chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt so sick for twelve hours after receiving second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt so sick for twelve hours after receiving second dose) in a 25-year-old male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Felt so sick for twelve hours after receiving second dose). At the time of the report, VACCINATION COMPLICATION (Felt so sick for twelve hours after receiving second dose) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.
Initial information received on 21-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four years old male patient who received a 0.25ml dose of FLUZONE QUADRIVALENT batch number: UT6262NA, expiration date: 21-Jun-2019  via intramuscular route in the left thigh on 09-Jan-2019. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included was MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) on 09-Jan-2019. It was an actual medication error due to vaccine underdose. A 4 years old male patient was administered 0.25 ml FLUZONE QUADRIVALENT. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none
Information has been received concerning a pt who on 06/09/00 was vaccinated with the first dose of varicella vaccine, first dose of MMRII. Subsequently, the pt developed a red rash. Follow up information indicated that the pt broke out in a rash around 7-10 days post vaccination. the rash persisted for around 2 weeks. The reporting physician indicated that maybe a rash secondary to vaccine itself and not an adverse reaction. Follow up information from the pt's mother that after 2 days of receiving varicella vaccine her son was experiencing very painful sores around the rectum. They began to heal and then flare up again. They have seen several doctors, but have not been able to identify the cause or remedy for the sores. They suggested that it may be some kind of allergy. Follow up information received from the pt's current treating physician indicated that the pt had received his vaccination from a different health care provider prior to her having seen him. The physician saw him for the first time on 09/06/00, and she saw him for the first time for an erosive diaper dermatitis which resolved over the next 4-6 weeks. The pt had a history of constipation and she felt that his diaper dermatitis was secondary to over flow of stool with skin irritation, because the child was not under her direct care at time of vaccination she did not feel she could report on the problems of his first reported experienced.
Itchy large rash on arm formed at injection yesterday and rash on neck today.  Rash on arm is still there today.  Hydrocortisone cream, my daily Zyrtec (taking previously already for hay fever), cold compresses?helps but doesn?t go away completely
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with the ZOSTAVAX vaccine at physician office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Patient has not received 2nd dose of the vaccine in more than 6 months from the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose of the vaccine in more than 6 months from the 1st dose) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025020A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose of the vaccine in more than 6 months from the 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose of the vaccine in more than 6 months from the 1st dose) had resolved.            No concomitant medication were reported. No treatment information was provided.   Reporter did not allow further contact
Vaccine admin 3:30PM; 6PM began with flush, itching of scalp, neck, ear, red, warm. Slept good. Sat ok. Sun 10/2404 woke up 7AM 1/4 1/2 diam round, raised reddish (4) on arm of injection site left.  Soreness at site, called Dr, stop Anti, give Zertex, by PM rash gone.
Moderna Booster (0.25ml) vaccine was drawn up after max 20 drawn doses allowed. Proper aseptic techniques were used during dose extraction and vaccine was inspected prior to administration. Patient was given correct dose (0.25ml) and was  monitored for 15 minutes after vaccination.  No adverse event occurred  after administration.
sore throat, dry cough, headache, congestion, runny nose. Patient has hx of pollen allergies. Patient took benadryl and singulair which has helped relieve symptoms. Recommended OTC cough suppressant and if  cough worsen contact primary provider.
Patient reported feeling fine the day of vaccination but when she woke up the next morning she had a headache. Around 1:00 pm when she was getting ready for work she started feeling shaky so she ate and then felt better. She went to work at 3:00. After being at work for about 45 minutes the headache and shakiness came back. She later started having pain in her lower legs and shoulders. She left work at 8:00 due to head ache and pain in legs and shoulders. She still felt shaky and had a mild headache the next day.  Her symptoms were completely resolved by 4/12/19.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        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.
Severe shaking for over 30 min.  Cold symptoms for about a week.  No fever.
anaphylaxis;   A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis". There was 1 case of anaphylaxis in the Pfizer-BioNTech trial.; Sender's Comments: Based on the limited information currently available, a case of anaphylaxis with bnt162b2 vaccine in this patient cannot be completely excluded
Initial report was received from a health care professional on 10 January 2012. A female patient (age and date of birth not reported) had received an injection of YF VAX (lot number, route and site of administration not reported) on 06 January 2011. On the same day twenty minutes after vaccination, the patient developed a metallic taste in her mouth. On 07 January 2011, she got nauseated and vomited and went to the emergency room (ER). No further information was available at the time of the report. The patient outcome was unknown. Follow-up information was received from a health care professional on 27 February 2012. The lot number for YF VAX was UH140AA. The patient received the injection subcutaneously in the left deltoid on 05 January 2012 (previously reported as 06 January 2011). The patient went to a rapid care facility and was treated with intramuscular phenergan and oral ciprofloxacin and promethazine. The patient's concomitant medications included Combi Patch 50/140. The patient's outcome was recovered. Documents held by sender: None. Follow up information received on 11 and 14 May 2012: It was reported that the events recovered within a couple of days and the date of vaccination was confirmed as 05 January 2012 and onset date was confirmed as 06 January 2012. Documents held by sender: None.
Moderna COVID-19 Vaccine EUA - Woke up at 5:30am (3/18 - the day after the vaccine) with a fever of 101.2 degrees. Subsequently took 1000 mg of tylenol, the fever increased to 103 at noon. Took tylenol again at noon, and the fever increased to 104.5 at 6:00pm. Took 600 mg of Motrin after consulting a medical professional, the fever has reduced to 102 at 8:00 pm.
Fever; Headache; Lightheaded; This is a spontaneous report from a contactable consumer. A 27-year-old female patient received bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 09:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced Fever, Headache, Lightheaded; all on 31Jan2021 at 05:00 AM. No treatment was received for the events.
Night of dose 2 at 1100pm - chills; at 2:00am - chills stopped fever 100.5 & HA started; at 7:00am increase HA, nausea; at 10:00am fever increased to 102.5 (self treated with tylenol); at 1:00pm - exhausted slept until 5:00pm; woke up body rash (looked like a sunburn); slept from 7:00pm until 3:00am (24 Feb21) - woke with body covered in sweat - fever broke (98.7); at 5:00 am rash stopped getting worse, nausea gone; rash took 2 days to resolve, fatigue took 3 days to resolve, still getting HA on occasion
hrs p/vax pt exp limpness, dec lOC & ashen color; By paramedics report, thought to have elevated BP (exact value unk) & fever to 104; parents report hands, face, feet turned blue & was shaky w/resp distress; BP in ER 110/p;
Sick; Muscle and body aches; Nausea; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2023-713740 (Moderna).  A 69-year-old female patient received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Feb2021, 1 day after the suspect product(s) administration, outcome "unknown"; MYALGIA (non-serious) with onset Feb2021, 1 day after the suspect product(s) administration, outcome "unknown", described as "Muscle and body aches"; NAUSEA (non-serious) with onset Feb2021, 1 day after the suspect product(s) administration, outcome "unknown"; ILLNESS (non-serious) with onset Feb2021, 1 day after the suspect product(s) administration, outcome "unknown", described as "Sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported all vaccines made her sick, muscle and body aches, some nausea, headache the next day after the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
severe pain at injection site; hard/firm infiltrate; severe pain in her shoulder join; Inappropriate route of vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intraarticular). On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain, injection site induration, joint pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain and joint pain were recovering/resolving and the outcome of the injection site induration and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site pain, injection site induration and joint pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix intra-articularly and experienced instant severe pain in her shoulder joint and the pain was there for at least a week, then started to subside very gradually. There was a mark at the site of injection and the infiltrate was hard/firm. The HCP did not have the patient's initials, exact age, date of administration, or lot/exp as it was given at a different facility. There is a discrepancy with respect to the event sever injection site pain, in structural field it is given hopwever as per narrative description there is no mention about sever injection site pain. As per narrative description the patient experienced instant severe pain in her shoulder joint. Hence it is coded along with the sever injection site pain.
patient under eighteen years old received the first dose of Moderna COVID-19 Vaccine; A spontaneous report was received from a health care professional who was also a pharmacist concerning a 15-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) resulting in the event, COVID-19 vaccine to 15-year-old.  The patient's medical history, s provided by the reporter, included diabetes mellitus (DM). Concomitant medications reported included treatment for DM (unknown name).   On 09 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. The patient was under eighteen years old under special situation.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, COVID-19 vaccine to a 15-year-old, was considered recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
Patient was given a vaccine that was over 24 hours in room temperature. The advised temperature is no more than 12 hours in room temperature
Beginning on Aug 24th, Patient developed anxiety and OCD type behaviors. Feeling the need to use the bathroom several times before leaving the house, at stores, at school, etc with the fear of peeing his pants. A few weeks later his teachers informed me he would use the bathroom at every transition during the 2.5 hour school day. Patient developed nighttime anxiety - refusing to go to sleep, thinking he was seeing ghosts, and would wake up screaming that something was pressing on his stomach. He then became obsessed with picking at his upper lip causing bruising, swelling and bleeding. The anxiety has further developed to include fearfulness of eating because he thinks his food might kill him and asking if eating certain items will make him dead (his words exactly). He has tantrums that seem as though he mentally isn't there and then snap back to being his old self - loving and happy. We have sought the advice of his pediatrician on 9/23 - Dr. - as well as visiting an NP at the same facility on 10/11. Dr. ran blood work testing for strep infection leading to PANDAS which was negative, a Comprehensive Met Panel which was all normal and also a urinalysis which also came back with no bacteria or infection. NP is recommending psychiatric treatment. We have also tried to detox his body through an ionic foot bath on 9/24 and cilantro tincture, added Omega-3 and Apple Vinegar gummies to his everyday routine and bentonite detox drink. So far, no relief or changes have occurred as all anxieties are still present and snowballing.
Summary: Hypoxemia, loss of consciousness, altered consciousness, tachycardia. Lowest measured blood o2 was 85% after substantial improvement in symptoms. So blood o2 could have been even lower earlier in the event.  See these unedited notes from the event that I took: In hindsight: Awoke on floor. Location unknown. Ejected out of bed launching weight blanket across the room.   Dizziness and hallucinations to the point of incapacitated. Static feeling skin, face numb, could not see surroundings but saw gently moving white auras and shapes that disoriented. Symptoms worse lifting head up, altered consciousness. Loss of consciousness if symptoms progressed. Disorientation and vision returned with immobility, sense of touch returned predominately feeling tachycardia throughout body. Fingers and feet static but pulse.  Made it back to side of bed and collected phone at 11:55 recall seeing the time, but phone record shows it was actually 11:23. Vision returned but distorted, found the phone by its cold touch. Got back into bed, immobility helps. Tachycardia, no increased respiration. Symptoms returned trying to sit up. Took an ibuprofen 200 with water. 00:15 wrote the above this sweating but can make sense of surroundings.  Sensation similar to hypovolumeia. Suspect hypotension.  00:21. Feeling much better, find oximeter. Pulse 132 O2 86% 85%. Fingers warmed by heating pad. Different hands. Now Manually doing big gentle breathes periodically. Can compute mental math. Another ibu 200 with water. Can't accurately measure respiratory rate but seems normal. Sensation of pulse persists through body, ankles and ears. Sweating. Low grade headache  0027 102 bpm 92% o2. Use of albuterol hfa without symptoms of breathing problems. Balance problems when walking, surroundings shift mildly. Sense of touch works. Resolve upon laying down.  0034 97% 90 bpm oh shit moment of the severity of low o2  0035 96% 95bpm  0044 97% 97bpm  0056 97% 97 bpm. Flushing subsides. Headache still present. Very tired but way too keyed up.   0052 95% 101  0105 98% 90 no disorientation on sitting up. Feel fine apart from heart rate, a little headache, and tiredness  0119 97% 88. Brief lightheadedness standing up. Vision edge distortion. Resolved in seconds  0143 98% 88bpm. Fell asleep until 0744  0744 98 65bpm
This spontaneous report as received from registered nurse refers to a 66 year old female patient. On 08-OCT-2014 the patient was vaccinated with (Merck) PROQUAD (lot #, dose and route not reported) instead of ZOSTAVAX. Concomitant therapy was not reported. No adverse effects noted by the patient. Additional information has been requested.
No adverse symptoms reported.; 2 patients were vaccinated with improperly stored VARNAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 07-AUG-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot # S000132, expiry date 02-JAN-2021; exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature from 15 Fahrenheit degrees (F) to 46 F (from -9 degrees Celsius (C) to 8 C) for 3 hours and 52 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA004040:
Had hives on face within a day. Hives resolved with BENADRYL. Repetitive eye blinking (forceful) started within 2-3 days of vaccine. This lasted about 2 weeks then stopped.
Rash and swelling in the injection site associated with pruritus that appeared 7 days after vaccine administration