chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Impotence; Over all uneasiness; Severe joint pain; This spontaneous case was reported by a patient and describes the occurrence of ERECTILE DYSFUNCTION (Impotence) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERECTILE DYSFUNCTION (Impotence) (seriousness criterion medically significant), MALAISE (Over all uneasiness) and ARTHRALGIA (Severe joint pain). At the time of the report, ERECTILE DYSFUNCTION (Impotence), MALAISE (Over all uneasiness) and ARTHRALGIA (Severe joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Vaccine was administered several months ago and since then patient was experiencing impotence, severe joint pain and over all uneasiness. Otherwise healthy male with a family. No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment:  This is a spontaneous case, reported by a patient, concerning a male patient of an unknown age with no medical history reported, who experienced the unexpected serious (medically significant) event of Erectile dysfunction, reported as impotence, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. Patient also experienced severe joint pain and over all uneasiness. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a patient, concerning a male patient of an unknown age with no medical history reported, who experienced the unexpected serious (medically significant) event of Erectile dysfunction, reported as impotence, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. Patient also experienced severe joint pain and over all uneasiness. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
I experienced fever and chills approximately 14 hours after injection. 20 hours after I started experiencing nausea and vomiting. This all subsided around 34 hours post injection.
My left hand started getting numb and feeling swollen first thing in the morning.. It started off only in my left pinky and ring finger and is now in all my fingers.  My arm feels cold and my fingers are extremely tight and hard to move.  I have to squeeze and loosen to get maneuverable.  Since the 2nd injection the same thing is happening in my right hand.  Starting again with the pinky and ring fingers and progressing now with pain  in the tip of my right ring finger.  Aches and pain throughout the day.
Severe Body aches (muscular), chills, feverish, fatigue for approximately 18 hours. Symptoms moderately reduced with Ibuprofen. Redness, swelling, warm to the touch around injection site (continues as of this report)
lymphadenopathy of the right axilla with numbness and tingling in the right arm.  Symptoms started 1 day after administration on March 26, 2021. lymphadenopathy has resolved but numbness, tingling, and pain of right arm and right axilla remain.
Heart rate began to increase into the 120?s around noon but I did not notice. I began to feel chills around 7pm and my heart rate was 128. I started running a fever of 101.4 shortly after with chills. I took extra strength Tylenol and checked my temperature again at 3am and my fever was 100.3 with chills. I took Motrin and went back to sleep. I woke the next morning hot and sweaty with a temperature of 97.8.
Lethargy, left leg numbness, inability to bear weight - evaluated by primary care pediatrician next day, no problem found.
103 fever eight hours after vaccine. Resolved in 24 hrs. No treatment except Tylenol.
Admit to on 12/1/2021 due to shortness of breath.  Unknown discharge date
About 6-7 hours after receiving the second Pfizer COVID-19 vaccine, I had the onset of headache, vomiting, fever to 101, chills, rigors, and diffuse body aches. The symptoms improved with ibuprofen and tylenol. They resolved within 24 hours so about 36 hours post-vaccine.
Child was administered his second COVID vaccine on 2/15/2022/ The vaccine given had NO diluent added, making it 1.5x dose. Patient was observed for 30 minutes in office without any symptoms.
Patient vaccinated at approximatley 8:45 am.  Mother took patient to daycare.  About an hour later daycare attendant called mother because patient had abnormal eye movements, was lethargic, and had skin color changes.  Vomited once enroute to office.  Upon arrival pt had cyanotic extremities, diffuse urticaria, respiratory distress with grunting but no wheezing, an additional episode of vomiting in the office.  Given epinephrine and within 5 minutes color returned to normal and breathing was wnl.  Patient transferred to local ED where he was given an additional dose of epinephrine and benadryl.  Monitored and did well.  Sent home on pepcid, benadryl, and prednisolone.
p/vax pt devel vomit, diarrhea & fever of 101F; pt hosp x 4 days due to dehydration
swelling & pain w/redness encompassing upper arm; t101 w/in 24 hrs of inj; put on ATB; small raised brownish area @ site; no redness or pain;
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 03-SEP-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
The patient received TDAP, Hep B, and HPV without problems. Three - five minutes later the patient became pale, nauseated with sweating. The patient was sitting in the chair and her head was lowered & wet cloths placed on neck and forehead. She was escorted to exam room 6 - legs elevated on the table. After 45 minutes of resting, she was escorted to her car - with friend driving. A & O.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # L045954, expiry date: 17-NOV-2017 and lot# L048465, expiry date: 02-DEC-2017 (route of administration was not reported). Temperature excursion details were reported as: temperature: 9C and time frame 204 hours and 26 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. Additional information is not expected, because there is no consent to contact the physician.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies and concomitant medications were not reported. On unspecified dates the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose and route were not reported) lot # M013636 and expiry date: 15-FEB-2018. The vaccine was exposed to a temperature frame of 34.9 Fahrenheit for 336 hours. A data logger was used to record the temperatures. No adverse effects were reported. No additional information was provided. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
Fever Monday evening 103, APAP temp stayed @ 103 to MD could not find any illness to explain fever; Doing well now;
Spasm on both sides of her rib cage; Her whole trunk was achy; Fever; Nausea; Headache; Joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Spasm on both sides of her rib cage), PAIN (Her whole trunk was achy), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (Her whole trunk was achy), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain). On an unknown date, the patient experienced MUSCLE SPASMS (Spasm on both sides of her rib cage). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Headache, at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Spasm on both sides of her rib cage) outcome was unknown and PAIN (Her whole trunk was achy), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) was resolving.            No relevant concomitant medications were reported.  No treatment information was provided.
Syncope with hypotension; tx elevate lower extremities, cool cloth to forehead, orange juice, crackers.
Pre vaccinations states she has pseudo anaphylaxis  Approx 5:15p Became dizzy. 5:25 became flush red c/o pruritis c hives No dyspnea on c/o throat closing and other issues.  VS monitored qppox. 5:40p At pt request went to hospital via EMT. Was stable at shot time taken out of abundance of caution.  Took Singulair & Allegra 30 mins prior to vaccine
Pt recv vax on 11/2/98; on 11/6/98 pt exp encephalopathy, sleepiness, fever, stopped eating & drinking, matted/weepy eyes, relaxed arms; tx=I.V. hydration
On 4-13-12 redness, tender swelling over injection site. 4 cm area of pale blanching erythema and 3 cm induration no fluctuance.
Mild fever; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild fever) and MYALGIA (Muscle aches) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ERH732) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Mild fever) and MYALGIA (Muscle aches). At the time of the report, PYREXIA (Mild fever) and MYALGIA (Muscle aches) outcome was unknown.            The concomitant medications were not reported. The treatment information was not provided.
Approximately 15 - 30 minutes after the vaccine was administered person felt lightheaded and weak . At time of injection she felt a warm sensation at the injection site and left shoulder hurt .
Positive for COVID; Positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  A male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: E19261, Expiration Date: 31May2021), on 12Feb2021 as dose 2, single (Lot number: EL9267, Expiration Date: 31May2021) and on 02Dec2021 as dose 3 (booster), single (Lot number: FF2590, Expiration Date: 31Mar2022) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 2021, outcome "unknown" and all described as "Positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure. Clinical Course: It was reported that the patient was sick but not really sick. Had fever for a couple of days and was really tired and that was basically it. He was asking when he could receive the second booster. Finished Paxlovid one day last week. When indication for Paxlovid queried caller provided He was positive for Covid and diabetic. All three previous doses of Covid19 Vaccine were manufactured by Pfizer. NDC: 59267100001 (Dose 1), 59267100001 (Dose 2) and 59267100002 (Dose 3).; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
h/a;dog involved w/an unk animal & was bleeding;pt's dog bit her when was cleaning it;dog is fully vaccinated & appears well;29AUG95 f/u completed series w/h/a p/all doses;Lot# submitted is not valid (J0849);
Information has been received from a licensed practical nurse concerning a 78 year old female with hypertension, hyperlipidaemia and a history of palpitations who on 25-FEB-2008 was vaccinated with ZOSTER vaccine live (Oka/Merck) (lot number 658208/0886U) 0.65ml subcutaneous (site not reported).  On 26-JAN-2009 the patient developed a very mild case of shingles on her head.  The patient was seen in the office.  The patient's shingles was recovering.  Additional information has been requested.
On 9-26-2023,  one  day after receiving the vaccine and about 22 1/2 hours later, I developed sharp pain in the rt rib area that was worse to move or breathe.  After using heat and laying down, the pain subsided in about 2-3 hours and there has been no further recurrence.  I am not sure if this was related to the vaccine or not as I had no previous  reactions to Pfizer covid vaccines in the past.
Midnight 08/23/2021 at 3am body temperature goes down to 94.3 causing me to have tremors throughout my body, and high arterial blood pressure 189 with 100 with a plus above 100 beats. This event is repeated on 08/24/2021 midnight approximately 4 am, presenting the same symptoms of low temperature and increased arterial blood pressure. The events last about 15-20 minutes always at midnight.
Right arm swelling, became painful in the elbow, and itchy.  Spread to lower forearm and neck.  Taken to ER and received fexofenadine (180mg) and Augmentin (875mg)
Case number PHEH2012US013849 is an initial spontaneous report received from a physician on 09 Jul 2012 with a follow up information received on 30 Jul 2012. This report refers to a female patient whose age, medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that she was vaccinated with only 0.5 ml MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: M11071, expiry date: Dec 2013) intramuscularly on to specified site and did not receive MenA lyophilized conjugate on 09 Jul 2012. No adverse reaction was reported following the maladministration. Follow up information received on 30 Jul 2012: Patient demographics (height and weight) and expiry date updated.
Covid test result=Positive; Covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 30Nov2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 02Sep2022 as dose 2, single (Lot number: Fd7639), in left arm and on 01Nov2022 as dose 3 (orange cap; booster), single (Lot number: FF9442Z) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Jan2023, outcome "unknown" and all described as "Covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jan2023) Positive, notes: Nasal Swab.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information.,Linked Report(s) : US-PFIZER INC-202300272957 same patient, different dose/event;US-PFIZER INC-202300273027 same patient/drug, different dose/events (LOE);
Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 06-OCT-2009, the patient was vaccinated with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries as recommended by the healthcare professional. On an unknown date, the patient experienced shingles and on 22-FEB-2015, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages, as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and  the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Patient called reporting right lower extremity swelling that started in his right ankle about 45 minutes after his vaccination. The swelling gradually went up to his calf.
I is a few months After my daughter has rcieved the gardasil shot. On several occassions she has become sick out of the clear blue.  She will get a wave of nausea, faintness and dizziness.  After she vomits she will get the chills and a low grade temp. She is a otherwise healthy, athletic female. In the last three weeks this has occurred twice, however we have not kept track until recently, but there have been other episode of the same prior to the last few. After she recieved the first vaccination she passed out in the doctors office.
I have a very red arm at injection site. It is swollen and sore and is much larger than just injection site. It first appeared about 50 hours post injection. Cold compresses were applied but there was no relief.  Tylenol did not lessen  pain. It is currently 72 hours post injection and arm is on same condition.
This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age. The patients' medical history and concurrent conditions were not reported. On an unknown dates, in August 2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23, (lot # N005096, expiry date 22-OCT-2018). The vaccines were stored at a temperature excursion between 9°C to 25°C for a cumulative total of 6 hours and 35 minutes (first for 4 hours and 33 minutes and then for 2 hours and 2 minutes) (incorrect product storage). It was called because of a data logger. No adverse effects were reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of three reports from the same reporter source (linked to case #s 1708USA009475 and 1708USA010054). Additional information has been requested. Sender's Comments: US-009507513-1708USA009475: US-009507513-1708USA010054.
Woke up approximately 12 hours after vaccination, with severe chills causing my teeth to chatter and shaking all over.  Chills dissipated within about 4 hours.  Had a very bad headache which also began about same time as chills and lasted for approximately another 12 hours, even though I took tylenol and advil alternating every 4 hours.  Had a slight fever, approximately 1 degree over what I normally register for about 8 hours.  I showered about 36 hours after vaccination and immediately broke out in a rash (not hives)...more like prickly heat all over my stomach, neck, chest, stomach, inside arms.  This lasted until the next day; did not itch or cause any discomfort.