chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from healthcare professional on 03 October 2013. A 68-year-old male patient, had received second dose of FLUZONE (batch number UH888AA, route not reported in the deltoid) on 10 September 2013. The patient had diabetes mellitus, closed head injury and migraine as medical history and had received Ca channel blocker, aminoglycosides and migraine agents. On 02 October 2013 the patient was feeling dizzy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome of the adverse event was not reported. Documents held by sender: none. Addendum: 14 January 2014. Upon second medical examination of case at time of internal review the following has been modified in this case. Follow-up information received on 04 November 2013 (not entered previously) was added. The patient was treated with meclizine for dizziness. "The physician assessed it as unrelated". Follow-up information received from a healthcare professional on 24 February 2014: It was reported that the patient and doctor had spoken and it was determined to be unrelated. The patient used meclizine for 3-4 doses.
Suspected vaccination failure/no effect at all; shingles/ no effect at all; Stress is a major player in shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 60-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had first breakout as a kid around 10). Previously administered products included Shingles vaccine (had old shingles vaccine on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and stress. On an unknown date, the outcome of the vaccination failure, shingles and stress were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 28-Feb-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient had new two shots of vaccine months apart and had no effect at all. The patient stated that stress was a major player in shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
PATIENT RECEIVED MORE THAN THE RECOMMENDED DOSES OF COVID-19 VACCINE. PFIZER WAS ADMINISTERED 1/15/2021, THEN THE MODERNA SERIES WAS ADMINISTERED ON 4/24/2021 AND 5/22/2021.
Blister at site of influenza injection. Presently about 1.5 cm on 9/21/10.  Also itches.  Tdap given in other arm; fine.
I received  flu shot  at work as required by my employer. The first day I have minor pain. the pain get worse over the next weeks. by about week five I was not able to move my arm. I visited urgent care they referred me to  occupational health. My pain have improved after receiving NSAID  and continue to work with physical therapy.
sore arm; Rash is itchy; Large red rash at the injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), RASH PRURITIC (Rash is itchy), VACCINATION SITE RASH (Large red rash at the injection site) and HEADACHE (headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (sore arm), RASH PRURITIC (Rash is itchy), VACCINATION SITE RASH (Large red rash at the injection site) and HEADACHE (headache). In April 2021, PAIN IN EXTREMITY (sore arm), RASH PRURITIC (Rash is itchy) and HEADACHE (headache) outcome was unknown. At the time of the report, VACCINATION SITE RASH (Large red rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information for the events was reported.
Reports arm hurt at the injection site that day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Reports arm hurt at the injection site that day) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (Reports arm hurt at the injection site that day). On 06-Mar-2021, VACCINATION SITE PAIN (Reports arm hurt at the injection site that day) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Moderna Covid booster was given 0.25 mL IM at 1350.  Symptoms started at 1355.  EE stated she started feeling a "burning sensation internally" and said there was a "lace rash on arms and middle of chest.."  EE states she started feeling "very anxious" and kept saying "something isn't right."  VS taken were 118/71 and HR 64 BPM.  Gave Benadryl 12.5 mg oral suspension and monitored EE for another thirty minutes.  EE elected to go to the ED.  Escorted to ED by RN.  VS upon leaving EHS were:  BP 137/87 and HR 73 BPM.
Hives appeared on 3/19/09 and a vesicular rash around injection site.  Treated with benadryl
Pt had either a cellulitis in the left arm or a possible allergic reaction to the pneumonia vaccine. She had a line of redness & a red welt that was 4" below injection site.
Body aches all over, stomach pain. Symptoms started in October then had stopped and started back up three days ago.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 06-JUN-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J009706, expiration date: 15-AUG-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was an any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse, and refers to a 4 year old patient of unknown gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 24-AUG-2018, the patient was vaccinated with a improperly stored PROQUAD recombinant Human Albumin (rHA) (which had a lot # of R006750 and an expiration date of 03-SEP-2018; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccines experienced the following temperature excursion on an unknown date: 11.3 F for 1 hour and 11 minutes. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA013090.
Patient came into pharmacy stating vaccine tetanus given on 11/1/2013 gave him skin reaction. Slight swelling. Patient received MMR on 10/29/2013.
Intense feelings of dizziness.; Everything around head suddenly started to spin so fast for about a minute almost, couldn't even open eyes. Even with the eyes closed head didn't want to stop from spinning; get so dizzy and start losing balance that have to hold on something otherwise would fall; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Apr2021 at 03:45 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on unknown date in 2019 (10 months prior to the vaccination). Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Mar2021 at 03:45 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 04:00, the patient experienced Intense feelings of dizziness and everything around his head suddenly started to spin so fast for about a minute almost and he couldn't even open his eyes. Even with the eyes closed his head didn't want to stop from spinning. Then after few minutes got better but he still couldn't look up or down or a turn to the right or left. Even after almost 12 hours he could not turn his head up or down or to side. He got so dizzy and started losing balance that he had to hold on something otherwise would fall and turning the head up or down was the worst case with much more dizziness and spinning of the head. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event Intense feelings of dizziness, head spinning and started losing balance that he had to hold on something otherwise would fall was resolved with sequelae on 20Apr2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient got Janssen in April (location unknown to us) and came and got Pfizer at our pharmacy 7/29/21. He told us afterwards that his doctor recommended him to get Pfizer as a booster. Called patient today and he reported no side effects and is aware this is currently not recommended. He will not received second Pfizer dose.
About 1 week after receiving 2nd dose of a moderna vaccination,  patient states she  experienced gradual onset of shortness of breath.  Patient presents to PCP at week 3 post vaccination  due to increased shortness of breath.  PCP send patient for CT of chest and discovered bilateral PEs.  Patient was sent to emergency room, was treated with anticoagulants and sent home on anticoagulant therapy of Eliquis.
Itching and redness for 4 inches around injection site starting about an hour after injection. Nausea 1 day after injection. Still have mild nausea.
I63.512 ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY 3/23/2023 CEREBRAL INFARCTION D/T UNS OCCL/STENOSIS LT MCA
Information has been received from a nurse practitioner concerning a female (age not reported) who on approximately 20-FEB-2007 (approximately 6 weeks ago) was vaccinated with the first dose of Gardasil, injection. Concomitant medication was not reported. On 20-FEB-2007 (approximately 6 weeks ago), the patient developed erythema in the arm in which she was vaccinated as well as a pruritic rash. The symptoms developed the same day she was vaccinated. The patient sought unspecified medical attention. Subsequently, the patient recovered from erythema arm and pruritic rash approximately 36 hours later. Additional information has been requested.
?Covid arm? itching, swelling, redness, warm to the touch at injection site 8-9 days after injection
Information has been received from a medical assistant concerning a 17 year old female who on 27-APR-2010 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot # 0040Z, expiration date 03-NOV-2011). On approximately 29-APR-2010, 2-3 days post vaccination the patient experienced a body rash and shortness of breath. The outcome of the events was unknown. On 06-JUL-2010 the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot # 0450Z, expiration date 03-NOV-2011). On approximately 08-JUL-2010, 2-3 days post vaccination the patient again experienced a body rash and shortness of breath. On an unspecified date, the patient took an allergy testing (the result not reported). At the time of reporting, the patient was recovering from a body rash and shortness of breath. The patient sought unspecified medical attention. Additional information has been requested.
At about 5 or 6 PM that night, pt's left arm at injection site was swollen with rash on it. Pt took 2 bufferin (325 g) and felt better. Pt had no other signs/symtoms. Had no problems sleeping. In the am, arm still swollen, tender and warm to touch. But again pt feels fine and healthy. Pt feels he does not need any further care or any treatment.
blood clots; she did get really sick / she was displaying a lot of symptoms; fever; whole body was aching; fatigue; nauseated; bruises on the legs / now she's getting more / she would say they have worsened; This is a spontaneous report received from a contactable consumer (patient's mother). A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0182), via an unspecified route of administration in arm left on 14May2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received flu shot and experienced nausea. The patient experienced blood clots on an unspecified date, bruises on the legs, she was getting more, she would say they have worsened in May2021, fever on 15May2021, whole body was aching on 15May2021, fatigue on 15May2021, nauseated on 15May2021, and she did get really sick, she was displaying a lot of symptoms on an unspecified date. Patient started having bruises on the legs and thought that it might be related to blood clots. She mentioned that she also experienced the common side effects but she was not concerned of that as people she knew also had those symptoms but was more concerned about the bruising. On patient's legs, she had a bunch of bruises. Reporter was just really nervous about her daughter's bruises. When patient was working, she was not noticing, but today patient noticed her legs and said reporter it was a lot of them. Patient did get really sick with her first shot, she had a fever, she couldn't go to work the next day. Reporter was not sure if the patient should get the second dose on 04Jun2021. Patient's whole body was aching, she was nauseated, she was displaying a lot of symptoms. Reporter checked online and they said it was a normal thing. Patient came down and showed reporter the bruises. Patient wasn't really paying attention to them. Patient had one or two bruises when she noticed and at the time of the report she was getting more. They had worsened. Patient took ibuprofen (ADVIL) for fever and she felt better. Outcome of events blood clots and she did get really sick, she was displaying a lot of symptoms was unknown, of event bruises on the legs, she was getting more, she would say they have worsened was not resolved, and of other events was resolved.
Local erythema, induration, warmth, and tenderness to L upper arm from shoulder to elbow.
Patient spiked a temp to 101-103 this morning. Progression of redness. Has tried ibuprofen, BENADRYL, BENADRYL CREAM and didn't improve the redness. Swelling continued, diagnosis of Cellulitis, RX  clindamycin 75 mg/5 mL oral solution.
Skin rash near injection site; Severe migraines; This is a spontaneous report from a contactable consumer or other non hcp. A 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0178) via an unspecified route of administration in Arm Left on 12May2021 (age at vaccination 31 years old) as single dose for covid-19 immunisation. Medical history included no from an unknown date and unknown if ongoing. The patient did not have known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks and other medications in 2 weeks prior to the COVID vaccine. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0175) via an unspecified route of administration in Arm Left on 12May2021 (age at vaccination 31 years old) as single dose for covid-19 immunisation. There were no concomitant medications. Since the vaccination, the patient had not been tested positive for COVID-19. On 14May2021 the patient experienced skin rash near injection site, severe migraines. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Red, painful & itchy bumps with white heads - on rt. side buttock (underneath) - very painful. I can't take pain meds. I hallucinate.
Client was present in the clinic for her booster dose of Pfizer (Lot # FM0698), received to her LD at 1825. At 1830, the client?s mother alerted observation staff to attend to her daughter. The client presented with diaphoresis and pallor, reported changes to her vision and hearing, and appeared to have experienced a slight decrease in her LOC; answering questions only after much prompting. She was able to transfer to a WC and laid down on the cot at 1832. Her BP at 1834 was 106/64 laying, HR was 67, SPO2 was 98% on RA. No s/s respiratory distress was noted. Shortly after lying down, the client stated that she felt ?fine, now that I?m laying down? and reported that she only remembered receiving her vaccination and none of the events that followed immediately afterward. She was carefully assessed for s/s of an allergic/anaphylactic reaction. None were noted.  VS at 1840 were: BP 108/62 laying, HR 88, SPO2 100% on RA. The client c/o feeling shaky at 1841. She reported that she had only had a pretzel and a smoothie to eat for the entire day (and the smoothie was consumed after working out), but denied any history of vasovagal reactions. Juice and water were provided and consumed. She was also given a cover to help retain body heat. Shortly after consuming the juice, she reported that she felt better. At 1847, she was laughing and telling stories to her mother, who was at bedside. At 1854, she reported that she felt ?better. 95% normal? though she added that she was still feeling a little shaky. She was alert and oriented, responding appropriately to questions. No further diaphoresis was noted and her pallor had resolved. She denied further dizziness or hearing/vision changes. She continued to show no s/s of an allergic reaction. Her BP at 1857 was 112/64 laying, HR was 90, SPO2 was 99% on RA.  At 1859, she sat at the edge of the cot without assistance, reported that she felt ?okay? and denied any increased dizziness, vision/hearing changes. Her BP sitting was 108/70, her HR was 65, and her SPO2 was 99% RA. She remained sitting without difficulty. At 1902, she stood at the edge of the cot, BP was 108/66, HR was 78, SPO2 was 99% RA. She reported that she felt ?normal, but cold? noting that the vent was blowing directly on her.  She and her mother were educated on vasovagal reactions, what s/s to watch for, and when to seek medical care. They both verbalized understanding. She was also encouraged to report this reaction to her medical professionals the next time she presents for a procedure involving needles and to be sure to have adequate PO intake beforehand. Her mother reports that she will be home with her family and they will monitor her condition throughout the evening. The client was able to stand and walk without difficulty. She and her mother settled in observation for a few more minutes and exited the facility at 1916.
PT STATED SHE WOKE UP ON 04/07/2010 AT 7 AM WITH HER ARM SWOLLEN, AND IT WAS SORE.  SHE WENT TO TALK IN CLINIC ON DAY FOUR, DUE TO PROGRESSIVE PAIN AND SWELLING IN THE LEFT ARM.  SHE STATED SHE HAD A FEVER OF 101.3 TO 101.4 PER WALK IN CLINIC NOTE, NO SWEATS OR CHILLS, NO EARACHE, NO EYE DISCHARGE, NO SORE THROAT OR SWELLING OF THE THROAT, NO COUGH OR SHORTNESS OF BREATH.  AREA MEASURED AT WALK IN CLINIC WAS 12X 5 MM OVAL ERYTHEMA, TENDERNESS AND WARMTH.
pt recv vax 19APR96 & 6DEC96 pt exp extensive chickenpox w/100 lesions on scalp, mouth & trunk;
petechial rash on left leg 1 day after 1st set of vaccines (same thing happened to right leg 3 days after recent set of vaccines-pentacle given on right)
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 18-JUN-2013, the patient was vaccinated with the first dose of RECOMBIVAX HB 2.5 mcg/0.5ml (dose, route, lot # and expiration date were not provided). On 01-FEB-2014, the patient was vaccinated with the second dose of RECOMBIVAX HB (dose, route, lot # and expiration date were not provided). The physician inquired if the patient needed to restart the series or if the patient could receive the third dose. It was unknown if the patient sought medical attention. No adverse symptoms were reported. At the time of the report, the patient's status was unknown. Additional information has been requested.
consumer reports that mom, who has devel pneumonia twice w/in last 7 months; pt w/chronic lymphocytic leukemia, vaxed 9 yrs ago;
Moderna COVID?19 Vaccine EUA Irregular menstrual bleeding.  period-like bleeding only two weeks after last menstruation.
Abnormal Hives; fluid filled bumps; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Abnormal Hives) and BLISTER (fluid filled bumps) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 URTICARIA (Abnormal Hives) and BLISTER (fluid filled bumps). At the time of the report, URTICARIA (Abnormal Hives) and BLISTER (fluid filled bumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact