chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme injection site pain, red rash on injection site, headache, fatigue, dizziness, migraine, loss of appetite, extreme thirst, tremors in hands and feet lasting 2 days
Grand mal seizure, led to hospitalization. CT scan performed. Went to neurologist, MRI and EEG performed. Put on lifelong medication. I still need regular neurologist appointments, MRIs, EEGs, occasional hospitalizations, and monthly prescription costs.
Edema - arm twice as large in first day. Erythema - band 4" wide around arm at injection site. Reduced over 2 days with BENADRYL.
Dose #1: mild to med myalgias & arthralgias - localized onset 24 - 48 hours after dose. Dose #2: moderate to severe generalized myalgias & arthralgias; subjective fever; poor circulation onset 48 hrs after 2nd dose; lasted 4-5 days.
after his 12month shots that evening we took him to the ER because his he was having an allergic reaction,his eyes swole shut ,he had hives all over him ,his throat was swelling shut.  9/11/07 Received ER medical records which reveal patient experienced  cough, swollen eyes, red rash on 3/23/01.  Patient had been started on whole milk on day of vax & had been give chocolate milk for first time just prior to reaction.  Treated w/IM steroids & antihistamine & d/c to home on soy formula, steroids & antihistamine. FINAL DX: Allergic reaction to ??chocolate milk. 10/23/2007 Received school psychological report from parent which reveals patient diagnosed w/autistic disorder 9/2005.
This spontaneous report as received from a health professional refers to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-NOV-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). The temperature excursion of the administered dose of vaccine was 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax & pt devel thrombocytopenia which resulted in prolonged hosp;
Caller states she now has Covid-19/except she is positive for the virus; Caller states she now has Covid-19/except she is positive for the virus; her blood pressure is low: 127, 56, 70 SBP; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 84-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Local anesthetic in the teeth, reaction(s): "some adverse reactions ". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Caller states she now has Covid-19/except she is positive for the virus"; HYPOTENSION (non-serious) with onset Sep2022, outcome "unknown", described as "her blood pressure is low: 127, 56, 70 SBP". The patient had COVID-19. She went to urgent care Friday and saw doctor, doctor told her that her COVID was mild and her lungs were fine. The patient had gotten 2 of the Pfizer COVID-19 vaccine shots for primary series and 1 booster dose of the Pfizer COVID-19 vaccine, and a shingles vaccine. No problems with any of those vaccines. The patient had no breathing problems with COVID and no fever. She was prescribed Paxlovid on 23Sep2022. Doctor said she didn't need the Paxlovid because everything else was okay. The patient also took lisinopril and exercised a lot, did breathing exercises in the nursing home. The patient had not yet taken any of the Paxlovid. She explained that her lungs, body, blood pressure and other parameters were fine, except she was positive for the virus.
On an unspecified date, the child received Engerix-B and other, unspecified vaccines. The child was subsequently determined to have autism. Additional information has been requested. As of 4/18/02, the outcome of the event was not known to the reporter. The reporter considered autism to be possibly related to Engerix B. This report of autism is considered medically serious (OMIC).
This is a spontaneous report from a contactable nurse (patient herself).  A 53-years-old female patient received second dose of BNT162B2 ( COVID-19 VACCINE, Solution for injection, lot number EL3248, expiry date not reported), intramuscular in the right arm on 13Jan2021 11:15 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. The patient had no covid prior to vaccination. The patient was not pregnant at the time of the vaccination. Concomitant medications included first dose of varicella zoster vaccine rge (cho) (SHINGRIX) on 07Dec2020 at a single dose in the left arm for immunization; bupropion hydrochloride (WELLBUTRIN); and unspecified hormone replacement.  The first dose of BNT162B2 for COVID-19 immunization (lot EK5730; brand Pfizer,) was on 22Dec2020 07:15 AM via intramuscular route in the left arm. The patient was having sharp stabbing pains every 5-10 seconds in the left parietal occipital area; started about 13 hours after second vaccine (14Jan2021 03:00 AM). No treatment received in relation to the reported event. The patient was not tested for covid post vaccination. The outcome of the event sharp stabbing pains every 5-10 seconds in the left parietal occipital area was not recovered.
I think it was given IM instead of SQ; This spontaneous report was received from a consumer referring to herself of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not provided.     On 08-DEC-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength and dose were not reported, lot# was reported as T00370, expiration date was not provided) for prophylaxis. The reporter thought the suspect vaccine was given Intramuscular (IV) instead of subcutaneous (SQ). She wanted to know if it was ok if it was given IM.  This agent referenced the varicella virus vaccine live (oka/merck) (VARIVAX)  prescribing information (PI) regarding route of administration and method of administration. This agent referred the reporter to her healthcare provider. The reporter verbalized understanding and said if it was given IM instead of SQ she would call back.
This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On 08-MAR-2016, the patients were vaccinated with improperly stored ROTATEQ (lot # L020859 and expiry date 19-JANp-2017; lot# L029617 and expiry date 19-MAY-2017) (dosing details unspecified). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Details of temperature excursion: Temperature: 47.8F for 1 hour and 10 minutes. Previous temperature excursion: no. Data logger: Yes. Outcome: Supported. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt vacc. /w DTP/OPV mom reports fever of 103.4 (R). Irritable fever of 105.2 (R) at 4:00PM.
low grade fever; severe diarrhea for 3 days; intermittent vomiting; headache; This is a spontaneous report received from a contactable consumer, the patient. A 17-Year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: FP7534) as a single dose via an unspecified route of administration in her left arm on 20Mar2021 at 10:30 (at the age of 17-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On 21Mar2021, the patient experienced severe diarrhea for 3 days with intermittent vomiting, low grade fever and headache. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes for the events severe diarrhea, intermittent vomiting, low grade fever and headache was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
she received a Pfizer Biontech COVID19 (Comirnaty) vaccine and had multi inflammatory syndrome; This is a spontaneous report from a contactable consumer. This consumer reported for patient (daughter's boyfriend mom). A female patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient received a Pfizer Biontech COVID19 (Comirnaty) vaccine and had multisystem inflammatory disorder on an unspecified date. The reporter stated that she had heard of this only with patients that had Covid. The patient stated that she was told by the patient(nurse) that it was listed on side effects page. The reporter wanted to know what the truth was and trying to get clarification. The patient stated that she did not want her daughter to be influenced by misinformation. The outcome of event was unknown.    The lot number for bnt162b2, was not provided and will be requested during follow up.
febrile seizure; This spontaneous report has been received from a nurse practitioner and refers to a 6-month-old female patient. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), oral liquid, administered orally (exact dose, dose number, lot # and expiration date were not reported), and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) injection (dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported), and pneumococcal vaccine conj 13V (CRM197) (PREVNAR 13) (formulation, dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported), all for prophylaxis.  On an unspecified date, after vaccination, the patient experienced febrile seizure. The patient sought medical attention, she went to the emergency room the same night after receiving vaccination but did not get admitted to the hospital. The outcome of the event was not provided, however assessed as recovering as it was reported that the "patient was fine".  The causality between the event and the suspect vaccines was unknown. The reported stated that she did not know if the event was related to the suspect vaccines, a particular vaccine, or not related at all.
Pregnant-- 22 weeks 1 day EDD- 6/1/2022 Patient walked into Covid Observation Area after reporting heart palpitations and mild chest tightness 14 minutes after receiving Pfizer Booster. States she had Moderna for first 2 doses, developed fever of 103.4 after each dose, improved with Tylenol, lasted for a day and a half. States she wanted to try Pfizer today because of fever with Moderna. Patient states she also experienced more severe heart palpitations after first 2 doses of Moderna. Reports heart palpitations today not as prominent, and chest tightness lasted for a few seconds. Denies chest pain, has normal shortness of breath due to 22 weeks pregnancy. Patient states she ate breakfast this morning.    9:20 am- VS: BP 145/65, HR 82, RR 20, 02 SATs 99%RA   9:24 am-VS: BP 122/67, HR 86, RR 20, 02 SATs 99%RA   9:38 am- VS-BP 133/69 (lying), HR 88, RR 22, 02 SATs 99% RA- States chest tightness resolved, breathing in a little deeper and faster, palpitations lessening but still present.   9:49 am- Call placed to on call physician informed of patient symptoms above. No risk factors or cardiac conditions noted per MD chart review. States symptoms likely vagal response or stress response. Dr. offered to order EKG for patient to establish baseline as she has never had an EKG. Also stated if patient declines EKG and no other symptoms such as lightheadedness, ok for patient to be discharged home and follow up with her primary care provider for any concerning symptoms.   Patient declined EKG at this time, Dr. informed.   9:53 am- VS- BP 142/77 (sitting), HR 94, RR 20, 02 SATs 98%RA   9:54 am- VS- BP 127/74 (standing) HR 83, RR 20, 02 SATs 98%- Denies lightheadedness or dizziness with position changes. States she feels anxious because she wanted to wait until after she delivered baby to get the booster but had to get it sooner due to job requirements.    9:58 am- Patient discharged home in stable condition. Advised to follow up with primary care provider if symptoms persist. Also advised to seek emergent care for any worsening symptoms such as chest tightness, chest pain or shortness of breath. Patient verbalized understanding.
10/25/2005 - Received telephone call from patient reporting that on Friday evening (10/21/05) her right arm become red, hot and painful at the injection site down to the elbow.  Patient called her doctor, and MD adviced her to take Clindamycin 150mg. Received Pneumococcal vaccine on the right arm.  Started feeling chills after receiving it.
This is a spontaneous report from a non-contactable consumer. A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/ Lot number and Expiry date was unknown), via an unspecified route of administration, on an unknown date, as first dose, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient had a reaction occurred after the first dose of rather vaccine, experienced fever, nausea, headache, sore arm, and metallic taste in her mouth and lasted for 5 days. All symptoms subsided after 5 days except slight headache. Headache subsided after 7 days. She does suffer from Migraine headaches. Event took place after use of product. The outcome of the events fever, nausea, sore arm and metallic taste was recovered after 5 days and migraine headache/headache was recovered after 7 days.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
is scared; felt funny at work and had to come home from work; vaginal bleeding, described as the blood was completely red in color; horrible heavy cramps, described as felt like someone was grabbing her ovaries and twisting them; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (vaginal bleeding, described as the blood was completely red in color), MUSCLE SPASMS (horrible heavy cramps, described as felt like someone was grabbing her ovaries and twisting them), TENSION (is scared) and FEELING ABNORMAL (felt funny at work and had to come home from work) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCLE SPASMS (horrible heavy cramps, described as felt like someone was grabbing her ovaries and twisting them). On 15-Apr-2021, the patient experienced VAGINAL HAEMORRHAGE (vaginal bleeding, described as the blood was completely red in color) and FEELING ABNORMAL (felt funny at work and had to come home from work). On 16-Apr-2021, the patient experienced TENSION (is scared). At the time of the report, VAGINAL HAEMORRHAGE (vaginal bleeding, described as the blood was completely red in color), MUSCLE SPASMS (horrible heavy cramps, described as felt like someone was grabbing her ovaries and twisting them), TENSION (is scared) and FEELING ABNORMAL (felt funny at work and had to come home from work) had not resolved. Unknown          No concomitant medications were reported. Patient was asked to monitor her bleeding and often she has to change her sanitary napkin.  The action taken with mRNA-1273 in response to the event was not applicable.
High Fever of 103, vomitting, not responding to parents, convulsions,blood work done and high white blood cell count 1/5/10 DC summary received for date 7/13/08 to 7/14/08. DX: sepsis, fever. CC: 2 day h/o fever. Pt parent states intermit fevers x6months, multiple infections during past 6 months. OV 7/13/08 DX: leukocytosis. CC: fever, irritability, cough. Assessment: (+)dysuria, vomiting, fever. Pt parent states nasal congestion intermit x6months. Pt admitted.
NO ADVERSE REACTION. VACCINES WERE GIVEN IN ERROR. PROVIDER DISCUSS WITH PARENT THAT 2 MONTH VACVINES WERE GIVEN IN ERROR INSTEAD OF HEP B DOSE #2.
Patient was administered immunizations on 9/2/20. Mother states she noticed a red spot and bump at injection site. She states by the next day the redness has spread down the arm. She called today (9/4/20) to report redness spreading, hot to touch, and temperature 99.6 F. She was advised to come in to see the pediatrician. she agreed. Doctor assessed the site, diagnosed as cellulitis and patient was started on antibiotics. A call was placed to the immunization program coordinator. She will reach out for further advisement.
received the 1st dose of the vaccine back in October 2019 / received the 2nd vaccine this morning at 9am at; Excruciating pain; Shoulder pain; Excruciating pain spreading to the neck; Weakness; not being able to lift her left arm; Using muscle pain creams; This case was reported by a consumer via call center representative and described the occurrence of pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 30th october,2019 refer case id US2020AMR197051).   On 30th September 2020, the patient received the 2nd dose of Shingrix. On 30th September 2020, 2 hrs 30 min after receiving Shingrix, the patient experienced pain, shoulder pain, neck pain, weakness, injected limb mobility decreased and myalgia. On an unknown date, the patient experienced drug dose administration interval too long. The patient was treated with hydrocodone bitartrate + paracetamol (Vicodin) and  (Muscle Pain Cream). On an unknown date, the outcome of the pain, neck pain and weakness were not recovered/not resolved and the outcome of the shoulder pain, injected limb mobility decreased, myalgia and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the pain, shoulder pain, neck pain, weakness, injected limb mobility decreased and myalgia to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. It was reported that patient received the 2nd dose of shingrix vaccine at 9 am on 30th september,2020 and at 11:30 am she experienced excruciating pain that seems to be spreading to the shoulders and neck. She also reported not being able to lift her left arm and also stated she took half of a Vicodin and was using muscle pain creams and a cold compress for the pain. Patient stated that the pain from the 2nd dose was worse than the pain from when she "cut half of her finger off. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR197051:same reporter
Initial report received from a healthcare professional (physician) on 10 September 2012. A 02-month-old patient whose gender medical history and concomitants medications were not reported; had received intramuscular (IM) DAPTACEL injection (batch number, dose, dose number were not reported) in left thigh region on unspecified date. 12 days after vaccination, the patient has small amount of petechiae on both lower extremities. The patient had blood work done which was negative. It was reported that MD did not had patient chart and could not provide further information. Details of treatment was not reported. The patient's outcome was unknown. Documents held by sender: None.
Information has been received from a health care worker concerning a 73 year old female who on 08-OCT-2007 was vaccinated (site and route not reported) with a dose of pneumococcal 23v polysaccharide vaccine (lot#658074/0961U). On 09-OCT-2007, post vaccination, the patient developed arm pain, numbness and weakness. There was no redness or swelling at the injection site. The arm pain, numbness and weakness lasted for 5-7 days and then resolved. The patient received unspecified medical attention and recovered. This is one of several reports from the same source. Additional information has been requested.
30Apr90 pt vax; 2 days latr devel fever, parotitis.  Sx persisted.u
HUGE RED RASH ABOVE LEFT KNEE; This spontaneous report received from a consumer concerned a 67 year old male. 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 not reported, batch number: Unknown) dose was not reported, administered on 31-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-SEP-2021, the patient experienced huge red rash above left knee. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of huge red rash above left knee was not reported. This report was non-serious.
Redness, warmth, induration - diffuse tightening + pain with touch. Treated with augmentin and will follow up tomorrow 05/08/09.
Starting about 2 weeks after the 2nd dose of Pfizer vaccination, I experienced chest pain, rapid heart beat and heart flutter. Since these symptoms still continue, I am filling out this form. Not able to return to normal activity state every since the 2nd dose of vaccination. Still requiring rest and strenuous activity avoidance in order to manage heart flutter and chest pain.
6mins post vaccination, pt c/o dry throat and chest pain.   Vitals: @10:05 BP 130/85, HR 67, RR 15, Sat 100% on RA Pt brought to triage area.  Pt sat in chair, no swelling or SOB.  NP at chairside.  Pt sat in triage for 15min.  symptoms resolved.  Pt stable and released from the vaccination site.
None currently   - Patient received moderna booster dose on 10/04/21  Intramuscularly in the Left  Arm.  Moderna Vaccine expired 10/03/21.
hives, severe itching started shortly p/7PM;still had some hives but was getting better by 15OCT98 9AM;pt started some DPH 6PM much better;