Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: stomach was kind of queasy; arm hurts; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single, in arm for covid-19 immunization. The patient's relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Covid-19 first vaccine, Manufacturer: Pfizer, Date given: Unknown, NDC: Unknown, Lot: Unknown, Expiration: Unknown, Anatomical location: arm, Time given: unknown, Dosage: Not provided, She said the first vaccine her arm was sore and she got home and felt fine and at 5 o'clock she was exhausted and she laid down and she woke and had soup and she was fine), for Covid-19 immunization, reaction(s): "her arm was sore"; Bnt162b2 (Covid-19 first vaccine, Manufacturer: Pfizer, Date given: Unknown, NDC: Unknown, Lot: Unknown, Expiration: Unknown, Anatomical location: arm, Time given: unknown, Dosage: Not provided, She said the first vaccine her arm was sore and she got home and felt fine and at 5 o'clock she was exhausted and she laid down and she woke and had soup and she was fine), for COVID-19 immunization, reaction(s): "at 5 o'clock she was exhausted". The following information was reported: NAUSEA, outcome "recovered", described as "stomach was kid of queasy"; PAIN IN EXTREMITY, outcome "unknown", described as "arm hurts". Therapeutic measures were taken as a result of nausea.  Additional information: Reaction / Event as Reported by the Primary Source for Translation: Case of massive diarrhea with Paxlovid, Date of start of reaction/event:23May2022, Outcome of reaction/event at the time of last observation: unknown, Reaction / Event as Reported by the Primary Source for Translation: She tested positive for Covid-19 after receiving Covid-19 vaccines, Outcome of reaction/event at the time of last observation: Unknown. Drug(s) Information: Proprietary medicinal product name: Paxlovid, Action(s) taken with drug: Unknown, Batch/lot number: GA1529, Dosage text: ritonavir 100 mg; nirmatrevir 150 mg; by mouth  Pharmaceutical form (Dosage form): Tablet, Indication as Reported by the Primary Source: Covid. Other Conditions: No, Investigations: No, Is Paxlovid a Pfizer product: Yes, Paxlovid manufacturer: unspecified, NDC number of Paxlovid: 0069-1085-30, Expiry Date of Paxlovid: Feb2023, Is Covid-19 vaccine a Pfizer product: Unspecified, Covid-19 vaccine manufacturer: unspecified, NDC number of Covid-19 vaccine: Unknown, Reason for no lot number: of Covid-19 vaccine: Other: Caller doesn't have this information. Expiry Date of Covid-19 vaccine: Unknown, Other Products: No.  Additional Context: Calling about Paxlovid.  She tried calling 3 times and call hung up.  Consumer said she isn't good with pushing buttons and is willing to admit to a certain stranger.  Consumer was diagnosed with Covid-19 with an at home test.  Consumer said she had a case of massive diarrhea.  Asking if it is ok if diarrhea comes back if she can something for the diarrhea or if will the medication affect the Paxlovid.  She doesn't want anything to affect the Paxlovid.  She said she is a shareholder in Pfizer and has lots of shares thanks to her dad. Consumer said she is a retired 75 year old. Consumer said she wanted to give call handler heads up when in business don't worry about social security and social security is not the end all and she hopes call handler has started an IRA or something like that if call handler is counting on social security call handler is in trouble.  She said even if call handler puts away 5 dollars a month over years. Consumer said to not sell her email and that makes her nervous.  She said to just call her because she gets so much junk.  Address and email address are unknown. Event date: Started at 3:20 in the morning on 23May2022. Seriousness criteria: She said things are not as tight as she would like them but not as bad. Consumer said she took an over the counter medication yesterday and she took one pill.  Name and dosage are unknown.  She said she is going down the hall and she said she is old and will take her a second or two.  Consumer said she is using a magnifying glass.  She said depends on how the printing is if she needs a magnifying glass. Product: She provided manufactured by Pfizer labs a division of Pfizer incorporated.  She said the box was hard to open and she had to tear the box at first. Consumer said Lot is GA1529 or 6a1529.  She said there is listed. She said the medication is a tablet because she cant take them apart.  She said medication is pre dosed and she takes 3 pills in the morning and 3 pills at night. ritonavir 100mg, nirmatrelvir 150mg, 5 days of medication and the count is 30. She said after the diarrhea she was sitting in the kitchen and she was wondering so she went on the web and she said she has had Pfizer's regular shot and two boosters.  She said massive diarrhea is a sign of Covid and she took a test that was sent through the mail from the government and the test came up positive and she almost threw up.  She called her pulmonologist and left a message and he called her back and she said she has heard there are a lot of false positives and the doctor told her there are not that many false positives and he said he is prescribing Paxlovid and to go get it. Treatment: Over the counter medication. Consumer confirmed she had 4 shots. She said she had 2 regular shots and two booster shots.  Consumer confirmed she was diagnosed with Covid after receiving the vaccines. Covid-19 first vaccine, Manufacturer: Pfizer, Date given: Unknown, NDC: Unknown, Lot: Unknown, Expiration: Unknown, Anatomical location: arm, Time given: unknown, Dosage: Not provided, Covid-19 second vaccine, Manufacturer: Pfizer, Date given: Unknown, NDC: Unknown, Lot: Unknown, Expiration: Unknown, Anatomical location: arm, Time given: unknown, Dosage: Not provided. Covid-19 third vaccine first booster, Manufacturer: Pfizer, Date given: Unknown, NDC: Unknown, Lot: Unknown, Expiration: Unknown, Anatomical location: arm, Time given: unknown, Dosage: Not provided. Covid-19 fourth vaccine second booster, Manufacturer: Pfizer, Date given: Unknown, NDC: Unknown, Lot: Unknown, Expiration: Unknown, Anatomical location: arm, Time given: unknown, Dosage: Not provided. She though diarrhea was one massive flu thing or she was in trouble and she said she was in trouble.  She said this give her time to do things she has been putting off for five days.  VACCINE SUPPLEMENTAL FORM  Vaccination Facility Type: First vaccine was received at a Pharmacy. Vaccine Administered at Military Facility? No, Facility Name: Unknown. She said she lived at (withheld) and moved.  The second vaccine was received at the local county health and that was when vaccines first came out and she first in line and she was not taking any chances.  The booster vaccines were received at a grocery store.  Consumer said she feels badly for not having all the information. History of all previous immunization with the Pfizer vaccine considered as suspect; Vaccine Name: Pfizer Covid-19, Lot Number: Unknown, Expiry Date: Unknown, Route, Anatomical Location: Arm, No. of Previous Doses: Date: Unknown, age at Immunization if date not available: Not provided. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: No; consumer is asking if call handler is referring to flu vaccine?  She said she doesn't mix vaccines. Adverse Event (AE) Details: Tested for Covid-19 after receiving Covid-19 vaccines. Time of Onset: (24-hour clock): Not provided. Did any AE(s) require a visit to: Emergency Room: No; Physician Office:  No; If the patient was hospitalized, how many days was the hospital stay: No. Prior Vaccinations(within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): Not provided. AE(s) following prior vaccinations: None or Unknown. Adverse Event: Onset Age: Vaccine/Brand Name: Vaccination Date: She said the first vaccine her arm was sore and she got home and felt fine and at 5 o'clock she was exhausted and she laid down and she woke and had soup and she was fine.  The second vaccine she was not tired and her arm hurts and she said she thinks that happens with all shots.  The next day her stomach was kid of queasy and she took an over the counter Tagamet and she was fine.  She took one Tagamet.  She said with the two booster vaccine there was no problem.  The first booster her arm was sore.  With the second booster the guy gave the vaccine great and she didn't feel the shot. She there were no adverse effects.  She said she was waiting for her arm to start hurting. Patient's Medical History (including any illness at time of vaccination); None or Unknown, relevant history; no. Family Medical History Relevant to AE(s): No. Relevant Tests: None or Unknown. For Lack of Efficacy, request the following information if not included in the initial report What is the primary infection site; Unknown; Known If known, please specify: No, Please specify any secondary site(s) (e.g. empyema): Not provided. Are there predisposing factors: Unknown, Was a culture performed: No, If Yes, was the culture positive? N/A,  If Yes, was serotyping done: No. Please specify the culture source (e.g. blood): N/A. Please specify Antipyretic Use (around the date(s) of Vaccination): Not provided. Consumer said the mediation Paxlovid tasted really weird and wasn't before and the web said that might happen. Consumer said she has breath spray and she don't care if her mouth tasted funny as long as she doesn't have to go to the hospital and she feels better. Is there a product complaint to report: Yes. Description of Product Complaint: Product complaint 1; Consumer tested positive for Covid-19 after receiving Pfizer Covid-19 vaccines.  Caller received 4 vaccines total. Product strength and count size dispensed: Not provided, Additional lot numbers: Unknown, Is a sample of the product available to be returned, if requested (Y/N): Not provided, Packaging sealed and intact? Not provided. Product complaint 2, Description of complaint: Consumer said Paxlovid tasted really weird. Product strength and count size dispensed: ritonavir 100 mg; nirmatrelvir 150mg; count 30 Additional lot numbers: Unknown. Is a sample of the product available to be returned, if requested (Y/N): Not provided Packaging sealed and intact: Yes. Product complaint 3, Description of complaint: Consumer had to use magnifying glass to read Paxlovid packaging information. Product strength and count size dispensed: ritonavir 100 mg; nirmatrelvir 150mg; count 30, Additional lot numbers: Unknown. Is a sample of the product available to be returned, if requested (Y/N): Not provided. Packaging sealed and intact; Yes The information on the batch/lot number for [BNT162B2], has been requested and will be submitted if and when received.