chrisvoncsefalvay/vaers-outcomes huggingface dataset:
0.9% preservative free normal saline from a bag was used to reconstitute 25 vials of Pfizer vaccine on the morning of 5/26/2021 due to a shortage of saline vials. The on-site logistics personnel consulted with the on-site State representative once the shortage was identified. The pharmacist was provided bags of normal saline. The pharmacist consulted the May 19, 2021, Pfizer COVID-19 EUA with regard to vaccine preparation which states, "ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. This diluent is not packaged with the vaccine and must be sourced separately. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent."
pt presented to clinic for visit in 8/26/2021. reports multiple symptoms developed on the day after the vaccination and have persisted since: persistent fatigue, headaches and lower back and bilateral hip pain. pt reports 6 days post vaccination she developed an erythematous, vesicular tender rash below right axilla and to right breast, which has increased in size and spread.
Systemic: Pt has rash on back and opposite arm, states resembles shingles-Mild, Additional Details: Pt has rash on back and opposite arm, states resembles shingles
sm c/o pain, swelling and redness on (L) arm and swelling (L) axillary region. Seen by Dr at the medical center
It was the patients first COVID-19 Pfizer vaccine dose and he was sitting in the waiting room after his vaccination and came to get me to tell me that he did not feel well. He was sweating and then proceeded to vomit. We had him sit in the other exam room and gave him some water. After that he started saying his arms were tingling and going numb, when that happened I discussed with him calling EMS and instructed the PCT to call EMS. When EMS came the pt said he was feeling better and signed a refusal to go with them to the ER. The pt had a friend who was in the store with him that was going to drive him home. He was able to sit for about 30  minuets when he stated that he was feeling better and was wanting to go home. PCT walked him to the car. He was instructed that if at any time he started having symptoms again that he needed to go to the ER.
Developed sudden onset rapid eye blinking within 24 hrs of flu shot. Had previous episode 8/06 (not related to flu shot @ that time). Pt. still continues to have eye-blinking 6 days later. Being followed by neurologist, bld. wk and MRI pending.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 29-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 168 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 16 hours with the lowest recorded temperature of 31 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Gradual progressive, respiratory difficulty, tingling in hand and feet and eventually gait imbalance over one week prior to admission. Diagnosis highly consistent with Guillian Barre, patient treated with IV Immune Globulin 0.4gm/kg for 5 days. Imporvement noted after first dose.
Limp following Hep A & Influenza vaccines, given 11-16-2010 & almost completely resolved by 12-6-2010. Initially, patient did not walk for 1-2 days, then walked with a limp. By 11-24, he limped when starting to walk, then walked normally, but limped when running. 12-6 - Limp seen once in 3 days. Hip, leg, exam nl.
Patient received the shot on 9/15/19 and next day she experienced, fever, swelling, redness ,and site of injection was hard, hot and and red and had it for 6 days and just about healing according to the patient. She experienced a stinging feeling upon receiving the shot.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical details: Patient received Paxlovid for COVID-19 Treatment from 06Dec2022 to 11Dec2022. COVID reoccurred within 4 days of stopping Paxlovid worse than before.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Throat tightened and was sore, sinus' clogged and draining, tight band around chest - short of breath, cough, light headed, hot and cold, body pain, nausea, vomiting and diarrhea.  Pulse was 100 for 18 hours.  I was unable to move and it was difficult to speak.  My symptoms dimished slightly at 10 p.m. and I slept 20-40 min. at a time all night long with extreme discomfort. I had friends checking on me because I didn't want to go to the hospital
swelling between his nose and eyes area; Swelling node on neck; swelling node on his neck and Lymph node under right arm; Tingling sensation; Burning sensation; Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm), SWELLING (swelling between his nose and eyes area), LYMPHADENOPATHY (Swelling node on neck), LYMPHADENOPATHY (swelling node on his neck and Lymph node under right arm) and PARAESTHESIA (Tingling sensation) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm). On 17-Feb-2021, the patient experienced SWELLING (swelling between his nose and eyes area), LYMPHADENOPATHY (Swelling node on neck), LYMPHADENOPATHY (swelling node on his neck and Lymph node under right arm), PARAESTHESIA (Tingling sensation) and BURNING SENSATION (Burning sensation). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Swelling, at a dose of 50 mg once a day. On 23-Feb-2021, PAIN IN EXTREMITY (Soreness of arm), SWELLING (swelling between his nose and eyes area), LYMPHADENOPATHY (Swelling node on neck), LYMPHADENOPATHY (swelling node on his neck and Lymph node under right arm), PARAESTHESIA (Tingling sensation) and BURNING SENSATION (Burning sensation) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
In February 2017 I started to notice that Patient would sporadically stop breathing in his sleep .  As time went on, I noticed that it was happening more frequently and lasting longer with accompanied snoring.   He was starting to gasp in his sleep after his respiration's were becoming less frequent.  I made a new patient apt with an ENT on  5/31/2017. He had a sleep study done on 6/3/2017 which showed moderate sleep apnea.  His tonsils and his adenoids were so enlarged that it was obstructing his airway when he was sleeping. I was told the only way to fix this issue was to remove them.  He had to have surgery to remove his tonsils and adenoids at 2 years old!  His tonsils  and adenoids were part of his immune system and were damaged by the vaccines he received.   Now that he no longer has this appendage in his body to fight off infection he is more susceptible to infections.  His tonsils were enlarged due to an immune response from the  toxic irritation in the tissues from the vaccine ingredients from the influenza vaccine and from the measles, mumps and rubella vaccine or the combination of the two.   In January 2017 he started to get headaches after he would run around.  He would tell me his head hurt and he would cry after exertion.  This still exists to this day. He stays well hydrated so dehydration is not a factor.   He noted global pain around his head that last for around a minute after running for over 2 minutes duration.
1/2/08 Vesicular rashes on face and chest. 1/7/08 Vesicular rashes on trunk, legs, and arms.
she felt dizzy 10 minutes post vaccine after standing up...this subsided minutes later. (note: patient used to give herself injections , so not fearful of injection) , now patient has severe muscle pain from groin, down legs and into feet with tingling, bilateral.  far more intense than she's ever experienced.  feels 'foggy', not like herself, having a harder time concentrating, and very tired all the time.
This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions/allergies were not provided. On 10-APR-2013, the patient received a first dose of GARDASIL, (route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. It was reported that the patient received a second dose of GARDASIL (route, lot number and expiration date were not provided) on 18-JUN-2013, and the third dose of GARDASIL (route, lot number and expiration date were not provided) on 31-JUL-2013. No adverse effects were reported. Additional information has been requested.
Slight swelling at injection site on day of vaccination that dissipated within 12 hours. A week later, I was awoken by extreme itching, bruise-like pain, and swelling and redness at injection site. Area was firm to the touch. Did not respond to Cortisone cream, but did respond to ice packs and Benadryl. Resolved within 24 hours.
Fatigue. Dizziness. Myalgia, headache, weakness next day of receiving MENACTRA.
Patient complained of pain radiating down her right arm, followed by numbness and tingling in the 4th and 5th digit. A couple days after, patient called and wanted us to know she was having these symptoms.  After 2 weeks patient called to report this continues, at that time she was referred to a employee health provider. Prednisone was prescribed, and EMG were ordered. At this point patient returns call wanting to see Ortho before EMG results are back. Case filed with Insurance.
Local Swelling 9cm Lengthx x 8cm Width, Redness, Slight Warmth. Child walking, talking, acting his normal self. Mother will use ice pack at home.
next day I was sick like as if I had the flu. arm was super sore, chills, fatigue, etc. then I had a redness that was like a sunburn that was swollen and raised on the bicep where I was injected. It was very hot, raised, and swollen. lasted several days. it didnt fade until yesterday (3/8) I took ibuprofen for the pain the first few days
Rash that appeared on the right arm, then moved down the patient's back, then to the right arm, and finally across the anterior chest over the course of 3 days.  Patient reports taking Benadryl for discomfort/itching, and that rash is improving.  However, patient still reports some itching on posterior right arm and lower back towards the hip.
This spontaneous report as received from a consumer refers to a 42 year old female patient. On an unknown date the patient was vaccinated with GARDASIL 9 dose 1. Other suspect therapies included GARDASIL. On 21-JUN-2016, 1 day after onset of therapy the patient experienced interchange of vaccine products. On an unknown date the patient experienced adverse event. The outcome of interchange of vaccine products and adverse event is unknown. The reporter considered interchange of vaccine products to be not related to GARDASIL 9 and GARDASIL. The reporter considered adverse event to be not related to GARDASIL and GARDASIL 9. {Additional information has been requested. Additional information is not expected.}
Was seen in the ER with chest pain, elevated pulse (130?s), and B/P 170/80. At this time 1/16/2021 I am still having intermittent chest pain
13 days difference between first and second shot; A spontaneous report was received from a consumer concerning a 68-years-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) 2nd dose 13 days after 1st dose/ inappropriate schedule of product administration.  The patient's medical history was not reported. Concomitant product use was not provided by the reporter.   On 09 Mar 2021, prior to the onset of the symptoms, the patient received their first planned doses of mRNA-1273 (Batch number: 031A21A) intramuscularly for the prophylaxis of COVID-19 infection. On 22 Mar 2021, prior to the onset of the symptoms, the patient received their second planned doses of mRNA-1273 (Batch number: 014M20A) intramuscularly for the prophylaxis of COVID-19 infection.  On 22 Mar 2021, the patient received 2nd dose of Moderna vaccination 13 days after 1st dose. Treatment information was not provided  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   The outcomes of the event received 2nd dose of Moderna vaccination 13 days after 1st dose was considered resolved on 22 Mar 2021.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: 031A21A) with no associated AEs.
Information has been received from a physician concerning a 70 year old male with hypertension and cholesterol levels raised both controlled with medication who on 06-OCT-2008 was vaccinated with influenza vaccine (manufacturer unknown) in the left arm. On 07-OCT-2008 was vaccinated with a dose of ZOSTAVAX (lot # 659408/0300X) (Oka/Merck). The vaccine was administered with a physician prescription at a local clinic. On 07-OCT-2008, the patient experienced localized reaction red, hard painful spreading down the arm to the elbow on the right chest area then breaking up into knots. The patient had a fever of 100 that lasted one day with malaise lasting one week. The patient was not in bed and did not have a headache. At the time of this report, the patient was not actually seen by a provider during the course of the reaction. The patient's wife questioned whether the vaccine was kept adequately frozen since the patient and her husband heard it had been transported from another pharmacy 40 minutes away and also there was a delay of about a half hour from the time they were told that the vaccine was being prepared till the actual receipt of the injection. The clinic clarified that the vaccine was stored transported from another pharmacist off site in a cooler with ice packs. The clinic also mention that the Company was contacted and mentioned that a lot check was done on the vaccine lot and found no problems in their data. This is one of several reports received from the same source. Additional information has been requested.
arm started to itch about midnight,   next day it was slightly pink,  arm felt warm, put neosporin on area,  stayed itching for about three days and it is still slightly pink  as of today (21/25/21) with two  spots of  darker pink at top and below pinkness and covered about a 3" area.
On 07/19/2001 the patient's step mom called to verify chicken pox outbreak. On 7/20/2001 the patient developed 39 fluid filled areas with red rings around them. The patient has a slight fever with no itching. The patient is being treated with Calamine lotion and Tylenol for the fever.
Case number PHEH2016US029299, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 60 years old female patient. Past medical history and concomitant medications were not reported. The nurse stated that first temperature excursion of FLUCELVAX Quadrivalent at 52F for 1 hour occurred on 18 Oct 2016. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml intramuscularly on 20 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34F and lasted 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2F three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error (incorrect product storage).
Pt presented at ED 01/18/2022 with right sided facial droop and right arm weakness with mild aphasia and slurred speech. Dx basla ganglia infarct and hypertensive emergency. Transfered to Hospital for admission. Pt tested + for COVID 01/19/2022. Pt had received Jannsen vaccine 04/30/2021 and Pfizer booster 12/13/2021.
ADMINSTRATION ERROR: Patient forgot she had already received the Bivalent and received a second does.  As of today 2/8/23  pt. states no symptoms or side effects at this time.
12 hours after injection - chills.  12-20 hours after infection, mild fever and body aches.  20-48 hours afterwards - 80% energy level, lethargic, minor chills
1238 staff member received vaccine, 1245: staff member reported feeling dizzy with vital signs taken: bp-155/97, P-77, O2@98%, R-16.   Reported to pharmacist who adm. vaccine, staff member was given water and told to stick around an additional 15 min for monitoring. 1257: Pharmacist rechecks staff member and notices Blotchy redness to her neck and chest,  does not report signs of itchiness but does feel warm,  window opened nearby,  cont. to monitor staff member, 1320: staff member reports she feels better. 1309:  staff member rechecked by pharmacist,
administered with an expired vaccine /receiving a dose from an expired vial; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine /receiving a dose from an expired vial) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A, 032L20A and 025L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Fluad 65+ (Dose number 1) on 20-Oct-2021. Past adverse reactions to the above products included No adverse event with Fluad 65+. Concomitant products included LOSARTAN, FLECAINIDE and RIVAROXABAN (XARELTO) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 05-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine /receiving a dose from an expired vial). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine /receiving a dose from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient's concomitant medications included Atrial Fibrillation medication  It was also stated that there were no adverse events experienced till date  Treatment information was not reported   This case was linked to MOD-2021-377205 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Significant follow-up contains dose and route of administration, anatomical site of injection for vaccine On 08-Nov-2021: Follow-up received contains Non significant information. On 08-Nov-2021: Follow up received contained: Updated Address of the reporter, Patient demographics - Race and Ethnicity, Historical vaccine information, Concomitant medication information;
RECEIVED VARICELLA VACCINE ( SECOND DOSE) LOWER PART OF LEFT UPPER ARM 1/19/09. SEEN 1/21/09 WITH 9CM BY 7 CM AREA OF ERYTHEMA AND MILD SWELLING AND MILD TENDERNESS AT SITE OF THE VARIVAX IMMUNIZTION NOT THE HEP A SITE.NO FEVER. REC RX TYLENOL AND BENADRYL RESOLUTION PENDING
I cannot move my arm past my elbow. If I do,it causes extream pain. I can't lay on it. It wakes me up at night. I tried aspercream and motrin and it didn't help. I can't do my taebo workout,fully move my arm or lift my 21month old daughter because of the pain in my sholder. If anyone touches my shoulder with anything more than a feathery touch, I yelp with pain. If it doesn't feel better soon, I will have to go to the doctors.
Patient states she took the 2nd dose on the same day as the first day of period and had slight clotting on the last day.  She then missed 2 pills in started spotting again.
I have had cheek filler in my face a couple of months ago. The areas in my cheeks were the filler was placed got swollen and hard after the Covid19 vaccine. Within 24 hours, the reaction had subsided. Altough I have no lasting effects from it, I felt I should report it.
Menstruation (7 days) -  Super heavy flow and cramps. Required diapers and changing tampons every two hours.
headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) in a 78-year-old female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication was provided. Treatment medication was not provided.
Information has been received from a physician concerning one patient who was vaccinated with PNEUMOVAX (Lot#1295X, therapy date, route, site unspecified). The patient experienced reaction that required treatment with antibiotics. The reaction was "severe enough that the patient may have needed to go the emergency room but was treated in the office instead." Subsequently, the patient recovered. This is one of several reports received from the same source. Additional information has been requested.
swollen lymph nodes (felt like a lump) in neck and rash on lower lip and chin
Cervical lymph node swelling (L) side. Hives to neck and chest. Vaccine applied to (L) upper arm.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 06-JUN-2017, the patient was vaccinated with an expired dose of GARDASIL lot # M014929 and expiration date of 27-MAY-2017, for prophylaxis (dose and route of administration were not reported). No adverse effect reported. Additional information has been requested.