chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am just getting over Covid and I was vaccinated and I still got it.; I am just getting over Covid and I was vaccinated and I still got it.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002591). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "I am just getting over Covid and I was vaccinated and I still got it.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PC 12JUN91 cried over 4hrs p/immun; still distressed; 13JUN91 pt did not see MD still unsettled; 14JUN91 Seen by MD probable vax rxn, to have DT in future;
I woke up with a 100.2 F fever with aches and pains the morning after getting the injection. The second day, my arm got very sore and felt hot and swollen around the injection site. The red area was about 5 inches long and 3 inches wide. The redness has all resolved now, but I still have a little pain in my arm more than a week later. It is improving, so I suppose it will completely go away in a few days.
Information has been received regarding a case in litigation from a lawyer, an approximately 62 year old male patient, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2013, at approximately 61 years of age, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a healthcare provider. On an unknown date in 2014, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.
eyesight blurry; irritated; agitated; I didn't feel confident to stand up; lightheaded; got very hot; sweating everywhere; felt like I was going to faint; nauseous; headache; back muscle hurt; sore; blood pressure really high (it spiked); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (lightheaded), FEELING HOT (got very hot), HYPERHIDROSIS (sweating everywhere), PRESYNCOPE (felt like I was going to faint) and NAUSEA (nauseous) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced DIZZINESS (lightheaded), FEELING HOT (got very hot), HYPERHIDROSIS (sweating everywhere), PRESYNCOPE (felt like I was going to faint), NAUSEA (nauseous), HEADACHE (headache), MUSCLE SPASMS (back muscle hurt), BACK PAIN (sore), HYPERTENSION (blood pressure really high (it spiked)) and FEELING ABNORMAL (I didn't feel confident to stand up). On 17-Jan-2021, the patient experienced IRRITABILITY (irritated) and AGITATION (agitated). On 18-Jan-2021, the patient experienced VISION BLURRED (eyesight blurry). On 15-Jan-2021, FEELING ABNORMAL (I didn't feel confident to stand up) had resolved. On 18-Jan-2021, FEELING HOT (got very hot), HYPERHIDROSIS (sweating everywhere), HEADACHE (headache), MUSCLE SPASMS (back muscle hurt) and BACK PAIN (sore) had resolved. At the time of the report, DIZZINESS (lightheaded), PRESYNCOPE (felt like I was going to faint), NAUSEA (nauseous), HYPERTENSION (blood pressure really high (it spiked)), VISION BLURRED (eyesight blurry), IRRITABILITY (irritated) and AGITATION (agitated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
This spontaneous prospective pregnancy report was received from a pregnant female patient of an unknown age, reporting on herself. The patient did not have any pertinent medical history, concomitant medications, drug reactions or allergies. On 21-NOV-2016, the patient had her last menstrual period (reported as "last montly period"). Then on 22-NOV-2016, the patient was vaccinated with her second dose of VARIVAX (lot #, expiration date, strength and anatomical location were not reported) and other suspect therapy included a sterile diluent (manufacturer unknown) (lot #, expiration date, strength and dose were not reported); both administered subcutaneously, as prevention from varicella. On an unspecified date in April 2017 (reported as "at an unspecified time last week"), she had an ultrasound and her physician said that it showed that everything "looked good". At the reporting time, the patient was 21 weeks pregnant and it was stated that no treatment was given for the vaccine exposure during pregnancy. The outcome of the pregnancy was pending and the fetal outcome was unknown. The estimated due date (EDD) of the pregnancy would be on 28-AUG-2017. No product quality complaint (PQC) was involved. Additional information has been requested.
Weakness, lethargy, severe pain at vaccination side and on same side as vaccination site, fever began around noon. Pain and weakness got more severe as the day progressed. Skin became very pale and child wheezed. Fever (101.5) responded to Motrin, but by 6 AM on the 21st, the fever was 103.5 Motrin brought it down to 101.5 By 10 a.m. fever was 100. Dr. prescribed rest, fluids and watchful care and suggested we report the adverse event. Patient had a low grade fever the rest of the the day, rising to 101.5 again about 6 p.m. Note: All symptoms except fever were gone by 10 AM on the 21st.
I had a reaction the the third injection. Soon after my first 2 injections of Lymerix I started having leg and joint pain. I now have arthritic pain all over my body. I cannot carry or lift anything of weight. There are days I need to help to get out of bed. I need MS Contin for pain. I will never be able to work again. I have vision problems and nausea and weakness. The annual follow up states "I am still the same-MD put me on Prednisone which has helped. Without Prednisone and MSContin-Cr, I cannot handle the pain and to move my body without these medications.
Anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration, administered in left arm on 02Apr2021 09:45 as single dose for COVID-19 immunisation. Medical history included type 2 diabetes, hypothyroidism, and allergy to: shellfish, penicillin, all narcotics, mold, catfish, vaccinium berries, peaches, somegrass and trees. Concomitant medications included levothyroxine sodium (SYNTHROID), cholecalciferol (D3), famotidine (PEPCID AC), biotin, and salbutamol sulfate (VENTOLIN ACCUHALER). On 02Apr2021 10:00, the patient experienced anaphylaxis. Treatment for the event included Ventolin, steroids antihistamines and nebulizer. The event result in Emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of event was recovering.  Information about lot/batch number has been requested.; Sender's Comments: Due to a strong drug-event temporal relationship the company deems there is a reasonable possibility that the reported anaphylaxis is related to BNT162b2.
Cough; THIN RHINNORHEA; "SHAKING" PERIOD POST FALLING ASLEEP; RED BUMPS ON BACK WHICH HAVE BEEN SPREADING, SOME ARE CRUSTING OVER; LEFT DELTOID BECOMING HOT TO TOUCH, SWOLLEN, REDDENED AND TENDER; Cellulitis; Allergic reaction; SWOLLEN FROM ELBOW UP INTO AXILLA; SWOLLEN FROM ELBOW UP INTO AXILLA; BRUISED LOOKING; Information has been downloaded from regulatory authority (US-SP-2011-03710).  This spontaneous report was received from a healthcare professional concerning a 4-year-old male patient. The patient's concurrent conditions gastrooesophageal reflux disease (GERD), asthma, seasonal allergy, developmental delay, Specific allergy (drug), shaking, tonsillectomy, adenoidectomy, tympanostomy tube insertion, allergic rhinitis, chronic sinusitis, otitis media, contact dermatitis, urticaria and allergy to nuts; his concomitant medications included esomeprazole magnesium (NEXIUM), cetirizine hydrochloride (ZYRTEC), fluticasone propionate (FLONASE), albuterol sulfate (manufacturer unknown), albuterol sulfate (PROAIR) and beclomethasone dipropionate (QVAR). The patient's medical history and previous drugs reactions were not reported.   On 15-JUN-2011, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), by subcutaneous, lot #13212 for prophylactic vaccination (strength, dose, dose schedule, anatomical site of injection and expiration date were not reported) and diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (DAPTACEL), lot # C3473A, by intramuscular route, for prophylactic vaccination (strength, dose, anatomical site of injection and expiration date were not reported).   On the same day, the patient experienced cellulitis, allergic reaction (hypersensitivity), swollen from elbow up into axila (extensive swelling of vaccinated limb and lymphadenopathy), left deltoid becoming hot to touch, swollen, reddened and tender (vaccination site inflammation). On 27-JUN-2011, the patient experienced red bumps on back which have been spreading, some were crusting over (varicella). On an unknown date the patient experienced cough, bruised looking (contusion), shaking period post falling asleep (tremor) and thin rhinorrhea (rhinorrhea).     On 27-JUN-2011, the patient recovered from the events of cellulitis, hypersensitivity, extensive swelling of vaccinated limb, lymphadenopathy, contusion and vaccination site inflammation. The outcome of tremor, rhinorrhoea, cough and varicella was reported as resolved.    The causality assessment between the suspect vaccines and all the aforementioned events was not reported.       The events of the cellulitis, hypersensitivity, extensive swelling of vaccinated limb, lymphadenopathy, contusion, vaccination site inflammation, tremor, rhinorrhea, cough and varicella were considered to be medically significant.   Lot number 13212  is an invalid lot number for varicella virus vaccine live (oka/merck).; Sender's Comments:  2011-03709:
Patient returned 11/2/16 complaining of pain at site of injection. Slight redness present. Recommended seeing MD if troubles. Saw MD on 11/4/16. He said slight cellulitis. Ordered BACTRIM. Ordered Nabumetone 11/7/16
She still has muscle pain in left arm. No visible rash or bruising noted. Also reports bone pain in upper left arm.
Interchange of vaccine product; Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): MOD-2023-718100 (Moderna).  A 49-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Sep2022, outcome "unknown"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine product". Clinical course: Patient has received one Moderna booster (date received unknown) and described a side effect of fever with the Moderna booster that "lasted slightly longer" than any side effects experienced with their Pfizer vaccine doses. The fever experienced following their Moderna booster was described as mild and subsided within a half day. Respondent also had been infected with Covid (Sep2022). Experience of symptoms with Covid also described as mild, limited mostly to fever and cough.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Patient states she had a sharp "lightening bolt like" pain in her arm when it was administered. She feels it is poor technique. Arm painful and sore, hurts to rotate, extend up and her left hand has numbness from her fingertips to her wrist. Spoke with patient 3 days after administration and still claims above.
Presented to ER and admitted on 10/30/21. 73 year old female presents with nausea, vomiting and diarrhea. She has had symptoms for about a week.  She reports around 10 bowel movements a day, loose, nonbloody, with lot of mucus, with tenesmus, associated with history of eating out. She reports nausea and vomiting developing after few days of having diarrhea.  She reports she has had similar symptoms in the past (7-8 years ago), that she "almost died." She lives with her daughter who has covid. She denies any fever or respiratory symptoms other than her chronic COPD symptoms.   Hx of diverticulosis. Her vitals on presentation Temp 98.6, HR 75, BP 115/70, RR 20. Labs significant for +ve COVID, Creat 1.80, CT chest shows no evidence of active COVID 19 involvment of lung but shows worsened chr fibrosis.CT chest- worsened chronic lung fibrosis.  Pulmonary fibrosis-H/O methotrexate induced lung injury in 2016,  hypoxic, started on NC oxygen.  Pulmonologist on board- eventually required OptiFlow.  Creatinine 1.8. on IV fluid. - AKI resolved On COVID 19 treatment (ceftriaxone, doxycycline, remdesivir) .  ID and pulmonologist consulted. Oxygen requirement improving.  No short of breath, was on OptiFlow-switched to NC oxygen on 11/14/2021.  Walk test done.  Requires home oxygen, no new voiced concerns.  Patient was medically stable for discharge  Home on 11/15/2021
Pt received flu shot in office. Just after walking out of the exam room she had syncope with collapse, eyes rolled back. Head/face struck metal scale on the floor as she fell, resulting in through and through laceration to lower lip. Pt unresponsive for a few seconds and then regained consciousness and was able to answer questions. Ambulance called and pt transported to nearest ER where she had 7 seconds of asystole and compressions initiated. Air transport to hospital where pt was monitored overnight in ICU and then on floor, no further episodes noted. Presuming vasovagal episodes but asystole remains unexplained. No prior episodes of syncope for pt. Will be following outpatient with cardiology.
Patient received her first dose of Moderna on 5/4/21.  She broke her Left big toe on 5/13/21 at work.  She was treated at Medical.  They sutured her left toe and buddy taped them together.  Advised her to follow up with the orthopedic and workmans comp. She refused tetnus shot at that time r/t having the Covid vax within 14 days.   On 5/31 Patient noticed her left ankle was swollen and somewhat painful so she went to the ER Medical.  She was diagnosed with a DVT and placed on Xarelto.  She also agreed to take the tetanus shot at this time.
Swollen Lips; Tingling of the tongue; This case was reported by a other health professional via call center representative and described the occurrence of lip swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced lip swelling and tingling tongue. On an unknown date, the outcome of the lip swelling and tingling tongue were unknown.   It was unknown if the reporter considered the lip swelling and tingling tongue to be related to Shingrix.  Additional details were provided as follows: The age vaccination was not reported. The reporter stated that, after vaccination with 1st dose of Shingrix, the patient experienced swollen lips and tingling of the tongue. The reporter asked for 2nd dose recommendation, if the patient experienced adverse reaction after 1st dose. No additional details available at the time of reporting. The reporter consented to follow up.
This spontaneous report as received from a pharmacist refers to a 46 year old male patient with diabetes, depression, high blood pressure and high cholesterol and none drug allergies. On 15-APR-2014 the patient was vaccinated with ZOSTAVAX (subcutaneous, lot#: J011826, expiry date: 26-DEC-2014). Concomitant therapies included simvastatin (manufacturer unknown), lisinopril (manufacturer unknown), metformin, LEXAPRO, glimepiride and JANUVIA. On 16-APR-2014 the patient developed "flu-like syndrome". The patient's wife sought medical attention and called the pharmacist. No lab diagnostic studies were performed, there was no treatment given for the event. The outcome of the patient developed "flu-like syndrome" was reported as not recovered/not resolved. Additional information has been requested.
Numbness & tingling of hands and feet, muscle aches, lethargic, headache, backache.
76hr post vax pt had 10 second episode while nursing & jerking of all extremities;mom stated that was nursing;mom was watching TV-not looking @ child when felt the child movement;duration was approx-not timed;pt would cry when pacifier take
Chills; Nausea; Chest congestion; Nasal congestion; Diarrhea; Cough; Body aches; This is a spontaneous report received from a contactable consumer (patient's husband). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0186), via an unspecified route of administration, administered in Arm left on 21May2021 at 09:30 as dose 1, single for COVID-19 immunisation. Medical history included blood clots from an unknown date and unknown if ongoing. Concomitant medication received as Inflamma-Less by Irwin Naturals on an unknown date. Reporter stated that she is not on the supplements. She was on other medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient received vaccine facility name in Kroger pharmacy. My wife and I got our vaccines from the same pharmacy and pharmacist. We both got it on our left arm. We got our first shots 3 days apart (she was after myself). I showed symptoms exactly 5 days after that includes but is not limited to nausea, chest congestion, nasal congestion, diarrhea, cough, body aches and chills. She was now showing the same symptoms exactly 5 days after her shot. On 26May2021 at 08:00 the patient experienced chills, nausea, chest congestion, nasal congestion, diarrhea, cough, body aches. The outcome of the events was reported as recovering.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021621155 same reporter, vaccine and AE, different patient.
on day 8 I felt itchy and noticed swelling and redness; I applied topical hydrocortisone cream; the following day still red, swollen and slightly itchy
About 5 minutes after the shot I felt pain in the area where they put the shot. About 15 minutes later I started to feel disoriented, lightheaded and felt like I was going to lose consciousness and I felt my heart racing. When they took my blood pressure it was 148/80. Then I started to have difficulty breathing. They took me to the ER in the same facility but the symptoms had resolved I believe because I drank plenty of water while I had the symptoms.
patient felt like there was something in her throat; Patient felt more dizzy; Trouble breathing which got worse; Patient started feeling dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Patient started feeling dizzy), DYSPNOEA (Trouble breathing which got worse), OROPHARYNGEAL DISCOMFORT (patient felt like there was something in her throat) and DIZZINESS (Patient felt more dizzy) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006CZIA) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 23-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced DIZZINESS (Patient started feeling dizzy). On 25-Apr-2021, the patient experienced DYSPNOEA (Trouble breathing which got worse). On 26-Apr-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (patient felt like there was something in her throat) and DIZZINESS (Patient felt more dizzy). On 25-Apr-2021, DIZZINESS (Patient started feeling dizzy) had resolved. At the time of the report, DYSPNOEA (Trouble breathing which got worse) and OROPHARYNGEAL DISCOMFORT (patient felt like there was something in her throat) outcome was unknown and DIZZINESS (Patient felt more dizzy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment medications information provided.
Pt received her first dose of Moderna on 01/14/2021.  Pt experienced a delayed adverse reaction of diarrhea starting on 01/17/2021 and lasting through 01/18/2021.