chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5ml syringes that had been provided by health authority were used to draw up diluent for mixing the 5-11 year old Pfizer COVID-19 vaccine vial on 12/16/21.  Diluent drawn up and injected into the vaccine vial was 1.6ml rather than 1.3ml.  Diluent was measured on the 5ml syringes incorrectly:  Counting each mark as 0.1 rather than 0.2ml.  This resulted in the vial being mixed with 0.3ml extra diluent.  Vial had a bonus dose (so 11 doses total).  Patient was given a vaccine dose at 90% of the correct concentration.  Error has been reported to Pfizer.  Families are currently being contacted by letter and by phone to be alerted of the error and offered a re-dose if they would like this.  No adverse effects to patients have been reported.
Pt received a FLUAD shot instead of a FLUARIX shot...no known adverse outcomes.
10min p/vax pt exp chest tightness & SOB;wheezing occurred;p/albuterol nebulizer tx w/o improvement;to ER w/inc wheezing & SOB;given epi, DPH, Tagamet & micronephrine nebulizer tx w/slow improvement;3.5x4cm reddened area @ inj site;
PATIENT EXPERIENCED CRAMPING AND PAIN IN LEFT ARM BELOW THE INJECTION SITE PARTICULARLY IN THE PALM.   PAIN WAS DESCRIBED AS SIMILAR TO BUMPING 'FUNNY BONE' AND PERSISTED FOR AT LEAST 15 MINUTES WHILE THE PATIENT REMAILED AT THE PHARMACY IN CASE OF ALLERGIC REACTION.  I ASKED THAT THE PATIENT CONTACT ME IF THE PROBLEM PERSISTED OR ANY OTHER PROBLEMS CAME UP.  AFTER 7 HOURS I HAVE NOT HEARD FROM THE PATIENT AS PRESUME THERE WERE NO OTHER PROBLEMS
Rt leg became warm, erythematous, indurated; @ 530 noted child looked ill; temp 103, irritable, limp, vomiting high pitched cry, taken to ER; OK x/local tenderness; given APAP;
Site: Swelling at Injection Site-Medium, Systemic: Fever-Medium, Systemic: Lymph Node Swelling-Severe, Systemic: Tinnitus-Medium
The evening of the day the child received the vaccines, they started running a fever. The next day the child complained of their head and neck hurting. After two days of fever and complaints of a stiff neck and sore head, the child was taken to the local ER. Many tests were done and it was discovered that there was something in the neck. The child was transported to a hospital where they were admitted for 5 days. The diagnosis was a retropharyngeal abscess. The child received IV antibiotics and had interventional radiology done to drain the abscess. The child had no previous illness before receiving the vaccine. The child was also diagnosed with the RHino virus and Strep throat at the ER.
Nausea, chills, light sensitivity,  migraine, pain radiating through left arm ( couldn't move arm after several hours), loss of appetite,  emotional mood swings, twitching in left hand and eyes, lethargic,
large local rxn 9>10x10cm) w/in12hr;irritability, nausea & restless sleep x 24hr;pruritic rash on legs & back x 24-72hr;
6SEP97 pain, swelling & heat surrounding inj site;bright red & hot to touch about the size of tennis ball;7SEP97 taken to ER & treated w/ATB & antihistamine;8SEP97 redness fading but swelling & warmth persists;no systemic sx;
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gended.In July 2014, the patient was vaccinated with a first dose of GARDASIL. Then in September 2014, the patient received a second dose of GARDASIL (routes, doses, lot # and exp date were not provided). On 27-JUL-2015, (reported as "today"), the patient was supposed to receive the third dose of the vaccine but they received GARDASIL 9 as the third dose (interchange of vaccine products). No adverse effects reported. Additional information has been requested.
Dizziness; Bad cramps like menstrual cramps; Back ache/ back pain; Felt flu-like; Super sweaty; Acid reflux; Feeling fuzzy headed; Big and warm knot at the injection site; Excess sleeping; Congestion; Swollen nose; Big and warm knot at the injection site; Chills at night; Joint pain/ pain in knees; Fever; Pain at the injection site; Exhausted; Headache; Deviation from dosing schedule (more then 35 days between 1st and 2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DYSMENORRHOEA (Bad cramps like menstrual cramps), BACK PAIN (Back ache/ back pain), INFLUENZA LIKE ILLNESS (Felt flu-like) and HYPERHIDROSIS (Super sweaty) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Aug-2021, the patient experienced DIZZINESS (Dizziness), DYSMENORRHOEA (Bad cramps like menstrual cramps), BACK PAIN (Back ache/ back pain), INFLUENZA LIKE ILLNESS (Felt flu-like), HYPERHIDROSIS (Super sweaty), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), FEELING ABNORMAL (Feeling fuzzy headed), VACCINATION SITE MASS (Big and warm knot at the injection site), HYPERSOMNIA (Excess sleeping), NASAL CONGESTION (Congestion), NASAL OEDEMA (Swollen nose), VACCINATION SITE WARMTH (Big and warm knot at the injection site), CHILLS (Chills at night), ARTHRALGIA (Joint pain/ pain in knees), PYREXIA (Fever), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Exhausted), HEADACHE (Headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Deviation from dosing schedule (more then 35 days between 1st and 2nd dose)). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of extra strength. On 05-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Deviation from dosing schedule (more then 35 days between 1st and 2nd dose)) had resolved. At the time of the report, DIZZINESS (Dizziness), DYSMENORRHOEA (Bad cramps like menstrual cramps), BACK PAIN (Back ache/ back pain), INFLUENZA LIKE ILLNESS (Felt flu-like), HYPERHIDROSIS (Super sweaty), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), FEELING ABNORMAL (Feeling fuzzy headed), VACCINATION SITE MASS (Big and warm knot at the injection site), HYPERSOMNIA (Excess sleeping), NASAL CONGESTION (Congestion), NASAL OEDEMA (Swollen nose), VACCINATION SITE WARMTH (Big and warm knot at the injection site), CHILLS (Chills at night), ARTHRALGIA (Joint pain/ pain in knees), PYREXIA (Fever), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Exhausted) and HEADACHE (Headache) outcome was unknown.            No concomitant medication listed.   This case was linked to MOD-2021-254078 (Patient Link).
BODY ACHES; CHILLS; VERY SLIGHT FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced body aches, chills, and very slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and very slight fever. This report was non-serious. This case, from the same reporter is linked to 20210950993.
swelling of the neck and jaw bone; oversleeping; redness left arm; swelling left arm; hot to touch left arm; swelling of the neck and jaw bone; fever 103; pain at injection site left arm; headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling of the neck and jaw bone), HYPERSOMNIA (oversleeping), ERYTHEMA (redness left arm), PERIPHERAL SWELLING (swelling left arm) and FEELING HOT (hot to touch left arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (Cancer surgery of the ear cartilage) in January 2021.    On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced SWELLING (swelling of the neck and jaw bone), HYPERSOMNIA (oversleeping), ERYTHEMA (redness left arm), PERIPHERAL SWELLING (swelling left arm), FEELING HOT (hot to touch left arm), SWELLING FACE (swelling of the neck and jaw bone), PYREXIA (fever 103), VACCINATION SITE PAIN (pain at injection site left arm), HEADACHE (headache) and MYALGIA (body ache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of UNK dosage form. On 03-Apr-2021, HYPERSOMNIA (oversleeping) and HEADACHE (headache) had resolved. On 04-Apr-2021, PYREXIA (fever 103) had resolved. At the time of the report, SWELLING (swelling of the neck and jaw bone), ERYTHEMA (redness left arm), PERIPHERAL SWELLING (swelling left arm), FEELING HOT (hot to touch left arm), SWELLING FACE (swelling of the neck and jaw bone), VACCINATION SITE PAIN (pain at injection site left arm) and MYALGIA (body ache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EP7533), at the age of 48, via an unspecified route of administration, on Apr 12, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. On Apr 13, 2021, patient experienced fever, swelling of lips, tingling sensation of tongue, stiff muscles, painful joints, severe headache and excessive urination. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of fever, swelling of lips, tingling sensation of tongue, stiff muscles, painful joints, severe headache and excessive urination: recovering (at the time of this report). No follow-up attempts needed. No further information expected.
Maybe Important:  I had COVID-19 Oct 2020 for 4 weeks, bad case, still have deep breathing issues, shortness of breath and get tired much quicker than I used to (I'm an avid Tennis player, several times a week). Shot Info:  from 3/5 10am to 3/6, no issues, I didn't even feel the shot, no soreness or other symptoms.  woke up at 2am (first noticed):  Very sore arm, Sore from head to toes, headache, sever chills/shaking, very tired, severe shortness of breath, joints (knees, hips, wrist) constant (not overly severe) pain. Severe symptoms lasted for 24 hours before starting to taper off, felt pretty good by Sunday 3/7 12pm/Noon. My chills were so bad, just getting up to go to the restroom 15 ft away, didn't know if I could make it back to the bed. Headaches was the last thing to go.
This spontaneous retrospective pregnancy report was received from a female patient, who was medical assistant, reporting on 17-year-old herself. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in 2008, the patient was vaccinated with 3 doses of GARDASIL injection (dose, route of administration, lot # and expiry date were not reported) for prophylaxis (reported as "adolescent vaccine"). On an unknown date in 2010, (reported as "at age 17"), the patient delivered a baby (details unknown). Follow-up information has been received from a registered nurse in physician's office on 02-APR-2018. The registered nurse wanted to know where this report came from because it was totally wrong. It was reported that, the patient had not been seen in this office since 2009 and the office had no information on any vaccinations or pregnancies the patient in this report had received. This is one of two reports concerning the same patient. Sender's Comments: US-009507513-1803USA004631.
Case number PHHY2011US33611 is a combined initial and follow-up spontaneous report received from a health care professional (HCP) on 19 Apr 2011. This report concerns a 16-year-old boy. His medical history was not reported. He was vaccinated with MENVEO (batch number: 100003, expiry date: Aug 2011) 0.5 ml dose, intramuscularly on 18 Apr 2011 which was stored incorrectly 55F, one hour every night for one month. No adverse event was reported.
12/12/22 presents to ED for "SOB, fever, left leg pain". PMHx of "PE" "Epilepsy"
Woke up at 3am with rapid heart rate and felt as if I were going to vomit. Tried to get out of bed to get to the bathroom to vomit and lost consciousness on the way there.  Experienced fecal  incontinence while unconscious. Extreme pain at injection site and swollen/painful lynph nodes on left side (which was the side I was vaccinated on).
COUPLE OF MINUTES AFTER RECEIVING THE VACCINE PATIENT GOT UP AND WALK UP TO THE REGISTER. DURING CONVERSATION WITH PHARMACIST PATIENT REMOVED HIS MASK AND SAID SOMETHING WHICH PHARMACIST DIDN'T HEAR OR UNDERSTAND. PATIENT FAINTED AND FELL ON THE FLOOR. AFTER FEW MINUTES PATIENT WAS ABLE TO MOVE AROUND AND COMMUNICATE. PARAMEDIC WAS CALLED AND TAKEN TO THE EMERGENCY ROOM FOR FURTHUR EVALUATION. ACCORDING TO NURSE AT ER PATIENT WAS FINE AND DISCHARGED AFTER COUPLE OF HOURS OBSERVATION. TRY CONTACTING PATIENT MULTIPLE TIMES VIA PHONE AND EMAIL BUT UNABLE TO COMMUNICATE WITH PATIENT AS OF NOW.
Pfizer-BioNTech COVID-19 Vaccine EUA Date of Tuesday, Mar 16, 2021.  Intense neuropathy pain in both feet and both lower legs mainly at night.  Difficulty sleeping.  This continued each night but during day of Friday, Mar 19, 2021 the neuropathy continued and the numbness and tingling migrated up into my legs  and into my arms and hands but not as intense as in my feet and lower legs  Tingling, shakiness felt in muscles is continuous now, not just at night.  I was scheduled to have 2nd dose today but decided not to go through with getting it.  Consulted with my APRN on phone and they advised to get 2nd dose and we would follow up if needed on neuropathy.  I decided I did not want the 2nd dose.
This spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender.No medical history or concurrent conditions were reported. On an unknown date, unspecified number of patients were vaccinated with an improperly stored GARDASIL (strength, dose, frequency and route of administration not reported) lot # J015378, expiry date 09-APR-2016 and lot # K007828, expiry date 02-MAR-2017. No concomitant therapies were reported. No adverse effects were reported. This is one of three reports from the same source.  Additional information has been requested.
2/19/21  6:30 pm start feeling fatigue. Right arm carpel tunnel started twitching randomly and frequently. This continued all evening and all the next day.  2/20/21  Woke with fatigue, upper arm pain round injection site, muscle pain randomly over body, joint pain in previous arthritic sites. Continued all day randomly. General feeling of tiredness or unwell. Evening the pain worsed, muscles contracting around spine creating spinal pains and severe headaches.  2/21/21  Woke feeling tired but better.  2/22/21  In the evening started feeling pain in spine and muscles in middle to upper back and cervical region. Lymph nodes under jaws and side of neck are painful and inflamed.  2/23/21  woke up feeling better.
Three weeks after second dose developed difficulty breathing as entering sleep causing insomnia and anxiety and panic attacks - ruled everything else out and was diagnosed as anxiety. Never had a history of anxiety prior to this.
COVID-19 symptoms started on December 21 with sinus congestion, coughing, 1 day of weakness, scratchy throat, and headache. I tested positive for COVID-19 on December 22. This is still ongoing.
Onset next day, c/o diarrhea, bad headache, malaise, & vomiting. Symptoms lasted 8 hours.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of GARDASIL 9 (lot # L027282 with expiration date 21-SEP-2017 and lot # reported as J006850 with expiration date 31-MAR-2016; dose and route of administration were not reported). No adverse effects were reported. It was also provided that during the previous call on 23-OCT-2015 (no adverse event were reported at that time), the medical assistant reported a vaccine temperature excursion and inquired about the stability of MMR II (Oka-Merck) PROQUAD, (Oka-Merck) VARIVAX and ZOSTAVAX, but none of these vaccines had been administered to the patients. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine was given to patient. Patient was moved to observation area and sat down. After approx. 5 min the patient was feeling light headed. Propped up her feet to rest and gave her water. Patient passed out and was unresponsive though she still had a pulse and was breathing. EMS was called. Before EMS arrived patient was alert and responsive again. Once EMS arrived pt BP 107/90. Pt was not taken to ER, she recovered and left on her own.
13MAY97 pt reported rxn to vax; 6MAY97 pt devel t101 & took APAP for temp;pt had inc temp x 5 days;pt c/o feeling fatigued 9MAY-10MAY; pt devel a fine red raised rash on chest, back & stomach by 11MAY was gone;saw MD dx rxn to vax;
Today we had a flu vaccine that seemed to have a broken spot under the end piece where you have the screw hub meet the smooth syringe. When the nurse went to inject a spray came out sideways across the room. We are confident this was not the needle but rather something in the syringe. We have looked at the rest of the box with no indication of issue- so possibly it was when the nurse pushed down to twist the needle on it cause a slight crack?
2 days after the vaccine was administered, patient reports she had a noticeable in pain in her joints, particular her knes and her lower back.  She also reports getting a headache.  Now, 11 days post vaccination she reports that she has the headache "off and on".  Instead of getting better, the joint pain has gotten gradually worse each day is now making it difficult for her to walk.
Beginning on Wednesday 9/7/2022 at 7:00 PM slight body aches. By Thursday morning 9/8/2022 at 7:00 AM severe headache and body aches. Symptoms appear to be better in the morning and worsen as day goes on. By nighttime, headache is so severe that I am woozy, dizzy and mildly delirious. Confusion and giddiness. Pain in cranium when turning head. Symptoms begin improving on Sunday 9/11/2022. Severity reduced to mild. Tiredness and slight headache. Pain when applying pressure to eyeballs. Monday 9/12/2022 symptoms virtuall gone.
Information has been received from a licensed practical nurse concerning a 14 year old male patient with attention deficit disorder and no drug reactions or allergies, who on 29-JUN-2010 was vaccinated IM with a 0.5 ml first dose of GARDASIL (Lot# unknown). Concomitant therapy included CONCERTA and STRATTERA. The nurse reported that on 30-JUN-2010 the patient developed a fever of 102F. On 01-JUL-2010 the patient developed headache, dizziness and body aches. On 01-JUL-2010 the patient was seen in the office. On exam, the patient was afebrile. A complete blood count was performed and revealed low white blood cell count of 3.2. The patient was advised to take TYLENOL and increase fluid intake. The patient sought medical attention by an office visit. At the time of the report, the patient had not recovered from headache, dizziness and body aches. Follow up information received from licensed practical nurse via medical records indicated that the patient was a male student, with no illness at the time of vaccination, who on 29-JUN-2010 at 11:00 was vaccinated with a first dose of GARDASIL (Lot# 0318Z) intramuscularly in his right arm. On 29-JUN-2010 at 16:00 the patient developed fever, body ache, headache, dizziness, anorexia and slight cough. It was reported that the patient experienced a temperature of 102 (units not reported). The patient was seen at a healthcare office on 01-JUL-2010 where he reported the same symptoms with the addition of fatigue. He was treated with TYLENOL (given at 9:30). His blood pressure was 90/60; pulse 60 and Respiratory rate 16. His physical examination was within normal limits. The patient ate soup, popsicles and pudding. His appetite was reported as OK. On the same date the patient had a low white blood cell count (3.2x10E3/uL); a high serum molybdenum test (10.2 %) and a low mean platelets volume test (6.9 fL). The patient continued on treatment with ibuprofen treatment/ further recommendations given to the patient included push fluids and rest. The patient recovered on 02-JUL-2010. No further information is available.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL3247), in right arm, on 11Mar2021 as dose 2, single (Lot number: EN6203), in right arm, on 15Nov2021 as dose 3 (booster), single (Lot number: 30135BA), in right arm and on 14Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 65 years, in right arm, all intramuscular for covid-19 immunisation; glucosamine (GLUCOSAMINE), (Batch/Lot number: unknown). The patient's relevant medical history included: "Elevated cholesterol (under control)" (unspecified if ongoing); "vasomotor rhinitis" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; ALFUZOSIN; CALCIUM D [CALCIUM;COLECALCIFEROL]; COQ10 [UBIDECARENONE]; LORATADINE; CETRIZINE; FAMOTIDINE; PRESERVISION AREDS 2; CHONDROITIN; RESTASIS. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jul2022, outcome "not recovered" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) Positive, notes: COVID test type post vaccination: Nasal Swab. The action taken for glucosamine was unknown. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No other vaccine in four weeks. Cold symptoms (head, nasal and chest congestion, productive cough with excessive mucus) beginning 10Jul2022. Subsequently tested positive for COVID-19 on 12Jul2022. Ae treatment Mucinex, saline nasal spray, Ponaris nose drops. No COVID prior vaccination. Patient was tested for COVID post vaccination. No known allergies.
Muscle aches and pains, numbness at times. 6 days after flu vaccine at ped neurology. Ibuprofen or Stilazin, or Naproxen. Discharge Summary received on 1/06/2005 states headache.