chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Didn't get 2nd shot under advice of pharmacist & doctor; itch on my arms; Red blistering rash under both arms and between legs & torso; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itch on my arms), RASH VESICULAR (Red blistering rash under both arms and between legs & torso) and INTENTIONAL DOSE OMISSION (Didn't get 2nd shot under advice of pharmacist & doctor) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     no specified medical history was reported.  Concurrent medical conditions included Lung cancer since 05-Feb-2020, Diabetes, Blood pressure fluctuation and Prostate cancer. Concomitant products included ENALAPRIL and ATENOLOL for Blood pressure management, METFORMIN, GLYBURIDE and SAXAGLIPTIN HYDROCHLORIDE (ONGLYZA [SAXAGLIPTIN HYDROCHLORIDE]) for Diabetes, TAMSULOSIN for Prostate cancer.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PRURITUS (itch on my arms) and RASH VESICULAR (Red blistering rash under both arms and between legs & torso). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Didn't get 2nd shot under advice of pharmacist & doctor). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at a dose of unknown. On 19-Mar-2021, PRURITUS (itch on my arms) and RASH VESICULAR (Red blistering rash under both arms and between legs & torso) had resolved. At the time of the report, INTENTIONAL DOSE OMISSION (Didn't get 2nd shot under advice of pharmacist & doctor) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Treatment medications of the patient included Benedryl.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Lot No. of the vaccine was provided. On 17-May-2021: Completed ADR, concomitant medications added, additional event information, outcome of previous events updated
Upper arm pain, above average,  deltoid muscle region.   Induration around injection site and pain.
HEADACHE; SOME MUSCLE ACHES; This spontaneous report received from a patient via a company representative concerned a male 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: Unk) dose, one total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced headache, and some muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and some muscle aches was not reported. This report was non-serious.
13-year-old son inadvertently received Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13-year-old son inadvertently received Moderna COVID-19 vaccine) in a 13-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13-year-old son inadvertently received Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13-year-old son inadvertently received Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.  The patient was supposed to get Pfizer COVID-19 vaccine.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX. On 30th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th April 2018, 4 hrs after receiving SHINGRIX, the patient experienced pain in arm. On 1st May 2018, the patient experienced influenza-like symptoms, malaise and general body pain. In May 2018, the patient experienced scar. On an unknown date, the patient experienced nerve pain, oral lesion and skin sensitization. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, nerve pain, malaise and general body pain were recovered/resolved and the outcome of the oral lesion and skin sensitization were recovering/resolving and the outcome of the scar was unknown. The reporter considered the pain in arm, influenza-like symptoms, nerve pain, malaise, general body pain, oral lesion, scar and skin sensitization to be related to SHINGRIX. Additional details were reported as follows: On the same day of vaccination, the patient experienced arm pain that resolved in 1 to 2 days. The patient stated that the day after receiving the vaccine, experienced flu-like symptoms that included malaise, body aches and general malaise and flu-like symptoms resolved within 24 hours. The patient stated that approximately 2.5 weeks following the SHINGRIX vaccine, experienced a lesion on the roof of her mouth that lasted approximately 2 weeks and the lesion had healed, however, there was still some sensitivity on the skin where the lesion was located and also that is feels like a little scar was there. The patient stated that approximately 2.5 weeks after receiving the vaccine, she experienced sharp nerve like pain in her back that felt like someone had shocked her and that pain lasted for 3 to 4 days before going away. The patient stated that he doctor recommended that she should not get the 2nd dose of SHINGRIX.
L THIGH REACTION 2.5/4 CM ERTHEMATOUS, MILD EDEMATOUS AREA 0.5 CM AWAY FROM ACTUAL NEEDLE MARK.
SHOT INJ SITE 4 HR AFTER DIZZINESS 18 HR AFTER TIRED/WEAK 18 HR AFTER HEADACHE 18 HR AFTER SHIVERING/CHILLS 30 HR AFTER
pt recv vax 4/13/98 & 7/14/98 pt was dx an ER w/coxsackie virus;pt devel a fever of 101-102;pt was rechecked in an office visit & dx w/varicella;
Information has been received form a health professional concerning a 4 year old female with no known medical history who on 18JUL2000 was vaccinated in the left arm with a first dose of varicella virus vaccine live. Concomitant vaccination the same day included a third dose of hepatitis b virus vaccine given into the left arm and a first dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live given in the right arm. There was no illness at the time of vaccination. On 27NOV2003 the patient broke out with mild varicella. Subsequently, the patient recovered. No further information is expected.
tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable Nurse reported for self. This 42-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 22Dec2020 08:00 on Left arm at single dose (Lot # EH9899) for covid-19 immunisation. Medical history, concomitant medications were none. The patient tested positive for Covid in 25Dec2020. The patient was scheduled to receive the second dose in 08Jan2021 so should the patient get it. (Further clarified the dates and years). Outcome of the events were unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded.  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.
Chills Rapid heart beat dizziness  Onset of symptoms was within 5 minutes but were mild and subsided after approximately 20 minutes
None until 12 hours after injection.   12 hours later, Injection site became very hot, red and swollen.  Started with fever, chills, muscle aches, lethargic,  unable to sleep, dreaming,    Fever started at l00.6,  then went up to 101.7 the next day.    This lasted around 48 hours, fever is down to normal for the most, but my arm is still very red, swollen and hot.   It is about the size of a baseball.    My overall feeling is better, but not completely normal.
I had ringing in my ear like a buzz sound. I went to a hearing doctor and another doctor in another area. I had a significant drop of hearing in my left ear and that was compared to a hearing test that I had previously done at a pharmacy. It seems to sometimes get better and then it will get worse again. I thought it was almost gone but whenever I got the booster it came back and it was severely worse. I also had a CT Scan done to test for a brain tumor or anything like that but that came back normal. I have another follow up appointment scheduled.
Soreness of shoulder, radiating to arm and neck. Dr diagnosed as rotator cuff inflammation.
Patient Received first dose of COVID-19 vaccine Moderna on 4/20/21 and second dose of COVID-19 vaccine Moderna on 5/18/21. Patient stated to vaccinator RN that after 35 minutes after receiving her second dose Moderna she felt short of breath. Patient stated that she took benadryl. Patient stated that she felt a lot better after 5 minutes.  Patient stated that she did not go to the ED, urgent care or PCP. RN submitted a medical consult via message to Vaccine Operations Leads, requesting to proceed with the COVID booster vaccine Moderna. Per Dr., approval to proceed with COVID booster vaccine Moderna was obtained from medical consult team via message from RN, Vaccine Operations Lead. Client received COVID booster vaccine Moderna Lot# 069H21A on 12/18/21. The client did not report any symptoms during the 30 minute observation period. RN educated client on possible adverse reactions and when to seek medical care. Patient left vaccination site with her mom at 1340 unassisted and with a steady gait.
25JUN92 t103.1 ax (w/o point added); pt seen by MD 26JUN92 w/highest temp 104; pt lifeless but had a good noc;
Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of VARIVAX (Merck) (lot#, route and site of administration not reported). Subsequently, the patient experienced "some type of injection site reaction". Unspecified medical attention was sought. At the time of reporting the patient's outcome was unknown. Additional information has been requested.
States experienced palpitations, fever of 103 degrees, chills, nausea, & weakness about 12hrs after receiving vaccine.  Took Ibuprofen and symptoms resolved the next morning.  Was not evaluated in the ED.  Feeling "much better" today.
Mouth tingling and burning, throat feels a little swollen, mouth tastes like metal, itchy hands and head, loss of clear verbal articulation
diarrhea; soreness in arm; aching; headache; fever; sever chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN IN EXTREMITY (soreness in arm), PAIN (aching), HEADACHE (headache) and PYREXIA (fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-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), PAIN IN EXTREMITY (soreness in arm), PAIN (aching), HEADACHE (headache), PYREXIA (fever) and CHILLS (sever chills). At the time of the report, DIARRHOEA (diarrhea), PAIN IN EXTREMITY (soreness in arm), PAIN (aching), HEADACHE (headache), PYREXIA (fever) and CHILLS (sever chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Tdap vaccine was administered after expiration date on 20OCT13. No signs or symptoms vaccine readministered.
malaise; low grade fever; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (malaise) and PYREXIA (low grade fever) in a 73-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: FLU Shot on 27-Sep-2023. Past adverse reactions to the above products included No adverse event with FLU Shot. Concurrent medical conditions included Tremor and Insomnia. Concomitant products included PROPRANOLOL for Tremor.    On 13-Oct-2023 at 3:10 PM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 14-Oct-2023, the patient experienced MALAISE (malaise) and PYREXIA (low grade fever). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, MALAISE (malaise) and PYREXIA (low grade fever) had resolved.            Patient had Reflux disease. Patient's all previous shots were from Moderna and she never had any problems in the past.
No additional adverse effect reported; Incorrect product storage; This spontaneous report was received from an office manager referring to a female patient of unknown age. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 28-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number T013541, expiration date 17-OCT-2021 (dose and route of administration were not provided) for prophylaxis. No adverse events were reported.         The vaccine underwent a temperature excursion beteween -14 degrees Celsius (°C) and -10°C with an average of -13.6°C for 1 hour. There were no previous temeprature excursions. The call was due to digital data logger.  On 06-AUG-2021 a telephone call was received from the reported who stated that all the information concerning the case was given, thus no further information was available.
Patient called on 4/19 and stated that when she received the first dose on 3/23 she got a rash on the arm that was painful to the touch and itching.  Said it occurred several days later.  Sounds indicative of covid arm
Rash on (R) shoulder, large wheal at site of injection, began day of vaccination, BENADRYL prn for itch.
This spontaneous report was received from a health professional refers to an unspecified adult patient of unknown age. On 25-FEB-2016 the patient was vaccinated with a dose of expired RECOMBIVAX HB (lot # J008505; expiry: 07-FEB-2016) (dosing regimen unspecified). No adverse effects reported. No further information was provided. Additional information has been requested.
Patient had swelling of left arm index finger.  It was difficult for the patient to move the finger.  The following day it did resolve.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 23-FEB-2018, the patient was vaccinated with an improperly stored dose of VARIVAX with lot # N012131, expiration date on 17-APR-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of -14°C to -10°C (-13.5C) degrees Celsius for 17 minutes, and temperature excursion of -9°C to 8°C (2.5C) degrees Celsius for 96 minutes. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effects were reported. The outcome was reported as Supported.
Pt developed swollen lymph node on left side of neck on 1/3. She went to Urgent Care, and lab work is pending. Covid test was negative.
tiredness; itchiness all over his body; generalized rash; high fever (103.0); injection site redness and soreness; injection site redness; injection site soreness; Initial information received on 29-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/ non-health care professional via Medical Information (MI) (Reference number- 00835189).  This case is linked to case 2021SA365482(CLUSTER).  This case involves a 3-year-old male patient who experienced tiredness (fatigue), itchiness all over his body (pruritus), generalized rash (rash), a high fever (103.0) (pyrexia) and injection site redness and soreness (vaccination site inflammation) after receiving vaccine IPV (VERO) [IPOL].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 19-Aug-2010, the patient received a dose of suspect IPV (VERO) (lot D0674-1 and expiry date: not reported) (Suspension for injection) via unknown route in unknown administration site for prophylactic vaccination.  On 19-Aug-2010, the patient developed a non-serious tiredness, itchiness all over his body (pruritus) (fatigue), generalized rash (rash), high fever (103.0f) (pyrexia), injection site redness and soreness (vaccination site inflammation), injection site redness (vaccination site erythema) and injection site soreness (vaccination site pain) same day following the administration of IPV (VERO).  Relevant laboratory test results included: Pyrexia - On 19-Aug-2010: 103 [103]  It was not reported if the patient received a corrective treatment for the events.  On an unknown date, the patient recovered from the all events.
Slowness - not grabbing objects anymore, not pushing up on arms (posture), no attempts to crawl, poor coordination as well as eye contact. No more cooing - less crying - seems to have more problems with alertness. Encephalopathy - possible brachial neuritis except for crying she was reaching milestones until then. Flapping arms now and lethargic behavior (up to present) 3/9/06 Received medical records from PCP which revealed patient experienced PDD; allergy s/s of cough, congestion & runny nose; constipation; lethargy; & esotropia/ss. 4/10/06 Received medical records from hospital.  No new terms/ss
This spontaneous case, initially received on 19-Oct-2018, reported by other non-healthcare professional (consumer), concerns a 31-year-old, adult female patient. The patient's current conditions included pollen allergy. The patient did not have an egg allergy. The patient's concomitant medication included over-the-counter (OTC) ALLEGRA for allergy. On 04-Oct-2018, the patient was administered AFLURIA QUADRIVALENT [dose: 0.5 ml, route of administration, anatomical location, batch number, expiry date: not reported]. On the same day, in the evening, 8-10 hours after vaccination, the patient experienced lightheadedness, dizziness, nausea, extremity and facial numbness. The patient also experienced clonic-like and dystonic type movements of arms and legs, which resulted an inability to move any extremity. Eventually, the emergency medical services (EMS) was called and the patient was taken to a local hospital for evaluation. At the hospital, the patient was treated with BENADRYL which did not relieve but relaxed her and ATIVAN resolved the contractures. On 05-Oct-2018 (past midnight), the patient was discharged from the hospital. On an unspecified date in Oct-2018, 48 hours after onset of the events, the patient had recovered from the events dizziness, nausea, numbness, clonic and dystonic movements and movement disorder. On an unknown date, the patient developed muscle soreness and weakness. On an unspecified date, after returning home from the hospital, the patient contacted her primary care physician (PCP) as well as pharmacy where she was vaccinated. Patient was instructed never to receive flu vaccine again. At the time of this report, the patient had not recovered from the events muscle soreness and weakness. The reporter assessed this case as serious (hospitalization) and considered the causality of the events as related to the suspect vaccine.
7 days following injection (1/16/21), developed new onset tenderness, very mild red/ring-like rash around injection site, and mild inflammation of axillary lymph node (could feel the enlargement pretty easily in arm pit). Progressed over a period of 24 hours. Resolved ~48 hours later completely (1/19/21),
Immediatley after the vaccine, patient complained her arm was tingly and itchy. This continued despite the cold compresses and warm compresses we alternated with. By the evening her arm was slightly swollen, red, and blotchy looking. The next morning she didnt say much about it and went to school didnt complain about it at all other than it being uncomfortable. Appearance wise it seemed alot more irritated so we continued with comfort of warm and cool compresses because her doctor said this could happen and was normal I even used calmine lotion which I use often when she plays outside and brushes up on poison ivy. The following day she complained it felt worse, she showed me her arm and it indeed looked worse. It was swollen to almost the size of a baseball, bright bright red and painful yet extremely itchy. There were raised bumps surrounding it and she even had a linear rash across her belly and what looked like hives. I called the pediatrician on call number and the nurse told me this was all very normal and not considered a allergic reaction. I administered her Benadryl and the hive type rash was gone however the bumbs around thw injection and the awful swelling was still present. She clearly had a allergic reaction, if your child was allergic to peanuts would you keep giving them to them because her doctor claimed it was the only real source of protein or would you find otherways to get the protein she needed?
I had my annual gynecology appointment on March 6, 2023, they noticed that my blood pressure was elevated. They took it again when the appointment was ending, my blood pressure was still elevated. I was advised to see my primary care physician to get checked. The next day my PCP, had me come in to check my blood pressure and again it was elevated. I am now taking Amlodipine/Besylate to help keep my blood pressure regulated. I have a follow up visit on March 30, 2023, to see if this medication is keeping my blood pressure steady.
Patient said 4 hours after the vaccine was given she had pain in her arm- pain to the touch, but she took over the counter pain med and applied Aspercream and it helped with the pain - then the next day she had pain also and again applied the topical cream and it seemed to help.  She also had noticed some swelling in the legs from her knees to her ankles.
Tingling arms and legs, weakness diagnosed by neurologist with Guillain Barre syndrome.
Pt vaccinated with Pneumovax 23 developed pain, swelling & erythema at injection site; chills & fever. No further details wee provided.
pt recv vax; fever 105; convuls, turned red, unable to sleep; PC to er; was told nl rxn; apap given; recovered