chrisvoncsefalvay/vaers-outcomes huggingface dataset:
can't lift his arm horizontally without pain.; shoulder and arm soreness; hurt at injection site; shoulder and arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (can't lift his arm horizontally without pain.), PAIN IN EXTREMITY (shoulder and arm soreness), VACCINATION SITE PAIN (hurt at injection site) and ARTHRALGIA (shoulder and arm soreness) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-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 LIMB DISCOMFORT (can't lift his arm horizontally without pain.), PAIN IN EXTREMITY (shoulder and arm soreness), VACCINATION SITE PAIN (hurt at injection site) and ARTHRALGIA (shoulder and arm soreness). At the time of the report, LIMB DISCOMFORT (can't lift his arm horizontally without pain.), PAIN IN EXTREMITY (shoulder and arm soreness), VACCINATION SITE PAIN (hurt at injection site) and ARTHRALGIA (shoulder and arm soreness) outcome was unknown.            For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable.   No concomitant and treatment medications were reported.
No additional AE; Improperly Stored Vaccine/Administered/ Temperature (1.53°C); This spontaneous report has been received from a registered nurse concerning a patient whose age and gender was not reported. No information was provided regarding the patient's pertinent medical history, concomitant medication, previous drug reactions, or allergies.  On an unspecified date, the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number 1687292 and expiration date 25-AUG-2022, which was verified to be valid for prefilled syringe formulation) was improperly stored below 2 degrees Celsius (°C) at 1.53°C for 30 minutes (min); there were previous temperature excursions below 2°C on unspecified dates, 1.29°C, 1.43°C, and 1.38°C for 45 min each (product storage error).   On 07-AUG-2021, the patient was vaccinated with the improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, dose number, vaccination scheme frequency, route of administration, and anatomical location of vaccination were not reported).  No additional adverse events (AE) were reported.  This is one of three reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2108USA002930: US-009507513-2108USA002942:
Patient received Adacel instead of DTaP for her 4th immunization. The child tolerated well, no adverse reaction.
pt recv vax 15NOV95 & devel a red,circular,flat,sl itchy rash by 10PM which lasted for 3 days;also exp dizziness & nausea w/in 3hrs of inj;pt recovered;
Patient called pharmacy at approximately 12 pm the day following the immunization administration. She was given the vaccine at about 3 pm on 08/10/17. Patient reports redness and a whelp on left arm that radiates downward. She endorses pain and limited movement in her arm. Patient also reported pain in her spine after she received the vaccination and was waiting in store, but this was not reported before leaving. Pharmacist recommendations are for the patient to take diphenhydramine and acetaminophen and use cold compress. Counseled patient to see primary physician if symptoms worsen or if additional symptoms present such as body aches or fever. She indicated that she does not currently have a doctor, so she has been directed to go to the ED if necessary.
Fri Feb 8 - received vaccine. Sat Feb 9 - 24 hour arm super sore Tues Feb 12 - eyes burning, brain fog Thurs Feb 14 - possible reaction to new shampoo/cond - scalp, face, ears, neck felt burned and itched Sun Feb 17 - injection site has itchy red whelp about the size of a silver dollar - began benadryl 12.5 q 6 hours Mon Feb 18 - injection site has doubled in size, still itchy unless benadryl onboard; went to minute clinic and received tapered steroid pack
Case number PHEH2013US002672 is an initial spontaneous report received from a pharmacist on 29 Jan 2013. This report refers to a 12-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A11052) intramuscularly on 16 Jan 2013. It was reported that on the same date, right after administration, he developed redness and swelling at injection site. He was given two rounds of unspecified antibiotic by a physician and the area was still red and slightly swollen. No further information was provided.
On 07/15/2000, the patient developed a "generalized vesicular rash that consisted of more than 100 lesions. The physician noted that this was the worse case of breakthrough, or even wild type, that she has seen. The patient was afebrile and had no exposure to wild type virus" Follow up information  from a physician reported that the patient was seen in the office on 07/17/2000 and it was noted that some of the lesions had crusted. On 08/01/2000 the patient recovered. No further information is expected.
The patient has extensive and severe shingles covering most of his right shoulder, anterior and posterior. Treatment started with Zovirax 11/17/00.
5 min after vaccine administration employee became pale , clammy and fainted.  3 mins later he was awake, oriented and alert.  He answered questions appropriately.  BP 67/42 and O2 Sat 97 %.  EMS arrived at 12:10 , EKG done Blood Glucose 124.  At 12:18 BP 118/75  O2 Sat 100 %.  Employee states he is feeling well.   Employee stated after that he has a history of fainting only with blood draws.
Pfizer-BioNTech COVID-19 Vaccine  Urticaria/hives on all body parts lasting 4 days.
A physician reported that a 3 month old male received an injection of Prevnar in March 2001. On 05/11/2001, when he was 5 months old, the child was hospitalized. Streptococcus pneumoniae serotype 14 was isolated from blood and CSF specimens collected on 05/12/2002. Diagnoses of pneumococcal meningitis and bacteremia were made. The physician indicated that the child did well, with "some residual neurologic symptoms." The follow up states the infant developed hemiparesis. A neurological work-up was performed for seizures and hearing. The infant had no hearing loss. The hemiparesis subsequently improved. As of the date this was reported, the hemiparesis had not completely resolved.
swollen lymph node again, not as big as first time but its still there, going away very slowly; I have felt very tired, fatigued, felt like I worked all day even though I had not worked; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph node again, not as big as first time but its still there, going away very slowly) and FATIGUE (I have felt very tired, fatigued, felt like I worked all day even though I had not worked) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph node again, not as big as first time but its still there, going away very slowly) and FATIGUE (I have felt very tired, fatigued, felt like I worked all day even though I had not worked). At the time of the report, LYMPHADENOPATHY (swollen lymph node again, not as big as first time but its still there, going away very slowly) was resolving and FATIGUE (I have felt very tired, fatigued, felt like I worked all day even though I had not worked) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was not applicable.   This case was linked to MOD-2021-270094 (Patient Link).
Itching; soreness in right arm similar to flu shot experience; Some small tightness in my throat and rib cage; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Some small tightness in my throat and rib cage), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE PAIN (soreness in right arm similar to flu shot experience) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L2O4) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced THROAT TIGHTNESS (Some small tightness in my throat and rib cage). On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness in right arm similar to flu shot experience). On 16-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching). On 16-Jan-2021, VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE PAIN (soreness in right arm similar to flu shot experience) had resolved. At the time of the report, THROAT TIGHTNESS (Some small tightness in my throat and rib cage) had resolved. The throat tightness lasted for 10 mins      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient drank orange juice for the symptoms.
This is a spontaneous case from a contactable physician reporting 3 cases. This is the first of three cases. A 74 years old female patient received the first dose of PREVNAR 13 (lot J49846, Exp date 29Feb2016) on 20Nov2014 intramuscular in the left arm at 0.5 ml, single dose. Medical history included hypertension, hypothyroidism, mixed hyperlipidemia, allergies, arthritic pain, reflux esophagitis since 2008, herpes, acquired polyneuropathy since 15Jul2013, benign hypertensive heart disease since 27Aug2013, COPD, gout (unknown episode) with hyperuricemia, left ventricular hypertrophy since 25Jul2013, medullary nephrocalcinosis since 1942, peripheral vascular disease since 14Aug2014, senile osteoporosis and temporal arteritis since 01Apr2014 all ongoing. Concomitant medications included amlodipine 5mg tablet once a day by mouth for hypertension; levothyroxine 50 micrograms tablet 2 tablets once a day on an empty stomach by mouth for hypothyroidism; pravastatin 40mg tablet once a day by mouth for cholesterol; WAL-ITIN 10mg tablet as needed by mouth for allergies; CENTRUM SILVER tablet one daily by mouth for vitamin supplementation; Ibuprofen 400mg tablet by mouth once a day and as needed for arthritic pain; PRILOSEC 40mg capsule once a day by mouth for acid reflux; VALTREX 1 gram tablet once a day by mouth for suppression of herpes; METOPROLOL ER 100mg tablet once a day by mouth for blood pressure; FORTEO 20 micrograms intradermal once daily for osteoporosis. The patient did not received concomitant vaccination nor vaccines in the 4 weeks prior to the administration of PREVNAR 13. On 18Dec2014 the patient experienced injection site severe cellulitis which required an emergency room and was treated with antibiotics. The patient was not hospitalized due to the event. The outcome of the event was resolving.
The patient is a healthy 35 yo male with a history of GERD with Barrett's esophagus who experienced an adverse reaction after receipt of two vaccines on 02 NOV 20. He reports these as typhoid and YF-VAX but Agency documentation is rabies (Rabavert SKB ArBA731B) and YF-VAX (PMC UJ091AA-1/21). Facility has a progress note documentation YF-VAX and typhoid (Typhoid Vaccine Vi Capsular Polysaccharide,  Lot #  R1F781M Expiration date 09/2021).  He reports he received IIV 3 days later, although he thought receipt dates were Friday and following Monday. The IIV is documented as 10 NOV, but the other elements are incomplete and may be a late entry.  He reports he experienced no immediate adverse reaction after either vaccine receipt episode and denies oral/face/throat/tongue swelling/ urticaria, pruritis, Chest pain, cough, wheezing, SOB, n/v/d. He reports several days later he developed a pruritic fine  papular erythematous dermatitis with discrete lesions initially to his arms then his abdomen. He denies vesicles, bruising, or tenderness. He was post op from his laparoscopic surgery and all the incision sites all developed similar peripheral dermatitis, but much more pronounced symptoms at incisional sites. He was seen in surgery clinic for post op 13 NOV 20 who submitted an allergy consult (photo of dermatitis in note) and ER 16 NOV who cultured the site which was negative and prescribed hydroxyzine.  The rash fully resolved in 7-10 days. He denies any associated systemic symptoms (fever, headache, myalgias, arthralgias, n//v/d). He has no history of AE to any vaccines.
Information has been received through the Merck pregnancy registry from a 21 year old female with seasonal allergies and a history of ureteric reimplantation (1996).  On 10-JAN-2007, the patient was vaccinated with the first 0.5 mL dose of Gardasil (Lot# not reported).  Concomitant medications included Augmentin, ibuprofen and unspecified prenatal vitamins.  It was reported that the patient later found out that she was six weeks pregnant.  The patient underwent a pregnancy test (date unknown).  It was reported that the patient has had no ill effects from this.  The patient sought unspecified medical attention.  At the time of this report, the outcome of the event was unknown.  Follow-up information was received from the patient who reported that she gave birth to a healthy baby boy on 03-OCT-2007.  The patient reported that labor and delivery went smooth and the baby was healthy and normal.  Additional follow up information was received from the physician.  Laboratory results included quad screen from 26-APR-2007 which was normal and ultrasounds results from 25-APR-2007 which were normal.  An ultrasound from 25-JUL-2007 revealed a low lying placenta which the physician considered to be within normal limits and on an unspecified date was considered to have resolved.  The physician reported that on 03-OCT-2007 the baby was delivered by a cesarean section due to cephalo pelvic disproportion.  Upon internal review this was determined to be a serious other medical event.  Additional information has been requested.
Received first 1/15/2021 with no adverse reaction.  Received 2nd dose 2/9 @ 0846 with no adverse reaction or report of feeling ill.  Traveled to store and arrived approx. 2 hours after receiving vaccine.  Daughter stated patient felt well and had to go to the restroom to have BM.  Collapsed in bathroom.  Transported by ambulance to Hospital @ 1439 in cardiac arrest.  Was in PEA and went in v fib back to PEA. Resuscitation efforts initiated and patient expired with time noted at hospital records at 15:11.
tested positive for Covid 19; tested positive for Covid 19/ she is asymptomatic; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot Number: EN6199) as a single dose for COVID-19 immunization. Medical history included exposed to someone with COVID 19. The patient's concomitant medications were not reported. The patient was due to receive the second dose on 25Mar2021. She tested positive for COVID 19 on 23Mar2021 after being exposed to someone with COVID 19. She was asymptomatic. She asked if she still get the second dose of the vaccine on 25Mar2021. Her rapid test was negative on an unspecified date but her 24 hour test on 23Mar2021 was positive. The outcome of the events was unknown. The events were assessed as serious-medically significant.  Follow-up attempts are completed. No further information is expected.
I took the vaccine to travel. I moved on 4/29/21. The first night at a hotel, I had severe leg cramps: the left leg was toes to hip spasms lasting over 2 hrs. The right leg a bit less severe (toes to knee, also + 2 hrs). I did not receive food on the +5 hr flight and was dehydrated. I stretched etc as normal, with no results. At 2am, I went to the salt water pool and went between the pool and hot tub for about an hour. The next day I saw a huge bruise on the back of my right leg, above the knee. This repeated for 4 more nights, although less severe. Each morning I woke with another bruise: right leg above the knee = 3 bruises (purpuras), (con't below)
Heart palpitations since receiving the 2nd dose; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 14May2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 COVID-19 vaccine. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) and verapamil (MANUFACTURER UNKNOWN); both for an unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 23Apr2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On an unknown date in 2021, since receiving second dose, the patient experienced heart palpitations. The heart palpitations resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 06Sep2021, the patient underwent Nasal Swab SARS CoV-2 test and the result was unknown. Therapeutic measures were not taken as a result of heart palpitations. The clinical outcome of the event heart palpitations was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Reoccurrence of upper respiratory; positive antigen test; positive antigen test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 03Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE], start date: 17May2022, stop date: 20May2022; MUCINEX, start date: 18May2022, stop date: 19May2022; NYQUIL, start date: 18May2022, stop date: 20May2022; ZINC, start date: 17May2022, stop date: 22May2022; VITAMIN C [ASCORBIC ACID], start date: 17May2022, stop date: 22May2022; VITAMIN B12 [MECOBALAMIN], start date: 17May2022, stop date: 22May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17May2022, outcome "not recovered" and all described as "positive antigen test"; UPPER RESPIRATORY TRACT INFECTION (medically significant), outcome "not recovered", described as "Reoccurrence of upper respiratory". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Positive; (26May2022) Negative; (02Jun2022) Positive; (17May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, upper respiratory tract infection.  Clinical course : Reoccurrence of upper respiratory symptoms and positive antigen test on day 16 (02Jun2022) after initial symptoms and positive pcr and antigen test taken on 17May2022 (started paxlovid). Had made full recovery (no symptoms) and negative antigen test on day 9 (26May2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt fully vaccinated.  COVID positive on 11/14/2021.  Pt presented to the ED with cough and nasal congestion. She states 3 days ago the cough worsened and she began to cough up mucous.  Fever Tmax 101 today.  no chest pain, no chills, no diaphoresis, no ear fullness, no ear pain, no headaches, no myalgias, no rash, no shortness of breath, no sore throat and no wheezing.  Chest x ray showed no acute process.  Not hypoxic in the ED.  Discussed possible consideration for monoclonal therapy.  Pt agrees to us texting her name, phone number and MRN to Dr monoclonal tx office.   Cough medication and albuterol for home.  Given rx for pulse ox for home and discussed reasons to return to the ED.
2 INCH ACROSS RED BULLSEYE FORMED UNDER BANDAGE.  ARM HURT.  WAS NOT ITCHY AND THERE WAS NO TEMPERATURE.  TODAY, 1/28/13 IT APPEARS AS A SCAB OVER INJECTION SITE AND REDNESS HAS DISAPPEARED.
Patient was diagnosed with Guillain Barre syndrome 11 days after flu vaccine. Presently hospitalized at hospital.
FAST HEART RATE, WHICH LASTED ABOUT 10 MINUTES; ABDOMINAL PAIN IMPROVED AFTER 25 MINUTES FROM TAKING IBUPROFEN, IT WENT AWAY AFTER 40 MINUTES; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included: reacted to iron injection, and concurrent conditions included: non smoker, abstains from alcohol, wheat, nut and sea food allergy, rhythm issues, and tachycardia, and other pre-existing medical conditions included: The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 19-OCT-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. Concomitant medications included flecainide for tachycardia.  On 22-SEP-2021, the patient experienced fast heart rate, which lasted about 10 minutes. On 22-SEP-2021, the patient experienced abdominal pain improved after 25 minutes from taking ibuprofen, it went away after 40 minutes. Laboratory data included: Heart rate (NR: not provided) 117-120 beats per minute. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fast heart rate, which lasted about 10 minutes, and abdominal pain improved after 25 minutes from taking ibuprofen, it went away after 40 minutes on 22-SEP-2021. This report was non-serious.