chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe shoulder pain, limited range of motion since first COVID-19 shot in March 2021. No prior shoulder or arm pain or mobility issues. Doctor diagnosed vaccine induced shoulder bursitis and indicated the vaccine was injected into the bursa and not the muscle.
I have not been feeling good; congestion; cough; head; body aches; severe diarrhea; Shingles; felt like she had the flu; Severe chronic fatigue; cant think or concentrate; has never been so sick; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0164), via an unspecified route of administration in arm left on 27Jul2021 (at the age of 64-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included degenerative disc disease from Jul1991 and ongoing, patient medical continuing. The concomitant medications of the patient included she takes blood thinners, but nothing that would make her feel like that. The History of all previous immunization with the Pfizer vaccine considered as suspect and the list all vaccines administered on same date with the Pfizer vaccine considered as suspect were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The AE(s) following prior vaccinations and Family Medical History Relevant to AE(s) were reported as none. The patient experienced I have not been feeling good, congestion, cough, head, body aches, severe diarrhea, shingles, felt like she had the flu, severe chronic fatigue, cant think or concentrate, has never been so sick on an unspecified date. the patient said she was caregiver, and she was not able to do her job. She said that she was going back to the urgent care. She stated that 3 days after she received the first dose of the Covid-19 Vaccine she had severe congestion and cough, headache, and body aches. She felt like she had the flu. She went to urgent care and was negative for Covid. She was told it was the flu and was provided antibiotics for treatment. She said that she had been tested at least 14 times for Covid and they have all been negative. She said that she got shingles and Saturday and Sunday she had severe diarrhea and had never been so sick. She was going back to urgent care to see what they can give her so she could work. She said that she also experienced chronic fatigue. Her body and head felt like she cant think or concentrate because she hurts so bad. She was so exhausted and something was wrong and she was not getting the second shot. She does not think that she was supposed to felt like that. In hindsight she wished she had never got it. The patient underwent lab tests and procedures which included sars-cov-2 test: all been negative on an unspecified date. Therapeutic measures were taken as a result of, felt like she had the flu that included antibiotics. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Immediately after administering SQ MMR and Varicella, redness/warmth and hive noticed. Patient was not in any respiratory distress.
severe psoriatic plaques covering 60% of skin, no hx of skin lesions prior to vaccine
Patient was given both flu and COVID vaccinations. After vaccinations (within 5 min) patient attempted to move from being seated on the ground to a nearby chair. Patient stood up, attempted to walk to the chair, fainted, and fell face down into the pavement. Patient regained consciousness and sat up. It was then discovered she had a large cut under her chin and was bleeding from the chin, teeth, and left ear. EMS was immediatley called. Patient was slightly confused and complaining of nausea at this time. Patient was transferred to a laying position with feet elevated. BP 86/46 and pulse 45 was taken by the school nurse. She also reported pupils round, equal and reactive, approx 2mm in size. Continued below
aches; flu like symptoms; fever; chills; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included TRAZODONE, OMEPRAZOLE, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), OXYCODONE and MORPHINE for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN (aches), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (aches), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
On April 8, 2021 patient received his second dose of Moderna COVID-19 vaccine at pharmacy at 1:08pm.  Patient waited the appropriate 15 minutes, and then left pharmacy.  He reported no adverse reactions to our staff during that time, and did not call afterward to report any adverse reactions.  At approximately 4:30pm on April 10, 2021, I received notification that patient was found DOA at his residence.  No other information is available at this time.
2 days after vaccination patient experienced a severe generalized pruritic rash from the shoulders to the feet.  He also felt terrible for the next 10 days with severe general malaise. He continues to have a residual rash over his back and abdomen with persistent itching. The patient felt so terrible that he is reluctant to get the second dose.
This is a 28 Years old Male presenting for initial allergy evaluation. Patient reports he received his first COVID vaccine (Moderna) on base on 8 Jan 2021. Was in his usual state of health. Waited 15 minutes without adverse reaction. About 35-40 minutes after vaccination while driving home, felt like his tongue was bigger inside his mouth. Patient's wife is a nurse, looked in his mouth, also felt the tongue and uvula were swollen. He did think his airway was compromised. Also had fever about 7 hours after the shot (~100F) resolved with Tylenol. Admits to soreness at injection site and generalized arthralgias for 2 days after injection. Denies associated lightheadedness, syncope, shortness of breath, wheezing, cough, urticaria, conjunctivitis, rhinitis, vomiting, abdominal pain or diarrhea.  Swelling persisted 1.5-2 hours and spontaneously resolved. Did not seek medical attention. Presented to POD for second COVID vaccine dose (due 5 Feb 2021) and was turned away after mentioning his symptoms and was recommended to follow-up with the clinic. He has never experienced swelling before. Vaccines are otherwise up to date; has tolerated all other vaccines. Denies a history of anaphylaxis. Denies adverse reaction to any prior medications. Denies a history of adverse reaction to venom and latex. States gluten sensitive (bloating, diarrhea after ingestion). Denies a history of food allergies. Reports he is allergic to cats and has seasonal allergy symptoms controlled with Benadryl PRN.  Denies a history of adverse reaction to polyethylene glycol (PEG), a polysorbate, or polyoxyl 35 castor oil containing injectable or vaccine. Takes an OTC stool softener PRN containing docusate and sennosides.
Fatigue, muscle aches, headache, tiredness for about 24 hours.  fatigue lasted about 48 hours.
Pt. reports half-dollar sized area was pink when she woke morning after vaccine. Area was itchy. Over weekend redness, swelling and itching increased. On 2-24-14 saw doctor. Noted 3 1/2 x 3 cm mild raised erythema with surrounding 7 cm faint erythema.
This spontaneous report was received from a physician refers to his 1 year old son. Physician stated that his son was born healthy. Patient had no known allergies. On 17-JUN-2006, the patient was vaccinated with a dose of RECOMBIVAX HB (lot # 650890/0144R, expiry: 31-AUG-2007, dose and route unknown). On 20-JUL-2007, the patient was vaccinated with a dose of MMR II (lot # reported as 01834, expiry: January 2009) and VARIVAX (Merck) (Lot # reported as 07804, expiry: May 2009). Approximately since an unknown date in 2007, the patient demonstrated symptoms within the autistic spectrum between the age of 1-4 years. The symptoms the child displayed include tip-toeing, withdrawn, lack of eye contact and speech delay. Physician states many therapies were used for treatment such as speech therapy, occupational therapy but no prescription medications were used for treatment. The physician states his son does maintain a gluten-free diet. Patient had sought medical attention. electroencephalography (EEG), Magnetic Resonance Imaging (MRI) of head and genetic testing were all negative. Physician states it was unknown what could have caused these symptoms of autism spectrum and questions whether it could be any of three vaccines. The outcome of autism spectrum symptom was reported as recovered completely by 4 years of age (unknown date in 2010). Physician states there is still no known reason for his son's autism spectrum symptoms. Additional information has been requested.
Three days post vax pt developed a low grade temperature, achiness, pox on arm and leg (3-4), and headache. The second week post pt developed pox (2) on face, diarrhea, and continued with achiness. Pt was out of work for two weeks.
Patient had localized reaction with erythema, tenderness at the injection site. Also developed blurry vision initially in the R eye four days later and then in the L eye as well five days after that. Only near vision was affected and it is described as being a white spot off to the left of the visual axis. She has been seen by an Ophthalmologist and supposedly had a normal exam including fluorescein angiography. Field of vision showed no gross abnormalities. She is also c/o headaches that are described as dull, biparietal, constant not associated with N/V, flashing lights, or other neuro symptoms. She is scheduled for MRI on 2/15/05.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown demographics. The nurse reported that an unspecified number of improperly stored doses of ZOSTAVAX (lot # L002424, expiry date: 23-APR-2016) were inadvertently administered to the patients (incorrect product storage) on unspecified dates. No adverse events were reported. Outcome was unknown. No product quality complaint was involved. The case is also related to MARRS#1510USA007930 (same reporter link). Additional information has been requested.
Eyes "puffed up"; This spontaneous case was received on 02-Oct-2021 from other non-health professional via Med Communications (reference number: SEQW21-03183) and concerned a male patient, of an unreported age.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, indication and anatomical location: not reported). The batch number was not reported.  On an unknown date, unknown amount of time after receiving influenza virus vaccine polyvalent, the patient's eyes 'puffed up'.  The outcome of the event was not reported.   The reporter did not provide causality assessment.  The case was assessed as non-serious.   The case is linked to case 202103301 (the same reporter).  Company comment: A male patient, of an unreported age was vaccinated with influenza virus vaccine polyvalent. An unknown amount of time after receiving vaccine, the patient the patient's eyes puffed up, as reported. Causal role of the suspect vaccine is unassessable, due to unclear temporal relationship.; Sender's Comments: A male patient, of an unreported age was vaccinated with influenza virus vaccine polyvalent. An unknown amount of time after receiving vaccine, the patient the patient's eyes puffed up, as reported. Causal role of the suspect vaccine is unassessable, due to unclear temporal relationship.
Pt recv vax on 3/9/99; on 4/13/99 pt exp sudden screaming, red petechia on legs &hips x 3 days
Case number PHEH2015US026920 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 47-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 07 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day, the temperature was fine. It was a new refrigerator and there had not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Tingling/burning on left jaw (began w/I 10 minutes of vaccine and is still present 2+ hours later) Headache
Fever with papular vesicular rash and UR with sxs 2 weeks after VARIVAX. Toddler diagnosed with OM & probable chickenpox rash. Rx fever with TYLENOL, x 1 week and OM with Amox. No daycare or out in public until afebrile x 48hours & rash resolved.
Vaccine may have been stored under condition that departed from the manufacturer's recommended specification, so the manufacturer deem vaccine not viable and recommends a repeat dose.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 41-year-old female patient received BNT162b2 (BNT162B2), on 20Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 41 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; DHEA; ZINC; FISH OIL; PREGNENOLONE; IRON; IODINE; B12 [CYANOCOBALAMIN]; ASHWAGANDHA; VITEX AGNUS CASTUS. Past drug history included: Marcaine, reaction(s): "Known allergies: Marcaine"; Lidocaine, reaction(s): "Known allergies: lidocaine"; Augmentin, reaction(s): "Known allergies: Augmentin". Vaccination history included: BNT162b2 (DOSE 2, SINGLE; Lot number: FH8027), administration date: 12May2021, when the patient was 40-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 1, SINGLE; Lot number: ER8731), administration date: 21Apr2021, when the patient was 40-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 17Aug2022, outcome "unknown", described as "body aches"; NASAL CONGESTION (non-serious) with onset 17Aug2022, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 17Aug2022, outcome "unknown", described as "coughing"; PYREXIA (non-serious) with onset 17Aug2022, outcome "unknown", described as "fever of 102F". The events "fever of 102f", "coughing", "congestion" and "body aches" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, cough, nasal congestion, pain. Additional Information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient was treated with Paxlovid.
Rash; fever; severe chills; head ache/head ache lingering 6 days after; joint pain; kidney pain; lethargy; difficulty concentrating; This is a spontaneous report from a contactable nurse. A 46-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), intramuscular on 06Jan2021 at single dose (right arm) for COVID-19 immunization. Medical history included celiac disease and allergies: gluten. The patient's concomitant medications were not reported. On 06Jan2021, the patient experienced rash, fever, severe chills, headache, joint pain, kidney pain, lethargy, and difficulty concentrating. The main symptoms lasted about 48 hours, and headache was lingering 6 days after. There was no therapy for the events. There were no other vaccine in four weeks and no other medications in two weeks. The patient underwent lab tests and procedures which included nasal swab was negative on 06Jan2021, post vaccination. Outcome of event head ache/head ache lingering 6 days after was recovering;  outcome of the rest of events was recovered on 08Jan2021.   Information about Lot/Batch has been requested.
Stayed for 15 minutes, reaction came approximately 10 minutes after I left the pharmacy. Adverse episodes occurred twice; once approximately half hour after injection that occurred for 30 minutes, second approximately 30 minutes after first that occurred for approximately 30-40 minutes.  Felt rush through my body Arms first, then across my chest up over my back and into my face White, clammy palms Tingling in arms/fingers Blood felt "itchy" Tingling in lips Trouble breathing Extreme thirst Vision impairment Throbbing feeling in neck that persisted for first day Joint pain Numb teeth  Evening Fever/chills  Day after Extreme fatigue  Shortness of breath Feeling ?off?
Moderna booster made me feel so bad; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (Moderna booster made me feel so bad) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Moderna booster made me feel so bad). At the time of the report, FEELING ABNORMAL (Moderna booster made me feel so bad) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no relevant medical history, who experienced the non serious event of feeling abnormal. The event feeling abnormal exact occurrence unknown with respect to the booster dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This case was reported by a healthcare professional and described the occurrence of elevated alanine aminotransferase in a 49 yr old female subject who was vaccinated with hep B vaccine recombinant (Engerix B). The reported is the subject. The subject medical history included acid reflex and sinus headache. Concurrent medications included Motrin IB sinus (Motrin sinus) and Pamotidine (Pepcid). On unspecified dates in 1992, the subject received a three dose series of hepatitis B vaccine (unk manf). On an unspecified date before 13Feb06, a hep B surface antibody titer was low. On 13Feb06 the subject received a dose of Engerix B in the left arm as the 4th dose in the hep B vaccination series. On 13Mar06, 29 days after vaccination with Engerix B, the subject experienced lump injection site and injection site pruritis. The subject was seen at a physician's office. Blood tests performed on 13Mar06 revealed an increased level of hep B surface antibody, an elevated immunoglobulin level of 468 and elevated levels of alanine aminotransferase at 102, aspartate aminotransferase at 74, alkaline phosphatase at 276, and gamma glutamyl transferase at 227. The subject reported that the night before the labs were drawn on 12Mar06, she took one Motrin IB sinus. The injection site lump and pruritis resolved after 3 days. On 11May06, a retest blood sample was performed. The results showed an alanine aminotransferase level of 90. The outcome of the elevated levels of immunoglobulin, aspartate aminotransferase, alkaline phosphatase, and gamma glutamyl transferase were not reported. Increased alanine aminotransferase and increased aspartate aminotransferase were assessed as medically serious by manf (OMIC).
PATIENT STATES SHE FELT "WEIRD" (DIFFERENT TASTE IN MOUTH; TOPOF HEAD AND LEFT ARM FELT NUMB; A LITTLE DIZZINESS BUT SHE SAID SHE'S DIZZY MOST OF THE TIME SINCE HER BOATING ACCIDENT). PATIENT REQUEST AND DRUNK HALF A BOTTLE OF WATER; AFTER SHE SHE SAID THE WEIRD TASTE IN MOUTH IS NO MORE. PT WAS ENCOURAGE TO EITHER WAIT A LITTLE FOR OBSERVATION OR GO IN THE AMBULANCE FOR FURTHER OBSERVATION. SHE DECLINED BOTH BUT RATHER DECIDED TO HAVE HER FRIEND(WHO CAME WITH HER) BRING HER TO THE HOSPITAL.
Pain at injection site, pain throughout my left arm, pain in left armpit, fever up to 102 degrees, chills, body aches, headache, and tiredness. Nearly all of these symptoms started 7 hours after injection. I took one 200mg Motrin 15 hours after injection to keep the fever down. I don?t believe my fever got any higher than 101 since the Motrin. Forty-eight hours later and I feel much better. I still have pain in my arm and armpit.
Severe Muscle pain occurred from the time of vaccination for 2 days.  Rash appeared days following the injection, 2 weeks later and it hasn't changed at all. Red bumps, around the area where shot was given.
MASSIVE CLOTS IN LIVER; BLEEDING FROM SPLEEN; MASSIVE CLOTS IN LEGS, STOMACH; This spontaneous report received from a consumer via a company representative via social media (JNJNews account ) concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On an unspecified date, the patient experienced massive clots in legs, stomach and liver and bleeding from spleen. The patient was hospitalized on unspecified date. Number of days hospitalized was unspecified. The reporter stated that, "My sisters boyfriend is in the hospital with massive clots in his legs, stomach, and liver after taking JNJNews vax. Bleeding from spleen. At best blood thinners & dialysis the rest of his life." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from massive clots in legs, stomach, and massive clots in liver, and the outcome of bleeding from spleen was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20220404326- covid-19 vaccine ad26.cov2.s- Massive clots in liver, bleeding from spleen, massive clots in legs, stomach. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Patient was given monovalent vaccine instead of bivalent vaccine. Patient states that they were feelin body aches, chills, and a horrible headache the evening after the vaccine was given. Patient also states that they took some Tylenol and that it helped with the headache.