chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling really bad; pain; tested positive for Covid-19; This is a spontaneous report from a contactable consumer (patient).  A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  the first dose,via an unspecified route of administration on 28Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She started "feeling really bad, having pain, and felt like something ran over her" after the vaccine was given. She went to her MD and tested positive for Covid-19. She asks, "Can I take the second dose on 24Feb2021?'The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive. Outcome of event was unknown. Case was assessed as non-serious (Serious: No).  Information about lot/batch number has been requested.
lump under lt arm 6hr p/3rd doses in series w/accompanying soreness & aching;
15 minutes after injection: out of nowhere became extremely dizzy, nauseous,  and fainted. stayed on floor, drank water, juice, crackers, tried to get up but was too weak and almost fainted again. sweating profusely and cloudy vision so lied back down. After 1+ hour felt mostly better so left .   30 minutes into my drive home felt sudden onset of nausea, left fingers tingling & numbing with save wave of extreme dizziness. Pulled onto median and called 911. My face started stiffening into a pucker like position and my muscles all through my body stiffened, but weakened with sharp tingling. I couldn't stand so they carried me out of car and took me to Hospital.   The rooms were full so I  was in wheelchair waiting for room, shaking profusely, blue fingers, nauseous, dizzy and couldn't stand on my own. I was able to go to restroom w/assistance but My muscles were stiffened for 1 hour+ and over and i felt awful. over the course of 5 hours I gained strength back and started to feel better with just mild headache and nausea.   They did EKG, blood panel and chest xray which looked ok. Diagnoses as allergic reaction and told me to come back if more issues.   The day after shot and every day since have had a headache at base of neck and pressure in cheek/forehead + nauseau + dizziness and extreme tired. Today is 14th and no headache today.
Fainted immediately after vaccine; slow to recover. Was placed in supine position with legs elevated.  Cold compress to face and neck applied.  Became concscious after a few minutes but it took about 50 minutes until she was able to sit up without feeling lightheaded again.  C/o fatigue.  After returning to consciousness, given fluids ie, water, juice and cola.  BP initally 100/60 P 80 but this fell to 80/40 and 60 before recovery.
extreme discomfort in her chest; liver enzyme that normal is 40 and it was 110; Dose Number : 1; Date of start of drug: 16Apr2021; Dose Number : 2; Date of start of drug: 28May2021; This is a spontaneous report from a contactable consumer (patient's mother). This is the second of two reported. This report concerns events occurred after the second dose. A 16-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0180), administered in left arm, on 28May2021 at 18:00 (at the age of 16-years-old) at dose 2, single for COVID-19 immunization. The patient was not pregnant. Medical history included ichthyosis vulgaris. No COVID prior vaccination and no COVID tested post vaccination. The patient had not known allergies. Concomitant medications were not reported. No other vaccines were received in four weeks and no other medications in two weeks. The patient received the first dose of BNT162b2 (lot number: EW0164) on 16Apr2021 at 13:30, at the age of 16-years-old, administered in right arm for COVID-19 immunization and experienced extreme radiating nerve pain in her arm to her fingertips. The reporter purposely waited 6 weeks for her second vaccine because she had adverse reactions to her first. The patient suffered extreme discomfort in her chest on 01Jun2021 at 03:00 AM. She described it as something sitting on her chest not allowing air in at a level 7 w 10 being dead. She had been taken to emergency room (ER) immediately. There she received an EKG, heart and lung scan and bloodwork on 01Jun2021. All that showed up was a liver enzyme that normal was 40 and it was 110, on 01Jun2021 at 03:00 AM. No treatment was administered in response to the events. The events were reported as non-serious and they required emergency room/department or urgent care visit. The patient had recovered from the events extreme discomfort in her chest and liver enzyme that normal is 40 and it was 110 in Jun2021, the outcome of the other event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021669577 same patient/drug, different doses/events
Mild shortness of breath within 30 minutes of vaccination, alleviated by Benadryl given at the clinic.  Flu like symptoms starting that evening (unsure what time, as I was trying to sleep). Arm soreness where I received the vaccine, muscle aches that kept waking me up throughout the night, headache, fever, slight congestion, chills and sweating, nausea, dizziness when I stand up, fatigue. As of 4:00 PM on 1/29 (the day after the vaccine) I am still experiencing this list of flu-like symptoms.
Fever with chills for 2 days Weakness/malaise/muscle pain for 2 days. Hives with itching for 1 day
Big red rash beneath the injection site. Started experiencing symptoms late Monday and progressed into late Tuesday, October 1st, 2019.
I am feeling extremely dizzy, any time I move my head the room spins and my ears get hot. I feel achy all over my body and very very cold. As the day has gone on the dizziness has gotten worse. At times it feels like I?m going to faint. (I haven?t yet fainted)  I have not tried any treatment yet hoping it doesn?t last longer then today.
Pain at injection site for 3 days Low grade fever 100.4 x 24 hours Fatigue x 24 hours
1700 - chest tightness, swollen throat 1800 - BENADRYL 2 tabs PO 1930 IV established, Ranitidine 50 mg IV, SOLUMEDROL 62.5mg IV BENADRYL 25mg IV 2100 - much improved, lungs and throat clear O2Sat 95 percent RA P-101 T 98.2 R-22 BP 138/82.
May have received vaccines possibly compromised; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   On an unknown date, the patients received Bexsero and Engerix B. On an unknown date, an unknown time after receiving Bexsero and Engerix B, the patients experienced incorrect storage of drug (Verbatim: May have received vaccines possibly compromised). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-Mar-2023 A clinic manager reported that data logger for the fridge was not recording temperature from 14th December 2022 to 20th February 2023.  A total of 165 patients (including vaccines from other manufacturer) might had received vaccines that might had been compromised. The reporter stated that could be a possible adverse event but yet to determined. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patients might received Engerix-B and Bexsero vaccines after temperature excursion, which led to incorrect storage of drug.
pt recvd vax 1JUN95 & w/in 24hrs pt devel a low grade fever & chills;10 days following vax the pt devel a one centimeter diameter of redness around inj site, which felt was related to vax;devel red indurated lesion w/pruritus;
09/28/2022 my symptoms started with sore throat, fatigue, nasal drip, cough and mild fever. I went to the clinic for a test on 10/02/2022 I was positive. They prescribed me antibiotics for 10 days 2 times a day. I took TYLENOL as needed.
Pt recvd MMR vax on JUL90 & DEC91 lab eval revealed that did not have a pos titer for rubella;
Client came to vaccination site at 1715 for his 2nd Pfizer dose on 06/13/21.  After being seated with RN, he expressed concern about receiving his 2nd dose due to the reactions he experienced after receiving his 1st dose.  RN requested Lead RN speak with the client regarding his concerns.  At 1720 Lead RN spoke to client.  Client stated that 1 ½ days after getting his 1st dose, he experienced soreness & tenderness in the axillary area of the left arm.  Client stated that 3 days later his axillary area began swelling.  The swelling continued below his axillary down the left side of his abdomen and onto the left side of his back.  Client stated the pain level was a 4 on a scale of 0-10.  He also stated there was no discoloration or redness in any of the areas where he experienced swelling.  On day 10 the left side of the client?s neck began to swell.  He also started to experience discomfort at the injection site and arm fatigue.  Client stated at no time did he experience any trouble breathing, shortness of breath, or chest pain.  Client stated he has been dieting and lost 145 lbs. in the last year.  He previously had high blood pressure, but no longer does.  He also stated the only other underlying conditions he has is a thyroid problem (hypothyroidism), and he is not medication compliant.  Over the last 6 months he has only taken his levothyroxine intermittently.  In the last 2 months he has not taken any of his levothyroxine until a few days ago.  Client takes no other medication, but is allergic to penicillin-based antibiotics.  Client stated he gets dizzy, hallucinates, and swells up in various places on his body.  However, he does not experience shortness of breath or trouble breathing.  Client did not take any medication for the side effects he experienced after receiving his first Pfizer injection or seek medical treatment.  Client stated all the swelling began to subside on day 17.  Lead RN performed a medical consult with Clinical Care Coordinator who authorized moving forward with administering client a Pfizer 2nd dose in the opposite arm with a 30-minute observation.  Prior to RN administering vaccine, Lead RN educated client on normal vs adverse effects of the vaccine.  Lead RN confirmed with client that he has access to a HCP for follow-up, if needed.  Lead RN also recommended client follow-up with his HCP regarding his hyperthyroid condition.  Lead RN instructed client to seek emergency care if he experienced shortness of breath, trouble breathing, or chest pain at any time after leaving the vaccination facility.
They both had a reaction of arm pain from the first and second dose.; This is a spontaneous report from a contactable consumer (patients daughter). A 93-years-old female patient received bnt162b2 (COVID 19 vaccine, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. Reporter stated that her mother and her both received their second doses of the COVID vaccine and both had a reaction of arm pain from the first and second dose on an unspecified date. Patient received the second dose last Friday, and a couple of days later patient developed a red blotch below the injection site. The red blotch was 4-5 inches long, and 3 inches wide. It was warm to the touch. It would not go away. Patient was concerned about the blotch on her arm. It was a couple of inches below the injection site. She would just like to get over to Medical Information to ask them. She did not feel like it was a life or death situation so she would just like more information. Patient said the blotch did not hurt. The outcome of the event was unknown.  Follow-up attempts have been completed and no further information is expected.
Pt had flu like symptoms fever and pain at injection site on 10/06/2013 pt has a 2" radius redness at injection site, warm, and inflamed.
Mild chest tightness; Blood pressure 127/66; This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an intramuscular route of administration in the left arm on 19Apr2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included blood pressure medication (UNKNOWN MANUFACTURER) from unknown date for blood pressure. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in the left arm on 29Mar2021, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 the patient experienced mild chest tightness and blood pressure 127/66 (unspecified units). The patient did not receive any treatment for the event. Patient did not visit to the doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care for adverse events. On 19Apr2021, the patient underwent tests for blood pressure and the result was 127/66 (unspecified units), heart rate was 65 (unspecified units), oxygen saturation was 96%, and body temperature was 36.5C. The reporter reported that patient experienced mild chest tightness, but stated she did not take medications for blood pressure in the morning of the vaccination. At 09:53 her blood pressure was 127/66, heart rate 65; O2 saturation 96%, temperature 36.5C; she denied need for higher level of care. She reported that she will take blood pressure medication with hydration once she leaves hospital vaccine clinic. She left at 10:20 symptom free. The clinical outcome of the events chest tightness and blood pressure 127/66 was recovered on 19Apr2021.   No follow-up attempts are needed. No further information is expected.
A non-serious spontaneous report of half a dose of FLUMIST squirted in eyes and face was received from a registered nurse concerning an 11-year old female. No medical history or concomitant medications were reported for this patient. FLUMIST was administered on 14-Oct-2010. Upon follow up on 10-Nov-2010 there was no side effects, symptoms or anything to report after the FLUMIST sprayed in her eyes and face. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
had a delayed response; erythema/rectangular shape about 3.5 inches by 2 inches on the deltoid; tenseness underneath the skin; felt dense; looked like a bad rash after you take a band aid off; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION COMPLICATION (had a delayed response), ERYTHEMA (erythema/rectangular shape about 3.5 inches by 2 inches on the deltoid), TENSION (tenseness underneath the skin), FEELING ABNORMAL (felt dense) and RASH (looked like a bad rash after you take a band aid off) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (sulfonamides).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION COMPLICATION (had a delayed response), ERYTHEMA (erythema/rectangular shape about 3.5 inches by 2 inches on the deltoid), TENSION (tenseness underneath the skin), FEELING ABNORMAL (felt dense) and RASH (looked like a bad rash after you take a band aid off). At the time of the report, VACCINATION COMPLICATION (had a delayed response), ERYTHEMA (erythema/rectangular shape about 3.5 inches by 2 inches on the deltoid), TENSION (tenseness underneath the skin), FEELING ABNORMAL (felt dense) and RASH (looked like a bad rash after you take a band aid off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment medications were reported.
Member waited in the Immunization's waiting area for 30 minutes plus. The member stated he felt fine when checking out with the team, before leaving. The member came back to the clinic shortly after leaving and stated he was having a reaction. The member's face was bright red and the member stated that his lips felt tingly and numb. The provider was notified and examined the pt as well as asked about swelling in the throat. The member denied SOB and swelling in the throat. The Immunization's team was directed to give benadryl 50 mg. Benadryl was given IAW provider's order. The patient remained in the care of the Immunization's team after the medication was given. After 45 minutes of observation the patient's condition got worse. The patient complained of itchiness in arms and the patient had notable hives and redness on the arms, back, and chest. The patient denied SOB and swelling in the throat. The medical provider was consulted again and ordered epi be given to the patient since did not improve and got worse. Epi was given and the patient was transferred to the local ER, in case his symptoms continue to progress and not improve.
Vaccine leaked out while being administered; A spontaneous report was received from a 60-year-old, female nurse, who was also the patient, who received Moderna's COVID-19 vaccine and experienced vaccine leaked out while being administered.   The patient's medical history was not provided. Concomitant product use was not reported.  On 30 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the vaccine leaked out while being administered. There was a puddle on the floor about the size of a quarter. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was unknown.   The event, vaccine leaked out while being administered, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 (Lot number: 025J20-2A).  There were no reported adverse events associated with this case.
About 2 months after the second dose of the Pfizer COVID-19 vaccine series, the patient developed fevers and headache around late June 2021. The fevers and headache have remained persistent. One week after the fevers, he developed bilateral lower extremity weakness and decreased sensation around July 14, 2021. Due to sudden acute weakness, he was admitted to the Hospital for evaluation on July 14th, 2021. The weakness was ascending and also began to include his bilateral arms.
While working at my desk @ 10:00 April 1st,  felt a severe jaw pain, radiated around to back of neck, down back, around to chest. Became very SOB.  Called 911.  Ambulance took me to hospital ER then ICU.  Developed exquisite headache.  Given pain meds and slept. Dr saw me the next morning.  I had not had a heart attack. They had no DX.  I think I had a 23 day delayed reaction to shot #2.
migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ZOLMITRIPTAN for Migraine.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 24-Feb-2021, the patient experienced MIGRAINE (migraine). On 28-Feb-2021, MIGRAINE (migraine) had resolved.
Approximately 15 hours after vaccine I was running a fever and severe backache. Unable to sleep , went to kitchen for a Tylenol.  I fainted and fell back onto tile floor.
C/O of difficulty to swallow saliva and throat dryness after covid -9 vaccine. Vitals taken: B/P 140/80, P79, R18, Ox 98% RA Doctor checked pt's mouth, no swelling. 10 minutes after pt states "I can fee my tongue now, feel better." Pt was observe for 30 more minutes.  Pt was rechecked and vitals taken: B/P 138/85, P77. Pt discharged home in stable condition.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: When patient was given vaccine she appeared calm, She told me she did not like needles. Said she had Tetnus vaccine in recent past and was more anxious about that than she needed to be. Said she had scheduled thios vaccine 1 hour prior and wanted to get it over with.  She moved outside vaccine area to seat. Approx. 2 min later,she approached drop off counter,asking for water and said felt faint. She fell and her face hit base of a plastic floor stand. Mouth bleeding,
fatigue ("felt like I'd been hit with a Mack truck"); chills; minor fever; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sales representative. A 33-year-old female patient received BNT162B2 (COMIRNATY; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. About 8-12 hours after the second dose of vaccination, the patient experienced fatigue ("felt like i'd been hit with a mack truck"), chills and minor fever on an unspecified date. It was reported that the event took place after the use of product. The outcome of the events was unknown at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The afternoon after receiving the shot he noticed numbness and tingling is the ring and pinky fingers of the arm he received the injection in. The affected fingers have continued to be numb. He has noticed diminished grip strength. He called the doctor after he noticed the symptoms. They told him that it should get better after a few days. It still was not feeling better the Monday after feeling receiving the vaccine, at which time I talked to him. I advised him to see his doctor to be further examined and have not since heard from him.
Information has been received from a physician concerning a 12 year old female who on an unspecified date was vaccinated with a second dose of VARIVAX (Oka/Merck) (route and administration site not reported). Subsequently, 10 days after the vaccination, the patient developed a mild case of chickenpox on her trunk. The patient was treated with loratadine. The patient was recovering from the chickenpox. The patient sought medical attention via a phone call. Additional information has been requested.
NOT BREATHING, WENT LIMP, EYES ROLLED BACK, DIDN'T RESPOND.  AFTER 35-40 SECONDS PATIENT STARTED BREATHING AND CRYING.
23 days after vaccination pt. developed 5 red patches on chest and back.  Maximum size 3 cm.  MD noted central flat erythemtous area surrounded by red papules, no vesicles or discharge.  Moderately pruritic. Also 3 white, painful 3-5mm white plaques on mucosa of cheeks and lips.  Vaccination site was still scabbed at this time.  No fever or systemic symptoms.  Lesions resolved without treatment within 3 weeks.
5 days after vaccine administered I had severe chest pains that persisted for 1 week along with severe eye pressure and pain, and severely headaches.  I also acquired a hematoma and severe bruising at injection site.