chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHHY2011US45467 is an initial report received from a physician on 25 May 2011. This report refers to 2 patients who were vaccinated with MENVEO (batch number: unknown) intramuscularly. These patients received only the Mer A lyophilized conjugate component which was reconstituted with sterile diluent (instead of reconstituting it with Men CYW liquid conjugate).
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6208), in right arm, on 09Apr2021 as dose 2, single (Lot number: ER8733), in right arm and on 14Aug2021 as dose 3 (booster), single (Lot number: FA7485) at the age of 48 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "crohn's disease" (unspecified if ongoing); "known allergies: crustaceans" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA. Past drug history included: Venofer, reaction(s): "Allergy". The following information was reported: COVID-19 (medically significant) with onset 02May2022 at 08:30, outcome "not recovered", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Testing positive again after negative". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) Positive; (02May2022) Negative. Therapeutic measures were not taken as a result of Covid-19, vaccination failure. Clinical course: Patient received anti viral treatment with Paxlovid (from 23Apr2022 to 28Apr2022) lot number (FY5657). Patient received any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously receive a COVID-19 Vaccine. Patient was treated with Humira for crohn's disease.
Client received Moderna #1 on Jan 8th and Moderna #2 on Feb 5th. She tested positive for COVID-19 on May 2nd and is asymptomatic.
Felt warm, mom picked up, went into sz for about 3-4min then threw up was limp & unresponsive; Taken to ER, temp 102.5F; Blood work was done, to see MD today;
MENACTRA was scheduled to be delivered on 5/31/19, but they did not get the vaccine until 6/4/19 and when they opened ice packs were in the container but it was not frozen; 14 years old patient recived booster dose of MENACTRA; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked with This case is linked to cases 2019SA193300, 2019SA193302, 2019SA193307, 2019SA193303, 2019SA193304, 2019SA193305, 2019SA193306 and 2019SA158240 (same reporter).  This case involves 14 years old female patient with who was vaccinated with 0.5 ml first booster dose MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6365AA and expiry date was not reported) via intramuscular route in the arm NOS, on 30-May-2019.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage and inappropriate schedule of vaccine administered.  It was reported that MENACTRA was scheduled to be delivered on 31-May-2019. Caller stated they did not get the vaccine until 04-Jun-2019. Caller stated when they opened ice packs were in the container but it was not frozen. It was stored incorrectly from 31-May-2019 to 09-Jun-2019.  It was unknown if any adverse event occurred.  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.   List of document held by sender: none.
Severe left-sided neck and head pain; Severe left-sided neck and head pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2021 13:00 (Batch/Lot number: unknown) at the age of 74 years as single dose for covid-19 immunisation. Relevant medical history included: "no" (unspecified if ongoing), notes: Structured information(Patient episode name): No. The patient's concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (1st dose of vaccination), when the patient was 74 years old. The following information was reported: NECK PAIN (non-serious), HEADACHE (non-serious) all with onset 28Feb2021, outcome "not recovered" and all described as "Severe left-sided neck and head pain". The event "severe left-sided neck and head pain" and "severe left-sided neck and head pain" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of neck pain, headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I lost taste and smell when I had covid - lasted about 6 weeks.  Happened again after first vaccine and was still the case when I got the second one yesterday; I lost taste and smell when I had covid - lasted about 6 weeks.  Happened again after first vaccine and was still the case when I got the second one yesterday; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (I lost taste and smell when I had covid - lasted about 6 weeks.  Happened again after first vaccine and was still the case when I got the second one yesterday) and AGEUSIA (I lost taste and smell when I had covid - lasted about 6 weeks.  Happened again after first vaccine and was still the case when I got the second one yesterday) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (lost taste, lasted for 6 weeks.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, the patient experienced ANOSMIA (I lost taste and smell when I had covid - lasted about 6 weeks.  Happened again after first vaccine and was still the case when I got the second one yesterday) and AGEUSIA (I lost taste and smell when I had covid - lasted about 6 weeks.  Happened again after first vaccine and was still the case when I got the second one yesterday). At the time of the report, ANOSMIA (I lost taste and smell when I had covid - lasted about 6 weeks.  Happened again after first vaccine and was still the case when I got the second one yesterday) and AGEUSIA (I lost taste and smell when I had covid - lasted about 6 weeks.  Happened again after first vaccine and was still the case when I got the second one yesterday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by the reporter. No  concomitant medical  provided by the reporter
In the afternoon the day the vaccine- client became dizzy, throwing up ran a fever of 101. It lasted approx 1 1/2 days.  Client used TYLENOL.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CHF" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result; Negative; Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not receive other medication in 2 weeks. Patient had no known allergies. COVID-19 Rebound - positive home tests following 2 days of negative ones. Patient received Paxlovid (anti viral product, Lot number: GC4035) from 13Jun2022 to 17Jun2022 for COVID-19 treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
pt recv vax 22OCT96 & 23OCT96;pt devel vomit, diarrhea w/o fever 48hr p/vax;pharmacist related there were other pt that exp v,d who did not recv vax;this is one of 25 cases reported by a pharmacist;
Patient felt hot, dizzy, light headedness and pre-syncopal. Patient put flat, BP 90/60. Did not LOC, recovered BP 120/60, HR 99. Taken by EMS to hospital.
This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 62-year-old female patient who received SHINGRIX (batch number 5S34K, expiry date 13th March 2021) for prophylaxis. Concomitant products included POLYSPORIN. On 26th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 26th October 2018, less than a month after receiving SHINGRIX, the patient experienced itchy rash and red rash. On an unknown date, the outcome of the itchy rash and red rash were not recovered/not resolved. It was unknown if the reporter considered the itchy rash and red rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. The patient claimed that she cut herself on her elbow after the shot and then she got a rash soon after down her arm that had been itchy with red sports and it was spreading. The registered pharmacist claimed that the rash was on her forearm and above her elbow area. The batch number of SHINGRIX diluent was reported.
This spontaneous report was received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of COMVAX lot # J013884, expiration date: 19-AUG-2016 and lot # J009691, expiration date: 29-NOV-2015 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient came for a J&J Covid 19 vaccine as a walk in. Patient experienced a fainting spell (? LOC 1 to 2 seconds) in pharmacy almost immediately following administration. Symptoms dizziness, pale, slightly disorientated. 911 was called. They assessed patient H/R slow but normal, BP low but normal. Advised patient to go hospital for further review but patient declined. Patient sat in pharmacy sipping water till he felt better to leave.
rash all over body, fever. headache, body pains and joint pain. rash never went away. I still have rash on arms, chest and legs today.
I had a patient contact me today in regards to their booster shot. They received the shot on 9/25/21 (friday). Patient states from friday to tuesday morning they lost her memory and has no recollection of any events. Patient lost her atm that day as well she said. Stated she did not eat or drink anything during that time and slept for 4 days. Patient is a 77 yo female.
Events occurred 15 to 30 min p/vaccinee rec'd a 2nd Engerix-B dose 7SEP90; Put under observation ( ? emergency room). sx were still persisting 2 hrs post inject;Diaphoresis;dizziness;nausea;severe headache;
pt stated that about 2 days after she got her 2nd dose of the covid vax that her right arm was sore and itchy and red from the shoulder down about 2/3 down her arm.  She also had experienced some fatigue and loss of appetite.   She has been using Zyrtec and using cortisone cream.  The NP at the independent living has taken at look at it and her PCP has seen a picture of it but she has not been prescribed any medicine at this time.
Patient stated she did not have her vaccine card but said she got Pfizer as first dose back in January.  The 2nd Pfizer shot was given and after shot was given, she found her vaccine card 15 minutes later and it was actually Moderna that had been given as first dose.  Patient was feeling fine as of about an hour after dose given.
Pt was pregnant, but not aware, at time of initial Pfizer vaccine.  She did not get second dose once discovering she was pregnant.  She started having vaginal bleeding on 6/22/21, was sent to ER and determined to have had a spontaneous abortion.
In late February 2023, my left ear was plugged up with a 'roaring sound' and my right ear would come and go.  From time to time the right ear would pop and I could hear again but not the left.  I saw a PA on March 2nd and I discussed options for Flonase but gave me a Z-Pack instead.  I took Zyrtec with decongestant.  I began to feel better, and my ears cleared up by the time I finished Z-Pack.  But the next day they were plugged again on March 10th.  I saw another doctor and he put me on Prednisone.  My ears cleared up on day 5, March 15th, of this medication.  On March 23rd both ears were stopped up again.  I saw another doctor in the same office on March 24th.  He has me taking Flonase and Zyrtec at night.  My ears are better, but they are not perfect.  I don't have the roar anymore, but they are somewhat plugged.  The doctor said he could see an air bubble behind my right ear drum.  I have an appointment with ENT in June. The stuffiness and echo in my ears are worse in the morning.
Myalgia, Fever, FATIGUE Narrative:  EMPLOYEE STILL WITH COMPLIANTS OF BODY ACHES AND FATIGUE. REPORTS FEELING MUCH BETTER THAN YESTERDAY (/28/21; FEBRILE 99.5) AND TAKING NAPROXEN
This spontaneous report was received from a healthcare professional who reported that on unspecified dates, an unspecified number of doses of RECOMBIVAX HB (intramuscular injection, dose number, route, batch and lot #, expiration date not reported, could have been administered to an unspecified amount of patients. No adverse events reported. Further information was not provided. This is one of several reports from the same source. Additional information has been requested.
2nd vaccine 2/21/21, L arm, Pfizer COVID 19, LOT EM9810 Hospitalization 11/14/2021
Hives,  Day 3, 5 spots; Day 4, expanded to 25 spots
Cough and heavy ness in breathing . I got the vaccine on Saturday 3rd April and today is 6th April  11pm central time and my throat feels sore , dry cough and heavy breathing
Temperature 101.5 tympanic reading...local reaction: red area from shoulder to just above the elbow/warm to touch.
Moderna Vaccines received on 1/21/2021 and 2/18/2021. Hospitalized on 7/19/2021-7/22/2021 for COVID 19, UTI, and weakness
9 days after 3rd Moderna shot, he couldn't move out of bed at about 9PM due to extreme back pain. He thought it was due to gardening earlier in the day and taking Advil reduced pain and helped him get out of bed for urination. Over next few days, he also felt pain in right abdomen.  His primary doctor ordered ultrasound and MRI and result indicated cancer has spread to entire liver and to spine causing extreme pain.  My father passed away on 2/5/22 while waiting for biopsy procedure in ER.
The flue gripa /Flu - hasn't had one for over 5 years; Throat itches; Sneezing frequently; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (The flue gripa /Flu - hasn't had one for over 5 years), THROAT IRRITATION (Throat itches) and SNEEZING (Sneezing frequently) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced INFLUENZA (The flue gripa /Flu - hasn't had one for over 5 years), THROAT IRRITATION (Throat itches) and SNEEZING (Sneezing frequently). At the time of the report, INFLUENZA (The flue gripa /Flu - hasn't had one for over 5 years), THROAT IRRITATION (Throat itches) and SNEEZING (Sneezing frequently) outcome was unknown.            No concomitant medications reported. Treatment included Natural remedies.  It was reported that patient had vaccination two days before Surgery related to sight and it was a requirement for her to be vaccinated. She stated that she hadn't had flu for over 5 years but blamed it on travelling and weather changes.   This case was linked to MOD-2022-440630 (Patient Link).
a 16 month old female received Adacel instead of Daptacel/ No AE; a 16 month old female received Adacel instead of Daptacel/ No AE; Initial information received on 01-May-2019 and additional information also received on same day regarding an unsolicited valid non-serious case, from a nurse.  This case involves a 16 months old female patient who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number: U6103AA, expiry date: 25-Oct-2020, via unknown route in the right leg instead of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] on 29-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation; POLIO VACCINE (POLIO) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  No side effects were 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.  Documents held by sender: none.
Next few days had a normal reaction-fatigue, joint pain that lasted for approximately 3-4 days. 8 days later developed a reaction at injection site-redness, swelling, warm to touch, nerve pain radiating down arm. Treated with OTC Antihistamine, ibuprofen and topical cortisone cream. Also, nasal congestion and slight sore throat
BAD BODY ACHES; 102 FEVER; This spontaneous report received from a consumer 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, start therapy date were not reported 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 subject experienced bad body aches, and 102 fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 units not specified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 102 fever and bad body aches was not reported. This report was non-serious.
11/98-fell on shoulder; 11/98-low back pain,2/99 viral URI w/poss allergic component,3/2/99 w/chest pains, PVCs & shortness of breath, seen in ER, 3/19/99 seen @ hosp & started on MgO2 & Timoran
Patient received vaccine about 1415 and felt "dizzy" at about 1440pm. Pt was able to follow basic commands, appeared pale, and mother stated she "fainted." Pulse and o2 level were 70 and 97% on RA. Pt observed for 20 more minutes and was able to walk, A&O X4. Mother stated she usually feels dizzy when she gets lab work done; per mother, pt had not had anything to eat since last night.
Initial report received via search of the literature on 16 April 2013. This case contains information for 1 of 22 patients whose clinical data were provided. Information regarding the other 21 patients is captured in case numbers 1995-00224, 2003-02926, 2006-03086, 2006-03230, 2011-03827, 2013-02288, 2013-05188, 2013-05251-05263 and 2013-05269. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 inactivated influenza vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. This case which involved a 59-year-old male patient who had received Trivalent inactivated influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and 31 days later reported the onset of GBS. No further information was provided. Outcome was not reported. Documents held by sender: none.
This case was reported by a physician via call center representative and described the occurrence of local reaction in a 78-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced local reaction, pain, erythema and induration. On an unknown date, the outcome of the local reaction, pain, erythema and induration were unknown. It was unknown if the reporter considered the local reaction, pain, erythema and induration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that the patient developed a local reaction after receiving a dose of SHINGRIX and symptoms reported were pain, redness, area of induration 5 inches in diameter. The healthcare professional reported that the patient was actually not her patient but a patient of her husbands; husband was also a doctor. The HCP stated they do not have further address details or information of facility in which the patient received the vaccine. No further information was available at the time of report.