chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a consumer (patient parent) on 18-Aug-2015. A female patient (age was not reported), whose medical history and concomitant medications were not provided had received a dose of Meningococcal vaccine (dose details, batch number, route of administration and site of administration were not reported) on an unspecified date. On an unspecified date, 14 days post-vaccination, the patient developed meningitis. Laboratory investigations and corrective treatments were not provided. At the time of this report, patient was recovered from the above mentioned event on an unspecified date however she had a shunt. Upon internal review, this case was considered serious due to important medical event: meningitis. Documents held by sender: none.
Patient's COVID-19 vaccinations: 12/28/2020, 1/20/2021, and  9/9/2021. Patient was seen on 2 18 2021 stating he has been told his skin was  looking "yellowish" and pale, therefore labs were drawn. Patient had a critical  lab value of Hgb 3.8 and referred to the ED for transfusion. Per H&P, patient  endorses headaches that began after he received his second COVID-19 vaccine.  Low hgb related to acute on chronic severe iron deficiency anemia, most likely  secondary to cameron lesion per EGD 2/22/2021.
I called patient today to talk to him about his. Patient told me that he thought he was having a reaction to his Td booster yesterday. Patient stated that he was having B/L leg pain #8 on pain scale and that he could not straighten out his right let. I paged doctors: no call back. I talked to another doctor and she said that she did not think any symptoms were related to Td booster. I told doctor that I was going to sent Pt to ER because the patient did not have these symptoms yesterday. I called patient and told him to go to ER. I gave him patient info about his doctors and told him to bring his list of medication with him. I told patient I would call him later in afternoon.
soreness at injection site has not yet resolved; shivering; fever came on last night; headache is mild; fatigue / more tired than normal; weird muscle pains; Aching all over; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 11th November 2020, less than a day after receiving Shingrix, the patient experienced shivering and fever. On 12th November 2020, the patient experienced injection site pain. In November 2020, the patient experienced headache, fatigue, myalgia and general body pain. The patient was treated with paracetamol (Acetaminophen) and paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, fever, headache and fatigue were not recovered/not resolved and the outcome of the shivering was recovered/resolved and the outcome of the myalgia and general body pain were unknown.   The reporter considered the injection site pain, shivering, fever, headache, fatigue, myalgia and general body pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient himself. The age at vaccination was not reported. In morning of 11th November 2020, the patient received 1st shot of Shingrix intramuscularly in right deltoid.  The reporter did not have the lot number or expiration date. The patient's right arm where the injection was given was not sore or painful immediately but it was at the time of reporting. He said it was not red or swollen.  The reporter stated that not long after he received the shot he began experiencing weird muscle pains that come and go and then he began aching all over.  The patient experienced fatigue and said that he was more tired than normal. Also reported headache which was mild but had not resolved even after taking acetaminophen or Tylenol.  The patient had fever which came on last night from the day of reporting and recorded as 99 degrees.  It had not resolved even though he took acetaminophen or Tylenol.  He did experience a good deal of shivering as well which resolved after taking 3 Tylenol (acetaminophen) last night.  The reporter consented to followup.
This spontaneous report was received from a health care worker referring to a 12 year old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 28-SEP-2015, the patient was vaccinated with unspecified improperly stored doses of GARDASIL 9 (lot # L016428, expiration date 30-JUL-2017), (routes, doses and anatomical sites of vaccination were not provided). It was reported that the temperature of excursion were the following: 53.6 F for 392 hours, 58.5 F for 465 hours and 46.2 F for 15 hours, respectively. The outcome of excursion was not supported. Co-suspect therapies or concomitant medications were not provided. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Swelling at the Injection Site; Redness at near the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at the Injection Site) and VACCINATION SITE ERYTHEMA (Redness at near the Injection Site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blind.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the Injection Site) and VACCINATION SITE ERYTHEMA (Redness at near the Injection Site). At the time of the report, VACCINATION SITE SWELLING (Swelling at the Injection Site) and VACCINATION SITE ERYTHEMA (Redness at near the Injection Site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Major soreness in arm starting 6pm day of vaccine, and continuing through 3/2.  Fatigue and nagging headache 3/2.  Resolved by 3/3.
Following day patient developed fever 103, chills, vomiting, 48 hours after vaccine patient developed diarrhea which lasted 2 days. She was covid tested 1/9/2021 which was negative.
soreness in his arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On 5th January 2021, the patient received Meningococcal B vaccine. In January 2021, less than a week after receiving Meningococcal B vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Meningococcal B vaccine.  Additional details were provided as follows: The reporter was patient's parent. The patient's current age was reported as 17 (unit unspecified). The age at vaccination was not reported. The patient received Meningococcal B vaccine and was still complaining of soreness in his arm. The reporter wanted to know was this normal.
5-10 minutes post vax, the pt complained of her head hurting, her stomach was a bit upset, and maybe a little lightheaded. The next morning her mother contacted physician stating that her daughter had continued to have symptoms. She was advised to report symptoms.
diarrhea; does not feel good; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and MALAISE (does not feel good) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical  history is provided and concomitant drugs are provided,.     On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea) and MALAISE (does not feel good). At the time of the report, DIARRHOEA (diarrhea) and MALAISE (does not feel good) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient called to discuss symptoms she experienced last night after having received both meningitis vaccines. She went to a concert the same evening after receiving both vaccines. Patient reported  experiencing nausea w/o vomiting, vertigo, sweats, HA and confusion while at the concert.  Patient's mother stated patient had sudden onset of headache, sweats, difficulty speaking, generalized weakness, vomiting, numbness around mouth, cramping in hands while at concert. Symptoms began resolving once patient was removed from the concert. Patient had not consumed any new medications to mother's knowledge. She had Menactra and Trumenba in the office earlier in the day.    Per mother, Patient has returned to normal at this time - Reported at 5:22 pm the day after receiving vaccines and going to concert.
Swelling of the throat; This spontaneous case was reported by a patient and describes the occurrence of PHARYNGEAL SWELLING (Swelling of the throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PHARYNGEAL SWELLING (Swelling of the throat). At the time of the report, PHARYNGEAL SWELLING (Swelling of the throat) outcome was unknown.            No concomitant medications were reported.  It was reported that patient received the booster, the 4th one before the bivalent one.  No treatment medications were reported.
heart arrhythmia; hot flashes; night sweats; nocturnal urinary incontinence; flu like symptoms; body aches; headache; This case was reported by a consumer via call center representative and described the occurrence of cardiac arrhythmia in a 62-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   The patient's past medical history included heart disorder (Not specified) and animal bite. Previously administered products included Rabavert with an associated reaction of arrhythmia (1st dose received on 11th December 2019, refere linked case US2020AMR009367).   On 14th December 2019, the patient received the 2nd dose of RabAvert. On 15th December 2019, 1 days after receiving RabAvert, the patient experienced cardiac arrhythmia (serious criteria GSK medically significant), hot flashes, night sweat and urinary incontinence. In December 2019, the patient experienced influenza-like symptoms, general body pain and headache. Rechallenge with RabAvert was positive. On an unknown date, the outcome of the cardiac arrhythmia, influenza-like symptoms, general body pain, headache, hot flashes, night sweat and urinary incontinence were recovered/resolved.   It was unknown if the reporter considered the cardiac arrhythmia, influenza-like symptoms, general body pain, headache, hot flashes, night sweat and urinary incontinence to be related to RabAvert.  Additional details were provided as follows: The patient received Rabavert vaccination for post- exposure prophylaxis. The patient received 2nd dose on the afternoon of December 14, 2019. She experienced the flu like symptoms of body aches and headache. The patient also reported heart arrhythmia, hot flashes, night time sweating, and urinary incontinence at night after 2nd dose. All events had been resolved at time of report. The reporter consented to follow up.
feeling of burning and needles (not numbness) poking me throughout body; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EWO158) via an unspecified route of administration in the right arm on 10Apr2021 at 14:00 as a single dose for COVID-19 immunisation.  The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications included TRI-LO-MARZIA  and nature made multi vitamin gummies (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 06:00, the patient experienced feeling of burning and needles (not numbness) poking  throughout her body. The patient reported that the feeling of wearing clothing hurted her. The clinical outcome of the event feeling of burning and needles (not numbness) poking throughout her body was recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
w/in a few hrs of vax arms & legs began to twitch, vacant stare, cyanotic-taken to MD immed temp spike to 105;
L arm/hand numbness; blood pressure abnormality; chest pain; respiratory distress; This is a spontaneous report from a non-contactable other-HCP. This other HCP reported for a 73-Years-Old (same age at vaccination) female patient that she received the first dose of bnt162b2 (BNT162B2, Lot number EN6205), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medication was none. She had not been back to her pcp for "several years". No known history of HTN. She did have a blood pressure cuff at home. During her 15-minute waiting period after the injection on an unspecified date, the patient began to experience L arm/hand numbness. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality, chest pain, rapid progression of symptoms and respiratory distress. Treatment included: no therapy. Follow up response was excellent. Patient discharge: stable to go home and follow up with PCP. Outcome of events was unknown.  No follow-up attempts are possible. No further information expected.; Sender's Comments: Based on the information provided, and on a close drug-event temporal association,  the Company  assessed there was a reasonable possibility that the reported serious events  were related to the suspect vaccine  BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient received her second dose of Moderna 06/05/2021 at 12:31pm. Within a minute, she fainted. Had patient lay flat on the ground, feet elevated on a chair. Patient became responsive within seconds after elevating her feet. EMT arrived soon afterwards to take vitals. She rested at the pharmacy for 30-60 minutes, stated that she was feeling fine. A friend came to pick her up and drive her home.
Slurred speech, extreme confusion and disorientation, headache, blurred vision. Symptoms of mild Demetia increased to meditate to severe dementia in a matter of hours.
Osats down to 80; Pulse upwards of 130; A spontaneous report was received from a health care professional, concerning a 93-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Osats down to 80 and pulse upwards of 130.   The patient's medical history, as provided by the reporter, included hypertension and heart disease. Concomitant product use was not provided.    On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 05 Jan 2021, around 20 minutes after vaccination, the patient's oxygen saturation was down to 80 and she had a pulse upwards of 130. The patient was given 3-4 L of oxygen, but did not respond, so, epinephrine was administered. Emergency medical services (EMS) was called. The patient's oxygen saturation was around 90 with pulse ranging from 80-120 after EMS arrived.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, Osats down to 80 and pulse upwards of 130, was unknown.; Reporter's Comments: This case concerns a 93 year-old, female patient with medical history of hypertension and heart disease, who experienced events of oxygen saturation decreased and heart rate increased. The events occurred approximately 20 minutes after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Weak; Fatigued; Fever; Muscle Aches; Couldn't Taste; Pounding Headache; This is a spontaneous report from a non-contactable consumer (reporting for a friend). A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine includes 1st dose of bnt162b2 on an unspecified date for COVID-19 immunization. The reporter's friend (who is a doctor) could not leave bed for one whole day after the 2nd shot and felt weak, fatigued, fever, muscle aches, could not taste and pounding headache on 14Jan2021. The patient did not receive treatment for the events. Prior to vaccination the patient has no COVID. The outcome of the events was recovered on Jan2021.  No follow-up attempts are possible. Information about batch/ lot number cannot be obtained.
Nausea began around 5am about 12 hours after the shot. Still feeling naseous 36 hours later to the point I cannot do daily activities. Moderate fatigue, slept almost all day 1/23 and 1/24
Approximately 17 days after shot I am having  very bad pains in my shoulder, neck and back. Similar to typical flu symptoms. Loss of balance very often since shot and VERY TIRED.  No nausea, headaches as yet.
Headache and mild to moderate vertigo. Occurs daily at approximately noon and continues through falling asleep. Difficult to complete daily tasks due to dizziness.
Pt is a 12mo F Kw/no significant PMH who presents with 1 day h/o fever and shaking episodes. Pt received 12mo vaccines 1 day PTA and began having episodes of shaking and fevers, with a Tmax 102 measured at home. Pt was given TYLENOL for fevers. That night parents noticed brief jerking movement during sleep that woke her. Pt would wake briefly, cry, and then went back to sleep. This happened intermittently throughout the night. On DOA pt had several episodes where she would start crying and stiffen arms and legs for approx 10 seconds. Pt would then go limp, stare straight ahead, and be unresponsive. This would last an addition 10 seconds, episodes lasted total 20-30 seconds maximum. No cyanosis, no LOC. Pt did have possible fall off bed while with grandma last week. NO NVD, rashes. Pt has also had URI symptoms and cough intermittently for the last 3-4 weeks, was seen by PMD and diagnosed with viral URI. Pt had total of 5 episodes at home and was then brought to ED. In ED pt was febrile and noted to have several more episodes. A head CT was performed which was abnormal, showing (R) otomastoiditis. Pt was admitted to the floors for management. Pt was transferred to floors and continued to experience fevers and seizure activity. Pt was given a loading dose of phenobarbital. Pt continued to have seizure episodes, which decreased after loading with additional phenobarbital and KEPPRA. Maintenance doses were started for both. Metabolic panel to R/o inborn errors of metabolism was sent in light of normal MRI. Because of persistent fever, CSF studies were drawn but were not c/Kw infectious process. Pt had PCR equivocal for influenza and was started on TAMIFLU. Pt continued to improve on antiseizure meds. Serial EEGs were obtained daily on 3/5, 3/7, 3/8 and 3/9. Neurology had started a daily dose of phenobarbital at 2.5mg/kg bid and then continued to titrate up the KEPPRA dose until both.
RN administered vaccine in drive through setting and asked pt to park and wait for 15 min. following vaccination.  She done so and after 15 minutes she left the facility.  Right after that, on her way home, she began to have trouble swallowing, her lips were numb, and her tongue was tingling.  She was brought back to the clinic by her caregiver and evaluated by EMS.  She was given oral benadryl per patient and held for monitoring.  After this, patients symptoms began to improve and everything went back to normal.  She was released from EMS care back home.
fever above 103, repeated high pitched screaming for hours followed by extreme sleepiness for 2.5 days loss in appetite, swollen leg, tired, not interested in playing for 5 days
Information has been received from a registered nurse concerning a pt who was vaccinated with varicella virus vaccine live from 1995 to 1996. In approximately October 2001, the pt developed chickenpox. Subsequently, in approximately October 2001, the pt developed a secondary bacterial infection that resolved. Also reported were 25 patients who were vaccinated with varicella virus vaccine lived from 1995 to 1996 and starting in late October 2001 developed varicella (WAES0112USA01674). Unspecified patients (including this patient WAES0203USA01902 and the 25 patients WAES0112USA01674) were vaccinated with the following lot numbers of varicella virus vaccine live: 616869/0244D, 617077/0249D, 608320/0405B, 608580/0408B, 608669/0427B, 610247/0445B, 626714/0667H, 610249/0745B, 610250/0751B, 624647/1111E, 619269/1337D, 616996/1500B, 1357S (invalid lot number), 1503D (invalid for this product), 1657B (invalid for this product), 0739L (invalid for this product) and two children's lot numbers are unknown. It was noted that this outbreak varicella began on 10/30/2001 and went until February 2002. It was noted that this outbreak occurred in a very affluent community, where the pediatricians aggressively used (varicella virus vaccine live) since it became available. The children in this community are seen by a large pediatric group of 26 physicians that rotate through approximately 7-8 different practice sites. It was noted that two of the 26 children were twin siblings who both received the same lot number (lot number not specified). The reporter expressed a concern about if there were any relationships between certain lot numbers. It was noted that the valid lot numbers provided above were unrelated by batch. The reporter noted that she did plan to do site visits to the practices to determine their storage practice. It was reported that isolates were being collected and serology confirmed varicella. It was noted that this group of children were in one community which was very stable and it was believed that the children in this community are 25-30% immunized against varicella. Additional info has been requested.