient dad and advised him of the mistake and that he should keep an eye on him, making sure if he starts to have any high fevers to take him to the Emergency room, or rashes that he bring him into the clinic if its low grade to give him ibuprofen or Tylenol  and other (high grade fevers or major symptoms please take the patient to the ER.
FLUVAX administered on 10/7/10 at 2100.  At 2240, patient was observed to have red, raised, itchy areas on arms and welts on her back.  She was scratching at the areas.  Order received from on-call physician for Benadryl 25mg PO Q 4 hours PRN, which was given and effective.
The patient was in the clinic to receive the Moderna Bivalent booster. She was mistakenly given the Moderna monovalent vaccine. She received the vaccine on 11/15/22. The error was discovered 11/18/22 when inventory counts were found to be off. The administering nurse was notified by the clinic supervisor and county nurse manager and asked about the incident. The administering nurse contacted the patient, explained the events, and scheduled patient to be revaccinated. The patient has exhibited no symptoms and has agreed to be revaccinated. The administering nurse has been counseled on how to prevent further medication errors.
Patient received 1st dose Pfizer today approximately 11:20 am, requested to receive vaccine while standing. Patient reported feeling "tingling feeling in chest, arms, and face. I felt like I was seeing colors" immediately after vaccine was administered. As per MD, patient was unresponsive for 5 seconds, noted to be very pale. Assisted from standing to sitting position. Initial B/P 81/34, HR 56, O2 sat 100% on room air. After 5 seconds, when patient became more alert, given 1 bottle of water and 1 cup of orange juice. Emergency medical services (EMS) called. Re-checked vital signs approx. 11:30 am B/P 100/59, HR 67, O2 98%. Patient denied SOB, lightheadedness, dizziness, stated relief in tingling. EMS arrived to evaluate patient. Patient stated relief in all symptoms, patient refused to go to ER for further evaluation. Instructed patient to call 911 if any feeling of fainting, dizziness, lightheadedness, loss of consciousness, SOB, chest pain, rash should develop. Verbalized understanding, escorted by mother to home.
Red raised area @inject site, appr 1(r)-2" wide x 3" long w/2 red streaks running across front of arm into armpit; area tender, sore & warm; states afebrile; 430PM PC to pt; rx: Erythromycin x 5 days; pt applied cold packs & feels better;
Left arm (the whole arm) is swollen; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left arm (the whole arm) is swollen) and HEADACHE (Severe headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, 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 (Left arm (the whole arm) is swollen) and HEADACHE (Severe headache). At the time of the report, PERIPHERAL SWELLING (Left arm (the whole arm) is swollen) and HEADACHE (Severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 67-year-old male patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 03-APR-2013, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and/or zoster-related conditions.   On or about 15-APR-2013, the patient presented shingles. As a direct and proximate result, the patient had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a direct and proximate result, he suffered severe and permanent physical injuries, including but not limited to shingles, as well as other severe and permanent health consequences; additionally, he had incurred significant expenses for medical care and treatment, his injuries and damages were permanent and would continue into the future.    The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Entire body red confluent pruritic rash which began about 12 hours after the vaccine and progressed. Includes lips and base of penis. Some edema of lower extremities. No SOB, tongue swelling, hypotension or other signs of anaphylaxis. Outcome is that I started him on a 5-day course of prednisone 40mg qd.
Fever; Pain in the stomach; Burning head; Weakness; Felt very hot; Discomfort in the stomach; Not feeling hungry; Very weak; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), ABDOMINAL PAIN UPPER (Pain in the stomach), BURNING SENSATION (Burning head), ASTHENIA (Weakness) and FEELING HOT (Felt very hot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PYREXIA (Fever), ABDOMINAL PAIN UPPER (Pain in the stomach), BURNING SENSATION (Burning head), ASTHENIA (Weakness), FEELING HOT (Felt very hot), ABDOMINAL DISCOMFORT (Discomfort in the stomach), ABDOMINAL DISTENSION (Not feeling hungry) and ASTHENIA (Very weak). The patient was treated with PARACETAMOL (ADVIL 6 PLUS) at an unspecified dose and frequency. On 25-Jan-2021, PYREXIA (Fever), ABDOMINAL PAIN UPPER (Pain in the stomach), BURNING SENSATION (Burning head), FEELING HOT (Felt very hot), ABDOMINAL DISCOMFORT (Discomfort in the stomach) and ABDOMINAL DISTENSION (Not feeling hungry) had resolved. At the time of the report, ASTHENIA (Weakness) and ASTHENIA (Very weak) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Received varicella vaccine on 10/02/2004 developed fever, emesis about 36 hours after shot. On 10/08/04 end of 6th day, red, itchy papules on forearm.
Pt recvd vax 930AM on 27JAN92 & was in MD office @ 2PM when mom noticed bottom lip quivered & vomited; pt was taken to ER where temp was 104.7 R @ 230PM; pt given APAP & IV started; d/c next day;
This spontaneous report was received from a consumer (father), refers to a young female patient (daughter) of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. Reporter stated that his daughter received her second dose of VAQTA, intramuscularly, a full two weeks earlier (in 2014; exact date unknown) that the recommended six month timeframe by pediatrician. Reporter recently received a statement of 'non-compliance improper spacing' letter form the Health Department which stated that his daughter needs 'another' vaccine. Reporter was asking for guidance on this request asking if it was indeed necessary. The outcome of the event was unknown. No product quality complaint (PQC) was involved. No other adverse event information was given. Additional information has been requested.
Nosebleeds; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0158) via an unspecified route of administration in the left arm on 15Apr2021 at 14:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid cancer and thyroidectomy. The patient had no known allergies to medications, food, or other products. Concomitant medications included thyroid (ARMOUR THYROID), ethinylestradiol, etonogestrel (NUVARING) and unspecified vitamins; all taken for unknown indications from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 16Apr2021 at 18:00, the patient had nosebleeds. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event nosebleeds was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient became withdrawn and began to experience what he described as depression.  He shared these feelings with his Mom that he just didn't feel like his old self and that he was feeling very depressed.  Patient remembers sharing some very depressive feelings with his Mom on the night before his 16th birthday March 18, 2011.
12:58 Pt c/o tingling to R forearm. Vitals assessed B/P 200/96, HR 65, O2 sat 96%. Approx.. 5 min later pt c/o heat/warm sensation to head. No other c/o, no SOB, no rash, no N/V. Pt has hx of HTN, he took his meds this am. Pt reported approx. 5 min later that heat/warm sensation is gone & the tingling to R forearm is decreasing.  13:08 BP 158/90, HR 68, O2 sat 96%. Pt is feeling better, very little tingling to R forearm. No other symptoms.  13:22 B/P 150/80, HR 63, O2 sat 96%, Pt is going home with wife. He was notified  if any other symptoms occur. Pt did not called this time.
covid arm, red rash on right arm on March 15, 2021 AM, 6 days after 2nd dose of Moderna Covid-19 vaccine. both shots were administer to right arm. Red rash around the shot spot 3.5 x 2.5 inches.  Itching. Took 2 benadrills at night on March 15, 2021.  no visible change AM or PM March 16, 2021.   visit internal medicine Dr. on March 16, 2021, Informed that I have "Covid-19 Arm". keep an eye on it
arm hurt a little after second dose; little lump after second dose; a bit swollen after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt a little after second dose), SKIN MASS (little lump after second dose) and SWELLING (a bit swollen after second dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Autoimmune disorder. Concomitant products included HYDROCORTISONE, PREDNISONE, FLUDROCORTISONE, VENLAFAXINE HYDROCHLORIDE (EFFEXOR), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), LORAZEPAM (ATIVAN), POTASSIUM CHLORIDE, OXYTOCIN and DOMPERIDONE (NAUSEA) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt a little after second dose), SKIN MASS (little lump after second dose) and SWELLING (a bit swollen after second dose). At the time of the report, PAIN IN EXTREMITY (arm hurt a little after second dose), SKIN MASS (little lump after second dose) and SWELLING (a bit swollen after second dose) outcome was unknown.            Medical history includes IG deficiency Concomitant medication also include B12 injection, vitamin, asthma medication, migraine medication, itchy skin medication, IBS stomach medication.  No treatment medication was reported. No lab data was provided by the reporter   This case was linked to MOD-2021-272094.
MMR recvd on 2APR92; 3APR92 hive-like, itchy rash appeared on face, around waistline & top of hips; no rxn to prev immun; no allergies to eggs or chicken; no temp elevation or any other sx present;
Tingle in left side of face, chin, and Burning in Back from Right arm to left arm, Treatment, with Doxycline and Predisone, second day   some re-leaf.
Initial report received from healthcare professional on 25 September 2012. An 83-year-old female patient, who had allergy to penicillin, levofloxacin and sulfa with the history of hypertension, arthritis, anemia, lack of mobility in arms and asthma, had received intramuscular dose of FLUZONE HD vaccine (Lot number: U4490AA) in left deltoid on 05 September 2012. The illness at the time of vaccination was rash under right armpit. On 06 September 2012, i.e. one day post vaccination, the patient had pain at injection and lack of mobility of left arm. On 24 September 2012, the patient visited the doctor and complained of redness and swelling at injection site but now resolved, still painful at injection site. The redness and swelling at injection had resolved on unspecified date. The pain at injection site was persisting. Outcome of lack of mobility of left arm was not reported. Corrective treatment was not reported. The patient's outcome was not recovered. List of documents held by the sender: None. Follow-up information received from a healthcare professional on 23 November 2012. Illness at the time of vaccination included pain under right armpit. On an unspecified date, the patient had recovered.
She had the best two weeks she has had in the last 10 years; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age and gender received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot numbers and expiry dates were not reported), via unspecified routes of administration on unspecified dates at single doses for COVID-19 immunization. Medical history included ongoing trouble hearing and Dercums. Concomitant medication was not reported. The patient reported that she had a rare autoimmune disease called Dercums which affected all the systems. She was told by the CDC that it was safe to take the Pfizer COVID shot with her disease. She has had both COVID shots and everything went perfect, her reaction to the shot was amazing. She had the best two weeks she has had in the last 10 years, did not know why or how. Everything worked, all the broken parts worked. Every week, someone with Dercum would also inform her that they felt so good after the Pfizer COVID vaccine. The outcome of the event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Site swelling and raised fluid filled vesicle 15 mm in circumference and 2 mm in height. Approximately the size of a dime coin.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (318 patients received dose from vials beyond 30-day use by date) in a 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 037C21A) for COVID-19 immunization. No medical history reported. On Jun 16, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Jul 21, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Jul 21, 2021, the mRNA-1273 (Moderna COVID-19 vaccine), patient administered expired product (318 patients received dose from vials beyond 30-day use by date). On Jul 21, 2021, administered expired product (318 patients received dose from vials beyond 30-day use by date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Date of refrigeration of vaccine: May 7, 2021. This case linked to MOD-2021-363751, MOD-2021-363716, MOD-2021-364760, MOD-2021-363226, MOD-2021-364245 (patient link).
I had the injection in my left upper arm on July 6, 2005. The next day I experienced site symptoms of heat, swelling and tenderness. The 2nd day I experienced fever and severe joint pain in all my joints. On the third and 4th day I had fevers up to 102 degrees, diaphoresis severe enough to soak the bed, and the site developed a hard lump. The fever left the 5th day but heat swelling and pain continued in the injection site. By the 9th day the pain and heat had decreased but a large 2-3 inch x 1 inch hard mass remained under the skin in the injection site. The mass persists to this date - 21 days later- but it is much smaller in size about 1 inch long and  1/2 inch wide. The injection site occasionally itches.