chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COULDN'T GO TO THE BATHROOM FOR SEVERAL DAYS; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced couldn't go to the bathroom for several days, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and couldn't go to the bathroom for several days was not reported. This report was non-serious.
Large bruise about 1 1/4 inch in diameter at the injection site of the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 21May2021 at 17:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimotos thyroid disease. Patient previously took azithromycin (ZYTHROMAX) and nitrofurantoin (MACROBID) and experienced drug allergy. Concomitant medications included torasemide (TORSEMIDE), levothyroxine sodium 88 mg (SYNTHROID), ascorbic acid, calcium carbonate (CAL C) and vitamins nos (MULTIPLE VITAMIN); all for an unknown indication and from an unknown start date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22May2021 at 06:00, the patient experienced large bruise about 1 1/4 inch in diameter at the injection site of the vaccine. The patient did not receive any treatment for the event. The clinical outcome of the event large bruise about 1 1/4 inch in diameter at the injection site of the vaccine was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pulsatile tinnitus, ongoing. Driving me crazy at night.  Yellow Jacket sting which turned into cellulitis. Never have I ever!!
Patient received vaccine on 26 Feb. Patient noticed paresthesia in his 4th and 5th toe the day after.  Symptoms gradually got worse every day since then. He can hardly walk. He is having cramps throughout his body, especially when he turns with his upper body. This occurs anywhere from mid-section to the whole back. It is all over his chest as well. On Sunday he had a normal MRI Brain and C-spine. They thought is could be Guillain -Barre syndrome. He is weak as well. It started as a little weak in his legs, really noticed it when his hand grip was decreased. It is worse and now involves his entire body. He has no strength: lifting a book bag, using utencils, writing, fine motor tasks, walking. Everything is difficult. He wobbles when he walks. No pain. His calves constantly feel like they are in knots. He is ambulating with a cane currently. He has lost 10 pounds in 2 weeks. No diplopia. No bulbar symptoms. No bowel/ bladder incontinence. Balance is off. No tick exposures. No rashes.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: PT SHOWED A REDNESS AROUND INJECTION SITE ABOUT TENNIS BALL IN DIAMETER, SHE REPORTED AS NEVER HAVING ISSUE IN PAST, I SUGGESTED BENADRYL AND SHE WILL FOLLOW UP WITH PROVIDER ON 10/10 IF NEEDED
I experienced a rash on the right side of my back it was painful and itchy, tenderness in right arm and tiredness.
8-10-15 patient called to report severe soreness, swelling, and tender to touch since the evening of injection - has used ice and Ibuprofen all weekend (3 days).
No symptoms immediately following administration of vaccine. Rash erupted on trunk and arms approx. 48 hours following injection. Onset of moderate-severe periorbital edema 6 days after administration of vaccine.
One(1) hive on the right side of face, hair & ear itchiness, client seen & cleared by EMS
Patient was given Fluarix vaccine although she stated that she had previously had a flu vaccine for the 2021-2022 season, given more than one month prior, according to the patient's mother.
minutes after receiving the vaccine, I began feeling very light headed, my breathing became heavy,  my hands and feet began to tingle, became ice cold and and then went numb. felt like I was about to lose consciousness. I had to lay down for about 5 minutes before I started feeling any sort of normal.  Just about everyday since the Shot I have had a a high pitched ringing that comes and goes and a sever migraine that does not change if I take any medication (Advil). the only way to feel better is to sleep. yesterday was the worst yet.  when I contacted my pharmacist that administered the vaccine they informed me that they did not report my initial side effects and only after I called today were they going to report them.
The day of the vaccination blood pressure went up. Then on 01/13/2021 she developed some rash starting by earas, eyes and then all over body. Patient refers she also take Methotrexate for her medical conditions.
Mild but noticeable shortness of breath occurred within an hour or two of receiving the vaccine. Not serious enough to seek medical attention. Subsided after about 4-5 hours. Arm soreness at the site for several days.
There were no adverse events. The patient was 17 at the time of vaccination and Moderna COVID 19 is indicated for 18 and older.
COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2022 at 14:00 as dose 1, single (Lot number: EN6201), in left arm, on 31Mar2022 at 14:00 as dose 2, single (Lot number: ER8732), in right arm and on 09Nov2021 at 15:00 as dose 3 (booster), single (Lot number: EW0173), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Apr2022 at 16:00 as dose 4 (booster), single (Lot number: 049LCIA), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1; RA" (unspecified if ongoing), notes: Type 1; RA; Fibromyalgia. degenerative disc. under active thyroid; "Fibromyalgia" (unspecified if ongoing), notes: Type 1; RA; Fibromyalgia. degenerative disc. under active thyroid; "degenerative disc" (unspecified if ongoing), notes: Type 1; RA; Fibromyalgia. degenerative disc. under active thyroid; "under active thyroid" (unspecified if ongoing), notes: Type 1; RA; Fibromyalgia. degenerative disc. under active thyroid. Concomitant medication(s) included: ENBREL, start date: Mar2022, stop date: 25Nov2022; HUMALOG, start date: Jan1992; LEVOTHYROXINE, start date: Jan2011. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Apr2022 at 16:00, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was Adult (18-64 Years). Other medication in 2weeks was reported as yes. Patient received Paxlovid treatment from 01Dec2022 to 06Dec2022 for Covid-19.  Conclusion: The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6201, lot ER8732, lot EW0173 fill lot EN5333, lot EP8684, lot EP8725 and the formulated drug product lot EN5322, lot EP8571, lot EP8606. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Some soreness in the muscle for 24 hrs.  Light-headed, nausea and fainted ~18 hrs. after the vaccine.
Hives on left arm, back, right side, and leg. occurred a week after the vaccine was given. no additional treatment sought.
Tested positive for Covid 19.  Symptoms included body aches, fever, headache and congestion
Patient received an undiluted Pediatric (orange cap)  Pfizer dose. 0.2 ml's
Immediately after flu vaccination adm., rashes B/L UE were visible, skin red and warm on chest, no resp distress noted. Resp are even and labored.
I got so sick for at least a week after each; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 IMMUNIZATION, reaction(s): "I got so sick for at least a week after each". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I got so sick for at least a week after each".  Additional information: I have had 3 covid-19 vaccinations. I got so sick for at least a week after each. Must I have another shot?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300104327 Same patient, different dose, same event;US-PFIZER INC-202300219752 Same patient, different dose, same event;
2/28/06 - Unconscious episode - Dx s/p concussion. 3/30/06 - Evaluated lightheadedness. 5/24/07 - Evaluated with syncope episode. 8/22/07, 10/22/07, 2/21/08 received GARDASIL. 8/22/07 - 2/21/08 received HEP A. 7/3/08 Evaluate syncope. 9/11/08 Mom states seizure disorder - requests form.  10/06/2008 PCP records received. Pt with several year hx of intermittant dizziness, lightheadedness, headaches and tunnel vision s/p concussion. W/u have been (-) thus far except iron deficiency anemia-treated. Most recent recorded incident 5/07 with low blood sugar. Seen 7/3/08 in F/U of ER visit for syncopal episode. Pt reported feeling weak prior to incident then pt's eyes rolled back and had jerking movements. Pt remained semi-conscious.  Likely dx: Vasovagal  Syncope. Referred for Echo and EEG.  1/16/2009 MR received for DOS 6/26/2008 with DX: Syncope. Pt presented after episode of dizziness and syncope with loss of consciousness while having an abrasion from a fall cleaned.  Pt has appeared pale x several days. PE WNL exept for superficial abrasions. Assessment:  Spell, 2' to vasovagal from pain.
This spontaneous report as received from a pharmacist refers to a 64 year old male patient with no known drug allergies. On 01-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous. The pharmacist reported that the patient had an adverse event at injection site after being administered ZOSTAVAX. It was reported that the pharmacist administered ZOSTAVAX on 01-JUN-2013 to the patient and on an unspecified date in June 2013 the patient experienced redness at injection site. The redness was approximately an itch and a half in diameter around the site of injection. The patient did not seek medical attention. No treatment was given for the patient. At the time of the report, the patient was still experiencing this however it had not gotten any worse. Additional information has been requested.
Feeling of fluid in left ear; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the right arm on 10May2021 at 08:45 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received tetracycline (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received  the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 12Apr2021 at 08:45 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. On 11May2021 at 07:00,  morning after receiving the second vaccine, the patient felt fluid in left ear which had continued to persist for a second day, even though the patient tried sleeping on left ear to help it to drain. The patient did not have the feeling of fluid in his ears for as long as he could remember. Since the vaccination, the patient had not been tested for COVID-19.  No therapeutic measures were taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event felt fluid in left ear which was continued to persist for a second day was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
chronic fatigue, oral decay, depression, memory loss,un-explained rash and scars that come and go , numbness in feet and fingers, joint and muscle pain, tumor in uterus.
Focal seizure without fever one day following MMR/VARIVAX. Admitted to hospital.
Patient woke up at 3:00 AM and noticed hives on face, neck, chest and bilateral arms. She also had a big red splotchy area at injection site.
I experienced a fever of 103, aches and pains in both arms, headaches, nausea, red rash on my arm and hives on my chest area.
Arthritis pain has become worse; Injection site continues to be red; Right Arm feels very Hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Right Arm feels very Hot), ARTHRITIS (Arthritis pain has become worse) and VACCINATION SITE ERYTHEMA (Injection site continues to be red) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy, Diabetic (Patient is diabetic since 1990.) since 1990 and Arthritic pains (Arthritis pain seems to have increased since vaccine.) since 2015. Concomitant products included ATORVASTATIN for Cholesterol, METFORMIN, SITAGLIPTIN PHOSPHATE (JANUVIA), EMPAGLIFLOZIN (JARDIANCE), INSULIN DEGLUDEC (TRESIBA) and INSULIN LISPRO (HUMALOG) for Diabetes, DULOXETINE HCL and FUROSEMIDE for Heart disorder, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Right Arm feels very Hot) and VACCINATION SITE ERYTHEMA (Injection site continues to be red). On 20-Apr-2021, the patient experienced ARTHRITIS (Arthritis pain has become worse). The patient was treated with Physical therapy (Ice) for Vaccination site warmth; Physical therapy (Accupuncture) for Arthritis and Physical therapy (Ice) for Vaccination site erythema. At the time of the report, VACCINATION SITE WARMTH (Right Arm feels very Hot), ARTHRITIS (Arthritis pain has become worse) and VACCINATION SITE ERYTHEMA (Injection site continues to be red) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE WARMTH (Right Arm feels very Hot) and VACCINATION SITE ERYTHEMA (Injection site continues to be red) to be possibly related. No further causality assessment was provided for ARTHRITIS (Arthritis pain has become worse).    The red area on the Injection site is approximately 2 inch in circumference.  Patient used numerous creams/ointments/lotions and acupuncture for arthritic pain and currently patient on pain medication with increased dose for arthritic pain.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant follow up received on 09-JUL-2021. Vaccine information, patient demographics, medical history, current conditions, concomitant medications, new adverse events and AE outcome updated. Contact details updated.
exposure during pregnancy; had breast pain; painful swollen lymph node in my left armpit / breast area.; Flu like chills; fever fluctuated from 99-101.5 F; my body felt like it was hit by a truck; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the left arm on 21Mar2021 (at the age of 32-years-old) as single dose for COVID-19 immunisation. Medical history included thalassemia minor. The patient did not have any allergies to medications, food, or other products. The patient's last menstrual date was on 18Dec2020. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included pyridoxine hydrochloride; doxylamine succinate (DICLEGIS) and glucomannan (GARDEN OF LIFE PRENATAL), for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN0202), via an unspecified route of administration in the left arm on 28Feb2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was pregnant during vaccination with gestational period of 13 weeks. On 22Mar2021 at 02:30, 12 hours after the second dose she had flu like chills, her body felt like it was hit by a truck and she had a fever that fluctuated from 99-101.5 F. These symptoms lasted from 02:30 on 22Mar2021 until 10:00 on 24Mar2021, when she woke up and the fever broke. On 24Mar2021, in the morning, she had breast pain and noticed a painful swollen lymph node in her left armpit/breast area. The expected delivery date was on 24Sep2021. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events chills, general body pain, breast pain, fluctuating fever and painful lymphadenopathy. The clinical outcome of the events chills and general body pain were recovered on 24Mar2021 at 10:00 while that of breast pain, fluctuating fever, painful lymphadenopathy and maternal exposure during pregnancy, first trimester was unknown.
Got COVID after 1st dose; Never received dose 2; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in 2018).   In 2020 the patient received the 1st dose of Shingrix (intramuscular) .5 ml and did not received  2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced covid-19 and incomplete course of vaccination. On an unknown date, the outcome of the covid-19 and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     Additional Information: GSK receipt date: 08-NOV-2022 Reporters comment: The reporter was patient,she received the first dose of shingrix about 2 years ago . The patient stated that she got covid and never received dose 2 .  She also mentioned she had shingles in 2018. The reporter consent to follow-up. Additional Supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
They had sore injection site arms; Felt slightly fatigued; Arm was sore for a day; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (They had sore injection site arms), FATIGUE (Felt slightly fatigued) and PAIN IN EXTREMITY (Arm was sore for a day) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 001B21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu vaccine (Slightly fatigued) and Flu vaccine (sore injection site arms). Past adverse reactions to the above products included Fatigue with Flu vaccine; and Vaccination site pain with Flu vaccine.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form, fourth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and fifth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (They had sore injection site arms), FATIGUE (Felt slightly fatigued) and PAIN IN EXTREMITY (Arm was sore for a day). At the time of the report, VACCINATION SITE PAIN (They had sore injection site arms) and FATIGUE (Felt slightly fatigued) outcome was unknown and PAIN IN EXTREMITY (Arm was sore for a day) had resolved.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  It was reported that the patient had received 5 Moderna doses and loves Moderna'. The patient had no other side effects and reported that she doesn't feel that this was an adverse event.   Treatment medication information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-710705 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710705:Master case
swelling of the face - left side; swelling of left arm; weight gain of 6 lbs
inj site lt arm red, warm, & swollen;pt also c/o numbness @ times, & tingling in fingers;pt advised to take APAP or motrin q 4hr PRN pain, & use cold pack @ site;