chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received pneumococcal vaccine 10/13/09-L-arm. Pt. states that she began chills,fever 10/13/09 in PM hours. L-arm was very swollen, tender, hot to touch. Fever subsided in AM on 10/14, but arm continued to be hot, swollen, tender. Saw MD on 10/16/09 and was treated with antibiotics for cellulitis. Condition improving, arm still painful.
Headache, Temperature 101.1 ,fatigue, lasted approx. 24 hours
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 67-year-old female patient who received Shingrix for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. In September 2018, the patient received the 1st dose of Shingrix .5 ml and Influenza vaccine Quadrivalent 2018-2019 season. In September 2018, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced general body pain, chills, fever, feeling unwell and drug administration error. In September 2018, the outcome of the general body pain, chills, fever and feeling unwell were recovered/resolved. On an unknown date, the outcome of the drug administration error was unknown. It was unknown if the reporter considered the general body pain, chills, fever and feeling unwell to be related to Shingrix and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The patient received Shingrix and flu vaccine at the same time in the left deltoid, which led to drug administration error. Both vaccines were administered about three weeks ago from the date of reporting but the patient could not provide a specific date. The night when the patient received vaccines, the patient developed the chills, aches and fever. When the patient woke the next day, she did not feel well but the chills and fever were gone and she went to work. All events were resolved within 2 days. The patient does not recall the name of the flu vaccine but she told it was for those over 65 as it was a bit stronger.
Angioedema type of reaction: Itching of both eyes. Itching , redness, and slight swelling  of cheeks, elbows, knees, knuckles of both hands about 48 hours post vaccine.  I have had this type of reaction previously - unknown trigger, not related to a vaccine. I took one benadryl dose, and called my PCP office. The nurse took the info, and advised me to take another benadryl if needed, and to call her back in 1 hr.  I called her back reporting that the reaction had subsided. She game the same advise and told to make sure to call back if needed.
Hospitalized 12/9/2021-still currently admitted; COVID-19 positive 12/1/2021; fully vaccinated  HISTORY OF PRESENT ILLNESS: Patient is a 79 y.o. male with past medical history of parkinsons disease, prostate cancer s/p prostatectomy.    Began having symptoms 11/28. Positive home test 11/30. + test at facility 12/1. MAB 12/4. Fever 102 after MAB, none since. Feeling weak and off balance after MAB. Had cough and rhinorrhea, fatigue prior to MAB but no fever. Minimal SOB. SOB now progressively worsening. Dyspnea with exertion worsening. Today unable to ambulate, Feeling very weak. "crumpled to floor" trying to stand. No chest pain, Chest feels heavy. No pleuritic pain. Cough with minimal sputum. No nausea, vomiting, diarrhea, abdominal pain. Denies urinary complaints. Minimal appetite, no loss of smell or taste. Able to stay hydrated. Having mild headaches. Has chronic lightheadedness with parkinsons. Per neuro notes has mild orthostatic hypotension. No other acute symptoms.   CHIEF COMPLAINT: Pneumonia due to COVID-19 virus   ASSESSMENT / PLAN: COVID Pneumonia Acute hypoxic respiratory failure secondary to above              Symptom onset 11/28              COVID +: 11/30 on home test, + at facility 12/1              Received MAB 12/4              CTA thorax: No PE. Moderate to severe covid pneumonitis.               Pulse ox at home 80's for a couple days and dipping into 70s since last night              Received hydrocortisone 200mg for contrast prep, will hold off on decadron today and start 6mg daily in am              Prn antitussives, albuterol MDI              PRN tylenol for fever  Chief complaint Pneumonia due to COVID-19 virus   Assessment and Plan   Pneumonia due to COVID virus Acute respiratory failure secondary to COVID - To complete Decadron for 10 days - currently on room air at rest.  Bedside nurse to evaluate oxygen requirement with ambulation. - No longer need for severe isolation per infection control  Dispo:  SAR versus home with home health care based on patient's progress with the PT OT
Patient developed fever, headaches, enlarged tonsils, fatigue, and diagnosed with EBV mono in October after getting vaccine on Aug 31 and Sept 29. She had prolonged course of mono complicated by a tonsil bacterial infection.
When my pharmacist started to inject me, it hurt so bad that I jumped and he had to stick me again. Since then, I have been unable to lift my arm all the way up with out pain. In my shoulder, extreme pain in shoulder to take off T-shirts. Cannot raise arm all the way up at my shoulder. Take aspirin and apply ice from time to time.
No adverse events or treatment required.   Vaccine was expired at time of administration.  Case has had no issues or trouble since given vaccine.  Vaccine expired 4/13/2022
On 3/21, 10 hours after shot 101 fever. 11 hours after shot fainted Fever for 24 hours 36 hours after shot developed swollen lymph nodes in neck that lasted 4 days
History Chief Complaint Patient presents with ? Fatigue     all sx started saturday night  ? Generalized Body Aches ? Sore Throat ? Headache     Sinus pressue  ? Chills ? Fever     100 this morning     Patient is a 39 y.o. female    HPI Had first vaccine last week. Pt presents with concerns of possible Covid 19. Pt reports the following symptoms that started 2 days ago. Sinus pain and pressure Yes  Thought was allergies when first started. Fever/ chills Yes Headache Yes Body aches Yes  Has fatigue Cough Yes Sob No Sore throat Yes Nausea/ vomiting/ diarrhea. No Loss of taste or smell No Medications used:Yes Tolerating fluids:Yes Tolerating. solids:Yes Smoke exposure:No Exposed to someone who tested positive for COVID 19: Yes History of asthma, bronchitis, pneumonia. No
Administration of vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant mediations were not reported. Treatment information was not reported.
injection site ache / dull pain at the site of the injection; ache all over the body; This case was reported by a pharmacist and described the occurrence of injection site pain in a elderly male patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date 25th September 2021) for prophylaxis.   On 16th July 2019, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain and generalized aching. On an unknown date, the outcome of the injection site pain and generalized aching were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and generalized aching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number of the Shingrix was updated as 4H9G2 from 4H952, as per sales's data sheet. On 16th July 2019, the patient got NDC shot 58160-08232 11 The patient stated that, currently remodeling the house, so did get ache all over the body, but the ache at the site of the injection lingers on. The reporter consented to fiollow up.
Felt a little achy; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt a little achy) and FATIGUE (Extremely tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (Felt a little achy) and FATIGUE (Extremely tired). On 16-Mar-2021, PAIN (Felt a little achy) and FATIGUE (Extremely tired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-390033, MOD-2021-390023 (Patient Link).
Lt arm pain, redness and swelling Nausea Headache Metallic taste in mouth  Last x 3 days  Treated with Ibuprofen
Information has been received from a physician concerning a 48 year old female patient with a history of heart surgery for stent in August 2009 and no known allergies who on an unspecified date was vaccinated with a dose of MMR II (lot number not reported). Concomitant therapy included aspirin. The physician reported that the patient was non-immune to rubella but was positive for measles and mumps as per a titer on 07-MAR-2010. The patient was told when she was college age that she needed a vaccination but she did not know if it was for MMR II. She did not receive it. She also told after giving birth that she needed a vaccination but she did not know what is was for and did not receive it. Unspecified medical attention was sought. The outcome of the patient was not reported. Additional information has been requested.
Pt stated that she was feeling lightheaded, vision became blotchy. We had the Pt sit down, and about a minute later she stated that she needed to vomit. Pt did vomit into garbage afterward. Pt stated that she felt better after.
Muscle weakness and face numbness in right arm, right leg, right side of face, and left calf and foot.
arm hurt; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced arm hurt on an unspecified date. The outcome of event was unknown. The patient also received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation and experienced arm hurt, achy with a slight headache, tired and felt generally sick.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This initial spontaneous report was received from a physician referring to a 4 month-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 04-SEP-2015 at 11:58 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
It was reported in a published report, title stated above regarding a case in litigation concerning an approximately 17 month old male who on 23-APR-1998 (age at time of vaccination was 16 months) was vaccinated with a dose of MMR II (manufacturer unknown). The patient's family brought a petition alleging that thimerosol caused immune dysfunction that allowed the MMR II (mfr. unknown) to establish a chronic infection in the gastrointestinal tract, causing autism. The patient had developed normally as an infant but regressed after receiving the vaccine. The patient's medical records up to the point of vaccination at 16 months of age do not list the words that the patient was using. However, family videos show possible developmental problems before administration of the vaccinations that the parents blame for the autism. Upon internal review autism was considered to be an other important medical event. This is one of two reports from the same source. No further information was available.
Pain; Lump; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient reported for herself). A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on Aug2021 (at the age of 61-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history was and concomitant medications were not reported. Patient had both doses of the vaccine, 1st dose was on Aug2021 and 2nd dose on 10Sep2021, and after 1st dose she only experienced pain and lump (did not mention the specific body part) in 2021. And after 2nd dose, she experienced leg pain within 24 hours, Legs were hurting, feet were burning and really had bad pain. patient had massage to ease the pain, it was hard to sleep and never had this before. She did not take any pain medication or any other drugs in the past. Asked if has anybody reported like leg pain after getting the shot of the Pfizer COVID 19 vaccine. The outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Received PNEUMOVAX injection 9/29/14 about 1 pm at pharmacy. By that evening my arm was red, swollen and very sore - redness was large area surrounding the injection site which was in back of left arm. Next day 9/30/01 fever was 103 - called pharmacy and was told to take TYLENOL. 10/114 - area of redness had progressed with streaks of redness toward back - continued to be very sore, red and swollen - temp 101 - called pharmacy was told to go to ER. Was seen in ER - temp down by then - had taken TYLENOL, but arm still very reddened, swollen and sore - Picture attached that was taken in ER. See by MD and was told never to take vaccine again as the next time the reaction will be worse. Was sent home with prescription for KEFLEX which I started taking that evening. Had been sleeping almost non-stop since Monday evening with no appetite, very nauseated and weak. 10/2/14 - I awoke with lesion on left eyelid, red eye and sores in nose - I thought I had a stye - used moisture eye drops to relieve the symptoms - very painful eye. Still feeling very weak with no appetite with periods of lightheadedness and felt like I was going to pass out. Still sleeping most od the time. Gradually the redness went away, but arm continued to be sore, itching and hypersensitive to clothing. Eye continued to get worse. 10/7/14 - saw my eye doctor and was told I had herpes in eye and nose due to the low resistance from the pneumonia shot. Was prescribed Acyclovir for the herpes and an antibiotic eye ointment. Gradually started to feel better but lightheadedness remained for another week or so. Left arm continues to hurt, itches even after almost 5 weeks post injection.
12:43pm = administered FLUZONE. 12:55pm = pt reports throating tingly and dizzy; Called 911; Check BP - 114/82; Paramedics came and rechecked hydration/eating vitals OK. 1:55pm - patient felt OK and left pharmacy.
BLOOD CLOTS IN URINE; URINATING BLOOD; FELT ACHY; This spontaneous report received from a patient concerned a 43 year old male. 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: 1805020, and expiry: 25-MAY-2021) dose was not reported, administered, 1 total, to left arm on 19-MAR-2021 around 06:00 PM for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, 12 hours after vaccination patient felt achy which had resolved in 24 hours. On 20-APR-2021, patient experienced blood clots in urine and had urinating blood lasted till evening of same day. The patient visited emergency room for same symptoms and admitted on 20-APR-2021, discharged around noon on same day. The patient was given with IV fluids and no other medications were administered. The patient had undergone blood test, urine analysis, computerized tomography (CT) scan and results were nothing urgent to consult. The patient had planned to do follow-up with urologist on 28-APR-2021. Laboratory data included: Blood test (NR: not provided) negative, computerized tomography (CT) scan (NR: not provided) negative, and Urinalysis (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clots in urine, and urinating blood on 20-APR-2021, and felt achy on 21-MAR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: - Covid-19 vaccine .Ad26.Cov2.S- Blood clots in urine . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
BODY ACHE; CHILLS; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a patient via a company representative 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, intramuscular, batch number: Unknown) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-MAR-2021, the patient experienced body ache, chills, fever, headache and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body ache, chills, fever, headache and nausea was not reported. This report was non-serious.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 08-JAN-2016, patient received improperly stored VARIVAX dose 2, from lot # 665413/1128Y (dose and expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Employee  developed approx. 2"X3" rash in sternum area which developed a couple of hours after administration of vaccine. Employee states he noticed the rash after working out because the area became red and itchy. Rash/redness "went away" by morning time. Did not take any medications.
Patient fainted after recieving vaccines while sitting. Patient stated she had muffled hearing for 5 minutes after recovering.
extreme headache lasting 2 weeks, followed by moderate headaches for 2 weeks more red itchy swollen rash at injection site approx 4" long by 3" wide starting 3 days after vaccination and slowly fading after 2 weeks
Patient's mother snuck patient into pediatric line after being told that this patient did not quality for the Pfizer 5-11 dose, and needed to received the Pfizer 12+ dose. Dose was given by RN.
Patient given PREVNAR 13 and PREVNAR 13 was given 2/11/15. Patient did not have any reaction.
The shot hurt pretty significantly, then the arm truly hurts at shot site muscle. Extreme uncontrollable shivering and teeth chattering in the night, that I could not control. Today, 9/13/2019 such extreme pain in all muscles.
w/in 10min of DTP pt appeared pale & had syncope episode lasted 10 seconds, no sz activity, was hypotonic & pale lasted approx 10 mins;
Fever of 101.9; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101.9) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of 101.9). At the time of the report, PYREXIA (Fever of 101.9) outcome was unknown.            Treatment medication was unknown
Pls Note:  1st shot: 2/9/21 26 hours post 1st Moderna. * Left arm paralysis. Severe pain through upper body arm. Wrists, left fingers did not function well or grip..  99 degree fever. Chills. took antihistime and tylenol bed.  symptoms alleviated by next morning. except for sore injection site and some fatique.  2nd shot 3/9/21  reaction lasted 2.5 days.  2 hrs post 2nd shot 4 pm. trouble walking, off balance,  severe pain, chills, No fever, next day 3/10/21 semi conscious several hours, disoriented.  tingling arms hands. Above side effects alleviated after 2.5 days NOTE:  1 week post 2nd vaccine. Arms, hands and wrists weakened. cold, tingling. weak grip bi laterally. Poor dexterity. *** :CURRENT LEFT inner elbow bone Acute burning pain. feels like neuropathy? (vaccinated arm)  Onset since vaccine.  -
Patient came to our  facility  and got Janssen vaccine . while entering her information in state immunization system found that she already had her Moderna  two doses one in December and January . Patient did not mention about that to  us  before getting the Janssen vaccine and stated that she did not get any Covid vaccine  in her consent form.
4?x4?  square patch just below the injection site.  Red, irritated, itchy, hot, firm and painful to the touch. Has not resolved. Experienced fever of 101.8, headache, chills, fatigue and dehydration for approximately 24 hours after second dose. These symptoms have resolved.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-DEC-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K016966, expiration date 10-MAY-2017, dose and route not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion five times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 72, 29 and R;  24, 32 and R; 104, 33 and R; 24, 31 and R; 112, 30 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Unable to walk, stand, eat by mouth, unable to use bathroom, seizures, passing out becoming unresponsive. My daughter has been in the hospital since Feb. 2015.