chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; got 1 dose years ago; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 28-NOV-2022 Reporter's comment: The reporter was the patient. The patient received a dose of a shingles vaccine about 2-3 years ago.  He did not know which shingles vaccine he received but thought he got 1 dose.  The patient recently developed shingles.  The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Patient returned to the pharmacy complaining that she was feeling weak/lightheaded/nauseous.   I had her sit at the pharmacy; she had a drink and we monitored her for almost 1 hour.  I had a technician sit with her the entire time and i checked in with her approximately every 15 minutes.  After about 30minutes she began stating she was feeling some improvement.  After about an hour she stood up and walked around to see if she was feeling well enough to leave.  She stated she was and left the pharmacy area at 130p
Redness - silver dollar size - at administration site 2 days after shot which went down after a few more days, then 7 days after shot patient woke up sweating and stuffed up in his chest.  No fever just sore and itched a little.
Two weeks after receiving the vaccine, the site developed redness and intense itching. The red area was approximately the size of a quarter. The doctor recommended using Benadryl ointment and cool compresses, which I did. The site returned to normal in about 10 days.
A non-serious spontaneous report of flu-like feeling - achy, malaise, nausea and diarrhea has been received from a consumer concerning a 45-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received a single dose of H1N1 on 27-Oct-2009. On 27-Oct-2009, within one hour the patient felt symptoms of flu-like feeling - achy, and malaise. By day two, the patient's temperature was 100 degrees F. On an unknown date the patient had diarrhea and nausea as well. The patient reported she is feeling better, with some symptoms continuing. Additional information received 03-Nov-2009 and incorporated into narrative: new event terms and outcomes.
The patient reportrf having swelling on her arm where the shot was injected and developed a welt.
Pain and itch at injection site, worse for 24 hours and decreased daily after Feb. 12
pt recv vax 8MAY96 & 29MAY96 pt exp rash w/6-7 vesicular lesions on back & stomach & fever approx 101;
fatigue/feeling tired; chills; is not feeling great; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from Jan2021 to Jan2021 at a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. It was reported that the patient has fatigue/feeling tired and chills and is not feeling great; all on unspecified dates. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.
Gravida 1 at 20 weeks gestation when she received her second vaccine dose. EDD is 8/19/2021. Currently still pregnant. Presented to the emergency department with weakness and post a fall after her legs gave out. Progressive lower extremity weakness and numbness with MRI changes in brain and spinal cord concerning for acute disseminated encephalomyelitis (ADEM), transverse myelitis. Has been hospitalized since 4/5 and given IV solumedrol, IVIG, and consideration of plasmapheresis and potentially cyclophosphamide if she continues to worsen. Still admitted with continued worsening on 4/10.
This case was reported by a pharmacist via sales rep and described the occurrence of chills in a 72-year-old patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020) for prophylaxis. Previously administered products included ZOSTAVAX (received on 20th October 2009).  On 9th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills and influenza-like symptoms. On an unknown date, the outcome of the chills and influenza-like symptoms were unknown. The reporter considered the chills and influenza-like symptoms to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported, however, it could be 71 or 72 years. The patient was a hospital employee. Concomitant medications, vaccination facility, and other specific details were unknown, as no further information was provided during the call. The reporter gave consent to be contacted for follow up information. This case was one of the 9 cases reported by the same reporter. The reporter stated over the phone that about half of the eight patients had experienced flu-like symptoms, one of which was another doctor who could not go to a work related event the next day because of the symptoms. It was unknown which of the eight patients was the concerned doctor.
My menstrual cycle has not been normal since receiving the first and the second dose of the moderna covid vaccine (my cycles have been extremely predictable my entire adult life). After receiving the first dose of the moderna covid vaccine, I had a light period about 13 days before I should have, and then a regular period on schedule.  After receiving the 2nd dose, I didn't have my regularly scheduled period (I am going on 15 days late as of today).
The evening of 4/20/2022, I had constant coughing, with lots of post-nasal drip triggering cough reflex, I woke up around 4am, 04/21/2022, coughing and gasping for breath. 96.7°F, 94% SPO2, 59bpm. I took a Home Covid-19 test with positive result. I never had a fever, but my wife had a fever for 5 days.
Passed the 42 days recommended interval for second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Passed the 42 days recommended interval for second dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Passed the 42 days recommended interval for second dose). On 28-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Passed the 42 days recommended interval for second dose) had resolved.            No relevant concomitant medications were provided. No treatment medication was reported.
neurological symptoms: left side of body weakness and lack of coordination, Severe sensitivity to hot or cold. Severe dropsy, hardly any grip and can't feel if holding anything. sxs continued and patient called and reported:  Body jerking, jolts 'electric shocks', eyes squeeze shut, most involuntary  movements 9/1/2021.  Muscle spasms throughout body at night reported by patient at appt 12/10/21
Guillain-Barre syndrome (BLE numbness, fatigue, bilateral shoulder blade pain and muscle pain in both thighs. Numbness extended from mid-thigh down to both feet causing difficulty with his gait. 8 days of intravenous immunoglobulin. Also concern for transverse myelitis, started on steroids. Acute urinary retention, started on FLOMAX. Patient hospitalized and then transferred to rehab center. Patient has persistent/residual bilateral lower extremity weakness, gait abnormality, and urinary frequency plus urgency. He is continuing physical therapy and seeing neurology.
Staff express light headiness at 8:55am  continuous monitoring / vitals taken and documented on occ. health chart.   9:05 am heart palpations started per staff. At this time staff provide info that she had a scheduled appointment to recieve a heart monitor. 9:08 am coughing started which staff stated coughing starts when her heart palpations began per past experience. Md suggest epinephrine but staff refused . (documented on chart). Staff requested albuterol (steroids per use in past ). Albuterol provided and staff self administrated at different intervals  (9:24am/9:32 am/9:39 am) Staff stated feeling better after each albuterol inhalation. Continuous monitoring and vital taken and documented .  9;15 am EMS notified for transport to local hospital (ER) for evaluation . Staff was alert and able to express /talk coughing was randomly /shorter duration.
Approximately around 1030 pm started having body aches and shaking chills. Finally fel asleep and then woke up around 2am 1-21 and had a major head ache body aches checked temp it was 101.7. Took Tylenol woke back up 4 hours later had chills and body aches temp was 100.9 took more Tylenol every 3-4 hours had fever around 4pm I took some vitamin c and Tylenol did not have any fever after that.  Woke up next morning 1-22 with arm pit slightly sore progressively got worse theouhtout day. Woke up 1-23 moderately sore to touch and move
I felt more tired than usual the day after receiving the vaccine. i was exposed to COVID-19 when my husband tested positive. I tested positive for COVID-19 in 01/2023. I had chills and felt very tired. I contacted my doctor and was advised to take zinc and a cough medicine.  As of today, I feel better with no lingering symptoms.
Last Menstrual was April 2020 and been in menopause. Mentstrual came on within hours after the second shot  Brief Dizziness on second night of second shot.  No fainting or rapid heartbeat.  No nausea or fever
Mild headache, mild stomach ache, severe chills, moderate left arm pain, reasonable right arm pain, light to moderate low back pain, light to moderate leg pain. I didn?t take anything for the pain or chills, I just dealt with it. The chills lasted an hour or two and the sore body pain reasonably subsided by morning. I still feel some soreness now but it?s minimal compared to last night.
Patient had 3 doses of Pfizer COVID vaccine on 11/3/21, 3/10/21, and 2/17/21, and was hospitalized on 2/2/22 for acute hypoxic respiratory failure and is still hospitalized today, 2/3/22
client was in observation station. became weak and daughter with her. notified EMT on site and was pale, ashen and not responding. Laid client on cot and elevated her feet. became responsive. Vital signs done and bp 157/68 and pulse 76. Became responsive. sat up client and states that she had coffee and some yogurt this morning. provided client with juice and pretzels. felt ok and declined further medical treatment.
He received the 2nd dose of Shingrix vaccine on 10/25/2019 at 0848. Later that evening he developed a fever, chills, sweats and myalgia. He also reported that he had a lump and two blisters  at the injection site about the size of a dime. The blisters popped in the shower the next morning.
I woke up the morning after I received vaccine with positional vertigo. I have had it once before, about 10 years ago, but it was after a sinus infection. I have no congestion, no ear issues. It has now been almost a week, and the vertigo persists. It is especially worse when I go to bed and when I get up too fast.
Tendonitis developed in my left arm after 4 days or so.  After 3 weeks, I visited my primary doctor who diagnosed the tendonitis and gave me a steroid shot in my shoulder.  This alleviated much of the pain, but an overall achiness still exists today (more than 5 weeks after the vaccination).  This condition has prevented full motion of my left arm and impacted my sleep.
Moderna COVID?19 Vaccine EUA  Swollen lymph nodes in armpit on same side as shot was given
Patient received Tdap and varicella vaccine on 7/12/2007.  Mom calls clinic on 7/18/2007, reporting day after vaccine pt developed congestion, then two days after vaccination pt developed red bumps on face and yesterday 07/17/07 pt started wheezing.  Parent denies pt has fever. Parent reports she has not taken child to the doctor. This nurse recommends to parent that she take pt to doctor, parent verbalizes she will take child to doctor. Parent instructed to call back clinic after doctor visit and or nurse will follow up with parent.
4hr after dizzy -lightheaded- headache. Stomach nausea with temp.
Patient presented to the ED and was subsequently hospitalized for respiratory center depression, fall, laceration within 6 weeks of receiving covid vaccination.
Pt. called pharmacy and reported having flu like symptoms 5 hrs after receiving flu shot. I.e., painful cough, runny nose, sneezing.
Patient received 2nd dose 2 weeks after 1st; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose 2 weeks after 1st) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Denied) for COVID-19 vaccination.     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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose 2 weeks after 1st). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose 2 weeks after 1st) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment medication were reported   Reporter did not allow further contact
About the week after the booster I was experiencing really bad chest pain. I went to see my cardiologist that day. They did an ultrasound and found inflammation around my heart. They told me to take some aspirin and it resolved itself in about 5 days.
17 and received vaccine; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 and received vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 and received vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 and received vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.
has not had second dose and it has been over 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not had second dose and it has been over 42 days) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not had second dose and it has been over 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not had second dose and it has been over 42 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information and concomitant medications were reported.
Upset stomach - no appetite. Body aches. Very tired. Slept 12 hr. Chills. No thermometer. Wife said did not feel like fever. Got flu shot after working night shift, woke up feeling bad.
ARM STIFFNESS; NUMBING PAIN; LIGHTHEADEDNESS; FATIGUE; This spontaneous report received from a patient 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 MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced arm stiffness. On MAR-2021, the subject experienced numbing pain. On MAR-2021, the subject experienced lightheadedness. On MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm stiffness, numbing pain, lightheadedness and fatigue was not reported. This report was non-serious.
36 hours of severe chills and muscle soreness (especially in injection site arm; lasted for 5 days).
Initial case was received from a healthcare professional on 26 April 2013. A two-month-old female patient received an intramuscular injection of PENTACEL, sanofi pasteur Ltd., (lot number, site, side and dose in series not reported); Hep B, other manufacturer; PREVNAR, other manufacturer; and ROTARIX, other manufacturer (lot numbers, routes, sites, sides and dose in series not reported) on an unspecified date. By evening of vaccination (unspecified date), the two-month-old would not take her bottle and was coughing. Mom thought the infant's throat was swelling. The infant became pale and blue around the lips and was taken to the emergency room (ER). The patient's past medical history was not reported and illness at time of vaccination was reported as none. Laboratory and diagnostic tests were reported as unknown. Treatments were not reported. The patient's outcome was reported as recovered on an unspecified date. Documents held by sender: none.
a rash or hives; arm swelled up on the injection site; a rash or hives; it also was a little sore but it went away in about 4 days; it itched; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (a rash or hives), VACCINATION SITE SWELLING (arm swelled up on the injection site), RASH (a rash or hives), VACCINATION SITE PAIN (it also was a little sore but it went away in about 4 days) and PRURITUS (it itched) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced URTICARIA (a rash or hives), VACCINATION SITE SWELLING (arm swelled up on the injection site), RASH (a rash or hives), VACCINATION SITE PAIN (it also was a little sore but it went away in about 4 days) and PRURITUS (it itched). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 28-Jan-2021, URTICARIA (a rash or hives), VACCINATION SITE SWELLING (arm swelled up on the injection site), RASH (a rash or hives), VACCINATION SITE PAIN (it also was a little sore but it went away in about 4 days) and PRURITUS (it itched) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient presented to the pharmacy 3 days later after flu shot with swelling on her underarm and forearm. Pt was advised to take BENADRYL/cold compress and to seek medical attention.
Patient came back 5/20/14 with swollen, warm, tender injection site accompanied by pain and headache, site was a light purple about 3 inches long. No fever or chills.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027a21a) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia (high pain tolerance due to fibromyalgia) and High cholesterol. Concomitant products included DULOXETINE for Fibromyalgia, ROSUVASTATIN for High cholesterol, VITAMINS NOS for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 800 mg. In March 2021, HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to  (E2B Linked Report).; Sender's Comments:  :2nd dose
Anaphylactic shock; A spontaneous report was received from a female consumer who received Moderna's COVID-19 Vaccine and experienced anaphylactic shock.  The patient's medical history was not provided. No concomitant product use was reported.   On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 31 Dec 2020, after vaccine administration, the patient experienced anaphylactic shock and was taken to the hospital. No treatment information was provided.  On 01 Jan 2021, the patient reported feeling much better.  Action taken with mRNA-1273 in response to the event was not reported.  The event, anayphylactic shock, was considered resolved on 01 Jan 2021.; Reporter's Comments: This case concerns a female patient with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of anaphylactic shock. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the onset of the event on the day of vaccination, a causal relationship cannot be excluded and the event was considered possibly related to the vaccine.
About 7-8 hours after receiving the injection I developed a low-grade fever, had pretty intense chills, and became very weak.  My arm also began to hurt about 4 hours after injection and that lasted for the next day and a half.  I ended up sleeping for over 13 hours the night after getting the vaccine.
About 14 hours after the injection I began running a high fever- the highest was 103. Along with severe body shaking, chills, body aches and pain, mild headache, earache, sore throat, coughing, and loss of emotional control. Used Tylenol and ice packs for the fever and pain. Took 4 hours to get things tolerable. Early Sunday morning I only had a slight headache, sore throat and earache-which are probably due to my seasonal allergies.
Information was received from a healthcare worker concerning four patients who between 05-SEP-3012 through 19-SEP-2012 were vaccinated with a dose of PNEUMOVAX 23 (Lot # H013581, expiration 03-MAY-2014). The reporter stated 4 patients received PNEUMOVAX 23 from the same lot and all patients reported having redness, soreness, pain, swelling, and warmth at the injection site on the day following administration of the vaccine. All 4 patients had sought medical attention. Treatment was "ice". All of the patients were recovering at the time of the report. No further information was provided. Additional information was requested.