chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got the shot and I got the shingles/Suspected Vaccination Failure; I got the shingles.; Pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shot and I got the shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: I got the shingles.) and pain (Verbatim: Pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by a patient via interactive digital media. The patient was told to get the shingles shot too, so he/she went and got the shingles shot.  The patient got the shingles.  The patient was an herbalist and looked in his/her books and it said chickweed and yaro made a tea out of it and then dab it on with cotton balls. It makes feel so much better and took the pain away. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
(L) arm local reaction initially itchy then painful. 10 cm erythema, induration, tenderness area VVX site.
Patient received covid vaccine in mass clinic, documentation shows they received Pfizer 12+ vaccine at age 11.  Unable to reach family to verify which vaccine they received from the documentation on the Covid vaccine card.  This could be an error of giving the wrong vaccine or an error of documentation.
We booked an appointment for her 2nd dose for 4/2/21.  That date no longer worked for her, so she booked her own appointment online for a 2nd dose for 3/29/21.  We informed her that she was early for the 2nd dose, but she wanted to proceed.  She was given the 2nd dose 3/29/2021.
Patient is 14 year old male given 0.25ml Moderna Booster vaccine in error. Patient should have received Pfizer booster; not Moderna as Moderna is not offered to adolesence under 18 years of age. Patient monitored for 30 minutes after administration. No adverse effects noted. Mother of patient informed of error. Moderna Medical Dept notified and no further action or recommendations advised from Moderna.
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in an unspecified number of patients who received BEXSERO. On an unknown date, the patients received BEXSERO. On an unknown date, less than a month after receiving BEXSERO, the patients experienced pain in arm, fever, mobility decreased and influenza-like symptoms. On an unknown date, the outcome of the pain in arm, fever, mobility decreased and influenza-like symptoms were unknown. It was unknown if the reporter considered the pain in arm, fever, mobility decreased and influenza-like symptoms to be related to BEXSERO. Additional details were provided as follows: The age of vaccination for patients was not reported. The reporter stated that, multiple patients experienced reactions after receiving the BEXSERO, which included really sore arm, not able to lift the arm for a couple of days, flu like symptoms and fever. The office had been noticing this trend with the vaccine. The office just started using the vaccine about a month ago and the vaccines were administered over the June to July time frame.
child became unresponsive, clenched teeth, unable to stand alone, vomited, eyes dilated, unable to speak, headache, called 911 was transported to the hospital emergency room
Adverse event - heart rate 198 for 60 seconds. 27 weeks pregnant with di/di twin pregnancy. Mild preeclampsia. EDD 12/3/18.
immediate loss of energy; sore arm; shaking; feeling completely depleted/feel worse; complete loss of appetite; had a low temp of 99 for a day and a half; fatigue; lost 22 lbs; This is a spontaneous report from a contactable other hcp (the patient, reported for self).  A 68-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL0142) single dose via an unspecified route of administration, administered in arm left on 05Jan2021 14:00 as for COVID-19 immunisation. Medical history included asthma, diabetes (Diabetes mellitus). Concomitant medication included metformin 500 mg, empagliflozin (JARDIANCE) 10 mg both taken for unspecified indications from unspecified dates. The patient did not have COVID prior vaccination. On 08Jan2021 14:00 three days after the event patient felt an immediate loss of energy, combined with a sore arm, shaking and feeling completely depleted. I went home and continued to feel worse, shaking, complete loss of appetite, and fatigue had a low temp of 99 for a day and a half. Continued to feel bad, staying in touch. Also lost 22 lbs. The patient did not tested COVID post vaccination. The outcome for all the events was recovered.  Follow-up attempts are completed. No further information is expected.
Redness and inflammation at right deltoid injection site of DTaP.  Called parent 06/24/2003, no answer, left message, no return call.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M204, 022A21A and A11C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third 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 SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-365207 (Patient Link).
pt recv vax;mild URI dx and low grade T;1 1/4 hr of sz assoc w/ high fever of 104.9;adm to hosp;spinal tab and blood work done; had episode of starring spells;2 wk later referred to neurologist;
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 22-NOV-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot, expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.3 and 3.0 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
"deathly ill"; fever; headache; general aches; swollen painful arm at injection site; swollen painful arm; Tingling in hands and wrist; scapular pain; inability to sleep; pain in her neck; chills; being bed-ridden; inability to eat; upset stomach; "feeling like I had the flu"; weakness; fatigue; Feeling like I have shingles; inability to move arm; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th October 2020, several hours after receiving Shingrix, the patient experienced feeling unwell, fever, headache, general body pain, injection site swelling, injection site pain, tingling, scapula pain, sleeplessness, neck pain, chills, bedridden, unable to eat, upset stomach, influenza-like symptoms, weakness, fatigue, vesicular rash and injected limb mobility decreased. On 19th October 2020, the outcome of the feeling unwell, headache, sleeplessness, bedridden, unable to eat, upset stomach and injected limb mobility decreased were recovered/resolved. On an unknown date, the outcome of the fever, injection site swelling, injection site pain, tingling, scapula pain, chills, weakness, fatigue and vesicular rash were not recovered/not resolved and the outcome of the general body pain, neck pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix. The reporter considered the fever, headache, general body pain, injection site swelling, injection site pain, tingling, scapula pain, sleeplessness, neck pain, chills, bedridden, unable to eat, upset stomach, influenza-like symptoms, weakness, fatigue, vesicular rash and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. After receiving Shingrix, within couple of hours, the patient experienced side effects.   On 17th October 2020, several hours after receiving Shingrix, the patient experienced swollen painful arm and headache. The patient had feeling deathly ill, fever, general aches, inability to move arm, tingling in hands and wrists, scapular pain, inability to sleep, pain in her neck, chills, being bed-ridden, inability to eat, upset stomach, feeling like she had the flu, weakness, fatigue and feeling like she had shingles.  No lot or expiry date was known.   The reporter did not consent to follow-up.
Dizziness, NauseaVomiting,  Tingling feeling Narrative: Patient returned after 1.5 hours. Monitored an additional 30 minutes. Tingling sensation and nausea diminished. Upon return at 1420: 130/84, HR 79 o2 98%; Recheck 1425: 118-81, HR 73 O2 97%; 1440 120/81, HR 73 O2 98%; 1455 127/85, HR 71 O2 99%. VSS stable. Per patient request, 25mg Diphenhydramine administered by staff Patient sent to ED for further observation.
Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medications was not reported. On unknown dates the patients were vaccinated with GARDASIL (lot # K011562 with expiration date of 08-APR-2017; strength, dosage, frequency and route unspecified), which were post temperature excursion. No adverse effects were noted by any patients. This is one of several reports received from the same reporter. Additional information has been requested.
Took the vaccine @6pm.  When I woke the next morning I had several pockets of swelling on my face.  By noon, I had a rash on my face, neck and upper torso.  I took allergy meds but it didn?t help much.  It took 5  days to subside.   Wasn?t sure if it was the vaccine because I expected a adverse reaction  to happen within 4hrs.   But when I took the second shot 3 wks later, it happened again and quickly; within several hours.  That?s when I realized it was most likely the vaccination.
15 DAYS AGO WE DID GAVE THIS PT THE PREVNAR 13 VAC. 15 DAYS LATER SHE CAME BACK AND SAID SINCE THEN SHE GOT PNEUMONIA, BUT WHEN I CALLED DOCTOR OFFICE REPORT. THE PERSON WORKED AT OFFICE SAID THE CHEST X-RAY WAS CLEAR.
All over and joint aches, weakness, nausea, dizzy, sweating, temperature of 101 after Tylenol, unable to eat and redness and heat in a 2 inch raised stripe around my arm. Had the shot not oral where some of these are listed. Felt like/ wanted to die took Tylenol every 3 hours and forced fluids.
Ten minutes after receiving the vaccine, pt reported feeling a lightheaded and  let us know that she was going to stay for an extra 15 min.  walked pt to recovery first aid area. Gave the patient water and crackers.  Pt reported feeling her heart rate felt fast and a she felt a little out of breath. removed pt mask.assessed pt, medical history, vaccine history. took vital signs, pulse ox, notified supervisor. continued to offer water and snack and suggested pt stay here until feeling better. stayed with patient until she felt better.
At 3 a.m. on 9/28/21 I awoke with total body shivering that lasted one hour.  I was extremely bloated, constantly releasing gas through my mouth.   After taking an anti-gas pill,  I vomited a quart of brown fluid.  A bit later, I had  extreme  diarrhea that filled the toilet.  I was thereafter for more than two  weeks weak and had limited appetite until 10/14/21.  I am still not 100% recovered.
2nd day after injection I had a red circle around the injection site that was red, hot, and swollen hard with tenderness.  That went away by day 3. Say 7 the round red spot returned. Again, the spot is very hard. Lymphnodes under left arm and in left neck seem to be slightly swollen.
product storage error temperature too low with no reported adverse event; administered to patient post excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves an adult patient of unknown gender to whom influenza quadrival A-B vaccine [Fluzone QIV] was administered after product experienced an excursion with no reported adverse event.   It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was administered unknown dose of suspect influenza quadrival A-B vaccine, suspension for injection (dose, strength: not reported; UT7683NA: expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination (immunization) after product experienced an excursion with no reported adverse events (product storage error; latency: unknown) (poor quality product administered; latency: same day).  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.   Action taken: Not applicable.   Outcome was 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.; Sender's Comments:  SAD20230220001440: SAD20230216001803:
My sister got the vaccine! And  still got Single/ Suspected vaccination failure; My sister got the vaccine! And  still got Single; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: My sister got the vaccine! And  still got Single/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: My sister got the vaccine! And  still got Single). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-JUL-2023 The case was received from the patient's sibling interactive digital media. The patient got the vaccine and still got shingle, it was bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 09-DEC-2014, the patient was vaccinated with a dose of MMR II (route, dose, frequency and lot # not reported) which had undergone a temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Skin rash covering arms, spreading to ears, face, and legs; some of the bumps have progressed to forming a head; treated with Benadryl; rash is ongoing as of 8/21/12.
Reaction occurred 3 days after vaccination. presenting high fever, pain muscle, accelerated heart rate, very severe pain in joints, rash and very red eyes.
AE's following both Moderna doses; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (AE's following both Moderna doses) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 IMMUNISATION REACTION (AE's following both Moderna doses). At the time of the report, IMMUNISATION REACTION (AE's following both Moderna doses) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Permanent disfigurement of my muscles; it's like my arm is sunken where they gave me the shot; permanent disfigurement of her 'nerve' and her muscles; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 59-years-old female patient received BNT162B2 (Pfizer COVID-19 Vaccine, Solution for injection, Lot Number: EL1284; Expiration Date: Apr2021), via intramuscular route of administration in left arm on 27Jan2021 (vaccination at the age of 59-year-old) as unknown, single dose for covid-19 immunisation. Medical history included allergy from an unknown date and unknown if ongoing. Concomitantly patient was taking allergy pills (Singulair, I think I do not know). Patient had not received any other vaccination within 4weeks. On 27Jan2021, almost immediately same day, the patient experienced permanent disfigurement of her muscles, it was like her arm was sunken where they gave her the shot. Patient reported that she got vaccine in Jan2021 and had permanent disfigurement of her 'nerve' and her muscles. Patient asked if it was part of side effect and had it happened to anyone else. No treatment was taken for the event, as patient stated that nobody knows what it was. They had not seen this before. Reporter seriousness was unspecified. No investigation assessment was done. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Patient reports that since her 2nd dose of Pfizer on 1/8/21, she has had chronic fatigue, on and off daily fevers, and brain fog. Patient has been evaluated by PCP but no explanation provided.  Patient has never tested positive for COVID. Reports that her symptoms are very different than those caused by menopause which she has had for a few years already. Patient has called off work several times due to her symptoms.
01/11/22 reports to Birth Center Triage for "regular contractions getting stronger". PMHx of "Anxiety disorder"
Slight nausea; Arm pain/soreness; Raised red blotch on shot arm; Pins and needles sensation in shot arm; Chills; Sore joints (knees and right hip); Sharp pain at the base of skull on right side behind the ear; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 17Apr2021 at 11:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis, low blood pressure, pelvic floor dysfunction, pudendal neuralgia and sulfonamide allergy from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took hydrocodone (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN) and diclofenac sodium (MANUFACTURER UNKNOWN) and experienced drug allergy. Concomitant medications included paracetamol (TYLENOL), diazepam (VALIUM), cannabis sativa (MARIJUANA), and unspecified multivitamins; all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 18Apr2021 the patient experienced slight nausea, arm pain/soreness, raised red blotch on shot arm, pins and needles sensation in shot arm, chills, sore joints (knees and right hip), sharp pain at the base of skull on right side behind the ear and fatigue. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events slight nausea, arm pain/soreness, raised red blotch on shot arm, pins and needles sensation in shot arm, chills, sore joints (knees and right hip), sharp pain at the base of skull on right side behind the ear and fatigue was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Towards the end of Dec I developed a severe cough to the point where I couldn't really catch my breath. I visited a Dr. who gave me medication that didn't really help so he referred me to an allergist who gave me a another medication which helped. I then went to a lung Dr. who prescribed another medication which helped clear up the cough.
Shoulder had usual soreness but by 1:30am I also had pain in head, neck, spine and if you can imagine even in my fingers and toes! I couldn't eat anything, the smell of foods made sick to my stomach, I was dizzy and couldn't even sit up... was miserable. This is day 3 and I'm just starting to feel better. The same thing happened with my 2nd dose lot#ER8737 but more intense and was ill for a longer amount of days.
pt describes swelling, redness @ inject site lt arm; other sx included fever, vomiting, couldn't move arm;
fatigue, vomiting, diarrhea, headache, chills, fever, arm swelling,