chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NIGHT SWEATS, VOMITING, LOOSE STOOLS, COUGH, FATIGUE, LOSS OF TASTE AND SMELL, NASAL DRAINAGE
fatigue; fever; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), FATIGUE (fatigue) and PYREXIA (fever) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 24-Feb-2021, the patient experienced FATIGUE (fatigue) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (arm pain), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Heart Palpitations and shortness of breath   Holter monitor heart study in progress at this time
reports numbness and tingling  on L hand radiates to elbow continues with symptoms at this time.  Motor skills intact
1545 PATEINT TOLD DAUGHTER SHE "FEELS LIKE SOMETHING IS IN HER THROAT" PATIENT IS SUCKING ON COUGH DROP AND IS ABLE TO SWALLOW. PATIENT IS ALERT AND ORIENTED X3. SPEAKING. 1610 PATIENT TOLD DAUGHTER SHE WAS OK TO GO HOME. PARAMEDIC INSTRUCTED DAUGHTER TO CALL 911 IF PATIENT STARTS FEELING SHORT OF BREATH OR IS UNABLE TO SWALLOW. PATIENT CONTI ES TO BE ALERT WITH ON DISTRESS NOTED
Patient had seizure after a few minutes of administering Janssen covid immunization - 1st dose - patient passed out and was in and out of it while lying on the floor for a couple of minutes.  We immediately called 911 and patient was already awake when 911 got on the scene.  Patient reported that she was very tired and achy all over.  Patient stayed in the store for few more minutes and went home.
feel sick; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feel sick), NAUSEA (nausea) and VOMITING (vomiting) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced ILLNESS (feel sick), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, ILLNESS (feel sick), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Upon internal review on 04-Aug-2021, the age was corrected to 37 years.
Break thru covid infection between Dose 2 and 3 of covid vaccine.  Had antibodies IV. illness lasted 2 weeks. several weeks before I felt myself again.  mild covid infection after dose 3 of covid vaccine. did not feel ill, only had cold symptoms.  had antibody therapy. 1/3/2023 very sick, dizzy, fever, severe fatigue, nausea and generalized weakness for 10 days. took 2 weeks to recover.  self medicated with OTC Tylenol, advil, fluids and rest.
low grade fever; feels shaky right now; This is a spontaneous report from a from a non-contactable consumer (parent) received from Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced low grade fever and feels shaky right now. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Diarrhea, blood in stool one day after vaccine was given. Day six pt still had diarrhea with some blood.
Malaise, myalgia, fatigue.  Began about 4 days after the 2nd Pfizer vaccine. Lasted 10 days.  I presumed it to be a viral syndrome but it was atypical and felt strange.  It felt like when I had COVID in Nov 2020 but milder and without the respiratory symptoms or loss of smell.  It finally resolved after 10 days or so.  Later, after reading about the delayed local reactions to the Moderna vaccine, I thought that a delayed SYSTEMIC reaction was also possible.  In my best clinical judgement this was a DELAYED SYSTEMIC REACTION.
Right eyelid swelled up; Tongue swelled up on the bottom left side; quarter-sized hives on my left arm, thighs and back; Occasional eye swelling; This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 22Apr2021 10:15 (at the age of 58 years old) as dose 2, single for covid-19 immunization. There were no medical history and concomitant medications. The patient had no covid prior vaccination. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient received the first dose of BNT162B2 on 24Mar2021 at 11:30 AM for Covid-19 Immunization administered at the left arm at the age of 58 years old. The most recent COVID-19 vaccine was administered at a pharmacy or drug store. It was reported that on 24Apr2021 at 06:00 PM (18:00), also reported as 48 hours after 2nd dose, patient tongue swelled up on the bottom left side and patient broke up quarter-sized hives on my left arm, thighs and back. Four days after dosage, 26Apr2021, his right eyelid swelled up. Patient was reported to still consistently experiencing large hive breakouts throughout body and occasional eye swelling a week after dosage (Apr2021). The events were reported as medically significant. There were no treatments received in response to the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Reporting administration error per Agency. We contacted Pfizer for expiration dates, pfizer vaccine specialist advised expiration dates and deemed vaccines viable at the time of vaccine administration. Pfizer vaccine vials only include manufactuarer dates on the box and vials. Therefore, we contacted pfizer to attain expiration dates directly from them.   No adverse reaction reported from the patient at the time of vaccination and no adverse reaction reported since given the vaccine.
Erythematous bulbous rash on both arms but more prominent on vaccinated arm. Itching in feet. 12/6/14-medrol Dosepack. Rashes still progressed 12/13/14 oral and intra muscular steroid therapy. Rashes regressing. Pt also used OTC Benadryl tablets and gel.
CHEST PAIN; RIGHT ARM PAIN; HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 150 pounds, and height was 59 inches. No past medical history or concurrent conditions were reported. The patient was not pregnant at the time of report. 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 24-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021, the patient experienced chest pain, right arm pain, headache and was hospitalized (date unspecified). She was en route to MRI and had to hang up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm pain, chest pain, and headache.  This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210427406-covid-19 vaccine ad26.cov2.s-Chest pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210427406-covid-19 vaccine ad26.cov2.s-Right arm pain, headache. This event(s) is labeled per Agency and is therefore considered potentially related.
02/07/21 through 2/13/21 slightly fatiqued, took all his prescribed medications, ate breakfast, lunch and dinner was drinking eight 10 oz bottles of water. On 02/14/21 was very tired had a difficult time breathing after taking the normal meds. He took a breathing treatment with his prescribed Ipratropium Bromide and Albuterol Sulfate via home nebulizer. This did not improve his breathing. He was very weak and breathing was labored. 911 was called by wife. 911EMTchecked pulse and breathing. Informed him they would give him a breathing treatment.He started to go limp. EMT's got him to Ambulance and to Medical Center to the ER. Heroics done.  He died. Pulmonary and Cardiac Arrest
Information has been received on 26-MAY-2017 regarding a case in litigation from a lawyer and a consumer regarding a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 09-SEP-2009 at a pharmacy, as recommended for routine adult health maintenance 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-SEP-2014, the patient was treated by a physician at a health clinic for a vesicular outbreak that was diagnosed as severe shingles with neuralgia. On or about 12-APR-2016, the patient was treated by a physician for a Mooren's ulcer related to keratoconjunctivitis secondary to herpes. The patient has further been diagnosed with thrombocytopenia since being inoculated with ZOSTAVAX. Thrombocytopenia is a serious disorder involving depleted platelets, and is commonly found among adults with shingles, especially in patients like the patient who experience repeat outbreaks of shingles. The patient was prescribed famciclovir and hydrocodone-acetaminophen for management of his painful symptoms. 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. Upon internal review, Mooren's ulcer and thrombocytopenia were considered to be medically significant. Additional information has been requested.
shingles appeared on left side midline back to midline front; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 13Jul2021 10:45 (Batch/Lot Number: EW0198) as dose 1, single (age at vaccination 41-year-old) for covid-19 immunisation. Medical history included hypertension and herpes zoster from an unknown date and unknown if ongoing (I have been diagnosed with Zoster Herpes in the past. Took Valacyclovir 1 Gram for 7 days - blisters and pain subsided), Known allergies: Statins from an unknown date and unknown if ongoing, COVID prior vaccination: Yes from an unknown date and unknown if ongoing. Concomitant medication(s) included metoprolol (METOPROLOL); zolpidem (ZOLPIDEM); diazepam (DIAZEPAM); estradiol (ESTRADIOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took valacyclovir [valaciclovir] for pain and blister. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. The patient experienced shingles appeared on left side midline back to midline front on 21Jul2021 02:00. Therapeutic measures were taken as a result of event. It was reported shingles - received 1st dose on 13Jul2021 on 21Jul2021 shingles appeared on left side midline back to midline front. Patient have been diagnosed with Zoster Herpes in the past. Took Valacyclovir 1 Gram for 7 days - blisters and pain subsided. The patient second vaccine on 03Aug2021. The outcome for event was recovering.   Follow-up attempts are completed. No further information is expected.
Ringing in both ears. Stuffiness in ear and inner ear pain. Been trying to take supplements zinc, NAC, ginkgo biloba, multi vitamins and Claritin. Ringing still persisting after 11 days
Severe tinnitus left ear  still going on, 4 days later. Had same problem after 3rd dose with right ear and temporarily loss hearing due to nerve. The 3 rd dose was lot 014F211A
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 in 05/2022. I was prescribed Paxlovid and did not have any complications taking the medication. I was sick for about three weeks. Since the vaccine, my rheumatoid arthritis is worse in my hands and arms. The pain is hard to manage in my hands. The rheumatoid arthritis was manageable prior to the vaccine.
Pt complained of sore throat and fatigue the afternoon of his immunizations. Told his mother several days later that he's also had trouble swallowing, headache, malaise also. Mother unsure of duration of symptoms. Pt doing well now. Suggested to Mom that pt see his former allergist and have subsequent immunizations in Dr controlled setting.
Received Typhoid-Typhim IM. MD said to glue it despite the age. Said it would be okay. 5 hours later, had brown watery diarrhea. Had diarrhea for 5 days (per Dr.).
Physician came  in to get 2nd Pfizer vaccine early. Two physicians came in together (husband and wife) and stated they were able to schedule early. One was given the vaccine and the other was not. When he showed the RN the vaccination card, she noted it was early, but provider stated he was going to Germany for 18 days and needed it early. Vaccine given. Second provider was counseled that it was too early and was not given vaccination.  No adverse reactions reported but this is a medication error as dose 2 was given too early.
Heavy and painful periods. So painful it feels like labor. I have never had this much pain. Bleeding has increased by a large amount too!
Left arm sore at the needle site and the site muscle feels tight like a ball and still hurts after 2 days; This is a spontaneous report from a non-contactable consumer, the patient. A 73-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 12Mar2021 at 15:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID19, blood pressure high and cholesterol high. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On 12Mar2021 at 18:00, the patient experienced left arm sore at the needle site and the site muscle feels tight like a ball and still hurts after 2 days. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left arm sore at the needle site and the site muscle feels tight like a ball and still hurts after 2 days was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative:  86-year-old male with a history of chronic systolic heart failure and chronic kidney disease stage III presented to emergency department with 2 weeks of worsening shortness of breath and anorexia. On evaluation he was found to have an elevated BNP, slight elevation in troponin to 0.07 without change in EKG from baseline, and a chest x-ray that was clear except for a spiculated mass that is being followed with CT on an outpatient basis. With these findings the patient was given a loading dose of aspirin and started on IV Lasix; cardiology was consulted. The patient was then found to be Covid positive and was admitted to a contact precaution room. The patient required no supplemental O2 and was saturating well on room air. It is speculated that the patient's milder than expected course of COVID-19 is secondary to being fully vaccinated. On hospital day 2, the patient was doing well without any acute events and no new or worsening symptoms. H
Son could not feel his legs and all his joints were locking up. He was taken to the Hospital EM and Dr notified.
When speaking with mother about sister's adverse reaction she reported that patient had some redness, swelling and pain to both of her thighs when immunizations were given. She administered Benadryl and Motrin as recommended per her pediatrician.
coughing, swollen tongue, area under the tongue swollen, fever 100, chills, swollen eyes, discharge from eyes, headache
Nurse states vaccine leaked from patient's left arm during ID administration; patient did not receive full dose. Same nurse repeated ID administration on the same arm (left arm) successfully. No patient complications noted.
Fever,  chills, fatigue, arm soreness, feeling ?out of it?.  Fever and chills lasted 12 hours.  Exhaustion, fatigue, arm soreness and ?out of it? feeling lasted 36 hours.
I had a missed miscarriage - the baby stopped developing but my body still thought I was pregnant. My first OB appointment was on April 19th - it was supposed to be the 8 week appointment, but the baby dated at 6 weeks exactly with no heartbeat. The doctor ordered a HCG test and a viability scan for 10 days later. I returned on April 29th for the viability scan and it showed that the baby did not develop (confirmed by two doctors). I had a dilation and cutterage procedure at the Hospital on April 30th.  Last menstrual period: Feb 16, 2021 Due date: Nov 23, 2021  Missed miscarriage at 6 weeks + 0 days
High BP; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing); "migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Marcaine, reaction(s): "Drug allergy"; Morphine, reaction(s): "Drug allergy"; Fentanyl, reaction(s): "Drug allergy"; Codeine, reaction(s): "Drug allergy"; Doxycycline, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "not recovered" and all described as "COVID 19 Treatment"; HYPERTENSION (non-serious), outcome "unknown", described as "High BP". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical course: Patient had Paxlovid Treatment from 21Jun2023 to 25Jun2023  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300238444 same patient/different drug and AE;
Fever, chills, body pain, rash, swollen arm. Got PNEUMOVAX 23 Monday 10-16-17, admitted to hospital 10-18-17. Still cannot move arm 10-20-17. White BC count over 20,000 still very ill. As of 10/21/17 arm still very sore but no fever.
8 hrs post vaccine, got headache, chills, no fever, felt like the worst flu I ever had for  12 hrs, felt slightly better but still quite ill, tired, joint ad body aches, headache. Could not eat or get out of bed
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 39 years, in right arm for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) in 2 weeks included: BUPROPION, start date: 01Sep2020, stop date: 28Jul2022. The patient was not pregnant at time of vaccination. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown results, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19. It was reported that, the patient had prolonged terrible taste in mouth, similar to rotten grapefruit. Therapeutic measures included Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment started on 27Jul2022 and stopped on 28Jul2022, Lot number: GA7394, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Left deltoid site, redness, slight edema, noted pt. still c/o pain at injection site. (Soreness to touch). 2 cm x 2.5 cm size/side.
From telephone contact with reporter on 08/10/01, it was stated that a 2 month old male infant received a Tripedia lot # UO515DA, an ActHIB lot # UA606AA and IPOL lot #T08412 vaccination on 08/09/01. The patient experienced a local reaction of redness and swelling at the symptomaticly by physician, the reaction resolved.
environmental allergies; woke up with a lot of sinus pressure; sinus pain; This is a spontaneous report from contactable consumer (patient) via a Pfizer sponsored program. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient received the first dose of the Covid vaccine on 18March2021 and was scheduled to receive the second dose today. Patient stated that she has environmental allergies and woke up with a lot of sinus pressure today. Patient asked if she is able to receive the second dose today. Patient asked if she can take an naproxen sodium (ALEVE) before receiving the vaccine today. She received her 1st dose of the vaccine last March 18 and she is due today which is April 8 for her 2nd dose. Patient said that she has environmental allergies and sinus pain. Patient was asking if she can put off getting her 2nd dose or how many days should she wait before getting the 2nd dose. Outcome of events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.