chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller stated she received the Pfizer covid vaccine first dose on 26 March 2021, she broke out in rash all over the body this morning; Injection site tenderness; She had a knot about the size of a quarter at the injection site; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EP6955, Expiration date: Unknown), via an unspecified route of administration, administered in Arm Left on 26Mar2021 13:40 (at the age of 62-years-old) as dose 1, single for covid-19 immunization at school. Vaccine was not administered at specific facility. Medical history included knee replacement (a few years ago) and pancreas issues (but her pancreas had not acted up in a few years) from an unknown date and unknown if ongoing. Family Medical History Relevant to adverse events was not provided. The patient's concomitant medications were not reported. No other products. No prior vaccinations (within 4 weeks). No adverse events following prior vaccinations. No additional vaccines administered on same date of the Pfizer suspect. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). Reported she got her first Pfizer COVID-19 Vaccine on Friday, 26Mar2021, and now had a rash all over her body. She said she called her doctor, and her doctor told her to call Pfizer to see what Pfizer said about her rash. She stated she was fine after getting her COVID-19 Vaccine on Friday, 26Mar2021. She said on Saturday (27Mar2021) she had some tenderness in the injection site area. She said she had a knot about the size of a quarter at the injection site. She said this morning on 29Mar2021, she had a rash all over. She said she did not start any new products or foods to cause her rash. Caller asked why it would take so long for a rash to start if she had the COVID-19 Vaccine on Friday, 26Mar2021. The caller was advised she would be transferred to Pfizer Medical Information for further assistance with her question. Reported she was fine today (29Mar2021) and had called Pfizer to find out if she needed to go the emergency room, or if she could take Benadryl for the rash. The caller was advised that Pfizer does not give medical advice, but she would transfer to Pfizer Medical Information for further assistance. Reported she does not take any medications. Caller was given report reference number. The adverse events did not result in emergency room and physician office. No Relevant Tests. The outcome of events vaccination site pain, vaccination site mass and rash was recovering.  No follow-up attempts are needed. No further information is expected.
2 days after having received an influenza vaccine 0.25mL, the pt developed diffuse facial swelling including eye swelling/ptosis.  No respiratory problems were noted (-) rash, no vomiting/diarrhea.
This spontaneous report was received from an office manager regarding an approximately 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-MAY-2017, the patient was vaccinated with one dose of improperly stored M-M-R II, lot # M029230 with expiration date 08-JUN-2018 (dose and route were not reported), for prophylaxis in combination with sterile diluent (Manufacturer unknown) (lot #, expiration date, dose and route were not reported). The storage temperature and time frame for M-M-R II was 47 to 77F for 11 days. There was no previous temperature excursion and the call was because of a data logger. The sterile diluent did not underwent a temperature excursion. No adverse effect was reported.
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 17-DEC-2018, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R005865 with expiration date in 22-OCT-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001849: US-009507513-1907USA001848: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
10pm laughing; Crying fit for over 60 mins; 15 min sneezing fit; stopped up nose bleed; Head and neck became worse/pain was worse; foggy in judgement; felt different and headache started, neck, her left shoulder and arm; felt different and headache started, neck, her left shoulder and arm; felt different and headache started, neck, her left shoulder and arm; felt different and headache started, neck, her left shoulder and arm; felt different and headache started, neck, her left shoulder and arm; This is a spontaneous report from a contactable consumer (patient). This 69-year-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN5318 and Expiration date was not reported) on 28Jan2021 at 09:30 hours via an unspecified route of administration, administered in left arm as dose 1, single (age at vaccination: 69-years-old) for COVID-19 immunization. Patient had unspecified medical history and had known allergies. Patient had no other vaccine in four weeks. The patient took other unspecified medication/concomitant medications within two weeks of the vaccination. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 28Jan2021 at 09:50 hours, 20 mins after the shot, patient felt different and headache started, neck, her left shoulder and arm. Patient came home and took 650mg of Tylenol, at 14:15 hours, patient had a 15 min sneezing fit, stopped up nosebleed, head and neck became worse and foggy in judgement, at 22:00 hours, patient had laughing and crying fit for over 60 mins until she fell asleep. Patient stated that nosebleed and headache continued for 25 days, 24/7 pain levels 6 & 7. Patient had doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit for the events. Therapeutic measures were taken as a result of the events and treatment included Tylenol, nurse on site and urgent care. The outcome of stopped up nosebleed and headache were recovered on 22Feb2021 (25 days duration) and not recovered for rest of the events.  No follow-up attempts are possible. No further information is expected.
8 days after receiving the shot I was out for a run and had a heart attack.  The septal region of my heart was enlarged but nothing else was showing...  all arteries wide open, heart functioning at 55, cholesterol 171.  My troponin levels were 76...
Information was received on 01-SEP-2017 from a lawyer regarding a case in litigation concerning a male patient who was inoculated with a dose of ZOSTAVAX vaccine on or about 01-OCT-2011, administered by a physician at a physician's office, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-NOV-2011, the patient was treated by a physician at a care center, for the onset of a severe vesicular rash accompanied by a weakened immune system, which was diagnosed as severe herpes zoster, or shingles. On or about 01-OCT-2015, the patient was treated by a physician at a hospital urgent care for recurrent zoster outbreaks that were resistant to antiviral therapies. The patient has been prescribed VALTREX, prednisone (manufacturer unknown), ZOSTRIX HP and VICODIN for management of his painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
pt rcvd vax; pt exp pain at inject site, headache, swelling of left side of face; muscle swelling at inject site & difficulty breathing; pt taken to MD; lab evaluation was norm;
blister like rash from inj site on lt arm, upper arm,side of neck & onto face;
Vaccine protected him from inflammation after getting stung 8 times by fire ants; A spontaneous report was received from a consumer concerning a 45-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events patient believes vaccine protected him from inflammation after getting stung 8 times by fire ants.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the event(s) patient believes vaccine protected him from inflammation after getting stung 8 times by fire ants.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), patient believes vaccine protected him from inflammation after getting stung 8 times by fire ants was resolved.
sx started 24JUN95 swelling @ site-softball red & hot to touch; t102-vomiting also visit to ER; PNC inj given
Lungs hurts/lungs hurts when takes deep breath; Back and front part were hurting; Left upper arm is a little bit tender; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (Lungs hurts/lungs hurts when takes deep breath), BACK PAIN (Back and front part were hurting) and INJECTION SITE PAIN (Left upper arm is a little bit tender) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 08-Mar-2021, the patient experienced PULMONARY PAIN (Lungs hurts/lungs hurts when takes deep breath), BACK PAIN (Back and front part were hurting) and INJECTION SITE PAIN (Left upper arm is a little bit tender). The patient was treated with ACETAMINOPHEN for Pain, at an unspecified dose and frequency.   At the time of the report, PULMONARY PAIN (Lungs hurts/lungs hurts when takes deep breath) and BACK PAIN (Back and front part were hurting) had not resolved and INJECTION SITE PAIN (Left upper arm is a little bit tender) outcome was unknown.      No concomitant medications reported.
Received injection around 9:30 AM on 10-11-12. Itching started that night around 7:00 pm. Hives started a couple of days later. Saw PCP on 10-24-12 given cortisone injection and oral medication.
COVID+ on 5/10. Admitted for chest pain and SOB on 5/14.
vaccine was administered outside of our facility - reported by patient ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------------------------- J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/2/2021 UNSPECIFIED ANXIETY DISORDER R09.02 HYPOXIA 4/2/2021 UNSPECIFIED ANXIETY DISORDER
0448 CHEST PAIN AND SHORTNESS OF BREATH; 0450 02SAT 100% WITH NO WORSENING IN CONDITION OBSERVED AN ADDITIONAL 15 MIN. 0512 PT BETTER WANTS TO BE RELEASED. INSTRUCTED IF CHEST PAIN RETURNS TO GO TO er. 170/79; 63 HR; 100% 02SAT
Patient was told to have a seat in the waiting room for 15 minutes after vaccination. Against medical advice, he left immediately. Employee called the pharmacy and informed us patient was in the bathroom feeling like he was going to throw up, his vision was going black and he was tingling. Our pharmacist brought an epi-pen to the bathroom immediately, however, patient had left the building before pharmacist could evaluate him.
3rd dose of Hepatitis vax administered 3JUN91 followed by chills, fever, joint aching & fatigue 4JUN91;
86-year-old male with COPD, chronic hypoxic respiratory failure dependent on 3 L supplemental oxygen at home, hypertension, hypothyroidism, asthma, BPH, glaucoma.  Presented to the ED via EMS with a 5 day history of shortness of breath with cough and positive COVID-19 testing outpatient.  Patient reports being fully vaccinated against COVID-19.  On arrival to the ED, oxygen saturation was 97% on 3 L supplemental oxygen via nasal cannula.  Heart rate 97, respiratory rate 20.  Patient is COVID-19 positive.  Chest x-ray reveals bilateral pneumonia.  VACCINE DATE: 3/10/2021 HOSPITALIZATION DATE: 8/16/2021
Case number PHEH2014US001305 is an initial spontaneous report received from a pharmacist on 14 Jan 2014 with the follow-up received on 08 Feb 2014. This report refers to a 12-year-old male patient. His current condition included egg allergy. Concomitant medications were not reported. This patient under 18-years of age was vaccinated with FLUCELVAX (batch number: 009031A, expiry date: Jun 2014) into left deltoid at a dose of 0.5 ml intramuscularly on 08 Jan 2014. No adverse event was reported following the inadvertent administration. Follow-up received from a pharmacist on 08 Feb 2014: Concurrent condition and site of vaccination was updated. Following an internal review on 18 Au 2014, a significant correction as done for the information received on 08 Feb 2014: The labeling of the event "Inappropriate age at vaccine administration"changed from listed to unlisted and added second indication as "adult product administered to child."
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A patient (no qualifiers provided) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0182, expiration date: Aug 31, 2021), on May 18, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced product dose omission issue (missed his second dose), taste disorder and parosmia (affected his taste and smell); onset 2021, with outcome of unknown. No follow-up attempts possible. No further information expected.
Patient is a 26 year old female who has completed a 15-minute observation period with the following signs and symptoms of an adverse reaction: other - initially have dizziness and anxiety right after vaccination, while in the observation area and while sitting down beside her boyfriend, suddenly fainted for 20 seconds. No head injury. No urinary or bowel incontinence. .  Witnessed syncope. Pt has a hx of fainting spells after vaccination. Ate lunch at 11am.  Vital sign and observation. given water.  stable vital signs, physical exam unremarkable. stable to go home
Patient c/o dizziness about 5 minutes post-vaccination.  Denies SOB or CP. Transported to ED by dritical care transport team where she started to c/o headache upon arrival.
pt recv vax 7OCT97 & approx 4mo later in FEB98 a small amount of hair loss was noticed;
This spontaneous report has been received from a nurse referring to multiple unspecified patients. The patients' medical history, concurrent condition and concomitant therapy were not reported. On multiple unspecified dates, the multiple unspecified patients received doses of improperly stored ROTATEQ (lot#M038207, expiration date 02-MAY-2018) (dose, frequency and route were not reported). The vaccine was exposed to temperature excursion of 47 F to 77 F for 3 hours and 47 minutes and the data logger was involved. There was no previous temperature excursion. No adverse effects reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA000098:
Patient completed the Pfizer vaccination series (1st dose on 2/2/21 and 2nd dose on 2/28/21). Patient developed symptoms on 7/28/21 (chills and fatigue) and test positive for COVID-19 on the same day
This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 78-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection), at the age of 78, intramuscularly, in upper left arm, on Feb 9, 2021, single dose, for COVID-19 immunisation. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, formulation solution for injection), intramuscularly, in upper left arm, on Jan 19, 2021, single dose, for COVID-19 immunization; patient experienced pain in her right wrist/left wrist. Family medical history relevant to AE included both of her parents had arthritis. The patient 's medical history and concomitant medications not reported. On Feb 9, 2021, patient experienced pain in her ankle and patient experienced little bit more pain on an unspecified date. Patient said she got the second vaccine yesterday afternoon Feb 9, 2021 and had a little bit more pain. She was in bed last night and started having pain in her ankle. She said that it is tolerable. She read that joint pain was a side effect. She inquired regarding how long it takes before that clears up and if this permanent damage or will this go away. The outcome of pain in her ankle was recovered last night on Feb 9, 2021. The outcome of little bit more pain: unknown. Information on the lot/batch number requested. Follow-up attempts completed. No further information expected.
Case symptom onset was 7/28/2021 which included runny nose, sore throat, headache, cough, wheezing, shortness of breath, nausea, abdominal pain and diarrhea.  As of 7/30/2021 case was still symptomatic.
ACHING JOINTS; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced aching joints. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aching joints, headache, and nausea. This report was non-serious. This case, from the same reporter is linked to 20210458817.
This is a spontaneous report from a contactable consumer (patient).  A 72-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: BN5318, expiry date unknown) in the School or Student Health Clinic, via an unspecified route of administration on 01Feb2021 at 00:15 on the right arm at a single dose for COVID-19 immunization.  Medical history included cardiac effusion and mild emphysema both from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ciclosporin (NEORAL), mycophenolate mofetil (CELLCEPT [MYCOPHENOLATE MOFETIL]) and losartan (manufacturer unknown).  The patient previously took Cipro and tacrolimus and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced low pulse and high blood pressure on 04Feb2021 at 09:00. The patient did not receive any treatment for the event. The outcome of the events was unknown. The events were reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19.
COMPLETE AWFUL FOR NEARLY 48 HOURS; STUCK IN BED; FLU LIKE SYMPTOMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced complete awful for nearly 48 hours, stuck in bed, and flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from complete awful for nearly 48 hours, stuck in bed, and flu like symptoms. This report was non-serious..