chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient came in for a typhoid fever vaccine but was given yf-vax intramuscularly instead of subcutaneously with no reported adverse event; patient came in for a typhoid fever vaccine but was given yf-vax intramuscularly instead of subcutaneously with no reported adverse event; Initial information received on 20-Oct-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case is linked to cases 2023SA326768(CLUSTER) and 2023SA326767(CLUSTER).  This case involves a 9 years old male patient who  came in for a typhoid fever vaccine but was given yellow fever vaccine - [YF-VAX] intramuscularly instead of subcutaneously with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Oct-2023, the  patient came in for a typhoid fever vaccine but received 0.5 ml (dose 1) of suspect yellow fever vaccine, Solution for injection, (lot UJ819AA; Expiration Date : 18-APR-2024: strength not reported) via intramuscular route in the arm nos (unknown if left or right) instead of subcutaneously with no reported adverse event (incorrect route of product administration) (wrong product administered) (latency on same day).  Action taken: not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
I had severe diarrhea , burning in the stomach. They out me on Omeprazole . everything I ate went right through me.
Redness around injection site, swelling, pain. 24 hours later swelling increased to include entire upper half of her leg. Large red spot taking up the entire front part of the thigh.  Spot is hot to the touch and hard. Child complains of pain.
1.  A red raised and slightly sore circle appeared on the 3rd day.  This was much less sore than the similar response after the 1st dose. 2.  Fatigue lasting approximately one week. 3.  Significant daily  hair loss seemed to occur after the first dose and is happening again, starting about 10 days after each jab.
In the first several days following the vaccine I had "normal" reactions such as redness and aching.  This improved gradually and seemed resolved by the following Saturday, 1 week later.  However, the second Sunday after the vaccine (8 days later on 1/24) I had a very large, red, itchy, area on my arm in that location with small red rash bumps.  Over the next 24 hours it got extremely swollen and inflamed and the skin temperature was 101.8 degrees on the surface.  It developed a painful "lump" under the skin and the area was hard.  The redness increased in diameter and I went to Urgent Care where they wondered if it was cellulitis and put me on an antibiotic.  However, by Wednesday 1/27 it was still red and swollen and I followed up with my General Practitioners office.  They explained that they have seen several of these cases and added a steroid to go with the antibiotic.  The redness is mostly resolved, but settling some near my elbow and still quite itchy.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient developed a fever after receiving PNEUMOVAX 23. The patient sought an unspecified type of medical attention. The outcome of the adverse event was unknown. The relatedness between the adverse event and PNEUMOVAX 23 was not provided. Additional information has been requested.
This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot#M041384, expiry date 07-JUL-2019) for prophylaxis since 15-MAR-2017. No adverse events were reported. Temperature of 47 degree Fahrenheit to 77 degree Fahrenheit and time frame was 6.5 hours. There was no previous temperature excursion. It was stated that it was because of data logger. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA001645: US-009507513-1706USA001646: US-009507513-1706USA001647: US-009507513-1706USA001643: US-009507513-1706USA001644: US-009507513-1706USA001382.
Information was received from a Registered Nurse who stated that the refrigerator temperature rose to 16C time of excursion 67 hours (wore case), affecting MMR "(not supported)". The reporter stated that vaccines had experienced a previous temperature excursion of 14C for 12 hours. Temperature ranged and time frame: 16C for 67 hours and 14C for 12 hours. This is one of several reports received from the same reporter. Additional information is not expected because the registered nurse stated she did not want to receive any further follow up letters.
I received the 1st Covid vaccine dose on March 8 . Minor tenderness and fatigue 1st 2 days. Then on March 11 and still today, March 13, I have had tingliness on my face and chin and nausea. It seems to be getting worse and not better.  I have been taking Benedryl.  Is this normal or what should I do?
immediately my tasted buds were effected and I could not taste food.  I could feel my taste buds go numb as soon as I got the injection or at least that is the best way I can describe it.  I started getting fever around 6pm and felt like I had a cold.  Runny nose and sore throat.  My fever went up to 104.8 for about 3 hours then came down to 102.5 for the remainder of the first night.   Felt better the next day on 5/11/21 but got a fever again that night.  Today I feel a little better and my taste buds seem to be coming back a little.
35 years old female called to report an adverse reaction after receiving her first P-fizer dose on 04/13/2021 @1415, patient reported that on 04/15/2021 @0800 she developed arm sore, very tired, next day, throat sore, chest pain and tightness, fever, difficulty breathing, stomach bloating painful, headache. patient denies any allergies, patient reported that she takes omeprazole for acid reflux. patient was instructed to seek medical attention due to the chest tightness and difficulty breathing. consulted with nurse
Pain, itching, feverish 3 inch X1.5" oblong dark red spot with pink fringe of another inch. Still present but smaller.
temperature excursion of unknown cause at 0.7C for 25 hours and 24 minutes /no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 8 year old female patient for whom reported temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes (Product storage error), while he received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], IPV (VERO) [IPOL] (batch number and expiry date not provided) via an unknown route at an unknown administration site for prophylactic vaccination and and INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [FLUZONE] (batch number: UJ452AB and expiry date: 30-Jun-2021]) via an intramuscular route at an unknown administration site for prophylactic vaccination on Dec-2021.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   It was a case of actual medication error due to product storage error temperature too low. [Latency: at the same time of vaccination].  Reporter reported a temperature excursion of unknown cause. PENTACEL, IPOL, FLUZONE QUADRIVALENT MDV AND PREFILLED SYRINGES, MENACTRA, ADACEL, and DAPTACEL at 0.7C for 25 hours and 24 minutes. Caller reported opened Ipol MDVs and opened Fluzone quadrivalent MDVs. See related cases. Caller reporting excursion occurring in December 2020. Caller reporting 11 doses of Fluzone quadrivalent MDVs were administered post excursion. See related cases. Caller with question on viability of administered vaccines. Additional Description of event Adverse events :MA reporting a temperature excursion of unknown cause. Caller reporting PENTACEL, IPOL, FLUZONE QUADRIVALENT MDV AND PREFILLED SYRINGES, MENACTRA, ADACEL, and DAPTACEL at 0.7C for 25 hours and 24 minutes. Caller reported opened Ipol MDVs and opened Fluzone quadrivalent MDVs. See related cases. Caller reporting excursion occurring in December 2020. Caller reporting 11 doses of Fluzone quadrivalent MDVs were administered post excursion  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
SWELLING,REDNESS AND HOT MID ARM ABOVE ELBOW,CHILLS,NAUSEA
Patient had redness and swelling at the injection site as well as serious nausea. Patient not dizzy or lightheaded, but very nauseous 2 days after injection.
This case was reported by a healthcare professional and described the occurrence of incorrect route of drug administration in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent vaccination included Salmonella typhi Vi capsular polysaccharide vaccine given on an unspecified date. There were no concurrent medications. On 2 November 2008, between 09:00 and 16:00, the subject received a dose of FLULAVAL 0.5 ml, subcutaneously, This was the incorrect route of drug administration. FLULAVAL should have been administered intramuscularly. Within 12 to 24 hours following injection of FLULAVAL, the subject experienced injection site pain, redness and swelling. At the time of reporting, the events were improved. In the reporter's opinion, the events  were probably related to treatment with FLULAVAL. The reporter stated that approximately 200 adults were vaccinated with FLULAVAL via deep subcutaneous injection during a flu clinic. Out of these 200 plus subjects, four females reported local reactions of pain, redness and swelling within 12 to 24 hours of vaccination. One of these subjects was seen by the on-site physician who diagnosed it as a secondary infection and treated it with antibiotics and TYLENOL. It was reported that the adverse events were improving, but unknown if they resolved. Linked cases include: A0759176A, A0759183A, A0759188A and A0759190A.
Patient called pharmacy in the evening of 11-15-19 and complained about her arm being numb from shoulder to forearm.  The patient stated that it started the morning of 11-15-19.  Patient was advised to see a doctor immediately.  Patient stated she was going to make an appointment with her doctor.
Information has been received from a physician concerning a 16 year old female who on 24-OCT-2008 was vaccinated with the first dose of GARDASIL.  The same day she received additional vaccines VARIVAX (Oka/Merck), (duration and dose not reported), DTAP (manufacturer unknown), MENACTRA and HEP A (manufacturer unknown).  The physician reported that the patient experienced throwing up for a week, after receiving GARDASIL and VARIVAX (Oka/Merck).  The patient outcome was not reported.  The patient sought unspecified medical attention.  Additional information has been requested.  1/22/08 MR received from PCP. WCC with multiple vax 10/24/08. TC from parent 10/29/08 with report of injection site swelling and 2 days of nausea. Not seen in the office for c/o.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 19-AUG-2015, the patient was vaccinated with an improperly stored dose of VAQTA "10pk 25U/0.5ml SD LLok wCap Ped" which had a lot number of L013324 and expiration date on 24-APR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the VAQTA vaccine had one temperature excursion of 24 hours. The lowest recorded temperature was 33 F (0.555555556 Celsius) and the highest recorded temperature was not mentioned. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Information was received from a registered nurse concerning a female patient of unknown age. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot number, dosage, and route of administration not provided). It was reported that the patient experienced an allergy to the PNEUMOVAX23 (date unknown). The outcome of the allergy was not provided. This is one of two cases from the same reporter concerning the same patient (see MARRS#1703USA007500). Additional information is not expected.; Sender's Comments: US-009507513-1703USA007500:
Patient received her first Moderna dose on 03/12/21  at 1:24pm in the Right Deltoid, Lot# 036A21A,  no reaction after 15 min. No reaction was reported 15 min. after her second dose which was in the opposite arm. See was being watched by her family members that evening, family members did not report anything at that time. Her temperature on 4/16/21 was 97.1
Patient was admitted on 7-22-2022 with covid and pneumonia.  Patient complained off general fatigue, malaise and shortness of breath.  Patient was on her way to the hospital for a monoclonal antibody infusion and passed out, which led to her evaluation in our ER, where she as then admitted for evaluation and treatment of symptoms.
PATIENT EXPERIENCED SYNCOPE UPON VACCINE ADMINISTRATION WITH PALENESS, SWEATING, DIZZINESS, AND LIGHTHEADNESS. THIS BEGAN IMMEDIATELY UPON VACCINE ADMINISTRATION. PATIENT REPORTED EARS SOUNDED PLUGED AND LEANED FORWARD WITH DIZZINESS. SYMPTOMS FULLY RESOLVED WITHIN 30 MINUTES.
Patient was given a Zostavax vaccine as opposed to a varicella vaccine.  Contacted patient's mother.  Patient is having no symptoms.
Information has been received from a LPN concerning a patient who was vaccinated on 04/06/1998. On 08/25/2000, after the patient's sister was vaccinated with varicella virus vaccine live on 07/25/2000, the patient developed a maculopapular rash that included less than 20 lesions on his arms, legs and back. Some of the lesions had reportedly crusted and scabbed over. The patient also experienced lethargy and a fever. After being seen by a physician it was felt that the patient's symptoms were not chickenpox, "but were consistent with duck itch, which is a term used to describe mite bites that children get when swimming in water inhabited by ducks. 4 additional patients had similar experiences following exposure to varicella virus vaccine live. Follow up information indicated that a specimen was sent for PCR analysis and the results were negative for varicella zoster virus. Additional information has been requested.
Client in today with soreness , itching, and swelling from upper arm  Clients states complaints started on 6/17.  Injection site noted with swelling and warm to touch.
Day 3 started with right side belly pain. Started mild, ended up being severe and was taken to urgent care and then hospital. Patient was admitted to hospital 2 times in the course of 3 weeks with a total of 16 days didn?t know patient. Nerve pain in the right side of abdomen consistent with appendicitis, however appendix was normal according to drs.  She has been in pain and on gabapentin since.
Patient presents to ER with a history of lung cancer and receiving Chemo treatment, SOB and weakness. Patient is being treated with  Dexamethasone.
Slight left arm pain in muscle near injection site.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 29-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: El3247), dose 1 via an unspecified route of administration in left arm on 26Jan2021 at 13:15 (at the age of 29-years-old) 1ST DOSE SINGLE for Covid-19 immunisation. Patient's medical and concomitant medication history were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. The patient experienced slight left arm pain in muscle near injection site on 26Jan2021 at 21:00. The adverse events did not require any treatment. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
PNEUMOVAX 23 syr. A few hours later I had pain redness hard lump and it has continued for three days but not that bad.
SSHL sudden sensorineural hearing loss in right ear. ENT prescribed 2 weeks of prednisone, followed by a mini myringotomy incision with a solution of  buffered dexamethasone. Audiograms showed severe unilateral SSHL.  Hearing never returned, no improvement. Tinnitus also present.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with GARDASIL (lot number unknown) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced a "neurological impairment". It was unspecified if the patient had sought medical attention. The outcome of neurological impairment is unknown. This is one of several reports received from the same source. Additional information has been requested.
Left ovary stabbing on/off pain. I also had some of the expected side effects (fever of 101.5, chills, sore muscles, and tiredness). Ovary pain stopped in 24 hrs after vaccine given, other symptoms stopped in 34hrs more or less. I did take Ibuprofen 400mg twice, and 200mg once, when fever was higher than 100.4.
Mixed 1.3 ml with vaccine and gave to patient instead of 1.8 ml. No adverse events at this time. Patient waited 15 minutes without sx.
little tiny bit of swelling; The initial case was missing the following minimum criteria: All other sources. Upon receipt of follow-up information on (10Feb2021), this case now contains all required information to be considered valid.   This is a follow-up spontaneous report from a Pfizer Sponsored Program COVAX US Support. A contactable 81-year-old female consumer reported for herself that she received bnt162b2 (Formulation; Solution for injection), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DSOE for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced little tiny bit of swelling on an unspecified date. she had a little tiny bit of swelling which she iced and it went away.  Therapeutic measures were taken as a result of little tiny bit of swelling. The outcome of the event was resolved.  Information about lot/batch number has been requested Follow-up attempts completed. No further information expected.
Insomnia, can  not sleep   10 to 15 hours a week , headache comes and goes with blurred vision never had a problem before the shot.
pt broke out w/urticaria on back & inc lt arm;no wheezing or SOB;redness subsiding;
Patient developed itching on back afternoon of receiving vaccine and later developed painful whelps on right side which then spread to underarm pit to right breast.  Patient also feels exhausted.
-Headaches, dizziness, yellow discharge, nausea, painful throat, pain behind my eyes, pain near my cerebral cortex and spin, knee pain, etc.  -I started to become more sensitive to irritants -cough that lasted for a good 2 months and at times would skip a day -3 months of extreme cramping for period, and abnormally heavy flow survived on iron pills and even went home early the first time. need to change pads every hour/hour and a half -My normal seasonal allergies started acting weird then I sneezed twice and both my eyes felt warm and were completely red looked like Subconjunctival hemorrhaging  (3 witness) didn't take picture because I was freaking the out on the inside and was at work. It lasted for about 40 minutes off and on after antihistamine.  -Throughout the first 3 weeks, I could feel the vaccines path from my throat to nose to behind eyes back down toward my lungs but never went that far (though had a 2 month cough).  -Find the times, dates and more information in initial health check-in by v-safe after vaccination health checker. The program will time out before I can finish typing it all. You have my permission or call me if you want a voice statement.  Don't know if there are any permanent damage yet for me I'll figure it out 4-7 years from know.
Caller did not report the patient has experienced any side effects from the administration.; the patient was accidently administered PROQUAD and VARIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 30-SEP-2021, the patient was accidently administered measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) 0.5 mL, lot # T034826, expiration date 11-APR-2022 (route of administration and anatomical location were not provided) and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 mL, lot # T032318, expiration date 22-SEP-2022 (route of administration and anatomical location were not provided) for prophylaxis (accidental overdose). The nurse did not report the patient has experienced any side effects from the administration (no adverse event).
Anaphylactic shock, unspecified, initial encounter on 2023-08-02.
Arm/shoulder pain since the injection on 9-27-17. Worse at night.
Saturday 01/23/2021 staff started having headache and chill.  Sunday, staff started sore throat.  Took Tylenol but it didn't help.  On 01/19/2021 Covid test done and the result was negative.   Scheduled 2nd vaccine on 01/28/2021.
Immunization given at 9:30 AM 07/20/2001. During day continued to run fever. Tylenol given every 4-6 hours. Took to ER at 10 PM 07/20/2001 with seizures.
A few hours after the patient received tdap and typhoid vaccine. Patient had symptoms of cough, wheezing, redness, palpitations and mild swelling around lips. Patient took BENADRYL 25 mg. and symptoms calmed. But, patient came back into the office several hours later (12:30pm) and was seen again. After an exam, the patient was given a KENALOG shot, and water to hydrate. Patient was observed in the office, after 15 minutes, patient was feeling better, after 30 minutes, even better. Patient vitals were monitored during this time and stabilized. After 1 hour, the patient was discharged with no symptoms.
I was bed ridden as a result of the following vax on Monday,  07 Dec 2020: Influenza, 6 month and older (4-valet) (single dose) .5 ml 12/7/2020 Administered Shingrix 12/7/2020 Administered Tdap