chrisvoncsefalvay/vaers-outcomes huggingface dataset:
G1 @ 24.1wks (EDD 6/25/21)  presented with cramping - closed cervix and thought to have a UTI; represented 4hrs later with increasing contractions and was 1-2cm dilated & 80% effaced. Admitted to our tertiary care hospital at 24.2wks due to preterm gestation at which point she was 3cm dilated/100% effaced and actively contracting. She has been treated with tocolytics and received betamethasone for fetal lung maturity. She has currently stopped contracting but is still in guarded condition regarding risk for recurrent preterm labor & delivery
Patient given varivax on 11/29/1999.  Seen in office 02/04/2005 with varicella infection.
Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was provided.  No treatment medication  was provided.
20 doses that were administered after the temperature excursion; A spontaneous report was received from a pharmacist concerning 20 patients, who received Moderna's COVID-19 vaccine (mRNA-1273)  after the temperature excursion.  The patients medical history, was not reported. Concomitant medications was not reported.   On unknown date, prior to the onset of the events, the patients received their planned doses of mRNA-1273 (Lot number: 025A21A) for prophylaxis of COVID-19 infection.   On 02/25/21 at 12:35pm Thursday, 10 vials were delivered in a frozen container, moved to Ultra Cold -66.5°F at 12:40pm. 1 vial moved from ultra-cold storage to room temp 70°F on 02/28/21 at 9:43am to use for patient administration. 1 more vial moved from ultra-cold storage to refrigerator on 02/28/21 6pm to be used for patient administration on 3/1/21.Interim disposition of vials: returned to the freezer/refrigerator, or maintained at room temperature: Vial 1 Maintained at room temp 70°F 02/28/21 at 9:43am for administration. Vial 2 Maintained at room temp 70°F 03/01/21 At 9:05am. The other 8 vials were moved from ultra-cold storage to room temperature with the purpose of salvaging on 3/1 at 11:40 am.Visual inspection noting any vaccine state change (e.g. were frozen vials thawed, were thawed vials re-frozen, were they visualized at all): Vial 1: Frozen vial thawed at room temp to liquid state from 9.43am to 11:30am 02/28/21. Vial 2 thawed in refrigerator 6pm 02/28/21 and liquid when opened at 9am 03/01/21.Proposed Use by Date (date of vaccination clinic, patient appointments, etc) Vial 1: Used for patient appointments starting at 11:30 am and completing at 3 pm on 2/28. Vial 2 used for patient appointments starting at 9:15 am until 11:40 am on 3/1/21.Number of vials/doses impacted: 20doses (2vials) Pertinent details: whether the vial(s) were punctured, any previous excursions with the impacted vial(s) Vial 1 punctured 1130am Sunday 02/28/21 . Vial 2 punctured 09.05am Monday 03/01/21.They thawed the vial from Sunday 02/28 943am at room temp and administered to 11 patients.The vial thawed from Sunday 02/28 at 6pm was placed in the refrigerator and we began to administer at 9.15am Monday. 9 patients received this vaccine.  No laboratory details was provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of the report,the outcome of the event expired vaccine used was resolved.; Reporter's Comments: This case concerns a patient who was administered mRNA-1273 (Lot number: 025A21A)  after the temperature excursion (Out of specification product use.  There was no associated adverse event reported for the event of out of specification product use.
Pediatric Pfizer administered to 13 year old child. Parent informed of incorrect dosage administered and educated on side effects. Informed that the second dose should be administered 21 days from 11/10/2021 and should be the Pfizer-BioNTech COVID-19 Vaccine authorized for 12 years and older. Mother verbalized understanding.
MEDICATION ERROR; GIVEN  EXPIRED DOSE; This spontaneous report received from a pharmacist concerned a 49 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1820095 expiry: 04-JUL-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced medication error, and given expired dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the medication error and given expired dose was not reported. This report was non-serious.
Lightheadedness / dizziness occurring periodically throughout the day for a few weeks, and still ongoing Unexplained upset stomach for several weeks
In the past month (late in January 2022) I have developed intermittent pain in heels of my feet on standing. This is making it hard to walk any distances. I have ongoing visits with physical therapy for hand and wrist pain so I asked there if she had any ideas I might try. I currently am between PCP, and have a "First Visit" scheduled for May (soonest available) to discuss my concerns. I have been wearing compression socks designed for "plantar fasciitis". This seems to help, but the pain does not completely go away.
Chest pain and shortness of breath for about 3 hours. It occured 3-4 hours after anthrax vaccination (1st). Patient went to a local ER where he was treated with Albuterol nebulizer, PO benadryl, an unknown PO pill, and IM steroids. Released from the ER and given Rx Medrol, pepsid, benadryl, and an epi pen. Followed up today at TAHC with provider.
I have been post-menopausal without symptoms for over a year. I am now experiencing several hot flashes daily. Sometimes up to 10 per day.
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. On or about 06-OCT-2010, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the long-term 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 condition of herpes zoster. On or about 13-MAY-2014, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain.  As a direct and proximate result of the 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.
when walking at a moderate pace, feel pain in upper left arm, spreading through chest to upper right arm pain stops after resting feel tired and sleepy in general
Initial and follow up information has been received from a healthcare worker concerning a 36 year old female patient who on 30-OCT-2008 at 09:55 was vaccinated with a dose of PNEUMOVAX 23 (lot # 660685/0619x). Concomitant vaccination included influenza virus vaccine (unspecified) (manufacturer unknown). On an unspecified date the patient developed cellulitis of the arm, at the injection site, after receiving the vaccine; on 03-NOV-2008 the patient was diagnosed with "allergic dermatitis with myalgia due to the pneumonia vaccine". The patient sought medical attention, through an office visit. On follow up information received on 12-DEC-2008 the patient developed erythema and induration in the right deltoid. The patient recovered about 1 week later. The cellulitis of the arm, at the injection site was considered to be disabling. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the center and was released. This is one of two reports from the same source. No further information is available.
No adverse event; received a vaccine after the 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine after the 30 day use by date) and NO ADVERSE EVENT (No adverse event) in a 28-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine after the 30 day use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a vaccine after the 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (received a vaccine after the 30 day use by date).    No concomitant medication were reported.  The patient received first Moderna Covid 19 vaccine primary series on 16-MAY-2021 with Lot number 022B21A and expiration date was 28-Sep-2021 in left Arm of administration, patient reported no Adverse Reactions. The patient received second Moderna Covid 19 vaccine primary series on 13-Jun-2021 Lot number 036C21A expiration date was 1-NOV-2021 left Arm of administration and patient reported no Adverse Reactions. The patient received first Moderna Covid 19 vaccine booster dose on 21-DEC-2021 Lot number 041J21A expiration date 28-APR-2022 was not known left Arm of administration and patient reported no Adverse Reactions. No treatment information was provided by the reporter.
on her lower back four more little red welts; it doesn't burn, though once in a while it does; she is worried about the rash; This is a spontaneous report from a contactable consumer or other non hcp (patient self reported).  A 74-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EM9810; Expiration Date: Jun2021), via an unspecified route of administration in Arm Left on 12Feb2021 (11:00) as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient previously received the first dose of BNT162b2(Batch/Lot Number: ENS318, Expiration Date: May2021) in her left arm on 22Jan2021 (about 11:00AM) for COVID-19 immunisation and experienced patch on her back and red welt the size of a quarter. Concomitant medications included: reported stated that says that she was only on one medication and takes magnesium calcium, curcuma longa- turmeric; vitamin c- ascorbic acid, ergocalciferol- Vit D, the basics, taken for an unspecified indication, start and stop date were not reported. No further information provided about her medication or vitamins.  The reporter says after her second shot on 23Jan2021, she developed on her lower back four more little red welts, and she doesn't know if they could be from the vaccine. Reporter says that her welts have stayed about the same, she hasn't gotten any more, it is the same basic ones. She says that the first one looks like it is going away, and the others are smaller that appeared after the second dose, they are the size of a dime. She says she was putting Aloe Vera Clear Gel on it since it is unscented and has no smell or nothing. She says that this product is an old one, but is still clear and didn't turn colors or anything. Aloe Vera Clear Gel UPC number. LOT/EXP: Unknown, caller says this product doesn't have this information to provide. She says the bottle says healing therapy, apply liberally to sunburn or irritated skin as needed. Reporter stated that she was concerned because her sister looked at the welts and asked her if she thought she got shingles from it, and she was like no, it doesn't burn, though once in a while it does, and sometimes it doesn't itch, it is not something that bothers her, it's just there. No Investigation Assessment was reported. Outcome of the reported events were unknown.   Follow-up attempts are completed. No further information is expected.
Patient was cleared by administration. Patient identified with 3 identifiers- then confirmed he was here today for his 2nd dose of Pfizer vaccine. Patient was given Pfizer vaccine. When completing his cdc vaccine card it was noted he had Moderna 3/10- patient than stated he had Moderna  011A21A on 3/10/21. Clinical lead was notified and Administrative leader, Administrator and Clinical lead for Vaccine .
Patient states that he's developed numbness of right arm and fingers.  12 hours after immunization in same arm  Lasted two hours.  Later developed shaking, chills, and flu-like symptoms and nausea.
pt recv vax 1030AM 5DEC97 & several hr p/lunch pt vomited, felt warm, took nap for several hr;upon arising felt warm given APAP;short time later asked for a drink & was found laying on floor shaking 3-4min p/confused, dazed;
FREQUENT FALLS, WEAKNESS, COUGH,, HYPOXIA, RESPIRATORY FAILURE
Sight of injection became red, swollen and itchy within 18 hours after injection.  Patient developed a fever of 100.5, aches and pains, and joint pain.  She felt a hard lump that would not go away at site of injection.  Recommended at day three to take a Benadryl 25 mg, which relieved itching and swelling started to resolve.  At day 8, she is still having joint pain, especially in her knee and feels as if she can't put weight on that leg.  She was referred to her provider to follow up.
Fever 104.6 @ 7PM day of immun; rt thigh painful-no swelling went to hosp ER; 8FEB92 fever 105.2; sl ear infect dx;
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 06-AUG-2013 (lot # H021608, exp.: 13-AUG-2015). This is one of the report from the same source, linked reports. Additional information is not expected.
She developed redness and swelling on the upper deltoid muscle, large amounts of diarrhea, throat felt intermittent "funny like it is touching itself".  She was evaluated by allergy and was recommended to get the Janssen Covid 19 vaccine under close observation in hospital/ED. She received the vaccine on October 4, 2021. She had initial tight fuzzy dry throat with numb tongue within 20 minutes but never developed breathing concerns or coughs.  Pain below the injection site, after discharge she became dizzy, body aches, fatigue, and a sense that she was feverish, but did not get a fever. She has nausea on the first day of the injection.  Yesterday she woke up with her left arm, armpit, and left breast swollen and tender. She notes this has decreased but her arm and armpit is tender and swollen. She notes that the Tagamet has helped, she has not had any nausea or diarrhea.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  Medical history and concomitant medications were not provided.  On or about 27-SEP-2012, the patient was vaccinated with ZOSTAVAX (route and lot # not provided) at her primary care physician's office as recommended for routine health maintenance for the prevention of shingles.  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster.  On or about 31-JAN-2014, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles.  On or about 08-MAY-2014, she was treated by that same physician for ongoing and worsening symptoms of severe shingles outbreaks.  On or about 30-JUL-2014, the patient required further medical treatment for worsening symptoms.  She was treated for ongoing shingles outbreaks on 17-DEC-2014.  On or about 04-AUG-2016, the patient was treated by another physician for severe herpes zoster conditions.  She was treated again by this same physician for worsening symptoms of this outbreak on or about 11-AUG-2016.  The patient was prescribed valacyclovir (VALTREX), acyclovir and prednisone for management of her painful symptoms.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The persistent strain of herpes zoster/vesicular outbreak that was diagnosed as severe shingles was considered related to ZOSTAVAX. The outcome of the events were not recovered. Additional information has been requested.
Fever 100.4, headache, nausea, body aches, right arm soreness
I went from a COMPLETELY healthy individual to thinking I strained a muscle shoveling snow for the zillionth day in a row, how weird.  Then the headache began, the pain on the right side of my ribs, front to back, got excruciatingly more painful over the weekend.  Finally Monday night the stupid rash developed. About 5 days after the pain began.  Telehealth nurses said what they thought it was but said I should visit a live person who did it as shingles within a out half a second.
Body Aches, chills followed by fever which progressed to 102.4,  Became faint with vomiting.    At 32 hours developed red rash at injection site (pain and itching)
Redness, swelling and pustule at site of injection (very itch, pustule burst 7-10-17 and redness and swelling almost gone).
Pt called 10/31/08 said had blurring vision, earache, itching, & hives.  in our conversation pt stated had. hives, & itching previous to shot.  I attribute "reaction" to her previous allergy- not sure all symptom resolved by one week
patient falsified immunization paperwork to say she had never received any doses of moderna but had received in early 2021. at the time of administration she was not eligible for 3 rd booster and wasn't caught on cairs until after.
no adverse event, moderna confirmed 216K22A was viable until 2/21/23 despite beyond use date of 1/22/23.
Non-responder to the MMR vaccine and the Hep B vaccine series, mostly meaning I'm immune for a short time and it wears off quickly; This spontaneous report was received from a consumer via Pfizer referring to herself, a female patient of unspecified age. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not provided.  On an unspecified date, the patient was administered hepatitis B vaccine (recombinant) (manufacturer unknown) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (doses, routes of administration, anatomical sites of vaccination, lot numbers and expiration dates were not reported) as prophylaxis.   The patient stated that she was a non-responder to hepatitis B vaccine (recombinant) (manufacturer unknown) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) vaccine series, mostly meaning that she was immune for a short time and "it wears off quickly" (therapeutic response shortened).   The outcome of the event was unknown. The causal relationship between the suspect vaccines and the event was not provided.
Extreme pain and burning sensation in abdomen (Day 4-6), extreme pain (bone/joints/muscles) in left arm (Day 6-8)
Generall body aches, headache, fever (never got over 99.5), fatigue.  Started late Friday, 1/22/2021, stayed in bed all day on Saturday and slept (1/23/2021), and felt much better by Sunday noon (1/24/2021).  No problems since.
Voice is Hoarse; Hurts to swallow; Had a sore throat and became worse throughout the day; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (Had a sore throat and became worse throughout the day), DYSPHONIA (Voice is Hoarse) and ODYNOPHAGIA (Hurts to swallow) in a 57-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (fourth dose) on 06-Apr-2022. Past adverse reactions to the above products included No adverse event with Pfizer.    On 22-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 24-Oct-2022, the patient experienced OROPHARYNGEAL PAIN (Had a sore throat and became worse throughout the day). On 25-Oct-2022, the patient experienced DYSPHONIA (Voice is Hoarse) and ODYNOPHAGIA (Hurts to swallow). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Had a sore throat and became worse throughout the day), DYSPHONIA (Voice is Hoarse) and ODYNOPHAGIA (Hurts to swallow) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Oct-2022, SARS-CoV-2 test: Negative.         No concomitant medications were provided. The patient had received 5 doses of COVID-19 vaccines by intramuscular injection. Patient received her first dose on 17-Mar-2021 with lot number 031A21A, second dose on 14-Apr-2021 with lot number 029A21A, third dose on 3-Nov-2021with lot number 032F21A and fourth dose Pfizer on 6-Apr-2022.  The patient was out of the country and returned last week Monday. Patient tested negative for COVID-19 on Tuesday prior to receiving her most recent vaccine on Saturday. Patient has been taking acetaminophen and ibuprofen.
This spontaneous report as received from a physician, via company representative, refers to three patients of unknown age and gender. On an unknown date patients were vaccinated with GARDASIL (dose and lot number were not reported) 1 intramuscular injection, for prevention of HPV. Concomitant medications were not reported. Physician reported that on an unknown date, the patients "passed out" after being injected with GARDASIL. The outcome of passed out was not reported. The relationship between GARDASIL and the event was not reported. Additional information has been requested.
Rash started the night after injection covering whole body.  Slightly itchy.  Benadryl was given.